Ethics and Law in Biological Research (Nijhoff Law Specials, 52.)

ETHICS AND LAW IN BIOLOGICAL RESEARCH

NIJHOFF LAW SPECIALS VOLUME 52

The titles published in this series are listed at the end of this volume

Ethics and Law in Biological Research

Edited by

Cosimo Marco Mazzoni

MARTINUS NIJHOFF PUBLISHERS THE HAGUE/LONDON/NEW YORK

Published by: Kluwer Law International P.O. Box 85889, 2508 CN The Hague, The Netherlands [email protected] http://www.kluwerlaw.com Sold and Distributed in North, Central and South America by: Kluwer Law International 101 Philip Drive, Norwell, MA 02061, USA [email protected] Sold and Distributed in all other countries by: Kluwer Law International Distribution Centre, P.O. Box 322, 3300 AH Dordrecht, The Netherlands

Library of Congress Cataloging-in-Publication Data is available.

Printed on acid-free paper. ISBN 90-411-1742-3 © 2002 Kluwer Law International Kluwer Law International incorporates the imprint Martinus Nijhoff Publishers. This publication is protected by international copyright law. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior permission of the publisher. Printed and bound in Great Britain by Antony Rowe Limited.

Table of Contents

Foreword

ix

THE LIMITS OF SCIENCE AND BIOLOGICAL INVESTIGATION Ethics and Law in Biological Research Cosimo Marco Mazzoni

3

Human Genome Technology from the Viewpoint of Efficiency and Justice Peter Koller

9

The Human Genome Project and the Geneticists' Responsibility Alberto Piazza

21

Human Dignity as a Regulative Instrument for Human Genome Research Jurgen Simon

35

Bioethical Anxieties Concerning the Limits of Biological Research Mauro Barni

47

The Perception of Possible Knowledge and Changes in Common Morality Carlo Flamigni

57

Information and Decision Eligio Resta

67

Biomedical Law: The Aims and Limits of Regulating Biomedical Science and Technology Amos Shapiro

75

vi

Table of Contents The Epistemic State - The Legal Regulation of Science Mariachiara Tallacchini

79

II. CLONING: BIOLOGICAL AND MORAL ASPECTS Some Fundamental Evils in Generating Human Embryos by Cloning John Finnis

99

Thinking About Huxley's Brave New World: Was it Wrong to Create a Genetic Hierarchical Society? Is it Wrong to Prevent One? Bernard Gert

107

From Random Procreation to Standardized Reproduction Jacques Testart

115

The Problem of Reproductive Cloning Francesco D. Busnelli

125

The Point of View of a Medical Geneticist on Human Cloning Bruno Dallapiccola

135

The Mystery of the Scantiness of Arguments Against Cloning Luigi Lombardi Vallauri

141

Making the Right Use of Law: The Cloning Dilemma Stefano Rodota

153

The Right to Genetic Disobedience: The Iceland Case Amedeo Santosuosso

163

Medicine as Science and Art: Anxieties at the Dawn of the Third Millenium Paolo T. Scarpelli

173

Clones and Golems Carmel Shalev

187

III. CLONING IN POPULAR IMAGINATION Doppelganger Temptations Adriana Cavarero

195

Table of Contents

vii

After Dolly: New Forms of Genetics Capital Sarah Franklin

203

Cloning and Balanced Ethics John Harris

207

The Future of Clones Mario Jori

213

Cloning: Taboo Subject for Public Debate in France Dominique Mehl

227

Nude Pigs and Headless Clones James Reston, Jr.

233

Dolly and deja vu: Facts and Fiction about Human Cloning Jon Turney

241

Index

253

This page intentionally left blank

Foreword

A debate on the contents and limits of biological research calls for a few preliminary considerations. Scientific research in general - and more specifically research in the field of biotechnologies - has become the protagonist of discoveries that exert a formidable impact on public opinion. And popular opinion is every day challenged by the media, so that it becomes not only a spectator and a witness of these developments, but is also to a certain extent forced to become a judge or arbiter of those cases that human and animal genetics have been investigating over the last decades. The man-on-the-street is thus confronted by moral positions ranging from cautious approval, to wait-and-see attitudes, to unconditional condemnation. One need only think of the issue of human cloning, whether for reproductive or for experimental purposes, which is so often presented to public opinion in such a way that encourages (or even expects) the man-in-the-street to pass judgment and formulate an ethical evaluation. Ordinary men and women, possessed with an average cultural background and a normal ethical sensitivity, are thus asked practically every day to give an ethical judgment on the quality of a scientific result, even before they are given the elementary scientific notions on which that judgment should be based. Scientific forecasts are frequently uncertain as to their aims, and scientists are involved in the ethical evaluation of the results of their own research. Yet, the results of scientific pursuits are capable of producing immediate effects on the daily life of every human being. Consequently, the need and the right to contribute, alongside scientists, to an accurate assessment of the effects of science on society is something that is widely - and strongly - felt. The issue of cloning is widely addressed in this book which is a collection of essays reflecting a considerable range of different cultural experiences and different ethical underpinnings. Cloning, more than other biological discoveries, is the most accessible and most readily perceived point of convergence from which ethical judgments on the current developments of scientific investigations can be proposed or formulated. Cloning is also the "paradox" on which the confrontation between scientific research and popular imagination is focused. IX

x

Foreword

The authors of the essays in this book took part in an unusual and stimulating Meeting between scholars from different countries and with different cultural backgrounds, held at the European University Institute, at San Domenico di Fiesole, near Florence, on 27-28 November 1999. The essays are based on the papers and discussions at that Meeting. Mariachiara Tallacchini and I jointly worked at the organization of the Meeting, sharing the original idea, drawing up the preparatory documents, selecting speakers and planning the work sessions. I am especially grateful to her for her collaboration. Fiesole, October 2001

Cosimo Marco Mazzoni

I. The Limits of Science and Biological Investigation

This page intentionally left blank

Ethics and Law in Biological Research Cosimo Marco Mazzoni

1. THE TECHNOSCIENCE DEBATE AND LEGAL ANALYSIS I will say here just a few words regarding the purpose of this collection of essays, or, at least, the purpose that was in the mind of the person who first suggested the topics to be discussed. Why I would have thought the topics to be important should be fairly obvious. Any contemporary exchange of ideas on scientific research and the limits that might be imposed on biological science cannot avoid dealing with issues of the sort addressed here - issues that currently loom large in the public imagination. What we have tried to do in these essays is to bring to bear on these issues the views of scholars from highly varied backgrounds: e.g., genetics, gynaecology, law, sociology, psychology, moral philosophy and literature. In these pages, we will find experimental scientists and scholars in fields such as the cognitive and social sciences attempting to engage in dialogue with each other as to what should be the appropriate aims of biological research. Although the choice of topics was easy, the implementation of the exchange of views was quite challenging for all involved. The speakers had to address each other across divisions between disciplines, and they frequently had to do so speaking different national languages. Moreover, the ultimate goal of the exchange was more than mere communication. As the title of this collection of essays suggests, the goal was to search for a common path toward a shared ethical underpinning for biological research. For this to happen, professionals from differing disciplinary backgrounds will be required to travel together along the same path, even though it may be a path unfamiliar to all of them. Scientists have only rarely established communication and dialogue with positive jurists or sociologists - although they may have had more frequent interchange with moral philosophers. Europe is only now beginning to catch up with the United States as regards encouraging a continuing interface between science and law. In this new relationship, science will no longer be able to stand apart as something separate from other disciplines. On those rare occasions in the

CM. Mazzoni (ed), Ethics and Law in Biological Research, 3-7 © 2002 Kluwer Law International. Printed in Great Britain.

4

Mazzoni

past when experimental science has ventured out of the laboratory, it has invited analysis of the value implications of its work only from philosophy. The social sciences and, especially, law have until now been left out of the picture. Yet never, before now, has experimental science been such an important part of our everyday life. Its advances are increasingly broadly divulged to the public. The man in the street now considers himself as having the capacity (and the right) to make judgments about the appropriateness of research that can have an enormous impact on his society. Today, as never before, experimental science needs to become the object of what jurists call "social control." I will thus speak, from the point of view of a jurist, on the subject of the collapse of the boundary that has, until now, prevented dialogue and exchange between technoscience and legal analysis. On a more general level, I want to recognize the common ground that the social sciences and the laboratory sciences have come to share - apparently almost by chance. Some time ago, experimental science broke out of the laboratory into the market place, creating enormous benefits to both the market and the laboratory. The commercial world was quick to understand the profit potential of modern technoscience. But, science applied to industry and, then, to the market place in recent decades had to be brought under governmental regulation. And such regulation gave rise to the very familiar debate over the tension between "freedom of research," on the hand, and protection of society, on the other. Today we are witnessing an entirely different sort of dialogue. Biological research and studies in human genetics are now coming up against a new source of criticism, a hitherto unsuspected referee - the man in the street. It appears that "the man on the Clapham omnibus" is bidding to become the arbiter of what decisions may be made in the field of biology. Mass media and scientific journalism seem to have become capable of making previously inaccessible information about disconcerting biological advances immediately comprehensible to the public. After all, what is it that is difficult to understand about the cloning of Dolly the sheep? Several North American scholars have suggested that this path toward full public comprehension of the advances that are being made in the biologic sciences (they were speaking principally of technological advances in human genetics) will eventually lead to democratic participation in the process of deciding which goals science should pursue. They have predicted that the day will come when forms of social control over scientific options will be a matter of public choices. The scenario that everyone seems to be calling for is one in which the science of the experts and the science of the general public will no longer be divided and kept separate.

Ethics and Law in Biological Research

5

The debate on cloning, in particular, is one in which the public is no longer willing to delegate decision-making to bodies of experts. The man in the street, as he is educated in science by the mass media, becomes increasingly suspicious of committees of jurists, philosophers, and other experts who seek to regulate biological research by law. The work of such experts seems to them a subterfuge, the aim of which is to establish rules of compromise for governing a conflict between separate spheres of science and society.

2. CLONING AS A PARADOX AND A METAPHOR From among the many meanings given to the word "cloning," at least since the birth of Dolly, I should like to offer two perspectives from my position as a jurist.

(a) Cloning as a Paradox The uniqueness of each life form has now come into question. Each living being is now both unique and not unique. The unrepeatability of life is today challenged by the fact that life has been repeated - at least mechanically in biological laboratories. By means of genetic modification procedures, man is today capable of reproducing life artificially, of giving life to animal entities. Previously, scientists were able to do this with plant life. The final stage of this development will be human cloning. Several developments in the recent past have given premonitions of this new power to control life. We have witnessed how - thanks to technological advances in life-support - it has become possible to postpone the moment of death. Death is no longer a natural event that concludes life. The ancient methods for detecting death, that were still in use less than thirty years ago, were based upon breath no longer infusing life and a heart ceasing to beat. Breathing and heartbeat were the very symbols of life. Man from his earliest times knew that life could be taken away. He considered the possibility of ending another man's life, or even his own, to be among his powers, even among his prerogatives. Today, he can also suspend, postpone, or prolong death, with life being artificially continued in an unnatural and forced manner. More or less contemporaneous with these developments have been those in the field of reproduction. Fertilization of animal ova is now achieved by techniques that only a few years ago would have been considered pure

6

Mazzoni

fantasy. These techniques have now produced something totally revolutionary: life can be created outside the natural realm. Man's scientific advances have given him the tools to intervene not only at the end of life, but also at the beginning. Today, cloning presents us with a paradox regarding the uniqueness of life. The gift of life is no longer associated with mythic origins in which it is solely the fruit of the mother's womb. Mother earth is no longer the only one who fertilizes and grants life. Women are no longer the archetype givers of life of Greek mythology and Christian tradition. Life has entered the age of technical reproduction. With the birth of Dolly, we can now say of the uniqueness of life what Walter Benjamin said of the uniqueness of a work of art (Schriften, Suhrkamp, Frankfurt am Main 1955).

(b) Cloning as a Metaphor The awesome scientific power that cloning represents to the public has made it a metaphor for the tension felt by the man in the street over his relationship with modern science. Cloning has become a prominent focus of the many questions raised in the minds of those outside the biology laboratories regarding the social, ethical, legal, psychological, and emotional consequences of research in the life sciences: What will be the effects of such research in nature and on human consciousness? What effects shall we hope for? What effects do we fear? Today, Dolly is an icon of what might be called the major Cult Mystery of our age: biotechnology. Despite the definitely non-spiritual nature of her immaculate conception, Dolly is surrounded by a supernatural aura. A sheep - the epitome of a being lacking individuality, has been raised to a protagonist on the world scene by the genius of modern science. Moreover, once Dolly comes to the end of her 12 or 13 years of earthly life, she has been guaranteed immortality. The services of the embalmer at the Edinburgh Museum have already been booked for this purpose. The only heresy in this religious picture is that Dolly is all-too-similar to us, since all living creatures share the same essential biological make-up. Dolly's existence underscores the undeniable dogma demonstrated by science more than a half-century ago that we are all made up of a handful of DNA. Today's biotechnology forces us to realize even more fully the dreadful paradox that haunted our ancestors, that inspired the first texts on life, and that created the myths and sacred scriptures through which man attempted to reconcile the fact that he is - at one and the same time - part of nature and totally separate from it. Dolly reminds us that we received the gift (or

Ethics and Law in Biological Research

1

perhaps we should call it the curse) of being able to study all other living things, to categorize them, to take them to pasture, and now even to fashion them according to our needs.

3. BIOLOGICAL RESEARCH AND THE ROLE OF THE JURIST In the context of the challenges presented by technoscience to society, the jurist may be able to play a crucial role. Whenever a jurist deals with a societal problem, he must do so by means of the establishment of a rule the statement of a law. In the process of establishing one rule, other rules will be excluded - perhaps all other rules. The function of the law lies precisely in this: to establish limitations if not precise prohibitions. I refer here to the role that law is being called upon to play regarding the relationship between experimental science and society. The interface of law and scientific research is still largely uncharted territory. But it holds the potential for regulating the behaviour of scientists without necessarily commenting upon the worth of their values. In regulating behaviour, the law will at best exert the function of a guarantor. At worst, it will be no more than a restricting force. Scientists speak frequently of the notion of the "autonomy of scientific research" in order to stress their devotion to the free pursuit of knowledge. But, in law, the notion of "autonomy" means "freedom within pre-established boundaries" - within circumscribed and pre-determined spheres of action. The definition and establishment of rules regulating scientific research thus acquires a special juridical meaning that contrasts with any notions of "freedom of science" implying complete freedom from rules imposing limits. Contemporary legal systems are now confronted with the challenge of appropriately regulating scientific practice and the product of those practices. In doing so, legal systems must break free of the Manichean alternatives that too often mark discussion of the issues in this field. A path must be marked between the stark choices of approving human cloning, on the one hand, and imposing a blanket moratorium, on the other. Although individual national governments may still be incapable of expressing a single, consistent viewpoint in the making of legislative policy, they must work to promote a broader and more articulated relationship between science and the law. In this process, the jurist has the capacity to play an important role. Professor of Law, University of Siena, Italy

This page intentionally left blank

Human Genome Technology from the Viewpoint of Efficiency and Justice Peter Koller

My paper aims at providing an assessment of human genome research and technology from the viewpoint of social efficiency and social justice. I want to do this in two steps. First of all, I shall try to clarify the general demands of social efficiency and justice. In the second section, I make an attempt to apply these general demands to human genome research and technology by regarding its various ways of application, such as genetic testing, somatic cell gene therapy, germ-line gene intervention, and cloning human beings.

I. THE REQUIREMENTS OF SOCIAL EFFICIENCY AND JUSTICE Efficiency and justice are the main standards of political justification on the basis of which we evaluate social relationships and social orders. When we regard social relationships or orders in view of their efficiency, we ask whether or not they are generally expedient or advantageous under current social conditions and with respect to the actual preferences of the individuals concerned. In contrast, when we raise the question of social justice we are asking whether or not social relationships and orders are generally acceptable from a moral point of view, i.e. an impartial perspective requiring an equal consideration of the fundamental interests of all people concerned. Since both efficiency and justice are not only highly vague, but also strongly contested, I would like to begin my considerations with some remarks on my understanding of these ideas and their normative requirements. Social efficiency, taken generally, means that social states of affairs are the better the greater their utility to the people concerned. This general formulation, however, is very vague, and requires a more precise interpretation. The most promising candidates for such an interpretation are the Pareto-principle and the Kaldor-Hicks-principle (Buchanan 1985, 4 ff; Hardin 1993).

CM. Mazzoni (ed), Ethics and Law in Biological Research, 9-20 © 2002 Kluwer Law International. Printed in Great Britain.

10

Roller

The Pareto-principle states that a social state of affairs x ought to be regarded as socially preferable to a state y, if in x, compared with y, at least one of the parties concerned is better off, and none is worse off. Consequently, a state of affairs is optimal, if it cannot be changed in such a way that at least one party would gain and nobody would loose. At first glance, this principle seems to be pretty plausible. First, it is very easy to handle, since it does not require any interpersonal comparison of utility; and secondly, it appears acceptable from the viewpoint of individual selfinterest. Yet, the Pareto-principle is of limited use, since it applies to cases only where one of the states of affairs in question is preferred by at least one of the parties concerned without diminishing the utility of others. So it cannot be applied to social states of affairs each of which is better for some parties, but worse for others. On the basis of the Pareto-principle, all these states are incomparable. Consequently, the principle does not lead very far, since it only works when the interests of the parties concerned are, by and large, in harmony, while it fails when these interests are in conflict. The KaldorHicks-principle is an attempt to cope with this failure. According to the Kaldor-Hicks-principle, a social state of affairs x is socially preferable to a state y, if x, compared with y, benefits at least some of the parties to such an extent that these parties could compensate the losers so that, at the end, nobody would be worse off. To be sure, this principle does not demand that the winners actually render compensation to the losers, but it only demands that such a compensation would be possible. Due to this fact, it can also be used for an evaluation of social changes where there are both winners and losers. Although the KaldorHicks-principle does also allow different efficient outcomes, it limits the range of these outcomes much more than the Pareto-principle. Yet, the Kaldor-Hicks-principle raises the question why we should accept it, when we take into consideration the fact that we could belong to the losers. In my view, the most convincing argument for a mere hypothetical compensation rather than an actual one runs as follows: If the winners were actually obliged to compensate the losers, they would have to pay not only the required compensations themselves, but also the transaction costs which would be caused by any compensation system. Since there are strong reasons to assume that these costs are not insignificant, many social changes which would bring important gains to the parties involved without the need of actual compensation could not occur. Even if it would certainly not be rational to accept a social change ex post when one already knows that one belongs to its losers, it seems rational to allow such changes ex ante, when one can expect that one would take benefit of the gains emerging

Human Genome Technology

11

from them (Coleman 1988, 115ff). In my opinion, this argument makes the Kaldor-Hicks-principle highly plausible, if the following condition is met: the additional gains which can be realized through changes to more efficient states of affairs without real compensation must be to the benefit of all parties concerned in the long run, though not in any particular case. Otherwise the individuals concerned would have no reason to take the risk of the possible losses of those changes. I think that this qualified interpretation of the Kaldor-Hicks-criterion provides us with an acceptable requirement of efficiency. Accordingly, a social change is efficient if it brings forth an increase of social value or widely desired goods and benefits, provided that this increase is to the benefit of every member of society in the long run. Since this requirement, as all criteria of social efficiency, refers to the status quo and the actual preferences of individuals, it may lead to results that are arbitrary from the moral point of view. Thus, a comprehensive evaluation of social affairs needs also moral standards which dominate efficiency and limit its application. The moral standards that apply to a social order as a whole are those of social justice. Social justice may be understood as the totality of those demands of justice which apply to the fundamental institutional order of a society as a whole, its essential rules, institutions, and affairs. This totality includes the following demands which refer to different aspects of a social order: (1) the demand of distributive justice that applies to a social order insofar as this order governs the distribution of social goods and burdens, i.e. the goods and burdens which are common to all members of the society since they either belong to their common heritage or arise from their coexistence; (2) the demand of transactional justice which binds a social order to the extent in which the social allocation of goods and burdens is carried out through voluntary transactions such as private contracts; (3) the demand of political justice which determines the use of power and authority in order to guarantee a peaceful and generally advantageous social order; and (4) the demand of corrective justice that regulates the correction of wrongdoings and injustices that may occur in social life, whether that correction may require compensation or punishment (Frankena 1962; Koller 1997, 295 ff). Among these demands of social justice, distributive justice plays a special role, since it determines the just initial distribution of rights and duties that ought to be assigned to the individuals when they get involved in private transactions, authority relationships, and interactions based on injustices. So distributive justice defines the initial conditions of the operation of all other demands of justice, and, therefore, has priority over them. This may be the reason why most disputes on social justice refer to the question of distributive justice, and why just these questions are so controversial.

12

Koller

Despite these controversies, however, in most societies there is a basic agreement on some fundamental, though rather vague and abstract, principles of social justice. This is also true of our modern, highly differentiated Western societies. Amongst the principles widely shared in these societies is a very fundamental principle of distributive justice which immediately follows from the idea that all human beings are of equal worth and have a claim to equal respect. This principle - I call it the principle of social equality - demands that all members of a society are to be treated equally and, therefore, ought to have an equal share of the common goods and burdens of their social coexistence, unless an unequal treatment or an unequal distribution seems to be justified by generally acceptable reasons (Hobhouse 1922; Rawls 1971; Miller 1976). This principle, taken alone, does not demand a particular distribution of anything, but only requires an acceptable justification for any unequal distribution of all those goods and burdens which belong to the common stock of all members of society. What this principle does require, in detail, depends essentially on two further premises: first of all, what objects ought to be taken as common goods and burdens that are subject to social distributive justice, and secondly, what reasons are to be thought as appropriate to justify social inequalities, i.e. an unequal distribution of those goods and burdens. As to the objects of distributive justice, I assume - in approximate accordance with Rawls and without further justification - that, in modern societies, they include at least the following five kinds of goods which, on the level of social order, take the form of individual rights that are to be connected with corresponding duties: (1) the general rights of the members of society, (2) their individual liberties, (3) their rights to political participation, (4) the social positions and opportunities, and (5) the economic resources of society. All those things are fundamental social goods which are distributed by the social order, and, therefore, are subject to distributive justice, the basic principle of which requires their equal distribution, unless social inequalities seem to be justifiable by generally acceptable reasons (Rawls 1971; Koller 1994). This leads to the question as to whether and to what extent social inequalities may be justified by convincing reasons. It seems obvious to me that, if there are such reasons, they must show that a social order which allows such inequalities to a certain degree serves the well-considered interests of all members of society better than a more equal social order. And this will only then be the case, if everybody, irrespective of his or her social position, can expect that he or she will fare better in this order than in any other social order allowing less inequalities. As a consequence, social

Human Genome Technology

13

inequalities are justified to the extent to which they are necessarily connected to a social order which, compared with alternative social orders without these inequalities, are in the long run to the benefit of any of its members. As a result, the basic idea of social distributive justice consists in linking the principle of efficiency with a further requirement, namely the moral requirement that any justification of social inequalities must start from a hypothetical state of social equality with reference to which it has to be shown that a social order allowing these inequalities is to the benefit of each of its members. Furthermore, the fact that the preferences of the individuals are mutually interdependent rather than independent suggests a substantial qualification of the extent of those social inequalities. For, if it is true that individuals value an absolute increase of goods less the greater the gains of their fellows, then it is reasonable to demand that social inequalities must be to the greatest benefit of those who take the least advantanged positions within the social order. And this leads to a principle of social distributive justice that, by and large, amounts to Rawls's difference principle. This principle demands that social inequalities are justified only to the extent to which they are necessarily connected to a social order that, compared with an order without these inequalities, is to the benefit of each of its members, in such a way that the least advantaged members take the greatest benefit. In my opinion, this is the principle of distributive social justice to which any justification of social inequalities must accord (Rawls 1971, 75 ff). When this principle is applied to the fundamental social goods previously mentioned, it is possible to justify five demands of social justice, namely (1) legal equality, (2) civil liberty, (3) democratic participation, (4) equal opportunity, and (5) economic justice. In contrast to Rawls's principles of justice, these demands are not in a strict lexicographical order, but in a relationship of interdependence which requires balancing them. The first three demands, however, do not allow any unequal treatment of individuals, because, in general, there are no acceptable reasons justifying inequalities of general legal rights, civil liberties, and political rights. Matters are different in regard to social positions and economic resources, which are the object of the two latter demands. Since, in the present context, I am interested only in economic inequalities that may result from social changes induced by technological innovations, I shall restrict myself to the last demand, namely economic justice. To what extent economic resources are social goods depends, in my opinion, on the development of the economic system, i.e. the degree of the

14

Koller

social division of labor and the mutual interconnection of economic activities. In a primitive society that consists of a great variety of independent and self-sufficient small units, each of which takes care of its own subsistence, the problem of distributive justice is constrained to the distribution of land and natural resources, but it does not concern the products of the units, because these products result from their independent economic activities rather than from their cooperation. The situation changes, however, when the economic system is characterized by a high degree of division of labor and significant interdependence of the economic activities of individuals. For in this case, society takes the form of a common enterprise of economic collaboration requiring a well-coordinated interplay between all members, an interplay which binds them together very closely and makes them dependent from each other. And this fact suggests that, at least in our advanced and highly differentiated societies, economic resources also ought to be understood as social goods that are subject to distributive justice. As a result, economic inequalities are to be regarded as justified only to the extent to which they are to the benefit of all members of society, particularly those who take the worst positions.

II. ASSESSING HUMAN GENOME RESEARCH AND TECHNOLOGY In principle, one can distinguish between human genome research as a scientific project, the most spectacular part of which is the encoding of the whole human DNA on the one hand, and the various technical applications of this research on the other, even though it is certainly true that both fields are closely interconnected. As far as human genome research as such is concerned, there is a widely shared agreement among experts that, according to the present state of knowledge and contrary to previous fears, it does not cause significant dangers and risks for the life and health of human individuals. Rather, most experts are convinced that this research will provide an enormous overall benefit not only to those societies who advance it but also for humankind as a whole, because it does not only grant an eminent growth of knowledge about the biological basis of human nature, but also creates fantastic opportunities to use this knowledge for the good of human individuals, particularly by preventing, curing and easing genetic maladies and defects (Bishop and Waldholz 1990; Shapiro 1991). Although I think that this expectation is pretty naive when one considers the real forces and interests which determine the course of scientific development, I assume in accordance with the prevailing opinion of experts that

Human Genome Technology

15

human genome research as such creates, in the long run, more advantages than damage to humankind and, therefore, meets the requirements of social efficiency and justice as well. There is a great variety of technical applications of human genetics the most important of which lie in the area of medicine (Gert 1996). Some of these applications are already employed with more or less success, many others will likely become possible in a not too distant future. The most promising technologies of applied genetics in human medicine are the following: (1) genetic testing, i.e. testing cells of human embryos or born human individuals, a method which makes possible the early diagnosis of genetic defects or maladies, but also the identification of normal genetic properties; (2) somatic cell gene therapy which aims at curing individuals of genetic defects by transferring normal alien genes to their somatic cells, a method which does not modify the genetic endowment of the individuals concerned; (3) germ-line gene intervention that consists in a genetic transformation of human eggs, sperm or embryo cells through transplanting alien genes in their germ-line cells so that their transformed genetic endowment will be passed on to their offspring; and (4) cloning human beings, the production of genetically identical copies of human individuals (or parts of them) which can be achieved either by embryo-splitting or by a genome transfer, i.e. a transfer of egg-cells of those individuals to alien core-cells. I shall try to evaluate these methods in regard to their efficiency and justice. As to genetic testing, we all know that, at the time being, there already exist a number of genetic tests that make possible an early diagnosis of various genetic maladies and properties at reasonable costs. And experts tell us that the ongoing development in genome research will lead to a multiplication of such tests which, due to their decreasing costs, will be available to a growing number of people. It is pretty obvious that this technology can bring significant benefit not only to many individuals but also to society in general. Testing human embryos, their screening, enables us to find out whether or not they suffer from certain genetic defects and take approprate steps to avoid an offspring with such defects. Furthermore, genetic testing can be also applied to born individuals and, if it turns out that they suffer from certain genetic maladies and risks, help them to take appropriate measures in order to prevent or minimize these maladies or risks. So this technology, if it is widely used in a population, can contribute significantly to decreasing the occurrence of hereditary defects within this population. On the other hand, however, genetic testing also involves various dangers and negative effects. First of all, there is the psychological harm of those individuals who learn that they have serious hereditary defects so that they

16

Koller

must expect with certainty or high probability that they will fall victim to them in the course of their life or that they have passed them on to their children. And one can suppose that this harm will be the greater the less means are available to cure or alleviate the genetic maladies or risks under consideration. Moreover, the availability of knowledge of the individuals' genetic dispositions will unavoidably create a significant danger that persons with a higher risk of getting sick will, in addition to their bad luck, be subject to social discrimination in the labor market, in private social relationship, and in market-governed systems of life and health insurance. Last but not least, since genetic screening facilitates not only the diagnosis of hereditary defects of human embryos, but also of their normal genetic properties, it will encourage potential parents who can afford such testing to tailor their offspring according to their personal desires (Shapiro 1991; Silver 1999). It is highly plausible that these effects of genetic testing will lead to a significant increase of the existing - certainly not entirely just - social inequalities, unless appropriate measure are taken to prevent them. One can expect that, since the growing knowledge of individual genetic properties will encourage new forms of social discrimination, and also because the access to genetic testing will, at least to a certain degree, always depend on the financial capacities of people, even if the tests for an early diagnosis of the most serious genetic maladies were made accessible to all by the public health system. What are the consequences of these results from the viewpoint of efficiency and justice? The psychological harm that may result from genetic testing is a price which has to be paid necessarily for the use of this technology, but it neither nullifies its general utility, nor makes it unjust, provided that it is made accessible to all people. More serious problems, however, flow from the other effects mentioned above. The danger of social discrimination against individuals with genetic defects or risks requires appropriate measures in order to protect these people effectively against discriminatory treatment. This task can certainly not be sufficiently met by legal regulations of the use of genetic knowledge, e.g. by prohibiting its use in certain spheres or establishing an individual right to informational self-determination (Cohen 1999). Rather, I think that an effective protection of those people can be achieved only by far-reaching measures of economic redistribution, such as granting them an appropriate level of health care irrespective of their income on the one hand, and providing them with a sufficient basic income on the other. Even stronger measures may be required in order to counteract the danger of growing social inequalities resulting from the opportunity to tailor the genetic properties of descendants at scale. I suppose that the only

Human Genome Technology

17

effective measure to prevent this danger is a strict prohibition of all genetic tests that are not directed at the diagnosis of serious genetic maladies and risks. I turn now to those methods which usually are called 'gene therapy', although they go far beyond therapy. In general, there are two methods of active intervention in the human genome both of which can be used not only for therapeutic treatment, but also for 'genetic enhancement', namely the attempt to improve the genetic endowment of human individuals: somatic cell gene therapy on the one hand and germ-line gene intervention on the other. Although, to my knowledge, both methods are still rather insecure and expensive at the time being, experts believe that they can and will be improved rapidly and used for the treatment of many genetic maladies very soon, if their further development is not obstructed by rigid legal restrictions. Both methods are welcomed by many people who are suffering from or threatened by maladies or risks with presumed genetic causes, such as breast cancer. Nevertheless, one must not forget that they also involve significant problems that may diminish their desirability or admissibility. In this respect, however, there are important differences between them. A somatic cell gene therapy which is directed at repairing defective cells of an individual by a transfer of alien genetic material does not differ essentially from traditional methods of treatment in medicine, provided that it meets the usual standards of treatment. One can suppose that, under this provision, somatic cell gene therapy fulfills the demands of efficiency, since its availability seems to be generally preferable to its absence, if one can expect to take benefit from it when one needs it. Much more difficult is the task to meet the demands of social justice, since this requires making somatic cell gene therapy equally available to all people according to their needs, unless an unequal treatment of individuals is justified for acceptable reasons. Such reasons are, for instance, the severeness of a genetic malady, the probable success of a therapy, the costs of treatment, the age of the individuals concerned, and so on, but certainly not the economic capabilities of people, particularly not if they suffer from genetic maladies or risks that affect their health or social opportunities negatively. This does not mean that somatic cell gene therapies are inadmissible as such, but it means that they must be made accessible to all people who need them rather than being a privilege of wealthy people. The situation is completely different in the case of germ-line gene intervention which consists in a genetic modification of the germ-line cells of human embryos. There are strong arguments to suppose that this method of genetic engineering is inadmissible as such, because it seems to be in conflict with

18

Koller

efficiency and justice as well. Germ-line gene intervention is, at least at the time being, not efficient, since it causes significant risks to the treated beings and enormous costs, while its targets can also be achieved by more harmless and less expensive methods, namely by genetic screening combined with singling out genetically defective human embryos (Gert 1996, 219 ff; Gert 1999). In addition, germ-line gene intervention is also incompatible with social justice, mainly for two reasons: first of all, even if this technology were an acceptable therapeutic method, its costs are and probably will remain much too high to make it available to all people according to their needs; and secondly, its legal admission would create an irresistible temptation to many wealthy people to use it for tailoring the genetic endowment of their offspring at scale. Both reasons suggest that germ-line gene intervention would lead to an increasing emergence of unjust social inequalities in the long run. Finally, I would like to say a few words about cloning human beings, the production of genetically identical human individuals by transferring their genome to an alien egg-cell. Since this method has already been successfully carried out with animals, one can expect that it would also be possible with humans without particular technical problems. Moreover, there are experts who think that, in a not too distant future, it will also be possible to create clones of parts of humans, e.g. bodies without a brain, which might function as transplant banks. As far as the cloning of whole human individuals is concerned, I think that prohibiting this technology is fully justified from the viewpoint of efficiency and justice. On the one hand, I cannot see that it could have any intelligible benefit, unless we consider the satisfaction of some people's eccentric desire for a duplicate of some persons - as themselves, Albert Einstein or Marilyn Monroe - as such a benefit. On the other hand, cloning whole individuals would cause serious problems, since one can suppose that it would probably be used only by mad people of whom one could not expect that they would be willing to respect the cloned individuals as equal and independent persons. So the availability of this technology would almost unavoidably lead to its misuse. This argument does not work in regard to the scenario that cloning could also be used for the production of genetically identical body parts that could function as a bank of human organs, such as kidneys, hearts and limbs. Since I do not know enough about the prospects of this method, I cannot discuss it seriously. But if it is true, as some experts assert, that it would be technically possible and could be made available to all people at reasonable costs, I don't see strong reasons of efficiency or justice that would make it inadmissible. Intuitively, however, I am strongly inclined to resist it. Perhaps one can raise other objections against this technology, e.g. objections of interpersonal rather than institutional morality.

Human Genome Technology

19

So much about the various technologies of new genetics from the viewpoint of efficiency and justice. However, it would be naive to assume that the real course of history will be determined by our social ideals and moral conceptions rather than manifest social interests and the laws of power which, in our capitalist world, mainly consists in the power of money. As a result, there is little chance that we will succeed in keeping the ongoing technological development within the limits at which they are desirable and permissible according to the requirements of social efficiency and justice, regardless how these limits are set. And this is certainly also true of human genome technology, since it is carried out in a decentralized way by many small firms spread all over the world and strongly demanded by innumerable people on a global market. Consequently, it is very likely that the development of genetic technology follows its own dynamics which can be regulated only marginally by legal restrictions, if it can be regulated at all. And this will lead to the result that the achievements of this technology will mainly serve the rich and wealthy people who will use it in order to strengthen their own and their children's social privileges at the cost of the worse off social groups. In a word, genetic engineering will tend to increase and reinforce the existing social inequalities which are certainly neither efficient nor just. If this assumption is only nearly true, then the regulation of genetic technology by legal prescriptions and prohibitions is certainly not sufficient in order to avoid even the most grave injustices that will result from this technology. Thus, beside such regulation further measures against growing social inequalities will be necessary, particularly two: first, a compensatory redistribution of economic resources from top to bottom, and second, the provision of equal access to the use of genetic technology through the public health system. Professor of Philosophy, University of Graz, Austria

BIBLIOGRAPHY Bishop, Jerry E. and Michael Waldholz (1990): Genome, New York. Buchanan, Allen (1985): Ethics, Efficiency, and the Market, Totowa, N.J. Cohen, Lloyd (1999): "The Human Genome Project and the Economics of Insurance: How Increased Knowledge May Decrease Human Welfare, and What Not To Do About It", Annual Review of Law and Ethics, vol. 7, pp. 219-238. Coleman, Jules L. (1988): Markets, Morals and the Law, Cambridge. Finnis, John (1980): Natural Law and Natural Justice, Oxford. Frankena, William K. (1962): "The Concept of Social Justice", in: Richard B. Brandt (ed.), Social Justice, Englewood Cliffs, N.J., pp. 1-29.

20

Koller

Gert, Bernard et al. (1996): Morality and the New Genetics, Sudbury, Mass. Gert, Bernard (1999): "Morality and Human Genetic Engineering", Annual Review of Law and Ethics, vol. 7, pp. 41-53. Hardin, Russell (1993): "Efficiency", in: Robert E. Goodin and Philip Pettit (eds), A Companion to Contemporary Political Philosophy, Oxford, pp. 462-470. Hobhouse, L.T. (1922): The Elements of Social Justice, London. Koller, Peter (1994): "Soziale Guter und soziale Gerechtigkeit", in: H.J. Koch et al. (eds), Theorien der Gerechtigkeit (ARSP-Beiheft 56), Stuttgart, pp. 79-104. Koller, Peter (1997): Theorie des Rechts, 2nd ed., Wien-Koln-Weimar. Miller, David (1976): Social Justice, Oxford. Rawls, John (1971): A Theory of Justice, Cambridge, Mass. Shapiro, Robert (1991): The Human Blueprint, New York. Silver, Lee M. (1999): "Reprogenetic Technologies and the Forces that Will Drive Their Use", Annual Review of Law and Ethics, vol. 7, pp. 3-12.

The Human Genome Project and the Geneticists' Responsibility Alberto Piazza

1. THE ANALYSIS OF HUMAN GENOME: OBJECTIVES FOR THE FIVE-YEAR PERIOD 1998-2003 By this title, the two major US agencies which granted the Human Genome Project - The National Institute of Health and the Department of Energy announced the ambitious schedule to complete the human genome sequencing by 2003, two years in advance of a previous projection (Collins et al. 1998). Eight main objectives were described. They will be summarised here, even if the effort (supported by Europe as well in a proportion of 30-40%) has already reached its main purpose of sequencing most (95%) of the human genome two years before 2003, in February 2001 (see the two special issues of Nature vol. 409 no. 6822 and Science vol. 291 no. 5507).

Objective no. 1: Sequencing the DNA of human genome Almost complete. In 1998 the genetic and physical maps of the genome were completed at a sufficient resolution (one genetic marker on average every 500,000-700,000 DNA nucleotides, with more than 50,000 mapped STS) to allow to carry on to the following sequencing phase with a frequency error not greater than one nucleotide out of 10,000. The projection of an exponential growth of working capacity was undoubtedly favoured by: (a) the competition between a private US company, Celera Genomics, and the publicly funded International Human Genome Sequencing Consortium; and (b) the policy adopted by the public scientific community working at the project to make the results immediately and freely accessible via internet. In fact, it was agreed that each "assembled" sequencing, even partial, longer than 1 kb should be released into a database accessible to the public within 24 hours of its generation.

21 C.M. Mazzoni (ed), Ethics and Law in Biological Research, 21-34 © 2002 Kluwer Law International. Printed in Great Britain.

22

Piazza Objective no. 2: Faster and more economical sequencing technology

The quantity of sequencings produced each year is growing at an exponential speed. From a 1998 rate of about 90 Mb at an approximate cost of $0.50 per nucleotide, the present development of innovative systems for automation, miniaturisation and robotics reduces the analysis of 500 Mb per year at a cost of about $0.25 per nucleotide.

Objective no. 3: Analysis ofgenomic variability Genomes are different from one another and this diversity is at the basis of the biological process of evolution. The most common variation is that where a DNA nucleotide changes into another nucleotide. These variations, which have an average frequency of about 1 every 1000 nucleotides in the human genome, are called Single Nucleotide Polymorphisms (SNP). A study of types, frequency and distributions of these polymorphisms, both at individual and population levels, is particularly important for the study of human evolution, and of diseases whose origin or predisposition are genetically controlled. SNPs are stable, numerous and more or less homogeneously distributed along the genome. As a consequence they lend themselves to be analysed on a large scale and will certainly be precious markers for the study of complex diseases such as cancer, diabetes, cardiovascular and mental diseases, to whose risk several genes contribute, each in reduced measure. Very sophisticated technologies are being developed for a fast large scale identification of SNPs on the whole genome (those publicly available in November 2000 were about 1.42 million, The International SNP Map Working Group 2001). Interestingly enough in April 1999 Nature magazine (15 April, p. 545) published an article announcing that 10 pharmaceutical companies (Astra, Zeneca, Bayerr, Squibb, Roche, Glaxo, Hoechst, Novartis, Pfizer, Searle, Smith, Kline) together with the Sanger Institute in Cambridge (United Kingdom) financed by the Wellcome Trust, had associated to grant a 45 million dollar project for the mapping of the genomic variation associated with the most common diseases. The Wellcome Trust laid down, however, an interesting condition for the realisation of this cooperative project, namely free and unconditional access to the map as it is elaborated, the idea being that with these pre-competitive projects the fast and immediate diffusion of information catalyzes a multiplication of inventions and of technological fall out which will prove much more profitable in the long term than the immediate profit.

The Human Genome Project and the Geneticists' Responsibility

23

Objective no. 4: Functional genomics The knowledge of the gene structure or of its components is a fundamental though not exclusive aspect of the project for sequencing the whole human genome. The following step is to know its function deriving from the interaction between each individual genome and its environment, first in the organism itself under normal conditions, then in contact with other organisms, e.g. those pathogen organisms whose presence is noticed by functional products of our genome to prime a more or less effective response. As a consequence the study of the so called "functional genomics" is a further challenge from the analysis of the human genome. It includes: (a) a comparison between DNA sequences with different structure to deduce directly their function; (b) large scale analyses of messenger DNA coming from various tissues and of expressed proteins; (c) different experimental strategies aiming at stripping genes of their function or producing an altered function in animal models; (d) strategies for the creation of libraries of DNA non-coding sequences but responsible for other functions such as control of genie expression, maintenance of the chromosomic structure, replication, recombination, etc. Unfortunately the technology for cloning full length human cDNA or for the identification of rare transcripts has not yet got beyond the experimental phase. At present the only available full length cDNA bank is that of Saccharomyces cerevisiae with just over 6,200 transcripts making up its genome. This is why this part of the Genome Project will use its resources on the development of these technologies in the coming years. Happily, on the contrary, in the last two years (1996-1998) the possibility of miniaturizing and reading automatically thousands of hybrids in parallel has had a decisive impulse on the technology for the simultaneous and parallel interrogation, with high sensitivity and accuracy of identification, of the expression profile of a complete repertory, in any case a very high number of transcribed genes. The method elaborated by P. Brown and collaborators at Stanford since 1996 (Brown and Botstein 1999) is based on robot assisted microdeposition and on the consequent cDNA chemical immobilization into microarrays on 2 x 2 slides which can contain about 10,000 cDNAs. The probes for the interrogation of these microarrays consist of variously coloured fluorescent cDNAs. The hybridation is read with the fluorescent microscope. The method elaborated by the Affymetrix (Lipshuz et al. 1999), differs from the previous one because the microarrays do not contain cDNA sequences but synthetic oligonucleotides. These microarrays are called DNA-chips because the technology adopted for their construction is based on photolithography, commonly used to design semiconductor microcircuits. The technique for

24

Piazza

"printing" oligonucleotides with a known sequence on a glass support enables one to lay out in a 1.28 x 1.28 cm microarray (chip) up to 400,000 oligonucleotides with a different sequence each 25 nucleotides long. Objective no. 5: Comparative genomics All organisms are connected by a common phylogeny. As a consequence an important part of the project is devoted to the study of genomes of nonhuman organisms; in fact on the one hand it is believed that the comparative study of genomes can produce useful models for the study of universal biological mechanisms and information for the analysis of more complex functions; on the other hand the study of less complex genomes than the human genome could constitute important and illuminating pilot experiments to test the effectiveness of technological innovations on a reduced scale to be later and systematically applied on a larger scale. The sequence of the Drosophila genome has been already completed (2001), while the completion of the murine genome sequence is imminent. Objective no. 6: Bioinformatics The informatic support has been no doubt essential for the development of this project. The sub-objectives the scientific community proposes to the informatics specialists are at least five: (a) improving the contents and usefulness of databases by making their structure more flexible; (b) developing faster algorithms for the generation, interrogation and annotation of sequence data produced in ever increasing quantity; (c) adapting the existing databases to the functional studies (see above); (d) elaborating more "intelligent" algorithms from a statistical point of view to represent, analyse and forecast analogies and differences between sequences; (e) creating support mechanisms promoting strong and flexible operative systems suitable for the production of software that can easily be transferred and extensively shared among users of different laboratories ("user friendly"). Objective no. 7: Education and training The Project has made necessary the training of a new kind of specialists, on the borderland between the strictly scientific disciplines (biology, medicine, mathematics, physics, informatics, engineering to all of which one can

The Human Genome Project and the Geneticists' Responsibility

25

associate the bio- prefix) and the disciplines which are inappropriately called "social" - as they are all "social" - (law, ethics, communication, sociology, etc.) The integration of subjects, therefore languages, with such different backgrounds is not easy. As a consequence a new term, genomics, was created: it includes the need of identifying a complex interdisciplinary competence of skills interlacing different topics, from bioinformatics for which there are few experts at the moment to patent legislation which must be considered on an international basis. The globalisation project towards which the economy of industrialised countries is pushing us, must necessarily affect educational and formative processes beyond their traditional disciplinary bounds. The academic world must restructure its teaching and research programmes: above all it must offer students more incentives to cultivate this new discipline which is being monopolised by few Universities often co-financed by private companies and several small industries; these are often the only immediate source for work for the new "genomicists", though their purpose is obviously profit and not training. Finally one should not forget the problem of how to present this new discipline to public opinion: the social and political impact of information in this field often causes emotional reactions, both because the information is given incorrectly, and because, particularly in Italy, scientific innovation is not yet considered an important factor for economic and cultural investment.

Objective no. 8: Exploration into ethical, legal and social implications Progressive knowledge on human genome will cause an extension and acceleration of genetic research. Thanks to this it will be possible in a more or less near future to extend genetic research to the diagnosis of an increasing number of genetic diseases, and also to the assessment of "genetic predisposition" to polygenic or multifactorial pathologies. Strictly speaking these are not genetic diseases, as they are conditioned by the presence of environmental factors, but they do have a hereditary basis, as they tend to affect subjects with a particular genotype. A typical example of a disease whose onset can be predicted through a genetic test is Huntington's chorea, which has a 1 out of 20,000 frequency in European populations and it shows itself between 30 and 50 years of age with a progressive loss of movement control and neurological (dementia) and psychic (affective disorder) problems until death occurs normally 15 years after the diagnosis, often by suicide. This is a terrible disease because of its late onset and its slow and fatal progression and is caused by the loss of neurons in the brain. It was among the first to be mapped on 4p

26

Piazza

chromosome through a linkage analysis by DNA restriction sites (Gusella et al. 1983). The gene was cloned 10 years later (Huntington's Disease Collaborative Research Group 1993). The DNA sequence showed the presence in affected subjects of repeated (from 36 to more than 100 times) trinucleotide CAG sequences inside the gene: by the number of these "triplets" it is possible to predict exactly if and approximately when the individual will develop the disease.

2. GENETICISTS' RESPONSIBILITY The explosive development of biotechnologies, which finds its perfect expression in the Human Genome Project, has made it urgent to pay careful consideration to the principle of responsibility, a much quoted ethical principle as it seems to characterise the complexity of our time. Like many other ethical principles, the principle of responsibility as well is polyvalent, therefore ambiguous, if it is not clear whom it is to be applied to: ourselves, our children, the surrounding animal and plant world? Responsibility itself cannot be an absolute value because one can propose varying ethical principles which are often incompatible, according to the subjects interested. Besides, how can a necessarily interdisciplinary process of ethical regulation, such as that to which biotechnologies are challenging us, be made compatible with "responsible" choices whose consequences, therefore responsibility control, go beyond the field of competence on which the choices are based? I don't know how productive it could be to attempt to answer these questions in general terms, but I would be happy if somebody could do it in my place. However I would like to contribute to such query for specific solutions in the only way I know, by considering my daily activity as scholar of genetics, the discipline I had the chance of studying and practicing for years. What are the responsibilities of the geneticists? Genetics holds a special place in the spectrum of biologic and medical disciplines: it can be shown by the role geneticists have to play as scientists and professionals, and for the emotional reactions raised by the terms with a "gene" root, often accompanied by the term "ethics" or "bioethics". Facing - as we all are, geneticists and non-geneticists - a world in which widely different and divergent ethical principles coexist, the idea of looking for one single ethics able to answer all ethical questions is too ambitious. Perhaps one should be content with a less ambitious goal: the elaboration, particularly in the medical field, of procedures and institutes ensuring the peaceful cohabitation of a large number of individuals who don't necessarily share the same moral opinions but obey the same laws of a lay and

The Human Genome Project and the Geneticists' Responsibility

27

democratic state. Individuals must be induced to live together without the use of force - which can manifest itself also under the form of moral enforcement - and with a sufficient quality of life, in spite of the diversity of moral and ethical systems of reference. The ability to conciliate different ethical imperatives is particularly exacting for geneticists. Their activity has different aspects with interlacing kinds of competence and responsibilities of different order. It is trivial and possibly misleading to say that all biological disciplines (and a large part of the medical ones) have their most advanced tools in technologies based on gene analysis. It is true, however, that geneticists' activities cover very different aspects. This is why their work is so fascinating and yet full of responsibility. At the risk of being schematic, one could define their figure with three statements. First: research is the root itself of their activity, more so than in other medical disciplines: this is because genetics can predict diseases much more than it can cure them, and its therapeutic capacity, the so-called gene therapy, stands out in perspective where technological innovation still needs very advanced basic research. The second statement presents itself as the negative of the first one: in practical terms the medical application of genetics consists mainly of diagnostic and preventive activity. Its essential tool is information, all the more effective as it is timely: the moment of the so-called "genetic counselling" does not consist in direct medical action on couples asking for counselling, but it must offer at the right time all the options enabling them to choose a reproductive technique suitable to their history and to the history of their genes. The third special characteristic of geneticists studying human genetics consists in asking themselves in what measure and according to which evolutionary paths we are biologically different, how, as a consequence, genetic diseases have evolved, because of which evolutionary mechanism they do not disappear in spite of the contrary action of natural selection and with what tools it is possible to eliminate them. Therefore: genetics and scientific research for diagnosing diseases and, hopefully, cure them someday. Genetics and information for timely prevention. Genetics and evolution to better understand our diversity, from the lessons of the past to the tools for a better planning of the future. This is not the right place for a general analysis of the ethical and social implications of the work, the function and the behaviour of medical geneticists. However we want to illustrate at least one specific though exemplary case of their responsibility, which will arise when they will be able to prescribe routine genetic tests to evaluate the risk of illness caused by "multifactorial" diseases, namely those diseases whose hereditary component has been ascertained not to be exclusive but partial, determined not by

28

Piazza

a single gene but by several different ones: it expresses itself more in the susceptibility to be affected by the pathology than in its higher or lower incidence. One of the reasons why genetics manipulating DNA and relative genetic tests arouse hopes and concern is the recent, though more and more relevant discovery of specific DNA mutations which, if associated with others or with unfavourable environmental factors, predispose to diseases of great social impact (at least in the western world) such as cancer, cardiovascular diseases, the various syndromes of senile dementia. These are frequent and serious diseases, therefore useful tests for their prevention, diagnosis and therapy potentially involve a high number of subjects. Besides, with regard to the non-medical but psychological, sociological and cultural aspects of these diseases, the potential offer of preventive genetic tests will certainly arouse echoes and expectations in public opinion which impose great sense of responsibility. Over the last twenty years many experimental tests have led to the identification of altered human genes (or their products) particularly in tumour cells: out of more than 6,600 hereditary diseases classified in the catalogue Mendelian Inheritance in Man by McKusick et al., at least 340 genetic characters predispose to the onset of cancer as the main expression of the disease or as its complication. In more than 20% of patients affected by cancer one can observe an oncologic history in a first or second degree family relative. 1 to 5% of all cancer cases is associated with syndromes of hereditary nature. Tumour is probably the consequence of the accumulation of mutations occurring in specific genes (DNA segments) coding for the control of proliferation, differentiation and cellular death and/or involved in the mechanisms of DNA repair. At the moment, through genetic tests it is possible to obtain clinically useful information (for an alternative medical decision of proven effectiveness) only in certain syndromes. In a second group of genetic syndromes predisposing to cancer, of which some responsible genes have been identified, genetic tests should only be offered in a context of genetic and clinical research, because the experimentation protocols are not sufficiently defined yet and/or have not shown proven diagnostic effectiveness. In particular one should emphasize the case of BRCA1 and BRCA2 genes associated with familial breast cancer (Ford et al. 1998) for the great social, psychological and welfare impact connected with this form of cancer. In the USA asymptomatic women though positive to the genetic test underwent a total mastectomy of their own free will (to what extent?) as preventive measure. These are exemplary cases of ethical and social responsibility of genetic counselling, as well as of structures and people who practise it.

The Human Genome Project and the Geneticists' Responsibility

29

The reductive attitude of some researchers, often encouraged by considerable financial support by pharmaceutical or insurance companies (in particular in those countries where the health service is private) to examine their fellow men mainly as "gene carriers" is exemplified in certain developments following the recent identification of genetic tests for the prediction of susceptibility to mental diseases, particularly those with a late onset like Alzheimer, nowadays ever more important due to higher life expectancy in western populations. Many genes have been associated to this seriously invalidating disease. Three of them may concur in the diagnosis, being associated with an early onset family form, while one is potentially predictive because one of its mutations is associated with a greater susceptibility of its carrier. The truth is -at the moment - that less than 2% of patients with Alzheimer carry one of the diagnostic mutations: patients who have already been clinically diagnosed get their diagnosis confirmed; the relatives whose test is negative are the only ones to take advantage from it because of their psychological relief; while the relatives with a positive test are in the situation of knowing their future without being able to rely on effective preventive measures and of possible therapies at the onset of the disease, apart from measures capable of delaying somewhat the first symptoms. Predictive genetic tests still give too many false positives and false negatives to be introduced into laboratory routine. The ethical responsibility of those who want to use these tests is further complicated by the fact that patients going to be affected by Alzheimer disease could have lost the capacity to give their consent to the genetic test. Any action decided upon by the genetic counsellor on the basis of the information derived from a genetic test on the affected person could have implications for his relatives. As a consequence, a responsible approach to the elaboration of a decision on behalf of a person affected by dementia should consist in appointing an individual with the function of taking the place of the person giving his consent, but also of including in the decisional process the assent of the other relatives, who could put forward their right not to know the results of the genetic test. The most balanced attitude towards genetic tests, specially if oriented towards the prediction of mental diseases, is to discourage their routine use until their benefit for the patients is clear. However, one should not eliminate them from genetic experimentation because the identification of genes associated with these diseases could result in more effective pharmacological treatments. I would like to close the question of responsibility by confuting a thesis which arose at the time of the hot discussions about Dolly, the famous sheep cloned by Wilmut and collaborators: according to that thesis, cloning could represent a final threat for biodiversity. There is no doubt that the

30

Piazza

cloning technique, if generalized and uncontrolled, tends to create a genetically more homogeneous population. But let us consider facts. First of all we must be aware that any therapeutic measure can become a threat to the genetic diversity of our species: so far we have not tackled the problem of this risk because one can easily work out that its effects are very remote and we have legitimate hopes that our cultural evolution will be able to activate suitable resources for its neutralization. Secondly we observe the following: animal breeding itself, which started systematically at the origin of agriculture in the Neolithic 10,000 years ago, derived from a technological innovation which transformed wild animals into beings useful to man, thus decisively contributing to the progress of our species and not to biodiversity of wild animals. It seems inconsistent and somewhat hypocritical, after more than 10,000 years of more and more refined technologies to get more and more advantages from animals (in food, transport, sports, etc.) to get alarmed if now they are used to produce industrial quantities of molecules useful to man also from a therapeutic point of view, (b) In concrete, one of the practical aims of Wilmut and collaborators by cloning the sheep was to produce industrial quantities of a-1-antitripsine, a useful substance for the treatment of emphysema. If the method is going to be economically favourable, towards whom should the "principle of responsibility" be applied? Towards the cloned sheep because it engenders the biological variability of sheep, or towards our children? Paradoxically, the cloning technology, which must be adopted with precise and well coded purposes also from the point of view of possible suffering for the animals, could be adopted, if economically feasible, for rapid repopulation of ecological areas in danger of extinction. Animals' biodiversity is a wealth our species has the duty to keep. But their cloning, if and when it is adopted, is certainly not an action against them, particularly if its purposes and means are adequately controlled. It is also necessary to be clear on biodiversity. It is known that the biologic variability of domesticated animals (at least those for whom data are available) mainly depends on the cultural complexity of societies where they are bred (Hall and Ruane 1993): in Nigeria for example, where there are as many as 235 different ethnic groups, but the demand for culture and market is scarce, there are 14 million sheep and goats, but only two varieties: one for the sheep and one for the goats (Sumberg and Mack 1985). Nowadays there are more than 3000 varieties of domesticated animals in the world, whose geographical distribution depends both on ecology and above all on the cultural quality of human settlements (Hall 1996): in this practical context it appears that animal cloning, as it is useful to man and as man is able to control it without useless suffering to animals, can be a threat to biodiversity remote enough for us not to have to worry about it now.

The Human Genome Project and the Geneticists' Responsibility

31

At the same time I believe that we must feel ethically responsible for the lack of adequate communication between scientific and "lay" world, including political and cultural institutions and newspapers. Scientific topics are being discussed in Italy, but the feeling is that science still belongs to few, and that it is not part of most people's culture. In other words, science hasn't the strength to have an effect on the life of a nation, and to enrich it materially as well. This substantial carelessness (typical of Italy and the reason why in our country a lower percentage of funds is allotted to research than in other European countries) is a disastrous consequence of a process of cultural cloning much more dangerous than experimental cloning. Those who practice science must feel the responsibility of informing those who don't, of putting themselves at their service to explain the ever more complex, ethical and non-ethical problems involved and to give them confidence, by convincing them that science generates resources for the future and it is much more convenient to create such resources oneself rather than buy them from others' monopolies. Professor of Human Genetics, University of Turin, Italy

REFERENCES Brown, P.O. and D. Botstein, Exploring the new world of the genome with DNA microarrays, in "Nature genetics", 21, 1999, pp. 33-37. Collins, F.S., A. Patrinos, E. Jordan, A. Chakravarti, R. Gesteland, Le Roy Walters, and the Members of the DOE and NIH Planning Groups, New Goals for the U.S. Human Genome Project: 1998-2003, in "Science", 282, 1998, pp. 682-689. Ford, D., D.F. Easton, M. Stratton, S. Narod, D. Goldgar, P. Deville, D.T. Bishop, B. Weber, G. Lenoir, J. Chang-Claude, H. Sobol, M.D. Terre and Members of Breast Cancer Linkage Consortium, Genetic heterogeneity and penetrance analysis of the BRCA1 and BRCA2 genes in breast cancer families, in "American Journal of Human Genetics", 62, 1998, pp. 676-689. Gusella, J.F., N.S. Wexler, P.M. Conneally, S.L. Naylor, M.A. Anderson, R.E. Tanzi, P.C. Watkins, K. Ottina, M.R. Wallace, A.Y. Sskaguchi, et al., A polymorphic DNA marker genetically linked to Huntington's disease, in "Nature", 306, 1983, pp. 234-238. Hall, S. and Ruane, Livestock breeds and their conservation: a global overview, in "Conservation Biology", 7, 1993, pp. 815-825. Hall, S., Human ecology and the evolution of livestock, in "Anthrozoos", 9,1996, pp. 81-84. Huntington's Disease Collaborative Research Group, A novel gene containing a trinucleotide repeat that is expanded and unstable on Huntington's disease chromosomes, in "Cell" 72, 1993, pp. 971-983. Lipshutz, R.J., S.P.A. Fodor, T.R. Gingeras and D.J. Lockhart, High density synthetic oligonucleotide arrays, in "Nature Genetics", 21, 1999, pp. 20-24. Sumberg and MackK, Tropical Animal Health and Production, 17, 1985, pp. 135-140. The International SNP Map Working Group, A map of human genome sequence variation containing 1.42 million single nucleotide polymorphisms, in "Nature", 409, 2001, pp. 928-933.

32

Piazza

Appendix I Alberto Piazza HUMAN GENOME PROJECT: THE STATE OF THE ART (1999) High resolution genetic maps High resolution physical maps EST maps (Expressed Sequence Tags) Human genome map in figures Genomic sequencing of non-human organisms HUMAN GENOME PROJECT IN FIGURES (1998)

Chromosomes

1

2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 X Y Total

Mapped genes

Presumed genes to be mapped

593 327 273 213 232 332 304 178 223 192 372 313 93 178 150 207 351 83 354 123 92 144 417 30 5181

1201 969 765 512 592 648 647 491 502 532 666 576 244 415 407 355 567 236 428 349 89 232 362 23 10607

Total genes

Total ESTs

Total STSs

ESTs (STSs) mapping genes

1794 41992 5280 3114 1296 28009 4378 2257 1038 22129 4307 2015 725 17069 5339 1478 824 19656 3731 1529 980 22760 3608 1893 951 21636 4973 1594 1206 669 18678 3021 725 19991 2382 1248 724 14446 2720 1371 1038 37260 5075 1755 889 22947 3269 1585 5707 2053 703 337 593 20014 2027 1047 557 15713 1955 1029 849 562 13926 2077 918 22427 2981 1263 523 319 6116 1420 1114 782 14408 1686 472 11008 1545 758 3441 1348 305 181 565 376 13515 1476 874 779 15125 4719 421 106 53 926 15788 428900 66511 30181

Other Micropolysatellites morphisms

829 779 728 605 661 646 574 613 471 519 560 553 364 358 312 374 405 291 305 310 221 162 491 32 10334

426 280

649 378 344 384 428 327 154 253 643 201 150 185 207 285 478 77 241 105 178 216 577 125 6865

Source: Genome database, Johns Hopkins University, http://gdbwww.j gdb.org/.

Total polymorphisms 1255

1059 1377 983 1005 1030 1002 940 625 772 1203 754 514 543 519 639 883 368 546 415 399 378 1068 157 17199

33

The Human Genome Project and the Geneticists' Responsibility HUMAN GENOME PROJECT Human Genome Sequencing in non-human organisms (1998)

Organism SV40 Mitochondria! DNA Saccharomyces cerevisiae Escherichia coli Bacillus subtilis Synechocystis sp. Archaeoglobus fulgidus Haemophilus influenzae Helicobacter pylori Methanococcus jannaschii Borrelia burgdorferi Mycoplasma pneumoniae Mycoplasma genitalium Methanobacterium Thermoautotrophicum Caenorhabditis elegans Drosophila melanogaster Mus musculus Homo sapiens sapiens

Genome dimension (in megabases)

Sequenced genome (%)

Year

Identified genes (estimated)

0.005 0.0166 12.1 4.6 4.2 3.6 2.2 1.8 1.7 1.7 1.3 0.8 0.6

100 100 100 100 100 100 100 100 100 100 100 100 100

1978 1981 1996 1997 1997 1996 1997 1995 1997 1996 1997 1996 1995

37 6,220 4,288 4,000 3,168 2,471 1,740 1,590 1,692 863 677 470

1.8 97 165 3,000 3,000

100 100 9 0.2 6

1987 1998

1,855 19,100 (100,000) (60,000-70,000)

34

Piazza

Appendix II Alberto Piazza HUMAN GENOME PROJECT: OBJECTIVES FOR THE YEARS 1998-2003 1: 2: 3: 4: 5: 6: 7: 8:

Sequencing human genome DNA Faster and more economical sequencing technology Analysis of genome variability Functional genomics Compared genomics Bioinformatics Education and formation Ethical, social and legal implications

BIBLIOGRAPHY G. Keller and H.R.Snodgrass, Human embryo stem cells: The future is now, in "Nature Medicine", February 1999, p. 151. P.R. Billings, In utero gene therapy: The case against, in "Nature Medicine", March 1999, p. 255. H. Schneider and C.Coutelle, In utero gene therapy: The case for, in "Nature Medicine", March 1999, p. 256. R.P. Lanza, J.B. Cibelli and M.D. West, Human therapeutic cloning, in "Nature Medicine", September 1999, p. 975.

Human Dignity as a Regulative Instrument for Human Genome Research Jurgen Simon

1. INTRODUCTION The new biotechnology creates new possibilities for scientific activity that have an ethical dimension. It is important that an examination of the developments in this area exists so that the people are able to accept the progress or deny it, their views based on solid arguments. One ethical principle by which innovations can be judged is that of human dignity. This can be understood in the sense that human dignity is a basic principle with a wide field of application. The basic importance of human dignity is revealed by the fact that the notion "dignity" has become increasingly incorporated in national laws and constitutions, and in European and international regulations and declarations. This was especially the case in the twentieth century, as a reaction to tyranny that treated humans as objects and left them in a position without any dignity. The summit was reached with the violent activities in the national socialistic area in Europe. The first international document in which the notion of "dignity" was introduced was the preamble of the Charter of the United Nations, 26th May 1945, which referred to the dignity of the human personality. In Germany, human dignity is the highest principle, regulated in Article 1 of the Constitution: (sect. 1) "The dignity of the human being is untouchable. Their respect and protection is the obligation of all governmental authority." Respect and protection is the obligation of all governmental authority. The double function constitutes values as well as rights.1 The strange phenomenon is that the concept of human dignity is increasingly treated as a legal term, although it is not one. It is here that ethics and law touch and overlap each other in the notion of human dignity. While human dignity is undoubtedly a basic frame of Hailer/Ritschl (1996), S. 91 (101).

35 CM. Mazzoni fed), Ethics and Law In Biological Research, 35-45 © 2002 Kluwer Law International. Printed in Great Britain.

36

Simon

reference in ethics, based upon a credal assertion, as such, concerning the status of a human being, it has found its way into the preambles of constitutional texts without being designated as an originally ethical frame of reference.2 It operates as a broad axiom from which at least certain prohibitions and negations can be deduced. Such deductions occur often in connection with the double reference of human dignity and human rights, whereby it is not clear from the outset whether the latter are grounded in the former or whether the two function independently as frames of reference. The principle of human dignity must be examined if it is really to contribute to the solution of problems and fulfil the role of "regulative principle of bioethics", despite the fact that it is over-used and that the notion as such is anything but distinct.

2. HUMAN DIGNITY AS A PROVOCATION OF BIOTECHNOLOGY When the European Convention on Human Rights and Biomedicine was presented to the public in July 1994 there were many protests. The convention regulating a Europe-wide framework for handling the progress of human biology and human medicine, following the convention for the protection of human rights and basic freedoms of the Council of Europe, was especially criticized in Germany on the grounds that it did not offer enough guaranteed protection and so did not correspond to the demands of human dignity. There are no final protective regulations in this convention. But it should be used as a guideline for new legislation in countries with little or no regulation in the area of biotechnology. In the preamble of the convention it is stressed that the human being should be respected as an individual as well as a member of the human species, and that human dignity has to be respected. A corresponding prohibition was already confirmed by the German Federal Constitution Court in 1992.3 Article 13 of the convention prohibits manipulations of the human genome so as to change the genetic characters of the following generations. The importance of human dignity in modern biotechnology can be illustrated using some examples in the area of human genetic and reproductive medicine. 2.1. Embryo Research Embryo research is one field in which human dignity plays an important role. This kind of research is very important in order to obtain scientific 2 3

Hailer/Ritschl (1996), S. 91 (99). BVerfGE 87, 209 (228).

Human Genome Research

37

knowledge and legal regulation of embryo research; it seeks to balance the respect for the nascent human life with the benefits that can be produced by advances in scientific knowledge. But the question of the "use" of embryos for highly important concrete research aims, such as saving human lives, is not without problems. In German law even the embryo is protected by the human dignity requirement, with the consequence that no use is allowed even though the embryos may be sacrificed for the benefit of human life. By this procedure human embryos would become an object and this is an offence to human dignity in Germany. In this case the general emotional appeal to human dignity is used in the form of a knock-down argument in the medical-ethical field. Rational analysis and logical argument has not taken place or is avoided in favour of what seems to be acceptance of a foregone conclusion and an alldominating assertion.4 This is evidenced by the fact that roughly the same catalogue of basic human rights is part of nearly all constitutions of the world, whereas there is a complete lack of unanimity with reference to the moral status of the human embryo. On this point both opinions diverge widely between and within national cultures. While the German Embryo Protection Act strictly prohibits any form of embryo research, embryo research is legal in Great Britain on condition that the research is clinically relevant, that the donor of the tissue consents and that the zygote is cultivated in vitro only up to the stage of development of 14 days.5 The extent and the intensity of the disagreement on this point should be a warning to all politicians eager to enforce a so far extended principle of human dignity by penal sanctions.

2.2. Predictive Diagnosis A further problem and a further principle of human dignity are presented by predictive diagnosis. The knowledge of the genetic predispositions of a human being has private and social consequences for the individual (and his relatives), who has a right to information in Germany, given by Articles 1 and 2 of the Constitution. But does he also have a right not to be informed? It seems logical that this right should also be accorded as a part of human dignity and the right of personality.6 But this reveals several problems, as for example the handling of results of genetic testing. The Alexy (1986), S. 21. Human Fertilisation and Embryology Act, sect. 1, 3. Munch (1985), Art. 2 Rz. 22 a.

38

Simon

right to self-determination, including the right to maintain secrecy, can be in collision with the interests of information relating to third parties. There must be a weighing up of interests. A special case relating to passing on genetic results to third parties is that of prenatal diagnosis. It seems to be a problem to make this diagnosis, which touches the interests of the human being to be born later, because of the parents' wish to know about probable diseases or handicaps of their children, and perhaps to decide on an abortion. The human dignity of the nascent will not be respected if human dignity means protection. Therefore sex selection by applying this diagnosis is principally not permitted in Germany because the unborn life can not be object of the parental disposition. But there is no possibility for the nascent to express his human dignity in the sense of self-determination. If he could express himself he would perhaps agree to this diagnosis. This point of view of human dignity cannot be respected. This is generally speaking the ruling opinion in Germany, though one gets the impression that the inherent emphasis and the inherent concept are exploited simply in order to avoid the difficulty of giving rational arguments for legal injunctions against not welcomed practices. The fact that practices like P.G.D. are rejected more or less emotionally is by itself not sufficient to justify either the moral judgement that they are inherently immoral or the penal sanctions imposed. By functioning as a knock-down argument the human dignity argument offers an easy way out of this dilemma.

2.3. Gene Analysis, Gene Therapy Research to discover the individual human gene-structure is allowed in relation to human dignity and Article 1 of the German Constitution. But the application of these gene analyses has to be judged within the context of genetic data protection which forbids any overall recording of the genestructure of an individual, apart from specific disease-related pictures. In particular, so-called mass screenings for gene analysis are not allowed. In Germany the general personality right of Article 2 sect. 1 in conjunction with Article 1 sect. 1 of the Constitution contains the liberty of the analysed person to decide about the use of his data and his right not to be informed. There is no obligation to receive information, even taking into account the interests of the partner, the risk of heredity or some highly important research aims. In this sense a gene analysis of an unborn life with the aim of abortion in case of life risks being not much more than normal diseases would be against the Constitution.

Human Genome Research

39

Another situation raising concern is somatic gene therapy. The aim of this therapy is the modification of the genetic make-up of somatic cells, or the transplantation of somatic cells of another species to humans. If the knowledge about the genetic program reveals possibilities of curing genetic diseases or at least of alleviating the situation of the sufferer, then it is the duty of the medical researcher to develop such a therapy. Therefore the procedure of somatic gene therapy is not an offence to human dignity, and is allowed. But the gene transfer into human germ cells will be treated in another way. Germ-line gene therapy, which involves modifying genes so that they can be passed on to future generations, has not yet been successfully performed on humans, and there is a consensus against its use. There is a danger of uniformity of the gene-pool because this therapy will be an offence to the individuality protected by human dignity and Article 1 of the German Constitution. Furthermore there is a special prohibition in the German Embryo Protection Law. But there is another consideration with respect to freedom of self-determination. What if the treated person agrees with the procedure of germ-line therapy even if there is no possibility of doing it? Has the autonomy of the patient to be neglected because of the protection aspect? This is a very important problem because of two different aspects of human dignity, with no solution at the moment.

2.4. Human Cloning Human cloning is the deliberate creation of a human being that is genetically identical to another human being or has the same nuclear gene set as another human being. Human cloning be carried out by nuclear substitution, either by replacing the nucleus of an embryo, or replacing the nucleus of an egg with the nucleus from an embryonic cell, and since the birth of the sheep Dolly, by somatic cell nuclear transfer, in which the nucleus of an egg cell is replaced with a nucleus of a somatic cell taken from an adult. In general cloning by nuclear transfer is not acceptable in terms of human dignity. The protection of human dignity is also extended to life produced by nuclear transfer even when there is no "fertilisation" in the normal sense.7 But fertilisation also includes the nuclear substitution of an egg. In terms of the protection aspect of human dignity, cloning human beings is not allowed because the cloned human being can not be asked if he agrees with the procedure affecting his birth. He gets his genetic criteria because Keller/Gunther/Kaiser (1992), § 8.

40

Simon

of a decision and a technique carried out by other people. The worst case will ultimately be the cloning of a lot of human beings. There the technical aspect has priority. The clone himself cannot be asked if he agrees, and after his birth it is too late to ask him. The German Embryo Protection Act contains a regulation prohibiting human cloning (§ 6). Human dignity guarantees the individual and not uniform life. Human beings would be used to prove that it is possible to produce genetically identical human beings without respect for their personality.8 But there is once again the question of whether this regulation corresponds to the high Constitutional principle of human dignity. In terms of freedom of self-determination and autonomy there is no possibility for the clone to make his own decision about being born by cloning procedure. There is a conflict between two aspects of human dignity. Before a human being can be born by cloning the human who is being cloned would be the subject of several experiments. During this time the human being will be used as research object. It is likely that human cloning by any method will soon become illegal in all EU countries because of the pressure for a global legal ban on the development and use of this technique on human beings. In fact many European countries have already signed the European Convention on Human Rights and Biomedicine and its additional protocol on the prohibition of cloning human beings. This protocol makes what was implicit in the Convention explicit by declaring that "any intervention seeking to create a human being genetically identical to another human being, whether living or dead", is prohibited. Since "genetically identical" is defined as "sharing with another the same nuclear gene set", somatic cell nuclear transfer is included within this prohibition. Furthermore there are a number of another international instruments banning human cloning. For example, in November 1997, UNESCO published the Universal Declaration on the Human Genome and Human Rights, which stated that practices which are contrary to human dignity, such as the reproductive cloning of human beings, shall not be permitted. Also in 1998 the EU passed a Directive on the Legal Protection of Biotechnological Inventions, which states that "processes for cloning human beings" are unpatentable. This is very likely to act as a disincentive for commercial research and investment into cloning. Interesting in this context is the attempt made by Benda, the former President of our Federal Court of Constitution, to derive prohibition of the technique of human cloning directly from the "essence" of man. According to Benda it is an elementary right of anyone not to be genetically Haberle (1992), § 20 Rz. 92; Benda, NJW 1985, S. 1730 (1733).

Human Genome Research

41

the exact copy of one of his parents. Characteristically this kind of natural law argument is presented without any further explantation.9 No consideration is given to the fact that the existence of identical twins makes it doubtful whether genetic individuality is really part of the "essence of man" in any not purely normative sense.

3. THE IMPORTANCE OF HUMAN DIGNITY There are two consequences resulting from the different examples and problems concerning human dignity. First of all human dignity in Germany is one word that includes two principles. It is not only an objective principle but contains as well an active part realised by the right of personality.10 In Germany the jurisdiction has developed this right with the task to guarantee the personal life sphere and to maintain the basic conditions thereof in the sense guaranteed by the highest principle of the constitution. The right of personality includes the protection of the private, secret and intimate sphere with the right of self-determination, and in the medical area the right of patients' autonomy. The ethical-legal principle of human dignity guarantees the basic rights of life and integrity as well as the right of self-determination, with the necessity of consent for all interventions of third persons. In the medical area the self-determination of patients is intensively discussed as the problem of "informed consent" as a prerequisite for all medical activities, influencing all decisions in medicine and research. These problems have already been described for the areas of gene analysis, germ-line therapy and human cloning. The right not to be informed about whether or not a disease is in one's family, and if it is, when it will appear, can be very important for the individual. But on the other hand if someone wishes to have information about diseases, it may be unavoidable that the tests performed also give information about family members who were not tested and perhaps do not wish to have information. So, for example, because of a prenatal diagnosis a mother will know whether she herself will be ill or not the next time. This principle contains many potential problems. The second fact is that every form of development of human life is the subject of human dignity, creating a wide field of application and a special importance. Human life exists from the fourteenth day after conception and is independent of age and the ability of judgement. The German Federal Constitutional Court already decided that even the nascent has human 9 10

Benda, NJW 1985, S. 1730 (1733). Enders (1997), S. 311.

42

Simon

dignity because the potential abilities of the earliest human being are enough to justify this dignity.11 A variation or degradation of human dignity is not acceptable. These two reasons qualify human dignity as a regulative principle, but because of the problems created "inside" this dignity because of the two principles, there is a danger that human dignity becomes an unfounded formula. This is difficult to understand because the meaning of "dignity" is easy to describe. The problems normally begin with the relationship between dignity and humans because there is a variety of what is meant by "human", and this ultimately leads to a lack of determination. In fact, human dignity is an open and undetermined phrase, making necessary a review of its historical development. The main aspects of human dignity are the picture and the idea of the human being, from two different perspectives: the biological on the one side and the Christian and philosophical on the other side. From the biological view the human being is a part of living nature and follows natural laws. He is the highest developed living being on earth and belongs to the category of vertebrate animals and mammals. The view of natural science influences, consciously or unconsciously, the conception the human being has about his own nature and about what it means to be a human being. Modern biotechnology has made the human as a biological being more and more transparent; the procedures of nature become more clear and more explicable, and can be modified for the future. In the old philosophy dignity had a double sense. Dignity was the expression of a social position in society, and consequently one could have more or less dignity. Dignity was different for every human being, with humans having a special position as compared to non-human creatures. This position was explained in a Christian and a philosophical way. To justify this special position in terms of the Christian ideas, the phrase "imago-dei" has been used, defining the human being as the crown of the whole creation. Another justification was given by philosophical ideas. In the renaissance Pico de Mirandola explained the human being as the being with possibilities which could be chosen by him, this being the expression of his dignity.12 The human being gives himself his aims. He is able to determine his will because of his intelligence and his intellect. His freedom is his dignity. During the Enlightenment the basis of a moral picture of the human being was born. The modem sense of human dignity is related very closely to Immanuel Kant and his philosophy. For Kant, the picture of the human BVerfGE 39, 1 (41). Wassermann (1989), Art. 1 Rz. 3.

Human Genome Research

43

being is based on the idea of moral autonomy and the individuality of each human being, and the fact that it cannot be repeated. Human freedom is expressed by the fact that the human being is willing to follow the idea of mere intellect. The autonomy of human will as the reason of human dignity is determined by the quality of will to give oneself a law - independent of empirical reasons. Kant transfers the objective law into the formal lack of contradiction of a subjective will able to being generalised. Because of his nature the human being is a person with absolute worth, being at the same time different to all other beings without intelligence and having only a small worth as a thing. The Christian and philosophical ideas form the picture of the human being for the German Constitution, and the intellectual basis from which the guarantee of the human dignity derives. This picture has been modified over the years.

CONCLUSIONS When the idea of human dignity was born, and later, when the German Constitution came into existence, developments in biotechnology were completely unknown. Nowadays these developments relate directly to the fundamental principle of human dignity, and in a certain sense threaten this principle. Critics complain that human dignity is only a general clause, which allows many opinions to be defended using the argument of human dignity. But instead of resignation this could be the beginning of a new orientation. The initial anthropocentric understanding of dignity, the basis of the German Constitution, does not lead to a fixed picture, closed to alternative interpretations and prohibiting a correction or modification of the picture of the human being. The understanding of the Constitution has to be adapted in the light of human developments, including activities in research and science. It is the duty of a Constitution and its values not only to describe the "status quo" but also to offer solutions to many problems and situations, without being a general or an unfounded formula. Human dignity is a good example of this: it is not a static notion, but rather follows the dynamic of the developing picture of the human being, so that the sense of human dignity is modified over the years.13 The openness of major values, such as human dignity, enables the Constitution to be applied to social and cultural developments influencing the legal and ethical reality and order, without leading each time to a concrete modification of the Constitution. These are the prerequisites of a good Constitution, Caspar (1999), S. 347.

44

Simon

and are the only possible way of dealing with developments and progresses in the area of biotechnology. There is, for example, the demand of animal rights activists that the dignity of animals should be recognised as well as human dignity, as an expression of a modified picture of humans, nature and the relationship between the two. The actual discussion of this problem shows how far the concept of human dignity has already been modified, and how far it could be modified. It can be said that the public needs a regulative principle for its own orientation and to enable it to judge modern developments ethically, especially in the area of biotechnology. A regulative principle is the basis of public acceptance of developments in biotechnology. Until now the value of human dignity represented a generally accepted standard of ethics, and there was a good relation on the national and international level between the discussion of bioethics and general ethical discussions. This seems to be a helpful analysis of the functions and capacities of the notions of human dignity also applicable to medical ethical problem cases. "Most problems in medical cases have to be dealt with in the context of the social matrix and also often with reference to the individual story of the patient" and very few medical ethical problems can be settled in an absolute way.14 Trading with embryos and the definition of death in relation to the exploitation of organs are just two examples of problems requiring wider consideration. However, even some of these and related problems cannot always be resolved for the protection of the patients in question, and the conception of human dignity inside the German Constitution has already been intensively discussed on the issue of abortion. "This concept was and is incapable of carrying the burden of proof in complex questions of medical ethics and legislation pertaining to it. But it has always needed a minimal frame of ethics and rights for understanding."15 In this way it can be called a dialogical concept in the sense of Rawls or Habermas16 and at the same time in some cases a conversation stopper, setting an issue and tolerating no further discussion. If the problems inside the idea of human dignity as shown by the examples are not solved soon there is a great danger that the consensus described above will be destroyed, with the consequence that there will be a lack of a regulative principle in bioethics. Professor of Law, University of Luneburg, Germany Hailer/Ritschl (1996), S. 91 (102). Hailer/Ritschl (1996), S. 91 (102). Hailer/Ritschl (1996), S. 91 (104).

Human Genome Research

45 LITERATURE

Benda, E. (1985), Humangenetik und Recht. In: NJW 1985, S. 1730. Caspar, J. (1999), Tierschutz im Recht der modernen Industriegesellschaft, Baden-Baden. Enders, C. (1997), Die Menschenwiirde in der Verfassungsordnung, Tubingen. Haberle, P. (1995). In: Isensee J./Kirchhof P./Haberle P. (Hrsg.), Handbuch des Staatsrechts I, Heidelberg. Hailer, M./Ritschl, D. (1996), The general notion of human dignity and the specific arguments in medical ethics. In: Bayertz, K. (Hrsg.), Sanctity of life and human dignity, Niederlande, S. 91. Munch, I.v. (1985), Grundgesetzkommentar, Band 1, Mimchen. Wassermann, R. (1989), Grundgesetz Bd. 1, Alternativkommentar, Neuwied.

This page intentionally left blank

Bioethical Anxieties Concerning the Limits of Biological Research* Mauro Barni

1. THE PRINCIPLES AND THE CHOICES Of fundamental importance for the forensic physician and particularly for the methodology of his professional investigation and practice (characterized by case histories) is the disturbing question of scientific limits, "necessarily" immovable for the protection of "human dignity" (authoritatively proposed by Professor Jurgen Simon as a regulatory parameter for research on the human genome) in the dramatic confrontation between respect for values and freedom in research. In the Italian juridical tradition, still firmly rooted in its Roman origins, the mainstream follows ordinary law even though the instrument in question has not adapted itself to the incessant growth of scientific advances. So far, the results of a legislative transposition of the regulations existing elswhere (clinical experimentation, radioprotection, European convention on human rights and biomedicine, etc.), in an attempt to develop more logical guidelines, have been negative. In the case of assisted procreation, we have witnessed an authentic legislative "shipwreck". There is much debate regarding the role of guidelines (greatly in vogue in Europe), of the codes concerning professional discipline (absorbing much from the bioethical lesson) which in Italy have been reinforced, though with some contradictions, in the field of deontology (assisted procreation, informed consent, privacy, etc.). However, the basic prospect of an ethical regulation-validation transferable onto a functional plane remains vague. Apart from a general consensus regarding the main principles derived from the two-fold formula of 1. "don't * The reflections inspiring this paper are the result of a working experience and research, conducted under the guidance of Laura Canavacci, Doctor of research in Deontology and Medical Ethics, as part of a research project on "Clinical experimentation: the role of ethical committees" (1998-99) promoted by the University of Siena and by Monte dei Paschi di Siena. The unabridged paper will be presented upon its completion.

47 C.M. Mazzoni (ed), Ethics and Law in Biological Research, 47-56 © 2002 Kluwer Law International. Printed in Great Britain.

48

Barni

damage" and 2. "maximize" all possible benefits while "minimizing" all possible damage (a formula whose roots are ingrained in the origins of deontology), a univocal and credible strategy regarding the application of these principles is lacking due to a profound dichotomy in the interpretation of the conceptual foundations of bioethics. Even though a type of approach has been delineated which foresees that the fulfilment of moral duties concerning human subjects is absolute - or at least a priority - compared to any other possible type of consideration; on the other hand, moral issues related to experimentation are interpreted as current principles, a balance of which, each time motivated also in relation to any other useful consideration, represents the best form of moral protection for the specific field. The tendencies towards a more apparent heterogeneity therefore concern, on the one hand, the protection of individual human rights of those directly or indirectly involved with the experimentation and, on the other, the necessity to promote general wellbeing through the progress of scientific knowledge. Evident propensities towards one or the other of these opposing theoretical attitudes regarding the ethical standards of research are found within the principal codes and fundamental guidelines, some of which have already acquired historical significance. In fact, in the sphere of Anglo-Saxon culture, it is possible to find, both in the Nuremberg Code1 and in the Declaration of Helsinki,2 the theoretical foundations pertaining to the absolutist or axiomatic position, relating to a deontological type of theoretical guideline. In the relatively more recent regulations, pertaining to the Belmont Report3 and to the Code of Federal Regulation,4 one senses a prevalent need for balance and an attitude regarding moral principles devoid of absolutist characteristics. In order to highlight the contrasts between the diverse orientations regarding the role of ethical principles in biomedical research and its limits, bioethical speculation relies not only on exemplification but also on case history or sectorial procedures. Thus a spontaneous methodology has developed and has led, more recently, to applications of this methodology on a doctrinal level, even though the shift from a general theoretical level 1

The Nuremberg Code, in trials of war criminals before the Nuremberg Military Tribunals under control Council Law N.10, October-April 1946, U.S. Government Printing Office, Washington, vol. 2, pp. 181-182. 2 World Medical Association, Declaration of Helsinki, 1964, (reviewed 1975, 1983, 1989). 3 The National Commission for Protection of Human Subjects of Biomedical and Behavioral Research, The Belmont Report, U.S. Printing, Office Washington, 44 Federal Register, 18 April 1979. 4 National Institute of Health, Code of Federal Regulation, 46 Federal Register, 26 January 1981.

Bioethical Anxieties Concerning the Limits of Biological Research

49

to a specific decision on a particular issue (for example, conduct of experiments or resource allocation), implies enormous differences tied to contingency options and variations. It should be sufficient for one to remember the classic "case" of "experimentation" on humans conducted on healthy, but weak and incompetent subjects! The theoretical attitude concerning principles, well expressed by Hans Jonas'5 classic paper, supported an integral respect for these principles in order to prevent an otherwise inevitable "reification" of human subjects involved in experimentation. To deny absolutely any moral validity in a strategy of striking a balance among all the demands involved (legitimized by consequentialist conceptions like, for example, utilitarianism), presupposes a recourse to universally accepted ethical principles capable of conferring validity to the limits placed on experimentation; which is not at all realistic since, in the USA, the National Commission for the protection of human subjects of biomedical and behavioral research,6 disengaging itself to some extent from the principles inspired by the Belmont Report (the principle of benefit and that of justice) has absolutely delegitimized any recourse to non-therapeutic experimentation, but does not exclude this eventuality, considering the ethical principles stated in the general theses to be valid only as prima facie when other circumstances do not question their validity. This implies, in similar cases, recourse to an independent judgement and, eventually, to an Ethics Committee (EC) legitimized to evaluate the opportunity of applying, or not, non-therapeutic treatments. This institute (the Institutional Review Boards - IRBs) is responsible for establishing a balance between moral principles and the validity of specific, concrete circumstances in which the need for a similar recourse presents itself. This illuminated decentralization has not produced, at least in our biomedical reality, an acceptable methodology in the biomedical field, practical and adaptable as a useful working instrument. The remaining doubts concern the following basic questions:7 (a) the nature and importance of principles related to bioethical evaluation; (b) the function of principles in ethical debate; (c) their interpretation towards a correct moral analysis of the questions; (d) the possibility of access to other evaluations (of general interest) not so obviously correlated to ethical problems; 5

H. Jonas, Philosophical reflections on experimenting with human subjects, in Fruend, P. (ed.), Experimentation with human subjects, George Braziller, New York 1969, pp. 1-31. 6 The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Research Involving Children (September 1977), Federal Register 8 March 1983. 7 L. Canavacci, / principi del consenso informato, Edizioni Medico Scientifiche, Torino 1999.

50

Barni

(e) identifying and overcoming questions diverse from those concerning moral debate. Of decisive importance in increasing doubt are the weight and eventual legitimization of serious and important deviations, waiving the basic ethical principles, since it appears difficult to call upon a guaranteed objectivity founded on iterated and accepted evidence, uninfluenced by optional contingencies and guaranteed by a specific (does it exist?) authority and experience. Regarding every other dominant characteristic, the insuppressible fact of moral pluralism remains, although this truth eventually thwarts, at least in part, considerations of a group of experts on the bioethical implications of biotechnologies, consulted by the European Commission regarding the 5th program on outline of research and technological development: 1998-2002.8 "Moreover, the very concept of fundamental principles is philosophically debatable, if we mean by it an ethical evaluation, and must necessarily be based on immutable and absolute standards and values and not, more modestly, be guided by rules that have been determined over time and are therefore dependent on a context and prone to evolution. Fundamentalism is only one way of considering ethical or moral questions." From the preceding paragraph, it clearly emerges that a reference point for analyses in a European debate on bioethical questions resides in our conviction that, when speaking of fundamental principles, we are not referring to absolute truths, believed to constitute the world or human nature, universal and immutable. On the contrary, we are referring to rules that, although connotated differently according to their interpretations, remain a product of human culture and sensitivity and, as such, are mutable and not necessarily nor universally valid. "Expressed in this way, the concept of fundamental principles can be usefully interpreted in a more positive and legal, rather than metaphysical and theological manner. This concept refers to general basic values and standards meeting with general consent, even though a consensus is not always possible regarding its interpretation and practical application."

2. THE CASE HISTORY MODEL In order to circumvent the basic antinomies, an idea has emerged of an authentic dialectical inversion of the terms that lend priority to the procedures (and to Ethics Committees, ECs) regarding moral questions (Jonsen 8

Opinion of the group advisers on ethical implications of bioetechnology to the European Commissions, n. 10 The Ethical Experts of the 5th Research Framework Prgogramme, 11 December 1997.

Bioethical Anxieties Concerning the Limits of Biological Research

51

and Toulmin9): this is the model entitled "new case histories" which, without denigrating the basic values of moral principles, aspires to reflect them and modulate them along essentially particularistic and pragmatic lines. The starting point for a definition of the profile of the new case history methodology is represented by strong analogies between the clinical diagnostic procedure utilized by medical science, and ethical argumentation: "no professional enterprise today is closer to moral practice, or better exemplifies the special character of practical inquiries, than clinical medicine". Medicine makes use of both science, intended as theoretical knowledge, and practical capacity, explicit in clinical experience: in this sense it may consider itself to be an example of how theory and procedure are interwoven within the same discipline, taking advantage of both theoretical scientific knowledge and specific treatment methodologies, defining its own conditional and contingent truth in order to enrich the perception of a theoretical point of view but, above all, to reconstitute a state of well-being in the individual. For, in medicine, the priority must be assigned to practice and procedure, since a guarantee of objectivity is not to be found in formal deductions (with individual clinical judgements descending from theoretical knowledge), but in the power of the analogy between the characteristics of the new analyzed "case" and those of similar, previously noted cases of which the clinical practitioner has either direct or indirect knowledge through study, consolidated experience and authoritative guidelines capable of inspiring a diagnosis and incorporating it within the ranks of scientific laws. Diagnostic and therapeutic conformity is not guaranteed by procedures of logical formalization but by an analogy between the cases examined and paradigmatic ones registered by clinical taxonomy and promoted in the ranks of the specific patrimony of medical science, reinforced by epidemiological-statistical and experimental validation. As a result, each diagnostic conclusion only possesses a presumed character, remaining open to a possible reconsideration if there appear signs or indications previously unnoted or irrelevant, similar to new and important evidence revealed by the successive course of the illness. For Jonsen and Toulmin bioethics, like medicine, possesses a practical vocation with perspective and an eminently empirical orientation, therefore the commonly used expression "applied ethics" is redundant, and the expression "theoretical ethics" contains an illusory and counterproductive idea of the same moral concept. The reconstruction of rigorous moral theories, 9

A.R. Jonsen, S. Toulmin, The Abuse of Casuistry. A History of Moral Reasoning, University of California Press, Berkeley, Los Angeles-London 1988.

52

Barni

Toulmin maintains, "entails a departure from the real context of moral life and is animated by an illusory necessity for moral certainty: it is nothing more than mystifying fetishism". To refuse the infallibility of conditioning theoretical presences in the ethical dominion, maintaining that appropriate ethics signifies immersing oneself from the start into the concrete reality of the case, does not exclude that the argumentative procedures through which case histories are treated follow rational criteria. In other words, the foundation and confirmation of a correct morality can never be represented by the relationship between moral theory and individual judgement. It must be established through formal deductions, applying the standards relative to the theory in concrete ethical cases. The relationship between general theory and particular, individual judgements is indirect and substantial; in this manner a theory of cases is developed. But experience has taught us the complexity involved in its realization due to persisting uncertainties regarding the procedures to be followed and the credibility of criteria not universally applicable nor accepted, on either an ethical or a political level.

3. THE LIMITS OF THE NEW CASE HISTORY METHOD The case history method rejects a perspective that seeks to address moral questions from the point of view of abstract principles codified within ethical theories. The motivation for this refusal derives from the radical conviction that ethics, like medicine, constitutes a practical domain and, as such, eludes formal and deductive argumentative rules. This type of definition seems to be an excellent key for interpreting the difficulties that may arise, for example, in an endeavour to analyse "theoretical" ethical standards protecting subjects involved in biomedical experimentation and, particularly, subjects incapable of consent. These standards are expressed in official documents through the lofty evocation of abstract principles (autonomy, benefits, solidarity, responsibility, etc.), whose function, as an effective guide for practical conduct, is completely lacking in clear, non-controversial indications with which to inspire action. In addition, the advisory and guiding role played by ECs assures only theoretical deductions and formal interpretations of the relationship between those ethical principles and individual judgements that do not appear too weak or arbitrary, extravagant or conformist, rigid or contradictory, evanescent or doomed to failure. Therefore the proposal of the theory of a new case history method, with argumentative criteria borrowed from the analogical method, utilized for

Bioethical Anxieties Concerning the Limits of Biological Research

53

practical ethical decisions, could represent the only serious path to uniformity, objectivity and transparency, as an instrument for the concrete conduct of the ECs. It still holds true that the members of an EC called upon to discuss a specific case, referring to the moral taxonomy related to the problems in question, cannot claim total theoretical neutrality without displaying a naivety similar to that of the philosophy of pre-Kuhnian science, which believed in the possibility of an observation of facts in the absence of any theoretical influence whatsoever, a virginal perception and therefore neutral in respect of the phenomena in question. In other words, it becomes necessary to consider that the members of the EC, in the role of "case history" examiners, cannot filter their observation of the cases from the partiality of their original theoretical positions. So, bringing the analysis onto a more general level, it seems that the case history method, although presenting itself as a theory-free method, is incapable of freeing itself from its strong original epistemological assumptions, decisively influencing a further analogical analysis of the cases. With regard to moral theory, only if we intend a system within which the standards, revealed as fruitful regarding the moral experience, are harvested and organized, rather than a purely formal instrument, fruit of a disembodied rationality, can a case history methodology come alive and become capable of operating without negating values or underestimating their importance. However, flexibility "without compromises", derived from the centrality of the moral debate echoed by an empirical investigation of the cases in which the standards are applied, making it possible each time to "refine" the same general laws, remains, today, an illusion.

4. THE NECESSITY FOR MORAL PLURALISM A basic impediment remains the acquisition of the broadest possible consensus. The case history method does not take for granted a consensus on original moral positions, which would imply the use of a common taxonomy in paradigmatic cases. Since contemporary societies manifest no apparent sign of a shared morality, the case history method cannot be an efficient instrument in resolving the moral problems of a pluralistic society. If the nature of human morality were rational, responding to formal logical principles, an agreement regarding the concrete cases would have to be considered as necessary as the correctness of its solution is selfevident. But since morality also relates to the sphere of affects, feelings, desires, personal aspirations and the personal vision of a better life, an

54

Barni

agreement can only be hoped for, and is certainly not necessary, like those solutions to problems that similarly cannot be considered necessary and necessarily univocal. This view of morality considers the advantage of explaining the true motives behind moral behaviour taking its impetus from an experimentalistic vision of the moral experience. The case history method makes available a debatable method based on the comparison of concrete cases and thus is capable of encouraging reflection on the possible consequences, on the life of human individuals, of adopting particular ethical convictions. Still, there remains an inflexibility in moral presumptions concerning the choice of particular ethical determinations that humanity has assumed in the course of its history, and the reassuring path of formal rationality has been discarded for reasons repeatedly mentioned. But even a path of sensible, informed rationality inevitably entails similar side effects. In Italy, a shared patrimony is far from the reality. Therefore it is certain and comforting (for those who don't indulge in fundamentalism) that some choices are expressed with great clarity within laboriously conceived documents of intense practical and theoretical importance. Obviously, to define as vague those stances which are fundamentalist and intolerant regarding moral principles does not resolve the methodological problem of the function and nature of moral principles: an effort to interpret philosophically the significance of a recourse to fundamental principles which remains constantly essential, and to clarify the type of relationship that should be established between the definition of general principles and practical determinations derived from individual moral judgements.

5. CLOSING REFLECTIONS The Italian experience in the field of ECs needs to be based on these considerations. Although initially very promising, it soon lost its innovative qualities and has been entirely superseded by recent events.10 In fact, the need to re-direct most of the energies of the ECs to address the problems of clinical experimentation of new pharmaceuticals has practically interrupted the rising debate within local bioethical committees, where there has been a radicalization of moral options with an increasing scarcity of support for those aiming at examining objectively the issues raised by case histories. The weakness of the case history method, which 10 Ministero Delia Sanita', Decreto ministeriale, 15 luglio 1997, Norme di buona pratica clinica dell'U.E., G.U. 18 agosto 1997, serie gen., n. 19.

Bioethical Anxieties Concerning the Limits of Biological Research

55

however remains the only practical, viable solution, has given in to a prevalence of principles. My hope is for a refounding of the EC, operating only through a total diversification concerning the committees for the experimentation of Pharmaceuticals; but this is a contingent subject. In general we can only - considering our present reality - resort to an "elaboration" informing the decisions made by a "comparison" between moral positions expressed in relation to case histories organized into general categories, from which guidelines can be derived, constituting a solid indication for eventual growth and, in the meantime, a parameter for case history reference at the levels of local ethical committees or at least at the operative level. The clearest example is represented by the European Convention of Human rights and Biomedicine (Oviedo, 4-IV 1997) and by the added protocol that came out of it: on cloning, transplants, xenotransplants, biomedical research, genetical research, etc. The meticulous preliminary search for a possible consensus, founded not only on principles but also on viable decisions and programmes, is perhaps the most empirical, but also the most rational path to elaborate modalities and timing schedules, boundaries that respect both man's dignity and the needs of scientific progress. Ordinary laws are inflexible, non-deformable instruments, if not modified by other laws. They are often ideology-driven or confused, becoming functionally inept, while new deontological codes can benefit from contemporary technical advancements and bioethical anxieties. It is fairly easy to avoid entrusting the "responsibility" for decision-making to ECs, and this can give rise to differences between different places, despite the fact that any evaluation of experimentation with pharmaceuticals has increasingly global implications. Therefore the existing laws and guidelines remain the only guarantee possible today for the greatest possible fairness in defence of personal and human rights: and the more authoritative they are (although lacking the strength of legally binding obligations), the greater will be their tecnical and moral application. Without underrating the prerogatives of members of Parliament, consensus and decisions in the field of bioethics are not issues to be negotiated politically, but moments of cultural specificity whose roots reach deep into the ancient and perennial inseperability between science and humanism. The role of the ECs remains to be briefly considered. They must recover their resemblance to interpreters, not only in the "sense" of the principles each time called forth, but also in the "reflection" that they project onto the case histories, as well as their right to refuse technical certification, considering it to be pertinent to an ad hoc committee.

56

Barni

In this refounding of the ECs in a search for limits, consistency, conformity and evolution, the function of the philosopher re-emerges within the context of our present moral experience, distancing ECs from the IRBs: "the philosopher's mission may be to reflect on different fields of experience in the most general possible terms; but this is not to say that they must do so only in completely general terms". Professor of Medical Law, University of Siena, Italy

The Perception of Possible Knowledge and Changes in Common Morality Carlo Flamigni Greatly differing positions exist regarding the limits which should be imposed on science and biological research and each of these positions tends to exclude the others. My own personal opinion is that none of these positions can be recognized as having the capacity and strength necessary to force the opposite side into an admission of error. And since it's difficult to suggest that some of these positions should be excluded from the discussion because of their moral inadequacy, the only possible solution is to try and make the various theories coexist, leaving them space for spontaneous confrontation. This, therefore, is my personal opinion. Society has lived for centuries with the certainty - naive, open to criticism and perhaps mistaken, but basically pleasing - that material progress would never come to an end. This optimistic vision of the future originated in a positive evaluation of the role and aim of scientific research, and was based upon a very particular interpretation of complex events: longer life-expectancy, progress in the medical field, recreational use of leisure time, the diffusion of culture and its overflowing down to the "lower" social classes. Thus, we have a society in evolution, moving happily towards progress science being the engine of this transformation, technology recognized as the wheels allowing the movement. This is the period of scientism, with science and technology considered the highest threshold attainable by human thought. It is hardly necessary to emphasize the errors of scientism, to underscore the limitations of our present civilization. What was defined the "industrial cornucopia" has polluted the earth with every kind of poison and slag. It has provided a tiny percentage of humanity with low-quality goods and services, often costly and even more often flawed, and it is highly likely that our children will have to bear an ever-increasing workload in order to maintain the few luxuries that we enjoy today. Powerful anti-scientific movements are born and make converts as a reaction to scientism. For example, the early 1900s witnessed the explosion of a markedly anti-scientific, neo-romantic revolt which is cropping up 57 CM. Mazzoni (ed). Ethics and Law in Biological Research, 57-65 © 2002 Klmver Law International. Printed in Great Britain.

58

Flamigni

again today, albeit in more rational and less aggressive terms. The vision of the future is modified, looked upon with suspicion and fear in some cases; those cultural positions, which sought to imagine and envisage the man of tomorrow, collapse; many ideologies and men lose their faith in science and people, deprived of hope, seek comfort and a reason for living in religion, in superstition and in fanaticism, thus seeking satisfaction for their own personal need of spirituality. So, nowadays, a strong anti-scientific position is felt, in which the rejection of an exclusively technological and rational knowledge of the world joins forces with serious accusations brought against modernity and progress, identified by some as evil. A global philosophical reasoning seems to be gaining ground; according to the questionable philosophical tradition of spiritualism, it does not make distinctions, it does not know historical authenticity, it speaks in general terms about science, technology, industry thus putting everything into the same category. The result is an antiscientific obscurantism, cloaked from time to time in openly ideological, revolutionary or religious convictions. Science stands accused of subjecting the natural world to its wishes, of alienating and brutalizing man, of throwing social organization into disorder. Personally, as a researcher, I have experienced a slow but constant prevalence of intolerance, although the geographic distribution of this intolerance varies considerably. The accusations which are leveled at the technological society - confined to only one part of the western world - are known. A society, they say, that is desperate, selfish, longing only to glut itself; a society in which nature is continually attacked - in its integrity, perhaps even in its sacredness and where attempts are made to modify the natural characteristics of man. A society, both ruthless and irresponsible, that threatens to torture and kill its children, that takes advantage of the unprotected, that authorizes abortion and euthanasia, that shows no respect for the beginnings of life, that sets traps along man's very path. How can salvation and moral comfort be found in a society such as this? How can we help but foresee a terrible future for this society or even no future at all? An evaluation of the attack on science, and the consequent demand for urgent and severe political and social control of scientific research, requires time and certainly I could not do it in an analytic way. I will limit myself to a few comments. First of all, it is not possible to discuss these questions without a preliminary distinction, as fundamental as it is trivial: • science is one thing, a discipline directed at knowing; • technology is another thing, a discipline directed at doing.

Possible Knowledge and Changes in Common Morality

59

If we were to discuss science alone, our reasoning would be simple. By accepting the theoretical definitions just enunciated, we must consequently accept the fact that science is not, nor can it be, bound to ethical constraints, neither can it be subject to any political control as it is the moral right of man to know all things. To quote Luhmann: since the 17th century, science has imposed on society the idea that science alone is qualified to judge what can be known and that this depends on the state of research. This means - and here Luhmann himself quotes Heisemberg and Godel - that science works in an infinite world in which limitations are self-imposed. So, if scientific progress is to be prevented (Luhmann repeats), it must be done through prohibitions; and prohibitions will be flaunted in order for true knowledge to be acquired. Therefore, society cannot dictate to science which knowledge is permissible; if this is the case, then science is autonomous and is not responsible for the consequences that knowledge can procure. Again, I quote Luhmann who affirms that ethics cannot expect to be able to formulate efficient prohibition if it wants, at the same time, to be a theory of moral behavior, that is, free behavior, or rather a behavior that proves itself only when free of various kinds of constraints. If science is oriented towards knowledge, then a neutrality of science exists. It is not true that "anyone who acts, acts for a purpose, sensible or senseless." It is not true that moral questions are unavoidable. If moral constraints are lacking, the principle collapses according to which the ethics of research cannot neglect the ends of research, in the same way that it cannot neglect the means - or the concrete procedure being followed. The questions: Why this research? Who guides the research? are senseless questions. However, the entire construction of this argument is imperfect, it being untrue that science is not subject to ethics; the two are linked by the use of those means adopted by the scientist in his pursuit of knowledge. Science is not the eye that scrutinizes, but rather the hand that searches and manages to understand by observing those changes brought about by the self-same hand. Science "does". Science is not only a system of knowledge, but also a human activity which aims at producing knowledge and therefore cannot avoid the general conditioning of every human activity. The problem is whether science should be inspired by choices dictated by value judgments which must take into consideration the plurality of values, and whether knowledge is or is not indifferent to values. The alternative is to be guided by pragmatic

60

Flamigni

criteria (Is knowing this particular thing worthwhile or not? And is it worthwhile knowing this or rather that?). There has been a further evolution which has modified the distinction between science and technology even more; the scientific community has invited the financers in. Economics have entered the fray. Research is costly and society expects to recover its expenses. As a result, funds for basic research have been progressively reduced. Politics also interferes with scientific research, at times indirectly, at other times directly. I can quote a recent example. Recently, a law was passed whereby relations between the Faculty of Medicine and hospitals have been greatly modified, thereby crushing (I hope this term is comprehensible) the Clinical institutes up against the Hospital Wards, to the exclusive benefit of the State-run Hospitals. But scientific research in the medical field research which nowadays makes great demands on those involved - needs the exact opposite, that is, a vertical university set-up, with Departments capable of linking applied research to basic research; the answer has been that of creating horizontal departments (the new, irrational "mixed" departments) and so much the worse for medical research in our country. So, the way of obtaining knowledge has changed; knowing and doing are often indistinguishable. The problem of knowledge is increasingly bound to the instruments through which knowledge is acquired, and those instruments have become an integral part of knowing. The significance of "technology" and "knowledge" draw ever closer to each other. One thinks of Kuhn's definition of technology: an effective manner of doing things which simultaneously knows its reasons for doing and feeds on its specific background of theoretical knowledge. Actually, the technological system is indifferent regarding its objectives, at least up to a certain point. It is a world that lives unto itself, that tends to nourish itself and whose continued development is also its reason for existing. So it is possible to foresee a contrast between the expression of the will of the people, and the new forms of power and decision-making in the technological economic system, and this applies to all forms of research. Thus nowadays it is difficult to distinguish between science and technology, in this complex interweaving of knowing and doing, of economics and science. The indissolubility between technological development and its possible repercussions on mankind brings about a new concept of consequential probability; it becomes necessary to ask if the end in research justifies the consequences. The concept of the researcher's responsibility thus becomes apparent. But the problem cannot be that of alienating knowledge, as the latter

Possible Knowledge and Changes in Common Morality

61

cannot be rejected. However, it is possible to control knowledge even to the point of reaching the extreme limit of halting investigation for fear of the consequences. This means postponement and not prevention. The power of technology derives, therefore, from confrontation - which, in some cases, can become conflictual - between cognitive acquisitions and their possible applications on one hand, and the customs, traditions and ways of thinking which are dominant in society on the other. To know and to be able to do a thing does not mean wanting to do it, but the effective possibility of doing it is already an element sufficient to disturb the peace and quiet. This conflict has complex origins. One of the dominant thoughts of society relates, for example, to the risks involved, to the fear that any evident advantages in the use of scientific knowledge be linked to the possibility of catastrophic damage, even if unlikely. A few rapid reflections: • An evaluation of very unlikely but very significant events varies subjectively in quite a considerable way; in other words, there is no possibility of consensus and neither is there any wish for consensus. • With regard to the risk, a tendency to schizophrenia dominates here; we are much more tolerant of risks that we attribute to ourselves than those imposed on us by others. Actually, cigarette smoke causes more deaths than industrial waste does, and more illness is caused by bad eating habits than by consuming genetically modified foods. Thinking about it: this means that, in reality, no law of reciprocity exists. And so it is right to ask what sense there is in continually referring to ethics which are based on consent and on reciprocity when we know full well that no basis exists for these principles. • The continual pressures exerted by ideologies and religions, very preoccupied with their own survival, have diverted attention away from the real problems and onto marginal topics. There is a lack of awareness that the risk factor should be applied also to technological innovations approved by all. Professor Tognon, a geneticist from Ferrara, has discovered a virus in the genome of many individuals which, it was always believed, is characteristic of monkeys. It is possible that the crossing of this virus into the human genome has been made possible by certain vaccines (such as that against poliomyelitis) which were prepared by cultivating the virus in the kidney cells of monkeys. As mass vaccinations were involved, a wide diffusion of the virus can be expected, since nowadays it has become part of the inherited genetic make-up of a large number of human beings. It is true that no

62

Flamigni

pathogen effect has yet been attributed to this virus, but the situation may change in the future. In any case, it is a problem which should be the subject of careful analysis: as far as I know this has not been done yet. Furthermore: we stop to consider semantic banalities relating to the concept of personal life instead of discussing real problems. For the sake of time, I will limit myself to two examples, chosen from among those I consider to be "real" problems. The first concerns the experimental nature of almost every technique of assisted fertilization, experiments performed directly on man. For example, we still know little about the possible long-term results of the technique of microinjecting spermatozoa taken directly from the testicles - and therefore not yet completely "mature" - which may possibly cause abnormalities in genome imprinting that may only become manifest at a later date. The consequences are not yet fully understood since the children born using this technique are only a few years old. This experimental nature should be the main source of worry for those preparing the rules and regulations for infertility therapy, but those experts seem to be giving all their attention to the fate of abandoned embryos instead. The second problem seems to me to be even more important. Indeed, we should all be aware of the fact that assisted fertilization techniques are disciplined by fairly lax scientific regulations, they are relatively easy to apply, they represent the last resort for many sterile couples, and are now almost generally ethically accepted, so much so that fifty years from now, the harsh discussions of today will probably appear ridiculous. What is it, instead, that strongly characterizes these techniques and makes them truly important and extraordinary? These techniques represent a compulsory step towards pre-implantation gene therapy and towards the conservation of personal fertility for future use. It goes without saying that these may be epoch-making modifications in the history of mankind. Gene therapy will allow the elimination of a consistent number of single-gene diseases, eliminating the need to sacrifice embryos or fetuses, and allowing many children to live a serene, normal and high quality life despite congenital genetic abnormalities. The preservation of their own gametes or gonads (as well as opening complex and, for some, alarming scenarios, on which I do not wish to dwell) will allow many people, otherwise destined to become sterile due to anti-cancer treatment or to gene make-up, to keep alive their hopes of becoming parents. And so it continues; we are being urged to interpret as dreadful and evil scientific events that deserve, at best, a calm, critical analysis. This is done distilling fears and phantoms from distorted interpretations of historical reality and from fantastic envisaging of unimaginable consequences.

Possible Knowledge and Changes in Common Morality

63

This point would also merit a rapid analysis, especially for one of the most controversial and slandered subjects, that of cloning. It is true that, as time passes and emotions die down (since emotions are always and in any case unfavorable to a rational analysis of the events), the discussion on the birth of the first cloned sheep has started to become more tranquil, and some truth has begun to emerge. But, the announcement of the cloning was greeted as the signal of the arrival of a new Satan, one of the many devils that scientific research seems capable of producing continually (although this one smelled of sulphur even more), and these premises certainly have not done anything to encourage a more rational analysis. Indeed, the controls carried out on the growth and development of cloned animals have shown that a clone only partly resembles the individual from whom it originated, and with whom it shares its genetic patrimony. This, among other things, confirms what was known about identical twins, who always have different IQ levels if brought up in different families. Bearing that in mind, the feeble motives for which some people have already asked to be cloned, appear even more evident. These requests have been made, above all, in the United States, and even the most emotionally understandable ones seem absolutely irrational. The real problem is that the purpose of research on human cloning has nothing to do with satisfying either insane love of self or immense, inconsolable bereavement. So, if for a moment we ignore the ideological, magical or even religious interpretations of life, and we imagine a human cloning technique controlled scientifically and socially, and freed from the fear of unexpected collateral effects, what then do we find so aberrant and dreadful about the production of individuals starting from somatic cells? Are we really speaking about crazed nihilism or about the decomposition of life? Would it not be more honest to ask who on earth would want to utilize this technique, once we explain to everyone that it is practically impossible to make a replica of themselves or their loved ones? Would a few madmen do it, those able to amass considerable riches to fund their own stupidity? So what? What possible damage could these idiots do to mankind? And, in any case, in order to give birth to these babies, would it not be necessary to provide a womb to accommodate them, and love to nurture them? (Even a fool is capable of love.) Personally speaking, I believe that studies carried out on human cloning will be useful only to increase knowledge about reproductive biology and to open new frontiers for the possibility of constructing (cloning) organs useful for transplants, and thus precious for mankind. A less visceral and anti-scientific attitude is basically what is requested by those who continue to ask that scientific research be allowed to live in a regime of liberty, controlled by a secular society.

64

Flamigni

To finish, it seems to me that a system of dogmatic prohibitions is growing and falsely rational support is being given to it, extracted with ability from the category of phantoms and visceral anguish. On this subject, the example which strikes me as being most enlightening is that of the so-called eugenics, depicted as a subtle but dramatic aggression against that which, more than anything else, makes man what he is, his genetic identity. I believe, regarding this, that the gene therapy which is presently being dreamed by geneticists (not, as yet, a concrete possibility) is nothing other than a new, perhaps more modern, but not a "different" form of therapy, necessary in order to remove pathological genes and to replace them with normal ones. Every different interpretation, every allusion to positive, improved or creative eugenics is made in bad faith, sciencefictional bad faith, but not for this is it less idiotic or malevolent. However, it is probably not the most striking values which condition the choices of science, but - despite religious opinion - a more general disposition of the human general conscience, that which, in other words, is defined as common sense morality. If what I have said is true, then the idea that, compared to the relative autonomy of science, there is always a general regulation of the social application of scientific discoveries, it could prove to be Utopian, because it does not take into consideration the capacity of disintegration and transformation possessed by that which many define as "the intuition of possible knowledge". Common sense morality is formed in each one of us through multiple influences. Nowadays, the need is felt for a different influence which derives from ethics adapted to an ever-changing situation, ethics which are capable of adapting to the constant evolution of knowledge, but which are also able to safeguard some fundamental characteristics of the human species. The relationship between common sense morality and perception of possible knowledge is kept alive and effective by the diffusion of knowledge and by the promotion of specific cultures, and it is precisely against this diffusion that traditional morality takes its stand (when not doing worse, such as spreading erroneous knowledge or dogmas). Only non-dogmatic ethics can accompany in time that interaction between common sense morality and the intuition of possible knowledge, capable of allowing - in a systematic and longitudinal way - scientific research to find answers to existing questions and letting these answers express themselves in inexorable, positive changes of natural society. To conclude: it is true, in science, neutrality does not exist, but neither does control of science exist that is not partial, momentary and unreal. Every different sensation is due to our short-sightedness. No researcher

Possible Knowledge and Changes in Common Morality

65

truly has the right to give advice in order to exit from this impasse. If it were allowed, I would suggest modulating control, making the development of knowledge harmless for man's moral sensitivity which is also, fortunately, capable of being modulated. In the meantime, it is civilized - although perhaps useless - to continue to lock heads over our doubts while leaving in peace our certainties. Professor of Gynaecology, University of Bologna, Italy

This page intentionally left blank

Information and Decision Eligio Resta

1. FREEDOM FROM CHANCE Genetic information is an expression with a wide range of meanings and it poses questions on an equally wide range of issues: what it really is or should be, what it should be like and how it should be used, who it belongs to and how it should circulate; even whether it should be someone's property or can be sold. These issues are not merely the domain of debates among experts. They are everybody's concern and so should be included among "public ethics" problems; yet it would be more correct to give them back their ecological dimension since they are related to our living conditions. I have been concerned for a long time with the problem of identity and the lost certainties of the self (not so much "a governing sovereign", according to R. Musil). Therefore I have always considered genetics the scientific language that offers relevant information on the problem of identity. There is no doubt that genetics, for what it does, focuses on the relation between science, chance and freedom. This problem, much debated, has not been solved yet; in fact, that which gives information on data relating to life should also reduce chance and increase freedom, assuming that freedom and chance are inversely proportional. Obviously things are much more complicated and it happens that - this is the case of genetics - a "control" exerted over chance does not correspond to an increase of either individual or collective freedom; far from being a restraint, this is a real incentive to research. Here lies the scientific question of genetics, given the increasing request that ethics and law provide standardization and regulation, in order to define the space to be left to chance or freedom in research. Yet there are some contradictory counterfactual effects: the uncertainty that we aim to reduce by regulation affects our discussions on the regulations to be adopted. Therefore the anxiety shifts from the technological-scientific level to the ethical-juridical one, displaying something structural that should be 67 CM. Mazzoni (ed), Ethics and Law in Biological Research, 67-74 © 2002 Kluwer Law International. Printed in Great Britain.

68

Resta

considered in terms of a general theory. So the ambiguity, the compromises, the legal moratorium (as Pietro Rescigno says) of public policies should perhaps be analyzed with an anthropological approach to investigate in depth the forms and contents of our communication processes. Here, too, attention to paradoxes can be a way to acquire small bits of knowledge, rather than leading to a decision-making paralysis based on prejudices justified by an imaginary ethics. Anxiety can be positive in so far as it helps us understand the difficulty of legal systems when faced with the unusual dimension that genetics has presented us with in recent years. Genetics can be defined, as Piazza, did, as a scientific system that: (1) is research-based; (2) adopts "information" as its code; (3) defines "biological diversity" and "evolution" as its field. This definition is particularly meaningful because it implies a complex mechanism not merely governed by technology or ideological and manipulative reasoning. First of all it is based on research; this means that genetics lives on research because it is neither therapy, nor the application of scientific directives. Another element connected to the particular character of research is information, making genetics not simply a set of protocol procedures aiming at diagnostic or therapeutic actions, but actually a system of genetic expertise providing knowledge for individuals and the system as a whole. It is not easy to say who the interlocutors or beneficiaries of this information are, as it would imply judging those who misappropriate information, a field that concerns both ethics and the law. Finally there is the third element, the fact that research aims at enhancing the value of biological diversity. This may mean that the task of genetics is to preserve biological diversity, but it may equally mean that biological diversity is the starting point of genetic research. This is perhaps the most interesting question to debate, but we are not going to treat this argument here. My paper aims at providing an assessment of genetics built on research and its function in storing and communicating information. In a nutshell, genetics is a communication system working with and around information. From this point of view it is the child of its time, since what is important these days is not content but information potential: ours is the age when even capitalism defines itself as "wisdom-based" transferring the value of "technical assets" exclusively to a vast production of information. This means that: (1) a paradoxical communication of the various systems, including that of personality, is produced about the given information; (2) information makes individuals more aware but not more free; (3) we may be individually more informed but also more uncertain; (4) and therefore more lonely; (5) lastly, we may be more informed and for this reason share a greater collective responsibility and solidarity.

Information and Decision

69

2. WE CAN Do ALL THAT WE CAN Do First of all we must dispell the illusion that legal arguments will allow us to find the ultimate criteria needed to solve the problems that biotechnology has raised in public opinion. We must acknowledge this, if we are to avoid unrealistic debates based on imaginary premises. The implicit request the scientific community is addressing to our legal systems is to provide a definition of principles (if not outright rules) to discipline or guide our actions in relation to the growing possibilities offered by the introduction of new technologies. The latter have not only produced a growth of knowledge but have also changed radically the range of available possibilities: this change produces discontinuity in the common language, interrupting hermeneutic compatibility. Philosophy of language has already defined such a condition as "adlinguisticity" by which new language possibilities are experimented within language possibilities, with the result of compatible incompatibilities. Therefore new technologies have altered what was a reassuring communication mode, making it increasingly difficult to find overlapping codes in the domain of life. New technologies are by no means a threat to life; there is instead an ecological dimension of the problem regarding life or oikos as a whole, which cannot be confined to specific scientific domains. The question is how to regulate the world and at the same time surpass its limits from the inside with paradoxical effects. As a consequence, the conflict between the code of technology and that of the law, both referring to "life," seems to be insoluble. If the code of technology is "being able to do" and the question is "what can we do?", then the tautological answer will be: we can do all that we can do, anything we are capable of doing, that is. The limit is the ability to do something, and the purpose is the progressive removal of the limit. On the other hand, ethics and law state that we cannot do everything we are capable of doing, and the conflict lies in not being allowed to do something that other codes tell us we can do. As Nietzsche wrote in his Genealogie der Moral, we can do what we naturally do, like killing, deforesting, producing misery; whereas it is definitely Utopian to affirm, by law, that we cannot do what we can and are doing. Since technology is a power that greatly increases the possibilities of what we can already do, law would be expected to be an even greater power capable of neutralizing it. By mimetic effect, law would be equally or more powerful than any other technology, with paranoid results as I explained when I defined law as pharmakon, that is both poison and antidote, illness and treatment at the same time. The problem has no easy solution at the moment. It can only be understood better. Legal principles, for instance, cannot be considered as ultimate

70

Resta

solutions in order to provide cogent rules capable of governing the "chance" outcome produced by technology. The principle of "human dignity" laid down in laws, constitutions and declarations (if a definition of dignity is indeed possible), explains nothing about the possibility of limiting or favouring a certain biotechnology. How can cloning or not cloning a human being be against dignity, if this action can save other human beings? This is always true: genetic testing on animals is allowed in order to get information for the benefit of human beings. But even animals are living beings, so they cannot be deprived of their "dignity" either. This is a very important problem, with no easy solution, even by hermeneutics. It is not different for the question of genetic information. To get genetic information may signify to know causes and effects of a certain biological status, but that does not mean that decisions (when possible) are easily made. It is much more difficult when no decision can be made, as in case of genetic diseases for which there is no therapy, where the anguish of making or not making a decision can only increase. This is where the right not to be informed comes in: whether it is better to be informed or not is difficult to say. More information on the complexity of an identity does not necessarily mean an increase in decision-making capacity. On the contrary, the more informed, the more uncertain we are, since frequently informed decision increases solitude.

3. UNCERTAINTY, IGNORANCE, RISK We must therefore analyse the meanings and models of decisions taken on the basis of more or less information. Not by chance, J. Rawls in his theory of justice employed the "ignorance veil" to build models of fairness: in order to reach fairness we have to suppose that individuals, groups or generations make decisions or choices avoiding knowledge and biases. The example is really appropriate: the more complex the information, the less easy the decision. We can statistically reduce the uncertainty, but we cannot eliminate the counterfactual effects, or the "hope principle" (Das Prinzip Hoffnung), or the right to chance. Predictability does not rule out chance and does not reduce (as normal therapies do) every "biography" to "biology" (this is true even for cloning). Neither ethics nor the law can be of help: the law would have to recognize at the same time the right to be informed and the right to ignore. The law would have to transfer the solution to a congruent generalization, like the right of the individual to choose. This is a tautological reflexivity that leaves the decision-making process unchanged. The game thus goes back to the information/decision circuit, and here genetics becomes a very interesting observation ground.

Information and Decision

71

The conflict between information and decision in the field of genetics becomes the well-known struggle between complexity and contingency. Information produces complexity and decision has to reach contingency (decision comes from de-caedere, that is to cut from a field of possibilities). The individual is more and more lonely because he is overloaded with possibilities and compelled to express just one preference. Genetics is only a producer of complexity, since it is not concerned with therapeutic solutions. From the viewpoint of the relationship between knowledge of the context on the one hand, and the act of decision-making on the other, we have three models of decision: decision under ignorance, decision under uncertainty and risk decision. Decision under ignorance starts from lack of knowledge of the causes and boundaries of the problem, and ignores the effects of decision. The economy of time is only in the present. On the other hand, decision under uncertainty is conscious of the outline of the problem and faces the ambiguity of alternative solutions but the effects of which are independent from the choices. Finally, risk decision, which is closer to genetic information, starts from a condition of full awareness and wellknown data, but it is not able to calculate the consequences of the decision. The risk is inherent to choice, but people cannot say or predict that nondecision-making avoids any risk. This kind of decision is future-oriented but involves the incalculability of chance which is independent from the individual's decision. The hazard of risk decision is the typical case of rationality bound by constraints (as Luhmann says "liberty is the result of haste"). Decisions based on genetic data are said to be typical of uncertainty or risk. Information reduces the uncertainty of the past but increases the uncertainty of the present and the future (as happens with DNA evidence in the trials). The risk of genetically informed decisions concerns increasing expectations: more problems can be solved, more risks are involved and the risk means running the risk. We will never know what the "ecological" consequences for future generations will be of adopting or not adopting certain solutions on the basis of the information we possess today; yet we cannot help making decisions or avoiding risks.

4. PREDICTION, PREDISPOSITION, PREDESTINATION Genetics is by definition research and information on relevant parts of a story describing identity. Like all other identities, genetics has no homogeneous time dimension because it is between past, present and future. Genetic information is identity datum, rather than limit or resource. Datum means

72

Resta

any peculiarity given to us, either imposed or donated. Not by chance our own identity data are written on an "identity card" so that we may be identified, distinguished and not confused with another. These data come from a story of "distinctive features" but they also point to a future story as well, where the attempt is made, regardless of the subject, to confuse biography with biology. In fact in German the roots of the words history and destiny (Geschichte, Schicksal] are overlapping, as if to bind together past and future. That is the case of genetics and identity. The broadest knowledge of data and genetic sequences corresponds to the fullest information on genetic "history" and the possible destinies as well. The term predictability means exactly this: we can reconstruct a destiny from history by causal or statistic inference. Predestination is mainly applied to biological evolutions or diseases. This could be useful to increase knowledge in decision making if it were not for "the demons of life" that bring about uncertainty. It occurs because of the hope principle, or because of trust in uncontrollable data, or prevalence of biography over biology, or rather the "romantic" attempt to write history in one's own words; it may be something else but the only effect is the re-opening of the range of possibilities. Therefore more informed may signify, in spite of everything, more uncertain, since it is no longer possible to believe that the results are certain or that the risks are predictable; there may definitely be an increased responsibility and a different perception of the other human being involved in the decision, but the imponderability of decision-making is by no means cancelled. Being "pre-disposed to" and "pre-disposed for" increases the anxiety of choosing for the future which is "risk" by definition. As Hobbes declared in early modern times, "troublesome more when easy", where everything is linked to a decision that exposes the individual in all the elements that characterize his identity. If it is a matter of anxiety, it is not a new one: in religious ethics the link between history and free destiny, with its right to chance, was deeply investigated in early modern times as well, just as intensively as scientific-technological research today forces highly difficult issues upon individuals in this social age. The history of those times is similar to ours, especially in the similarity between yesterday's notion of theological predestination and today's genetic predisposition. At that time, a predestination-based ethics had reduced the responsibility burden of individual free will and individual conscience. It is not worth committing oneself to the struggles of this world, to the search for goodness, if God's plans are already made and everything depends on the inevitability of God's will according to which all actions have already been judged. Then theology re-introduced the value of grace, to provide autonomy of choice

Information and Decision

73

and economics of responsibility; religious ethics vouched for that and predestination was given its counterweight. In a less religious vision, genetic predisposition to certain consequences is equal to predestination, where one will expect at least the uncertainty linked to the hope principle or to faith in unpredictable developments in genetics. As I said above, anxiety can be healthy, as in this case, since it helps place the issue of decision-making within a context of awareness of existing paradoxes. The risk belongs to the decision-maker, who chooses by using information from another system, with consequences on himself and on relational fields far greater than his own world: in extreme cases, the rule is that everything could be different but nothing can be done to make this happen. Genetic information links us to the past but increases the mechanisms that make the future imponderable. From this point of view, genetic data are a communication paradox with any other system. That explains why, within the context of social systems (where ecology is a "world" to the systems), each system claims priority for its own code in biotechnological research and, at the same time, there is a constant search in other systems for a universal rule and a universal decision-making principle. Likewise economics will claim priority for its own utility code (costs and benefits), and technology will demand autonomy for its research, independently from its goals or the possible users of its results, and medicine will herald its objectives and reasons. Local dialects (of any code and system) will be universalized, unless the problem-solving is transferred elsewhere. All this explains the frequent reference to law and to ethics, and from these systems to mechanisms that are increasingly based on reflection. An example is the case of public decisions to be made in the field of bioethics: faced with the full range of codes and moral entities, they have given up regulating the problem by neutralizing the risk of decision. Thus they have transferred everything to the level of procedural decision to enact Entparadoxierungen: they have decided not to decide, leaving decisions to specific bio-ethical committees whose task it is to place the experience within the system/s and decide according to the power of attorney they have been granted. The question of ecological decision-making is thus reduced to detail and transferred from the core of the system to the periphery. The effect is that this neutralization incorporates the paradox of decision-making into a system for all systems; despite this, we are not immune from risk and still start quarrelling about who should represent whom in the decision-making committees. There is no meeting point between competences and interests. Meanwhile the real risk, that of the political system appointed to decide for everyone, is merely delayed.

74

Resta

From the point of view of ecological communication, we can foresee the "paradoxical" context of the problem. Sooner or later the coercion to decide will oblige politicians to resort to general clauses in order to save the highest possible number of possibilities within any system. The result is that we will transfer the decision-making to peripheral regions where the individual is left alone. This already happens in Italy, where judges are asked to decide on a particular bioethical case according to general criteria like "dignity", "gratuitousness", "the best interest of the child", "the right to parenthood". In the "domain of life" the problem is the conflict between a number of different fundamental rights: right to life versus a "Leopardian" right not to be born, right to non-discrimination versus a "Stirnerian" right to uniqueness, and so on. And we have no meta-rule to follow to help us reach a fair adjudication. A judge is better than a concealed decision-maker without responsibility. Nevertheless, the judge is obliged to decide but not able to do so. What can be demanded is a correct argumentative procedure so as to make as visible and generalized as possible the social information concerning the issue. In a deliberative model of democracy the role of geneticists, and scientists in general, becomes once again that of researchers and information providers. Professor of Sociology, University of Rome, Italy

Biomedical Law: The Aims and Limits of Regulating Biomedical Science and Technology Amos Shapira

I would like to start with a general remark on the role of law in the problem area we are discussing. I believe that legal science does have an important role to play, in a meaningful multidisciplinary co-operation of the kind we contemplate. If the primary responsibility of biologists and other scientists is to elaborate scientifically sound research proposals, and if the main task of ethicists and philosophers is to articulate relevant socio-moral principles, jurists can contribute to the normative engineering of the bioethical field, After all, women and men of law are well suited, by schooling and by training, to reason from broad norms to specific fact situations, to analyse concrete cases in the light of normative abstractions, to synthesize guiding rules from an aggregation of particular rulings, to balance varied - and sometimes conflicting - claims of interest and fairness. Biomedical law is a fast growing discipline, converging on a variety of traditional legal fields, such as contract, property, criminal, administrative and constitutional law. Scholarly endeavours in this emerging juridical field are to a large extent prescriptive rather than descriptive in essence. Their main task is programmatic: to articulate the considerations that ought to guide societal decisionmaking in an attempt to transform a non existing 'lex lata' - the present law - into a satisfactory 'lex ferenda' - the desirable future law. Another characteristic of biomedical law is its close affinity to human rights jurisprudence. In view of their presence in every day reality biomedical human rights - relating to issues of life and death, health and sickness - are not too difficult to recognise and to identify with. Also, due to the novelty, complexity and sensitivity of bioethical dilemmas, law proposals must focus not only on particular existing practices and alternative regulatory measures, but also on the social, moral rationale underlying such practices and suggested regulatory measures. And responsible law reformers in an area surrounded by cultural and emotional debate must be careful 75 C.M. Mazzoni (ed), Ethics and Law in Biological Research, 75-77 © 2002 Kluwer Law International. Printed in Great Britain.

76

Shapira

not to substitute feelings of indignation and anxiety for reasonable judgement. I believe that, in a pluralistic society, people of varied religious and humanistic persuasions are prone to display a wide diversity of moral attitudes towards the novel technologies affecting reproduction and genetics, human dignity and social control, family integrity and professional responsibility, freedom of scientific research and state regulation. Such profound diversity makes it highly unlikely that any suggested normative scheme will be accepted by everyone without reservation. This is not to say that the law cannot or should not provide one major source of guiding principles in the bioethical sphere. But to be fair and effective, such principles ought to present a carefully balanced common social and moral position. And one must also bear in mind the inherent limitation of all regulatory law in a free society. Such law should only attempt to set the really necessary directives, the minimum inhibiting limits, the reasonable requirements calculated to guarantee a tolerable societal life. In the words of professor J. Goldstein from Yale University Law School, writing on a different theme (the issue of parental authority regarding medical care for new-born children): "the law must sometimes acknowledge that it does not know what the conventional wisdom is; that what is a right answer for you is maybe a wrong answer for me, and vice-versa, that none has the right answer for everyone". It follows that what is legally permissible is not necessarily socially desirable, or morally praiseworthy. Individuals and groups may voluntarily opt, for instance on religious grounds, for more stringent norms of behaviour. Within the broad limits of the law, should our society make room for different moral judgement? The law just can not guarantee an absolute and uniform quality of all human transactions. Now, to trumpet in an academic setting such as this, the virtues of scientific freedom, is of course to preach to the converted. We all cherish and champion the cause of valid, honest and unimpeded scientific research. The opportunities offered by contemporary biological technology for the betterment of the human condition are overwhelming, but so also are the many risks involved, first and foremost the danger of dehumanisation in the sense of treating humans as a means rather than an end. The law is one device, not the only one, which can be used to curb instances of unjustified risks, manipulation and abuse. Yet, as noted by some other scholar, and I quote again: "law needs to be regarded as a powerful instrument with its own potential for harm, and like medicine, it must only be employed judiciously". Now, three brief remarks concerning the discussion we had. First, professor Mazzoni in his opening address rightly pointed to the necessity of informing and educating the public, the man on the Clapham omnibus

Biomedical Law

77

which runs in London. Of course, this is extremely important, for obvious democratic reasons. If we want a democratic process to unfold in making decisions on the matters we are discussing, the public must understand what we are talking about, what are the risks, what are the benefits, what are the pros and what are the cons. And here, of course, the media, can and should play a major role in cultivating public opinion, in educating the public, in imparting information to all of us. However, I must admit, from my own experience, that the journalistic coverage of novel technological advances has hardly been outstanding and praiseworthy. More often than not, journalistic treatment has been superficial, ignorant, sensational, manipulative, damaging, and exaggerated both in trumpeting unrealistic expected utility or benefits and in portraying an inflated picture of the risks and dangers, allegedly involved in certain technological developments. A second comment. Most speakers this morning when discussing the human genome enterprise, focused on anticipated benefits and risks to individuals in consequence of genetic screening diagnosis or therapy. We have not yet given sufficient consideration to genetic screening and therapy programmes addressed to population groups defined by race or ethnic origin. Such groups could readily be subjected to stigmatisation, prejudice and discrimination as a result of such a process. I believe that this specific aspect of genetic science deserves special attention. Finally, the often referred to concept of human dignity is rather vague in formulation and nebulous in meaning. It is highly culture-dependent and value-sensitive. I doubt that it will be easy to synthesize a transcultural, transnational definition of the concept of human dignity in general, and in the bioethical context in particular, which will be acceptable to one and all. For instance, does the concept of human dignity protect an embryo in the same way and to the same extent that it seeks to protect a five year old child, or an adult reaching the age of fifty? Is an embryo a fullfledged human being endowed with human dignity, like all of us sitting here now? I don't believe that there is a uniform, commonly acceptable answer to this dilemma, which is transcultural and transnational in its dimensions. Still we should endeavor to better understand the complex and diverse contours of the concept of human dignity as it relates to biomedical research. Professor of Law, University of Tel Aviv, Israel

This page intentionally left blank

The Epistemic State - The Legal Regulation of Science Mariachiara Tallacchini

The best rulers are scarcely known by their subjects. Lao-tzu, Tao Te Ching, XVII

1. BlOETHICS, BlOLAW AND THE LEGAL REGULATION OF SCIENCE

For a long time emphasis was placed on the need to let the bioethics debate develop freely, without the intervention of premature or untimely legal constraints. The suggestion that law was not a valid instrument for regulating bioethical questions was based on a number of reasons. The first of these was the novelty of this kind of problems and the speed of technological change, to cope with which legislative procedures appeared excessively rigid and laborious. A second reason was that bioethical problems emerged in concrete situations, which, made it difficult to solve particular cases within the framework of general norms (in common law countries the difficulty was overcome more smoothly thanks to the judicial system). A third and final argument against law-making within the bioethical ambit was the difficulty for pluralistic systems to unify largely divergent moral and/or religious conceptions, thus impinging upon subjective legal rights which could be better solved by personal choices, or so it was believed. These perplexities have been overcome in the last few years by the serious, concrete problems caused by the lack of rules in the bioethical field problems of individual health, collective safety and health, and the perverse effects triggered by the clash of existing normative arrangements and situations resulting de facto from new biomedical technologies (inconsistencies between family law and reproductive technologies, to cite but one example). These contingencies have thus given way not only to the legal regulation of bioethical issues in single national legal systems, but also to the pursuit of normative approaches common to more than one country, as has been 79 CM. Mazzoni (ed), Ethics and Law in Biological Research, 79-96 © 2002 Kluwer Law International. Printed in Great Britain.

80

Tallacchini

the case of the Convention on Human Rights and Biomedicine in the Council of Europe.1 However, the move from bioethics to what has been christened biolaw risks taking place with a somewhat narrow perspective of the topics under discussion. By this I mean that biolaw is widely seen as a mere codification of bioethical positions, often with the sole variant of mediation or bargaining - due to the need for democracy - among different bioethical ideologies. Far from the result of a written, ratifiable transposition of ethical visions, the legal regulation of bioethics stands out for distinctive traits of its own. More specifically, one element that needs to be stressed is the different relationship between facts and values which emerges, respectively, in the domains of bioethics and biolaw. In bioethics, which seeks mainly to determine the principles and rules of individual action, an explanatory link between facts and values does not always appear necessary - both in religious perspectives and in perspectives based on the separation between facts and values (ethical non-cognitivism). Otherwise, the collective and democratic dimension of modern legal systems and the collective, 'universalizing' dimension of science and technology would appear to indicate the explanatory link between facts and values, not only as a practical necessity but also as a distinctive theoretical foundation. The fact is that science as a whole has always constituted not only a body of cognitive methods but also a value - the value of knowledge founded on and institutionally pursuant of an investigation into reality whose degree of acceptability and 'shareability' is constantly questioned. This value assumes a characteristic role in democratic and pluralistic societies, which sometimes struggle to compact round shared values. This does not mean that we have to 'sanctify' scientific knowledge. However, if, on the one hand, we have to acknowledge that scientific and social systems share a number of principles, on the other one of these principles is the axiological status of science, which is what makes it a value as opposed to a power in the hands of a few.2 The indissolubleness of the bond between epistemology and normative choices seems to be the axiological nucleus of relations between law and science, justifying the partial conceptual autonomy of biolaw from bioethics. 1

Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine (Convention on Human Rights and Biomedicine), 4 April 1997. 2 Cf. M.L. Goggin (ed.), Governing Science and Technology in a Democracy, The University of Tennessee Press, Knoxville 1986.

The Epistemic State

81

But this nucleus represents only one of the elements of the vast, still largely unexplored panorama of regulatory questions raised by science.

2. The Legal Validation of Science: The Epistemic State The social implementation of science and the attenuation of the clear-cut separation between the laboratory and the outside world - on account of the fact that many technologies can only be tested in the environment have given law an original new role as a regulator not only of scientific activity, but also of scientific knowledge.3 Law assimilates the contents of science in growing quantities and in an increasing number of ambits; it validates scientific knowledge, establishing which propositions may be deemed reliable and capable of producing legal effects. In short, if law acquires scientific notions, it also shapes science through legal criteria. To regulate science, it has to acquire the knowledge and methods of science. The complex mutual relations between science and law are thus by no means dependent on the reference that legal norms make to parameters fixed by science. The translation of science into legislation is a complex process. This is partly because, when it has to translate scientific entities legally, law sets out from world images that are not firmly rooted in common sense (to which many legal concepts still owe a great deal), partly because scientific discourse is governed by rules, forms of rationality and ends that are relatively precise and different from legal ones, and partly because of the characteristic effects produced when a scientific proposition is transposed onto the normative language. Even when it simply involves adopting a scientific definition - and normative documents relating to scientific contexts are increasingly packed with defining premisses - the legal translation of science gives rise to so-called 'prescriptive definitions', which reflect the imperative character assumed by the scientific definition when it becomes the subject of a legal norm. In fact, the scientific-normative definition stands as a 'protected' truth, it becomes unquestionable unless it is revised or abrogated by law, 3

Cf. S. Jasanoff, The Fifth Branch. Science Advisers as Policymakers, Harvard University Press, Cambridge Ma. 1990; K.R. Foster, D.E. Bernstein, P.W. Huber (eds), Phantom Risk. Scientific Inference and the Law, M.I.T. Press, Cambridge Ma. 1993; S. Goldberg, Culture Clash. Law and Science in America, New York University Press, New York 1994; S. Jasanoff, Science at the Bar. Law, Science, and Technology in America, Harvard University Press, Cambridge Ma. 1995; K.R. Foster, P.W. Huber, Judging Science. Scientific Knowledge and the Federal Courts, M.I.T. Press, Cambridge Ma. 1997.

82

Tallacchini

since it can be modified only by an ulterior normative intervention and not by being questioned within the scientific community. Moreover, its consequences are different from those of a merely scientific definition insofar as its legal enactment supports and justifies the technical-normative arrangement that depends upon it,4 and it implicitly deprives any different opinions of institutional legitimacy. Hence the problem of the statute of dissenting science, by which I mean positions rejected or only partially accepted by the official scientific community, and, as such, not assumed by law or not even viewed upon as 'good science'.5 Finally, scientific-normative truth makes the question of which criteria should be used to evaluate and validate 'good' science a crucial one. Another aspect of the relationship between science and law might be defined as 'the legal creation of scientific entities', achieved, for instance, through the patent system. These are situations in which law decrees the legal existence - which often coincides with the possibility of existence itself - of new entities created by science through the granting of patents. This 'creation by authority' of new scientific processes and products has acquired distinctive characteristics with the patentability of biological material.6 Until not very long ago, the laws of nature were obviously not subject to legal patentability, since nature can be discovered, not invented.7 The 4

A concrete example could be that of norms for the treatment of laboratory animals, in which the whole technical discipline depends on the normative assumption of the proven evidence that the animals feel 'pain, suffering and anxiety' (art. 2, D. Igs. n. 116 of 27.1.1992). 5 Until 1993, the rule for admitting scientific experts was based on the so-called Frye standard, that dated back to 1923 (Frye v. United States, 54 App.D.C. 46; 293 F. 1013; 1923 U.S.): 'When the question involved does not lie within the range of common experience or common knowledge, but requires special experience or special knowledge, then the opinions of witnesses skilled in that particular science, art, or trade to which the question relates are admissible in evidence. (...) Somewhere in this twilight zone the evidential force of the principle must be recognized, and while courts will go a long way in admitting expert testimony deduced from a well-recognized scientific principle or discovery, the thing from which the deduction is made must be sufficiently established to have gained general acceptance in the particular field in which it belongs'. In 1993, with Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579 (1993), the U.S. Supreme Court held that judges have the ultimate power to define who an expert is. «(T)he 'general acceptance' test of Frye v United States (...) is not a necessary precondition to the admissibility of scientific evidence (...). (...) a federal trial judge must insure that any and all scientific testimony or evidence is not only relevant but reliable; and (3) in a federal case involving scientific evidence, evidentiary reliability is based on scientific validity». 6 Cf. F.B. Rudolph, L.V. Mclntire (eds), Biotechnology. Science, Engineering, and Ethical Challenges for the 21st Century, Joseph Henry Press, Washington D.C. 1996; E.S. Grace, Biotechnology Unzipped, Joseph Henry Press, Washington D.C., 1997. 7 In Parker v. Flook, 437 U.S. 584 (1978), the U.S. Supreme Court pointed out that 'method (...) in which the only novel feature is a mathematical formula, held not patentable, (...) since assuming the formula to be within prior art'.

The Epistemic State

83

philosophical implications of patents8 have attracted growing attention since, with the technological manipulation of living materials, the separation between ideas of discovery and invention, previously defined in relation to inorganic matter, has become increasingly less obvious. The assertion of the substantial equivalence between inert and biological matter (composed of the same basic substances)9 has not only introduced the equal patentability of biological artifacts and entities, but has also made the law the place where the boundaries are staked out between 'work of nature' and 'human work'.10 These two examples of problems in the relationship between science and law stem from the more general problem of the uncertainty that connotes relations between the two domains of knowledge. Relations between law and science are in fact characterized by a general situation of uncertainty involving both science and law. The science encountered by law is a revisited system in terms both of its way of considering facts and of its presumed neutrality vis-a-vis values. Science no longer appears as certain, neutral knowledge, which law should simply acknowledge without any attempt at evaluation, but a domain of knowledge with broad margins of discretion both from the point of view of objective data and from that of scientific opinions. Accordingly, both "objective" and "subjective" uncertainties exist in science. The idea of objective uncertainty denotes the various forms of indetermination resulting from the complexity of knowledge, from the lack or insufficiency of data, from the unforeseeability of outcomes and from the

8

R. Eisenberg, Patents: Help or Hindrance to Technology Transfer?, in F.B. Rudolph, L.V. Mclntire (eds.), Biotechnology. Science, Engineering, and Ethical Challenges for the 21st Century, cit., pp. 161-172; A.D. Moore (ed.), Intellectual Property. Moral, Legal, and International Dilemmas, Rowman & Littlefield, Lanham 1997. 9 The U.S. Court of Customs and Patent Appeals (CCPA), in In re Bergy 563 F.2d 1031 (1977), established that, as far as patentability is concerned, 'the fact that microorganisms are alive is a distinction without legal significance'. 10 In the leading case Diamond v. Chakrabarty, 447 U.S. 303 (1980), concerning the patentability of an engineered microorganism, the U.S. Supreme Court stated: 'Einstein could not patent his celebrated law that E = me2; nor could Newton have patented the law of gravity. Such discoveries are manifestation of nature, free to all men and reserved exclusively to none. (...) respondent's micro-organism plainly qualifies as patentable subject matter. His claim is not to a hitherto unknown natural phenomenon, but to a nonnaturally occurring manufacture or composition of matter a product of human ingenuity [...]. His discovery is not nature's handicraft, but his own'.

84

Tallacchini

stochastic character of forecasts.11 The idea of subjective uncertainty alludes instead to the values underpinning scientific judgements,12 which have both theoretical and effective influence. To identify the values which influence the work of scientists is not to devaluate the components of the objectivity of science, albeit within disciplines whose predictive and sometimes explanatory capabilities are weak. On the contrary, this awareness allows for a better, more objective connotation both of the effective progress of science and of the options available.13 In this situation of uncertainty, law becomes a 'coessential' element in the definition of scientific knowledge, which is socially constructed.14 On the other hand, the power of law over science renders all the more stringent the need to clarify and to control both which science law assumes as valid and the modes and criteria for doing so. In other words, law has to justify the scientific nature of its decisions. When the scientific community is not compact, but adopts a variety of theses or forecasts, law, called upon to solve an uncertain question, gives a prescriptive solution to an open descriptive knowledge. But since it is law which determines the conditions for science validation, when it makes a choice between different representations of scientific phenomena, certain scientific positions become imperative and begin to produce legal effects: for example, in the ambit of health allocations, with agreed economic subsidies to given drugs or therapies; or else in relation to the shouldering of risks with the determination of negligible or noteworthy levels of risk.

11

B. Wynne, Uncertainty and Environmental Learning: Reconceiving Science and Policy in the Preventative Paradigm, 'Global Environmental Change' 1992, June, pp. 111-127. Smith and Wynne distinguish among different kinds of uncertainty: risk, uncertainty and ignorance. As in risk conditions the negative outcome is known and its probability is quantifiable, uncertainty refers to situations where the negative outcome is known but its probability is unknown, and ignorance occurs when both the outcome and the probability are unknown. 12 'Subjective' uncertainty - by contrast with the 'objective' uncertainty due to the lack of scientific knowledge- refers to the non-neutral character of science, to its value-laden nature. Cf. K.S. Shrader-Frechette, Risk and Rationality. Philosophical Foundations for Populist Reforms, University of California Press, Berkeley 1991. According to Shrader-Frechette, scientific judgments can be affected by bias values, contextual values, and constitutive or methodological values. 13 S. Jasanoff, 7s Science Socially Constructed - And Can It Still Inform Public Policy?, 'Science and Engineering Ethics' 2, 1996, pp. 263-276. 14 S. Jasanoff, Beyond Epistemology: Relativism and Engagement in the Politics of Science, 'Social Studies of Science' 1996, Vol. 26, No. 2, pp. 393-418.

The Epistemic State

85

The situation that has arisen in the relationship between science and law configures a novel conception of the legal system and of the state, which may be defined as an 'epistemic state'; that is to say a conception according to which law determines valid scientific knowledge. Already in the second half of the Eighties, Schmandt and Katz spoke of a passage from an 'administrative state' to a 'scientific state' to point out the role which science plays in legal systems today. According to the authors, in this new sociopolitical arrangement science performs three functions: it is a product, it is a source of evidence and information, and it is a precise method of analyzing reality.15 The idea of 'epistemic state' adds something to this perspective. In fact, in Schmandt and Katz's analysis, albeit reshaping society and capturing the attention of law, for which it has become a major field of intervention and an authoritative method, science is still a totally separate entity from law, which merely acknowledges it passively in a situation of nonreciprocity. But the most recent interactions between law and science indicate that a much closer link now exists between the two sectors. In this sense, questions of scientific uncertainty are decisive, since decisions taken in conditions of ignorance, in which the indissoluble connection between facts and values reveals itself most conspicuously, make law the place in which particular facts and values are chosen and rendered authoritative.16 In such situations, it is crucial to establish which criteria are to be used for law to decide in the scientific ambit, since a generic appeal to sometimes divergent expert opinions would be insufficient. This means that law has to be acquainted with and screen the language of science, performing these operations on the basis of a conception of

15 J. Schmandt, J.E. Katz, The Scientific State: A Theory with Hypotheses, 'Science, Technology, & Human Values' 1986, 11, pp. 40-52. 16 The precautionary principle is the most interesting legal-scientific concept under discussion: see Commission of the European Communities, Communication from the Commission on the precautionary principle, Brussels 2.2.2000, COM(2000)1. The precautionary principle has been defined in the Rio Declaration on Environment and Development (14.6.1992), Principle 15: 'In order to protect the environment, the precautionary approach shall be widely applied by States according to their capabilities. Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing costeffective measures to prevent environmental degradation'. See also T. O'Riordan, J. Cameron (eds), Interpreting the Precautionary Principle, Earthscan, London 1994; C. Raffensperger and J. Tickner (eds), Protecting Public Health & the Environment. Implementing the Precautionary Principle, Island Press, Washington D.C.-Covelo Ca. 1999.

86

Tallacchini

scientific knowledge. But if this is the situation that systems now address on a daily basis at legislative, judicial and administrative levels, we have yet to see a transparent declaration of the criteria law uses to recognize and handle valid scientific knowledge, a definition of the values underpinning these criteria, the level of security adopted against risk, the destiny of unofficially accredited science and possible ways for it to be recognized with regard both to the freedom of scientists and to consequences for citizens. In view of the regulatory power which law has acquired over science, the two fundamental needs which emerge are for a reliable epistemology and for respect for democratic participation in science policy decisions.

2.1. An Epistemology for the Legal Regulation of Science The vision of science that currently underpins law would appear to oscillate between two opposed radical conceptions. The first is that of a reductionist neopositivistic epistemology, that is to say a position of the feigned neutrality of law towards science, invariably considered as certain through its concealment of margins of uncertainty, and assumed by law to be free of doubts. The second is that of an extreme epistemological anarchism or constructivism, in which science is viewed as totally undecidable, and in which the law takes arbitrary decisions on knowledge, rationally configured as being totally 'opaque'. (1) The first approach has two variants: taking for granted scientific certainty and hiding scientific uncertainty. (la) The first instance is exemplified by EU law vis-a-vis the 'principle of substantial equivalence'. The principle was elaborated for genetically modified foods to single out their possible health risks without holding back their introduction to the market. If a new food or food component is deemed substantially equivalent to existing foods or food components, the first are deemed equivalent to the second in terms of safety requirements (that is to say, engineered food or a component thereof may be considered as safe as their conventional homologues).17 17

Cf. Biotechnology and Food Safety - Report of a Joint FAO/WHO Consultation, Rome 1996: 'Substantial equivalence embodies the concept that if a new food or food component is found to be substantially equivalent to an existing food or food component, it can be treated in the same manner with respect to safety (i.e. the food or food component can be concluded to be as safe as the conventional food or food component)'. Report of a Joint FAO/WHO Consultation on the Role of Government Agencies in Assessing HACCP, Geneva, 2-6 June 1998.

The Epistemic State

87

Moreover, even when the substantial equivalence between genetically manipulated and traditional food is acknowledged - when, that is, products that cannot be grouped with known foods or food ingredients - the uncertainty resulting from ignorance of the properties of the new food does not necessarily lead to the adoption of particular cautions.18 The argument is that, since non-equivalence per se is not a synonym of lower safety, assessment procedures and tests are not necessary.19 The principle of substantial equivalence is relevant here in view of the legal process it has been subjected to. Born as a compromise procedure between science and market,20 it has been assumed by law as a scientifically sound procedure, justifying until very recently the non-labelling of genetically manipulated products, hence the nonprotection of the right to health and environmental information. Regulations 1139/98/EC, 49/2000/EC and 50/2000/EC have changed the situation, introducing compulsory labelling for foods containing GMOs. In terms of their normative qualification, such foods, once substantially equivalent, are now non-substantially equivalent. Albeit basically acceptable, this turnaround fails to reflect an acceptable regulation of scientific questions, since it makes no reference to the changing assessment of the possible risks of GMOs. The fact is that, interpreting the regulation, the provisions have been changed purely out of reasons of market convenience21 and on account of the lack of transparent and democratically controllable risk definition procedures. (Ib) The latter approach has been expressed in legal decisions which, in view of the uncertainty of some risks (in particular, risks from electro-

18 Cf. J. Fagan, A Science-Based, Precautionary Approach to the Labelling of Genetically Engineered Foods, http://www.natural-law.ca/genetic/FaganPrecaut.html; The Failings of the Principle of Substantial Equivalence in Regulating Transgenic Foods, http://www.naturallaw.ca/genetic/substantialequivbyJF.html (sites checked in June 2001). 19 Biotechnology and Food Safety - Report of a Joint FAO/WHO Consultation, cit: 'If a food or food component is considered to be not substantially equivalent to an existing food/component, it does not necessarily mean it is unsafe and not all such products will necessarily require extensive testing'. 20 Ibidem: '(•••) the concept of substantial equivalence is the most practical approach to address the safety evaluation of foods or food components derived by modern biotechnology. (...) Establishment of substantial equivalence is not a safety assessment in itself, but a dynamic, analytical exercise in the assessment of the safety of a new food relative to an existing food'. 21 Council Regulation EC 1139/98 concerning the compulsory indication of the labelling for genetically modified organisms, Preamble: 'whereas differences between (labelling) measures are liable to impede the free movement of those foods (...)'.

88

Tallacchini magnetic waves), have interpreted the non-quantifiability of risk - that is to say, a condition in which, according to the EU orientation,22 ought to envisage a presumption of greater magnitude of risk - as a situation in which there is no risk. A propos electromagnetic pollution, for example, the provision for the suspension of the building of a wave repeater has been denied by appealing to the uncertainty of possible damage. Since the risk is unquantifiable, it does not exist.23 When the margins of uncertainty in scientific knowledge are not adequately reported by science and reproduced by legal translation, the passage from the descriptive to the normative domain de facto increases concealed and occult risks, which are thus unduly imposed upon unwary citizens.

(2) An opposite view, definable as radical constructivism, tends to configure science as a form of undecidable, totally conventional knowledge. As a result, faced with the opaqueness and controversial nature of scientific facts, law decides irrespective of the scientific explanation of phenomena. This approach may assume three different variants. (2a) The first is that of methodological anarchism, which considers different opinions as being equivalent in content. This position is to be found when, in the name of respect for different cultural values24 or beliefs or different from official science,25 in domains of scientific competence it is deemed necessary for law to protect scientific and pseudoscientific opinions equally. (2b) The second connotation highlights the black-boxed character of many 22

Council Directive 98/81 EC (amending Directive 90/219/EEC) on the contained use of genetically modified micro-organisms, Art. 5.4: 'Where there is doubt between which of two risk classes are appropriate for the proposed contained activity(ies), the higher classification should be assigned until sufficient evidence justify the use of the lower classification'. 23 Cf. Tar Umbria, n. 1175 of 28.12.1998. 24 Cf. D.A. Farber, S. Sherry, Beyond All Reason: The Radical Assault on Truth in American Law, Oxford University Press, Oxford 1997. 25 In the controversy on the therapeutical effect of somatostatin, the Italian courts have pointed out that individuals have a right to receive free medical treatment (paid by the State) as far as a scientifically accepted therapy exists, which has been formally approved from the government. The State has no obligation to pay for alternative medicine, since the scientific validity of it is disputed. See, for instance, Ordinanza n° R.G. Pretura 247/98, Pretura di Milano, 26.1.1998, which stated that only official medicine can be supplied by the National Health Service (Servizio Sanitario Nazionale, SSN), and that only peerreviewed and legally approved medical treatments are acceptable. What is 'therapeutical' can only be 'objectively' defined by mainstream science and is not open to 'subjective' interpretation by lay people.

The Epistemic State

89

scientific problems, hence solves normative problems by identifying decision-makers as opposed to decision-making principles. It is this regulatory tendency that underpins the multiplication of authorities in sectors in which novelties, complexities or uncertainties require law to be prompt, flexible and reactive to concrete cases, albeit to the detriment of transparency and certainty. (2c) The third possible connotation is that of choosing values to be protected (despite all facts). This has been particularly true of damage to the environment. Since environmental damage is often uncertain the underlying causal nexus hard to ascertain, single causal contributions complex to identify and the emergence of damage sometimes delayed - some legislation has sought to reverse the burden of the proof, not only resorting to forms of strict liability, but also ultimately presuming the existence of a cause-effect relation between the event which causes the damage and potentially dangerous activity.26 But the configuration of responsibilities with no causation is certainly not in tune with the need for a more refined relationship between law and science. From the epistemological point of view, the use of legal instruments which are mere fictions not engaged with reality conveys a vision of science as totally indefinable. And to leave aside scientific facts means to black-box the decision from a political point of view. The two sets of epistemological positions outlined above appear equally inadequate within the framework of a general reflection on the legal regulation of science, in the sense that, albeit in opposite ways, they clearly separate facts and values in scientific knowledge. The first position assumes that science provides facts alone, the second argues that only values are decisive in the assessment of facts. Otherwise, a refined epistemology has to maintain a dialogue between facts and values, recognizing that each scientific position - especially when it has to inspire a public choice - is the complex product of interactions between theoretical analysis, factual considerations and axiological choices.

26

See the German law of 1990, Umwelthaftungsgesetz, which argues for a "presumed causal link" (Ursachenvermutung) between potentially adverse facts and an occurring damage. Cf. Umwelthaftungsgesetz (10.12.1990), par. 6,1: '1st eine Anlage nach den Gegebenheiten des Einzelfalles geeignet, den entstandenen Schaden zu verursachen, so wird vermutet, daB der Schaden durch diese Anlage verursacht ist'.

90

Tallacchini 2.2. Public Participation in Expert Decisions

The second need which the legal regulation of science has to meet is respect for transparent, democratic procedures. An important aspect of the question is public participation in expert decisions, which, at the same time, represents a prerequisite for a moderately constructivist vision of science acknowledging the socially determined components of scientific knowledge - and a guarantee of democracy in the social implementation of science.27 The first situation in which the judgment of laypersons became more important than that of experts was when informed consent28 emerged in the context of physician-patient relations. Outside the medical domain, one of the first applications of informed consent was in environmental risk.29 Another was in the field of biological risks for workers.30 Usually, however, the need for consent is correlated more to assessment of individual risk than to the overall acceptability of scientific-technological activity. It is necessary to observe, however, that in view of the huge power acquired by science and its market connections, informed consent is the only instrument we have for the discussion and social acceptance of the evolution of science. The reference to informed consent is an allusion to the need to elaborate a plurality of methods to enable the public to effectively 27

On the democratization of science see Commission of the European Communities, Governance and Expertise, 2000, Working Group I.b: Democratising expertise and establishing European scientific references (chair: Rainer Gerold), http://europa.eu.int/comm/ governance/areas/group2/inde_en.htm. See also A. Irwin, B. Wynne (eds), Misunderstanding science? The public reconstruction of science and technology, Cambridge University Press, Cambridge 1996. As far as public participation to science-based decisions is concerned, the most relevant international document is the Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters (Aarhus, Denmark, June 25,1998): 'In order to contribute to the protection of the right of every person of present and future generations to live in an environment adequate to his or her health and well-being, each Party shall guarantee the rights of access to information, public participation in decision-making, and access to justice in environmental matters in accordance with the provisions of this Convention' (Art. 1). 28 Cf. J.K. Mason, R.A. McCall Smith, Law and Medical Ethics, Butterworth, London 1994, p. 238: 'It is no longer a simple matter of consent to a technical assault; consent must now be based on a knowledge of the nature, consequences and alternatives associated with the proposed therapy'. 29 K.S. Shrader-Frechette, Risk and Rationality. Philosophical Foundations for Populistic Reforms, cit, p. 97: 'No matter how experts define a hazard, its imposition is ethically justifiable only if the persons affected by it have given free, informed consent and are compensated for the danger they face. (...) the obvious analogue for hazard evaluation and management is medical ethics (...)'. 30 Cf. Council Directive 90/679/EEC of 26 November 1990 on the protection of workers from risks related to exposure to biological agents at work.

The Epistemic State

91

acquire awareness of scientific and technological achievement instead of passively accepting it with either fear or ignorance. To date, institutional instruments have been lacking to democratically evaluate the orientation and directions of science. In these conditions, public consent cannot be simply presumed; in fact, the evolution of science is no longer univocally perceived as progress, but also as containing ambivalences which, albeit inevitable, need to be consciously and democratically discussed. The way things stand, science is breaking away from society, and it risks becoming a power without any foundations of legitimacy. This does not mean that single scientific projects have to be screened one by one, or that referendums are the only instrument to ensure true democracy. On the contrary, untimely consultations without the correct level of culture or the mere bureaucratization of decisions are good translations neither of diffuse, correct information nor of the public's concrete participation in scientific decisions. Ways of ensuring knowledge and assessing consent must be manifold and achieved at more than one level (political, juridical, market). What has been lacking to date is a detailed analysis of the modes and methods of law-making on scientific questions. It is possible, for example, to question the very legitimacy of ordinary forms of law-making in terms both of the majorities required and the procedures followed.31 Furthermore, the scientific-technological orientation of society fails to be adequately reflected in traditional political arrangements; the difficulties of political integration which movements and parties most focused on scientific questions issues have encountered (this is the case of environmentalist movements) are a clear sign of the absence of a consolidated scientifictechnological culture in politics. Lastly, the increasingly close relations between science and the market, risk freeing the progress of scientific knowledge from the possibility of control and social sharing. The general picture which emerges evidences the need for a plurality of sources of information on scientific issues. Some should be more technicalscientific and institutional in character; one example is the role played in the United States by information and regulatory agencies (FDA, NIH), empowered to enact technical norms. Others ought to be free and guided by market destination, albeit in compliance with technical and ethical standards. 31 The most emblematic case is the Icelandic deCODE project. As is well known, in 1998 the Icelandic Parliament enacted the Act on a Health Sector Database no. 139/1998, for setting up a databank including all the genealogical, clinical and genetic information related to the population. The very legitimacy of this Act has been highly disputed (see http://www.MANNVERND.is, http://www.decode.com; and GJ. Annas, Rules for research

92

Tallacchini

The need for information leads on to the question of participation. The very possibility of being acquainted with scientific, political and legislative decision-making processes may represent the beginnings of a participatory activity. The transparency and certainty of processes and decisions are the two inalienable - albeit ideal - elements underpinning the legal regulation of science. They make the legal filter a new element to guarantee relations among powers. Hence different nuances and degrees of informed public participation, ranging from the possibility of knowledge simply as a potential control to concrete expressions of acceptance - the more risks are individuated and individual.

3. FOR AN 'EPISTEMIC STATE UNDER THE RULE OF LAW': LEGAL REGULATION AS A PROCESS OF COLLECTIVE LEARNING AND 'SCIENCE OBJECTION' The regulatory power exercised by legal systems already supplement the conception which I suggest we define as the 'epistemic state'. As I have sought to demonstrate, such powers are presently exercised in disorderly forms in terms of their identification of criteria and are nontransparent in terms of the exercising of procedures. The legal management of science has to move in the direction of the formulation of principles and rules via a scientific and political debate whose content is as broad as possible and whose manifestations as open as possible. Given its inevitability, the growing process of the legal regulation of science must take place through a renewed version of the rules that have led to the formation and formulation of the state under the rule of law. What has been lacking to date in the messy and rhapsodic construction of the legal regulation of science is the formulation of an explicit, transparent epistemology that takes into account the most recent, critically attentive acquisitions of science and about science, not to mention the elaboration of procedures whereby citizens are not excluded from the directions undertaken by scientific and technological development and by resource allocation. The definition and implementation of principles and procedures for making effective, certain and sustainable the legal epistemology of science have to become an integral part of an epistemic state under the rule of law. Among the problems which this revision entails, it is possible to cite two on human genetic variation - lessons from Iceland, 'New England Journal of Medicine' 2000, 342 (24), pp. 1830-1833.

The Epistemic State

93

in particular: the choice of regulatory procedures (that is to say methods of law-making) and the possible right of individuals to dissent to science. As far as the first problem is concerned, there is a great deal of discussion about the most suitable ways of intervening in ambits which depend on the evolution of science and technology. There are a number of reasons for the inadequacy of traditional forms of law-making: the rapid evolution of scientific research and its outcomes makes ordinary legislative procedures too long and unsuitable anyway. Scientific and legal language still live in separate ambits and are rarely the patrimony of the same subjects. Uncertainty over the possible effects of new technologies sometimes induces rigid attitudes which leads to a straight alternative between prohibitions and permits. Though a certain type of imperative, centralized vision of law has, in all likelihood, exhausted its capacity for governing society, the alternatives have still to be explored and tested.32 The most interesting proposals are soft-law approach and procedures mustering representatives of different interests as a general procedure for the regulation of science. According to the first orientation, legislation on scientific and, in particular, bioethical issues ought to be 'sober'.33 In other words, it ought to fix fundamental principles, entrusting concrete, substantial choices to individual autonomy, both because it is basically individual rights that are at stake and because, by intervening over-zealously on subjective rights, law risks becoming ineffective - a fact which may be determined both by the rapid evolution of science (which renders legal provisions obsolete) and by the non-compliance of citizens. The other orientation, which is to be found in some studies on legislative reforms in the European Union,34 recommends the setting up of committees of experts and technical agencies, together with the consultation of all the 32

Cf. L.E. Trachtman, Science and Technology: Who Governs?, in M.L. Goggin (ed.), Governing Science and Technology in a Democracy, cit., pp. 141-164. 33 S. Rodota, Tecnologie e diritti, II Mulino, Bologna 1995, p. 204.. 34 N. Lebessis, J. Paterson, Recent developments in institutional and administrative reform, in O. De Schutter, N. Lebessis, J. Paterson (eds.), Governance in the European Union, Office for Official Publications of the European Communities, Luxembourg 2001, http://europa.eu.int/comm/cdp/cahiers/resume/gouvernance_en.pdf, pp. 259-305: "Pluralistic scientific expertise is, therefore, needed essentially for three reasons. First of all, it is required in order to make scientific decision-making more responsive. To be clear, it is not a question of holding scientific rationality hostage to irrational fears and unfounded concerns. Rather, it is a matter of reconnecting science and society as a means of coping with such fears and concerns. (...) The aim is thus to render political those choices which have traditionally been regarded as a matter purely for experts, irrespective of the extent of their ramifications and the scale of their error costs" (p. 287).

94

Tallacchini

parties involved in regulatory processes, as the most suitable method of making normative processes transparent, while at the same time ensuring the success of normative action - that is, compliance with the text of the law - adequately and preventively. The effectiveness achieved by the strategy of 'minimal' legal intervention alone may achieve its goal at the non-negligible price of leveling law over facts, that is to say confining itself to sanctioning the legitimacy of what is already happening - as was the case, for example, of the patentability of biotechnological inventions. The most promising approach would appear to be that of a law which 'promotes' and 'conquers' its effectiveness not by avoiding to regulate but by involving broad representation of actors and interests in decision-making processes (which, it is worth remembering, are made up largely of procedures of acquisition and evaluation of knowledge). This vision treats law not as a normative statement, but as a 'process of collective learning'.35 This conception makes law essentially a social phenomenon of knowledge, placing the descriptive dimension of law in a position, if not subordinate, at least jointly complementary to the cognitive one. Another argument of crucial importance in the definition of an epistemic state under the rule of law regards the elaboration of the modes and possibilities for citizens to dissent against the epistemic choices of the legal system; in other words, the configuration of the citizen's right to break away from the state's scientific-technological choices. If the legal system disciplines or allocates resources in scientific sectors connotated by uncertainty (according to the different definitions considered above), the need emerges to counterbalance the decision-making power of legal systems by instituting multiple and differentiated forms of respect for individual positions. It is necessary, in short, to guarantee a set of procedures to allow not only the control and democratic transparency of legal criteria for the validation of science, but also the effective participation of individuals in the choices made jointly by science, market and law. However, provided it can be legitimately and democratically made, the legal decision to support scientific and technological methods which have high margins of uncertainty and/or generate situations of conflict must provide citizens with guarantees, if evidence is lacking that scientific progress cannot result

35

Cf. N. Lebessis, J. Paterson, The Future of European Regulation: A Review of the Workshop llth June 1997, Forward Studies Unit, which argues for "a vision of the regulatory process as a process of collective learning".

The Epistemic State

95

from methods that are less uncertain in terms of individual36 and collective37 risks, and conflicts of interest.38 Citizens must be acknowledged the right not to adhere to the state's biotechnological choices, whenever they are not without high margins of risk or uncertainty. The legal instrument I have in mind, - more as a point of discussion than a statement - is a homologue of 'conscientious objection' and derives here not from moral disagreement but from scientific dissent. This situation may be described as the right to 'science objection'. This possibility of dissent might constitute a right to objection transferred from the domain of moral choices to the domain of scientific positions. When an individual does not share the scientific orientation adopted by the legal system, and if the dual circumstance of a decision in conditions of uncertainty and the involvement of a subjective right recurs, the citizen might be granted to make his or her position prevail over the one adopted by the legal system. This hypothesis is not totally extraneous to the provisions of some multiculturally-inspired legal systems. An example of what I am referring to may be found in the New Jersey Statute on brain death (1991), which states that, 'an individual will not be declared dead on the basis of neurolog-

36 Law n. 210 of 25.2.1992 and Draft Law n. 92 of 4.4.1997 on the compensation for people harmed by compulsory vaccinations and blood transfusions are proof of an ex post compensation for risks from which law has failed to protect citizens. The 'formation of modern health awareness on the basis of adequate health education of the citizen,' described in art. 2.1 of Law n. 833 of 23.12.1978 on the National Health Service, must comprise awareness of uncertainty about many aspects of medicine. 37 Such as risks of xenogenetic infections in xenografts: cf. Committee on Science and Technology (Rapporteur: Mr Gian-Reto Plattner, Switzerland, Socialist Group), Report, Doc. 8166 revised, 15 October 1998, http://stars.coe.fr/doc/doc98/edoc8166.htm.; Recommandation 1399/1999 of the Committee of Ministers pleading for a moratorium on all clinical xenotransplantations. 38 The IOM document, Non-heart Beating Organ Transplantation: Medical and Ethical Issues in Procurement, National Academy Press, Washington D.C. 1997, first reports that, 'defining and determining death are much more critical in organ donors than in other patients', moves on to speak about organ removal when the heart is no longer beating, pointing out that the precautions to be taken to avoid breaking the delicate balance between the interests of the donor, who is still alive, and the recipient. More specifically, it addresses the problem of the administration of drugs (heparin as an anticoagulant and pentolamin as a vasodilator) designed to conserve the organs to be removed, but such as to accelerate the decease of the donor, as well as the lawfulness of invasive practices or practices that are painful for the dying donor. This report discusses (...) the safeguards against conflicts of interests. These include separating decisions about and management of care with respect to life support withdrawal and donation (...)' (p. 9).

96

Tallacchini

ical criteria if this would violate the individual religious beliefs'.39 The norm is correlated to provisions on organ donation, but it does not deal with the problem of agreement to donation. It does not take in the individual's position on transplants, but questions the very notion of brain death, from the definition and legal consequences the individual may withdraw, if he or she objects to the concept of death founded on those scientific parameters. How far and with which applications a right to object to science may in future find space in the regulation of science is a question which still has to be thought out. It is not unfounded, however, to believe that when the legal decision in favor of a particular value envisages the possibility of individual dissent, likewise, when an uncertain scientific position is adopted by law, in some circumstances or on particular issues, a possibility for individual dissent has to be guaranteed. The new forms of law-making and new rights connected with science represent only two very general features of the guarantees that an 'epistemic state' has to offer citizens. But the lines which will combine to portray the image of the state under the rule of law in the age of science have still to be drawn in. Professor of Legal Philosophy, Catholic University, Piacenza, Italy

39

New Jersey Statutes. Annotated. Declaration of Death, 26:6A-5, St. Louis Mo., West Publishing, 1991, pp. 232-235.

II. Cloning: Biological and Moral Aspects

This page intentionally left blank

Some Fundamental Evils in Generating Human Embryos by Cloning John Finnis

Some cloning is of cell lines, or is a matter of tissue culture. The cells thus produced are histologically identical to the cell or cells (e.g. skin or liver cells) from which they have been cloned. The new cells are like the antecedent cells: they lack the genetic primordia for self-directed development as a self-sustaining whole organism organised for development into a mature individual and member of a sexually reproducing animal species. Even when the cells are parts of, or derivative from parts of, a human organism, cloning of this kind does not involve the intrinsic ethical issues which I shall point to in relation to production of embryos by cloning. There arise of course all the incidental issues that pertain to experimentation, consent, commercialisation, unwanted sequelae and iatrogenic illness, and so forth. But the development of cell cloning is, in itself, to be encouraged for its promise of significant medical advances. Some cloning is of embryos. In the term "embryo" I include the zygote, the morula, the blastocyst, and the embryo stricto sensu (not to mention the foetus) - that is to say, every instance of an organism - whether of one cell, two, or many - that has the genetic primordia for development into a mature individual member of an animal species. In using the term "embryo" thus, I follow the example of the pioneers of IVF (in vitro fertilization), who though well aware of the conventional terms and distinctions which I just recalled, used "embryo" to refer to even the earliest conceptus. That is how R.G. Edwards described "the beginnings of life", e.g. of Louise Brown in the first minutes or hours after her conception in his petri dish. He said, for example, that "resistance to injury is a property of the earliest stages of embryonic life, that this resistance lasts to the blastocyst stage and perhaps further, before fading after the embryos become implanted in the womb ...".1 1

Robert Edwards and Patrick Steptoe, A Matter of Life (London, 1981), 111.

99 C.M. Mazzoni (ed), Ethics and Law in Biological Research, 99-106 © 2002 Kluwer Law International. Printed in Great Britain.

100

Finnis

Referring to "the early stages of human life"2 and "the earliest period of human embryo growth"3 as the period of a day or two before and after the one-cell embryo divides into two, Edwards says: the embryo is passing through a critical period in its life of great exploration: it becomes magnificently organised, switching on its own biochemistry, increasing in size, and preparing itself quickly for implantation in the womb.4

Recollecting (at her birth) his appreciation of Louise Brown as one or two cells in his petri dish, Edwards added: "She was beautiful then and she is beautiful now." There is much to be deplored in decisions of the kind which Edwards made then, and which thousands of other medical technologists have since made, but Edwards has the great merit of frankness. Discussing his initial agreement in 1968 to work in vivo with the surgeon Patrick Steptoe, Edwards remarks: Ethical concerns hardly entered into our conversation. ... We were ... aware that our work would enable us to examine a microscopic human being - one in its very earliest stages of development. ...5

During the late 1990s a vocabulary was devised and popularised according to which there are two kinds of cloning to produce human embryos, embryo-cloning which is reproductive and embryo-cloning which is therapeutic. This vocabulary should be rejected as politicised and manipulative. Production of embryos by cloning is always reproductive, for it is always and necessarily reproduction - generation of one human being from another - even when the further aim is that the embryo so produced shall later be destroyed rather than proceed to independent life as a breathing child. And all uses of embryos as sources of organs, tissues, and cell lines for experimental study, or for use to improve the health of another human being, are non-therapeutic. In the use of the term "therapeutic" which has been universal and well-understood until the propagandist manipulations of 1998/9, a therapeutic intervention is an intervention directed towards the well-being of the individual on whom the intervention is conducted. In short, what is being called "therapeutic" as opposed to "reproductive" cloning is always reproductive, and de facto is never therapeutic. Whatever our ethical disagreements, we should reject the misappropriation of wellunderstood words to disguise the reality of what is being proposed, debated, and chosen. We should be aware that both the aim and the structure of the current 2 3 4 5

A A A A

Matter Matter Matter Matter

of of of of

Life, Life, Life, Life,

97. 95. 97. 83.

Generating Human Embryos by Cloning

101

manipulation of language are precisely the same as the manipulation by which the British Government continued, throughout the Second World War, to assure its people, most solemnly, that the targets of its air operations were all "military", even after it had adopted the precise, formal, and internally documented operational policy of selecting for destruction civilian houses and their civilian inhabitants in preference to factories producing war materiel. In choosing the wording of their public statements, the British authorities relied upon the conventional, well-understood distinction according to which a military target consists of persons or equipment engaged or preparing to engage in military operations, and the term "military targets" does not include hostages or other civilians even when their destruction would have beneficial military effects by discouraging military personnel, blocking the roads with refugees, and so forth. The structure of the propagandistic manipulation consisted precisely in using the well-understood words in a way which - as the audience were more or less unaware - would be appropriate (accurate) only if they were understood in a different way: viz., our targets are all military just because our ultimate aim in targeting them is military victory, and all our operations are directed towards that aim. In that aim-dominated application of the word "military" the statements of the British Government were substantially true, but the Government could not of course reveal that that was the way it was applying the word "military". Its statements were intended to be understood by their audience as referring not to the ultimate aims of the bombing but to the kinds of persons and things being attacked, since the audience wanted to be reassured that their Government was not pursuing its aim by illicit means, i.e. that there was no policy of attacking civilians as hostages whose destruction could hasten the ultimate aim of victory. But that indeed was the policy, from February 1941 to April 1945, as I show in detail in my book with Joseph Boyle and Germain Grisez, Nuclear Deterrence, Morality, and Realism (Oxford University Press, 1987). Similarly, the recent use by governmental agencies of the terms "reproductive" and "therapeutic" manipulates its audience by replacing the conventional uses of those terms with a new application which would be appropriate (accurate) only if attention is shifted, away from the kinds of things being chosen and done - the means - to the ultimate aims for which they are being chosen and done. So-called "therapeutic" cloning is reproductive, but is all or in virtually all cases non-therapeutic. It consists in reproducing human beings for the purpose of being consumed in experimentation intended immediately or remotely for the benefit of other human beings, for whose sake the individuals produced by cloning are to be sacrificed - without of course the possibility of their consenting or appealing. It will be said, of course, that

102

Finnis

they are also too young to notice their destruction. And that is true. But the question whether a human being who has been selected for destruction will be aware of his or her fate is never decisive for an ethical judgment on the question whether his or her rights are being violated by the choice to destroy him or her. In the wake of the war in which the major powers all, in their various ways, systematically violated human rights as a matter of high policy, the World Health Organisation and the Council for International Organisations of Medical Sciences, reflecting on the abuses of science in the practice of the defeated powers adopted the Declaration of Helsinki (referred to by Signer Barni). (With due respect to our chairman, Prof. Mazzoni, the need for rules limiting freedom of research is in no way a novelty.) The Declaration's key provisions were: 1.5 ... Concern for the interests of the subject of biomedical research must always prevail over the interest of science and society. III.4 In research on man, the interest of science and society should never take precedence over considerations related to the well-being of the subject.

So-called "therapeutic" cloning, since it is essentially non-therapeutic, i.e. is entirely unconcerned with, or prepared to sacrifice totally, the well-being of the human subject directly affected, is a gross violation of those principles, and of a fundamental principle of just governance and social life. It will be denied that there is a human subject here. But the denial is quite vain. You have only to scrutinise the language, the thoughts, the awareness and the decisions of those who want their baby to survive and flourish, and of those who use their skills for that objective, to see that when people's interests do not conflict with the interests of the embryo, they are perfectly well aware that they are dealing with an individual human being, a him or a her, a subject, a who not a what, as irreplaceable as a baby immediately before or after birth. It will be said that the early embryo is not a subject because it might be divided by natural monozygotic twinning or by artificially induced splitting during toti- or early pluri-potency. And indeed it might be so divided. But so what? One subject has been replaced by two (or more). The question whether one of the two (or more) is parent of the other (or others) because continuous with the initial embryo, or whether the initial embryo's life has simply been superseded by the new life of two, is of some theoretical interest. But its answer cannot affect the fact that the initial embryo had interests and rights as a human subject, and that the successor embryo or embryos equally have such interests and rights. It is utterly false to pretend that the possibility of twinning or splitting is evidence that the early embryo is not an integral organism, self-directing and fully equipped with all the radical

Generating Human Embryos by Cloning

103

capacities which, by their actuation in development, will be exercised in the activities including the thought, speech, laughter, etc., of that individual whose life began at syngamy and will typically continue, without break or irruption, for (say) ninety hours, or weeks, or months, or years. People might say that the early human embryo is not a human subject, because it is very small. And indeed it is. But science and civilisation make progress by substituting the reign of imagination and image dominated sentiments to reasonable judgement. And by every standard of reasonable judgement the fact that you in the first days of your life, and I in the first days of mine, were very small has no tendency at all to show that that very embryo which you were was not you, or that that very embryo, that small embryo, was not me. Each of us was even then and there equipped with our genetic constitution - do not say genetic blueprint, because we were and are three-dimensional, not two-dimensional - the whole genetic constitution which made you you and me, for better or worse, me. We all know this. If it were not useful, we would not dream of denying it. Arguments of the kind I'm criticising are not, I'm afraid, attempts to find out the truth of the matter, but rather are rationalisations of a result, an outcome, a product that is beneficial to many. It will be said that the criterion I am using to distinguish between production of cell lines, on the one hand, and of embryos, on the other, is unsound. The criterion is whether the new cell has the genetic primordia for self-directing development into a mature individual of an animal species, and it will be said that the notion of a species has been cancelled out, or soon will be, by advances in DNA-related science and techniques. I accept that there probably will emerge cases where it is debatable whether a collection of cells has the genetic primordia, the radical capacities, the organising principle which is the only basis for judging human beings to be fundamentally equal despite their manifest differences in every other dimension. There will probably be cases where it is not easy to say whether we have here a wounded human individual, misshapen and defective (perhaps by reason of his or her predecessors' decisions and desires), or rather a creature which, like a hydatidiform mole, is human in origin but not in nature, lacking those genetic primordia. But the existence of borderline cases should not make us hesitant about the manifold other cases where the fact is that we have a subject with the vigorously self-protecting and self-restoring animal specificity that we heard R.G. Edwards referring to. I have been considering so-called therapeutic cloning, which must be judged non-therapeutic because it intends for its subject neither the benefit of life after birth nor the benefit of a healthier existence before birth - but rather: consumption, exploitation and destruction. What then should we

104

Finnis

say about so-called reproductive cloning? This, as I have said, is reproductive only in the extended sense that it intends that the reproduction involved in all production of embryos by cloning shall in this instance extend, by the will or permission of the producers, to life after birth (provided it is not terminated earlier by their decision to abort it as defective or as in some other way inauspicious or unwanted, or contrary to a woman's (or some other person's) "right to choose"). So, let me call this cloning for maturity. For the sake of analysis, let us consider the case where all concerned are resolved to respect the life of any embryo generated by cloning at least as fully as he or she were a born child. What then should we say about this "pure case" or "ideal case" of human cloning - cloning for maturity without quality control by termination of life? I think we should say this. Generation of embryos by cloning, whether by splitting or somatic cell nucleus transfer, is a matter of asexual reproduction. The fact that cloning is copying is, biologically speaking, only an implication of that fact of non-sexuality in reproduction. As I have already emphasised, the embryo produced is a child as fully human, as incommunicably unique a person, as any ordinary twin or, indeed, as any other person. But the conditions or character of his or her generation by production dramatise something to be found, if less dramatically, in all generation of children in vitro, something that makes all these kinds of generation morally wrong, fundamentally or intrinsically. This moral significant fact is not of course the fact that technology is being put to use; still less is it the fact that what is being done is basically or biologically abnormal. No, it is rather the fact that is being chosen and done as an act of production. The aim of this choice and act is precisely to supply someone with a baby by trying to produce a baby by the in vitro procedures which, in the case on which we are focusing, are one or other of the procedures of cloning. How does this make the choosing act wrong? The answer is that products as such are assigned their meaning and value by the human makers who produce them, and the consumers who use them, and so the status of any product as such is sufc-personal. That initial relationship, of those who choose to produce babies with the babies they produce, is inconsistent with, and so inherently impedes, the communion which is appropriate in any relationship among persons concerning the basic aspects of their personal well-being, their fundamental good.6 In short, the relation of producers to product is a relationship of domination, which in itself is contrary to the dignity and equality which is appropriate to the parent child relationship. 6

See Germain G. Grisez, Living a Christian Life (Quincy, Illinois, Franciscan Press, 1987), 267.

Generating Human Embryos by Cloning

105

In procreation by marital intercourse, on the other hand, one and the same act of choice, made by each spouse, governs both the union (in which they experience and actualise their marital commitment) and the procreation of the child. The intentionality of this act remains governing even in a case when procreation depends on supplementing the act of intercourse by some technical means to assist the intra-corporeal union of gametes. So the child comes into being, in such cases, as a kind of gift supervening upon an act chosen for expressing the parents' union and common life, and as a kind of incarnation of that act, of that union, and so as a kind of partner in that common life, and thus with a fundamental parity or equality with the parents whose procreative act expressed, by its structure as mutual giving and receiving, their mutual commitment to each member of their partnership, to serve that partner through the whole lottery of a lifetime. Of course those who choose to produce a baby - to generate one in vitro, by cloning or otherwise - make that choice only as a means to an ulterior end. And that end may well include receiving the baby into an authentic child-parent relationship of communion, befitting those who share in personal dignity. If this intention is realised, it will be good for the baby as well for the parents. But it remains that the choice to produce the baby is the choice of a morally bad means to a good end, because the baby's initial status as a product is sub-personal. The significance of that status is most clear when the laboratory's defective products are discarded and its surplus products used for lethal experiments or exploitation and consumption. The character of IVF as essentially production is only more emphatic in generation by cloning. The radical separation of IVF from the act of marital union is only more radical and dramatic in generation by cloning which neither incarnates that union, as procreation does, nor even reproduces both father and mother, as sexual generation even in vitro does, but instead replicates a single person (who of course may or may not be the mother who supplies an egg, nor the mother who supplies the womb, nor the mother who undertakes the care for the child after birth). I have been sketching some main lines of the philosophical analysis which shows that the moral character of the choice and act of IVF, and a fortiori the moral character of generation by cloning, is essentially the same as slavery (which like IVF has its benevolent and good forms, whose benevolence - good aims - and beneficence - good effects - do not cancel out its fundamental evil). The question is thus one of equality in dignity, and of choice and acts which are disrespectful of that equality because (i) they do not conform to the Golden Rule that one must not do to others what one would not have done to us, or (ii) they set the will of the choosing person directly against some basic aspect of the good of a human person.

106

Finnis

We heard Professor Simon say, twice, that the principle of respect for human dignity is "modified by the years". His phrase reminded me of the famous passage in the main document of Roman law, where the slaveowning Roman jurists declare that by nature, and from the outset, all human beings are born equal, but then slavery arose: as Professor Simon might say, the principle of equality was "modified by the years" - in truth, of course, the principle of equality came to be unacceptable, and so was systematically, for millennia, violated by those who had power - powerful absolutism as well as democracies. In our philosophical and juristic discussions, we must not think that anyone can rationally derive ethical or other normative conclusions from sheer facts about people's opinions, from facts such as that many powerful people want to own slaves, or that many German or English politicians and voters want to make abortion widely available, whatever the Constitution may or may not say; or want and fight for the protection of certain subhuman animals more than they want the protection of unwanted human subjects. Nor may we think that the fact that a supposed moral or legal principle or rule is "open" is always a rational argument for preferring it to a more restrictive principle or rule. Nor should we think that the fact that certain arguments are "knockdown" shows that they are weak or fallacious or "emotional", though some undoubtedly are. Let me conclude by saying that the position in German law, which Professor Simon described to us with obvious signs of regret, is morally, that is to say rationally, superior in almost every dimension to the British position which he wanted us to think superior to the German, as I understood him. There can be little doubt, of course, that the British position, or rather the even more laissez-faire position of the United States, or Korea, is the position which will prevail in the medium term. But that is not an argument in its favour. The future is foreshadowed for us by the experience of the pioneer of IVF, Robert Edwards. For years his research was frowned upon by the ethical authorities of the medical profession and the scientific researchgranting bodies. But as soon as he had achieved his technological success, the same persons who had ostracised him rose to their feet, en masse, to applaud him, and to open their doors and their purses to his work. We should recognise that the crowd, including the crowd of the learned, follow power and technical opportunity. But we don't have to applaud, and we don't have to do likewise. Professor of Legal Philosophy, University College, Oxford, UK

Thinking about Huxley's Brave New World: Was it Wrong to Create a Genetic Hierarchical Society? Is it Wrong to Prevent One? Bernard Gert

I am going to talk about cloning that is done in order to produce adult human beings. Cloning of present adults to make future adults will be socially significant only if it is done together with genetic engineering, for such cloning done simply by itself is merely a curiosity, not anything that will have any impact on society at all. We have already seen that this kind of cloning of natural animals is simply a prelude to the cloning of genetically engineered animals. Although there is no question that the cloning of genetically engineered animals will have significant results not only for our food, but also for medicine, I am not going to discuss any of the issues that arise from the cloning and genetic engineering of animals, but shall restrict my discussion to the cloning and genetic engineering of human beings. The cloning of fertilized human eggs also seems to me to be of concern only if it is combined with genetic engineering. If it is done without such engineering, it might even provide an incentive to prevent, or at least delay, the practice of germ-line genetic engineering. For the cloning of fertilized human eggs may allow for investigating their genetic structure and then implanting only the clone of that egg which does not have any major genetic disease or significant genetic predisposition to a major disease. By making preimplantation screening easier and thus providing a way of preventing the birth of children with genetic diseases and significant genetic predispositions to diseases, it may reduce the demand for genetic engineering.1 1 See Edward M. Berger and Bernard Gert, "The Ethical Status of Germ-line Gene Therapy," The Journal of Medicine and Philosophy, Vol. 16, No. 6, December 1991; Bernard Gert, Edward M. Berger, George F. Cahill, Jr., K. Danner Clouser, Charles M. Culver, John B. Moeschler, and George H.S. Singer, Morality and the New Genetics: A Guide for Students and Health Care Providers, especially Chapter 10, Jones and Bartlett Publishers, 1996; and "Morality and Human Genetic Engineering," Jahrbuch fur Recht und Ethik - Annual Review

107 C.M. Mazzoni (ed), Ethics and Law in Biological Research, 107-114 CD 2002 Klmver Law International. Printed in Great Britain.

108

Gert

However, when the cloning of human embryos is combined with genetic engineering, it may have significant social impact. To understand the possible impact it may be instructive to talk about Aldous Huxley's Brave New World. In this book Huxley seems to have anticipated both cloning and genetic engineering, but in fact he did not really do so. And the difference between what Huxley wrote about and what we are now concerned with is morally quite significant. In Brave New World, the predecessor of genetic engineering that was used in conjunction with the predecessor of cloning was used to produce people of lower intelligence and generally of lesser all around abilities. The embryos were intentionally injured or made worse in order to produce clones that were suitable for taking on the unpleasant and boring physical and clerical tasks that needed to be done. Indeed, conditioning of the clones continued after birth in order to limit those things in which the clones took pleasure. Although harm was being caused to many individual persons, which is what the clones were, these actions were claimed to be justified by the societal good that was being maintained, perhaps even the societal harm that was being avoided. It is a plausible account of Brave New World, that a hierarchical but peaceful society was created by disabling many people, that is, by treating embryos to create people with lesser abilities or greater disabilities than they would have had if they had not been so treated. People were harmed for the greater good of society. Like Huxley, many readers of Brave New World did not like the hierarchical society portrayed there. They regarded the hedonism of the society to be quite shallow and the absence of deep emotions to be a loss that was not compensated for by the decrease in suffering. It is not clear that the readers' ranking of the goods and evils involved in that society led them to think of Brave New World as worse than the society in which they lived in 1932, but it does seem clear that most of them believed that with the scientific advances Huxley described that fictional society as having, it could have been a lot better than the one that Huxley described in Brave New World. We now live in a world that has even more scientific advances than those that Huxley envisioned for Brave New World. Whether our present society is preferable to that described in Brave New World, is an interesting question, but I am not concerned with the character of the society portrayed in Brave New World, but rather with the means used to achieve that society. Morality is primarily concerned with means, not ends. It is what we do, not what of Law and Ethics, Der analysierte Mensch - The Human Analyzed, edited by B. Sharon Byrd, Joachim Hruschka, Jan C. Joerden, Duncker & Humblot, 1999, by Bernard Gert, for arguments concerning human germ-line engineering.

Thinking about Huxley's Brave New World

109

ends we seek to achieve that is the primary concern of morality.2 Of course some ends are immoral, e.g., eliminating some racial, religious, or ethnic group, for there is no way that end can be achieved without acting immorally. But generally, most ends are morally acceptable, what is in question is the means employed to achieve that end. A hierarchical society need not be achieved, as Brave New World was, by immoral means, it may simply come about naturally as the natural result of evolution, that is, with no immoral actions taken by anyone. One natural result of more educated people marrying later may be that people of similar intelligence levels end up marrying even more commonly than they do now. This may result in a natural distribution of talents such that there is, even more than now, a rather stable hierarchy in society. Some people may think that a stable hierarchical society is not a good society. They may think that steps should be taken to prevent such a society from being established. In a world in which cloning, genetic engineering, or other biological ways of artificially creating a hierarchical society are not used, but in which marriage patterns and other social arrangements are leading to a stable hierarchical society, it is not clear what could or should be done to prevent this kind of society from developing. As far as I know, no one proposes that people be forced to marry and have children with people with a very different level of talents and abilities. Many propose, of course, that everyone, no matter what their level of talents and abilities, be given the opportunity to develop those talents and abilities to the greatest extent possible with the resources available to that society. Some, e.g. John Rawls, would even favor arranging the society so that those with the lowest level of talents and abilities would have a greater opportunity to develop those talents and abilities than those with higher levels of talents and abilities, as long as the overall benefits to this least talented group was higher than it would be if opportunities were provided in some other way.3 Doing this would reduce somewhat the hierarchical character of society. However, Rawls's view is not universally accepted, and some would favor providing all with relatively equal opportunities to develop their talents and abilities to the greatest extent possible, even though this might result in a more hierarchical society. Further, even Rawls holds that if providing greater opportunity to more talented groups would make things better even for the least favored group, then one should provide more opportunity to the more talented groups although this might result in a more hierarchical society. 2

See Bernard Gert, Morality: Its Nature and Justification, Oxford University Press, 1998 for a fuller account of morality. 3 See John Rawls, A Theory of Justice, Harvard University Press, 1971.

110

Gen

It is sometimes claimed that an egalitarian society is morally preferable to an hierarchical one. If this means that a society in which morality is applied equally to all people in the society and all are afforded the same protection by morality is preferable to a society in which morality is not applied equally to all people in the society and some people are not afforded the same protection by morality as others, then it is true that an egalitarian society is preferable to an hierarchical one. However, if morality applies equally to all people in the society and all are equally protected by it, and no one counts as deprived, then it is not clear that an egalitarian society is morally preferably to a hierarchical society. Even if it were, it is quite clear that in every society some people are more talented than others in those matters where talent is significant, that is, has important beneficial consequences for those having the greater talents, e.g. artistic talent, athletic talent, or general intelligence. It is not even clear that cloning and genetic engineering will result in a more hierarchical society in any given generation. However, what may result from cloning and genetic engineering is that this hierarchy continues through many generations, that is, the place in the hierarchy may be passed down from generation to generation in the same families. There may be much less social mobility; those born into a family with a certain place in the hierarchy will remain in that place, for they will have not only the upbringing that will suit them to this place, but also the appropriate genetic make-up. Some may think that this kind of society is less desirable than a society with greater social mobility, but I see no moral difference between a society with a great deal of social mobility and one with very little. One might think that there is a significant moral difference because in our present non-cloned and non-genetically engineered world, a society with a great deal of social mobility is associated with greater freedom than a society with very little social mobility. But this is because people with the appropriate talents may be prevented from moving up in such a society by arbitrary restraints. However, in a world where people are cloned and genetically engineered, the lack of social mobility may actually be correlated to the amount of talent a person has; it will just turn out that, unlike our present world, the amount of talent different generations of the same family have will be remarkably stable from one generation to the next. But suppose that one finds the prospect of this kind of genetic hierarchical society repugnant. To prevent such a society from developing, is it morally permissible to deprive people of their freedom to engage in cloning and genetic engineering? It is important to notice that this question is not at all the same question one might have asked the creators of Brave New World. The question that concerns us now is not is it morally permissible

Thinking about Huxley's Brave New World

111

to do what the people creating Brave New World did, namely, harm people in order to produce a genetic hierarchical society? Rather it is close to the reverse of that question, is it morally permissible to deprive people of their freedom in order to prevent the development of a genetic hierarchical society? As stated earlier, morality has more to do with means than with ends. Further, it is not clear that a genetic hierarchical society is morally either better or worse than a non-genetic hierarchical society, such as the one we now live in. Thus, the important point to consider is not what kind of society we may end up with, but rather what means are morally permissible for us to use in order to produce or avoid an egalitarian or hierarchical kind of society. Of course, it may turn out that cloning genetically engineered persons will lead to a society exactly the opposite of what I have been describing. It may be that after allowing cloning and genetic engineering, concern about a genetically hierarchical society will lead governments to make genetic engineering and cloning accessible to all. Thus parents of all walks of life may engage in genetic engineering and cloning in order to produce children who can move up in the hierarchy. There may a genetic competition that results in all children being improved to such a degree that after a few generations there is no one left to do the unpleasant and boring physical and clerical tasks that need to be done in all societies. Thus we may arrive at a genetically egalitarian society and discover that it is not a better society than the natural hierarchical society that we now live in. Indeed, it may be worse than an artificially produced genetic hierarchical society. Neither I nor anyone else knows what will be the result of allowing the cloning and genetic engineering of human beings. But as I said at the start of my paper, morality is primarily concerned with means, not ends. It is what we do, not what end we seek to achieve that is the primary concern of morality. Thus, especially if the end result of allowing the cloning and genetic engineering of human beings is not known, we should turn our attention away from the end and toward the means. What moral justification is there for depriving people of their freedom to create children in whatever way they want? There would be a moral justification for preventing cloning and genetic engineering if people were planning on acting as the creators of Brave New World did, that is, creating future actual beings with diminished abilities and talents. Doing this is itself immoral behavior and so it is justified to prevent people from acting in this way. But that is not the present situation. People want to create beings with enhanced abilities and talents. This is not immoral behavior. Whether this cloning and genetic engineering will lead to a genetic hierarchical society, or a genetic egalitarian society is beside the point. What justification is there

112

Gert

for depriving people of freedom to engage in cloning and genetic engineering? Though I hope it was not apparent from the first part of this paper, I am against the cloning and genetic engineering of human beings. However, I do not base my opposition on any view about the kind of society that would result from the cloning and genetic engineering of human beings. I can understand why some people are against changing something so basic as the way children are brought into the world. It is plausible to maintain that creating children has remained the same since before the beginning of recorded history. Of course, this is not quite true, there have been many changes in recent years, from in vitro fertilization to surrogate motherhood. We now even have to distinguish between the birth mother and the genetic mother. Many of these changes were opposed when they were first introduced, but none of them has had such obviously harmful effects that people who opposed these innovations can now say that it turns out that they were right; that such innovations in conceiving and gestating should not have been allowed. It is always scary to change fundamental ways of doing anything. But for those who wanted children but who could not conceive or bear a child in the natural way, these innovations were essential. All parents want the best for their children, why wouldn't they want their children to be the best they can be in every way, including genetically. If the past innovations were not disastrous, why think that this one will be? On the other hand, sometimes things do go wrong, and cloning and genetic engineering is something that could go wrong in a big way. So the question is: is concern that something might go wrong sufficient to justify restricting people's freedom to create improved children by means of cloning and/or genetic engineering? The claim that we will be disrupting the normal evolutionary process does not carry much weight. Modern medicine has already altered the evolutionary process in quite dramatic ways. Many people who would never have lived to reproduce are now doing so. Indeed, many think that the enormous increase in diabetes is due to the survival and reproduction of those diabetics who, without modern medicine, would never have survived. However, it is not merely modern medicine that affects evolution. Human beings have created societies that differ so much from the social environment in which evolutionary change took place, that it is not clear that natural evolution is occurring any more at all. It is often claimed that human beings are not intelligent enough to be allowed to create a new and improved kind of human being. The endless succession of wars shows that human beings will misuse the technological power that they have achieved. Given the scientific and technological

Thinking about Huxley's Brave New World

113

achievements that have been made during this last century, and especially the new medical achievements that will be made in the first century of the next millennium, perhaps we ought to wait until we see what we do with these new powers before we allow the creation of genetically engineered people. If we do not soon eliminate all of the major diseases, at least all of the major contagious or environmental diseases, then this may show that human beings cannot use even their benign powers appropriately. What hope is there then, that they will use these awesome new powers appropriately? I do not know. I am not optimistic. But I am also not optimistic that those who want to prevent the cloning and genetic engineering of human beings know what they are doing. What the creators of Brave New World did wrong was that they harmed people. Further, the harm was done by the government or state. What would be wrong about preventing people from engaging in cloning and genetic engineering of human beings would be that it would be harming people by depriving them of freedom. Further the harm would be done by the government or state. This suggests that those who do not like what was done by the creators of Brave New World, should not want the government to deprive people of the freedom to engage in cloning and genetic engineering. This is not the conclusion that I had anticipated when I started considering this question. It is not a conclusion that I am comfortable with, but if one holds, as I do, that considering matters morally, it is not the end that is most important, but rather the means adopted to achieve those ends, then this is not a surprising conclusion. However, those who know my previous work in this area, know that I am in favor of prohibiting the cloning and genetic engineering of people.4 I still believe that we should not yet engage in creating children by cloning and genetic engineering. We do not yet know enough to guarantee that the children so produced would not suffer significant harm. There are several unknowns with regard to genetic engineering, including interaction between genes that one had no idea were related at all. I still think that genetic engineering of human beings should be restricted to gene repair. But my reason for this restriction is not the reason that most people have for wanting to prohibit the cloning and genetic engineering of human beings. My view is that at the present time, the risk of harm to the children being created is too great to be allowed given that cloning and genetic engineering of the kind I am considering involves enhancement not therapy. Cloning for preimplantation screening should eliminate almost all need for even genetic therapy. Whatever small need for therapy that might remain 4

See note 1.

114

Gert

can be done by gene repair. Nonetheless, we all know that at some future time the risks of cloning and genetic engineering will be sufficiently reduced that we will come to regard it as safe to clone and genetically engineer children as it is to employ any of the new medical procedures and techniques. When that day arrives, we will have to consider the social and political questions that I have been discussing. My own view is that we would do well to oppose the cloning and genetic engineering of human beings on medical grounds, that is, on grounds of the risk of harm to the children so created. I am not confident that even this well grounded opposition will be sufficient to stop the cloning and genetic engineering of human beings. But if it is, then it will provide some time before we have to decide whether it is justified to oppose the cloning and genetic engineering of human beings on social and political grounds. Right now I think that we do not have enough information to make an informed decision on this matter. Professor of Philosophy, Dartmouth College, Hanover, New Hampshire, USA

From Random Procreation to Standardized Reproduction Jacques Testart

My paper will be more concrete than those of the previous speakers. It is almost a scientific paper, but not altogether. I shall project some slides, but it should in any case be easier for everyone to follow. Why more concrete? Because since the birth of Dolly the sheep, two years ago, the ethical debate on the possibility of cloning human beings has been hindered by stumbling blocks of a contradictory nature. On the one hand, despite endless discussions, no one has come up with good enough reasons to support human cloning. But, on the other hand, no one has produced undeniable reasons for opposing human cloning. So I would like to show you that there is a form of human cloning for which many good reasons can be found (medical, social and others), and that this form of cloning - embryo cloning - can be included among the aims of medically assisted reproduction. I mean that we can envisage the transition from assisted reproduction, offered in cases of sterility, to techniques whereby fertile couples can choose their babies. Until now the goal of medically assisted reproduction was to defeat human sterility, but it will gradually become more and more oriented towards knowing in advance the genetic make-up of the children that will be born. And I shall show you that in order to do this it will be necessary to engage in embryo cloning. But I should mainly like to stress the fact that cloning, contrary to what common knowledge holds, is not genetic manipulation: quite the opposite, it is a process of genome conservation (even at this meeting I have heard people say that cloning is genetic manipulation). I even heard Bernard Gert say that human cloning is significant only if related to genetic engineering. The term genetic engineering usually means genetic manipulation of the embryo. I should like to remind you that the feasibility of all these techniques still needs to be proven, despite the boasting and triumphant statements of our colleagues, the geneticists. Yet, I don't subscribe to the idea that cloning is significant only if applied to genetic engineering. I think it could be useful in the field of genetic identification: you don't interfere with anything, you simply observe,

115 CM. Mazzoni fed). Ethics and Law in Biological Research, 115-124 © 2002 Kluwer Law International. Printed in Great Britain.

116

Testart

you study the embryo, you establish certain parameters to detect how it would evolve if it were allowed to develop into a child and then you select the embryos according to these criteria, since modern assisted reproduction techniques almost always allow us to dispose of more embryos than we need. If medically assisted reproduction can rightly be included in the sphere of reproduction - and this to me seems evident - it is because there is a vast number of embryos, because they are available outside the human body, in vitro, and because there is no added suffering in the process of embryo selection. Furthermore, the act of cloning applied to an embryo (and this has already been said) is not at all the same thing, from a moral standpoint, as the cloning of an adult or of a child. The first victory of assisted reproduction strategies was that they enabled us to improve our chances of achieving fertilization: it improved our odds ratio. Increasing the number of female gametes available, we were gradually able to reduce the number of male gametes necessary for fertilization, while devising mechanisms to favour the union of the gametes. Thanks to these mechanisms today fertilization is successful in almost all couples. This is a completely novel phenomenon, and may allow us to pursue a new strategy, one aimed not so much at ensuring a higher probability of successful fertilization, but rather at improving the chances that the child conceived thanks to medically assisted reproduction techniques will be normal. This will require a considerable number of embryos and thus of eggs to fertilize. Let us remember that, by means of sexual intercourse (the natural way, that is), one oocyte alone is exposed to two hundred million spermatozoa entering the vagina. Thanks to artificial reproduction techniques - first insemination, later in vitro fertilization - we have succeeded in increasing the number of oocytes, that is of egg-cells produced by women subjected to hormonal treatment. It is quite usual to have between ten and twenty. Thanks to the technique whereby a single spermatozoon is injected into the cytoplasm of the oocyte, we now have a ratio of one to one in the number of gametes. I believe that this strategy, which has been used for several decades now and which aims to increase the number of female gametes, reducing the number of male gametes necessary for fertilization, has had its day: we shall never be able to do better than place a spermatozoon into an egg. And we can even introduce an immature spermatozoon into an egg which is not mature at the time it is collected. The main advances in assisted reproduction have consisted in favouring interaction between the gametes, in replacing the cerebral commands governing ovulation, in being capable of preserving gametes and embryos for a long time in liquid nitrogen, in resorting to immature gametes if necessary. And here we come to the last step: identifying viable embryos, or rather

From Random Procreation to Standardized Reproduction

117

normal embryos, which is not exactly the same thing. Since this is the stage we have reached today, there is a new strategy which will need to be developed, based on the availability of a large number of embryos in the laboratory. I should like to remind you that in order to exert quantitative control over the number of "products" (children per family), even before assisted reproduction, we have birth control. In other words, today a couple, and a woman in particular, can choose to have a child only when she wants to. Techniques of medically assisted reproduction allow women to become pregnant even in cases of sterility, and thanks to obstetric and perinatal care such a pregnancy will lead to a live birth. I would like to remind you that two centuries ago half of the children born alive died before reaching the age of five: a real revolution has therefore taken place in the field of human reproduction. The result is that couples - and women in particular - in industrialized countries no longer want to have seven, ten or fifteen children. With a few rare exceptions, they have 1.6 or 1.8 children, in some cases even 1.4 or less. And this is important, since that one child is going to be treasured and valued even more highly, and the mother will want the child even more. Let us now have a look at the qualitative aspects of this management of human reproduction, in particular of pre-implant diagnostics, by which I mean the genetic analysis of embryos available after the fertilization procedure but before they are implanted in the mother's uterus. This analysis will ascertain which embryos are normal Many embryos are available simultaneously for this selection and this will, potentially, allow us to dispose of a broad-ranging inventory of genetic characteristics from which to choose the embryo. There is a slight emotional factor involved in the elimination of a fertilized embryo, which our Anglo-Saxon colleagues call a pre-embryo precisely to underscore the fact that there should be little emotional value attached to it. More importantly, though, these embryos (pre-embryos) are outside the woman's body which means that their elimination is not a medical affair and can de done very easily. Furthermore, as we have seen, couples nowadays only want one or two children. One could envisage that, in the future, there may be a demand for preimplant diagnostics on an embryo, especially in the case of couples at risk: currently this type of genetic selection is performed on the embryos of many couples known to be genetically at risk in many countries in the world. But one could also envisage the same procedure being used in the case of sterile couples, who have undergone in vitro fertilization due to sterility: if we already have embryos in the lab it would be a shame not to take advantage of the available genetic techniques to select the embryos. This

118

Testart

is a procedure being adopted in the United States for women aged 38 or over: in some centres they are systematically offered embryo selection. Lastly, one could even accept a situation in which couples are offered in vitro fertilization with the sole aim of benefiting from the embryo selection procedure. Talking about human embryo selection, I usually use the word eugenics and usually people tell me that this is not eugenics. Yet, if we read the definition given by Francis Galton in 1904 ("study of those socially controllable factors capable of elevating or lowering the racial qualities of future generations, both physically and mentally"), we shall immediately realize that this is exactly what it is about. There is no contradiction, the only disturbing element is the expression "racial qualities". But I'd like to remind you that it's not used in a racist sense: in Galton's times the term race was used more or less the way today we use the term species, without racist implications. This definition can thus be perfectly well adopted today, just as I consider it appropriate to use the term eugenics. I'm not talking about the activities of the Nazis. I'm referring to a form of eugenics that held sway in democratic countries in the early part of the 20th century, from 1907 to 1933, let's say, in the United States and in certain European nations: there, individuals judged unfit to procreate children of quality were sterilized, and this was done with the assistance of physicians in those democratic countries. It was highly unlikely that this classic form of eugenics would have ever been effective, the main reason being that when one sterilizes a man or a woman it is a random process, governed by chance. There are so many mutations involved in the process of gamete production, gametogenesis, that there is practically no sense at all in intervening before the production of embryos. Equally, meiosis, that is the cell-division procedure that gives rise to gamete production, distributes the genes in a random and unpredictable manner. There are furthermore psychological aspects that cannot be controlled: a man will form a couple with a woman in an unpredictable way and we have no way of knowing which of the millions of spermatozoa will actually fertilize the ovum. Human fertility is very weak and this means that eugenic practices need only do very little to "raise the quality of future generations". Add to this the fact that environmental factors can interfere with genetic factors and, luckily, with individual and social resistances against eugenic planning which has always been an authoritarian process. We can compare the advantages of the various eugenic procedures in relation to the objective pursued. Firstly, the oldest of all eugenic methods, the one used by the Greeks, which consisted in suppressing the newborn at birth. This was not particularly well accepted, either by the couple or

From Random Procreation to Standardized Reproduction

119

by society at large; furthermore, it had absolutely no effect whatsoever on improving the genetic make-up of the population. One can also pursue the same objective, but addressing the potential parents, with genetic counselling, which is fairly well accepted by society since it is not really seen as an authoritarian process. This means helping the couple, advising them on the decision to take, although no couple is ever particularly satisfied when they are told that it would be best to abstain from procreation. But, yet again, no genetic improvement of the species will ever be achieved by these methods, nor by sterilization, which has been practiced for a long time (and is still practiced to this day in certain countries). Abortion (and by this term I refer here to a medical intervention that discontinues a pregnancy when it has been ascertained that the foetus displays an abnormality) is not terribly well accepted by society, and it never leaves the couple satisfied. Furthermore it is of no interest from the point of view of eugenics. But, on the other hand, the technique of embryo selection, meaning that no embryo that does not meet a specific definition of normality is transferred into the uterus, is a technique that is socially acceptable and is also accepted by the couple. If the couple has fifteen embryos and wants two children, they will prefer that these two are chosen from among the normal embryos. In this case there is also a possible effect of genetic improvement of the species if the scale on which the procedure is performed (large number of embryos and couples to be treated) is vast enough. If some embryos are homozygous for a severe abnormality they will be excluded. Among all the embryos that are observed under a microscope (in our example there are fourteen), first of all we shall rule out these four, considered the most abnormal despite the fact that some of them are heterozygous and therefore will only be carriers of the disease. Then we have a group of five embryos who are all at risk, meaning that they are not exactly abnormal, but they do carry the genes that make them susceptible to certain diseases. These embryos will be ruled out as long as we can dispose of other embryos of better quality. The study of the susceptibility to risk factors is undoubtedly the future of genetics: it will soon eradicate all single-gene diseases that we are beginning to investigate and identify. There are not many of them; polygenic diseases, on the other hand, are far more numerous and will require much more research before we have finally mapped them in the genome. After that we will identify the second-choice embryos, the ones that are not bad, but do in any case present some small flaw. This form of diagnostics calls for an in-depth analysis of the genome which has not yet been achieved: what I am showing you here is a projection into the future. In the end we

120

Testart

are left with, say, three normal embryos which we shall transfer into the uterus. One could at this point, since we know the sex of these embryos, take advantage of the knowledge and suggest to the couple that they can choose the sex of their baby. That's not an entirely innocent procedure. What is the advantage of this selection of embryos as compared to the prenatal diagnostics that we already practice today? In prenatal diagnostics there is only one foetus in the mother's womb and the foetus is examined in search of a single specific pathology (for the simple reason that, if one were to search for ten pathologies in each foetus tested, we would always end up by finding something and have to eliminate them all). This can only be done very rarely since pregnancy isn't that easy to achieve in a woman. A woman can get pregnant, generally speaking, once a year. This means that overall the number of embryos or foetuses one could subject to foetal genetic analysis every year would only be one per woman. When you perform an embryo selection, the number of embryos present at the same time in the test tube, in vitro in other words, is usually about ten, sometimes more if the woman is young. So we have a lot of embryos available for testing. And this test can be repeated several times a year. In other words, every year we shall dispose of several dozen embryos in order to diagnose a variety of different conditions: using the selection procedure our diagnostic potential is incomparably superior to that offered by prenatal diagnostics. I believe that this is truly important to understand that we are entering a new age in human selection processes: the potential is incomparably greater than it was with the old techniques. What can we do to increase the current medical effectiveness of this embryo selection procedure, called pre-implant diagnostics (PID)? Today only a few hundred children in the world have been born with this procedure of PID, since the technique is very cumbersome and not very widespread in its application. But for the future one can envisage the possibility of choosing among a large number of embryos: instead of selecting from among ten or twenty, we shall be able to choose from a hundred or more embryos. In order to do this we shall have to increase the number of ova produced by the woman. I shall talk later about the techniques that will allow us to do this, although they are already being experimented in animals. Once we have the embryos available, we shall be able to multiply the genetic characteristics that we are searching for. Human genome programmes are being developed in many countries; they will supply us with genetic probes to investigate a number of genetic mutations, of particular features of the genome, so that we can envisage studying several hundred in the future. To increase the amount of genetic information obtained from

From Random Procreation to Standardized Reproduction

121

each embryo it will be necessary to increase the number of tests we perform on a cell, or increase the number of cells tested. Later, I will show you how this can be done. I believe that we will end up by cloning since the main problem with these cumbersome and expensive techniques is the following: once you have ascertained that an embryo is a quality embryo, it only has one chance out of ten to become a baby after being transferred into the uterus. This is a productivity rate that is absolutely incompatible with the economics of healthcare: a chance in ten of a good embryo becoming a normal child is a totally unacceptable efficiency ratio. What will happen is that this embryo, the selected embryo, will be multiplied so as to increase its chances of becoming a single child: several identical embryos will be cloned, and one at a time they will be unfrozen and implanted into the woman, one at a time at each monthly cycle, until one of them succeeds. To show you that this procedure is neither science-fiction nor something belonging to the distant future, let me tell you that there are already similar procedures being developed in animal studies. Let's see how you can increase the number of embryos, the number of ova to be fertilized. We could intensify hyperovulation hormonal treatments in the woman, but there is a limit to this and we would not succeed in producing a vast increase. We could repeat the cycles of in vitro fertilization with this diagnostic procedure and freeze the embryos, but this would be hard on the couple. We could produce ova in vitro, from oocyte laboratory cultures: highly promising experiments in this field have been performed in several countries. We could also grow small ovarian follicles in large numbers and raise ova from them. We could envisage ovarian grafts after freezing, even xenografts, ovarian fragments from another species, not the human species. This has already been done. Gosden recently grafted human ovaries onto the same woman, but he also grafted sheep ovaries and monkey ovaries onto mice, obtaining ovarian growth and proving that the procedure is feasible. To multiply our diagnostic potential we can perform a variety of different tests: we can examine a single cell for a wide range of different characteristics (we can already investigate twenty different DNA sequences in a single cell). But we could also multiply the embryo cells to be examined, since we know how to cultivate them to blastocyst stage (five or six days), thus producing for our test purposes dozens of cells. But even better, we can do what Bongso did in Singapore six years ago, something very few people have talked about: from a five or six day old human embryo cell (a blastocyst), grown in culture for three weeks, he obtained three million cells. On such a vast number we could run all the tests we want. Since the human genome is made up of a hundred thousand genes, with three million

122

Testart

cells available it's certainly not going to be a lack of cells that is going to stop us from running all the tests we want. Then it is necessary to increase the probability of a live birth after the selection process. Research work has shown that embryos selected for their normal chromosome make-up stand a greater chance of yielding a live birth, simply because chromosomal abnormalities are the cause of miscarriage. But we could equally increase the probability of live births by other means: multiplying the number of embryos (which is something we have known how to do in mammals for twenty years now), promoting cell division, or transferring embryo cores into enucleated ova. If we clone before implantation we could even obtain an abundance of absolutely genetically identical embryos. It's worth remembering that embryo cloning has already been performed in primates: baby monkeys have already been born with this technique. Thus, we know primates can be cloned with this procedure. Ovarian conservation, in my opinion, will play an important role in the future, in our animal experiments. Ovaries are removed and frozen; after a certain period of time they are unfrozen and implanted into a female, the same one or another, even a female of a different species, and they develop. Practically speaking, human in vitro fertilization offers us the possibility of harvesting small ovarian cortical fragments from young women, to set them aside and use them twenty or thirty years later. Today PID is not a very effective technique since we have to make do with about a dozen ova which leaves about six embryos after each fertilization attempt. Embryo selection allows us to choose about half the embryos (if we only look for the major pathologies and don't give ourselves too many qualitative criteria to abide by). After transferring these three embryos we would obtain only 0.3 children per test, which is a very poor result. I imagine that in the future, using the methods I have just described, we should be able to dispose of about a hundred ova per woman, especially if we freeze ovarian fragments taken from young women. Using this procedure we could obtain dozens of embryos. Genetic selection would then allow us to select only one or two: we could become much more demanding than we are at present, we could eliminate a large number of them, since we would have so many resources available. Then we could produce copies (clones, that is) of the best embryo, and be sure that we would obtain at least one live birth. We would then have to be obliged to destroy the remaining frozen clones, in order to abide by the ethical considerations that forbid us from producing an army of identical children, at first at least ....

From Random Procreation to Standardized Reproduction

123

I think that, if we are to restrict this type of eugenics based on embryo selection, we should not define what we mean by severe pathologies: you know that this is not done nowadays in the case of prenatal diagnostics performed on pregnant women. There is no legal definition of a disease that would justify the elimination of a foetus. In each case the final decision is the result of consultation between physician and patient, and every time the decision is taken in consideration of the particular situation. Although there may be a general consensus among geneticists, there is nothing codified by law. In any case, excesses are unlikely since the woman carries only one baby in her uterus and its elimination is a very painful process, both physically and morally. There is a sort of natural regulation against eugenics, since pregnancy is a unique event and it occurs inside the mother's body: if it took place in a test tube it would not have the same implications. In the case of embryo selection, a definition of those pathologies authorizing PID could provide a safeguard. But we could not have a transparent, or visible safeguard since it would be contrary to human rights to put in writing that certain human beings can be eliminated. Thus, there would only be one way to restrict embryo selection if we are to avoid falling into the trap of perfect eugenics: restricting the number of pathologies that we can look for in the embryos of each couple, without defining them. This is what I proposed, this is what the French law imposes, but France is the only country that contemplates such a legislation and I don't know how long it will last. Clearly if we restrict PID to a single-gene pathology (a mutation) to be searched for in the embryo, even without specifying which one, we shall enormously reduce the risk of eugenic practices. But we could also accept the elimination of all those embryos that have a chromosome too many, or one too few: in fact, this would have no eugenic consequences since individuals with this type of chromosomal abnormality are hardly ever capable of reproducing. Conversely, as far as mutations are concerned, it would be advisable to look for only one mutation per couple, in all the embryos produced by this couple. This, therefore, is a proposal. I should simply like to add that I am currently carrying out a survey among my international colleagues to verify whether they agree with this suggestion. Generally speaking, the French appear to be in agreement with my proposal; this may be the result of the vast number of debates we have had on the topic and also of a very particular cultural attitude encouraged by our Ethics Committee. Conversely, our British colleagues, and even more so the Americans, find that this proposed restriction would be stupid: if you are scientifically capable of detecting fifty pathologies, they say, why not make use of this ability to ensure the greater happiness of child and

124

Testart

parents alike? I fear that it will be thanks to simplistic reasoning such as this that we shall allow a new type of eugenics: "soft", generous, democratic eugenics. Director of Research at INSERM, Paris, France

BIBLIOGRAPHY J. Testart, B. Sele, Toward an efficient medical eugenics: is the desirable always the feasible?, Hum. Reprod: 10, 3086-3090, 1995. J. Testart, La procreazione assistita, II Saggiatore, Milano 1996. J. Testart, Des hommes probables. De la procreation aleatoire a la reproduction normative, Le Seuil ed., 1999.

The Problem of Reproductive Cloning Francesco D. Busnelli

1. With regard to the issue of cloning, that so far has been on the fringe of my reflections on the law of biomedicine, my first reaction was to think that it represents a non-problem for a lawyer. And this for two reasons. First, the categorical prohibition of human cloning in several documents: from the Resolution of the World Health Organisation (14 May 1997) to the UNESCO Universal Declaration on the human genome and human rights (3 December 1997, art. 11); from the opinion of the Italian National Bioethics Committee (CNB) on Cloning as a bioethical problem (21 March 1997) to the Reponse au President de la Republique au sujet du clonage reproductif of the French National Consultative Bioethics Committee (CCNE) (22 April 1997) and to the Report of the American National Bioethics Advisory Commission (NBAC) with the subsequent "message" of the President of the United States about the "Cloning Prohibition Act" (9 June 1997); from the Additional Protocol to the European Convention on Biomedicine, adopted in Paris on the 12th of January 1998, to the European Directive 98/44/CE on the legal protection of biotechnological inventions (6 July 1998, art. 6, par. 2, lett. a); finally to the Declaration of the Italian National Bioethics Committee on the patenting of cells of embryonic human origin (25 February 2000). All these documents, at first sight, leave no room for subversive interventions by lawyers, who, by definition, cannot afford to be revolutionary. Secondly, the scenario that the advocates of cloning propagate - "cloning in lieu of donors gametes, cloning as a source of organs or tissue, replacing a dead child"1 - seems quite futuristic to me. And lawyers are not prophets. 2. On the contrary, cloning is a problem also for lawyers; or rather, an array of problems. Moreover, it has become a significant "testing ground" 1

See J.A. Robertson, Liberty, Identity, and Human Cloning, 76 Texas Law Review 1998, 1378 ff.

125 C.M. Mazzoni (ed), Ethics and Law in Biological Research, 125-133 © 2002 Kluwer Law International. Printed in Great Britain.

126

Busnelli

to examine, both in theory and in practice, the possible interface (or clash points) between ethics and law (or, rather, between ethics and rights) and, specifically, between constitutional principles and legal rules. 3. Piercing the veil of the "condamnation vehemente",2 the first problem we come across is that there are several forms of cloning: from cloning to "clonings", so to speak. Keeping to the Italian experience, it may be useful to mention that a bill proposed by the Secretary of Health on the basis of the conclusions reached by a Working Group of the National Committee for Biosafety and the Biotechnologies,3 clarified that animal cloning only requires the provision of rules and safeguards, not a general ban. Indeed, the orders of the Secretary of Health, that repeatedly had prohibited, even though for limited periods of time (while a regulation was lacking), every form of cloning, both human and animal,4 have turned out to be a paralysing "straitjacket". In fact, the order issued on the 22nd of December 1998 was different to the previous ones, excluding from the ban the cloning of transgenic animals in order to produce life-saving drugs or to safeguard species from extinction.5 But even in human cloning, it is possible to distinguish between reproductive and non-reproductive cloning; and, within this second type, also to distinguish between the production and culture of cells of embryonic or adult origin which cannot themselves give raise to the constitution of an embryo, and the technique of production of embryos whose development is stopped at a more or less advanced stage in order to obtain immunocompatible cells for cellular therapy.6 With regard to the first technique, the opinion of the French CCNE appears to be widely shared. While noting that "it is a customary and long established practice of great usefulness for diagnosis and therapy", the French Committee had concluded that "it raises ethical issues which are not fundamentally different from those raised by other aspects of biomedical research".7 2 See Comite Consultatif National d'Ethique pour les Sciences de la Vie et de la Sante (CCNE), Reponse au President de la Republique au sujet du clonage reproductif, where the need to start an in-depth analysis, and not to stop at the vehemence of feelings, is clearly stated (25). 3 Ministero della Sanita - Ufficio legislative, Schema di disegno di legge recante norme in materia di donazione umana e animale e di cessione di gameti ed embrioni umani (February 2000). 4 Ord. 4 June 1997; ord. 4 September 1997; ord. 23 January 1998; ord. 30 June 1998. 5 Ord. 22 December 1998, art. 1, comma 2. 6 See F.D. Busnelli, E. Palmerini, Clonazione, in Dig. IV-ed., Disc, priv., sez. civ., Agg., Torino, 2000, 142 ff. 7 CCNE, op. cit., 26.

The Problem of Reproductive Cloning

127

As far as the second technique is concerned, however, there are conflicting opinions. Absolutely adamant is the French CCNE, for example, in maintaining that this technique, apart from being an infringement of the rule that forbids the creation of embryos for research purposes (1. 29 July 1994, art. 16-4), would be a "monstrueuse inhumanite", and it "is astonished to see it promoted by scientists at times distinguished in their field".8 On the contrary, a recent editorial of the magazine "New Scientist" urges "to approve therapeutic cloning" in order to avoid that, otherwise, "researchers move to countries where there are no rules about cloning techniques".9 4. Now, considering only reproductive human cloning, the first problem to tackle is to identify the basis for the strict ban that is apparently common to all the above mentioned national and international documents, and others in the same line. Clearly enough, they share "the deep emotion"10 brought about by the birth of Dolly, the cloned sheep, in February 1997; and, as a consequence, the concern - more instinctive than logical - that the method "that was used to create Dolly the sheep" might be applied, in the near future, to human beings.11 Likewise, they seem to have in common the widespread feeling of repugnance that reproductive cloning has stirred up among people, on both sides of the Atlantic. It has been reported12 that even the creator of Dolly confessed that he would find it offensive to clone human beings. However - as it was rightly affirmed - "repulsion is not an argument", and "things considered to be repugnant yesterday are today accepted without any problems".13 To tell the truth, these reactions seem impulsive or emotional ones, and they might be determined by (even radically) different ethical views. In fact, the impression of a general consensus is only apparent, while the ethical foundations to which these documents refer turn out to be greatly different on a careful analysis, and reflect completely distinct legal (or, rather constitutional) principles. 8

Ibid., 29. New Scientist, 29 January 2000, cited by G. Corbellini, Disinformazione: una clonazione continua, in Sole-24 ORE, 12 febbraio 2000. 10 CCNE, op. cit., 25. 11 President's Remarks announcing the Proposed "Cloning Prohibition Act of 1997, 9 June 1997. 12 L. Kass, The Wisdom of Repugnance: Why We Should Ban the Cloning of Humans, 32 Valparaiso Univ. L. Review 1998, 686, quoting a news report published on The New York Times in February 1997 whose title is intriguing: Sports of the Times: Could Jordan Be Cloned? Not Exactly. 13 L.R. Kass, op. cit., 687. 9

128

Busnelli

The document of the American NBAC solemnly affirms that cloning a human being is "morally unacceptable". However, it adds: "at the present time", making clear that it is because these techniques are not yet perfect from the standpoint of a "safe usage". Therefore, the ethical basis for the ban is "the issue of safety"; and the legal form to enforce it is that of a moratorium. From the ethical standpoint, the if of reproductive cloning is not at issue; it is a matter, instead, of how and when to do it. In the European documents, moral unacceptability of reproductive cloning reveals a radically different basis. The Additional Protocol to the European Convention on Biomedicine affirms that cloning must be prohibited because it leads to an "instrumentalisation of human beings". And the French CCNE document refers, more drastically, to an "intolerable chosification de la personne",14 while the Italian CNB condemns the "assault on biological unity of human beings".15 In Europe, therefore, the ethical foundation of the cloning prohibition is to protect "human dignity"; and the prohibition is unconditional: "no derogation ... shall be made".16 Indeed, the prohibition directly concerns the if of reproductive cloning. Finally, the Resolution by the World Health Organisation is more cautious. After saying that using cloning to reproduce human beings is not ethically acceptable, it finishes with "an invitation to the Director-General to take initiatives to clarify and evaluate the ethical, scientific and social consequences of cloning with regard to human health"; and the DirectorGeneral, on his part, calls for "wisdom",17 provided that reproductive human cloning is still banned. Here, the aim to reach a programmatic compromise at an institutional level and to shorten the distances between two ethical conceptions, that nevertheless remain distinct, is clearly evident. 5. The difference among ethical conceptions is reflected, from the legal point of view, in the constitutional principles and legal systems that are inspired by them. 5.1. A legal system, that has as its fundamental goal individual liberty and freedom, not as a social value (freedom for) but as a "condition of ethical

14

CCNE, op. cit., 27. CNB, La clonazione come problema etico, 21 marzo 1997. 16 Additonal Protocol to the Convention on human rights and biomedicine on the prohibition of cloning human beings, art. 2. 17 An "optimistic line" that emerges from the Report of Hiroshi Nakajima, can be found in the document of the Italian National Bioethics Committee (1998). 15

The Problem of Reproductive Cloning

129

and moral conceptions" (freedom from)18 acknowledges a principle of reproductive freedom, to make it possible to procreate "children of choice".19 This legal system makes the protection of the unborn child dependent by the objective aims of the society.20 In this legal system it is not possible to condemn in principle reproductive cloning. Therefore, the position of the scholar who thinks it should be regarded "as an exercise of procreative liberty and granted the special respect usually accorded to procreative choice", is coherent. There would not be anything wrong - this is the given example - in "a situation in which the parents want another child and are so delighted with the existing one that they simply want to create a twin of her, rather than take a chance on the genetic lottery".21 Less coherent, but, nevertheless, significant, is the position of the law philosopher who, after having said that reproductive cloning must lead to an expansion and not to a restriction of liberty, demonstrates preoccupation for a possible "explosion of claims for reproductive freedom": claims based on a "rampant individualism heedless of the interests of society".22 Finally, quite worrying is the statement of a researcher according to whom the liberal approach, "quintessentially American", turns out to be "regrettably inadequate as an approach to human procreation", to the extent that it is deprived of all the "anthropological, social and ontological elements that accompany the formation of a new life".23 5.2. Again by means of a general point, reproductive cloning seems not compatible with a legal system that has as its principal goal the protection of the dignity of all human beings;24 that extends this protection to the unborn child,25 giving him/her "an adequate protection in respect of the applications of biology and medicine";26 that does not acknowledge "reproductive liberty" as a subjective right, as well as not acknowledging abortion 18

H.T. Engelhardt, Manuale di bioetica, II ed., Milano, 1999, 98. J.A. Robertson, Children of Choice. Freedom and the New Reproductive Technologies, Princeton, 1994. 20 D.E. Johnsen, The Creation of Fetal Rights: Conflicts with Women's Constitutional Rights to Liberty, Privacy, and Equal Protection, 95 Yale L. Journal 1986, 599 ff. 21 J.A. Robertson, Liberty, Identity, and Human Cloning, op. cit., 1394. 22 R.C.L. Moffat, Cloning Freedom: Criminalization or Empowerment in Reproductive Policy?, 32 Valparaiso Univ. L. Review 1998, 584, at 601 ff. 23 L.R. Kass, op. cit., 688 ff. 24 Convention on biomedicine, art. 1. See also the Recital n. 4 of the Additional Protocol, where the extension of its application to "all human beings" is underlined. 25 Additional Protocol, op. cit., Recital n. 2. 26 Comitato Direttivo per la Bioetica (CDBI), Progetto di Protocollo sulla protezione deU'embrione e delfeto umani, art. 1. 19

130

Busnelli

as an unquestionable right;27 that, finally, is not orientated to the suppression of the "genetic lottery", but continues to consider the "mystery" of procreation as a value to be preserved and to be defended from the "fanatics of artifice".28 The law philosopher's reflection on this issue is persuasive: if the right of every human life to be a surprise in itself has to be respected, it seems evident that a cloned being has first of all been deprived of his liberty, that can prosper only under the protection of ignorance; therefore, nobody not even a parent - has this right, to deprive a future human being of his freedom.29 Coherently, the jurist does not hesitate in affirming that the "choice" of the baby to be procreated is a "stretch of authority". The "right to responsible procreation" cannot become an absolute abuse of power of a subject towards another, reduced "to the rank of a product and a programmed object".30 It is, more simply, an expression of the fundamental right, solemnly recognised to parents in the International Conference in Teheran on the Human rights in 1968, to "determiner librement et consciemment la dimension de leur famille et 1'echelonnement des naissances" (art. 16). Meaningful is the warning of the researcher who fears the advent of what he calls (improperly) a "normative procreation" characterised by a new eugenics "mou, democratique, consensuelle"; and consequently urges to preserve "the values of a lay humanism, not subdued to the traditional religions, but also not attracted to the new techno-science mythologies".31 6. Therefore, reproductive cloning is a problem; or better, it is not a problem in itself, but the problematical point where the profound gap between ethical conceptions and constitutional principles that divide Western Law emerges. In other words: it is possible, maybe, to admit that "so far as cloning is 27

A perfect example is offered by a decision of the German Constitutional Court. After having stressed that "a solution that guarantee either the life of the unborn or the right of the mother to abort is not possible", the court introduces the principle of "intolerableness" as a cause for exonerating the woman from "the duty to give birth". See Bundersverfassungsgericht, 28 maggio 1993, NJW, 1993, 1751 ff. In broader terms, M.A. Glendon, Abortion and Divorce in Western Law: American Failures, European Challenges, Cambridge (Mass.), 1987, 145 ff. talks about "abortion for cause" referring to the experiences of Germany, France, Italy, Spain, Portugal, Switzerland and Netherlands. 28 J. Testart, L'oeuf transparent, Paris, 1986, 30 ff. 29 H. Jonas, L'ingegneria biologica: una previsione, in Dallafede antica all'uomo tecnologico. Saggi filosofici, Bologna, 1991, 249. 30 J.L. Baudoin, C. Labrusse-Riou, Produire I'homme. De quel droit?, Paris, 1987, 183 f. 31 J. Testart, Introduction a Le magasin des enfants, Paris, 1990, 33; Id., De la procreation aleatoire a la procreation normative, forthcoming.

The Problem of Reproductive Cloning

131

concerned, the issue itself is relatively trivial".32 But surely the discordance and the inevitable conflict between ethics and constitutional principles, pitilessly laid bare by the issue of cloning, is not so trivial; and this, paradoxically, in a (not only economical, but also legal) context that aspires to globalisation. The way to a shared ethic is still long, full of obstacles, and it is not known what it will lead to: American Failures, European Challenges? Or American Challenges, European Failures? Or, finally, an overcoming of the two opposite systems? It has already been said that the lawyer is not a prophet. But he has the duty to compare the systems and to point out the principles that are useful in creating a constructive dialogue and to go ahead along a road that is necessarily based on a "minimalist" ethic. The principles that can be pointed out at the moment are at least three: the damage evaluation principle; the principle of precaution; and the principle of the best interest of the child. 6.1. The damage evaluation principle is not new in the biomedical field. One of its recent applications has been Recommendation no. 1399 (1999), formulated by the Parliamentary Assembly of the European Council on xenotransplantation. The problem of weighing up the health risks of xenotransplantation against their estimated benefits has been underlined; and, since the risks of rejection and the transfer of diseases remain uncontrollable, the Assembly has recommended that a legally-binding moratorium on clinical experimentation is introduced in all member states. Additionally, the Assembly has invited the Committee of Ministers to "take steps to make this moratorium a worldwide legal agreement". A worldwide legal agreement on reproductive cloning could prove to be a helpful measure, but not a decisive one: there are, in fact, even among the strongest supporters of the "reproductive liberty" principle and of the "children of choice", those who invoke a prohibition of reproductive cloning because there are still not sufficient guarantees to make sure that children so produced will live without significant health injuries.33 At the same time, a moratorium could prevent the development of a confrontation between opposite positions: those that discuss only the "when" and "how" of reproductive cloning, and those that are against the "if". 32

R.C.L. Moffat, op. cit., 605. B. Gert, Thinking about Huxley's Brave New World: Was it Wrong to Create a Genetic Hierarchical Society? Is it Wrong to Prevent One?, in Etica della ricerca biologica, a cura di C.M. Mazzoni, Citta di Castello, 2000, 132. 33

132

Busnelli

6.2. The principle of precaution concerns essentially the role of scientific research in those territories placed at the new frontiers of "human rights and the dignity of the human beings with regard to the applications of biology and medicine".34 Disturbing and at the same time encouraging pages have been written on the ethics of scientific research: "the research does not self-guarantee its own moral propriety. However the intrinsic ethical characteristic of research lies just in this: a researcher presupposes that the world in front of her/him has a meaning and he/she has a duty to keep this meaning in the continuous construction of new things".35 Dealing with the relation between ethics and the law, it is now clear that "the principle that scientists are not responsible for the consequences of their own actions is not acceptable anymore today".36 Nevertheless researchers' liability, when put in legal terms, cannot be restricted within the legal framework of Roman Law: diligence, skill, caution. Scientific projects necessitate a switch from a logic of prevention (useful to manage known risks) to a logic of precaution (that covers unknown risks as well). In other words, we must "manage scientific uncertainty; and management of uncertainty is the basis upon which the principle of precaution lies".37 Precaution aims "a privilegier 1'hypothese du pire, lorsqu'on peut redouter un dommage irreversible meme a long terme".38 However, this does not establish a shift from fault liability to strict liability; this means "to adapt liability for fault to contexts of uncertainty".39 Without any doubts this has as unavoidable consequence a possible limit to scientific initiatives. As was put in the recent French Rapport au Premier Ministre: "in the hands of a legislator or a judge" the principle of precaution "can be the best as well as the worst of solutions: the best when it succeeds in offering solutions really apt to ameliorate citizens, safety; the worst when it performs as a pillory that prevents any flexibility, discouraging any initiatives for innovation and progress".40 34

This is the full title of the European Convention on Biomedicine. F. D'Agostino, Etica della ricerca scientifica, in Bioetica nella prospettiva della filosofia del diritto, Torino, 1996, 56 f. 36 L. Battaglia, Dimensioni della bioetica. La filosofia morale dinanzi alle sfide delle scienze della vita, Geneva, 1999, 72, quoting Daniel Callahan. 37 L. Baghestan-Perrey, Le principe de precaution: nouveau principe fondamental regissant les rapports entre le droit et la science, D., 1999, 460. 38 Jacques Chirac, President of the French Republic, in the allocution with which he opened the 4th session of the UNESCO International Committee of Bioethics (CIB) (3 ottobre 1996). 39 GJ. Martin, Precaution et evolution du droit, D., 1995, Chron., 299. 40 Ph. Kourilsky, G. Viney, Le principe de precaution. Rapport au Premier Ministre, Paris, 2000, 213 f. 35

The Problem of Reproductive Cloning

133

6.3. The principle of the best interest of the child should correct, in its actual application, the unlimited freedom that, according to a libertarian conception, could legitimately reach licentiousness, giving freedom itself a "non-desirable reputation";41 it could change, in other words, reproductive freedom from "freedom for" into "freedom to", making possible a social control on its exercise. We can give the example of the English Human Fertilisation and Embryology Act 1990 according to which nothing is prohibited a priori, but everything is subject to selective scrutiny preventing health care providers from offering "a woman ... treatment services unless account has been taken of the welfare of any child who may be born as a result of the treatment (including the need of that child for a father), and of any other child who may be affected by the birth" [sec. 13 (5)]. The suggested use of the criterion of the best interest of the child would reduce the distance between "libertarian" models and "prohibitionist" ones. In both, there would be a preventive check of lawfulness, that would be entrusted in general abstract terms to the rule-makers in the latter, and left to the case by case approach to the competent agents in the former. 7. In the background a sort of super-principle stands out, that can be described as the "responsibility principle". This is the still relevant lesson of Hans Jonas, who invokes "a new kind of humility - a humility that, unlike any previous one, is not due to the narrowness but to the excess of our capabilities, that is the prominence of our ability to act on our ability to forecast, to evaluate and to judge".42 Professor of Law, Scuola Superiore S. Anna, Pisa, Italy

41

R.C.L. Moffat, op. cit., 603. H. Jonas, Tecnologia e responsabilitd. Riflessioni sui nuovi confini dell'etica, in Dalla fede antica all'uomo tecnologico, op. cit., 60 f. 42

This page intentionally left blank

The Point of View of a Medical Geneticist on Human Cloning Bruno Dallapiccola

I am in a particular position in the context of this debate, being one of the few geneticists round this table. Professor Testart was reminding us that cloning is not a matter of genetic manipulation, but rather of cell biology. I agree with him on this point. Before expressing the medical geneticist's point of view about this topic, I would like to refer back to other considerations of Professor Testart and our chairman, who suggested that one of the problems about human cloning, is that clones "don't have the right to decide". This is true. I also add that the success of natural and medically assisted reproduction is due to parents' relatively limited powers to decide. In other words the "science-fiction" techniques which allow today the monitoring of each moment of the reproduction, do not guarantee for a perfect genome in the zygote since each genome, not only the human, is highly imperfect. For this reason when we look for single Mendelian genes transmitted inside a family, we are still not able to identify the faults and imperfections occurring at the moment of conception. Notwithstanding some encouraging perspectives allow to foresee that in the next ten years, with about 1000 dollars expense, we could have the individual genome identity card, or, more realistically, the "photograph" of a substantial number of disease-genes. I don't know whether this will become quite soon a concrete reality. I think, however, that a real complex problem to make out concerns the susceptibility genes, discussed by Professor Piazza, and the autosomal recessive disease-genes (those manifesting only when present in the homozygote). We must remember that each healthy person is heterozygous for at least 2-3 or more dozen of genes and it is not easy to understand which kind of control could be carried out by manipulating the product of conception. Yet I look at this limit as a privilege of today's parents who, programming a child, go through a "mystery", or a "punishment", as the poet Ungaretti wrote in 1929, in any case a "gift" to be protected. But this is obviously the point of view of a medical geneticist.

135 C.M. Mazzoni <ed), Ethics and Law in Biological Research, 135-139 © 2002 Kluwer Law International. Printed in Great Britain.

136

Dallapiccola

For what concerns more specifically the problem of human cloning, I have only few comments to add to the previous presentations. In particular, I would like to think, briefly, of the questions that a patient, or simply the common man, might ask the medical geneticist about human cloning and to discuss some proposals, in order to clear up a few points that remain still difficult. It's clear that the "remodeling" of the genome, during the cloning procedure, is in many instances quite imperfect. Re-reading the original papers on animal cloning one realises the number of failures this technique has generated: animals with physical defects or growth alterations, demonstrating how difficult it is to regulate the "biological clock" when it is jeopardized by the transplantation of a somatic nucleus into the cytoplasm of an egg cell whose own nucleus has previously been removed. This aspect, anyway, has not struck public opinion as particularly worthy of note: in fact, after the birth of Dolly, a statistics survey conducted on a representative sample of the US population showed that 7% was interested in being cloned. I don't know if this result would still be confirmed today. Anyway very strong reactions came from the President of the United States and some Governments, as well as from several Scientific Societies, and even from Dolly's putative father, Jan Wilmut who, a few days after the publication of the article in Nature, was declaring that "human cloning is inhuman". A very generalised outcry upon a topic which appeared relatively far-off. When the technique of cloning was optimized and the highly efficient protocols on rats were set up, the debate stirred up and many people started to believe in the real possibility of cloning humans. On this subject, Clonaid is a web site of an American society which, for a fee of 200.000 dollars, is ready to collect cells of people interested in cloning. An article published in the magazine Nature Genetics, published a few weeks after Dolly's birth, outlined the more reasonable vision, far from any extreme positions, which bans the application of cloning to humans, but looks with interest at its potentialities, mediated by animals experiments. If we try to analyse why a person might think, hypothetically, of having himself cloned, we can pick out at least three main reasons: (1) the wish to have copies of himself; (2) cell engineering and consequently the production of specific DNA mutations; (3) the production of cells copies for therapeutic purposes (this seems to be, for many aspects, the most interesting perspective). (1) Why make a copy of an individual? Is not difficult to think of copies of animals, especially for their potential use in food and agriculture domains. Identical animals would be extremely useful for the pharmacological industry to try out medicines, for instance, on genetically identical subjects. The

The Point of View of a Medical Geneticist on Human Cloning

137

problem of making human copies doesn't exist at this stage. Nevertheless some people who, like me, are medical geneticists, have probably come in contact, over the years, with parents or relatives of patients who asked for a dearly beloved person, who died prematurely or in especially dramatic circumstances, to be "brought back to life" through human cloning. Others, and here I am referring in particular to the director of the National Institute of Health, after the birth of Dolly, who said human cloning could be a method of defeating sterility. It's clear, though, and this was confirmed by the previous speakers, that cloned subjects would definitely be aware of being the results of cloning; and presumably very few people would agree to have a cloned child whose life would be undoubtedly hard. Cloning, considered as a means of combating infertility, can't be merely a way of making human "photocopies". However, there is a quite interesting aspect, at least on a theoretical level: the use of cloning to allow women affected by a mitochondrial disease (the DNA present in the cytoplasm comes from the mother and is transmitted with the oocyte) to start a pregnancy in a genetically risk-free condition, because the cytoplasm would come from the egg cell of an healthy woman donor. On the other hand the relationship of phenotypical and genetic likeness between the "cloned" subject and the "parent" who donated the nuclear DNA, has already been discussed. There is a very useful example, among many references, to clear up this point. In the first half of 19th century two Siamese twins in Thailand lived to the age of 63; they had one body but two heads. Some studies conducted on these twins, rediscovered in recent years, showed that even though they were genetically identical, they had tastes, inclinations and habits that differed significantly. This important example shows that the environment exerts a powerful influence on the phenotype, as Piazza's and Flamigni's reports reminded us. A further difference is that the cytoplasm DNA of the cloned individual would be different from the DNA of the somatic cell from which the cloning was performed. (2) The most significant manipulation that genetics can produce, in the context of the issue of cloning, concerns the possible creation of animals having specific modified genes, useful as models for the study of some human diseases. For example, an animal carrying the mutation of the gene of cystic fibrosis is an important model for this disease. "Manipulated" cloning can have therapeutical implications. This was the case of Polly, a sheep cloned from engineered cells, capable of producing the protein of human coagulation factor IX. This genetic product, secreted in the milk of the cloned animal, can be used for the treatment of this hemorrhagic disease. (3) The problem of "therapeutic cloning" seems to be the most important

138

Dallapiccola

one today, because of its potential future consequences on man. Listening to previous speakers, I had the impression of a relatively old-fashioned vision of this topic. Clearly, when we talk about cloning we no longer think of what some people had proposed in 1997, speculating on the possibility of creating copies of animals/persons, in order to have in future some spare organs. This idea was ethically highly questionable, since the copies would have had to be sacrificed to achieve the therapeutic purposes. Now, only two years later, cell biology allows us to re-think the issue in a much more acceptable way. A paper in the September 1999 issue of Nature Medicine, on therapeutic cloning, has reviewed three main techniques for producing spare organs without creating the whole individual. The first concerns transfer between species; the second the use of stem cells; the third, the more Utopian, addresses tissue reconstruction. The problem of transfer between species is really interesting. Some studies show that removing the cytoplasm of an animal oocyte (for example a cow), and introducing in its place the nucleus of a human somatic cell, countless couples of these cells can be generated and used for therapeutic purposes. Some diseases, such as Parkinson's disease, diabetes and some types of cancer could be cured through these engineered cells. But the problem of the foreign DNA, originating from a different animal species, remains still unsolved. For this reason the US President immediately prohibited the therapeutic use of these cells. In the future, it may be possible to use human cytoplasm and human mitochondria to solve this problem. We must not forget that the transfer of mitochondria has been used in a totally different situation, in a context which is not strictly acceptable from a scientific and ethic point of view, that is to rejuvenate the oocytes of old women before in-vitro fertilization. But stem cells appear to be the most promising and important perspective of therapeutic cloning. It's well known that among our adult cells, some organs or districts of our body contain also embryo cells. For instance some research studies have demonstrated that in the bone marrow there are stem cells; when stimulated at the right time they can produce myoblasts. Other cell types, in response to specific stimuli, differentiate into cells of the nervous system; a more important source of these cells is the blood in the umbilical cord. I believe that the future of human cloning lies in the evolution of these discoveries. No more human copies, and probably no more copies of single organs, because at the moment this is not within the reach of technology, but more simply copies of differentiated cells, useful for therapy. Maybe we should look at this technology as the most immediate and effective way of conducting "gene therapy". Especially since, so far, standard protocols of gene transfer using viral vectors have not yet produced any significant therapeutic result. It is likely that new techniques,

The Point of View of a Medical Geneticist on Human Cloning

139

such as those based on homologous recombination, may change this negative trend in gene therapy. But it is not going to happen overnight. The use of stem cells, obtained by cloning, could thus become an important means for treating hereditary diseases. In the light of these considerations, one can say that cloning, in its biological prospective, as a tool for the production of cell copies, should not be condemned; rather it should be used for experimentation in animal models which will yield useful benefits for man. Professor of Human Genetics, University of Rome, Italy

This page intentionally left blank

The Mystery of the Scantiness of Arguments Against Cloning Luigi Lombardi Vallauri

1. I have chosen this title in the style of Peguy to stress from the outset the aspect of the debate on cloning that strikes me most. All the governments of the rich countries (those that can afford to indulge in bioethics), all international organizations, all Churches, a vast majority of moral philosophers and jurists from that same rich world, all appear to view cloning as a terrible danger for mankind, a criminal deed to be punished with severe penal sanctions. There is a formidable coalition against cloning. A strong call to build a dam against the danger of cloning. Every year hundreds of human beings are legally sentenced to death and executed, thousands die in ethnic-religious wars. Every year millions of human embryos and foetuses are aborted, billions of animals are slaughtered having been forced to live in conditions that are unworthy of their ontology and psychology. On these issues, as on almost all bioethical problems, opinions are divided. But not on cloning. There is no doubt that cloning is Evil.1 Why? Just like children, moral philosophers always ask why. "Daddy, what does cloning mean?" "Cloning, son, is to create a living twin of someone we love or we admire. We think someone is nice and so we copy him." "Daddy, are we allowed to create someone's living twin?" "No, we're not." "Daddy, why aren't we?" "Because it's a very bad thing to do." "Why is it a very bad thing?" "Because it's bad to be exactly like another person. You wouldn't be happy to be exactly like someone else, would you?" "Well, 1 cfr. G. Kolata, Cloni. Da Dolly all'uomo?, Raffaello Cortina editore, Milan 1998; R. Satolli and F. Terragni (editors), La clonazione e il suo doppio, Garzanti, Milan 1998; Comitato Nazionale per la Bioetica, La clonazione, Presidenza del Consiglio dei Ministri, Dipartimento per 1'Informazione e 1'Editoria, Roma 1998 (with an extraordinary essay by the jurist Sergio Stammati). And also M. Houellebecq, Le particelle elementari, Bompiani, Milan 1999, in which cloning is viewed only as positive, or W. Craven, La societd degli immortali, Piemme, Milan 2000, also focussing on the equation cloning equals immortality.

141 C.M. Mazzoni (ed), Ethics and Law in Biological Research, 141-152 © 2002 Kluwer Law International. Printed in Great Britain.

142

Lombardi Vallauri

Daddy, sometimes I would like to be as strong as Superman or to be someone who has had fantastic adventures ..." "Well, son, to be a hero you've got to put a lot of energies into your life, it's not enough to be born exactly like someone else. And anyway there would be no point in doing the things that he has already done, you would have to do different things." "But if someone is born exactly like someone else, can he do different things?" "Of course, son, twins don't have to do the same things or behave exactly like each other." "But then, Daddy, if twins can behave differently and do different things, why is it bad to be someone's twin?" "No, son, it's not bad to be someone's twin." "But then, Daddy, why can't we create someone's living twin?" The child in this exchange has hit the nail on the head: the scantiness of arguments against cloning. The weakness of the arguments can be demonstrated by a syllogism of sorts: To cause something that is not bad to happen is not bad. To be a twin is not bad. Therefore, to cause a twin to be born is not bad.

The "major" premise of the syllogism almost appears analytical. To argue the "minor" premise appears fairly easy: twins are neither worse nor do they live worse than non-twins. Otherwise we would be forced to suppress all multiple foetuses (but one) during pregnancy. If we refuse to resort to abortion then we would have to prepare for an emergency situation, like when we knowingly allow a severely handicapped child to be born. But this does not happen, and this is only common sense. Following the child's arguments, and based on the syllogism, I think that everything essential on the issue has been said. I could stop here, but since 1 still have some time I should like to add a few more arguments. 2. This is where we need to turn to the notion of the "right to uniqueness".2 Generation by means of cloning, unlike sexual generation, would deprive the clone (and perhaps even the original of which the clone is copy) of that uniqueness that is the right of every human being. This argument is weak. Firstly, it is not clear that there is such a thing as a fundamental right for each human being to uniqueness. Where is this right enshrined? In what does this right consist precisely? Do we mean biological uniqueness? This 2

The first mention I have come across of this right is in F. Mantovani, Le manipolazioni genetiche: profili penali, in Manipolazioni genetiche e diritto, Proceedings of the 35th National Conference of the Unione Giuristi Cattolici Italiani, published in "Quaderni di lustitia" 34, Giuffre, Milan 1986, p. 241 ff.: "Among the prerogatives of one's personality ... is the prerogative of one's own uniqueness ... starting with biological uniqueness: the right to one's genetic identity, to being a unicum": from which we can observe that the fact (of being unique) and the right (to be unique) are not too clearly distinguished.

The Mystery of the Scantiness of Arguments Against Cloning

143

is clearly a right that has been invented ad hoc with the clear intention of prohibiting cloning. It cannot be distinguished from the right not to be reproduced by cloning (a right pertaining to the clone or the clonal subject). It is a tautological right. But we cannot base the prohibition of cloning on the prohibition of abusing the right to non-cloning. So far, the assertion that "cloning must be prohibited because it infringes the right to uniqueness" is equivalent (as far as I can see) to the assertion that "cloning must be prohibited because it infringes the right not to be cloned". But if we admit that a non-tautological right to biological uniqueness exists (somewhere), it would appear clear that it is not infringed in any crucial manner by cloning. Already at a biological level, an individual is also his history: this includes interaction with the surrounding environment which - for example, in the development of the brain - is also biology. A cloned twin is notoriously a perfect mono-zygote when he is generated by cell division, and something in between a mono-zygote and a di-zygote when he is generated by the transplantation of a somatic cell nucleus. Now, not even monozygotic twins are absolutely identical, clonal twins would be even less identical. But even if we were to admit - for the sake of argument - that the biological identity is total (to start with), the decisive uniqueness, that is the personal uniqueness of the human being would be safe, since (and here I apologise for repeating a magic phrase of mine that dates back to 1984)3 "biology is not biography". Even in a situation where the cellular make-up is perfectly identical, with both being borne in the same womb, raised in 3 Comment to the paper by Mantovani in the above-mentioned publication, p. 291: "If it is not a tragedy for a woman to give birth to twins or triplets, I have difficulty in convincing myself that it is tragic or diminishing for someone to be born as someone else's twin. Uniqueness seems to me biographical rather than biological"; p. 292: "The right to uniqueness, if uniqueness is biographical rather than biological, is not immediately infringed by the hypothesis of cloning." See also interview with G.M. Pace, L'embrione: una questione aperta, Sperling e Kupfer, Milan 1998, p. 69: "Furthermore, to use a slogan, biology is not biography ... the right to uniqueness is already guaranteed by distinct biographies, by each person's personal history." In Bioetica, potere, diritto ("lustitia" 1984; the paper was presented at a 1983 Conference) I used different words, but the meaning was the same: "We may wonder whether cloning is not always a reductive act: in fact, it is an action that preordains its exact result. In view of the criteria we have adopted, I would deny this: to be the biological caique of Einstein ... does not reduce the overall autonomy of the person, if the person was not already abnormally reduced in the original. It would be reductive to produce, or reproduce, non-autonomous subjects ... to consider cloning per se reductive would mean, I feel, to tend towards an integral biological determinism" (to be found in Terre, Vita e Pensiero, Milan 1989, p. 127). I was arguing in favour of the "the fact that (from the viewpoint of the embryo's rights) gene selection appears licit, whether it be sexual or asexual (i.e. cloning)" (to be found in Terre, op. cit., p. 133). The expression "biology is not biography" can further be found, for example, in Satolli and Terragni, op. cit., pp. 16 and 85.

144

Lombardi Vallauri

the same family and social environment, as in the case of natural monozygotic twins and of cloned twins generated by cell-division, the mere fact that each individual, quantitate signatum, occupies a different position in space would expose him to a different fate. The roof tile would fall on his head and not on the head of the other twin; one would be injured in a car accident and not the other (monozygotic twins don't always fall off the same ski-lift simultaneously, reporting identical consequences from the fall). Not to mention the different sentimental, professional, existential experiences in their life. Since matter distinguishes ontologically, the hypothetical idem is not an ipse; the only true identity is ipseitas (sameness) and sameness includes and implies also individual personal history, which is necessarily unique. So, alongside material uniqueness we now must add uniqueness deriving from individual initiative and elaboration, properties pertaining to all superior beings, especially man. It is surprising that spiritualists have been so vociferous against cloning in the name of the right to uniqueness. Spiritualists hold that man has intelligence, freedom and perhaps even a spiritual soul: for a spiritualist, uniqueness should be abundantly guaranteed by the divine creation of each individual soul ("qui finxit singillatim corda nostra") or at any rate by the extraordinary spiritual make-up of every human being. Thus, matter and spirit guarantee, in different ways, the ontologicalexistential, personal uniqueness of the clone, even in the case of cell-division, of monozygotic twins. A fortiori, uniqueness or personal diversity would be assured to the clone of an adult: no clone of Einstein or Marilyn Monroe would re-discover relativity or would re-play the lead role in "How to Marry a Millionaire", and so on. Perhaps he would not even become a physicist, and she would not even become an actress. In truth, as Umberto Eco said so wisely, none of us has the slightest idea as to who or what our clone would become. To clone Einstein would mean to give a biological para-Einstein the opportunity to be a different person from the historical Einstein. If someone were to state in his last will and testament that "I do not wish to be cloned because I want to be unique", he would certainly not be shedding favourable light on his own level of intelligence. 3. Abundantly scarce (if I am allowed the oxymoron) is also the "ecological" argument against cloning. Here the focus is on the risk of reducing biological diversity, reproducing by cloning instead of by copulation. Until recently a great deal had been said about the threat to biological diversity with reference especially to species: now, there is no doubt that clones belong to their own species, to the same extent as non-clones, and that

The Mystery of the Scantiness of Arguments Against Cloning

145

therefore they would be perpetuating their species equally effectively. And, further, the threat to intra-specific diversity begins from a particular quantitative threshold; in a population of six billion human beings, I feel I can say (I am guessing, I admit) that biological diversity would not be in peril until we reach a threshold of several hundred million clones of different originals, and of several hundreds of thousands of clones of the same original. Furthermore, I believe that those precious mutations, so useful in environmental adaptations, theoretically favoured by sexual intercourse, may also occur in cloned subjects as well. And there are species who do not reproduce sexually who are perfectly capable of adaptations: indeed, they have been reproducing themselves by cloning with great success for hundreds of thousands of centuries. 4. To go back to the "right to uniqueness". If what I have said so far is correct, then the ontological-existential uniqueness of a clone cannot be a fundamental right because it is an undeniable, unviolable fact. Just as it makes no sense to prescribe (or prohibit) the impossible and the necessary, equally it makes little sense to confer upon someone (or to deny that person) the right to be that which he/she necessarily is. It makes little sense for the law to guarantee explicitly to a clone the right to uniqueness that matter and spirit already guarantee to him/her ontologically, existentially. It would make sense for the law to guarantee the clone's right to be treated in full recognition of the unique ontological existential entity that he/she is. Human behaviour - and the laws that discipline it - has the weird ability to deny the facts: not to prevent them from being so, but to presume a priori and fictitiously that they are not so. For millennia the law has denied (and in some places it still tenaciously denies) the fact that human beings are all ontologically equal, since they all share a common human nature: yet this has been denied, stressing conversely differences of race, sex, religion, as though this made human beings belong to a different species. Luckily in the legal codes of the rich world (the only world that can afford cloning practices) these distinctions have become unlawful. The principles upon which equality is based are the same that uphold individual uniqueness. For millennia the law has demanded that human beings be identical, ignoring or repressing diversity. Today, behaviour on the part of parents (or anyone else) aimed at preventing a clone from expressing his/her ontological uniqueness by exercising freedom of choice in religious, cultural, professional, sentimental, family affairs, would be considered unlawful. In order to approach the issue of cloning from the point of view of the right to uniqueness we don't need any special law: it will be enough to apply common law. No one would dream of doubting that a clone would enjoy

146

Lombardi Vallauri

all human rights; the discussion revolves around not how to treat him once he/she is brought to life, but whether he/she should be allowed to exist in the first place. Once in existence, a clone would be to all intents and purposes a non-discriminable (equal) and a non-predeterminable (unique/different) citizen optimo iure. The law would observe and reflect ontology. And this is the decisive point. Incidentally, I feel that the threats to uniqueness being denounced by the execrating majority when they refer to biological cloning are in no way less dangerous than the aggressions to uniqueness perpetrated by the principal agencies conducting the execratory campaign. For example, the concerted action of Catholic families, Catholic schools, Catholic parishes, Catholic youth movements on the critically defenceless younger generations may be seen as an attempt to fashion a culturally Catholic clone. Is it not the mission of religions to produce the highest number possible of monozygotic twins in faith? As we address the issue of possible future cloning, let's not forget the cloning processes that have gone on for centuries. To sum up. To be born a biological twin in no way deprives a person of his/her ontological-existential factual uniqueness, nor of the human faculty of self-determination. To be born a twin is not a misfortune if uniqueness and autonomy are respected. And this respect, called for by ethics, is already formally guaranteed by law. Thus we have solved in a humanly reassuring manner the problem as to how a clone should be treated, once he/she has been brought to life. Now we can examine with greater calm the problem of whether or not the clone should be created. To give life to a normally autonomous human being, whose autonomy will be fully observed and guaranteed, is not an execrable crime. 5. Some would have it that to create a clone is neither immoral nor unlawful in terms of the result of the act, but rather because of the modalities by which the act is accomplished. By "producing" a clone, instead of "generating" him/her through sexual intercourse, one is somehow considering him/her an object, a slave, a property. I admire this type of argument, because I find that bending over backwards is one of the most difficult tricks to perform. Anyone who can carry on an argument of this nature, must be a first-rate acrobat! But I think it's obvious that you can both engage in old-fashioned copulation and be a padre padrone, an authoritarian and proprietary parent; equally, you can clone your offspring without being a padre padrone. Expensive, painful artificial procreation teaches us how much devotion to life there can be in the resort to artifice. Those who hail copulation as the only truly human means of reproduction are celebrating animal-style reproduction. I appreciate and defend (in animals and myself

The Mystery of the Scantiness of Arguments Against Cloning

147

alike) animal instincts, but I realize that the specific characteristic of man lies precisely in artificiality - in all fields. Thus, if anything is specifically human, then it is artificial procreation! I don't see why it should be unethical to use a test tube or a scalpel, whereas it is ethical to do what the dinosaurs did. (You may say: but dinosaurs copulated without being bound by the bonds of indissoluble wedlock. To which I reply: one can clone an offspring even within the bonds of wedlock.) Neither cloning, nor any form of imaginable artificial procreation imply a master-slave mentality purely as a result of the modality. What was deplorable in slavery was treating as a slave a human being, not the fact that he had been treated as a slave when he was a spermatozoon or a zygote! After all, when we are in that stage of our lives we are all pretty passive. I'm sure that when I was a spermatozoon nobody ever asked my opinion, nor did they when I was a zygote: they treated me just like an object. Yes, I've got to admit it: I was once an object. Then gradually I became a subject and I am lucky in that - all things told - I have more or less always been treated as such. Therefore, cloning does not seem to me to be an execrable crime, neither in terms of the result of the act (giving birth to a twin), nor in terms of the modality (artificial procreation). 6. In the days of execration another argument also went round: age. According to this argument, a clone would be born old, since it would inherit the age of the original. This would infringe upon his right to be born as a newborn. When I heard this argument I was overcome by a very exciting vision: someone decided to clone an Egyptian mummy and the newborn baby, the very instant that he was delivered, crumpled to dust since he was 3600 years old ... and a day. On this point I immediately asked for expert advice from Alberto Piazza and Carlo Flamigni and they confirmed that it's not true: a clone is not born old. So that's not a problem. 7. But there are problems as far as the family of the clonal twin is concerned. The basic principle is that every human baby has the right to be bom in a family worthy of this name. But the notion of family varies enormously according to our different cultures and still today is subjected to vastly differing interpretations in different societies.4 There are a variety of good reasons in favour of the model consisting of a male father and a female mother who do not have other children with other spouses or partners. But these are not absolute reasons. For the sake of simplicity I shall in any case concentrate on this model, the standard model in our societies, and 4 L. Lombardi Vallauri, Filiazione artificiale e principio famiglia, in "Persona y Derecho" Vol. 41-1999/11, pp. 337-352; also in Studi in onore di Pietro Rescigno, II, 1998, pp. 443-455.

148

Lombardi Vallauri

will merely examine cloning within this family-type. For twenty years already I have been convinced that, on the issue of cloning and family, there is no such thing as a single answer valid for all situations: we need a short monographic study for each possible micro-constellation, even within a so-called normal couple. The simplest is undoubtedly cloning by cell-division. It results in the birth of completely new monozygotic twins, of unpredictable biological physiognomy. This hypothesis is absolutely identical to the birth of natural twins. If we wanted to be perfectionists, we could select the ideal zygote in vitro, clone it by cell-division and implant the clonal brood into a uterus, at the same time or at a later date. The genetic relationship between parents and offspring would be the same as in traditional procreation. The novelty starts when we do our cloning by transferring the cell nucleus. In this case, the hypothesis closest to our standard model of procreation, is what I would call homologous cloning, i.e. cloning done with material from the couple involved. The transfer of nucleus material from the husband (or long-time partner) to the enucleated ovum of the wife (or long-time partner), followed by implant into her uterus. The father will contribute 46 chromosomes instead of 23; the child will be a child of the couple, probably even more "his father's splitting image!" than usual. This type of cloning would rid us forever of any problems tied to paternal sterility, since every man carries within him thousands of billions of nuclei. Even if he were unable to produce even a single spermatozoon, thanks to this technique, he could fertilize all the women on Earth. But, in this instance, he makes use of the technique only to generate a child with his legitimate wife. Obviously, if you are a hair-splitter by nature, you will point out that in this case the clone's father is also his twin brother and that, in a traditional sense, the clone's parents (if the nucleus is what we consider the decisive element) are the man and the woman, the union of whose gametes produced the genetic formula of the father-cum-twin: in this case the clone's paternal grandparents. You will then say that there is something wrong in being the son of one's twin brother and the child of one's grandparents. But this would indeed be a biased way of presenting the case, rather like claiming that a homozygous twin, generated by the natural cleavage of the ovum, is the child of mother and father or (who knows?) of the cell of the morula of which he is the replicant. From our ordinary human point of view, this would be the child of a true father-mother couple. Homologous cloning performed inserting a nucleus from the mother is already something different (the reasons for such a technique could be to satisfy the desire of a father to have a girl-child that would be the exact

The Mystery of the Scantiness of Arguments Against Cloning

149

replica of his wife, or the mother's wish to give birth to a replica of herself who would be so lucky as not to be misunderstood by her mother ...). Here, the mother contributes everything, genetic material and gestation. She is a super-mom, it's a "one-woman-show" and the baby will be "her mother's splitting image!". The father will be a loving, caring father, will play the generous role of para-adoptive parent in a situation not all that dissimilar (although not identical) to that of St Joseph. The parents in the traditional sense - if we consider that the nucleus is the decisive element in relation to the rest of the cell - will be her maternal grandparents. And yet a different case, although still somehow homologous, is the cloning of a previous child bora to that couple: for instance, if the previous child died in an accident while still a baby and the parents wish him to relive in the new baby. Here they are parents in the traditional sense, real parents. If you are still in a mood for hair-splitting you might deplore the fact that these cases raise suspicions of incest, or quasi-incest. I'm sure you'll do it merely to get a kick out of bandying about the word incest, since even you must realize that there can be no incest (of the exciting kind) in a process that has entirely done away with sexual intercourse! Genetically speaking, in the first case the baby boy is the child of his paternal grandparents and his mother: an ethical commentator given to sensationalism would say that the mother had been fertilized by her parents-in-law! In the second case, the baby girl is the daughter of her mother and her maternal grandparents: quodammodo her mother has been fertilized by her own parents. In the third case, the previous child (boy or girl) has fertilized his/her own mother, also quodammodo. I haven't got the time to engage in a detailed ethical evaluation of these different and complicated family trees. If we accept as decisive the criterion of the prevailing interest of the weakest subject (the child) to benefit from a real family, the genetic profiles seem less important than the social and psychological ones, which in a stable heterosexual couple should presumably (but only presumably: anything can happen even in the best of families) be reassuring. We should therefore say: be a standard, stable couple and do as you wish. Along these lines, the abnormalities in these three cases of nucleus transferral should be relevant not as deviations from standard cultural archetypes as such (like our sensationalist commentator would have it), but rather as possible sources of psychological distress for the child. On the other hand, psychological distress is in itself culturally conditioned: if you reduce the cultural stigma, you reduce the psychological trauma. Taboos creates traumas, much more so than the reverse. But, if we believe that the trauma is ethically the element that counts, then all we

150

Lombardi Vallauri

need do is alleviate the cultural stigma. In today's cultural milieu I would imagine (but then I am neither a psychologist nor a sociologist) that the first case (transfer of paternal nucleus) is hardly traumatizing at all; the third case (knowing that you are the twin of a deceased brother or sister), is merely moderately traumatizing; but the second case (knowing that you are in toto your mother's daughter, with no genetic link to your father or your paternal grandparents) I would probably find very traumatizing indeed. But I have to stress that "probably". As I shall say shortly, in my conclusions, what is truly traumatizing is to have crazy parents. Next comes heterologous fertilization. For the sake of simplicity I shall again consider it as applied to a standard couple. This is the production/generation of a twin of a human being we admire or one who in any case is considered worth reproducing. This is by far the most interesting type of cloning. In 1984, among the many scenarios I envisaged, I imagined a dictator who wanted as his subjects thousands of clones of himself, or thousands of workers who were to be the genetic twins of the most hard-working and stakhanovite of his factory-hands, or soldiers genetically identical to his fiercest and bravest infantryman. I also imagined a supermarket, in a hypothetical liberal-democratic future, with huge, transparent freezer compartments containing frozen potential human beings, with photographs of the individual at all different ages: ordinary couples would wander by, pushing their shopping-carts and saying: "What do you think? Should we take that one? We're nothing special, we had better contribute a child like that to mankind, since he's sure to be healthy and clever ..." Individual gametes of worthy persons, or at any rate of healthy people, are already available on the market. From gametes to nuclei it's but a short step. A clone of the genius (Einstein), of the saint (Padre Pio), of the athlete (Cassius Clay), of the actress (Marilyn Monroe), of the top model (Naomi Campbell), of the artist (Mozart, Cezanne), of the Minister of Health (Rosy Bindi): these are temptations that are not all that easy to resist. The essential, as we all know, is that the clone not be pre-destined. From the point of view of what interests us here - the family constellation - in all cases of completely heterologous cloning we have something that resembles an asymmetrical adoption. The child, as in adoption, is genetically completely alien from the couple, as far as his nuclear DNA is concerned (90% of his self, let us say). But the father contributes precisely nothing, while the mother adds a genetic 10% and the gestation (that is, if the gestation does not take place in a newly designed, total incubator). Thus we have entirely eliminated our sensationalist ethical commentator's doubts on incest. Once we have dismissed the dictator's scenario (thanks to the law in force in the liberal-democratic states of the rich world, described in

The Mystery of the Scantiness of Arguments Against Cloning

151

paragraph 4), the only two remaining problems are: How to ensure that the social parents of the clone actually respect his freedom and vocational self-determination; How to overcome any trauma the child may suffer in learning that he is (a) genetically heterologous (more or less the same as an adopted child) and (b) the identical copy of a pre-existing human being, selected as an original because of his outstanding qualities. Both traumas - knowing that one is the child of "others" and knowing that one is the double of someone else - can easily be overcome by the loving care and intelligent support of one's "adoptive" parents. Whereas structurally "normal" parents, alas, can often be traumatizing and destructive. If we accept as our fundamental principle the priority of protecting the weaker subject - the child, that is - one begins to wonder whether we should not perhaps replace the notion of structural typology with that of psychological-existential typology: for example, instead of establishing the prerequisite of a "stable heterosexual couple", perhaps we should concentrate on a "loving and intelligently caring family", no matter what elements it is made up of. Ethically speaking, I see no serious objections. Juridically speaking, the objections are more significant, but they are technical in nature: the law is used to dealing with types that are as precisely defined as possible and "male", "female", "age x", "married" are clearly more precisely defined types than "loving", intelligent", "caring", "respectful". Nonetheless, what is truly important is to end up with good parents, and the real trauma is to be raised by crazy parents ... And the decision to procreate a child by cloning is not (if my reasoning so far is correct) automatically evidence of madness. 8. If we accept that to procreate a twin is not necessarily an execrable crime, since it does not mean to create a slave, a miserable and unhappy creature, then it becomes quite intriguing to discover the motives for this hyper-execration. This is the topic that the round table on popular opinion and collective imagination will address. I should just like to say that the mystery of this all-pervasive execration, coupled with the scarcity and scantiness of real ethical arguments, must have at least one (out of the many) very remote origin. There may be others as well. But the one that originates deep in our human soul is the nameless fear that the idea of life being entirely manipulable generates in relation to human identity. If "I" is something that can be manipulated (produced, reproduced), then "I" is no longer me, I am not myself. What am I? Who am I? The crucial philosophical problem of modernity is reductionism. On 31 December 2000 we shall come to the end of a century characterized by science's domination

152

Lombardi Vallauri

of the physical world (matter-force-energy) and a new century will begin, probably characterized by the domination of science over biological and algorithmic information (artificial life and intelligence). The circle is closing in on man. Cloning induces fear, the same fear caused by casting doubts on the identity of man. This is just one instance - the one nearest at hand - of the general practice of the "cultural production of the desirable ego": a practice as old as homo himself, perhaps one that is part and parcel of homo and which today has shifted from gymnastic and pedagogical techniques to molecular techniques. And so we witness this revolution, like an unstoppable flood with ontological implications, that comes crashing through any ethical or legal barrier we may erect, like the one that allows therapeutical interventions and prohibits improvements or constructive practices. Cloning is just a frontier region in the no man's land of complete mapping and reading of the human genome, the complete mapping and reading of the human brain as architecture and algorithm. And, connected to this, the creation of biological and non-biological supermen and wonderwomen, chemically induced superstates of conscience, and all the related problems concerning the rights of new human and extra-human subjects, the true value of our new reductionist mental achievements compared to our ancient ascetic, aesthetic, or mystical achievements. Fear is not suitable for a philosopher. What befits a philosopher is intellectual courage which - as Aristotle said - is the happy mean between cowardice and foolhardiness. Blowing your trumpet to sound a false alarm, or closing your eyes so as not to see, is not philosophy. Philosophy is motivated ontological wonder and should lead to lucid discernment of that which protects or threatens what is ontologically wonderful. Science-technology opens up brave new worlds to contemplation and multiplies the possible at a dizzying rate; accidentally, it can also produce squalor and horror. To stop science-technology as such is anti-human. I believe that philosophy and the law together have already done a fairly good job: ethical considerations incorporated into the rules and principles of positive national and international law already provide us with much of what is necessary to address "pleromatically", without cowardice or foolhardiness, the challenges of that which is new.5 Professor of Legal Philosophy, University of Florence, Italy 5 L. Lombardi Vallauri, La pratica bancaria difronte alle istanze etiche espresse dalle norme e dai principi del diritto nazionale ed internazionale positivo, Paper presented at the World Conference of Banks and Insurances, FIET, Geneva, 3 July 1996, in "Fiba-Notizie quadri", April 1997, pp. 1-18.

Making the Right Use of Law: The Cloning Dilemma Stefano Rodota

It is generally difficult for society to digest scientific and technological innovations whenever they concern, above all, the way one is born. It is easily understandable that one feels dismayed when confronted with the havoc seemingly made of parentage and generational mechanisms - the very uniqueness of each individual. The basic anthropological foundations of mankind have been challenged all of a sudden, in a matter of few years. This is a source of anguish and evokes haunting presences: it so happens that law is regarded as the sole social cure and pressing demands are made for rules, limitations, prohibitions. Having lost the rules given by nature, society sees itself mirrored in law and turns to it for reassurance rather than for getting protection. The cloning issue is typical in this context exactly because of its extreme peculiarity. Cloning marks the waiver of sexual reproduction; it challenges the uniqueness of individuals and makes human "serialisation" a reality; it is a manifesto of male superficiality. It is difficult to sort out this tangled mix of emotions and problems - which is why, with hasty simplification, law is regarded as a response, a tool for re-establishing order even more than for setting out rules. In the aftermath of the announcement concerning the birth by cloning of Dolly the sheep, various governments requested ethics committees and ad hoc commissions to draft reports on this subject, drew immediate conclusions therefrom and started an exercise which led quite rapidly, in January 1998, to an Additional Protocol to the Council of Europe Convention on Human Rights and Biomedicine which was signed by a number of countries - such Protocol including the ban on reproductive cloning. This document, like many others, sets out from the start that the scope of the ban is limited - as it only concerns human reproductive cloning. In other cases the ban has been relativised by linking it to the current state of the art and the recommendation that the issue should be reconsidered 153 C.M. Mazzoni <ed), Ethics and Law in Biological Research, 153-161 © 2002 Kluwer Law International. Printed in Great Britain.

154

Rodota

after some time.1 Additionally, even in countries that have stated, in a more or less official fashion, their support for a permanent or transitional ban, tests have been authorised and/or admitted when, in fact, they might be considered to conflict with the absolute rejection of this reproductive technique. In short, the cultural scenario is changing. On the one hand, there is an attempt to overcome the admissibility-prohibition antagonism by probing deeper into the multifariousness of cloning; on the other hand, there is growing awareness of the risks related to positions that, when hastily translated into legal rules, may impose inappropriate limitations on research and, above all, jeopardise any free exchange of opinions on an issue which cannot certainly be dismissed with authoritarian solutions. A more serene, thought-provoking debate has therefore begun. "Is cloning the absolute evil?"2 asks Gilbert Hottois. "Not banning cloning for the wrong reasons"3 is the warning given by Lawrence Tribe - whose standpoint on this issue has evidently shifted. Cass Sunstein's view is more radical and reflects, in a sense, the impossibility to take a clear-cut decision; indeed, he has created his own double (or clone, maybe) and suggested two model judgments which, based on the same premises, lead up to two opposite decisions.4 The debate among legal scholars is focussed on the foundations of this ban: is it enough to refer to human dignity, the uniqueness of each individual, the right to freely develop one's personality? However, a preliminary question is related to the adequacy of law as a means for rinding suitable solutions for these issues - that is to say, the role played by law within the new environment created by scientific and technological innovations. Two different viewpoints mark the boundaries of the debate. One is the fear of a "droit saisi par la biologic"5 - that is to say, deprived of its 1

House of Commons, Science and Technology Committee, The Cloning of Animals from Adult Cells, I, The Stationery Office, London 1977, XVII; National Bioethics Advisory Commission, Cloning Human Beings, Rockville, MD, June 1997, p. 106. 2 G. Hottois, Is Cloning the Absolute Evil?, in "Human Reproduction", 1998, n. 7; see also Essais de philosophic bioethique et biopolitique, Vrin, Paris 1999, pp. 72-73. 3 L. Tribe, On Not Banning Cloning for the Wrong Reasons, in M.C. Nussbaum, C. Sunstein (eds.), Cloning and Clones. Facts and Fantasies about Human Cloning, Norton, New YorkLondon 1998, pp. 221-232. 4 C. Sunstein, The Constitution and the Clone, in M.C. Nussbaum, C. Sunstein (eds.), Cloning and Clones, qv., pp. 207-220. 5 C. Labrusse-Riou (ed.), Le droit saisi par la biologie. Des juristes au laboratoire, L.G.D.J., Paris 1996. In his Foreword, Labrusse-Riou mentions the fact that the title of his book is framed after B. Edelman's Le droit saisi par la photographie, Maspero, Paris 1973. However, it is worth pointing out that L. Favoreau has referred to La politique saisie par le droit (Economica, Paris 1998) - which shows how complex and entangled are the exchanges between law and other sciences.

Making the Right Use of Law: The Cloning Dilemma

155

autonomy, unable to reflect and convey values other than those put forward directly by science with a thorough reversal of the subject-object relationship. Another is the risk of making authoritarian use of law as a shortcut for putting an end to a conflict - as a tool for imposing values that are not mutually shared.6 These two viewpoints underlie all the considerations on the limitations applying to law and the mechanisms of its application, which cannot consist any longer in traditional legislative instruments. Whenever the advent of law is called down from the start, this is not done in order to let law draw its conclusions from social developments or else take note of a situation that has already found, in a sense, its social legitimation. The advent of law cannot come at the end of the day. It should accompany the rising of the sun, yield its colours to the day: it is no chance that the term "sunset rules" is used to refer to rules that have reached the final stage of their transient existence. This does not mean that law cannot convey strong values, facilitate social promotion, be an active factor in social change. Indeed, the concept of "weak" law is quite remote from a vision in which law is fully aware of its limitations. Law is weak to the extent that it is ready to be influenced by external occurrences and become subjected to them; conversely, in the latter vision the approach to reality is quite different: law will explore the mechanisms underlying social organisation, identify the areas where legal regulation is appropriate and set itself to the task in those areas by selecting the most suitable techniques. Indeed, an imperialistic, all-pervasive concept of law entails the actual danger of rejection if social trends and conflicts are not perceived correctly (and in advance) because of the hasty recourse to general, all-inclusive measures. In this regard, useful clues are provided by the status of many regulatory measures concerning bioethics. Exactly in order to meet demands for a 360-degree regulation - often based on ideological grounds or else reflecting the need to assuage social fears - clumsy laws have been drafted including prohibitions and criminal penalties which have replaced the open-minded exchange of different viewpoints. This approach has actually done away with the basic issue and prevented its social metabolisation; in fact, there is the risk that it may make this confrontation harsher by challenging the legitimacy of certain stakeholders with no adequate reasons. Thus, it happens that such regulatory measures do not pass the test of their social implementation. In life - which is actually the province of any provision that is somehow related to bioethics - the time always comes 6

I have many times attempted to draw attention to this risk; see, for instance, S. Rodota, Question! di bioetica, Laterza, Bari, 1993, p. VIII.

156

Rodota

when the individual's choice makes itself felt with utmost strength. If a rule is felt to be an intolerable violation of one's own autonomy, social mechanisms come into play for isolating or circumventing such rule. The outcome for this process is not only a specific breach, but rather the overall de-legimitisation of the rule. Proof of the latter is given by a number of situations: from the so-called abortion tours up to the increasingly common reproductive tourism - which point to the search for a place where law has not inappropriately claimed to impose its own rule. The above considerations highlight the need for a sensible use of legislation so as to prevent its devaluation. Indeed, the devaluation of law does not result from its inflationary use, as is commonly stated, but rather from the loss of effective regulatory power. Still, whenever these increasingly complex issues are addressed one should not fail to consider that the demand for legal rules and prohibitions is often grounded or basically accepted - exactly in the socially most controversial areas - in those sectors that are on the forefront of innovation. This is confirmed by human reproductive cloning issues: acceptance of a ban is undoubtedly the reflection of a specific conviction, but it also points to the need for insulating the socially most controversial topic and soothing public concern, thus leaving the remaining activities free from restrictive rules. We are therefore in the presence of a sort of per differentiam legitimation. Scientists do not accept limitations just because it is increasingly difficult for scientific activities to be absolutely impervious to society-related considerations: above all, they accept such limitations in that they allow free manoeuvering room for research in all the areas falling outside their scope. However, even this policy may be problematic. Jacques Testart - who cannot be certainly considered to be unaware of the social impact of science - has challenged the simplistic view opposing human reproductive cloning to other types of cloning: indeed, he has highlighted the possibilities and opportunities provided by cloning embryos with specific features in order to have them possibly implanted and thereby increase likelihood of a pregnancy. Based on the interpretation of Article 1 of the Additional Protocol to the European Convention on Biomedicine, it does not appear that this practice is prohibited as the prohibition laid down in that article only refers to creation of a human being that is genetically identical to another human being, whether alive or dead. In order to probe deeper into this issue, the legal description of the embryo - i.e., whether it is a person or not - can be regarded as ininfluential. Indeed, the rationale of the prohibition laid down in the Protocol consists in the attempt to prevent a practice that will lead to reproduction or duplication of another individual and may cause the cloned individual to

Making the Right Use of Law: The Cloning Dilemma

157

lose his/her subjectivity on account of the comparison with the relevant model. However, this is not the case described by Jacques Testart, since the cloned embryo would only be implanted if implantation of the first embryo were to fail: as the model is non-existent, the "double" issue is irrelevant. And, if both embryos were to be implanted, the whole situation should be regarded in a different light - i.e., as a case of twin birth. In short, it would be an activity that is aimed at reproduction via a cloning technique; however, it would not fall into the human reproductive cloning scheme as currently envisaged by law scholars. Hence, in this case the foundations for a ban should be found in a different type of regulation concerning embryonic testing. The focus of the issue is therefore shifting to a different area, i.e. national laws; no clues can be found in the Convention on Biomedicine in order to rule out cloning in the case described above. The only express prohibition to be found in Article 18 of the Convention is related to creation of embryos "for research purposes"; however, in the case at stake the embryos would be created for reproductive purposes. More specifically, the Explanatory Report to the Protocol expressly refers to another protocol on the protection of embryos as regards "use of embryonic cells in cloning techniques" (see no. 2). No extensive construction of the Protocol is therefore admissible, and the latter anyhow considers "cloning as a biomedical technique" to be fully lawful and important with a view to the development of medicine. Thus, a clear-cut conclusion has been reached: "the provisions of this Protocol shall not be understood as prohibiting cloning in cell biology" (Explanatory Report, no. 4). Three different situations can be envisaged: cloning of human beings, which is forbidden; use of embryonic cells in cloning techniques, for which reference is made to a subsequent protocol and which therefore remains lawful; cloning of cells and tissues, which is considered to be definitely lawful. Having specified and limited further the scope of discussion, it is necessary to better define the place of cloning within the framework of reproductive techniques. It has been argued that cloning is to be included into the latter techniques, of which it would only be a variant.7 However, the features of cloning would rather point to a clear-cut solution of continuity, since cloning marks the passage to asexual reproduction - i.e., without either gamete fusion or parental genes combination. Thus, it is justified to consider cloning as a separate entity in respect of reproductive techniques.

7

See, inter alia, the wide-ranging study by J.A. Robertson, Liberty, Identity and Human Cloning, in "Texas Law Review", 76, 1998, pp. 1371-1456.

158

Rodota

Then, it is appropriate to probe soundness of the considerations concerning uniqueness, identity, equality, dignity and free development of a cloned being's personality. Hans Jonas has especially stressed "the individual's transcendent right to a genotype of his own which is not shared by others and is unique" - which led him to conclude that for a cloned human being "this right has been prejudiced a priori". These considerations have to do with the uniqueness concept, which is closely related to "a manifest right not to know, which is inherent in existence and would be denied to an individual who were compelled to know that he is another's copy".8 The above consideration - which I have myself often referred to - needs further analysis, especially as regards the right to a unique genotype. Apart from the difficulty of identifying non-trascendent foundations for this right, such a vision of the right to uniqueness entails the risk of a reproductionist stance according to which any individual can be explained by his/her biological rather than biographical traits. The debate on cloning has actually allowed re-affirming the inappropriateness of a "DNA mystique", of considering "the gene as cultural icon".9 In short, identifying individuals with their genetic heritage is against scientific evidence showing that personality is the result of a complex interaction between genetic and environmental factors - therefore, legal standards and safeguards should actually concern the latter features rather than simply apply to biological data. Indeed, the prevalence of biography over biology would ensure uniqueness of individuals. However, uniqueness is not equivalent to identity. The latter would manifest itself "visibly by means of the appearance of body and face". Conversely, with cloning "the symbolic value of the human body and face as supporting the individual in his/her uniqueness would tend to disappear".10 The resulting reversal of the relationship between genetic and personal identity would affect human rights and dignity. If the latter conclusion refers to the right to freely develop one's personality which would allegedly be prejudiced by cloning, we are facing again an issue that has already been mentioned and which I would like to address briefly below. Conversely, it would be excessive and quite dangerous to

8

H. Jonas, Tecnica, medicina ed etica. Prassi del principio di responsabilitd, edited by P. Becchi, Einaudi, Torino 1997, pp. 144-145. 9 D. Nelkin, M.S. Linder, The Dna Mystique. The Gene as Cultural Icon, Freeman, New York 1995. 10 H. Allan, Possibilites biologiques, impossibilites sociales, in H. Atlan, M. Auge, M. Delmas Marty, R.P. Droit, N. Fresco, Le clonage humain, Plon, Paris 1999, pp. 17-39.

Making the Right Use of Law: The Cloning Dilemma

159

consider cloning as a form of radical dispossession of rights which is beyond remedy. This line of reasoning results into inappropriately mixing quite different issues - from instrumentalisation of individuals to equality of individuals born according to different mechanisms, from self-perception to the perception of each individual by others. One may actually ask a question that is only seemingly trivial - i.e., if one can find a way for safeguarding the rights of cloned individuals, to what extent is human reproductive cloning also to be allowed? In a very schematic fashion, it may be argued that Jonas's view is focussed on the self-perception of cloned individuals: indeed, he refers to "a right of the subjective, rather than objective, sphere".11 Atlan would rather appear to attach greater importance to the individual being recognised by others as unique, therefore to his/her social perception; it is no mere chance that he does not refer to a subjective feature - i.e., the right not to know - but rather to an objective data consisting in the body-face pair. In the latter case it is necessary for the focus to be on the legal conditions possibly facilitating social acceptance of a clone, rather than on theoretically applicable prohibitions. If equality becomes the fundamental issue, the ban on donation cannot but apply to its use on a non-individual level with a view to creating, in a more or less blatant fashion, either privileged or subordinate groups. This hypothesis may be considered to be purely academic and smack more of Utopia than of reality; however, it allows identifying a criterion for analysis which can better help investigate the concrete situations where genetic techniques may be used for discrimination purposes. When addressing the equality issue in this way, it becomes immediately apparent that the risks of a caste society based on donation are infinitely lower than the much more actual risks of discrimination based on the selective use of genetic information. Analysing the demand for cloning may 12 be useful in order to better highlight the more general issues of access to reproductive technologies. Indeed, in both cases this exercise requires careful analysis of human rights issues and, in this regard, the radical features of the questions raised by cloning may have positive impact. As to the issues concerning exclusively individuals, if emphasis is put on the instrumentalisation of individuals allegedly resulting from cloning, one should refrain from inappropriately referring to considerations that might 11

H. Jonas, Tecnica, qv., p. 145. E.A. Posner, R.A. Posner, The Demand for Human Cloning, in "Clones and Clones" qv., pp. 233-261. A "shopping list" of possible questions can also be found in H. Jonas, Tecnica, qv., p. 141. 12

160

Rodota

result into challenging the reasons for procreation. Considerable social and cultural importance is undoubtedly to be attached to narcissist components, to the consideration of a procreative project that may also appear as a form of dispossession in respect of the entity which is its focus - exactly on account of its radical nature -, or even to the unprecedented problems to be coped with by a cloned person. However, these considerations cannot be automatically translated into legal approaches. The legal perspective runs the risk of being markedly distorted if the human reproductive cloning issue is addressed in an excessively emphatic or evocative manner. The emphasis is certainly excessive if the analysis is grounded on the slave = clone equation: indeed, from a legal standpoint it is technically inappropriate to equate cloning to reduction into slavery. Additionally, this metaphor is also biologically unsound as it is exactly the relationship between individual and environment that rules out the perennial dependence of a clone upon the relevant model. An even more emphatic and distorting argument is based on the reference to crimes against mankind.13 If use is made of these considerations, one cannot help wondering - in this as well as in many a similar case: who can exercise the right to interference for humanitarian purposes? - how the entities can be identified who are entitled to speak on behalf of mankind and have the power to impose both a ban on cloning and the severe penalties carried by any crime against mankind - which entails considerable implementing difficulties given the sensitiveness of reproductive issues. The reference to the human dignity principle is also quite suggestive as a justification;14 however, it is far from decisive. It plays a fundamental role whenever it is necessary to prevent commodification of such sensitive matters, as well as with regard to collective reproduction policies. However, it is difficult to use that principle as a determinant criterion in order to evaluate decisions that can be considered to fall into an individual's autonomy sphere. I would consider the right to freely develop one's personality to be more relevant, or anyhow more fruitful as a starting point. This right was given ample recognition in a more or less binding fashion: from article 2(1) of the German Grundgesetz to article 2 of the Italian Constitution. It allows taking duly into account the different needs expressed by the parties concerned - i.e., who would be interested in the use of cloning and who might be born by using this technique. The comparative assessment of rights and 13

M. Delmas Marty, Certitude et incertitudes du droit, in H. Allan, M. Auge, M. Delmas Marty, R.P. Droit, N. Fresco, Le clonage humain, qv., pp. 67-97. 14 See M.L. Pavia, T. Revet (eds.), La dignite de la personne humaine, Economica, Paris 1999.

Making the Right Use of Law: The Cloning Dilemma

161

interests, rather than a priori alternatives liable to the criticisms mentioned before, can promote continuation of a debate aimed at facilitating the development of rules for cloning in the most appropriate places and manner. Professor of Law, University of Rome, Italy

This page intentionally left blank

The Right to Genetic Disobedience: The Iceland Case Amedeo Santosuosso

On 17 December 1998 the Icelandic Parliament (Althingi), by 37 votes out of 63, passed a law authorizing the collection and processing of the medical and genetic data of the entire population of the island by private profitmaking companies. Behind the general and abstract wording of the licence granting procedure there is a very clear situation: the deCode genetics firm, set up with the help of U.S. capital by the Icelandic geneticist Kari Stefansson and which has already signed a deal for the use of research results with the pharmaceutical firm Hoffman-La Roche, which aims to develop and place on the market medicines for the treatment of twelve common diseases. This law merely has the appearance of a general piece of legislation but is in reality a very particular measure. And, reflecting on this well, it could not be otherwise, given that all the medical records of Iceland are a non-renewable single good. Under the project all Icelandic hospitals and treatment centres will be connected to a single network which links up to a central computer. All data collected by doctors from their patients will flow into this database as well as all the data already amassed on the deceased population (which have been available in detailed form for the last few decades at the public health service), genealogical data kept for a long time at churches scattered over the country and data on blood and tissue samples. deCode genetics will buy the right to use the data stored in the database for twelve years for profit making purposes. For its part, it must bear the costs of data collection and database construction, pay the Icelandic authorities the costs for preparation of the licence and a yearly fee for its application, including the work of the Ethical Committee and any access of the Health Minister to the database. The 270,000 inhabitants of Iceland are a source of great interest to geneticists since they all descend from one single progenitor group which settled on the island around 1000 years ago. As there has been very little 163 C.M. Mazzoni (ed), Ethics and Law in Biological Research, 163-172 © 2002 Kluwer Law International. Printed in Great Britain.

164

Santosuosso

contact with other peoples, strong homogenous characteristics have been preserved. Human groups with strong common characteristics, "original populations" or "historically interesting isolated peoples" are the subject of study in order to be able to understand the development and genesis of common diseases and develope gene therapies. The novelty in the Icelandic case lies not in the interest of geneticists nor in the collection of data by means of information technology but in the absolutely unheard of fact that a sovereign parliament has authorized a private firm to collect all data on the medical history and biological constitution of its own citizens, to process it and to use it for profit-making purposes with a virtually total exclusive right. The affair has given rise to an extremely heated debate both on the island and throughout the world. Supporters of the project, first of all deCode genetics, and, in a "highly incestuous way", the Icelandic government, argue that the database will benefit medical research with the discovery of new genes and therapies and that the method of collection complies with international data protection law. They further maintain that Icelandic scientific research and, in general, employment on the island will benefit. The front of opponents is gathered together in MANNVERND, an organization which may be found on the web (www.mannvernd.is) as the Association of Icelanders for Ethics in Science and Medicine. It is fighting against a law which it considers an attack on human rights, privacy and ethical, scientific and commercial standards. Numerous doctors have formally declared that they will not collaborate with the database. The Icelandic Medical Association (IMA) has opposed the project right from the start and, in its congress of October 1999, denounced the violation both of the principle of informed consent and of the trust between doctors and patients and vindicated the duty of doctors to ensure that these laws are respected. The World Medical Association (WMA) has sided with the Icelandic doctors, drawing irritated reactions from the Health and Social Security Minister. Anders Milton, WMA spokesperson, has denounced inadequacies in the coding system since the collection of a great mass of information on a limited number of people, as are the inhabitants of the island, does not rule out the possibility that individuals could be identified. Furthermore, even an individual refusal to supply data only stops the entry of new data and not the handling of data already on the database. The authoritative geneticist Richard Lewontin, in his significantly entitled article "People Are Not Commodities", which appeared in The New York Times on 23 January 1999, and in other papers of his raises numerous criticisms. Firstly, there is "an immense gap between what the public has

The Right to Genetic Disobedience: The Iceland Case

165

been told about the database and its reality, a gap large enough to be visible even from thousands of miles away". The informed consent procedure is a complete reversal of the standard demanded in medical research. Here it is not the person who asks for the data who must obtain consent but the individual who has the burden of requesting exclusion from the database, receiving no explanation of the uses to which these data may be put, so much so that it may be predicted that only "politically sophisticated" Icelanders will demand exclusion. The rhetoric on Icelandic nationality spouted by deCode genetics and its founder, Kari Stefansson, is also misleading given that the company was set up with the capital of U.S. firms. Lewontin finally criticizes the information monopoly logic which limits the access of scientists and health institutions, the secret contracts, the conflicts of interest and asks that Iceland be boycotted and excluded from international scientific cooperation.1 In the autumn of 1999 the first acts for the preparation of the agreement, i.e. the access of deCode genetics to the data of 30 patients at Reykjavik hospital without their consent, provoked strong reactions from some Members of Parliament and the Director General of Public Health. They invited the government to revise its decision. Some private citizens have already warned the hospital against giving third parties their data, threatening to remove the data from the hospital.

AN IMPOSSIBLE PRIVACY The Iceland case, the only one of its kind, is not as easy to tackle and criticise as may seem at first sight. There are numerous aspects to the affair. One of these is that of individual liberty to choose whether or not to participate in the database by giving data: the question of genetic and medical data privacy. Icelandic law, as most critics stress, does not provide in any point for the need for the informed consent of the people whose data are taken and handled. This is not simple chance. The notes to the law clearly state that "It would take great effort, time and money to gain consent from every individual" and that it is therefore preferable to adopt a coding system which makes the data anonymous and which cannot be reconstructed later 1

The numerous stances of the authoritative scientist and those of other scholars and associations may be found on the website www.mannvernd.is. The official voice of deCode is www.database.is.

166

Santosuosso

except with a decoding key.2 It is therefore preferable to make the information non-personalized rather than adopt the principle of consent to data collection. The latter would allow greater possibilities for study, but would be faced with numerous refusals. The will of the directly interested parties is therefore reduced to a "non-consent" form, to a request to opt out. The effectiveness of the system of (non) decoding has a decisive bearing on this question: it should make it impossible to connect anonymous data to its original subjects. The technical question is much debated in that the decoding key, as has been noted, must actually be in continuous use to allow new data to be added, errors to be corrected and links between health data and genetic and genealogical data to be set up.3 More generally speaking, however, the critical point is the possibility of doing without consent. According to some critics,4 on the basis of European data protection law, the exception to the principle of consent to data collection cannot be justified simply because non-decoding and nondiffusion after handling are guaranteed. However this criticism could fall down, as could the argument of violation of informatics self-determination for lack of consent, should the deCode genetic project be deemed a statistical epidemiological study, a type of study for which European law does not require consent provided that anonymity is assured.5 As regards the main concern that information about an individual may fall into the hands of groups who could use it for their own interests, such 2 "Clearly it would cost great effort, time and money to gain consent from every individual in a data collection envisaged here. This finance could otherwise be used to ensure confidentiality and build up the dispersed databases": Bill on a Health Sector Database. Notes to the Bill, Section III, 3, paragraph 3 in http://brunnur.stjr.is/interpro/htr/htr.nsf/pages/gagnagrensk. 3 Bogi Andersen, Einar Arnason, Skuli Sigurdsson, Kafkaesque Ethics For Post-Modern Vikings? E-mail of 23 August 1999, in www.bmj.com. The authors are Bogi Andersen, professor of medicine at the University of California, San Diego; Einar Arnason, professor of evolutionary biology and genetics at the University of Iceland and Skuli Sigurdsson, science and technology historian at the Humboldt University of Berlin. 4 MG Mclnnis, "The Assent of a Nation. Genethics and Iceland", Clin. Genet. 1999, 55: 234-9. 5 Council of Europe, Recoomendation N.R (97) 5: Art. 12: "Scientific research. 12.1 Whenever possible, medical data used for scientific research purposes should be anonymous. Professional and scientific organisations as well as public authorities should promote the development of techniques and procedures securing anonymity. 12.2 However, if such anonymisation would make a scientific research project impossible, and the project is to be carried out for legitimate purposes, it could be carried out with personal data on condition that: a. the data subject has given his/her informed consent for one or more research purposes [...]. In line with European law Legislative Decree 30/7/99, no. 281, rules out the need for consent when the handling of data "is intended only for purposes of scientific or statistical research". In other words consent seems to be indispensable only if there is no anonymity.

The Right to Genetic Disobedience: The Iceland Case

167

as insurance companies and employers, the Ministry of Health and Social Security of Iceland has reassured everybody declaring that, in the case of the Icelandic database, connecting individual data "cannot be regarded as reasonably possible without substantial effort".6 However there are those who argue that, because of its "highly incestuous" relationship with deCode genetics, the Icelandic government would maintain that the database was anonymous even if it were not so or if it were much less anonymous that the government would have people believe.7 In other words, if the deCode genetics project may be classed as an epidemiological study and if the decoding system is guaranteed to be adequate, all criticisms as to consent could prove to be weak. The principle of consent and its violation are also relevant from another point of view. So far we have spoken of consent to the taking and handling of data. It's a very different matter if we speak of consent to experimental treatment of the person, according to medical standard. On this point the Icelandic law is rather ambiguous. On the one hand it is precise, taking care to regulate a matter outside ordinary or experimental medicine (Art. 2), but on the other hand it uses notions such as patient (Art. 8) or doctor. This point is delicate in that some data are acquired within a therapeutic doctor-patient relationship but they will go into the database in a context which is not in the slightest therapeutic or medical, if not in an extremely indirect way and, anyhow, not for those supplying the data. In the Icelandic case, not asking for consent could therefore constitute a serious breach of international law on research, but only if the project is considered to be research on human beings. If, however, it is only statistical epidemiological research on data and not on people this argument too could be very fragile. The doubt remains, therefore, that individual protection offered by international treaties and domestic law on genetic and medical data privacy and clinical experimentation on humans are not an adequate and sufficient perspective in such a case as this, in which the past and present data of an entire people are at stake.

SCIENCE AND MONOPOLIES (A NEW TWIST TO AN OLD PROBLEM) The database project may be examined not only from the standpoint of single individuals but also from that of its intrinsic scientific correctness or 6

Ruth Chadwick, "The Icelandic database: do modern times need modern sagas?" BMJ 1999; 319: 441-444 (14 August) and BMJ 2000; 320: 234 (22 January). 7 Bogi Andersen, Einar Arnason, Skuli Sigurdsson, op. cit.

168

Santosuosso

ethicalness. This is the freedom of research and research ethics angle. There has been no substantial criticism of the scientific correctness of the database project and there seems to be no doubt that a project of this kind will be useful per se. However, the database is to be set up and run for the declared aim of financial profit. Therefore the study and research aspects could fall into second place behind the pure and simple exploitation of data. deCode genetics has replied to the perplexity of the Icelandic scientific community by stating that the goals and limits of the database are laid down in the law. Furthermore, they argue that the database will increase research opportunities for Icelandic scientists who will be able to access data and attract funds and scientists to Iceland. However, this defence does not take into account the fact that scientists who want to access the database may do so only on condition that they do not use or divulge information in any way which has an adverse effect upon the licensee's commercial interests (this is stated in the notes to the law). It is highly likely that any research carried out by universities or other public centres will be detrimental to the interests of the licensee. The question is whether the database represents a new kind of attack on scientific freedom or whether it is simply, from a commercial perspective, "a new twist to an old problem",8 that of the relationship between science and economic interests. The new twist could be the monopoly conferred on deCode genetics. The science-economic interests question remains open also if we examine it in the light of the Universal Declaration on the Human Genome and Human Rights, adopted on 11/11/97 by the General Conference of UNESCO (henceforth the UNESCO Declaration). The Declaration obliges states "to ensure the intellectual and the material conditions favourable to the free conduct of research in the human genome" (Art. 11). Obviously, everything hinges on the definition of research activity and on its relations with profit-making business activity. However, if the work of deCode genetics is considered as research activity it would undoubtedly be protected under the UNESCO Declaration and the law of the Icelandic Parliament would be almost a necessary piece of legislation. However, it is maybe a little too much to link a positive obligation on the part of the state to favour a certain type of research and, what is more, to legitimise a research monopoly by this general principle of research freedom. If we begin to reason in this way, debatable operations such as the Icelandic project not only risk becoming legitimate but paradoxically the more cautious legislative 8

Ruth Chadwick, "The Icelandic database. Do modern times need modern sagas?" BMJ 1999; 319 (7207): pp. 441-444.

The Right to Genetic Disobedience: The Iceland Case

169

choices adopted by other states could be contrary to the Declaration, such as the Swiss Confederation with its restrictive bill on genetic data. Furthermore the UNESCO Declaration forbids profit being made from the human genome but only in its natural state (Art. 4: "The human genome in its natural state shall not give rise to financial gains"), evidently omitting from the ban all gains arising from an increase in value due to human activity, even that of a private company operating by monopoly. The deCode project, also considered in the light of research freedom, could get round the scrutiny of criticisms based on the UNESCO Declaration. The UNESCO Declaration throws up some further questions which need to be analysed. The statements on research and treatment regarding the individual genome are based on a consolidated cluster of ideas and principles which are expressly referred to in the preparatory work. These are the principle of dignity, the right to equal treatment, rejection of all discrimination, the principle of solidarity between peoples and states, the right of all to live in decent conditions and to benefit from the advantages of scientific progress. We may ask ourselves, therefore, if these rights and principles are respected in the Icelandic case. For example, can we be sure that Icelanders are not being discriminated against with respect to the citizens of other states or that Icelanders as a whole are not being discriminated against as regards other peoples? Can it be ruled out with certainty that the premise itself of the project (the genetic homogeneity of the population) may feed some form of racial or social prejudice? And that this will not be fuelled by careless handling of the data? It is not easy to find satisfactory answers simply using the UNESCO Declaration, with its inevitable generalness and limits.

THE RIGHT TO GENETIC DISOBEDIENCE The question which the international treaties and domestic laws on genetic and medical privacy cannot tackle lies in this: all the members of an entire people and the institutions they have given themselves are facing the interests of the international genetic industry. At this level the fundamental question of the pact between citizens, society and state may be asked. We need to return to the Icelandic law and grasp its double content. On the one hand it is a law that makes it possible to have a " private licence " to handle the medical and genetic data of the population. On the other hand it guarantees that the Health Minister has access to the database and to the acquisition of data for compiling health reports, planning and policy making (Art. 5 point 7).

170

Santosuosso

Health Minister access is the noble part of the project which should also justify, from the point of view of public interest in the health of the community, the debatable assignment of the licence to deCode. However, leaving deCode out of the equation, it is doubtful whether a Health Minister has general indiscriminate power of this kind, without specifying any purpose. Of course the law states that the goal is to develop new and improved methods of achieving better health, prediction and diagnosis and treatment of disease as well as seeking the most economic ways of operating health services (Art. 10). But these are objectives or general ideas or are, in their turn, much debated. We need only consider the temptation of eugenic policies which could spring from the availability of this mass of data linked to disease prediction. The prospect of improving public health, therefore, does not justify anything. Limits need to be laid down which stop the rights and interests of the individual and the community itself being violated (in the name of the wellbeing of the community). It must never be forgotten that the declared aim of all the U.S. and northern Europe eugenic legislation, at the beginning of the 20th century and then in Germany, was to improve society. And, as for today, we cannot forget that international law sometimes limit the possibility of access or refusal to supply personal data actually referring to the concept of public health. In other words, ministerial power of access to data and to develop health plans, based on elements which allow disease prediction (and therefore on genetic data), appears to be itself a source of concern and requires that limits be fixed. It cannot be per se considered as something beneficial and safe which can legitimise the deCode project. We come, therefore, to the central point of a law which gives a private licence to the total heritage of medical and genetic data of the entire Icelandic people, past (from when the data first became available), present and future. The problem is whether a resource of this kind, non-repeatable and non-renewable, can be considered a resource of the state, of its representative institutions, of the nation or of the individual citizens. Who, of all these, has the power to dispose of this resource? The limits within which health institutions may operate have already been mentioned but the elective assemblies, what is more deciding by majority, certainly do not have unlimited powers. No theory of political representation includes the possibility of granting, for profit making purposes, goods of such a personal nature of the entire population. In short, it is a radical problem. If the state is recognised as having the power to assign personal data for commercial purposes by means of a contract,

The Right to Genetic Disobedience: The Iceland Case

171

individual citizens must first be recognised as having the same right (and with this there may not be any problems). It must then be asserted that citizens, by uniting in a society, have given up the right to their own heritage of medical and genetic data. A reference to this can be found in Hobbes' Leviathan where he deals with the argument of if and what man may renounce: The motive and end for which this renouncing and transferring of right is introduced is nothing else but the security of a man's person, in his life and in the means of so preserving life as not to be weary of it [...] sovereignty by institution is by covenant of every one to every one; and sovereignty by acquisition, by covenants of the vanquished to the victor, or child to the parent; it is manifest that every subject has liberty in all those things the right whereof cannot by covenant be transferred. I have shown before, in the fourteenth Chapter, that covenants not to defend a man's own body are void. Therefore, if the sovereign command a man, though justly condemned, to kill, wound or maim himself; or not to resist those that assault him; or to abstain from the use of food, air, medicine or any other thing without which he cannot live; yet hath that man the liberty to disobey.9

In the case of Iceland there is certainly no direct danger against which individuals or a society have to defend themselves, such as would be the case in a defensive war. The law is not even a majority decision on a health policy for a present defence against disease, which, although it should respect some inalienable individual rights, is justified by the current interest of public health and of citizens. In the Iceland case the public interest is future, merely possible and secondary and indirect with respect to a profitmaking business. It may be concluded that the Icelandic state and its Parliament have disposed of the heritage of the citizens without having the power to do so. The problem, therefore, is what the consequences are of a statement of this nature, considering that the decision was taken by a democratically elected Parliament. The actions of doctors opposed to co-operation, the criticisms of Icelandic associations and scientists, the warnings of individual citizens against using their data are, in this light, acts of denunciation of the state's lack of power to dispose of data in this way and a vindication of the fundamental right to one's own person, history and expression. In a word, demonstrations of the right to disobey. But if the Icelandic people claim rights for the simple fact of existing and if these rights today have a value beyond the purely national (as is always the case in this field) we need to ask if and what response the Icelandic case may have in the international community and what the risks will be. It is certain that if the two perspectives which explain the Icelandic affair T. Hobbes, Leviathan (1651), cap. 21.

172

Santosuosso

best are the violation of the antitrust law and the right to disobedience this means that genetics, its research and applications, raise problems the solution to which must be found in economics and politics rather than in ethics or law. And this is a matter of some import. Judge at the Tribunal of Milan, Italy

Medicine as Science and Art: Anxieties at the Dawn of the Third Millennium Paolo T. Scarpelli

In outlining the main events in the history of knowledge, Lakatos1 states that we derived from classical antiquity the idea that knowledge is a body of facts demonstrated by the power of human intellect or by evidence acquired through the senses. With Newton's physics (1687) we thought we had overcome all the doubts and scepticism of antiquity, since universal mechanics and gravitation seemed an impregnable fortress of eternal and unchanging knowledge. But with Einstein this belief collapsed. In physics Heisenberg's principle of indeterminacy (1916) further shook our faith in demonstrable knowledge or truth. If a particle's position and speed cannot be determined simultaneously with the precision envisaged by classical mechanics, there can be no such thing as natural determinism. Conversely, if we have no way of knowing exactly the initial conditions of a physical system, we cannot predict its evolution when it is subjected to an experimental intervention. Even in the field of formal systems, such as logics and mathematics, Godel, praised by many as the greatest logician after Aristotle, insinuated doubts with his celebrated "theorem of incompleteness" (1930-1931). So that today, as Lakatos says, very few philosophers or scientists still believe that scientific knowledge is, or can be, demonstrated knowledge. Since a strict determinism is impossible, all science can do is formulate "probable" predictions.2 Although this epistemological scepticism permeated physics and the exact sciences during the first half of the 20th century, it nevertheless did not prevent us from making huge advances in the field of science and technology: progress at lightning speed, in fact. In just a few decades we have witnessed a constant flow of impressive discoveries and inventions that 1

I. Lakatos, The methodology of scientific research programmes. Philosophical Papers Volume I and II. Cambridge University Press, 1978. 2 F. Laudisa, Causalita. Storia di un modello di conoscenza, Carocci ed., Roma 1999.

173 CM. Mazzoni (ed), Ethics and Law in Biological Research, 173-185 © 2002 Kluwer Law International. Printed in Great Britain.

174

Scarpelli

have exerted an immediate, powerful impact on medicine, bringing about critical changes in medical doctrine, in research methodologies, in clinical practice, and even in the organization of patient care. The flagship of these new discoveries is the DNA (Watson and Crick, 1953) and all the developments made possible by this discovery. In 1993 Tom Wilkie3 wrote that molecular biology, chemistry and genetics are advancing along converging paths and scientists are on the verge of attaining one of the most important goals of science: understanding the laws of human heredity. Now that the mapping of the human genome is almost complete, research programmes and predictions for the future are ready to start.4 Each patient's genotype will be analysed to determine whether there are specific mutations in the genes indicating susceptibility towards specific illnesses and predisposition to respond to specific drugs. This information will make new forms of primary prevention possible. Once the genetic study is completed, the physician will be able to place his patients on a lifelong bio-molecular screening process, so that diseases will be detected earlier or to enable him to give advice on the need to change diet or lifestyle. A detailed molecular knowledge of pathological processes and the identification of the optimal molecular targets for the development of new drugs will allow us in future to achieve an ideal tailorized treatment for each patient. Other advances in science and technology have had important repercussions in our clinical practice. They all occurred in the last forty years: ultrasonography (Ian Donald) was first used in 1957; the earliest transplants were performed in 1964 (from human to human) and in 1982 (from animal to human); the advent of immunoassay methods (Berson and Yalow) in the late 1960s, allowing us to assay in blood and in urine even minute quantities of endogenous substances that can help us diagnose and prevent diseases, that can identify viruses or measure pharmacological agents; the development of recombinant DNA technology, first applied in 1973, thanks to which we can isolate and analyse specific fragments of DNA and produce proteins, hormonal substances and monoclonal antibodies; computerized tomography, or CT scans (Godfrey Hounsfield), first appeared on the market in 1976 after a 9-year trial period; nuclear magnetic resonance became available shortly afterwards. Our current morphological investigation tools enable us to examine the structural make-up of tissues and organs, to understand their topographical relationship to each other, providing imaging so detailed and realistic that sometimes it is even better than direct observation. Some of these tools are also capable of exploring 3

T. Wilkie, Perilous Knowledge, The Human Genome Project and Its Implications. Faber and Faber Limited, London, 1993. 4 Science, Drug Discovery, vol. 287, no. 5460, 17 March 2000.

Medicine as Science and Art

175

the functional features of organs and of quantifying them. Thus, the systematic use of these investigation procedures has become indispensable in reaching a diagnosis unbiased by subjective influences, a diagnosis that cannot be contradicted or questioned. In our diagnostic procedures a review of the patient's clinical history, followed by instrumental and laboratory investigations, often now precedes or even replaces the traditional physical examination of the patient, a conventional practice which many general practitioners today consider marginal or obsolete. As a result, the majority of our semiology methods, so laboriously elaborated and perfected in the early years of the last century, have been abandoned. In the field of medical and surgical treatment, advances made over the past thirty years have been equally extraordinary. The development of pharmacology and surgery has provided us with such a repertoire of powerful and effective tools that we are now able to control a wide range of pathologies; never before have physicians been able to be so justifiably optimistic as to their chances of curing a vast number of diseases, formerly considered absolutely incurable. Over this same period, thanks to the advances of technology and other developments, our ways of acquiring and applying knowledge have changed as well. The problems related to these changes began to appear in the second half the 19th century when medicine - in order to free itself entirely from the doctrine of vitalism - definitively accepted experimental methods. It was 1865, the year that C. Bernard published his seminal work, Introduction a I'etude de la medecine experimental. As in physics, in medicine, too, experimentation aims at discovering the causes of phenomena. But in physics the purpose was to understand the laws governing natural phenomena, whereas in medicine the goal was to succeed in curing diseases. And the ultimate goal of curing a pathology must be the guiding ethical principle, a threshold that conditions every approach to knowledge and cannot be surpassed. On the other hand, in medicine we cannot adopt the classic experimental model of physics, which consists in studying the initial conditions of a given system, provoking a change by external intervention, observing the final result and then formulating predictions based on the initial conditions. It hardly needs saying that humans cannot be considered tout court experimental models. So we cannot study the effects of a potentially therapeutic substance simply by choosing a group of similar people, who share some pre-established characteristics, divide them up into two random groups, administer the substance to one of these groups and use the other as controls. In some cases we can make use of so-called spontaneous experiments: in a situation in which only a part of the population is naturally exposed to a given favourable or unfavourable condition we can judge the effects of this particular condition as though it had been experimentally produced.

176

Scarpelli

Because of all this it became necessary in medicine to find a new source of causal inferences. Epidemiology and statistics came to our aid. The former science was originally a special branch of hygiene, studying the onset and spread of diseases, primarily infectious diseases. Today epidemiology can be defined as "the study of the distribution of factors determining disease in human populations. Originally consisting merely in the activity of counting objects or events, epidemiology has developed into a science that formulates causal hypotheses relative to the events it counts and provides information and suggestions on methods aimed at controlling these same events."5 The history of statistics applied to medicine is very recent. It developed over a period of about forty years, from 1830 to 1870. In the early 20th century, thanks to the work of K. Pearson and R.A. Fisher, it became a real methodology and towards the middle of the century (cfr6) biology and medicine began to apply it regularly. This integration came after a short period when, as a result of the discovery of organisms, there was a widespread conviction that each disease had a single cause of bacterial origin usually - that needed to be discovered with the help of a microscope rather than with the methods of epidemiology. But, when infections were ultimately defeated by antibiotics, cancers and degenerative diseases of the arteries took over the top positions in the hierarchy of morbidity and mortality causes. And medicine at the time could offer no causal hypothesis for these pathologies. Epidemiological studies succeeded in providing an alternative method in our search for causal links. Statistical methods use a simple and ingenious principle to determine causal inferences: distribution and correlation. Distribution refers to the frequency of a disease in relation to gender, age and any other relevant characteristic. Correlations enable us to formulate causal hypotheses. For example, in case-controlled studies, the causal inference is determined by comparing the clinical history of a group of people affected by a given disease and another group of people, as similar as possible to the former, but not affected by the disease. Every element which is found to be present only in one of the two groups may suggest a possible cause of the disease: each hypothesis then needs to be checked. Epidemiology is mainly interested in environmental factors: interacting with the human organism, these factors can favour the development of a disease. Thus, to identify these factors will be the first step in our efforts at prevention. "Risk factors", which have now become a topic of daily conversation, are precisely this: the result of the interaction between 5

A. Parodi, Le cause fra medicina e filosofia, Erga Edizioni, Genoa 1997. F.D. Fuchs, M.J. Klag and Paul K. Whelton: Commentary, The Classics, a tribute to fiftieth anniversary of the randomized clinical trial. J. Clin Epidemiol. 53, 335-342, 2000. 6

Medicine as Science and Art

ill

the environment and the human body, in an overall perspective that recognizes the multi-factorial pathogenesis of a disease. Frequently risk factors are mistakenly considered the causes of a disease: but the cause of a disease is a necessary and sufficient condition for that disease to develop. With this statement we are accepting an ideal model (actually, not always valid) derived from bacteriology, according to which an agent is the cause of a disease if when it is present there is always disease and when it is absent there is never disease.7 Risk factors, on the other hand, are necessary but not sufficient causes for the onset of a disease. The concept was first formulated in 1950, thanks to the famous Framingham Trial, a study investigating degeneration of the arteries, based on the hypothesis that cardiovascular pathologies must be due to several different events interacting with each other that can be identified and to some extent quantified by statistics. Currently, epidemiologists are trying to integrate non-linear paradigms in their studies on the causality of complex phenomena, such as those regulating health and disease.8 In fact, a non-linear model would appear to be more suited than linear models in the analysis of events where the cause is made up of a wide range of component elements, each independent of the other, each neither necessary nor sufficient, but all indispensable in the overall complicated cause of disease. Control over causal inferences is the task of probability mathematics, on which statistics is based. If we can reject the null hypothesis, i.e. that the correlation between two events or - as in controlled clinical trials comparing the effectiveness of two drugs - that the difference observed between their effects is purely the result of chance, then the correlation or difference is called significant, statistically significant. The determination of statistical significance is based on a critical threshold of probability, established according to commonly accepted conventions, but nonetheless arbitrary. By applying statistical methods the physician acquires a suggestion of objectivity in the guise of findings that are statistically proven; the validity of these findings can further be strengthened by increasing the number of individuals examined and by repeating the trials. Today statistical analysis has become the accepted methodology for any research study into the causes and risk factors of diseases and for the evaluation of the effects of any type of treatment. No finding that is not expressed in statistical terms (and therefore which is not obtained through multiple sampling) is considered worthy of attention. Obviously, it is not a mere coincidence that probability mathematics acquired such a predominant role in medicine in 7

A. Parodi, Le cause fra medicina e filosofia, op. cit. P. Philippe and O. Mansi, Nonlinearity in the epidemiology of complex health and disease processes, in "Theoretical Med. Bioeth.", 19, 1998, pp. 591-607. 8

178

Scarpelli

the age of the computer, since data analysis and processing have become incommensurably easier and quicker. Statistical findings have done away with a centuries-old tradition in the field of diagnosis, prognosis and treatment which bowed to the superior judgment of the famous celebrities of the time, who had accumulated authority thanks to their experience, their practical achievements, their theories and the originality of their intuitions. Today, not only the authority of the physician (even famous physicians), but also his personal experience has lost importance, with all these figures calculated on the average findings relating to vast numbers of individuals. The mean behaviour of pathologies or of responses to treatment has become the foundation of our guidelines for diagnosis and therapy in many diseases. Guidelines, usually supported by international consensus, have become an official reference in all decision-making processes, one that cannot be ignored. The practitioner has willingly accepted the principle that, if we want to establish rules for the practice of medicine, then these rules cannot take into consideration the individual case, but must be based only on the unchanging characteristics of a disease or the effects of a treatment shared by a series of different individuals. It is interesting to note that every evaluation, for example of a pharmacological agent, calls for a biological homogeneity of the individuals included in the trial and that this homogeneity cannot be achieved by selection. It may appear paradoxical - and counter to common sense - but, in order to increase the homogeneity of the trial groups, the process whereby individuals are assigned the groups is done by chance, at random. In fact, since we are not in a position to know the entire range of biological characteristics of all people enrolled in the trial, randomization is the only way to achieve a correct distribution of diversity. But we must also bear in mind that randomization cannot entirely rule out evaluation errors, in particular those arising from unknown interactions between the various determinants of the disease.9 A physician will feel legally protected when he bases his decisions on findings of this kind, no doubt; in fact, his decision-making process will become almost impersonal, taken out of his hands, as it were. But psychologically he will not be entirely at ease. He will constantly find himself up against individual cases, in addressing which he will have to extrapolate the data from collective clinically controlled trails to apply them to individual patients that never took part in those studies. Any physician will be able to remember at least one or more cases of patients he has followed personally, whose outcome went against the findings of the trial. Practically 9

W.J. Steen (van der) and P.J. Thung, Faces of Medicine. A philosophical study, Kluwer Academic Pub., Dordrecht, Holland 1988.

Medicine as Science and Art

179

every day, in his clinical practice, he will feel the contradiction in applying "known" data, backed by statistical findings, to "unknown" individual cases, each one of which is a separate instance of a given disease. This contradiction does not appear soluble and we must accept that two different types of rationale lie behind individual and collective knowledge.10 Another uncertainty arises from what appears to be an intrinsic characteristic of epidemiological studies searching for the causal inferences in the field of non-infectious diseases. This type of epidemiology, called risk factor or observational or environmental epidemiology, has clearly identified the "most noticeable" determinants of some of these diseases (for example smoking in relation to lung cancer); but when it seeks to address the more subtle relationships between diseases and environmental causes or different lifestyles,11 it often appears to produce conflicting results, tending mutually to exclude the biological significance that they suggest. The application of mathematics to biology and medicine did not occur without regret for the loss of diversity. C. Bernard,12 in his celebrated Introduction, was ahead of his times and almost appears to have imagined the situation today: "I do not wish to condemn the application of mathematics to the study of biological phenomena since in the future it will be the foundation of medicine." But, further on in the text, he appears indeed to condemn it, when he writes: "the main difficulty in the application of mathematics to physiological phenomena is due to the complexity of the latter, which makes them imprecise and not comparable. The use of averages in physiology and medicine often only lends a false precision to the results and divests the phenomena of their biological nature." In his lessons at the College de France,13 he addressed the issue again: "Or, je le repete, la statistique n'est done pas une science; car le caractere d'une science est de donner des lois qui permettent de prevoir d'une maniere precise les

10

G. Bateson, Mind and Nature, A Necessary Unity, Bantam Books, 1980. G. Taubes, Epidemiology faces its limits, in "Science", 69, 1995, pp. 164-169. 12 C. Bernard, Introduction a I'etude da la medecine experimentale. J.B. Bailliere et Fils, Paris, 1865. 13 C. Bernard, Principes de Medecine Experimentale, Presses Universitaires de France, Paris 1947. "So, I must stress again, statistics is not a science: because the nature of a science is to provide laws enabling us to predict phenomena accurately and precisely (observation science) and to change them when they are within our reach (experimental science). In short, statistics can offer us no more than empiricism, in other words approximation, an empirical relation; it cannot tell us anything precise on specific facts, allowing us neither to predict them nor to reproduce them at will... We can thus say that statistical laws are relative and not necessary: whereas scientific laws are absolute and necessary. In fact, statistical laws only reveal the relationship between phenomena in a complex and indeterminate state of affairs; scientific laws reveal the condition of phenomena in a simple and determinate circumstance.". 11

180

Scarpelli

phenomenes (science d'observation) et de les modifier quand ils sont a notre portee (science d'experimentation). En resume, la statistique ne peut donner que ce que donne I'empirisme, c'esta-dire, une approximation, un rapport empirique, mais elle ne peut rien dire de precis sur le faits en particulier, ni pour les predire, ni pour les reproduire a volonte.. .On peut dire que les lois statistiques ou empiriques sont relatives et non necessaires; tandis que les lois scientifiques sont absolues et necessaires. En effet, les lois statistiques ne donnent que la relation des phenomenes dans une etat de choses complexe et indetermine; les lois scientifiques donnent la condition des phenomenes dans une circonstance simple et determinee".

Some of the greatest minds mankind has ever had have studied probability, without succeeding in ridding us of the aura of mystery that the layman is overcome by when he tries to approach it without the help of mathematics. In medicine, the concept of probability was introduced by Hippocrates and his followers, alongside the notion of trends and diseases.14 And it was this discovery that marked the transition from theurgical medicine to medicine as an observation science. Knowledge of a disease was acquired by observing that which did not change from one individual case to another, by recognizing that some patients shared a group of symptoms, in other words they presented a syndrome which at a later date, borrowing the terminology of zoological classifications, would also be called "natural genus". The disease thus became the reference paradigm to which the Hippocratic physician would compare each case, in order to formulate a diagnosis and decide a therapy. Sometimes he would merely be able to speak of a trend, since individual cases could differ from the paradigm in a variable way. He would always respect this divergence, evaluating in each case its probability of matching the paradigm or differing from it. Even the outcome of the disease was predicted by applying the same method, and in this Hippocratic physicians were fully aware that with their diagnosis and prognosis they were in no way attaining an absolute truth. At that time, the degree of probability was not expressed in numbers: it was a question of wording. The wealth of the Greek language was such as to enable our forerunners to denote a wide variety of "degrees of probability", to make the diagnosis and prognosis more accurate (most, several, many, etc.).15 The first reference to probability as something that can be expressed in numbers can be found in the treatise called Logic (one of the authors was Pascal), produced by the Jansenists at Port-Royal in 1662. In 1713 Bernoulli's Ars Conjectandi was published posthumously: this is considered a milestone in the study of probability. The full development of the concept occurred only a century later, with Laplace's Essai Philosophique sur les probabilites (1812). 14 15

V. Di Benedetto, // medico e la malattia, Einaudi, Turin 1986. V. Di Benedetto, // medico e la malattia, op. cit.

Medicine as Science and Art

181

Bernoulli and Laplace are the authors of the two most highly acclaimed intuitive definitions of probability. Bernoulli16 states that "probability is a degree of certainty that differs from absolute certainty like a part differs from the whole", while Laplace defines probability as "nothing more at bottom than good sense reduced to a calculus". And Popper17 wrote: "The logical probability of a statement is complementary to its degree of falsificability: it increases as the degree of falsificability decreases. Logical probability 1 corresponds to falsificability degree 0, and viceversa. The statement that can be most easily controlled, in other words the statement that possesses the greatest degree of falsificability, is logically the less probable statement, while the least controllable is logically more probable."18 Later he states (with a certain measure of irony): "Those who hold probability in high esteem should say very little, or rather they shouldn't say anything at all: tautologies will always keep probability highest".19 In any case Popper20 was not very interested in the problem, as is shown by this statement taken from the Italian translation of a lecture he never delivered, but which was later published in Conjectures and Refutations: "For us, in fact, science has nothing in common with the quest for certainty or probability or credibility. We are not interested in laying the foundations of the certainty or probability of scientific theories. Fully aware of our fallibility, we are only interested in criticizing them, in testing them, in the hope that we will discover where our errors lie, that we will learn from our mistakes and, if we are lucky, progress towards better theories." Actually, epidemiologists have attempted to provide definitions to explain the meaning and limitations of statistical knowledge, to make the position of those that use it easier. Lincoln E. Moses21 wrote: "When the laws of probability are known to have governed the acquisition of data, then statistical inferences have the force of logical consequences of these laws." Or Duncan Vere: "A controlled clinical trial is the only method to decrease doubt about the value of most new remedies; without it medicine would return to its historic subjection to bias, ignorance and personal gain. The problem is whether people are willing to pay enough to gain the prize of objectively accredited therapy".22 16

Quoted in J. Hacking, The Emergence of Probability, Cambridge University Press, 1975. K.R. Popper, Logik der Forschung, Wien 1934, 10 ed. 1994. 18 K.R. Popper, Logik der Forschung, Wien 1934, 10 ed. 1994. 19 K.R. Popper, Scienza e filosofia, Einaudi, Torino 1991. 20 L.E. Moses, Statistics in Practice. Statistical concept fundamental to investigations, in "New Engl. J. Med.", 312, 1985, pp. 890-897. 21 D. Vere, Controlled clinical trials: the current ethical debate (editorial), in "J.R. Soc. Med.", 74:2, 1981, pp. 85-88. 22 J. Kats, The silent world of doctor and patient, Collier Macmillan, London 1984. 17

182

Scarpelli

Over the centuries, the physiognomy, the social importance and the fortunes of physicians have changed several times in relation to cultural and political crises. Yet, the Hippocratic model of the patient-physician relationship survived until the end of the last millennium.23 According to this model, the physician practiced his art without distinction between his patients: each patient was called anthropos, to stress the absolute pre-eminence of the qualification "human being". The duty of physicians was to pursue the patient's interest and the code of behaviour to achieve this goal included two basic rules: to be useful or at least not to be harmful. The physician engaged alongside his patient in the battle against the disease, making available his scientific knowledge. And as the only depository of this knowledge he directed the battle according to his decisions, without having to inform the patient and without allowing him to participate in any therapeutic decision. The Hippocratic model, also called paternalistic model, is considered a model that totally ignores the patient's freedom. From the ideological viewpoint it has been subjected to two forms of criticism.24 The first, more moderate, known as the liberal model, rejects the authoritarian practice of the expert and aims to guarantee a minimum of autonomy to the patient. The second, more radical, is related to existentialist philosophy and calls for the need for life to be authentic. In the patient-physician relationship this means not only that the expert has no right to control another person's life, but also that he cannot interfere with it illegitimately. But even this latter model is open to criticism.23 The patient achieves authenticity only inasmuch as he makes his own decisions, but there is no certainty that these decisions will always be compatible with an appropriate treatment of his health. Furthermore it is clear that a model that recognizes the patient's right to exert control over what is done to his body and to have the final say relegates the physician's role to that of a neutral information provider: this may safeguard the patient's autonomy, but it destroys the integrity and autonomy of the physician. So we must accept that the patient must be made aware of the whole range of therapeutic alternatives, of adverse effects caused by any type of treatment and of their possible outcome, but also that the patient's decisions must be limited by the "aims of the treatment and the obligations of experts". Arnason25 sums this up as follows: "... the rights of the patient must have a sensible connection to the duties of the professionals". This critique is the basic rationale for his proposed third model, which he calls the cooperation model, founded on a 23

V. Arnason, Toward authentic conversation. Authenticity in the patient-professional relationship, in "Theoretical Med.", 15, 1994, pp. 227-242. 24 V. Arnason, Toward authentic conversation, op. cit. 25 V. Arnason, Toward authentic conversation, op. cit.

Medicine as Science and Art

183

patient-physician interaction based on dialogue. By dialogue, the physician informs the patient and supports him emotionally. This information is followed by a final consent (informed consent) given by the patient, which is the equivalent of self-determination. Only like this will we succeed in reconciling the physician's right to treat and the respect for the patient's individuality, safeguarding the integrity of both. The goal of this model fits into the context of post-modern philosophy opposed to the modern critique of medicine professed by M. Foucault, which "... has considered objectivity and technical rationality - the goals of scientific medicine - as non compatible with the recognition of the patient as a person whose autonomy and self-determination should be respected".26 According to post-modernist theory "the world of physician and the world of patient, cannot be unified in a kind of Hegelian synthesis".27 Yet the two worlds can benefit considerably by the cooperation between physician and patient that develops out of their clinical and existential dialogue. Quite apart from theoretical debates, the Hippocratic physician-patient relationship officially came to an end in 1990, when the Italian law accepted the principle of self-determination, passing a harsh sentence on a doctor who had decided unilaterally on a surgical procedure during an operation. From that moment onwards the patient's consent on therapeutic decisions became an indispensable legal safeguard for physicians. In practice, the law obliges doctors to provide their patients with detailed and truthful information on the nature of the pathology, on possible treatments and on prognosis, without expressing themselves in favour of one or the other solution. This information procedure is completed with a final declaration certifying that there has been no misunderstanding. But the operation is not as simple as it would appear. The patient may not be capable of understanding the information he receives or of realizing fully all its implications. Only people who do not have to address this problem every day can believe that all patients, without distinction, can easily acquire a complete awareness of their condition and of the problems related to it. Furthermore, the patient - although this occurs more rarely - may refuse to accept the information and decide to break off his relationship with the physician. In any case, in the information procedure the doctor may end up by losing one of his main prerogatives which is to do everything in his power to make the patient's life happier. As much as he may strive to offer the patient emotional support, he cannot help but illustrate, with greater or lesser emphasis according to the circumstances, the uncertainties in the prognosis, thus 26

N. Tsouyopoulos, Postmodernist theory and the physician-patient relationship, "Theoretical Med.", 15, 1994, pp. 267-275. 27 N. Tsouyopoulos, Postmodernist theory, op. cit.

184

Scarpelli

producing anxiety and, as Kats28 says, "creating a state of mind that is inimical to treatment." The Hippocratic model was abandoned also in view of other considerations: technological developments and the integration of physicians into society. Both these factors had negative repercussions on the patient-physician relationship. Having eliminated the humanitarian element from this relationship, they contributed to the loss of medicine as an art. The five essays published by philosopher and physician K. Jaspers between 1950 and 1955 contain the most exhaustive summing up of the problems raised by the extraordinary development of technology and the harshest critique of psychoanalysis. In the preface to the Italian edition, Galimberti29 sums up in two concepts the essence of Jaspers' thought: technology has firmly bound the criteria of knowledge to the objectivity provided by laboratory analyses and instrumental investigation, transforming the patient-doctor relationship into a relationship deprived of human contact. Psychoanalysis was called upon to fill this void of human contact between doctor and patient: but, being a dogmatic doctrine based on faith, it ended up by de-authenticating the relationship. The integration of doctors in society perhaps played an even more important role in the collapse of the Hippocratic model. It transported the patient-physician relationship into a community context, exposing it to a whole range of contradictory tensions. Basic health services and special facilities for the diagnosis and treatment of some diseases have proved capable of dissipating huge portions of the State's economic resources. The problem was addressed by re-organizing the facilities on a territorial basis, reducing the budget for management costs. Perhaps in an attempt to underscore the intentions of the reformers, the hospitals (which had already been deprived of their historical names) were renamed "companies", meaning that they were henceforth to be run as economic ventures regulated by the laws of profit-andloss accounting. And patients have acquired a new name as well: they are now referred to as "treatment beneficiaries". However well-meaning, this terminology will never be able to confer the same affective connotations of the word patient. Both the general practitioner and the "company" doctor were involved directly in the new expenditure-reduction policy. They are invited to collaborate, by reducing their requests for instrumental and laboratory tests, by choosing to prescribe less expensive drugs and by reducing the length of hospitalisation. The results achieved by the physicians are rewarded with promises of economic incentives or sanctioned by official 28 29

J. Kats, The silent world of doctor and patient, Collier Macmillan, London 1984. K. Jaspers, // medico nell'eta della tecnica, Raffaello Cortina Ed., Milan 1991.

Medicine as Science and Art

185

reprimands. This form of economic conditioning must fight against opposing demands, coming from a community that is continually alerted by the media with their daily or weekly reports of conferences, meetings, debates between experts on a wide range of medical topics, publishing statistics of morbidity and mortality, illustrating prevention campaigns, reporting in real time all recent discoveries, inventions and their possible applications. This new popular culture occasionally encourages people to self-determination in diagnosis and treatment, but more frequently induces them to demand of their doctors instrumental and laboratory tests or the prescription of drugs whose indications in no way match (or only very vaguely so) the patient's actual condition. Fear and confusion can expose physicians to conditions of extreme frailty. Economic restrictions make them afraid of providing the patient with an inadequate professional service; a decision to forgo some expensive laboratory tests or investigations will be accompanied by fear for the legal consequences of malpractice. The doctor's mind is distracted by his obligation to engage in a bureaucratic activity that makes the "human contact" approach with his patient, called for by the art of medicine, even more difficult. The loss of intimacy in patient-doctor relationships has produced in the patients an almost blatant lack of interest in the abilities of the physician, in his humanity and his abnegation. And nowadays the prevailing opinion is that successful treatment depends more on the availability of modern instruments and good organization than on the efficiency of physicians. To recover the humanitarian dimension in the physician-patient relationship, even if we accept that the individual nature of this relationship has changed by virtue of a new, collective principle of ethics, is one of the crucial problems facing modern medicine. Director of Postgraduate School of Nephrology, University of Florence, Italy

This page intentionally left blank

Clones and Golems Carmel Shalev

The discussion here today reminds me of the Hart-Devlin debate in the 1960s, about the enforcement of morals by the law.1 There the subject was sexual morality, and the role of the law in prohibiting prostitution and homosexuality. Here the subject is reproductive morality, and the role of the law in prohibiting reproduction of human beings by means of cloning. So it is not a coincidence that the man on the Clapham omnibus was referred to earlier. One of the lessons of the Hart-Devlin debate was that the sentiments of such persons - deep felt as they may be, and even if they constitute a majority - are not sufficient justification to restrict the principle of liberty. And the question we have been discussing today is whether there are any rational reasons to restrict the freedom of scientists to search for new knowledge, or the freedom of individuals to make decisions about reproduction. Our discussion takes place at the end of the 20th century, when we are aware more than ever before that there is moral and cultural relativism in the world. So I would like to contribute to our discussion some comments on the Jewish approach to the question of cloning, which is somewhat different from the Christian approach. The fundamental question that arises in relation to cloning is man's relation to nature, and man's relation to God. Whereas the Christian approach, as expressed by the Vatican, opposes human intervention in the Natural Law, it seems that the rabbis do not find much opposition to cloning in the sources of Jewish law (halakha). To the contrary the orthodox rabbis of today appear to be very much in favour of human reproduction in various medically assisted forms. There is also a very strong guiding principle in Jewish thought - "the healing principle" - that applies in different ways to questions of medical ethics. This principle acknowledges 1

H.L.A. Hart, Law, Liberty and Morality (Stanford University Press, 1963); Patrick Devlin, The Enforcement of Morals (Oxford University Press, 1965).

187 CM. Mazzoni (ed), Ethics and Law in Biological Research, 187-192 © 2002 Kluwer Law International. Printed in Great Britain.

188

Shalev

that God's creation is not perfect, and that there is an active role for human beings in correcting the flaws of nature and in healing the sick. The healing principle also finds expression in the kabbala - that is, in the mystical tradition of Judaism. Here it has a spiritual dimension, in the idea of healing the world (tikkuri). And it is in this tradition that we find the story of the Golem, which seems to be so pertinent to the question of cloning. The story of the Golem has been told in various versions and has evolved throughout the course of many centuries. In the twentieth century it was studied and retold by Gershom Scholem, the foremost contemporary scholar of the kabbala. According to Scholem,2 the origin of the Golem story was in 'The Book of Creation' (Sefer Yetsirah), a book that was written some time between the 3rd and 6th centuries and is referred to in the Talmud.3 Interestingly enough, the story was also recounted by Jacob Grimm. It was retold in the 20th century, too - and most lately by Cynthia Ozick.4 In Ozick's version, the Golem is a female who is created by a woman. But basically, the story of the Golem is the story of men imitating the way that God created Adam (man) out of earth (adamah) and conferred upon him speech and reason. In the book of Genesis, Adam, the first man, was created out of earth, and there was no woman in his creation. Similarly, in the traditional stories, there is no woman in the process of creating a Golem. The original form of the story tells us about the creative power of the righteous man. Through one's mastery of knowledge of the structure of the world, one may imitate the creative power of God and form a Golem out of earth. The knowledge pertains to magical transformations of the Hebrew alphabet and is of the kind of pure science, in that there is no practical purpose to the act of creation. At the same time there is a limit to the creative power of man, because the Golem is not fully human. In some versions it does not have speech, which symbolises the human spirit or soul. In other versions it does not have sexual or procreative power. In medieval times the Golem becomes the object of a mystical ritual. The act of its creation is an ecstatic spiritual or psychic experience, that results from meditating on all possible combinations of the 22 letters of the Hebrew alphabet. [There is an interesting parallel here to the genes, the alphabet of the human body.] The ultimate play with the letters of the alphabet is to utter the name of God. Still there is no practical purpose 2

Gershom Scholem, On the Kabbalah and Its Symbolism (Schocken Books, New York, 1969), chapter 5. 3 Sanhedrin 65b. 4 Cynthia Ozick, The Puttermesser Papers (Knopf, New York, 1997).

Clones and Golems

189

other than to demonstrate the power of the holy Name, and there is no objective manifestation of the Golem. It does not exist outside the sphere of meditation. The moment it is created it dissolves again into dust, returning to its element. By the 13th century we are receiving warnings that it is dangerous and destructive to compete with God. It is not the danger of the Golem becoming autonomous, developing overwhelming powers and turning against its human creator - a theme that appears in later times. Rather the concern is about the tension that the creative process arouses in the human creator. In other words, the problem is that man's imitation of or competition with God creates a conflict in the internal life of the human creator. In subsequent versions the Golem acquires practical functions to serve its creator. The Golem is no longer an expression of pure knowledge or magic and no longer disintegrates at the moment of its creation, but is a form of applied knowledge with a practical purpose and function. It is created to serve the needs of its creator and master. And then, in the 17th century versions of the legend, the servant - an automaton or mechanical man - becomes dangerous. Man playing God believes he can control nature, and finds his downfall. The technology gets out of hand, and is the destruction of its own creator. One of the most famous versions of the story - the legend of the Golem of Prague - originates from this period. It is related in connection with Rabbi Loew of Prague, known as the Maharal (c. 1520-1609), who was renowned for his knowledge and wisdom. The Maharal fashioned a golem who did all manner of work during the week. But because all creatures rest on the Sabbath, he turned it back into clay every Friday evening. Once, however, the rabbi forgot to do so. The congregation was assembled for services in the synagogue and had already recited the 92nd psalm, when the mighty golem ran amuck, shaking houses, and threatening to destroy everything. The rabbi was summoned. He rushed at the raging golem and reduced it to dust. The rabbi then ordered that the Sabbath Psalm should be sung a second time, a custom which has been maintained ever since in that synagogue, the Altneu Schul. The rabbi never brought the golem back to life, but buried his remains in the attic of the ancient synagogue, where - so goes the legend - they lie to this very day.5 And this is the story that we have from Jacob Grimm: "After saying certain prayers and observing certain fast days, the Polish Jews make the figure of a man from clay or mud, and when they pronounce the miraculous Shemhamphoras [the name of God] over him, he must come to life. Scholem, ibid., pp. 202-203.

190

Shalev

He cannot speak, but he understands fairly well what is said or commanded. They call him golem and use him as a servant to do all sorts of housework. But he must never leave the house. On his forehead is written 'emeth [truth]; every day he gains weight and becomes somewhat larger and stronger than all the others in the house, regardless of how little he was to begin with. For fear of him, they erase the first letter, so that nothing remains but meth [he is dead], whereupon he collapses and turns to clay again. But one man's golem once grew so tall, and he heedlessly let him keep on growing so long that he could no longer reach his forehead. In terror he ordered the servant to take off his boots, thinking that when he bent down he could reach his forehead. So it happened, and the first letter was successfully erased, but the whole heap of clay fell on the Jew and crushed him."6

When the Golem is created, he has on his forehead three Hebrew letters aleph, mem and tav - which form the word 'emeth, meaning "truth". When the first letter, aleph, is removed from its forehead, what remains is the word meth, which means "dead", and the Golem thus returns to dust. When the Golem servant leans down to take off his master's boots, the master removes the letter aleph from its forehead, and it collapses upon the master and crushes him to death. Thus the end of this human attempt to play God is the destruction of both the creature and its creator.

This brief and partial rendition of the golem legend and its evolution is rich in allegories that stimulate our minds and imaginations, and from which we may draw various morals or ethical lessons. For me, personally, the most striking theme in the story is that the threat of the golem is not external but internal. It is not that our discoveries and creations actually get out of hand and turn against us to destroy us, but that we are morally troubled by the power of our own minds and have need for internal restraints upon our own actions. In other words, from the place of empowerment that is bestowed by the liberal discourse of rights, we move into the sphere of responsibility. In this vein I would like to make two comments on the discussion that we have had today. The first one is a comment on social justice, the second one is a comment on autonomy. The first comment on social justice relates to our priorities in the allocation of resources to scientific research. One should note that the International Covenant on Economic, Social and Cultural Rights mentions the human right to the benefits of scientific progress. Article 15(3) of the Covenant is an undertaking of the States Parties "to respect the freedom indispensable for scientific research and creative activity", but it is preceded Jakob Grimm, Journal for Hermits (1808), id., p. 159.

Clones and Golems

191

by article 15(l)(b) which recognizes the right of everyone "to enjoy the benefits of scientific progress and its applications". Likewise, one of the overriding principles of international human rights law - the principle of equality - finds expression in Article 3, ensuring the equal right to the enjoyment of all rights set forth in the Covenant. So when we consider cloning, we should not confine ourselves to the value of the freedom of science and research. We also need to consider the consequences of the applications of scientific knowledge in terms of the individuals and population groups that are its beneficiaries. At the same time, we also need to be looking at the economic factors that define the parameters and agendas of scientific research today. We are accustomed to making a distinction between pure science and its applications, the technology. But in the world we live in today, this distinction has become somewhat blurred. At the clinical level of medical treatment, for example, it is often hard to know the difference between an innovative method of treatment and an experiment. At the academic level, too, the notion of "pure" research might be questioned at times, given the high costs of research and development and its funding by commercially motivated stakeholders. Thus, for example, we might discuss the ethics of medical conferences that are funded by pharmaceutical companies with an interest in marketing a certain new product, which is claimed to be effective in treating the medical condition that is the subject of the conference. Similarly, one of the issues raised by cloning is the power of the private market to influence the progress of science through the allocation of resources that is motivated by commercial self-interest rather than by concern for social justice. It is impossible to predict with any certainty who is going to benefit from this technology. From the lessons of the past, one can only say for sure that we can never know what advantages will accrue from our search for new knowledge. We look for one thing, and something entirely different unfolds. But at the same time, it is quite likely that cloning will benefit what one can generally describe as the "first" world. This is not simply a geographical matter, because in Europe and in the United States we have third world pockets within the first world culture. But it is also important to have a geographical global perspective. Consider, for example, the continent of Africa, where malaria is rampant - even though we know how to prevent malaria, and we know how to treat malaria. Then let us look at the money that is being spent on cloning. Ought we not to broaden our ethical debate with a global view, so as to make sure that the money goes to where it is of the most benefit to mankind as a whole? This is my first comment on social justice and on our priorities in the allocation of resources.

192

Shalev

My second comment goes to the notion of individual autonomy. One of the characteristics of moral dilemmas and other hard cases is that there does not appear to be a right answer. Whichever way we look at it, we seem to be in trouble. This is one reason why I hesitate to impose my own choice on someone else. If there is no right solution, we think it best to leave it to the individual to make his or her own decision. Individual autonomy includes the right to make mistakes, and to be responsible for the consequences of one's own choices. But responsibility is more than the right to make mistaken choices. The notion of responsibility also reflects the interdependence of human beings, because our choices have impact on others around us. We are not isolated atoms, and we do not live on desert islands. We are social beings by our very nature, and our actions affect others. My right to make decisions, and to be free from coercion in doing so, does not free me from my responsibility to reflect upon the probable consequences of my actions upon others with whom I live in relationship. From a legal point of view the idea of autonomy is a foundation of the doctrine of informed consent to medical treatment. Clearly, any application of cloning technology to human beings will require the informed consent of the participating individuals, whether as subjects of experimentation or as consumers of a new reproductive technology. One of the questions that could be asked is, what information should be communicated to those individuals to ensure that their consent is indeed meaningful, both free and fully voluntary. I would like to suggest that ethical considerations should also be part of the process of informed consent, so that the individual's right to benefit from the technology is accompanied by a sense of personal ethical responsibility. This leads us to the role of the clinician in communicating the ethical considerations. We have talked about the scientists, and we have talked about the clients, but the medical practitioner will mediate between the two. According to the doctrine of informed consent, it is the duty of the doctor to communicate to the patient whatever information is reasonably necessary for him or her to make a decision. It would therefore be the duty of the medical clinician to impart information on the ethical considerations of cloning, so that the individuals would be able to make their own decisions. This is by no means a trivial suggestion, since it is not at all self-evident that medical practitioners are at all sensitive to the ethical consideration. If the informed consent process is to include an ethical component, there would therefore be need for extensive public education and public debate. Director of the Unity of Health Rights and Ethics, Gertner Institute, Israel

III. Cloning in Popular Imagination

This page intentionally left blank

Doppelganger Temptations Adriana Cavarero

1. Our collective imagination on the issue of cloning in the late 20th century harks back to one of the classic themes of Western tradition, the idea of the Doppelganger, the double. The individual, the "original" so to speak, who is cloned becomes a "double" while being at the same time the "same" person. He is himself, redoubled. He is himself who becomes another, all the while remaining himself: another self outside himself. The salient feature of a double is his mirror-like nature. The first model in tradition is obviously the myth of Narcissus. But the image/clone of Narcissus was volatile, ethereal, disincarnate, fictitious: a mere eidolon, a reflected image of the self. Without the presence of the original, whose image the double reflects like a mirror, this eidolon has no life of its own. Although it is essentially an ephemeral game, this type of mirror image highlights one of the most curious aspects of contemporary collective imagination on cloning: the tendency to imagine the perfect contemporary existence of another self. Perhaps because of Dolly the sheep, who was presented to the public as an adult animal, our collective imagination cannot conceive of a clone as a younger individual, separated from its original by a time difference, but rather as an individual that is the same age as the original - or at least looks the same age. The difficulty of detecting, at a glance, the signs of aging in sheep undoubtedly contributed to this misunderstanding. In our collective imagination a clone is the exact reproduction of another "self", it is its mirror image, and basically its identical twin. But, compared to the empirical condition of twins, this more mythical notion of a mirror image would thus appear to raise to absolute terms the dimension of "sameness". Like in the story of Narcissus, here the other is another self, not simply someone who looks exactly like him. The mirror model transforms identical appearance into identity tout court. Almost as though wanting to make up for the volatility of Narcissus's eidolon, ancient civilizations proved capable also of imagining doubles according to models that conferred to the other being a robust autonomy. 195 CM. Mazzoni (ed), Ethics and Law in Biological Research, 195-202 © 2002 Kluwer Law International. Printed in Great Britain.

196

Cavarero

This occurs, for example, in Euripides, with Helen's famous ghost. As the double of the most beautiful woman on Earth, Helen's ghost leads her own independent life; actually, almost like a Mr. Hyde before his time, she enjoys a dissolute existence in contrast with the chaste mores of the original. And a similar episode can also be found in Plato's Cratylus: a statue (eidolon) of Cratylus, sculpted by an artist with divine powers who then breathed life into his creation, becomes another Cratylus, his double in other words, his living clone. This little-known episode from Plato, as well as being interesting because it tends to eliminate the distinction between the original and the copy, is also worth mentioning because of the notion that the eidolon is brought to life. The history of literature is in fact full of statues, puppets, idols that come to life, including the Golem of the Jewish tradition. A god or a magic power intervene to transform the eidolon into a living being. Thus, the notion of double is interwoven with the idea of bestowing life upon an artificial creature, complicating the issue but adding a dimension which allows us to focus on the core of the problem. Basically, the core issue is that of transcending natural birth processes. For this, a god or a magic power is necessary. In the myth of Narcissus, the focus is simply on a mirror, a natural phenomenon, a reflected image: no law of nature is violated. In the myths that tell of living idols (eidolon), on the other hand, natural laws are transcended and the extra-ordinary comes into play. The other self, who is not only identical in appearance but as alive as the original self, is never portrayed in the ordinary dimension of human existence. Inasmuch as he is extra-ordinary, he belongs by definition to the sphere of the imaginary and, more precisely, to that sphere where human desires, wishes and hopes dictate the rules of the game. As is shown by this mythical fantasy that has re-surfaced in our modern imagination stimulated by the notion of cloning, it is a wish for a double that has very deep roots indeed. The ordinary dimension of existence and the natural processes of procreation that give life to this existence are forgotten and left behind without regret. The temptation of having a double is irresistible. Far from making mythical irrationality the salient element, divine or magic powers are merely a congruous, rational means of satisfying this desire. To create the extra-ordinary, an extra-ordinary tool is needed. At this point it would be easy simply to say that the role of divine or magic powers in our day and age is played by scientists, rather like sorcerers' apprentices. Despite what simplistic newspaper articles would have us believe, the core of the problem is different and much more interesting. Compared to the classical portrayal of doubles, contemporary ideas on cloning display deeper desires of another nature, age-old tensions and even temptations. One of these is undoubtedly man's eternal dream: immortality.

Doppelganger Temptations

197

Investigating the deepest urges of eroticism, we traditionally refer to the notion of immortality in the species. But this immortality through our species, by a process of generation from father to son, soon turns out to be an old trick put about by philosophers: it has a miserable shortcoming, in that it offers no consolation for the fact that we know we are mortal in our "self". Our self, the self of each one of us, harbours only one fundamental wish: to last, forever. To live forever, as this self, not through our children and our children's children. If you replace a child with an eidolon, the situation does not change much. There is no reason why Helen's ghost should live longer than Helen, why Cratylus's artificial double should last longer than Cratylus. The classic notion of the double doesn't solve the problem. But when a double generated from the self - flesh from flesh - steps on the scene, things change. Cloning offers another dimension in which the dream of immortality can come true. The scientist, the so-called sorcerer's apprentice, so successful in shocking public opinion, is not a divine maker, an artist who breathes life into his creations. He is merely a midwife equipped with advanced technological tools. The double is generated by the original self: it is the original that redoubles itself. That's why public opinion continues to imagine that Dolly is a contemporary of her mother. To produce a clone of oneself as a newborn baby would appear too similar to normal procreation of life, which offers us only the vain promise of immortality through the species. To produce a clone of oneself as an adult - one's own adult double - has the virtue of setting in motion a mechanism of infinite reduplications that can lead to immortality of the self. Although it may appear paradoxical, the operation is simple: you merely have to clone yourself for an infinite number of times, producing each time an individual who is just a little younger. For example, every time you turn 35 you produce a clone of yourself aged 30. Clones of clones of clones, thus transforming immortality into eternity, and rendering meaningless the very concept of an original. The idea seems quite absurd. But then, why is it that the news of Dolly growing prematurely old (apparently not true, by the way) so deeply disappointed public opinion? Since it is not based on reality (in fact, it ignores it), collective imagination must be based on expectations, on desire, on longing, not on the objective scientific results it uses merely as the starting point for its fantasies. Actually, from this point of view, the foundations lie in the field of science-fiction. It thus becomes inevitable to mention the film The Boys from Brazil. The difference between the film and the scientific experiment that brought us Dolly, is that the movie story produced clones of a dead man. The dead man was born again, it's true; but to die and then to be born again is not

198

Cavarero

the same thing as to be born again, an infinite number of times, while remaining alive, and thus experiencing one's own immortality. The fact that in the film the clones were clones of Hitler is simply a detail. The essential point has nothing to do with the danger of cloning Hitler or the wonder of recreating Mozart, but rather the infinite horizon of individual desire that is evoked. The dream of immortality, in an age of democracy, affects us all. The temptation to create one's double breaks free of myth and becomes part of everyday longings, accessible to everyone. 2. To experience, while alive, one's own immortality, duplicating oneself infinite times, is a specific figure of desire, which the birth of Dolly has strengthened and speeded up. On the other hand, to be reborn infinite times, after having died as many times, is a figure of the dream of immortality, a much more ancient longing. In Western culture it appears in Plato's Republic and is called metempsychosis. In the ongoing debate on cloning, today, it is not rare to come across positions that underscore the total independence of the cloned copy. The new individual is an individual in his own right - they stress - rather like a homozygous twin: his body is identical to the original, but his personality, his spirit, his soul are his own. Body and mind. The classic distinction between body and soul, and the equally classic notion that the individual's identity resides in his soul, thus practically prevent the original and his clone from being "one and the same". In other words, they are two different people: it's not the same person being duplicated. The figure of the double thus only exists in the realm of the body. The soul can't be cloned (ergo, nor can the self). In Plato's myth of metempsychosis the opposite occurs, a sort of cloning of the soul. The soul is the same and it is cloned an infinite number of times in different bodies. What's at work here, in terms of imagination, is again our longing for immortality. It relates to a horizon, strictly Platonic, where the self is identified totally with the soul (psyche), while the body merely exerts an external function, it is a temporary shell. This is very far removed from the Christian idea of the resurrection of the flesh which restores corporeal characteristics to the notion of the self. It is even further removed from the idea (closer to us, historically) of a self that we tend to identify with a living body, in a fundamentally non-religious way. Although it is paradoxically close to the modern Cartesian idea of an Ego whose identifying characteristic is thought. But, apart from the complicated philosophical distinctions between body and soul, the fact remains (and it is curious, indeed) that fantasies surrounding cloning can be adapted to one or the other. In the field of collective imagination, and therefore of desire,

Doppelganger Temptations

199

the self will always attempt a wide range of combinations in order to dictate the rules of the game. Since it can't stop the course of time, like Parmenides' being, it becomes important to last in the evolving dimension of material time, in other words to be born anew, constantly, if possible while still alive, regenerating oneself as another, which is nonetheless the same. 3. The aspect of generation, evoked here, obviously addresses the exclusively female phenomenon of motherhood. A father takes part in conception, but in nature it is always a mother that generates, that procreates, that brings into the world another being. Ever since the origins of Western collective imagination, this natural process has always provoked evident reactive fantasies on the part of our so-called phallocentric culture. There are many and well known examples of this. From Zeus who delivers Dionysos from his thigh or Athena from his head, to the more subtle forms of mimesis of motherhood that Plato indulges in: where he insists on the philosophical experience of giving birth to true discourse, suffering labour pains and with Socrates acting as midwife. I have no wish to diminish Freud but, in the true patriarchal tradition, uterus envy has left noticeable traces in our Western culture, much more so than penis envy. In a culture obsessed by death and founded on the ability to kill, the power to give life is necessarily a highly disturbing power. As anthropologists of both sexes know, homo necans has for millennia been trying to wrest this power from the domain of women. And cloning satisfies this dream. Science is progressing at great speed, and progress can only go forward. Although today it is still a "passage" or a "tool" necessary to generate a double, the mother's uterus is clearly destined to disappear from the scene. At least, that is what collective imagination thinks. In the film Alien IV. The Resurrection (significantly, in Italian the title was Alien. La clonazione), the generation of the clone occurs entirely outside the uterus. It is artificial. The protagonist is herself an artificially produced clone, produced after a series of failed attempts that co-exist: she will give birth from her stomach, not her uterus, to a babyalien. The film is characterized by a post-modern multiplication of fantasies on motherhood and thus looks at generation from a variety of aspects. But the protagonist is in any case a woman; and the Alien monster, called Mother, is also female. After all, both Dolly and her original are female. Collective imagination has not yet been sufficiently stimulated by science or even by science-fiction: it is still having a hard time to free itself entirely from the femaleness of generating life. Seen from the patriarchal viewpoint, Zeus in mythology had already done better. Yet, Zeus, imitating what natural mothers do, had given life to another

200

Cavarero

being, not to a replica of himself. To understand the most genuine influence of patriarchal imagination it's necessary to focus on the idea of generating a double. In other words - and this is obvious - in cloning, the male mimesis of generation concentrates emblematically on the category of doubles, rather than on the act of generation itself. For this reason cloning is decisive in revealing the androcentric horizon of the popular fancies that surround it. Combining the myths on male procreation with those on mirror-image doubles, it reinterprets them and goes beyond them, revealing even more clearly the phallic ego. No category is more extraneous to the experience of motherhood than the double. Whatever sentiments (fear, joy) or fantasies the expecting mother may have of the child she is about to bring into the world, she never expects to give birth to her double, but to another being. To borrow Hannah Arendt's philosophical terms, the scenario of birth announces the entry into the world of a new human being, different from all those that are living in it, from all those that ever lived and that ever will live. Every newborn is a new, unique and unpredictable creature, of whom we ask "Who are you?" And it is this "who" that we address to the living being at the beginning of her/his existence that marks her/his uniqueness, and therefore the absolute distinction of the new creature, who is undoubtedly "other". Again, to use Hannah Arendt's terms: characterized as it is by the paradoxical plurality of unique beings, the human condition is a "natal" condition before it is a mortal condition. The mistake of the androcentric tradition lies precisely in the fact that it measured human existence, from its beginning, solely according to its dimension of mortality, ignoring the dimension of birth. The symbolic offspring of homo necans, male human beings do not procreate, they go hunting or wage war: they can deliver death and risk death. Is this not the origin of the Greek word andreia, which means both courage and virility? Fundamental in the process of civilization, in which males are the undisputed protagonists, the dimension of death guides both our symbolism and the imagination. We should therefore not be surprised that over the millennia the dream of immortality has always been the most powerful of desires. Nor should we be surprised that the same dream takes shape around the figure of the double, envisaged as regeneration of the self, a potentially infinite process, a process without end. The disturbing element that Freud sees in the idea of the double is probably less related to the question of identity than to the exclusive centrality of the notion of death. And we can see this once again in Plato. His system, in fact, revolves around ideas, eternal ideas: this system preserved ideas not only from death, but also from birth as the obliged entry into the ephemeral world of passing time. These ideas generate

Doppelganger Temptations

201

the perceptible world replicating themselves in copies, which are symptomatically perturbing not because they threaten the identity of the ideas themselves, but because they share the mortality of the world. Leaving aside the complexities of Plato's system (which is really difficult to summarize in a few words), the fact remains that it focuses on a central idea (as Irigaray and Derrida have already stressed): the idea of the Good, called the Father, capable of giving birth to children, intelligible or perceptible, that are his copies. Frequently denounced by the critics of metaphysics and (primarily) by Feminist theoreticians, this rationale is based on the notion of the "same" that can be generated by cloning the paternal original. As far as its inevitable androcentric connotation is concerned, the approach to cloning in today's collective imagination can thus boast very prestigious philosophical forebears. Conversely, a specifically female imagination - pushed into a corner by gender stereotypes and centuries of forced silence - can rely only on marginal texts (usually literary or autobiographical) and on the elementary knowledge provided by experience. In the case of motherhood, female tradition tells us that neither the double nor the self play any role whatsoever: that which is generated is always "other". Fantasies concern - if anything - relationships of dependence or autonomy from this "other": grown within the self of the mother and yet other than her, appearing as a fragile yet autonomous being. Here the notion of the same being finds no space at all. Suspended between joy and fear, what is at play here is the unpredictable, the formula "who are you?" This does not mean that women, living (inevitably) in a world entirely permeated with patriarchal culture, do not share the dream of immortality and are not fascinated by the notion of the double. Collective imagination has involved them, too - we know. Yet, we can't help but point out that the issue of cloning offers a good opportunity to question the spontaneity of this involvement. After all, we could start thinking that the celebrated "perturbing" element, the essence of the double further enhanced in the clone, is simply a feeling of repugnance for an action, a process that is attempting to separate the phenomenon of generation from its natural consequence, the appearance of someone who is "other". Only a hypertrophic "ego", modelled on the Cartesian thinker, would accept such a swap, to lengthen his own existence in exchange for the disappearance of the "other". Professor of Political Philosophy, University of Verona, Italy

202

Cavarero

BIBLIOGRAPHY 1. Plato, Cratylus. Plato, Phaedrus. Plato, Republic. Euripides, Helen. Ovid, Metamorphosis. 2. Hannah Arendt, Vita activa, Bompiani, Milan, 1988. Maurizio Bettini (ed.), La maschera, il doppio, il ritratto, Laterza, bari 1991. Walter Burkert, Homo necans, Boringhieri, Turin 1981. Adriana Cavarero, Nonostante Plat one, Editori Riuniti, Rome 1990. Adriana Cavarero, Tu che mi guardi, tu che mi racconti, Feltrinelli, Milan 1997. Jacques Derrida, Lafarmacia di Platone, in Disseminazioni, Jaca Book, Milan 1989. Massimo Fusillo, L'altro e lo stesso, La Nuova Italia, Florence 1998. Sigmund Freud, // perturbante, in Opere, vol. 9, Boringhieri, Turin 1989. Luce Irigaray, Speculum, Feltrinelli, Milan 1989.

After Dolly: New Forms of Genetics Capital Sarah Franklin

In addressing the topic of 'cloning and the popular imagination' it is of course necessary to turn our attention to Dolly, the cloned Scottish sheep via whom we all first learned that viable offspring could be cloned from adult cell nuclei. In addition to the fact she is a sheep, what is most important about Dolly is her viability: she is a viable offspring. She is valuable because she is viable, and her viability has many dimensions. In the brief time I have to speak to you here, I would like to explore some of the dimensions of Dolly's viability - not only as a sheep, but as an embodiment of national heritage, a form of intellectual property, and a form of genetic capital. The viability of British sheep has long been a source of their inestimable value to the British people. Sheep first came to Europe from Asia over 5000 years ago, and in Britain, as in many other parts of Europe, their unique ability to survive under the most inhospitable conditions, in some of the most exposed and remote parts of the country, and with very little assistance from their keepers, has made of them a highly prized, semidomesticated animal. Many breeds of sheep remain distinct in Britain. The diversity of British sheep corresponds to the wide range of environments they inhabit and the many uses to which they are put, for wool, for meat, for milk, for breeding purposes, and to improve the land. Indeed it is almost impossible to imagine the contemporary British countryside, its deforested green hills and dales, without imagining those hillsides covered with sheep. Sheep epitomise the countryside which belongs to the industrial heritage which gave the British landscape its contemporary form. Indeed, historians even claim the industrial revolution arose in the North of Britain in no small part because of the extent to which sheep had transformed non-arable land into soil fit for agriculture.

203 CM. Mazzoni (ed), Ethics and Law in Biological Research, 203-205 © 2002 Kluwer Law International. Printed in Great Britain.

204

Franklin

The unique importance of sheep to ideas of Britishness, of British industrial heritage, and British countryside was recently made explicit as part of a campaign to 'rebrand' Britain, for which John Wiliamson, a design consultant from the firm Wolff Olins, proposed 'three sheep representing complementary images of Britain - natural heritage and tradition; radical eccentric British culture and creativity; and [British] leadership in innovation, science and technology'. In this proposed rebranding strategy, ideas of nature, culture and industry are woven together in sheep's wool, to suggest the fabric of a nation. The importance of sheep to Britain's industrial heritage has always relied on the value of sheep as forms of capital. It turns out sheep have a very privileged place in the strategies of capital accumulation which made of Britain not only a leading industrial nation, but an empire. British sheep breeds were exported all over the world, and nearly all of the leading commercial sheep breeds in existence today arose in Britain. The Roslin Institute, where Dolly was both born and made, is a direct descendant of the Imperial Bureau of Animal Breeding, based in London. And the viability of sheep is as important to the British biotechnology industry today as it has been to Britian's industrial successes in the past. As sheep were instrumental to the emergence of the industrial revolution in Lancashire two centuries ago, so are they of equal importance to the industrialisation of life today. However, while it is not, therefore, 'new' to speak of animal bloodlines and animal genealogies as conduits for capital, or wealth accumulation, these have today taken a new form. While it is not unprecedented to observe the ways in which national economies are in part conducted through animal breeding, there is a new significance to the kind of reproduction Dolly guarantees as viable. In the same way sheep have been important to definitions of wealth, nation, heritage, and empire - so today they are beginning to redefine what it is to be human as well. Dolly is not only viable as an offspring, but as a scientific accomplishment. Her viability guarantees the success of a particular technique of reproductive biology, and her reproductive success is part of a larger corporate strategy. Dolly embodies a valuable form of intellectual property: she is the animal model for a patent which has recently been sold to the American corporation, Geron, for several million dollars. Dolly's net worth is now part of a publicly-traded company, in which her value is both as a kind of celebrity animal and as a kind of animal futures market. Dolly is, in sum, a unique form of genetic capital. One way to examine the importance of Dolly in the popular imagination

After Dolly: New Forms of Genetics Capital

205

is to consider the way in which her reproductive powers have been commoditised, traded, sold, and owned as forms of private property. This development comprises the uncomfortable end of our newfound proximity to sheep. It would be one thing if we could as easily imagine our separateness from sheep as we might like to: for they are, after all, often a figure of fun. However, it is also both very British and equally European to assume that people reproduce more or less in the same way animals do. Unlike many of the societies studied by anthropologists, in which human reproduction is seen to be distinct from that of animals, the Darwinian legacy of the industrial era tells us that we are in fact descended from animals ourselves. This means that, in a sense, Sheep-R-Us (which can also be read 'sheep are ewes'). This simple observation explains quite readily why there was such worldwide curiosity and disturbance surrounding the cloning of a sheep: because what can be done to sheep can by implication also be done to humans. This too is why the transformation of Dolly's genealogy into a form of 'live-stock' or breedwealth, bears heavily upon the public consciousness. The proximity of genealogy to capital is made that much more explicit. The dangers of this proximity have become more unsettling. The cross-breeding of human genes into sheep such as Polly, the first transgenic ewe, make us worry about the road ahead, whether there is going to be a ewe turn, and whether counting sheep may turn out to keep us awake at night instead. Perhaps in the same way we first became intimate with sheep by eating them, we now share another complicated vector of attachment in the discovery of how closely our own reproductive futures are intertwined with these woolly doppelgangers. After all, human DNA is already coiled up in the genomes of transgenic sheep like Polly, and it is in part this dilemma which leads us to so much joking and humour about the cloning of sheep. Sheep are in the popular imagination as human substitutes: and it is in this mirror that we see our own futures uncomfortably reflected back to us. Sociologist, Lancaster University, UK

This page intentionally left blank

Cloning and Balanced Ethics John Harris

I hope to say something in a moment about the role of public opinion in the regulation of science, and in particular procreation, but I want to start by clearing up some debris left over from the earlier part of the meeting. Some people clearly think that clones do not have genetic parents. This is false: a clone is the brother or sister of the nucleus donor, and has the same genetic parents as the nucleus donor. This is always true. Every time you clone and re-clone, every clone will always have two genetic parents, one male, one female, the parents that contributed to the original nucleus from which they are clones. So, it is nonsense to say that clones don't have genetic parents. Secondly, when the risks of cloning are considered, one factor in favour of cloning is seldom emphasized, and that is the predictability of the resulting genome. Since we have heard endlessly, and rightly, that genotype is not phenotype, that biology is not biography, clones will not be identical to the nucleus donors in any meaningful sense; however, they are likely to be free of predictable genetic defects given the known history of the nucleus donor. Possessing a predictably healthy and possibly long-lived genome may be advantageous, so the predictability of a clone, far from being a disadvantage, or boring, or reducing the role of chance in some unacceptable way, is, in fact, a positive advantage. One might ask the question of whether it is responsible to play the game of genetic dice that is normal sexual reproduction, when you can provide a proven genome. I'm not recommending this, I'm simply pointing it out. Of course if everybody did it, that would be problematic, but we know that that won't happen. The reasons are first, because of the costs and the elaborate technology involved and the residual attractiveness of sexual reproduction, and second, of course, because as has been pointed out endlessly in other sessions, to ban something because everybody did it would be disastrous. It would rule out among other things celibate and monastic orders for which Italy is rightly famous. 207 CM. Mazzoni (ed), Ethics and Law in Biological Research, 207-211 © 2002 Kluwer Law International. Printed in Great Britain.

208

Harris

One final thought from this very rich meeting: often, objections are made to doing things to embryos because embryos cannot consent, but the embryo cannot consent to anything we do to it, including for example, because we are its parents, making it black or white, or whatever. Unless it is clear that what we do to the embryo would be positively bad for it, we may surely go ahead. The claim that cloning would be bad for an embryo and a resulting person has not been substantiated. I want now to devote the rest of my time to the issue of procreative liberty, and in particular to the role of public opinion and public acceptance of science in the exercise of that liberty. And I shall take as my point of departure a recent report to the British government, a joint report of the advisory committees to the British government, the Human Genetic Advisory Commission (now disbanded), and the Human Fertilisation and Embryology Authority (still going strong). The report is called "Cloning issues and reproduction: science and medicine", and was presented to the United Kingdom Government in December 1998, and this is the report to which I refer. I want to deal with two issues that were raised in that report: the first is the role of public consultation in the determination of science policy, and the second the role of public acceptance of science. The report claims - I quote to you - that for any type of fertility treatment to function satisfactorily there has to be a degree of social acceptance of the measures being taken. Then it continues that it is quite clear that human reproductive cloning is unacceptable to a substantial majority of the population. "A total ban on its use for any purpose is the obvious and straightforward way of recognising this. The results of the consultation fully support the government policy in this respect." What happened was that the two committees attempted a public consultation exercise. They tried to discover what the public thought about human reproductive cloning, and they fed the results of this consultation, which were only negative, back to the report, and indeed this coincided with UK government policy, which is against reproductive cloning. The arguments in the passage that I've read are complicated, and I believe raise fundamental questions not only about the way morality evolves, but also about democratic theory, and obviously a complete discussion of its use is beyond the scope of this short paper. But let me make a number of observations. It's difficult to know whether the first claim made here is supposed to be an empirical claim. If it is, the degree of social acceptance required for satisfactory functioning is nowhere specified in the report, and needs to be spelled out. There are many procedures, and social practices, in every society, that are controversial, and may only have full acceptance among a minority of the population. Many of these nevertheless

Cloning and Balanced Ethics

209

involve important freedoms which are otherwise justifiable both morally and in terms of democratic theory. Among these, maybe (and I would not expect you necessarily to agree with these) are assisted reproduction for lesbian or gay couples, for post-menopausal women, equality in age to consent to sexual relations for gay and non-gay men (and women for that matter), needle-exchange schemes for intravenous drug users, contraceptive advice and treatment for children under sixteen, and so on. And of course it is a notorious fact that in the United Kingdom the majority of the population would like capital punishment, although we don't let them have it. So the claim that for any type of fertility treatment to function satisfactorily there has to be a degree of social acceptance of the measures being taken - I quote - appears as a truism, and it is certainly treated as one in the report and in other documents. However, it is plausible surely only to those who will be ready to accept that that particular fertility treatment is not acceptable; and moreover, who believe that it should not be tolerated. These are separate claims; very important freedoms are at stake, and it may be morally incumbent upon society to accept something less than satisfactory functioning in order to frustrate what John Stuart Mill memorably referred to as the "tyranny of the majority". So when a report, like our Government report, concludes that it follows from lack of public acceptance that "a total ban on the use of the technology for any purpose is the obvious and straightforward way of recognising this", it has been disingenuous to say the least. It is an odd idea that if things don't function well, the solution is a total ban. If however it is the lack of acceptance that makes the ban the obvious and straightforward response, we should note that this has never been part of either our moral or political theory, at least in Western democracies. The lack of general public acceptance of a social practice neither requires or even permits a total ban on its use for any purpose. If such draconian measures are justified, it must be because either morality or social policy requires it, not because the majority dictates it. It is, I want to suggest, one of the functions of democratic governments to uphold the freedoms and protect the moral rights and interests of minorities and even of individuals, and I venture to suggest it is one of the functions of Government-appointed advisory bodies - I sit on two in the United Kingdom - to remind governments of this obligation. Now of course if we have to defend access to procedures which seem unacceptable to the majority, this depends upon there being some plausibility to the suggestion that, for example, using cloning to reproduce does or could have some moral importance, does in fact or could in principle

210

Harris

involve significant freedoms, rights or interests of citizens. There should be - at least it seems to be - some initial plausibility to the claim that reproductive cloning could involve such real interests, rights and freedoms. Let me give you one example. Imagine a couple in which the male partner is infertile. Like many couples, they want a child that is genetically related to both of them; rather than using donated sperm they prefer to clone the male partner, knowing that from him they would get forty-six chromosomes, and from the female partner who supplies the egg there would be some mitochondrial DNA. Although in this case the male genetic contribution will be much the greater, both partners will feel justifiably that they have made a genetic contribution to their child, and they argue that for them this is the only acceptable way of having children of their own. It's difficult, I would suggest, to see this choice as reckless or trivial. In what way might it be illegitimate, unethical, or contrary to human rights or dignity? The couple are simply exercising their preferences about how to found a family by utilising cloning technology. I will end by making a few very brief remarks about the idea of procreative liberty, of procreative autonomy. When people express their choice about procreation, even in unusual or idiosyncratic ways, they are invoking an ancient, even if only recently established, example of what may be determined the fundamental right. This right or entitlement is found in all the principal conventions or declarations of human rights. Sometimes it is expressed as the right to marry and found a family, sometimes as the right to privacy and respect for family life. This right, or entitlement, is now usually discussed in terms of procreative liberty or procreative autonomy. It has a number of different sources: some see it as being derived from the right to reproduce per se, others as being derived from more important rights or freedoms. Certainly there's no widespread agreement as to the nature or the scope of this right, although values and liberties which normal sexual reproduction embodies are observed, but let me give two examples of the people who defend this right. The first is John Robertson, an American legal theorist. He says that the moral right to reproduce is respected because of the centrality of reproduction to personal identity, meaning and dignity. This importance makes the liberty to procreate an important moral right, both for an ethical individual autonomy and for the ethics of community or family that view the purpose of marriage and sexual union as the reproduction of offspring. Because of this importance the right to reproduce is widely recognised as a primary moral right that cannot be limited except for very good reasons. And Ronald Dworkin has defined procreative autonomy I quote - a right to control their own role in procreation, unless the state has a compelling reason for denying them that control.

Cloning and Balanced Ethics

211

Arguably - this is myfinalpoint - arguably Dworkin's and Robertson's accounts both centre on what I believe to be the key idea, namely respect for autonomy and for the values which underlie the importance attached to procreation. These values, procreation and founding a family, involve the freedom to choose one's own lifestyle and express through actions as well as thoughts or words, the beliefs and the morality which families share and pass on to future generations. So my claim is that unless it can be shown that the use of cloning technology is either so dangerous that it would be a crime to introduce it, or wicked or immoral in some other way, then there should be a presumption in favour of procreative liberty which would extend even to the use of cloning technology, provided that it proves reasonably safe, and at the moment there is no indication that it will prove unsafe. The focus in the United States legislation has been simply to stop funding for human cloning research, whereas in Europe generally, and in the United Kingdom in particular, the structures are much more severe, but only for contingent reasons. These are that the legal system in the United States doesn't enable the President to dictate to individual jurisdictions, so that all he can do (and has done) is to stop state funding for cloning. However, I think if the United States were able to implement the recommendations of the National Bioethical Advisory Committee (NBAC), which came out cautiously against cloning, at least for a fixed period, they would do so. Perhaps unfortunately for European countries we are more able to move swiftly to control and regulate. In England there's a de facto rather than a de jure prohibition. Professor of Philosophy, University of Manchester, UK

This page intentionally left blank

The Future of Clones Mario Jori

Whenever mention is made of human clones, the image that springs to mind for the mainstream is likely to come from Aldous Huxley's classic Brave New World, 1932. In this world created by Huxley's fertile imagination, it is the human being who is adapted physically, using genetic selection and perinatal engineering, in order to ensure his happiness in society: "Major instrument of social stability" is the name given in the novel to the technique of genetic human embryo manipulation that is ultimately cloning, accompanied by significant foetal manipulation.1 The technique is used to create harmonious labour squads of dozens of twins whose intelligence varies according to the work assigned to them. To tell the truth, the novel does not explain why dozens of identical twins are supposedly capable of doing group work together better rather than worse.2 At first sight, it seems to be more plausible to lower individuals' level of intelligence, so that they will be happy doing the lower tasks that society asks of them. And yet the factual presumption underlying even this idea is certainly false: it is simply not the case that less intelligent people are happy doing a low level of work and often the opposite is true. There is plenty of evidence of this in history and if what we need is examples closer to the present day we need look no further than our politicians. This problem is solved in the novel by combining the biological methods used with an intense process of educational conditioning. This point is worth stressing from the very beginning, because the situations imagined in Brave New World and our natural repulsion at the idea of squads of identical men, marching with empty eyes in an army or a factory, seem to be the only clearly identifiable element in our widespread 1

Bernard Gert's paper deals with the moral implications of the imaginary society constructed in this novel. 2 And of course the entire procedure requires a static society, where any kind of change has been banned, first and foremost technological progress. 213 C.M. Mazzoni fed), Ethics and Law in Biological Research, 213-225 © 2002 Kluwer Law International. Printed in Great Britain.

214

Jon-

emotional reactions to cloning; or that, at least, is what the press would have us believe. Nevertheless, the mass production of absolutely identical human beings is by far the least probable application of human cloning, perhaps the most salient reason for this being that any society intent on pursuing aims of this kind would require far more efficient and economic resources to achieve them. Recent history has demonstrated that totalitarian educational conditioning is more than sufficient on its own: there is simply no need for what would ultimately be rather ineffective and uneconomic cloning. And this is something that intelligent science fiction knows only too well. In a novel set on a planet devoted to uncontrolled bio-engineering, certain immoral clients commission the genetic production of a race of supersoldier clones from an unscrupulous firm. The result is a clamorous failure, summarised in this laconic comment from one of the story's leading figures: "They were trying to reinvent the grunt" (Lois MacMaster Bujold, Borders of Infinity, 1989). Whatever ethical and political problems are raised by human cloning, they certainly do not derive from reinventing the Nazi trooper. Like all Utopias, Huxley's novel is not really intended to be seen as a (failed) experiment in historical forecasting, but as a mental experiment in the realms of ethics and politics. Its main function is to force us to ask ourselves just how far we would be prepared to go in accepting the maximisation of social happiness as our supreme moral principle. Science fiction is full of philosophical messages that are no less instructive than Brave New World - and certainly far more successful as forecasters of the future. Here are some examples. In Natural State, a long science fiction story written by Damon Knight in 1954, North American industrial society is concentrated in a handful of independent, warring cities (New York versus Chicago and so on) that plunder each other for the mineral resources they need to maintain their sophisticated technology. The main character is sent out of New York on a mission to spy on the 'savages' who live in the no-man's-land between the cities, presumably in the natural state mentioned in the title, with a philosophically sophisticated play on words. In the end, our hero discovers that the non-city dwellers have actually developed a 'soft' technology that produces a much better life and is in reality far more advanced than its counterpart in the cities. Substantially, it is a biotechnology (they grow screwdrivers on transgenic plants, use genetically modified animals instead of mechanical vehicles and so on). Our city-born hero's first reaction is described as a mixture between the metropolitan dweller's disgust at the dirt and smells of the countryside and his horror at the unfamiliar shapes

The Future of Clones

215

of biologically unnatural, constructed phenomena. But he is gradually obliged to realise that any technology that exhausts nature and is therefore unsustainable will have to be replaced by a more effective technology, so he ends up converting (and gets his prize girl when he marries a stunning beauty whose job is genetic manipulation). It is fascinating to note, incidentally, that the feelings of the hero of this story written more than forty years ago describe quite unpretentiously, but with considerable acumen, several of the fundamental incongruities in the concept of nature espoused by today's 'green' movements, which often ambiguously reject things both natural and unnatural. In a science fiction novel written soon afterwards, Lester Del Key's Eleventh Commandment (1962), the hero is a geneticist doctor who returns from an Earth colony on Mars to the mother planet, which was devastated by an atomic war two hundred years before. He discovers that Earth is now overpopulated by a downtrodden proletariat, dominated by a Church that obliges everyone to comply with an eleventh - and supreme - commandment: "Thou shalt go forth and multiply", prohibiting abortion and all forms of birth control, in spite of poverty, diseases and malformations. Our Martian is horrified and starts to fight, until he discovers that the Church's strategy is perfectly rational, in that situation. This is because the human race is subject to mutations, as a result of atomic radiation, and nobody is capable of calculating which mutations, combined with which others, will eventually prove to be favourable. The best thing for the human race is therefore to keep on multiplying blindly and letting natural selection take care of everything. This novel's hero also ends up discovering that his ethical judgements and his feelings are turned inside out: and so he wins his prize girl, who of course is also very beautiful and with curves in all the right places, even though she is a genetic mess. That should be enough quotations from science fiction literature for the moment. If we consider them, we realise that they convey several philosophically interesting messages. The first is that we are not at all certain what we feel about biotechnological practices: indeed, we tend to swing back and forth between agreeing with them and being horrified by them. We usually, though not always, reserve our horror for the idea that it is human beings that are modified, if it is done against their will and outside the confines of the methods conventionally used for such modifications (which in practice means education and family upbringing). The science fiction authors I have quoted also tell us that our first reaction of moral indignation is often superficial, a reaction to the unknown and to the way things look, and may be overcome once we start evaluating it, mutatis mutandis, on the basis of the same moral principles we use to evaluate those things that are

216

Jori

familiar to us. This is ultimately a useful lesson in the ambiguity and superficiality of our conception of what is nature and natural. Natural nature is not clean, stable and tidy: on the contrary, anything that is clean, stable and tidy is not natural nature, but artificial. In short, these authors remind us that nature is neither a garden nor a zoo. This does not mean that I subscribe to the populist theory that 'lightweight' literature, of the kind that is written primarily to amuse and entertain, somehow arrives at the truth better or earlier than more 'serious' literature, of the kind that is written to argue a given case. It would be far too easy to fall into the trap: every one of us would obviously be able to pick and choose whatever suits our arguments best, fishing around in the huge sea of entertainment literature, where it is easy to find everything and its opposite. So it follows that the quotations mentioned above are merely the mirror of my own opinions: they do not constitute an argument capable of proving that these opinions are correct because of their being shared by popular opinion. Science fiction does, nevertheless, have one serious advantage over literature that sets out to describe a Utopia, whether positive or negative, not to mention over the daily press. Science fiction has a strong incentive, deriving from its underlying conventions as a genre of literature, to treat technological innovation as incidental, as an element or a background to a normal way of life. The fact is that it is a conventional part of the style of a science fiction story that the 'science fiction' elements are described as ordinary elements of the world (future or imaginary), thus constituting a strong incentive to discover the common ground between the new (imaginary) elements and the traditional ones. This approach has an unexpected philosophical advantage in the case of the more successful novels: one particularly effective way of reinforcing the literary effect of the normality and everyday ordinariness of the description of a science fiction situation is actually to apply our usual ethical principles and strengthen their effect to do it implicitly, 'behind the scenes', as it were. In this case, the underlying moral assumption is none other than the thesis that the ethical novelty resides only in the means and not in the ends. This means (implicitly) abstracting our ethical principles from their traditional applications and putting them to the test, examining the possible instances of their application to concrete (imagined and science fiction) cases. In other words, in its finest pages and in its most sensitive, intelligent authors, the stylistic conventions of science fiction produce technically speaking a strong, spontaneous inclination to the ethical technique known nowadays, with Rawls' terminology, as reflective equilibrium, which corresponds to the traditional mental experiment. To quote one of the best examples of which I am aware, this is the case

The Future of Clones

217

of the way in which human cloning is dealt with in several novels by Lois MacMaster Bujold. The future world she imagines has a government rather like Tudor England, with a not-exactly-absolute monarchy, an hereditary aristocracy and elements of authoritarian democracy. The Salic Law applies to the nobility, which means that only males inherit titles and the political powers entailed. Now, galactic civilisation provides this society with biotechnologies and genetic methods which by no means coincidentally are the same that we are now beginning to glimpse and discuss. The heir of a great family is secretly cloned by terrorists, who want to use their creation to harm the original. The plot is averted, but what is the clone's social, legal and political status to be now? The cloned heir and his parents have no hesitation in adopting him respectively as a brother and a son, while a series of well-calculated references to events off-stage, as it were, tell us that the political and legal battle for his official acceptance is won. The story is well told, because the aspects of principle are left in the background, while the story focuses on the clone's emotional and moral problems in making his entry into a 'normal' complex way of life (Lois MacMaster Bujold, Brothers in Arms, 1989, and Mirror Dance, 1995). Another story in the same setting has a certain Earl dying suddenly without leaving any sons. His earldom falls into the hands of his nearest male relative, a thoroughly despicable and probably criminal cousin, while the Earl's sister, who has actually been wielding the reins of power behind the scenes all the time, is disinherited because she is a woman. Undaunted, the resolute noblewoman checks into a galactic clinic, undergoes a sex-change and promptly claims power on the basis of the tradition of male domination.3 Very funny! But also a way of tacitly putting the moral question posed by such an event into perspective, with respect to the limits and the social prejudices that hold sway in the imaginary society, which are of course the same as our own (Lois MacMaster Bujold, A Civil Campaign, 1999).4 The tendency that is built structurally into everyday news media, both printed and television, is unfortunately quite the opposite. They have a 3

Incidentally, no sooner has the new Earl been officially recognised as a male and taken over power, than (s)he instantly conquers a beautiful girl (or, rather, the prize-girl conquers him). We have evidently come a long way along this road since the fifties models of science fiction. For an interesting treatise on the topic of the relations between the sexes, illustrated in an iconographically subtle triangle between the reality of the present day, the imaginary future and fifties style science fiction, see the recent film Starship Troopers, which the Italian critics, totally ignorant of the fabric of quotations that goes to make up the film, saw as nothing more than an extremely violent, militaristic blockbuster, which is no more than the surface which the film presents to us with nostalgic irony. 4 I should like to thank the author for her kindness in putting the entire text of her novel at my disposal before it was published, thus enabling me to quote from it as I have done here.

218

Jori

very strong incentive to instigate the hysterical howl, as a way of attracting the attention and interest of readers and viewers. As technological innovations (as I shall expound shortly) are already spontaneously frightening enough on their own, the press has a strong economic incentive, ceteris paribus, to treat every innovation as apocalyptic, as soon as it gets the chance or the excuse to do so, and to go no further than its superficial aspects; to treat every technological innovation, which often only concerns the means, as though human beings had never before attempted to find self-achievement or reach the same ends with other means; as though those other traditional means (and thus their relative ends) were not normally accepted. Generally speaking, the difficulties that face us when we deal with technological innovations are typical of biotechnologies, but by no means limited to them. They crop up every time that we have to do with anything either really or apparently new. Law and morals, in particular, have always had a very hard time coming to terms with technological innovation. As a whole, they have usually failed rather pathetically in their judgements. In order to be in a position to judge the technological future, you have to be capable of understanding it - and understanding it means predicting its effects. This is one of the most difficult of problems: Utopia, by which I mean a story about a Utopia, is one of the methods that has been used traditionally to attempt this almost impossible mental operation. With uncertain success: so uncertain that any success may well be attributed to chance rather than to foresight. Cultural commitment and the firm intention to write seriously do not appear to constitute an advantage for the purposes of successful understanding and predictions, as the examples mentioned above illustrate. Which is why it is worth looking for interesting ideas in science fiction, paradoxically because the genre aims at entertaining rather than demonstrating and despite the fact that the majority of science fiction has very modest aspirations when it comes to culture and literary value. So the difficulties involved in predicting, understanding and evaluating innovations are not restricted to biotechnology and cloning. They apply to everything new, but especially to all technologies, which have an unattractive penchant for bringing about continuous changes at mind-boggling speeds. We probably believe that we are quite well accustomed to technological progress by now, but that is far from the case. Nor would it be natural if we were. Even if we look at nothing but our period of recorded history, for five thousand years the history of mankind has been the history of agricultural society, whose basic materials remained substantially unchanged or underwent such slow change that it was practically indiscernible in the lifetime of an individual.

The Future of Clones

219

Change unsettles us because we know that it makes us change in unpredicted and unpredictable directions and, once we have changed, we are not ourselves any more. There are two normal reactions to important technological innovation. One, which applies to a small minority, is enthusiasm (of the kind we might have expected from Jules Verne, for example). The other is rejection and panic. Let me quote a relatively harmless example of what I mean. In his splendid book The History and Social Influence of the Potato,5 Redcliffe N. Salaman narrates how the potato was originally received in Europe (in the sixteenth century) with horror, considered unnatural (because its fruit grows underground), poisonous and ultimately, in the absence of any other evil attribute, aphrodisiac. The example is not aberrant, because the potato was also once an example of an innovative biotechnology. Note that in this case the object of dispute could make all the difference between living and starving to death, considering that a field of potatoes will feed ten times as many people as a field of wheat. New technologies have always encountered very strong resistance in popular imagery. So there is nothing new about biotechnologies. There are already some useful lessons to be learned about this aspect of the question from the examples I have mentioned above. What transpires from the title of Damon Knight's novel is that there is nothing new about biotechnologies; in actual fact, they are the most ancient form of technology, dating back to the invention of agriculture and animal husbandry. Nevertheless, certain types of biotechnology, such as cloning, have been seen as something different not only from the old traditional methods of animal husbandry and agriculture, which use similar means and have the same aims but are a constituent part of human history, but also from the less traditional methods of modern non-biological industry. What we find is that certain ways of using biology and genetics were already seen in this light by a science fiction writer in 1962. The novel about the eleventh commandment ("Thou shalt go forth and multiply") should actually remind us of another fact: that society itself is a form of biological manipulation of our Darwinian 'natural' nature, at least because it attenuates and channels our natural biological, environmental and sexual selection. A series of ancient, highly accepted factors, from curing disease or getting married to public hygiene, have had an effect on the selection of the species. Any total moral rejection of genetic manipulation should entail refusing to use any means whatsoever (and not just new means) that has an intentional effect on our species' genetics, which would 1949, Cambridge University Press.

220

Jori

not even mean remaining in the condition we are in at present, but going back to a natural or animal state, at the very least refusing to stop death caused by 'natural' diseases and suchlike and the relative selection that would lead to. If our biological world were to suffer some catastrophe, such as in the case theorised in the novel, when the mutations are caused by an atomic war, a 'Darwinist' solution might find adherents who would be prepared to argue along the lines that "We have failed; now let's allow nature to take its course". But what about today's real world? Frankly, I fail to see what even minimal moral attraction there may be in a more or less sweetened biological form of Darwinism. My reasoning for this stance is not suggested by the sixties science fiction author, but by the incredible Draft Protocol to the Council of Europe's 1997 Convention on Human Rights and Biomedicine, which aims at prohibiting human cloning. When I read this document (of which later), I was reminded of the old novel about the eleventh commandment. That does not mean that I am arguing that the convention sets out intentionally to propose extreme Darwinist morals, nor that any prohibition of human cloning is necessarily wrong. Only that it is obvious, as I shall argue later, that the underlying arguments are senseless and contradictory. Let's see, then, whether what we have established so far can help us get a clearer view of the moral and legal problem of the genetic manipulation of human beings. If something is new, we have to reduce it as far as possible to elements that are not new, but are legally and ethically familiar. The methods for doing this are tried, tested and traditional. As a first principle, we must be firm in not trusting to common moral feelings and intuition, which do not function well with regard to anything new. Secondly, we must use other rational tools that function better in situations such as these, such as analysing all the morally constituent elements and establishing their relations with known and/or accepted principles; or experimenting mentally with concrete cases (real or imaginary). The analysis functions by asking analytical questions, whose aim is to separate what is essential to making an ethical and legal evaluation in an unfamiliar case from what is accidental and contingent. We must then ask ourselves whether we consider technological change to be intrinsically good or bad. The obvious answer, albeit conditioned by the variety of ethics in the modern world, will be that change is intrinsically neither good nor bad. It depends on the effects, which must be evaluated, of course, on the basis of a system of (moral and legal) values. Inventions and new technologies bring about change, so it follows that they are good or bad as a function of their effects. Good effects mean good innovations; bad effects mean bad innovations.

The Future of Clones

221

Unfortunately, none of this gets us very far forward. The long history of the Industrial Revolution can tell us why. First of all, the effects that will take place in the future are unpredictable; then of course the effects of technology may be good for some and bad for others. All attempts to find the supreme and sole calculation of social happiness, inaugurated by Bentham and pursued by Marx, have proved to be miserable failures and dangerous illusions. Although we can predict (some of) a technology's immediate technological effects, we are unlikely to predict its further technological effects and even more unlikely to predict its social effects. All effective technologies produce others, in an explosion that defies calculation. Not many people know the origins of the carburettor, that source of incredible economic productivity, of social mobility, of atmospheric pollution and of thousands of deaths every year in every motorised country. It actually originated as a perfume spray, at first sight an absolutely innocuous, frivolous invention. So when we make our moral, political and legal evaluations of technology, we must be aware of the uncomfortable principle fact that we are operating in conditions of radical uncertainty and ignorance about the future. Biotechnologies (in this case the human variety) share this aspect with all other technologies: there is no moral difference. It has been proposed that we should exercise prudence, the result of a new, more realistic and modest view of science, especially with regard to environmental protection and human biotechnologies.6 This attitude is open to discussion: paradoxically, the principle of prudence is very risky. Once you exercise it, you must do so for every technology, which in practice means prohibiting every technological change. In other words, we can be reasonably prudent towards direct, immediately predictable effects, but not towards further and social effects about which we know nothing. Prohibiting change and innovation does not herald the golden age, it heralds the acceptance of the status quo. But this contains another, even more self-defeating paradox: not changing means accepting and submitting to the equally unpredictable changes that are already implicit in current conditions, in other words social, economic, climatic and biological changes. The social world does not stand still, even if we do not lift a finger. In the very short term it may look still, but we are at the mercy of cycles that roll on, even if things "don't change". That is what happened typically in pretechnological cultures, such as the cyclic crises that used to afflict pre6 See M. Tallacchini, Ambiente e diritto della scienza incerta, in Ambiente e diritto, I, edited by S. Grassi, M. Cecchetti, A. Andronio, Leo S. Olschki, 1999. The prudence we should exercise with regard to scientific discoveries is not of course the same as the prudence with which we should use the technologies made possible by science.

222

Jori

industrial agricultural societies. Nowadays we know that the impoverishment of farmers and peasants was structural and inevitable, until the next peasant rising or foreign invasion came along, when wealth would be redistributed and the cycle of extraction/coercion would start all over again. This is the attitude of the resigned preserver. I do not take up a stance here; I merely point out that an elementary mental experiment is enough to demonstrate that novelty is not so new and that old is not so safe. Is there anything else specific that still troubles us about biotechnologies and in particular genetic manipulation? It has been said that the results of genetic manipulation will spread on their own, escaping our control. We start by producing a mutated virus or a transgenic tomato and then our product escapes out into the environment. We are right to be disturbed, of course, and to ask whether enough precautions are being taken against known dangers; but any risk evaluation must also take into account the fact that biological technology is not the only thing that is escaping our control. Inanimate technology is also producing effects that are unpredictable in the long term. This is the result of technological innovation as a whole, not just and specifically of biological manipulation. As a matter of fact, we have already spread some decisive biological technologies in the environment, with unexpected effects. The first of these was the invention of agriculture. Is the technique of genetic recombination any more explosive than these? I very much doubt it. The opposite is probably the case: it is relatively more controllable and controlled than when rabbits and sheep were introduced to Australia. But should we not at least draw the line at modifying human genes, in other words ourselves? Should we scrupulously leave everything in this field to chance, which in this case we call nature? Cloning (whether human or animal) in itself actually goes in the opposite direction. The clone, as we know, is genetically (identical to) an individual produced naturally, unless the technique is combined with that of genetic recombination. Cloning itself, of course, could actually alter the human population's mechanism of reproduction, but that would call for a massive use of cloning as a means of reproduction, in which case the human race would introduce (artificially) a form of asexual reproduction (already a natural feature of various other species, either alone or combined with sexual reproduction). All of these problems are boiling together, in repugnant confusion, in the cauldron of commonly-held opinions about (human) cloning. This is what the explanatory report on the Draft Protocol has to say about human cloning at point 3: "Deliberately cloning humans is a threat to human identity, as it would give up the indispensable protection against the predetermination of the

The Future of Clones

223

human genetic constitution by a third party. Further ethical reasoning for a prohibition to clone human beings is based first and foremost on human dignity which is endangered by instrumentalisation through artificial human cloning. [...] As naturally occurring genetic recombination is likely to create more freedom for the human being than a predetermined genetic make up, it is in the interest of all persons to keep the essentially random nature of the composition of their own genes."7 To tell the truth, I find it hard to come up with any reasons why mentally sane human beings should want to reproduce themselves by cloning. But I also find it hard to understand the ethical reasons for all this hostility towards human cloning in general. One thing is certain: the above quotation presents no coherent and convincing arguments. What does the individual's freedom have to do with his genetic heritage? We know that there is a very vague relationship between a person's genetic heritage and his personality, but the latter depends far more directly on environmental and cultural influences. And even if that were not the case, is this supposed to mean that identical twins (or triplets or quads) are not free? Or is it supposed to mean that they feel less free? Is it then supposed to mean that children who share the same parents are less free than only children? And yet they certainly share a larger part of their genome than unrelated individuals do. So should we outlaw the family? The family and society's insistence that reproduction be the exclusive preserve of spouses signify a desire for the children of a family to share a biological similarity with each other and their parents: a far cry from being condemned by common morals.8 Perhaps fortunately (but this fact is entirely missed by common sense morality) the part of the genome that makes us different is insignificant with respect to the mass that is shared by all human beings. And the part that we share with all animals is only very slightly less. The whole argument makes no sense whatsoever. So let's look at the argument of the random character9 that the genetic choice is supposed to have. This is not senseless, but the problem is even more serious: it actually repeats word for word the reasoning behind Lester Del Rey's fictional Eleventh Commandment (Thou shalt go forth and multiply, at random). Let us suppose that the principle is valid (although 7

Additional Protocol to the Convention on Human Rights and Biomedicine on the Prohibition of Cloning Human Beings, Paris 12-1-1998. 8 In other words, it is an indisputable fact that biological uniformity obtained through human intervention is seen favourably by every social morality, provided this is done by traditional means. This moral attitude is not changed in the least by the fact that we now know that the common notion of the biological family is largely mistaken and misleading. It is not 'blood' that makes for similarities, but upbringing and a shared way of life. 9 This aspect is dealt with by Jacques Testart's paper.

224

Jori

the supposition does not imply agreement): nevertheless, it is valid for the Darwinian good of the species, not for individuals or their freedom or happiness. Then we have the reference to human dignity. We are all in favour of human dignity. As individuals, as citizens and as lawyers. It would be a sorry situation if we were not. And yet I cannot help feeling a fundamental sense of mistrust when I come across references to human dignity in an ethical reasoning: the argument is suspicious. It is usually used to shore up a tradition whose defence is otherwise untenable. Appealing to dignity is often the last resort when it has proved impossible to find any clear reason, any precise value, any defined subjective right that can be used to defend something that has always been the way it is. In the best of cases, human dignity means we have to bow to widespread strongly felt opinion. Just think of the frequently mentioned case of how corpses are dealt with and the removal of organs for transplanting. Don't misunderstand me: respecting widespread opinions is a reason that may well be valid in a moral argument, but then we should consider them for what they are and weigh them for what they might be worth against other principles and the ethical costs they may entail; we must evaluate them for their coherence with other moral attitudes. In reality, as we have seen, the strongest argument against human genetic engineering is the Darwinian one. Man cannot design himself because that would block all true innovation: man would design conservatively. Let's imagine the example of a super gorilla: if a gorilla were to design a super gorilla, he would never produce a man, but a bigger, stronger gorilla. We advance by strengthening what we already are, according to what we already know. But this is an argument whose ethics are highly incompatible with those that shore up the value of the individual and of individual freedoms. Lastly, let me close with a final comment about prudence. Do we not have a moral duty to be prudent about what we do not know about the effects that we do not control? As for global warming, so also for genetic engineering. I do not find the argument very convincing. Prudence is only tenable in conditions of relative knowledge, of relative knowledge of the risks involved and of guaranteed stability: it is not tenable when we really know nothing. A justified case of prudence is not crossing the road without looking, not because we don't know, but because we know a lot but not enough: we know that we can expect a vehicle, but we don't know when. But if we really did not know anything at all, would it make sense for us to stay motionless in a world that is changing beneath our very feet in any case? Maintaining the environment because of the risk of global warming exposes us to the risk of an ice age.

The Future of Clones

225

I cannot say right now whether or to what extent and on the basis of which ethics our genetic self-manipulation is a good or a bad thing. I can only say that the arguments I have mentioned are worthless and only indicate blind panic about innovation. In fact, they leave us at the mercy of what is for us the most fundamental of cycles, the one about which we know everything, but which, strangely enough, nobody mentions in these discussions. What am I talking about? Well, after a certain number of years of life, as things stand at present, all human beings die. As a risk, it is absolutely certain, well-known and catastrophic. If the argument of prudence holds, shouldn't we be running certain risks in order to make our lives last longer? Medicine is beginning to piece together the first notions about the mechanisms of ageing: even the newspapers tell us as much. As far as I can see, there is nothing very convincing about prudence, either. In conclusion, we should not be afraid of genetic manipulation and cloning only because the method is new. Which it certainly is in terms of the means, although as far as the principle is concerned, we have always practised manipulation of ourselves and of the world and we have always tried to influence the mechanisms of reproduction. What we have to do is study each case on its merits, to see whether the difference in the means leads to a different ethical or legal evaluation. Towards each case and what we know about it, we must maintain an ethically open and ethically critical attitude based on principles that enable us to adopt a moral stance vis-avis new methods. Which, in ethical terms, will not usually be as new as they seem. As for their effects, we have absolutely no idea what they will be. Will they make people happier? Better? We don't know. And in case of doubt, let's leave people free. Professor of Legal Philosophy, University of Milan, Italy

This page intentionally left blank

Cloning: Taboo Subject for Public Debate in France Dominique Mehl

No sooner had the news of Dolly's birth come through on the teleprinters on the desks of the journalists on duty that February morning, public opinion in France was overcome by an attack of panic. Although this probably did not reflect the opinion of the public at large (since their opinion was not asked), at any rate it was the reaction of the opinionleaders, the politicians. Thus, Tuesday 25 February 1997 French newspapers were full of declarations and condemnations, all going in the same direction: What has just happened in Scotland is inconceivable, unacceptable, intolerable! The issue is not worth discussing. The only suitable reaction is that of immediate prohibition. Philippe Vasseur, the Minister of Agriculture, declared: "... we shall erect the only barrier we have, the political barrier, the ethical barrier." Francois d'Aubert, Secretary of State for Research, went even further: "It is inconceivable that research projects should be undertaken to apply this cloning technique to the field of human reproduction." That same day Jean-Francois Mattei, one of the main authors of the French laws on bioethics, lashed out: "We must appeal to the authority of the United Nations to establish a world-wide regulation, the only measure capable of preventing disaster." Christine Boutine, a member of Parliament known for her relentless opposition to abortion and medically assisted reproduction, hurriedly submitted a bill calling for the urgent prohibition of cloning. The above are just a few drops taken from the ocean of incensed pronouncements, but they provide a good indication of the context within which the news was received in France. A front page merrily reading "Hello Dolly", the title The Economist put on its cover sometime in March 1997, a month after the birth of the clone, would have been unthinkable in France. At the time, the only debates that took place south of the Channel all revolved around who would come first in the race to outlaw the new technique. The only audible question was on the Chirac/Clinton competition: which of the two was going to act faster, and therefore prove braver?

227 CM. Mazzoni (ed), Ethics and Law in Biological Research, 227-231 © 2002 Kluwer Law International. Printed in Great Britain.

228

Mehl

Which of the two was going to prohibit first? Another question that succeeded in polarizing people's minds: was the law approved in 1994 sufficiently explicit to protect the French from human cloning? Since the law did not expressly use the term, although it did condemn and repudiate any form of manipulation on humans. The result was a hair-splitting analysis, a fine-tooth combing of the wording of the law, in which each term used was carefully weighed up, but in which a basic discussion on the principle of cloning was absent. In this context of virtuous indignation, devoid of any well-grounded argument, nobody in the French media bothered to ask the "other" party's opinion. Anyone who upholds human cloning can hardly be a reasonable human being. They must be either Americans, i.e. non-virtuous people, or mad ... or, even worse, mad Americans. The only voice that stood out amidst this chorus of condemnation during the first year of public debate on cloning was that of Robert Edwards: he expressed his opinions in a publication addressed only to a limited public, the bulletin of the CFDT trade union. No French newspaper took up the content of this article, although it could have stimulated a broader debate, going beyond the first knee-jerk reactions dictated by fear. It took several months before arguments in favour were illustrated to the French public. In fact, it was only thanks to scientists that the idea that a discussion was possible was first accepted. First, came the publication of the book by geneticist Axel Kahn:1 although declaring himself in favour of a ban, he did examine all the arguments in favour and against this new therapeutic and reproductive procedure. In September 1999 a book of essays by several authors,2 including an important contribution by biologist Henri Atlan, provided a highly articulated discussion of the issues, examining both scientific information and philosophical reflection. Jacques Testart's book,3 which was also published in the autumn of 1999, explained the arguments in favour: although the author condemned cloning, he did de-bunk some of the commonplace notions concerning identical reproduction. All these writings agreed, although based on different arguments, in rejecting the usage of this technique for reproduction purposes. But their opposition, their hostility was well argued and this at last allowed the French public to get an idea of the doubts, the uncertainties and the disagreements that accompany any bioethical controversy. They suggested differentiating between cloning for therapeutical purposes and cloning for Axel Kahn, Copies conformes, Nil, Paris 1998. Jacques Testart, Le clonage humain, Seuil, Paris 1999. Jacques Testart, Des hommes probables, Seuil, Paris 1999.

Cloning: Taboo Subject for Public Debate in France

229

reproduction purposes. They refuted the absolute notion of "entirely biological". They helped the reader examine the role and importance of our genetic heritage, of epigenesis, of environment, education and culture in the formation of an individual. They urged the public to approach the issue from the perspective of the individual's freedom and his role in relation to others. Thus, slowly, the thoughts of scientists replaced the words of the politicians and allowed us to progress from a discussion revolving around regulation and prohibition to one addressing the basic arguments. But civil society remained noticeably absent from this discussion. No significant opinion surveys were conducted. No mention of the non-expert opinions of patients or people undergoing medically reproduction procedures, or associations of national health service users. And, further, the opinion of French society in general on cloning remained sociologically unidentifiable. One might suggest, however, that for the time being it was fear that prevailed in the public. Fear of genetic manipulation, fear of de-humanizing procreation, fear polarised around the danger of eugenics. Ever since the first instances of medically assisted procreation and the development of prenatal diagnostics, the spectre of eugenics has haunted our consciences. Of course, our understanding of eugenics is primarily the result of the explanations and arguments provided by philosophers. The work of Pierre Andre Taguieff explained the history of this movement, born in the early 20th century within a hygienist context. His writings stressed the difference between a negative eugenics, aiming at eliminating diseases and handicaps, versus a positive eugenics whose goal is to intervene on the species. They highlighted the distinctions between eugenics as applied to somatic cells and eugenics involving germ-line cells. They underscored the difference between an individual eugenics without transmission to descendants, and a collective eugenics that could be codified in a state policy. Yet, despite all these explanations, eugenics remains - in French popular imagination and in the mind of politicians - purely synonymous with Nazi barbarism. Since then, eugenics only evokes destruction and murderous selection, elimination of undesirables. Eugenics is seen as the symbol of the concentration camps and the experiments of Doctor Mengele. And the mention of eugenics, in public debate in France, means condemnation out of hand. The use of the word "eugenics" equals anathema. Several factors can explain this peculiar characteristic of French public debate. Firstly, the decline of the idea of progress and the increasing mistrust towards science and its innovations. This increasing mistrust does not affect only human genetics and medically assisted procreation, but also nuclear

230

Mehl

energy, genetically modified organisms, information technology, medical experimentation ... But it is especially noticeable in the field of medical assistance to reproduction. The first "test-tube" babies were greeted in France as a sort of miracle, a scientific feat that could lead to progress in therapy. Finally, certain forms of sterility that medicine had not been able to defeat would be overcome. Hopeful parents, wanting children but thwarted by nature, would finally be able to satisfy their wishes, thus eliminating the suffering caused by sterility. As the techniques developed and improved, however, increasing reference was made to potential risks and "slippery slopes". Although only occurring very rarely, cases of postmortem or post-menopause conceptions became favourite topics and shook public opinion. Journalists hunted down cases of post-menopausal pregnant women in Italy, of parents choosing the baby's sex in England, of insemination provided to homosexual couples in Belgium, in order to stress the dangers inherent in these practices and their uncontrolled dissemination. The idea of therapeutical progress gradually faded and was replaced by an apocalyptic vision of scientists stopping at nothing. Secondly, the evolution of medical practice in the field of reproduction in France fitted into a cultural context characterized by the alliance between Catholicism and ecological movements. French Catholicism, even though the majority of French people are not regular church-goers, remains remarkably influential, especially among politicians. The hostility displayed by the most fundamentalist groups is echoed also by the more progressive elements in this field, and they all rally to the defence of the embryo from the first day of its conception. On the other side of the spectrum, ecology movements have developed a marked mistrust of genetic manipulation and embryo research in the name of the defence of nature. In the context of French politics, the alliance of these two currents of thought exerts a remarkable influence on bioethical debate. The embryo has become the hero of parliamentary circles. The respect of its integrity has become a leitmotiv of legislative debates. Parliament in the end outlawed embryo research; and the law approving pre-implant diagnostics was defeated in the Senate and was only saved at the eleventh hour by the Chamber of Deputies (and, in order to get it approved, a number of extremely restrictive limitations and conditions had to be included). The alliance of these two opinion movements has thus led to a provision that leaves no place at all for cloning, since any procedure affecting the embryo, even for diagnostic purposes, is illegal or quasi-illegal. A third factor can help us understand better why no heated debate ever took place in France on cloning. The laws passed in 1994 approved a lot of prohibitions: it's as though they had also prohibited discussion on the

Cloning: Taboo Subject for Public Debate in France

231

issues. Once the laws were passed, public controversy on bioethics died down. Although every day brings us something new in the field of scientific innovation or adds to the debate on reproduction practices and customs, our critical spirit seems to be asleep. Before the 1994 law there was a broadranging public debate, with a wide variety of ideas being proposed and upheld by a vast number of thinkers. Scientists, jurists, anthropologists, philosophers, theologians, journalists ... all took part in discussions where the prevailing elements were doubts, questions, cases of conscience. After the parliamentary debate all these voices were silenced and a form of unanimous consensus prevailed. It was as though the entire animated discussion that had accompanied the issue of medically assisted reproduction from the early 1980s to the mid-1990s no longer had any reason to exist. In this context, it's hardly surprising that a public debate on cloning failed to emerge. Why should one bother to discuss the issue since the law has already prohibited it? In actual fact, the law only fossilizes the situation. That's why the debate on medically assisted anti-sterility procedures evaded the issue of homosexual parenthood: it was already outlawed by the provisions on assisted reproduction and adoption. That's why the law on bioethics, which was supposed to be revised in 1999, has still not been included in Parliament's agenda, since it appears so dangerous to re-open the debate on the embryo and on anonymous donation of gametes. Ultimately, the status of the French public debate on bioethics illustrates clearly the prevalence of biopolitics, i.e. a reflection on laws and regulations, to the detriment of bioethics, an analysis of opposite convictions and shared doubts. Within this context, the hypothesis of human cloning awakened more nightmares than dreams, more instinctive defence mechanisms than clear thinking and imagination. Cloning remains unthinkable and to this day is a taboo subject in the bioethical debate in France. Sociologist, Ecole d'Etudes en Sciences Sociales, Paris, France

This page intentionally left blank

Nude Pigs and Headless Clones James Reston, Jr.

As I was preparing to come to Florence last fall, a number of articles had been appearing in the American press about events which seemed relevant to our conference. In the summer of 1999 an article in the New York Times carried the headline, "Human-Cow Hybrid Cells are Topic of Ethics Panel," and if one read down into the article, there was this paragraph, "The hybrid cow-human cells consist of the nucleus of a human cell inserted into a cow egg whose own nucleus has been removed. Factors in the cow egg are thought to make the human cell nucleus revert to its embryonic form." The general reader of this article might well conclude that if such research were not stopped, the new millennium will be populated not only by humans but by Minotaurs. In the week before the Florence conference, a major front-page article appeared on the tragic case in Philadelphia where an 18 year old boy died after receiving experimental gene therapy. Even though his rare liver disease was controlled adequately with traditional therapies, he was persuaded to volunteer for the radical gene therapy, after his parents had been assured of the safety of the procedure. Therein lies the poignancy of the desperately sick patient who is persuaded to endure experimental procedures. The Philadelphia case has become a major scandal in the United States. It has led to hearings before the U.S. Senate on the controls over gene therapy. The revelation of three more unreported deaths of a similar sort has deepened the scandal. Subsequently it emerged that the doctors had covered up some negative alarms about their procedures during testing on animals. The father of the dead boy subsequently testified before Congress that he was misled by the doctors about the benign nature of their treatment. The program has since been disbanded, but the scandal widens. Now we learn that more than a dozen other volunteers for gene therapy have been inadvertently infected with the AIDS virus. And so the general reader of this long and sad tale might reasonably conclude that there are many unscrupulous doctors lurking about, ready 233 C.M. Mazzoni (ed), Ethics and Law in Biological Research, 233-239 © 2002 Kluwer Law International. Printed in Great Britain.

234

Reston, Jr.

to experiment on any innocent, unsuspecting patient, either for fame, or more likely, for fortune. Beware of becoming a laboratory animal. Other articles, especially in the supermarket tabloids, were reporting the scheme of Hollywood super models to sell their eggs for invitro fertilization, or even conducting auctions for the highest bidder. The perverse dream is that perhaps such eggs might be matched with the sperm of a Nobel prize winning scientist (might he or she be a geneticist?), and from the petri dish would emerge the most brilliant, most beautiful human specimen ever decanted. Two weeks before the Florence conference an article appeared in the New York Times about a Massachusetts case in which a divorced couple were righting over the fate of their embryos which they had frozen before they became estranged. Who gets the eggs? Can they be used without both husband or wife agreeing? Or ... can they be destroyed without mutual consent. And so the general reader of this article might well conclude, to use Professor John Finnis's phrase in Florence, that "little people" reside in refrigerators all over America. On the political front, we Americans are having our debate about whether stem cell research can go forward unchecked or whether human cloning should be outlawed outright. In the United States Senate an act called "The Human Cloning Prohibition Act" has been proposed, but it would not make human cloning illegal, but merely prohibit government monies to be used in human cloning research and experimentation. President Bill Clinton has supported the prohibition on stem cell and human cloning research, but a Senator from Iowa, Tom Harkins, has argued in the Senate that no prohibition should exist in these areas. Such total freedom to experiment was celebrated by a scientist in Florence with the phrase that "it is morally legitimate to know all things." All scientific research, he argued, is by definition moral, since it is harnessed to the advance of knowledge. Senator Harkins likes to compare the advocates of scientific prohibitions on cloning to Pope Paul V, who in 1616 prosecuted Galileo for heresy after Galileo said the earth revolves around the sun. In Florence the Oxford don, John Finnis, shocked the conference when he predicted that a human being would be cloned within the next two years and that human cloning would be widely accepted in the West in the next ten years. Thus, the political debate which I mention above, seems unlikely to produce strict laws to stop this daunting eventuality. Judging from the gene therapy situation mentioned above, government oversight of experimental laboratory procedures has completely broken down anyway. Already a doctor in Chicago, Dr. Richard Seed, has announced that he will go forward with cloning a human being regardless of the restrictions.

Nude Pigs and Headless Clones

235

If he should succeed, he could become either a pariah or a visionary of science, or both in one lifetime, depending upon how society reacts. (This pariah-to-hero phenomenon took place within the span of only several years for the British doctors who succeeded in creating Louise Brown, the first in vitro fertilized baby. At their first professional conference after the artificial insemination, they were ostracized as pariahs, only to receive a standing ovation at the same conference two years later.) There are those who assert that no legal restrictions can ever stop such a process when huge fortunes stand to be made (just as huge fortunes were made from the cloning of the sheep, Dolly). As everyone knows, science is driven, if not by money, then by ego. If the general reader takes Dr. Finnis's prediction seriously, the countries of the West had better begin to prepare themselves for the cataclysm that will be the imminent announcement of the first human clone. (It was instructive to listen in Florence to the French sociologist, Dominique Mehl, speak of how France as a nation felt compelled to "protect" itself from the news of Dolly.) I've mentioned the general reader as if he were some sort of detached arm-chair couch potato, but actually, in this case, I am he. I was present at the Florence Conference ostensibly for two reasons. The second day of the Conference which I was asked to chair had the theme, "Cloning and the Popular Imagination." As a writer of popular books for a wide audience, I presumably could guide and contribute to the discussion of how this Brave New World of genetics and cloning might interest a popular audience. Additionally, as the parent of a severely handicapped child with renal and neurological disabilities, I'm a potential consumer of this bold new research, especially in the area of the mapping of the human genome and in the area of cloning and organ production. The mapping of the genome could once and for all provide a definitive diagnosis for our impaired daughter's rare condition and could present ethical questions about whether we are obliged to test our healthy children for potential difficulties. To move the discussion into the grotesque, should human beings ever be cloned, part of the motivation would be the cultivation of human organs for transplant. The potential consumer would face ethical questions from that Brave New World (the "Organ Store in the Sub-basement," as Aldous Huxley put it). It is daunting enough for a family to ponder the likelihood that the first breakthrough for living transplant might come from what is called a "nude pig," that is, an immunologically stripped pig called xenografts. What would we feel about transplanting a human kidney from a pig or a clone into our daughter? The subject of clones as slaves was discussed at the Florence conference, but not clones as raw meat.

236

Reston, Jr.

There can be no doubt that in the coming years genetic engineering and cloning will provide, if not raw meat, certainly raw material for a flood of novels and movies. To use the vernacular, genetics has become very "hot" in both New York and Hollywood. But it's well to return to that seminal work about genetic and social engineering, Aldous Huxley's Brave New World, and to remember what Aldous Huxley wrote in a foreword to the 1946 edition of his masterpiece. "A book about the future can interest us only if its prophecies look as though they might conceivably come true. ... In Brave New World this standardization of the human product has been pushed to fantastic, though not perhaps impossible extremes." Huxley's towering achievement lies in the prophetic quality of the work, seventy years later. The achievement is all the greater for the meager evidence in 1930 upon which the author focussed his imagination. In the 1946 foreword he states that, technically and ideologically, the world was a long way from bottled babies and groups of laboratory-created semi-morons. Suddenly, in the dawn of the new millennium, such a world does not seem all that far away at all. Indeed, the imminence of such a world accounts for this area being hot for the creative artist. The useful role of science fiction, at its best, lies in the ability of the creative artist to speculate on the ultimate consequences of current scientific processes. It is left to the imaginative seer to give us a picture of the fantastic but not impossible extreme. At our Florence conference the scientists and even the moral philosophers were reluctant to speak of controls and safeguards on genetic research and cloning experimentation. Thus, it seemed to me, the ground is ceded to the dramatist, with the specific intent to shock a wide, popular audience into its senses. And as the English writer, John Turney, remarked in Florence, "people will be influenced by fictions." In a sense the genre of film and books about biological engineering is already reasonably well developed. Over the years it has produced certain is recognizable character types. Mad scientist The mad and messianic and diabolical scientist with an obsession is perhaps our most recognizable stereotype. A good example is the film, "Boys from Brazil," where Gregory Peck plays Dr. Mengele, creating 94 little Hitlers from a vial of blood and a swatch of skin he took from Hitler in a "giddy moment" in 1943. Frankenstein The original Frankenstein book and movie provide us with two archetypes: the man of science "who creates a man in is own image, but did not reckon

Nude Pigs and Headless Clones

237

on God," as the opening to the Boris Karloff movie tells us and the monster that can emerge from laboratory experimentation with the chemistry of the human being. "Now I know what it feels like to be God," cries an exultant Dr. Frankenstein at bringing his creature alive before things go horribly wrong, and his monster nearly chokes him to death. Spurned scientist In the 1952 English film "Four Sided Triangle," cloning becomes the theme for a love conflict when two scientists fall in love with the same woman. The scientist who loses out clones a second paramour in his "reproducer." Clone and Drone In more recent times cloning becomes the stuff of comedy when in the film "Multiplicity" the lazy character of Michael Keaton creates a clone of himself to do all of his work. The scheme goes awry when Keaton's clone starts ogling Keaton's girlfriend. Silent virus In the novel, "Andromeda Strain," the horror of dormant, silent viruses emerging from the artificial manipulation of the human gene is the dramatic premise. Few would dispute the very real possibility that manipulation may unleash cells that mutate into unknown and uncontrollable malformations. Brave New World Updated In the brilliant Hollywood thriller, "Gallaca," we see a high tech modern world socially engineered with various emotionless classes of human product. In this film the recognizable hero of the passionate rebel who tries to beat the system, rides again. We see a baby emerge from the womb, a nurse pricking its finger for a drop of blood and dropping it into a machine which reads out a print-out: neurological probability, 60%; manic depression probability, 89% heart disorder probability, 99%; life expectancy, 30.2%. Such a possibility is scarcely fantastic or extreme. With the completion of the human genome mapping in two years, it is a distinct possibility, and very soon. From these stereotypes one can well imagine remakes and sequels and revisitations in the light of current events. Can a benign version of the mad scientist movie be far off which imagines Michael Jordan donating a vial of his blood and a swatch of his skin in a giddy moment in 2004 to produce 100 super athletes? Or a Frankenstein emerging from Dr. Seed's laboratory who gets away as the tough Chicago police roar up to arrest the clone's "father?" And think of the problems of disposing of the creature. It will not

238

Reston, Jr.

be as easy in the pro-life environment of America as incinerating the humanoid in a windmill. In our Florence conference Sarah Franklin told of the grotesque sheep like creatures that were the mistakes before the perfect Dolly came on the scene. Or now that we know Dolly experienced an unexplained, accelerated aging it's sure to occur to someone to take the premise of Oscar Wilde's Picture of Dorian Gray, produce a beautiful clone (perhaps the match of the super model and the geneticist) and then have it experience a human version of accelerated aging. Such a premise might also be used, dramatically, in the transplantation of animal organs into human bodies. At present scientists simply don't know what the long-term consequences of placing animal organs in human beings might be. It's left to the creative artist to speculate. And some of the language emerging from the animal-to-human transplant research is irresistible. A pig, immunologically stripped so that its organ will not be rejected in the human body, is known as a "nude pig." And to get over the abortion problem for a clone, work proceeds to create a clone without a brain (the brain being the definition of life). Such a creature is known as a "headless clone." "Nude pigs and headless clones". ... sounds like a good movie. Already some of the nomenclature of a new Brave New World has begun to affect our language. In Huxleyan terms President Bill Clinton is our Voice of Reason or Voice of Good Feeling. In the current political campaign we had a brief flirtation with the theme of whether Vice President Al Gore was trying to be an "Alpha male" like Clinton, when he was really a Beta male (family man rather than sexual predator). These are categories straight out of the social engineering of Brave New World. "Every centimeter of him was an alpha plus," one character remarks admiringly of a central character in Huxley's novel, and then later, we learn that it is the duty of the alpha male to be "infantile." This theme dropped out of the American political debate, after Prime Minister Tony Blair, a middle-aged man certainly, upstaged the American alphas with the announcement that his 42 year old wife was pregnant. To sum up, then, if scientists and moral philosophers insist on disavowing responsibility for imagining the end of current genetic and cloning research or denying any responsibility for imagining a master plan, if scientists insist that all science is moral by definition because it is simply the pursuit of pure knowledge, if moral philosophers insist that they are concerned only with current means not the ends of such scientific research, or if they assert, as one did in Florence, that the situation is simply too complicated morally to come up with a consensus since there are competing moral claims on both sides, then the ground is ceded to the creative artist. It will be the artist, not the scientist or philosopher, who will engage the general public in the debate over the end and the master plan.

Nude Pigs and Headless Clones

239

At the conference in Florence we heard a great deal from the scientist's or physician's viewpoint, but very little from the standpoint of the consumer or the client of this breathtaking new research. And yet the consumer needs to be heard from, especially in the initial application of this research to the human body. Very often, as in the case of the young man in Philadelphia, it will be the patient who will be taking enormous risk, not the doctor or the laboratory scientist. Wittingly or unwittingly, the patient becomes the laboratory animal. As the father of a severely handicapped child with both neurological and kidney impairment, I know very well the ambivalence of parents to whom new therapies are proposed when old therapies are inadequate. "We can always give your child another poison," a quite honest doctor once told us when normal medications were not working. But more often, it is what the recipients are not told that is the really poisonous and dangerous thing. In the week before I traveled to Florence, I asked my child's doctor whether medical research held out any hope for growing a kidney in the laboratory? This would, of course, be good news if true, for our current situation is to wait for someone else's child to expire, before our child can receive a kidney transplant. He said no - if it were a pancreas she needed, a laboratory produced pancreas might be imagined in the near future. But a kidney is too complicated an organ, with too many cells with different functions, ever to be produced artificially. Our immediate hope, he said, must be a xenograft, a nude pig. Fortunately, the problem is not cardiac, so we are not considering a baboon's heart. If a xenograft were possible, would we want it? I don't know. It's a moral dilemma. In the aftermath of the Florence session, an American professor spoke to me of how animal tissue, including pig's tissue, has long been used in human operation, and that in fact, his own mother had had such an operation. Still, with the use of cross-species transplantation becoming increasingly common in the years ahead, we are certainly facing a new creationism. Evolution by natural selection starts to sound like an arcane concept. Can the death of homo sapiens be far behind? The other opportunity, said my child's doctor, is human clones. Here one imagines a situation beyond Huxley's "organ store in the sub-basement." One imagines a human abattoir. There, headed and headless clones await their turn on the butcher table, for their sole purpose in life before death would be to furnish their organs to be "harvested," as the current phrase goes, for transplantation into the more valuable members of the new society. Writer and journalist, Chevy Chase, Maryland, USA

This page intentionally left blank

Dolly and deja vu: Facts and Fictions about Human Cloning Jon Turney

A range of feelings were expressed when news of Dolly's birth broke, though surprise and foreboding were most prominent. But to any long-time observer of debates about experimental biology there was probably another feeling stronger than these: deja vu. This feeling - that, somehow we have heard this before - tells us some interesting things about how we debate such technologies. There is both a compulsion to speculate about ultimate possibilities and, at the same time, a reluctance to engage with specifics. Again and again, a few archetypes, and a handful of stories, have been used to stand for a large set of technological possibilities. And, in this century, a particular technique tends to stand for the prospect of a wholesale biological revolution. For some years it was the possibility of in vitro fertilisation; the baby in the bottle. Now that "testtube" baby technology, in at least some of its variants, is accepted medical practice in many countries, cloning appears to have taken its place. It symbolises a whole complex of developments in the biosciences, and acts as a lightning rod for anxieties about their human consequences. The evidence for this comes partly from the way we often frame discussion of these technologies. Many commentators, bioethicists as well as journalists, use a small set of stories to evoke images of their possible effects on human lives. In many of these debates, from discussion of in vitro fertilisation and recombinant DNA to genetically engineered food and cloning, the most prominent "script" is a somewhat reduced version of Mary Shelley's Frankenstein. That novel has the quality of a modern myth because of its almost uncountable re-tellings. If we want to talk about that rather elusive abstraction the popular imagination we have to decide whether some stories are more important somehow than others: and Frankenstein is because it has that mythic quality. The story has a number of elements which help account for its enduring influence in framing reactions to modern science and 241 CM. Mazzoni (ed), Ethics and Law in Biological Research, 241-252 © 2002 Kluwer Law International. Printed in Great Britain.

242

Turney

technology, and especially to biological technologies. One is an ambivalence toward knowledge: an often-remarked part of the Western tradition. Ambivalence is a key term for our attitude to all of these technologies. We both desire and fear the sorts of things these technologies can deliver. And the idea of creating life stands for what we desire and fear most. That idea has stimulated a whole tradition of Frankensteinian storytelling over the last 200 years. "It's alive!" exults the near hysterical scientist at the climax of the creation scene in James Whale's 1931 film version of Frankenstein. And we know that his success, bringing to life a body of his own design, is the beginning of his downfall. Whale's is probably the most memorable of hundreds of such scenes, in plays, books, and comics, in cinema and television productions, which have repeated the basic elements of Mary Shelley's classic tale. What the author called her "hideous progeny" has been transformed from a minor novel into a full-blown cultural myth. Today, references to the story seem more numerous than ever. The more successful we become in turning life science into technology, the sharper grows our ambivalence. Frankenstein frames and gives shape to that ambivalence in ways we seem unable to do without. When we consider the progress of twentieth century biology we see great triumphs. Yet we fear that the triumph will turn sour. We recognise that there may be great benefits, but also see less well-defined threats in biological technology's ability to break down old boundaries, and dissolve taken-for-granted categories. There is something profoundly unsettling here, something which has always been implicit in the Baconian project for science which becomes ever less appealing the closer we come to achieving it. In fact, biology's dizzy onward rush from potential to real technology, its final subordination of the natural world to technique, brings to a new pitch tensions which have existed since the beginning of modern science. Geneticists today commonly ascribe this to an "anti-science" movement, even though opinion polls consistently fail to find evidence of any such thing. This response, also, is part of the reluctance to engage with specifics, with objections to particular scientific developments. It neglects to ask why an increase in manipulative power in the life sciences might provoke public disquiet. As we try and foster debate about the development and control of the technologies now coming on stream from academic and industrial bioscience laboratories, we must try to find a more satisfying account of the images shaping that debate than the assertion that it stems from "genetic pornography", to quote my University of London colleague and former chairman of the British Committee on Public Understanding of Science Lewis Wolpert.

Dolly and deja vu: Facts and Fictions about Human Cloning

243

To explain the endurance of Frankenstein, a good first move is to try to isolate what has survived in all the renderings of the myth since 1818. The story, for all its familiarity, is still a frightening one. It is frightening because it depicts a human enterprise which is out of control, and which turns on its creator. So much carries over from the earlier myths about the getting of knowledge. But Frankenstein is about science. What is more, the science is pursued, if not always with the best of intentions, then for motives which we can readily identify with. In the most striking re-tellings, the myth is never a straightforward anti-science story. There is something admirable about Victor Frankenstein in the novel, about "Henry" Frankenstein in James Whale's film, even about Peter Cushing's ruthless Baron Frankenstein in Hammer's sequence of films, and certainly about Kenneth Branagh's fresh-faced idealist in his misleadingly titled Mary Shelley's Frankenstein. Even so, our sympathies are always torn between Frankenstein and his monster. The Frankenstein script, in its most salient forms, incorporates an ambivalence about science, method and motive, which is never resolved. The retention of science in all the later derivatives of the story is the most striking feature of the myth. In the original text the creation of the monster is accomplished in a scant thirty pages. The scientific details are few. After the "brilliant light" of Victor's idea dawns we never learn more than how he eventually "collected the instruments of life around me, that I might infuse a spark of life into the lifeless thing that lay at my feet". Yet those first thirty pages supply the seeds of almost all of the images derived from Frankenstein which appear in so many variations in later stories about science and scientists. They include models for the scientist whose good intentions blind him to the true nature of his enterprise; "wealth was an inferior object; but what glory would attend the discovery if I could banish disease from the human frame and render man invulnerable to any but a violent death!", Victor proclaims. And so say all of us mortal readers. But Victor also personifies the scientist as Faustian knowledge seeker; "the world was to me a secret which I desired to divine", he remembers, and recalls that "none but those who have experienced them can conceive of the enticements of science"; or, as a narrow materialist, "On my education my father had taken the greatest precautions that my mind should be impressed with no supernatural horrors ... a churchyard was to me merely the receptacle of bodies deprived of life." There are also hints that science has some drive of its own, external to the will of the scientist, and eventually overwhelming him. "Natural philosophy", Victor reflects sadly, "is the genius that has regulated my fate". Amidst all the simplifications, deletions and re-elaborations of the original

244

Turney

which have occurred, the identification of Victor as a scientist remains. It is science which gives him his success, and that success gives him power over life. Even though his character was first drawn before biology was a separate discipline, Frankenstein is always a proto-biologist. So the endurance of the myth testifies to a deep disquiet about scientific discovery in general, and the science of life in particular. And it is a disquiet which Mary Shelley tapped into at a remarkably early stage in the development of modern life science. In fact, what we now call biomedical science, and the possibility of a technologically effective biology, have always been important in shaping the modern attitude to science. We have always been prisoners of the body, victims of morbidity and mortality, and we desire the power which biology might give us to relieve these burdens. This is easy to establish more recently. Medical and biological stories have long accounted for a large proportion of the press reporting of science, for example. Turn the pages of a major newspaper from the early years of this century, the San Francisco Chronicle, say, and you will find front page stories on radical new surgical procedures, on the possibility of choosing the sex of a baby, on proposed scientific techniques for prolonging life, and on putative cures for cancer. These stories show the early convergence between news-values and the territory of biomedicine. Biological research and medical practice mean birth, sex and death; suffering, disease and disability. Mary Shelley's earlier achievement was to unite these concerns with the Faust myth to create something new. Goethe's contemporaneous Faust, for example, is preoccupied with operating on the world, with physical and social transformation. Man will be transformed in Goethe's new world, but only through all the other changes Faust brings about. Frankenstein, on the other hand, is set on transforming humans directly. If he can discover the secret of life, then he can father a new species. To do so, he will experiment directly on the body. Here, Mary Shelley intuited the power of a threat which would come to seem graver as time went by. In a world where industrial and technological change was already apparent, there was one sphere of existence which was exempt. The natural world, although it could be reshaped by physical onslaught on the landscape, although it could be despoiled or laid waste, was not yet open to technological manipulation. The forms and varieties of creatures, the hierarchy of species, the biological imperatives of existence, were fixed points in an ever-changing world. The human body, too, provided an unchanging ground for experience of other changes. This does not mean, of course, that experience of the body, or ideas about its constitution, did not change. But the body itself was not

Dolly and deja vu: Facts and Fictions about Human Cloning

245

seen as changing by those experiencing the first rush of modernity. While the dead body had been anatomised for two centuries, in pursuit of a science of the interior which had made a deep impression on Renaissance and early modern culture, that science was still largely descriptive. The still living body was not yet subject to science's probings. But Mary Shelley made the necessary imaginative leap, and fashioned an image of a science working on the body to transform it. Striving to create a story to "awaken thrilling horror", she understood that the best horror story would be rooted in power over the body. Frankenstein focussed attention on that prospect at the beginning of the modern era. We still feel the pull of the story because that power is now ours for the asking. The Frankenstein myth, then, cuts to the heart of the Enlightenment project. And now we have lost faith in improving people through social means, we are left with a paradox. The perfectibility of man through technological means still appeals because we abhor the frail, mortal frame that we have. But we can only achieve perfection by putting the powers to do so in the hands of people as they now exist, imperfect as we know them to be. This is the most powerful generator of our ambivalence. I am arguing that the Frankenstein motif is one general reason for deja vu in relation to cloning. There are more specific reasons when we look at individual episodes of debate about recent biological technologies. There are particularly striking parallels with the history of in-vitro fertilization, as other contributors to this book also emphasise. Both were prefigured in literature. Indeed, the baby in the bottle is a twentieth-century icon, as Susan Squier has explored in detail. This tells us that the separation some would make between the imaginative realm and the scientific or the legal and ethical realm is unconvincing. There's a two-way street here: scientists are both influenced by and influence the popular image of what might be possible with technology. There was a similar build up for IVF and cloning, if you like. It was known that Edwards and Steptoe were hoping to achieve gestation after in-vitro fertilization in 1969 when they published micrographs of a fertilized egg in a Petri dish and there was ten years labour for them before Louise Brown's birth. Many of the arguments for and against IVF, especially those against, were pretty much the ones we hear now. To give just one example, the arguments which Leon Kass, the American bioethicist, advanced against in-vitro fertilization were essentially identical to the ones he now advances against human cloning: One can't ethically get to know how to do this; it's another step on the inevitable road toward the industrialization of reproduction and devaluing of the human subject. In The Ethics of Human Cloning Kass poses anew a choice he has been urging upon us for 20 years now, "whether it is a good thing, humanly

246

Turney

speaking, to say yes in principle to the road that leads (at best) to the dehumanized rationality of Brave New World". A third level of deja-vu is from the history of cloning itself. This is not just because of Aldous Huxley, even though Brave New World looms almost as large in these debates as Frankenstein. The singificance of artificial creation married with mass production has been cited many times. There are numerous examples in non-fictional commentaries on biology, at least since the late 1950's. The French biologist Jean Rostand, for example, in his book titled in English Can Man Be Modified? makes the possibility of human clones one of his major exhibits in a book which prefigures the biological revolution as it became a popular notion in the 1960's. Gordon Rattray Taylor's better known The Biological Time Bomb, from the late 1960s, is largely a rehash of Rostand. Then there was the moral panic which attended the publication of David Rorvik's 1978 book In His Image, which purported to be a non-fictional account of the first human clone. Rorvik, a US science journalist, claimed he had assisted in the cloning of a human being. He presented his story as fact, and provided extensive references to back up his claim that such a feat was possible. The claim was strongly denied by scientists, most notably by the British biologist Derek Bromhall, who was angry that his own work had been cited, and provided a convincing demolition of the scientific credibility of the story.1 Bromhall also accused Rorvik of presenting fiction as fact out of greed, glossing over his own claim about his motives in his epilogue where he expressed the hope that: "many readers will be persuaded of the possibility, perhaps even the probability of what I have described and benefit by this 'preview' of an astonishing development whose time ... has apparently not yet quite come. And if this book, for whatever reason, increases public interest and participation in decisions related to genetic engineering then I will be more than rewarded for my efforts".2

Here, Rorvik seemed to admit that the book was an attempt to exploit the difficulties scientists have in responding to claims like his. By deliberately blurring the boundary between fact and fiction, he hoped to provoke public discussion. In that he succeeded, aided considerably by the welter of scientific denunciation. Although the book was condemned as a literary confidence trick, it was widely read. What was, in truth, a badly written novel, with copious discussion of bioethics culled from the academic literature, became a literary guild selection, and the US paperback rights were sold for a quarter of a million dollars.3 1

Bromhall, D.( 1978). Rorvik, D. (1978), p. 181. 3 Easton, A. (1978). This review, in a science-fiction journal, concluded that Rorvik deserved "far more praise than blame" for making bioethics "accessible". 2

Dolly and dejd vu: Facts and Fictions about Human Cloning

247

For a final example, consider the episode where cloning was reported on the front page of the New York Times by Gina Kolata and made the covers of Time and Newsweek, among an enormous volume of other comment and condemnation. I am referring not to the birth of 'Dolly' but to 1993 when Gerry Hall and Robert Stillman achieved embryo splitting and announced it as "cloning". They then professed themselves amazed by the strength of the global response. And the treatment then in Time and Newsweek was again identical in almost every respect to what appeared after the birth of 'Dolly' in terms of the issues raised, the fictions cited, even the bio-ethicists quoted. Both also commented on the amount of prior discussion of cloning in fiction. Under the heading "Clone Hype", Newsweek's main report made continual references to both Rorvik's book and to stories about cloned dinosaurs and multiple Hitlers to stress what the work was not about. Time took a very similar line, while emphasising that the work had stirred a world-wide sensation, and that 77 per cent of Americans polled that week wanted to see such research either temporarily halted or banned outright. Their reporter observed that the actual research reported "seems, in many ways, unworthy of the hoopla".4 And the magazine made a point of showing how many of the bio-ethicists who contributed comment to the wider press coverage of the story were offering scenarios which went well-beyond existing technology. This suggestion was underlined with a separate article on "Cloning Classics", summarising fictions about the subject from Brave New World to Fay Weldon's novel The Cloning of Joanna May. The article opened with the observation that; "When it comes to dealing with cloning, ethicists and science-fiction writers have almost identical job descriptions". So what should we conclude from these several varieties of deja vu? Perhaps we should see cloning as the most visible symbol for our general anxieties about where bio-technologies might lead. IVF once filled that position, and was opposed by many. But when they are presented with the result, a large section of the public were beguiled by the ubiquitous images of the beautiful baby conceived through IVF. We might see that course recapitulated. We certainly already have something rather reminiscent of the government hesitation which characterised the handling of IVF regulation in Britain. It took many years after the birth of Louise Brown in the UK for the goverment to reach a position where it felt able to decide how to regulate this technology. Similar things seem to be happening with cloning. An official public consultation in 1998 produced a result - a recommendation from the committees who had been consulting, which Elmer-Dewitt, P. (1993). The Newsweek report is Adler, J. (1993). Both were cover stories.

248

Turney

went to ministers. But the ministerial response was to defer any decision until after yet another round of consultation. At the time of writing, a successor committee is still deliberating. So there is a familiar degree of non-decision making going on around the subject in the UK. But there are also grounds for supposing that history need not repeat itself. Some of the features of IVF which made it easy to naturalize won't be so easy to reproduce for the first human clone - even though the world will not look dramatically different the day after the first human clone is born. The first test-tube baby was represented as a nuclear family fulfilling itself. As one French headline put it it was: 'Victoire de la Science': 'Victoire de 1'Amour'. It was represented as simply a normal, heterosexual married couple being enabled to produce a child with some special technical assistence. Since then, IVF has been represented in the media as almost an unbroken series of success stories, punctuated by occasional moral panics over transgression of boundaries of age, race, or sexual orientation. Cloning might go the same way. But it might remain as a symbol of a step too far. Some of the issues it poses, and which are being explored in fiction, are older than Frankenstein. There are already more and more diverse stories about human cloning - around questions of identity, doubling, sexual threat and so forth - than there ever were about IVF. And those issues do seem to trouble people more than the mere fact of assisted conception, perhaps accounting for scientists impulse to insist that human cloning was always going to remain science fiction. This is one reason why the most recent episode in the cloning saga evoked a longer-running debate. The paradoxical result in Dolly's case was that she was the realisation of an idea which had been discussed for more than half a century, yet her advent in the flesh was treated as an enormous surprise. Newsweek suggested that: "Twenty years ago, when only the lowly tadpole had been cloned, bioethicists raised the possibility that scientists might some day advance the technology to include human beings as well. They wanted the issue discussed. But scientists assailed the moralists' concerns as alarmist. Let the research go forward, the scientists argued, because cloning human beings would serve no discernible scientific purpose. Now the cloning of humans is within reach, and society as a whole is caught with its ethical pants down."5

If so, it was not for want of trying on the part of some commentators. But this time, although there were still respectable arguments why human cloning was unlikely ever to be possible - which some scientists were quick to point out - there was a widely shared determination that the possibility should be considered seriously. Those who responded to Dolly, from Woodward, K. (1997).

Dolly and dejd vu: Facts and Fictions about Human Cloning

249

President Clinton with his call for a report "within 90 days" from his advisers, on down wanted to understand more clearly what human cloning might mean. Although it was widely recognised that cloning was still mainly a symbol for a broader set of technologies, that there were important issues around the industrial use of animals connected with Dolly's future as a drug incubator, and that cloned humans would most probably not be identical to their genetic forebears, it was the prospect of an end to biological individuality which really caught media audiences' attention. And fictional scenarios abounded as writers tried to help readers think through the possible implications. Time magazine, for example, which like Newsweek again made cloning its cover story, ran a four-page article on future ethical problems built around a series of tableaux from a hospital cloning laboratory of the future.6 To top that, it rounded off its special report on Dolly with a tongue-in-cheek science fiction story by Douglas Copeland.7 The magazine seemed to be taking seriously its suggestion in 1993 that ethicists and science fiction writers had similar jobs. This seems to suggest that creating fictions about the possible outcomes of applying biological technology to people is a legitimate contribution to debate. Both literary creation and scenario-spinning by bio-ethicists are ways of alerting society to possibilities which merit discussion before they are realised - certainly a view writers tend to share. Scientists, though, are not so sure. They may argue that the public are unable to distinguish fact from fiction. Non-scientists, it is suggested, interpret metaphorical warnings literally. Writers must therefore take responsibility for portraying wellintentioned science in a negative light. Commenting on films in the Frankenstein tradition, the distinguished British geneticist Paul Nurse suggests that "the real dilemma comes when the freedom of the artist to produce what they like has to be combined with the fact that these productions are taken by the public to be an absolutely true portrayal of science".8 His British colleague Ruth McKernan agreed that "the line between science fantasy as entertainment and science fact needs to be drawn more clearly".9 This kind of assertion radically oversimplifies the relations between media and audiences, fact and fiction, and the range of stories available at any one time. "Factual" stories are always framed in some way which is intended as a guide to interpretation - one reason for the journalistic invocations of 6

Kluger, I (1997). Copeland, D.( 1997). 8 In a public debate in London on 23 March 1995 under the banner: Monster Myths Are writers demonising the new genetics?. 9 McKernan, R.( 1995). 7

250

Turney

Frankenstein or Brave New World. But that does not mean that the suggestion that some piece of science is "like" Frankenstein's project or "reminiscent" of Brave New World is taken literally. Both literary criticism and media studies demand that we take a more sophisticated view of what goes on when diverse audiences assimilate a complex set of messages about science. From contemporary media studies, in particular, we learn that readers, viewers or listeners work actively to construct interpretations of media messages -just as they did in Mary Shelley's time. They are no more likely to simply imbibe the typical message of straight science reporting, characterised by Dorothy Nelkin as "selling science",10 than they are to leave Kenneth Branagh's film clamouring for all the laboratories to be closed down.11 There are always contending interpretations available, if not within a particular text then from other parts of the media landscape, or from the individual context of consumption. Denying this is itself part of the contest over interpretation. As this contest proceeds, various fictions seems to be playing a larger and larger part in discussion of cloning. This is partly a matter of popular reference. When researchers at Britain's Wellcome trust carried out a qualitative study investigating what people thought about cloning in 1998, Huxley's classic was one of the first things which came to mind - along with Frankenstein., Blade Runner and Invasion of the Bodysnatchers. Aside from these, as I have said, the idea of creating genetically identical humans has long been a favourite notion of novelists contemplating biological futures. Aside from Huxley's landmark story, other mainstream novels such as Ira Levin's The Boys from Brazil and Fay Weldon's The Cloning of Joanna May have shaped images of cloning. Levin's fancy that a group of Nazi fanatics might try and clone Hitler, taking care to make sure that his environment as well as his genes were like the Fuehrer's, parodies the project of building the master race and taps into some of our deepest fears about what biology might do. So in a different way does Weldon's tale, in which Joanna discovers she has been cloned by her estranged husband. Like Michael Crichton's racy Jurassic Park with its cloned dinosaurs, both were filmed, Levin's story in Hollywood, Weldon's by the BBC. Both are still highly readable. Weldon, incidentally, is not especially opposed to cloning on the evidence of this dark tale. The message of her novel, repeated a number of times, is that life is so awful that nothing scientists can do could possibly make it worse. 10 11

Nelkin, D. (1986). See also Einseidel, E. (1992). McLeod, J., G. Kosicki and P. Zhingdang (1991). Moores, S. (1993).

Dolly and deja vu: Facts and Fictions about Human Cloning

251

There are a range of other, less well known stories about cloning from science fiction authors, as has been emphasised by Jose van Dijk. Early examples include Kate Wilhelm's Where Late the Sweet Birds Sang or Pamela Sargent's Cloned Lives. Van Dijk highlights other authors, including Octavia Butler, Nancy Freedman and Amy Thompson, all of whom have produced stories in which doing is not necessarily a bad thing. She feels that they should be more widely read, to help correct what she terms an "imagination deficit" in our discussion of cloning. You can see what she means when you observe how much of the bioethicists commentary is still drawing on Huxley. Aside from Leon Kass, we now find the Christian fundamentalist Lane Lester suggesting that cloning signifies that Brave New World is "becoming reality". On the other hand, bioethicist Gregory Pearce, who wants to argue that human cloning is basically OK, suggests that Huxley has been misunderstood. Brave New World was mostly about behavioural conditioning and drugs, and in any case the bad things about Huxley's imagined society were tied up with loss of reproductive choice. Allowing cloning, says Pearce, would enhance reproductive choice, so Huxley is irrelevant. There are more creative uses of fiction than this, though. Princeton geneticist Lee Silver's Remaking Eden, for instance, starts with a "glimpse of things to come" which reads as if it comes straight out of a (rather weak) science fiction novel. There follows a fairly racy popular account of the science and policy issues of cloning and reproductive biology which includes lots of scenarios built around particular fictional individuals. There are "Jennifer and Rachel", for example, a mother and her clone in 2049, or "Alice" - a virtual child created on computer to help a couple at some unspecified date select their ideal genotype. And Silver's book, which suggests that all these developments are inevitable, finishes with an even grander story which imagines the evolution of humanity into separate, artificially created, species. Here, he writes very much in the vein of earlier science fiction authors like H.G. Wells, or perhaps Olaf Stapledon in Last and First Men. Also keen on fiction are Martha Nussbaum and Cass Sunstein, editors of the eclectic collection of essays Clones and Clones. This book, edited by a philosopher and a legal scholar, includes a range of commentaries scientific, philosophical, and ethical, as well as a chapter analysing myths and stories about clones, twins and doubling. But it finishes with a small section of new fictions. Unlike Silver's book, they are kept separate from the rest, but they are clearly seriously meant: they are "stories to think with", if you like. Together, all these stories suggest both that cloning will continue to loom large in the popular imagination, and that fiction will play a large part in shaping our image of future technological possibilities. Professor of Sociology, University College London, UK

252

Turney

BIBLIOGRAPHY Kaplan, E. Ann and Susan Squier (eds), Playing Dolly: Technocultural Formations, Fantasies and Fictions of Assisted Reproduction, Rutgers University Press 1999. Kass, Leon and James Wilson, The Ethics of Human Cloning, American Entrerprise Institute 1998. Kass, Leon, Making Babies: the new biology and the 'old' morality, in "Public Interests" 1972, 26, p. 18. Lane, Lester and James Hefley, Human Cloning: Playing God or Scientific Progress? Fleming Revell 1998. Levin, Ira, The Boys from Brazil, numerous editions 1996. Nussbaum, Martha and Cass Sunstein (eds), Clones and Clones: Facts and Fantasies about Human Cloning, Norton 1998. Pence, Gregory, Who's Afraid of Human Cloning?, Rowman and Littlefield 1998. Rorvik, David, In His Image: The Cloning of a Man, Hamish Hamilton 1978. Rostand, Jean, Can Man be Modified?, trans J. Griffin, Seeker and Warburg 1959. Silver, Lee, Remaking Eden: Cloning and Beyond in a Brave New World, Weidenfeld 1998. Squier, Susan, Babies in Bottles: Twentieth-Century Visions of Reproductive Technology, Rutgers University Press 1994. Taylor, Gordon, The Biological Time Bomb, Thames and Hudson 1968. Turney, Jon, Frankenstein's Footsteps: Science, genetics and popular culture, Yale University Press 1998. Turney, Jon, Sulle tracce di Frankenstein: Scienza, genetica e cultura popolare, Edizioni di Comunita 2000. Van Dijk, Jose, Cloning Humans, cloning literature: genetics and the imagination deficit, in "New Genetics and Society" 1999, Vol. 18, n. 1, pp. 9-22. Weldon, Fay, The Cloning of Joanna May, Fontana 1990. Trust Wellcome, Public Perceptions of Human Cloning, in "Wellcome Trust" 1999. www.wellcome.ac.uk/publications.

Index

abortion 44, 119 abortion tours 156 actual compensation 10 adlinguisticity 69 adult human cloning 107-14 Affymetrix 23 age fallacy 147 age of technical reproduction 6 AIDS virus 233 Alien IV. The Resurrection 199 Alpha males 238 Alzheimer disease 29 The Andromeda Strain 237 animal cloning 29-30, 63, 122, 126-7 animal dignity 44, 70 anti-science movements 57-8, 242 a-1-antitripsine 30 anxiety 68, 73 Arendt, Hannah 200 Aristotle 152 Arnason, V. 182-3 Ars Conjectandi 180 asexual reproduction see cloning assisted fertilization 47, 62 Athena 199 Allan, Henri 228 'attitude of the resigned preserver' 221-2 d'Aubert, Francois 227 authoritarian use of law 155 autonomy 192 legal/scientific dichotomy 7 patients 41 right 40 autosomal recessive disease-genes 135 The Belmont Report 48-9 Benda, E. 40-1 Benjamin, Walter 6 Bernard, C. 175, 179-80 Bernoulli, Johann 180-1 'best interest of the child' principle 'Beta males' 238

131, 133

biodiversity 29-30, 68, 144-5 bioinformatics 24 biological patents 82-3 The Biological Time Bomb 246 biotechnology 6, 26, 35-44 birth control 117 black-box decisions 89 Blade Runner 250 body part cloning 18, 63 Borders of Infinity 214 Boutine, Christine 227 Boyle, Joseph 101 The Boys from Brazil 197-8,236,250 brain death, New Jersey Statute 96 Brave New World 107-14, 213-14, 235-6, 246, 251 Bromhall, Derek 246 Brothers in Arms 217 Bujold, Lois McMaster 214, 217 burden of proof 89 Can Man Be Modified? 246 cancer 28, 138 case history models 50-3 Catholicism 146,230 see also religious issues cDNA 23 Celera Genomics 21 Christianity 42-3 see also religious issues A Civil Campaign 217 civil liberties 13 see also freedoms; rights Clonaid 136 Clones and Clones 251 cloning adults 107-14 animals 29-30, 63, 122, 126-7 arguments against 141-52 biological aspects 99-192 body parts 18, 63 embryos 99-108, 115-24

253

254 homologous 148-9 manipulated 137 moral aspects 99-192 perspective views 5-7 popular view 195-225 primates 122 reproduction 100, 104, 125-33 therapeutic 100-3, 137-9 see also Dolly the sheep; human cloning Cloning issues and reproduction: science and medicine report 208 The Cloning of Joanna May 247, 250 Code of Federal Regulation 48 collective learning 92-6 common enterprise of economic collaboration 14 common goods and burdens 12 common morality 57-65 communication systems 68 comparative genomics 24 compensation 10 computerized tomography 174 conscientious objection 95 consent option 19, 41, 90-1, 165, 192 constructivism 88-9 contingency 71 cooperation model 182-3 corrective justice 11 costs, sequencing analysis 22 Cratylus 196-7 Crichton, Michael 250 damage evaluation principle 131 data protection 38 databases 24, 163-72 death 5, 44, 96 decisions 67-74 Declaration of Helsinki 48, 102 deCode genetics firm 163-72 deja vu 241, 245, 247 Del Key, Lester 215 democratic participation 4, 13, 86 see also public participation designer babies 16-17 diabetes 138 diagnostic conformity 51 diagnostic procedures 175 difference principle 13 dignity 160, 224 biotechnological effects 70 identity relationship 158 legal issues 154 protection 47, 128 regulative instrument 35-45

Index vague concept 77 Dionysos 199 distinctive features 72 distributive justice 11-14 division of labor 14 DNA 174 human genome project 21-9 Dolly the sheep 6-7 biodiversity threat 29-30 deja vu 241 French reactions 227 media presentation 248-9 methods concern 127 public awareness 4 public perceptions 195, 197 viability 203-5 see also sheep Doppelgangers 195-202 droit saisi par la biologie 154-5 Drosophila 24 Dworkin, Ronald 210 ecology aspects 67, 69, 144-5, 230 economics 13-14, 60, 184-5 Eco, Umberto 144 ECs see Ethics Committees education 24-5 Edwards, R.G. 99-100, 106, 228 eidolons 195-6 Einsteinian physics 173 electromagnetic pollution 88 Eleventh Commandment 215, 219 Embryo Protection Act, Germany 37, 39-40 embryos cloning 99-106, 115-24 freezing 234 legislation 37, 39-40, 133 research 36-7 screening 15 splitting 247 emphysema 30 Entparadoxierungen 73 epidemiology 176-9 epistemic state 79-96 equality, legal 13, 19, 145-6, 159 Essai Philosophique sur les probabilites 180 'essence' of man 40-1 Ethics Committees (ECs) 49-56 The Ethics of Human Cloning 245-6 eugenics 64, 118-24, 170, 229 Euripides 196 European Convention on Human Rights and Biomedicine 36, 40, 55, 80 Additional Protocol 1998 153-4, 156-7

Index European Directive on the Legal Protection of Biotechnological Inventions 40, 125 European Regulations, food labelling 87 evolution 22, 27, 68 experimental methods 175 expert decisions 90-2 extreme epistemological anarchism 86, 88-9 fairness 70 family principle 147-51 Faust 244 fear factor 229 fertilization, assisted 47, 62 fiction 107-14, 195-202, 213-25, 236-8, 241-52 Finnis, John 234-5 Fisher, R.A. 176 forecasts 83-4 forensic medicine 47 Foucault, M. 183 The Four Sided Triangle 237 Framingham Trial 177 France 123,227-31 Frankenstein 236-7, 241-6, 250 freedoms chance in genetics 67-8 research 4, 47, 168 science 7, 59 freezing embryos 234 functional genomics 23-4 fundamental principles 50 fundamental social goods 12 fundamentalism 50 future of clones 213-25 Galileo 234 Gallon, Francis 118 gametogenesis 118 Gattaca 237 gene analysis 38-9 gene repair 114 gene stripping 23 Genealogie der Moral 69 geneticists' responsibility 26-31 genetic engineering 107-15 genetic identity 158 genetic pornography 242 genetically modified foods 87 genetics 26-31, 67-8, 71-4 capital 203-5 counselling 27 data protection 38 enhancement 17 identification 115-16 information 67, 70

255 predispositions 25, 37, 71-4 testing 15-16, 37-8 therapies 15-18, 38-9, 62, 113-14, 138-9, 233 genome transfer 15 genomics 22-4 germ-line gene therapy 15, 17-18, 39 Germany 35-45, 106, 160 Geron 204 Gert, Bernard 115 Godel's theorem of incompleteness 173 Goethe, Johann Wolfgang von 244 Goldstein, Professor J. 76 Golem legend 188-90 Greek myths 199-200 Grimm, Jacob 189-90, 196 Grisez, Germain 101 halakha 187 Hall, Gerry 247 Harkins, Tom 234 Hart-Devlin debate 187 headless clones 238-9 healing principle 187-8 Heisenberg's principle of indeterminacy 173 Helen 196-7 Helsinki Declaration 48, 102 hermeneutics 70 heterologous fertilization 150-1 Hippocrates 180, 182-4 Hobbes, T. 171 Hoffman-La Roche 163 homologous cloning 148-9 homologous recombination 139 hope principle 70, 72 Hottois, Gilbert 154 human cloning 15, 18, 39-41, 63, 135-9 Dolly the sheep comparison 127, 227-31 embryo cloning 99-108,115-24 genome technology 9-20 prohibition standpoint 125 reproductive cloning issue 127-33, 153-4 serialisation 153 human dignity principle 160, 224 biotechnological effects 70 identity relationship 158 legal issues 154 protection 47, 128 regulative instrument 35-45 vagueness 77 Human Fertilisation and Embryology Act 1990, United Kingdom 133 Human Genome Project geneticist's responsibility 26-31

256 objectives 1998-2003 21-6, 34 status 1998 32-3 human rights 36-7, 48, 75, 158 human-cow hybrid cells 233 Huntington's chorea 25-6 Huxley, Aldous 107-14, 213-14, 235-6, 246, 251 hypothetical compensation 10 Icelandic Medical Association (IMA) 164 Icelandic population database 163-72 identity 67, 71-2, 158 ignorance 70-1 IMA see Icelandic Medical Association imago-dei 42 immortality 196-8,200 immunoassay methods 174 improved sequencing technology 22 In His Image 246 in vitro fertilization 99, 105, 116, 234, 241, 245, 247-8 incest 149 individual autonomy 192 individual self-interest 10 industrial cornucopia 57 Industrial Revolution 221 information 67-74 informed consent 41, 90-1, 165, 192 Institutional Review Boards 49, 56 interdisciplinary communication 3-5 International Covenant on Economic, Social and Cultural Rights 190-1 International Human Genome Sequencing Consortium 21 intolerance 58 Introduction a I'etude de la medecine experimental 175 Invasion of the Bodysnatchers 250 Italy attitude to innovation 25, 31 cloning 126 deontology 47 ethics committees 54-6 judges' role 74 personality right 160 self-determination principle 183 Jaspers, K. 184 Jonas, Hans 15, 49, 133 Jonsen, A.R. 51-2 Judaism 187-92 see also religious issues Jurassic Park 250 jurist role 7 justice theory 11, 70

Index kabbala 188 Kahn, Axel 228 Kaldor-Hicks principle 9-11 Kant, Immanuel 42-3 Kass, Leon 245-6 Kats, J. 184 Katz, J.E. 85 Knight, Damon 214-15 knowledge 57-65, 80-1, 173 Korea 106 Lakatos, I. 173 language manipulation 100-1 Laplace 180-1 legal autonomy 7 legal equality 13, 145-6, 159 legal/scientific interface 7 legislative role, validity 79-80 Lester, Lane 251 Leviathan 171 Levin, Ira 250 Lewontin, Richard 164-5 liberty principle 187 Loew, Rabbi 189 Logic 180 Luhmann 59 McKernan, Ruth 249 mad scientists 236 Maharel 189 manipulated cloning 137 MANNVERND 164 mass media 4 Mattei, Jean-Fran9ois 227 media role 77 medical applications 15 medical journalism 244 meiosis 118 Mendelian genes 135 Mendelian Inheritance in Man 28 messenger DNA 23 metempsychosis 198 methodological anarchism 88 microarrays 23-4 microdeposition, robot assisted 23 military target definition 101 mimetic effects 69 de Mirandola, Pico 42 Mirror Dance 217 mitochondrial diseases 137 models, cooperation 182-3 monozygotic twins 143-4 moral pluralism 50, 53-4 morality changes 57-65 Moses, Lincoln E. 181

Index motherhood 199 multifactorial pathologies 25, 27-8 Multiplicity 237 murine genome sequence 24 Narcissus 195-6 Natural State 214 Nature 21-2 Nature Genetics 136 Nature Medicine 138 The New York Times 164, 233-4, 247 Newsweek 247-8 Newtonian physics 173 Nietzsche 69 Nigeria 30 non-cognitivism 80 Nuclear Deterrence, Morality, and Realism 101 nuclear magnetic resonance 174 nude pigs 235, 238-9 Nuremberg Code 48 Nurse, Paul 249 Nussbaum, Martha 251 objective uncertainties 83-4 observational epidemiology 179 oikos 69 oligonucleotides, synthetic 23-4 organ cloning 18, 63 ovarian conservation 122 Ozick, Cynthia 188 Pareto principle 9-10 Parkinson's disease 138 Pascal 180 patents 25, 82-3 pathogen organisms 23 patient autonomy 41 Paul V, Pope 234 Pearce, Gregory 251 Pearson, K. 176 perceptions 57-65 personal identity 158 personality 37-8 phallocentric culture 199 pharmakon 69 Philadelphia case 233, 239 philosophy of dignity 42-3 photolithography 23-4 physics 173 The Picture of Dorian Gray 238 PID see pre-implant diagnostics Plato 196, 198, 200-1 political interference 60 political justice 11

257 Polly the sheep 137, 205 see also sheep polygenic pathologies 25 Popper, K.R. 181 pre-embryos 117 pre-implant diagnostics (PID) 120 precaution principle 131-2 predestination 71-4 predictions 29, 37-8, 71-4 predispositions 25, 37, 71-4 prenatal diagnosis 38, 41, 120 prescriptive definitions 81 primate embryo cloning 122 primitive societies 14 Das Princip Hoffnung 70 principles 69-70 best interest of the child 131, 133 damage evaluation 131 difference 13 family 147-51 fundamental 50 healing 187-8 hope 70, 72 human dignity 35-45, 47, 70, 77, 128, 154, 158, 160, 224 indeterminacy 173 Kaldor-Hicks 9-10 liberty 187 Pareto 9-10 precaution 131-2 responsibility 26, 30, 133 self-determination 183 social equality 12 substantial equivalence 87 privacy 165 probability/trends 180 procreative liberty 208-11 production process 104-5 profit potential 4 protected truths 81-2 protecting values 89 protection of society 4 prudence 224 psychoanalysis 184 psychological harm 15-16 public opinion 4, 77 public participation 90-2 see also democratic participation radical constructivism 88-9 random procreation 115-24 randomization 178 Rawls, John 12-13, 44, 70, 109 Rawls's difference principle 13

258 reductionism 151 reductionist neopositivistic epistemology 85-8 regulation 7, 75-7, 79-96 regulation of science 79-96 regulatory aims 75-7 religious issues 72-3 Catholicism 146, 230 Christianity 42-3 intolerance 58 Judaism 187-92 spiritualism 58, 144 Remaking Eden 251 reproduction 5-6, 115-24, 146-7 reproductive cloning 100, 104, 125-33 reproductive tourism 156 Republic 198 research, artificial reproduction 5, 146-7 researchm, limits 47-56 resigned preserver attitude 221-2 resource prioritization 190-1 resource redistribution 19 responsibility principle 26-31, 133, 192 rights autonomy 40 genetic disobedience 163-72 human 36-7, 48, 75, 158 information 37 patient autonomy 41 personality 37-8,41 science objection 95 secrecy 38 self-determination 16, 37-41 uniqueness 142-6 see also civil liberties; freedoms risks 61, 70-1, 88, 90, 154, 176-7 Robertson, John 210 robot assisted microdeposition 23 Roman Law 132 Rorvik, David 246 Rostand, Jean 246 rules 7 Saccharomyces cerevisiae 23 safety aspects 128 Salaman, Redcliffe N. 219 The San Francisco Chronicle 244 scenario-spinning 249 Schmandt, J. 85 Scholem, Gershorn 188 Science 21 science fiction 107-14, 213-25, 236-8, 241-52 scientific autonomy 7

Index scientific journalism 4, 77 scientism 57 Second World War 101 Seed, Dr Richard 234-5 self 67 self interest 10 self-determination principle 37-41, 183 sequencing technology 22 sheep history 203 importance in Britain 204 transgenic 205 see also Dolly the sheep; Polly the sheep Shelley, Mary 241-6 Siamese twins 137 Silver, Lee 251 Simon, Professor Jurgen 47 single nucleotide polymorphisms (SNP) 22 slavery 105-6, 147, 160 SNP see single nucleotide polymorphisms social equality principle 12 social issues control 4 discrimination 16 efficiency requirements 9-14 implications 25-6 inequalities 9-20 justice 9-14, 190-1 orders 9 protection 4 relationships 9 soft-law approaches 93 somatic cell gene therapy 15, 17, 39 spiritualism 58, 144 see also religious issues spontaneous experiments 175 Squier, Susan 245 standardized reproduction 115-24 standards 52 statistics 176-8 Stefansson, Kari 163 Stillman, Robert 247 subjective uncertainties 83-4 substantial equivalence principle 87 Sunstein, Cass 154, 251 surrogacy 112 susceptibility genes 135 Switzerland 169 syllogism 142 synthetic oligonucleotides 23-4 Taguieff, Pierre Andre 229 Taylor, Gordon Rattray 246 technology misuse 18,112-13

Index technoscience debate 3-5 test tube babies 230, 241 Testart, Jacques 156-7, 228 The History and Social Influence of the Potato 219 theory-free methods 53 therapeutic cloning 100-3, 137-9 therapeutic conformity 51 therapies 15-18, 38-9, 62, 113-14, 138-9, 233 tikkun 188 Time 247, 249 Tognon, Professor 61-2 Toulmin, S. 51-2 training 24-5 transacion costs 10 transactional justice 11 transplants 174 traumatic effects 149-51 trends 180 Tribe, Lawrence 154 triplets 26 tumour cells 28 Turney, John 236 twins 143-4, 150 tyranny of the majority 209 UK see United Kingdom ultrasonography 174 uncertainties 70-1, 83-5, 179

259 uniqueness 5-6, 142-6, 158 United Kingdom (UK) 106 embryo research 37 in vitro fertilization 247-8 public participation 208-11 Second World War 101 sheep 203-5 United Nations Charter 35 United States of America (USA) 28, 49, 106, 211 Universal Declaration on the Human Genome and Human Rights 40, 125, 168-9 USA see United States of America utility 9-10 variability analysis 22 Vasseur, Philippe 227 Vere, Duncan 181 vitalism 175 weak law 155 Weldon, Fay 247, 250 Wellcome Trust 250 Whale, James 242 Wilkie, Tom 174 WMA see World Medical Association Wolpert, Lewis 242 World Medical Association (WMA) 164 xenografts 235, 239 xenotransplantation 131 Zeus

199-200

NIJHOFF LAW SPECIALS 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22.

D. Campbell: Abortion Law and Public Policy. 1984 ISBN 90-247-3107-0 J. Pictet: Development and Principles of International Humanitarian Law. 1985 ISBN 90-247-3199-2 J. van Houtte: Sociology of Law and Legal Anthropology in Dutch-speaking Countries. 1985 ISBN 90-247-3175-5 C.D. De Fouloy: Glossary of NAFTA Terms. 1994 ISBN 0-7923-2719-5 H.L. Zielinski: Health and Humanitarian Concerns. Principles and Ethics. 1994 ISBN 0-7923-2963-5 K.S. Foster and D.C. Alexander: Prospects of a US-Chile Free Trade Agreement. 1994 ISBN 0-7923-2885-X F.J.M. Feldbrugge (ed.): Russian Federation Legislative Survey. June 1990-December 7992.1995 ISBN 0-7923-3243-1 R. Platzoder (ed.): The 1994 United Nations Convention on the Law of the Sea. Basic Documents with an Introduction. 1995 ISBN 0-7923-3271 -7 D. Warner (ed.): New Dimensions of Peacekeeping. 1995 ISBN 0-7923-3301 -2 M. van Leeuwen (ed.): The Future of the International Nuclear Non-Proliferation Regime. 1995 ISBN 0-7923-3433-7 E.-U. Petersmann: International and European Trade and Environmental Law After the Uruguay Round. 1995 ISBN 90-411 -0857-2 V. Gowlland-Debbas: The Problem of Refugees in the Light of Contemporary International Law Issues. 1996 ISBN 90-411 -0085-7 A. Kaczorowska: International Trade Conventions and Their Effectiveness. Present and Future. 1995 ISBN 0-7923-3362-4 T.F. Acuna: The United Nations Mission in El Salvador. A Humanitarian Law Perspective. 1995 ISBN 90-411 -0123-3 H. Wiggering and A. Sandhovel (eds.): European Environmental Advisory Councils. 1996 ISBN 90-411-0873-4 E.A. Ankumah: The African Commission on Human and Peoples' Rights. Practice and Procedures. 1996 ISBN 90-411 -0130-6 B. de Rossanet: Peacemaking and Peacekeeping in Yugoslavia. 1996 ISBN 90-411-0192-6 A. Webster and K. Packer (eds.): Innovation and the Intellectual Property System. 1996 ISBN 90-411-0907-2 H. Bocken and D. Ryckbost (eds.): Codification of Environmental Law. Draft Decree on Environmental Policy. 1996 ISBN 90-411 -0911 -0 K. Lescure and F. Trintignac: International Justice for Former Yugoslavia. The Working of the International Criminal Tribunal of the Hague. 1996 ISBN 90-411 -0201 -9 G. de Nooy (ed.): The Role of European Naval Forces after the Cold War. 1996 ISBN 90-411-0227-2 M. Bertrand and D. Warner (eds.): A New Charter for a Worldwide Organisation? 1997 ISBN 90-411-0286-8

NIJHOFF LAW SPECIALS 23. 24.

E.-U. Petersmann: The GATTWTO Dispute Settlement System. International Law, International Organizations and Dispute Settlement. 1996 ISBN 90-411 -0933-1 G. de Nooy (ed.): Cooperative Security, the OSCE, and its Code of Conduct. 1996

25.

M. Bertrand: The United Nations. Past, Present and Future. 1997

26.

29.

D. Dijkzeul: The Management of Multilateral Organizations. 1997 ISBN 90-411-0356-2 G. de Nooy (ed.): The Role of European Ground and Air Forces after the Cold War. 1997 ISBN 90-411-0397-X M. Hilaire: International Law and the United States Military Intervention in the Western Hemisphere. 1997 ISBN 90-411 -0399-6 D. Warner (ed.): Human Rights and Humanitarian Law. The Guest for Universality.

30.

J.C. Hathaway (ed.): Reconceiving International Refugee Law. 1997

31.

G. de Nooy (ed.): The Clausewitzian Dictum and the Future of Western Military Strategy. 1997 ISBN 90-411 -0455-0 Canadian Council on International Law and The Markland Group (ed.): Treaty Compliance: Some Concerns and Remedies. 1997 ISBN 90-411 -0732-0 B. de Rossanet: War and Peace in the Former Yugoslavia. 1998

ISBN 90-411-0316-3 ISBN 90-411-0337-6

27. 28.

1997

ISBN 90-411-0407-0 ISBN 90-411-0418-6

32. 33.

ISBN 90-411-0499-2 34. 35. 36.

37.

38.

C.M. Mazzoni (ed.): A Legal Framework for Bioethics. 1998 ISBN 90-411 -0523-9 M. Mann-Bosch: Votes in the UN General Assembly. 1998 ISBN 90-411 -0564-6 L. Caflisch: The Peaceful Settlement of Disputes between States: Universal and European Perspectives. Reglement pacifique des differends entre Etats: Perspectives universelle et europeenne. 1998 ISBN 90-411 -0461 -5 R. Wazir and N. van Oudenhoven (eds.): Child Sexual Abuse: What can Governments do? A Comparative Investigation into Policy Instruments Used in Belgium, Britain, Germany, the Netherlands and Norway. 1998 ISBN 90-411 -1034-8 E.M. Barron and I. Nielsen (eds.): Agriculture and Sustainable Land Use in Europe.

1998 39. 40.

41. 42. 43.

ISBN 90-411-9691-9

K. van Walraven (ed.): Early Warning and Conflict Prevention. 1998 ISBN 90-411-1064-X S. Shubber: The International Code of Marketing of Breast-milk Substitutes. An International Measure to Protect and Promote Breast-feeding. 1999 ISBN 90-411-1100-X G. Prins and H. Tromp (eds.): The Future of War. 2000 ISBN 90-411 -1196-4 Choung II Chee: Korean Perspectives on Ocean Law Issues for the 21st Century. 2000 ISBN 90-411-1301-0 K. Idris and M. Bartolo: A Better United Nations for the New Millennium. The United Nations System - How it is now and how it should be in the future. 2000

ISBN 90-411-1344-4

NIJHOFF LAW SPECIALS 44.

45. 46. 47.

48. 49. 50. 51. 52. 53. 54. 55.

E. McWhinney: The United Nations and a New World Order for a New Millennium. Self-determination, State Succession, and Humanitarian Intervention. 2000 ISBN 90-411-1371-1 C.Y. Pak: Korea and the United Nations. 2000 ISBN 90-411 -1382-7 G. Prins and H. Tromp (eds.): The Future of War. 2000 ISBN 90-411 -1399-1 V. Gowlland-Debbas, H. Hadj-Sahraoui and N. Hayashi (eds.): Multilateral Treatymaking. The Current Status of Challenges to and Reforms Needed in the International Legislative Process. 2000 ISBN 90-411 -1448-3 G. Simpson (ed.): Detainees Denied Justice. 2001 ISBN 90-411 -1.552-8 C.A. Magarihos, G. Assaf, S. Lall, J.D.-Martinussen, R. Ricupero and F. Sercovich: Reforming the UN System. UNIDO's Need Driven Model. 2001 ISBN 90-411 -1669-9 K. Wellens (ed.): Resolutions and Statements of the United Nations Security Council (1946-2000). A Thematic Guide. 2001 ISBN 90-411 -1722-9 P. Soar (ed.): The New International Directory of Legal Aid. 2001 ISBN 90-411 -1718-0 C.M. Mazzoni (ed.): Ethics and Law in Biological Research. 2002 ISBN 90-411-1742-3 I. Omar: Emergency Powers and the Courts in India and Pakistan. 2002 ISBN 90-411-1775-X M. O'Flaherty: Human Rights and the UN: Practice Before the Treaty Bodies. 2002 ISBN 90-411-1788-1 Y. Beigbeder: Judging Criminal Leaders. The Slow Erosion of Impunity. 2002 ISBN 90-411-1815-2

MARTINUS NIJHOFF PUBLISHERS - THE HAGUE / BOSTON / LONDON