PROCEEDINGS

INTERNATIONAL BIOETHICS COMMITTEE OF UNESCO (IBC) Eighth Session

Volume I Division of the Ethics of Science and Technology of UNESCO

II Table of Contents

Introduction ...... 1

CHAPTER 1 Report of the Eighth Session of the International Bioethics Committee of UNESCO (IBC) (by Mrs Yolande Tano Bouah, Rapporteur of the IBC)...... 3

CHAPTER 2 Human Genetic Data: Preliminary Study by the IBC on its Collection, Processing, Storage and Use (Rapporteurs: Mrs Sylvia Rumball and Mr Alexander McCall Smith) ...... 21

CHAPTER 3 Report of the IBC on Ethics, Intellectual Property and Genomics (Rapporteur: Justice Michael Kirby) ...... 51

CHAPTER 4 Advice of the IBC on the Patentability of the Human Genome (14 September 2001) ...... 65

CHAPTER 5 Speeches at the Eighth Session of the IBC I. Mr Koïchiro Matsuura, Director-General of UNESCO (opening speech)...... 69 II. Mr Ryuichi Ida, Chairperson of the IBC (opening speech)...... 77 III. Mrs Anne Fagot-Largeault, Professor at the Collège de France (opening speech)...... 85 IV. Mr Ryuichi Ida, Chairperson of the IBC (closing speech) ...... 91

III CHAPTER 6 Composition of the International Bioethics Committee of UNESCO (IBC) in 2001 ...... 95

CHAPTER 7 List of Participants ...... 101

IV INTRODUCTION

The Eighth Session of the International Bioethics Committee (IBC) was held at UNESCO Headquarters in Paris, from 12 to 14 September 2001. The Director-General of UNESCO, Mr Koïchiro Matsuura, honoured with his presence the opening ceremony in which Professor Anne Fagot-Largeault, Chair of Philosophy of Biological and Medical Sciences at the Collège de France also took part. Around 350 participants from more than 70 countries throughout the world were present.

In accordance with the Agenda of this session, the IBC examined two draft reports drawn up by its working groups: the first on ethics, intellectual property and genomics and the second on the collection, treatment, storage and use of genetic data. These reports have since been finalized on the basis of comments and suggestions made by members of the IBC and other participants at the eighth session. A Round Table on ‘Education in Bioethics and Youth’ brought together several representatives of young people. The topics chosen by the participants in the Round Table and the diversity of their approaches illustrated the differences of experiences and projects in progress in the field of education in bioethics in different countries. During this session, and directly in line with the initiative taken by the Director-General of UNESCO to propose for the 2002-2003 biennium the elaboration of an international instrument on genetic data, the IBC proceeded with a hearing of three personal data protection commissioners. Furthermore, a state of the art on the ethical aspects of proteomics illustrated the place occupied by this new branch of research in the post-genomic era and the ethical issues that it can raise. Volume I of these Proceedings includes the report of the session, the speeches delivered and the list of participants. It also includes the Composition of the IBC, the IBC Report on ethics, intellectual property and genomics and the preliminary study of the IBC on the collection, processing, storage and use of human genetic data.

Volume II includes the presentations of participants in the Round Table and the hearing of Commissioners for the protection of personal data, together with the presentation on proteomics.

UNESCO

August 2002

2 Chapter 1

REPORT OF THE EIGHTH SESSION OF THE INTERNATIONAL BIOETHICS COMMITTEE OF UNESCO (IBC)

by Yolande Tano Bouah, Rapporteur of the IBC

I. Introduction 1. The Eighth Session of the International Bioethics Committee (IBC) was held at UNESCO Headquarters in Paris from 12 to 14 September 2001. It was attended by around three hundred and fifty participants from seventy different countries. 2. In accordance with the Agenda of this session (see Annex), the IBC considered two draft reports drawn up by its working groups: the first on ethics, intellectual property and genomics and the second on the collection, treatment, storage and use of genetic data. One session was devoted to a round table on ‘Education in Bioethics and Youth’ and a state-of-the-art on ethical aspects of proteomics was presented. Finally, Commissioners for the Protection of Personal Data were heard. 3. Meetings reserved for members of the IBC were held prior to the opening of the Eighth Session and immediately following its closure. These meetings provided the IBC with an opportunity to examine and adopt amendments to its Rules of procedure proposed by an ad hoc group set up for this purpose; to take stock of follow-up action on the recommendations made at the Seventh Session of the IBC; to adopt a work programme following the presentation of the implementation of activities carried out, particularly within the framework of the follow-up of the Universal Declaration on the Human Genome and Human Rights and, last but not least, to deliver an Advice on the patentability of the human genome (see Section IX of this Report).

3 II. Opening of the Eighth Session of the IBC 4. In his opening address, the Director-General of UNESCO, Mr Koïchiro Matsuura, expressed his consternation at the attacks perpetrated in New York and Washington on 11 September 2001. He condemned terrorism and pointed out that ethical reflection was more than ever necessary to promote world peace. He called attention to the pioneering role of the IBC in this area and recalled the preponderant role that bioethics would play in the post-genomic era. The patentability of the human genome, research applications and protection of genetic data are all topical questions to which solutions must be found at international level. In particular, he laid emphasis on the need to draw up an international instrument on genetic data. He described his initiative to create an inter-agency committee responsible for ensuring better coordination of the activities carried out by the various organizations of the United Nations system in the field of bioethics. He also referred to the Round Table of Ministers of Science on bioethics organised by UNESCO on 22 and 23 October 2001, which would be a highlight of the 31st session of the General Conference. Finally, he felt that the time had come for UNESCO to examine in detail the feasibility of preparing a universal instrument to cover all bioethical issues. 5. Mr Ryuichi Ida, Chairperson of the IBC, in turn stressed the fundamental importance of bioethics in the contemporary world. He reminded the meeting that vigilance was more necessary than ever, particularly in regard to human reproductive cloning. He summarized the fruitful work of the Seventh Session of the IBC (Quito, Ecuador, 7-9 November 2000) and of the Second Session of the Intergovernmental Bioethics Committee (IGBC) (Paris, 14-16 May 2001). He welcomed the Director-General’s proposal to create an inter-agency committee, as coordination of efforts in the bioethics area is essential to respond to the new problems raised by the exceptionally rapid progress of biomedical science. 6. In her address, Professor Anne Fagot-Largeault, Chair of Philosophy of Biological and Medical Sciences at the Collège de France, laid emphasis on the need for ethical reflection and action at international level. Although the pitfalls are real, pessimism is not in order. The diversity of cultural traditions might, from time to time, seem to pose an obstacle, but it is this very richness that embodies the possibility of defining common values and principles, as can be seen from the successful action of the IBC and the adoption of the Universal Declaration on the Human Genome and Human Rights in 1997. Patience, modesty and courage are the key words to ensure implementation of the principles set forth in the Declaration.

4 7. The addresses delivered during this opening ceremony are included in these Proceedings.

III. Round Table on ‘Education in Bioethics and youth’ 8. The Round Table on ‘Education in Bioethics and Youth’ chaired by Mrs Yolande Tano (Côte d’Ivoire), Vice-President of the University of Abobo-Adjamé, brought together several representatives of young people. Mrs Tano pointed out that this Round Table reflected a desire to enable young people, who tomorrow will be the relay for responsibility of bioethical action, to have their say: this in conformity with Article 20 of the Universal Declaration on the Human Genome and Human Rights, which stresses the vital need for education in bioethics. 9. The presentation by Miss Catalina Alvarez Irarragori (Cuba), Centre of Genetic Engineering and Biotechnology, underlined the risks of abuse linked to the biotechnological revolution. In particular, commercial interests must not be allowed to govern the progress of medicine. Scientists, university teachers, students, politicians and civil society should reflect collectively on the means of creating a framework for scientific research. The creation of a social contract could consolidate respect for ethical commitments. 10. The address by Miss Natacha Freitas (Portugal), Chairperson of the Youth Council of the UNESCO Club Vila Nova de Gaya, highlighted the importance of education and regulation in bioethics. A balance must be struck to enable regulatory provisions to provide a framework for scientific research without acting as an obstacle to it. In Portugal for example, since 1997 legislation has regulated the conditions under which medically- assisted procreation is permitted. Human life must always prevail over economic interests and clinical tests. The status of the human being, and in particular that of the embryo, must be defined. An international meeting on young people and bioethics will in fact be held in Portugal in 2002 to deal with some of these matters. 11. Miss Sandra Goritschnig (Austria), National Director of the International Association of Agricultural Students (IAAS), advocated wider dissemination of information. The patentability of the human genome, genetically-modified organisms (GMOs) and cloning were all matters of interest to the general public. It would therefore be appropriate for the public to take part in the debate and to be given the opportunity to form an opinion on the basis of enlightened information. With that end in view, students must be made aware of the ethical impact of their future

5 professional practices. An international and interdisciplinary conference for pharmaceutical students on the topic of bioethics would therefore be organised in Vienna (Austria) from 21 to 24 November 2001. 12. The increasingly close links between scientific research and industry were touched upon by Miss Young-bin Kwak (Republic of Korea), Department of International Relations of Seoul National University. Concerns about the possible risks of the use of biotechnology were being voiced increasingly here and there. The progress of science could lead to new forms of discrimination, which presuppose appropriate measures to protect human rights. The existence of international bodies, such as the IBC responsible for the protection of human rights in biotechnologies, is all the more essential.

Discussion 13. In the discussion which followed, the need for broadly disseminated scientific information and for the teaching of basic bioethics was reaffirmed. Over and above the mere transmission of ethical norms, education in bioethics must reconcile the development of a scientific, religious and philosophical cultures. To create greater awareness among young people, bioethical teaching could be envisaged at the end of secondary school studies. The need to formulate concrete proposals was also highlighted. A methodology is essential to determine the content of bioethical teaching. A programme capable of transcending cultural differences and promoting a universal understanding of bioethics must be defined. 14. Bioethics is based on a dynamic relationship between technological developments and ethical choices. The balance born from this relationship guarantees the limits within which science may progress. Bioethics can act as the guardian of fundamental rights and freedoms only if a permanent dialogue with researchers is maintained. 15. Mrs Tano thanked the four speakers. She welcomed the quality of their presentations and pointed out that the subjects they had chosen to deal with and the diversity of their approaches illustrated the experiences and projects under way in different countries in the area of education in bioethics.

6 IV. State of the Art on Ethical Aspects of Proteomics 16. The second session chaired by Professor György Kosztolányi (Hungary), Head of the Department of Medical Genetics and Child Development at the University of Pécs, was devoted to the hearing of an expert on the current state of ethical aspects of proteomics. 17. Professor Thierry Rabilloud, of the Laboratory of Cellular and Pathological Bioenergetics at the French Commissariat for Atomic Energy and Senior Editor of Proteomics, gave a brilliant presentation on recent progress in proteomics. He demonstrated the specificity of proteomic analysis and highlighted the similarities and differences between the use on one hand of genomic research and, on the other, of proteomic research. Finally, he outlined the role that proteomics could occupy in the post-genomic era and laid emphasis on the ethical issues which might be raised by this new branch of research.

Discussion 18. The participants focused mainly on the ethical challenges posed by proteomics. To the extent that proteomics is a purely analytical typing technique, the associated ethical problems it raises depend on the possible application to the living sphere, in particular to human beings. At the heart of these ethical issues, the key problem is the patentability of living matter. The need to distinguish between an invention and a discovery and not to treat human beings as mere material was affirmed. Similarly, fear was expressed that patents of living matter might be filed via proteomics research. 19. The setting up of protein banks was discussed. Proteins deteriorate faster than DNA and rapidly become unusable. This limited duration in time makes their use less problematic than that of genetic data banks. 20. Mr Kosztolányi thanked Mr Rabilloud for his highly instructive presentation whose rich content and interest were acknowledged by all the participants. He felt that the existence of a common field of study shared by proteomics and genetics had been made clearly apparent by this presentation.

V. Proposals of the IBC Working Group on Ethics, Intellectual Property and Genomics 21. At the initiative of the Director-General, an International Symposium on ‘Ethics, Intellectual Property and Genomics’ took place at UNESCO Headquarters from 30 January to 1 February 2001. Following this

7 Symposium, the Director-General entrusted the IBC with drawing up proposals for follow-up to this initiative. A working group, chaired by Mr Patrick Robinson (Jamaica), Judge at the International Criminal Tribunal for the former Yugoslavia, was therefore set up and convened in Paris on 13 and 14 June 2001 to prepare proposals for presentation and discussion at the present IBC session. 22. The session devoted to the examination of these proposals was chaired by Mr Hans Galjaard (Netherlands), Professor of Human Genetics and Head of the Clinical Genetics Department at Rotterdam University Hospital. Mr Galjaard called attention to the importance of the question of ethics, intellectual property and genomics and reminded the gathering of the key role that it must play in the reflection of the IBC. Judge Robinson, for his part, presented the broad outline of the draft report prepared by Mr Michael Kirby, Justice of the High Court of Australia. He pointed out that while this text stressed the advantages of the protection of intellectual property, it nevertheless called attention to the drawbacks of patentability of the human genome. He also pointed out that this report was drawn up by the working group in a concise manner to better clarify the proposals formulated. The quality of the document prepared by Judge Kirby and the clarity of the presentation by Judge Robinson were acknowledged by the participants.

Discussion 23. The recommendations formulated by the working group were the central point of the discussion. The recommendation concerning examination of Article 27.2 of the Trade Related Aspects of Intellectual Property Rights Agreement (TRIPS) that the World Trade Organization (WTO) to ‘clarify that it constitutes an exception of patentability in respect of the human genome on the basis of the public interest considerations’ attracted much comment. Article 27.2 seems to offer a margin for interpretation which should be the subject of joint study by the organizations concerned, in particular UNESCO and WTO. On the basis of considerations of public interest expressly referred to in Article 27.2(1) the exception from patentability for the human genome should be made clearer.

1. ‘Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or in order to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by their law.’

8 24. The issue of patentability and genomics must be dealt with in a balanced way. It is not a matter of outrightly rejecting all patents linked to genomics applications; nobody doubts its indispensable nature. Certain genetic sequences have already led to the production of valuable pharmaceutical preparations. The patent system is therefore necessary for therapeutic advances and excessive limitation might delay the introduction of new pharmaceuticals. The fear that the high cost of some pharmaceuticals obtained by genetic engineering might deprive a part of humanity of access to health care was expressed forcibly. Nevertheless, the question of the price of pharmaceutical products whose prohibitive costs sometimes makes them inaccessible to the most underprivileged members of society, especially in developing countries, must not be confused with the matter of patents. It would be opportune to seek a formulation that ensures access to pharmaceuticals for everyone or else to invite the laboratories to respect some moral obligations in the treatment of serious or presently incurable illnesses. An observatory to follow this matter could be set up under the aegis of UNESCO. 25. With regard to the possible creation, within the United Nations system, of a world fund to acquire for the benefit of humanity the intellectual property that is privately owned in relation to human genome sequences, suggested by the Working Group, the idea of launching an international appeal to persuade researchers to assign their intellectual property rights to such a fund was mooted. The term ‘mechanism’ as used in the IBC Report on Solidarity and International Cooperation between Developed and Developing Countries concerning the Human Genome would no doubt be more appropriate. The convergence of the two proposals of the IBC is to be noted, especially as it accords with the ‘Statement on Benefit Sharing’ Human Genome Organisation (HUGO). Bilateral agreements between a State and the pharmaceutical industry might be another approach. The example of South Africa and Brazil were mentioned as illustrations of possible solutions to this general problem. 26. The need to associate with and inform the general public was once again highlighted. Without enlightened and broadly circulated information, the wide-ranging creation of an awareness of these new issues would not be possible. 27. Judge Robinson thanked the speakers and reminded them that all the observations made would be taken into account in the finalization of

9 the Report(2). Mr Galjaard wound up the meeting by welcoming the fruitful debate to which the document had given rise and pointed out that the work of the IBC held out prospects for considerable progress in this field (see Section IX of the present Report).

VI. Hearing of Commissioners for the Protection of Personal Data 28. This hearing fell directly in line with the initiative taken by the Director-General’s proposal for the 2002-2003 biennium to begin the elaboration of an international instrument on genetic data, with particular reference to the collection, processing, storage and use of such data. In the framework of this initiative, three personal data protection commissioners were invited to consider the subject of genetic data from the angle which seemed most appropriate to them and to broach issues they considered to be the most important. 29. The meeting was chaired by Mr Roberto Andorno (Argentina), Professor of Civil Law. He referred to new forms of discrimination that might arise from access to genetic information, notably in the judicial field. Mr Andorno pointed out that this matter was such a pressing topic that the Argentine government had asked for it to be examined by the session of the United Nations Economic and Social Council in July 2001. UNESCO had in fact presented a document on this matter and ECOSOC had adopted a resolution on 27 July 2001. 30. The presentation by Mr Joël Boyer, Secretary-General of the Commission nationale de l’informatique et des liberté de la France (CNIL), outlined the French legislation applicable to genetic tests and data and data files or bases to which they might give rise. The specific nature of genetic analysis has been acknowledged since 1994 in French legislation which poses two series of conditions: the ultimate purposes and rights of individuals. There are three sorts of objectives: the characteristics of an individual may only be studied solely for medical or research purposes, within the framework of a judicial procedure either civil or criminal. Moreover in the areas of employment, insurance and social protection, any discrimination based on the use of genetic tests is a punishable offence. Finally the rights of individuals makes their consent imperative.

2. The IBC Report on Ethics, Intellectual Property and Genomics finalized on the basis of the work of the Eighth Session is available on the Internet (http://www.unesco.org/ethics) and published in these Proceedings.

10 Three situations might therefore arise: identification in civil matters, in criminal matters or in medical or scientific research. The question of dual consent and prior information, often overlooked, requires a more effective legal framework. It is the opinion of the CNIL that only the person directly concerned may inform family members who might be affected by genetic information. As to the databases, the French law of 6 January 1978 authorizes the automated treatment of personal data. The CNIL must be notified of everything: the use for which the database is intended, the nature of the processed information, the persons for whom this database is intended and the time for which the base is kept. 31. In her address, Mrs Bénédicte Havelange, Secretary-General of the Belgian Commission for the Protection of Privacy, recalled the fundamental nature of an issue that touched upon philosophy, ethics and science to the extent that in a sense genetic data constitutes the informational replica of the individual. In this context the Belgian Commission delivers opinions, acts as a mediator and provides information. Belgian law seems adequate at present. It does not comprise specific statutory provisions on the ultimate objectives of genetic analyses, but rather sets forth principles aimed at protecting rights and freedoms. In the area of insurance, whilst it is normal to seek to reduce the commercial risk, refusal of entitlement to insurance is not permissible. Belgian law therefore formally bans such practices. On the other hand, there are no specific laws in the field of employment, because no complaints had yet been registered on discrimination at the recruitment stage founded on genetic characteristics. In the criminal law area, the Commission had, however, issued a number of opinions notably concerning DNA samples taken in the course of criminal investigations and the databases set up. There is a need to reconcile public security with respect for individual liberties and the infallibility of scientific proof must be questioned. Finally, Mrs Havelange emphasized the need for a debate between all parties concerned, in particular between civil society and politicians. 32. Mr George Radwanski, Privacy Commissioner of Canada, laid emphasis on the importance of the Universal Declaration on the Human Genome and Human Rights, the only international instrument in this area. New norms for protection of privacy must accompany progress in research. The employment and insurance sectors, where particular vigilance is required, need a code for the protection of genetic confidentiality. This code should be both prescriptive and directive, seek to avoid abuse and give individuals from whom data had been obtained

11 the right to access the genetic information. It should comprise a series of clauses guaranteeing the fundamental and inalienable right of each individual to protection of his/her personal genetic information. In addition, the inalienable right of persons to their privacy must be asserted. For that purpose they must be given control over the collection and storage of genetic data relating to them. The respect for confidentiality is vital to avoid the dangerous path of discrimination based on genetic characteristics. The code should also take account of the right not to know. It should also prohibit discrimination based on genetic characteristics in the sectors of employment, insurance, education or criminal law. Dual consent, i.e. a requirement for renewed consent to be obtained from the individual if the same genetic sample were to be used for other research, should also be stipulated. Last but not least, supervisory mechanisms must be set up to ensure respect for such a code.

Discussion 33. These presentations raised many topics of discussion and paved the way for a debate in the IBC on the Draft Report of the Working Group on Genetic Data (see Section VII of this Report). 34. The absolute necessity for free and informed consent and the ambiguity of use and results of genetic tests were once again highlighted. Genetic testing might be too revealing or not revealing enough because it is often just a simple prediction. The predisposition of an individual to an illness does not necessarily mean that this illness will occur. The use of profiling in criminal investigations, which is still not properly defined in legislation, should not be allowed to encroach upon the integrity of persons. It would be desirable to strike a just balance between the rights of society and those of individuals. 35. The danger of discrimination against specific groups, in particular indigenous populations, was mentioned. Serious drifts could occur with claims to the genetic superiority of a particular group. To rule out that possibility it might be appropriate to make provision for exceptional situations. 36. Mr Andorno thanked the three speakers and pointed out that their highly informative presentations would no doubt make a precious contribution to the future work of UNESCO in the area of genetic data.

12 VII. Genetic Data: Report of the IBC Working Group 37. Given the rapid development of genetics resulting in a proliferation and extension of genetic databases and the increasingly frequent use of this data for non-medical purposes that were sometimes ethically dubious, and on the basis of the proposals formulated by IBC at its last meeting, the IBC had decided to set up a Working Group on Genetic Data which met at UNESCO Headquarters in Paris on 14 and 15 June 2001 under the chairmanship of Mrs Nicole Questiaux (France). 38. The Draft Report on the Collection, Processing, Storage and Use of Genetic Data was presented by the two Rapporteurs of the Working Group, Professor Sylvia Rumball (New Zealand), Assistant to the Vice- Chancellor of Massey University and Alexander McCall Smith (United Kingdom), Professor of Medical Law and Vice-Chairman of the Human Genetics Commission of the United Kingdom. Mrs Rumball called attention to the complex structure that sought to define the fundamental purpose of the collection of genetic data, the underlying principles of standards to be adopted for the collection, processing, storage and use of genetic data and the application of these principles; she expressed her conviction that the issue of genetic data justifies the elaboration of an instrument dealing exclusively with this subject. Mr McCall Smith, for his part, stated that the principles set out in the draft report could serve as a basis for the drafting of a declaratory instrument. He pointed out that a desire not to be too prescriptive at this stage of reflection in the IBC had inspired their joint work.

Discussion 39. Many comments focused on the need to make a clear distinction between the storage and collection of genetic samples taken for medical purposes and those obtained for research. Specific guarantees must be defined for each of these two uses. It would be desirable to provide a clear definition of the notion of ‘informed consent’. Consent of the donor must be sought whenever new research is undertaken on the same gene. The donor must be assured of the possibility of withdrawing this consent whenever he wishes. 40. In some cases, specific questions arise over the taking of genetic samples. In the developing countries, respect for the rights of the populations from whom genetic samples are taken must be safeguarded; in particular, their informed consent must be obtained on each occasion.

13 The consent of the donors must not be extorted but granted according to the rules of informed consent. The question of the profits earned by the pharmaceutical laboratories and the channelling of these profits back to the populations from whom genetic samples were taken was also raised. The allowances paid to donors are often derisory, measured against the profits earned by the laboratories. It would therefore be appropriate for databases to be exploited by the developing countries to enable them in turn to develop their research and medical infrastructures. In this regard, the final text of the report might incorporate a principle setting out a more equitable distribution of the profits of research in this field.

41. The fight against discrimination based on genetic characteristics, notably by insurers or employers, must be a priority in the different legal systems. With that end in view, it would be appropriate for States to make efforts to ensure that ethics asserts its supremacy over economic interests. The IBC might of course coordinate these initiatives and make its particular contribution to the efforts undertaken. If this desire of preventing discrimination were to play a clearer part in the report it must be combined with the principle of equality. 42. A particular study might be made of the rights of children referred to in the draft report in Guideline 19. The violation of the rights of children all over the world is a constant source of grave anxiety and must be dealt with in the report. In particular, the issue of consent for the pre- symptomatic testing of children at risk for late-onset disease needs to be given serious examination. 43. With more particular reference to the draft report, a number of observations were made. It would be appropriate for the notion of solidarity to be given greater prominence. For that purpose, the principle of solidarity should be added to the six basic principles detailed in the document. Similarly the notion of privacy must be associated with that of confidentiality. A paragraph dealing with the responsibility of researchers would also be welcome. As to the principle of ownership, this could be dealt with in the context of the notions of social conscience and security. As a general rule a more concise form and a clearer hierarchy of the stated principles could make the text more effective. Finally, the terms used in the Universal Declaration on the Human Genome and Human Rights should be employed whenever possible.

14 44. The Rapporteurs thanked the speakers for their comments and invited all those who so wished to forward their comments in writing with a view to the finalization of the report(3). Mr Andorno in turn thanked the Rapporteurs for their desire to highlight precise criteria that emerged from their document and felt that this concern for accuracy was certain to prove useful at the different stages of elaboration by the IBC of the instrument on genetic data.

VIII. Coordination of Activities and Reflection concerning Bioethics Carried out by Various International Organizations with a view to Enhanced Cooperation 45. This session, chaired by Mr Ryuichi Ida, Chairperson of the IBC, was in line with the initiative taken by the Director-General of UNESCO to propose the creation of an inter-agency committee on bioethics. Mr Ida pointed out that the Director-General of UNESCO had proposed the creation of this committee to Mr Kofi Annan, Secretary-General of the United Nations, to ensure coordination of the activities carried out by the various organisations in the field of bioethics. The establishment of this committee would be discussed at a consultative meeting at UNESCO Headquarters in Paris on 17 September 2001. Mr Ida pointed out that cooperation between the various international bodies was the surest way to promote universal bioethics. Contributing to this coordination between international institutions and organisations was a priority goal of the IBC. The representatives of four organisations – the European Commission, the Council of Europe, the World Health Organization (WHO) and UNESCO – outlined the broad principles of the activities pursued by their respective organisations in the field of bioethics. 46. Mr Georges B. Kutukdjian, Secretary-General of the IBC, gave a broad outline of the programme of bioethics to be proposed by the Director-General of UNESCO to the 31st Session of the General Conference. This programme is structured around four main subjects: 1) the role of the intellectual forum for the pursuit, in particular by the IBC, of reflection on issues that raise ethical, legal and social challenges, notably those whose examination by the IBC had been recommended by the IGBC at its second session, i.e. pre-implantation diagnosis and germ-line interventions; 2) normative action: together with the elaboration of

3. The report on the Collection, Processing, Storage and Use of Genetic Data can be consulted on the Internet (http://www.unesco.org/ethics) and is published in these Proceedings.

15 possible instruments, UNESCO would evaluate the impact of the Universal Declaration on the Human Genome and Human Rights and look into ways and means of strengthening its principles and assuring their implementation in national legislation; 3) the advisory role which UNESCO must play for the Member States and governmental and non- governmental institutions; 4) the desire of UNESCO to strengthen its action of education and bioethics awareness at all levels: education in bioethics has been encouraged in universities and is starting to be introduced in secondary schools. Dissemination of information has furthermore been ensured by a number of publications, notably the IBC and IGBC reports. 47. Mr Victor Boulyjenkov, representing the WHO, called attention to the main issues that his Organization wished to examine as part of a dialogue with UNESCO and other international organisations. These topics included medical applications of genetics and the possible discrimination they might generate; therapeutic applications of genomics for developing countries which must benefit in equal measure with developed countries; creation of an awareness of bioethical issues and the promotion of education in biomedical ethics in medical circles. 48. Mrs Barbara Rhode, Head of the Unit for Ethics in Science and Research at the European Commission, recalled the existence within the Commission of a consultative group – the European Group for the Ethics of Science and New Technologies at the European Commission (EGE). This group is made up of members drawn from different backgrounds who are invited to comment on major ethical matters in debates and hearings. A new division whose role is to examine research activities financed by the European Commission - not only concerning bioethics but also the ethics of the information society - had also been set up at the Commission. 49. Mrs Sandrine Sabatier presented the action taken by the Council of Europe, notably through its Steering Committee on Bioethics (CDBI), which was at the origin of the European Convention on Human Rights and Biomedicine and additional protocols dealing with specific issues such as human cloning. The CDBI also acts in the context of the public debate and gives its support to the European States which express such a wish. Finally the Council of Europe has set up a European Conference of National Ethical Committees (COMETH), which seeks to promote cooperation between national ethical committees at European level, public debate in the field of bioethics, assistance to the European countries that wished to establish a national ethics committee.

16 Discussion 50. During the discussion, the convergence of views of the various bodies represented was emphasized and the cooperation that( already existed between these organisations welcomed. The importance of their coordination in the area of normative action and with a view to common reflection had been highlighted. Moreover, such coordination is conditional on the establishment by the organisations themselves of a work plan and the prior definition of their priorities to create the necessary synergies. 51. An exhaustive list of the organisations working in the field of bioethics, specifying the respective terms of reference and objectives of the organisations concerned, would be a useful working instrument. In this regard, the Secretary-General of the IBC pointed out that UNESCO was preparing a directory of national, regional and international institutions, which would soon be available as a paper publication and also circulated on the UNESCO Internet site. 52. The international organisations should make a greater effort to ensure that the discussions between experts – which were certainly highly instructive – also be made accessible to the general public. The documents issued by the different secretariats would accordingly benefit from greater visibility. With that end in view, the different instruments available to reach the general public should be explored, especially the Internet. 53. Mr Ida concluded by stressing the need for closer coordination and cooperation between all intergovernmental, international and regional organisations for which the conditions were now brought together through the inter-agency committee on bioethics.

IX. Conclusions 54. In accordance with Article 7 of its Statutes, the IBC adopted by consensus the following Advice on the Patentability of the Human Genome (14 September 2001): ‘Article 1 of the Universal Declaration on the Human Genome and Human Rights states that: ‘The human genome…, in a symbolic sense, is the heritage of humanity’. Article 4 further states that: ‘The human genome in its natural state shall not give rise to financial gains’.

17 The rapid progress of genomics and research on its pharmaceutical and other applications, has led to a worldwide debate on the meaning of these provisions. Governments and non- governmental organisations have expressed concern that the patentability of the human genome might hamper genetic research and lead to a monopoly of this important new scientific knowledge. It is to be feared that such patentability might deprive many populations of the world of the benefits of therapies whose development was founded on knowledge of the human genome. To clarify this matter and to contribute to the subsequent development of an equitable system of intellectual property relating to the human genome, the IBC drew the Director-General’s attention to the following opinion: (1) The IBC, after considering this issue, is of the view that there are strong ethical grounds for excluding the human gneome from patentability; (2) It further recommends that the World Trade Organization (WTO), in its review of the TRIPS Agreement, clarify that, in accordance with the provision of Article 27(2), the human genome is not patentable on the basis of the public interest considerations set out therein, in particular, public order, morality and the protection of human life and health.’ 55. In accordance with Article 2 (2) of its Statutes, the IBC also defined its own work programme. Apart from the elaboration of an international instrument on genetic data entrusted to a drafting group, it retained the following subjects:

- pre-implantation genetic diagnosis (recommended by the IGBC); - germ-line interventions; - the possibility of drawing up a universal instrument on bioethics; - dissemination of information on bioethics; - follow-up of IBC reports dealing respectively with solidarity and international cooperation between developed and developing countries concerning the human genome and on the ethical aspects of intellectual property concerning genomics. 56. As far as the long-term work programme is concerned, the IBC entrusted its Bureau, after consultations with members of the IBC, with drawing up a list of topics by order of priority.

18 X. Closure 57. At the end of this Eighth Session of the IBC, the Chairperson, Mr Ryuichi Ida, welcomed the fruitful work achieved during these days of reflection and discussion. The efforts deployed by the IBC to deepen bioethical study were welcomed by the Director-General of UNESCO, Mr Koïchiro Matsuura, whose proposals were largely taken into account by the Committee at its working meetings. This session provided an opportunity to take a further look at the meaning of bioethics, its scope, its field of action and what it represents for humanity. It illustrated the responsibility of young people willing to continue the work already begun in order to prevent bioethics from remaining a mere pious wish and had enabled the challenges of proteomics in the post-genomic era to be better understood. The Eighth Session also enabled the importance of setting up a mechanism to assure closer coordination and cooperation between the various international organisations, as requested by the Director-General, to be assessed. As to the international instrument on genetic data, the Commissioners for the protection of personal data had put forward practical considerations on which the IBC and UNESCO would certainly build further when drafting that new instrument. Finally, the rich and precise observations put forward by the participants on the Draft Report by the Working Group on Genetic Data would certainly enrich the revision of the text before its finalization. 58. Before closing the session, Mr Ida thanked the members of the IBC for their active role and the passionate interest they had once again shown. He also thanked all the members of the UNESCO Secretariat who had contributed to the success of this session. Through their combined efforts and tireless determination the universal message of bioethics could be conveyed to humanity.

19 ANNEX I

EIGHTH SESSION OF THE INTERNATIONAL BIOETHICS COMMITTEE OF UNESCO (IBC) Paris, 12-14 September 2001 ______

Agenda

1. Opening of the Eighth Session of the IBC; 2. Round-Table on ‘Education in Bioethics and Youth’(1); 3. Ethical Challenges raised by Brain Research: Cerebral Imaging, Grafts, Implants – State of the art; 4. Ethical Aspects of Proteonomics – State of the art; 5. Report of the IBC Working Group on Genetic Data; 6. Hearings of Commissioners for the Protection of Personal Data; 7. Proposals of the IBC Working Group with a view to the Follow-up of the International Symposium on ‘Ethics, Intellectual Property and Genomics’; 8. Co-ordination of activities and reflection concerning bioethics carried out by various international organizations, with a view to increased co-operation; 9. Review of the Rules of Procedure of the IBC and follow-up on the Recommendations of the Seventh Session of the IBC(2); 10. Work Programme of the IBC for 2002-2003 and preliminary proposals for 2004-2007(2) ; 11. Closure of the Eighth Session of the IBC.

1. The Round Table is organized in co-operation with the Youth Coordination Unit of UNESCO (BPE/UCJ). 2. Items 9 and 10 will be examined during meetings reserved for the members of the IBC.

20 Chapter 2

HUMAN GENETIC DATA: PRELIMINARY STUDY BY THE IBC ON ITS COLLECTION, PROCESSING, STORAGE AND USE

Rapporteurs: Sylvia Rumball and Alexander McCall Smith

This Report was revised on the basis of discussions at the Eighth Session of the IBC (Paris, 12-14 September 2001) and of written comments sent by members of the IBC. It was further revised on the basis of discussions at the first meeting of the Drafting Group of the IBC (Paris, 11-12 February 2002) and written comments sent by members of that group. The purpose of the Report is to document the range of issues contained within the topic ‘Collection, Processing, Storage and Use of Human Genetic Data’. It is by nature a preliminary document and should not be regarded as definitive. It is recognized that some issues need further development, for example issues concerning databases, ownership of human genetic data, the differing requirements of identified, de- identified and anonymous biological samples and the impact of the purpose (medical, research, forensic, etc.) for which the samples were collected on the procedures. The guidelines themselves, including both their order and number, are to be regarded as preliminary. As agreed at the Eighth Session, this Report will be used by the Drafting Group of the IBC as a working document for the drawing up of an international instrument on human genetic data.

21 I. Introduction 1. Every scientific revolution brings with it a host of ethical and social questions. The so-called genetics revolution is no exception, giving rise to a broad international debate on how the undoubted benefits of progress in this area can be reconciled with certain core human values. 2. General guidance for researchers concerning the conduct of research with human participants has been provided in various international documents, particularly the Nuremberg Code, the World Medical Association Declaration of Helsinki and the International Ethical Guidelines for Biomedical Research involving Human Subjects of the Council for International Organisations of Medical Sciences (CIOMS). 3. One of the most significant contributions to this debate has been UNESCO’s Universal Declaration on the Human Genome and Human Rights, adopted by the General Conference of UNESCO in 1997 and endorsed by the General Assembly of the United Nations in 1998. This document, which was conceived and elaborated by the International Bioethics Committee of UNESCO (IBC), has proved to be a firm foundation for the debate, setting out basic propositions as to the moral status of the human genome. It represents international consensus on how our genetic inheritance should be treated, placing moral limits to what may be done with genetic knowledge. 4. The Universal Declaration on the Human Genome and Human Rights has proved to be a good reference point in a complex and sometimes confusing debate. Many voices have been raised, and there have been numerous statements on ethical issues by governmental and intergovernmental sources. Science itself has not ignored its responsibilities in this area and throughout the world scientific organisations have commented on the ethical principles that should guide the direction of scientific endeavour in genetics. The Declaration on Science and the Use of Scientific Knowledge, which was adopted at the UNESCO/ICSU World Conference on Science and endorsed by the General Conference of UNESCO in 1999, also provides guidance. As a result, a body of recommendations and regulations has built up. 5. The IBC has specific responsibility for promoting the Universal Declaration on the Human Genome and Human Rights and explaining its implications, a matter which it reported upon in its Report on this issue (Report of the Working Group on the Follow-up of the Universal Declaration on the Human Genome and Human Rights, 1999). The follow- up work has continued too, in a number of other forms. In particular, a

22 working group was set up to investigate issues of confidentiality, and this resulted in the publication of the IBC’s Report on Confidentiality and Genetic Data(1). 6. While there are indications that the Universal Declaration on the Human Genome and Human Rights is reaching its desired audience and is being taken into account in national deliberations, the need for UNESCO to play a role in the international debate on the ethics of genetics continues. Indeed, given the rapid developments in human genetics, with increasing numbers of genetic databanks being established, controversial uses of genetic data, and increasing non- medical use, it could be argued that this role is now more important than ever and is one that UNESCO is uniquely placed to fulfil. Through the encouragement of debate, UNESCO can assist individuals, institutions and States to translate the spirit of the Universal Declaration on the Human Genome and Human Rights into more concrete areas of concern. 7. At its meeting in May 2001 the Intergovernmental Bioethics Committee (IGBC) of UNESCO made the recommendation that the IBC should, when examining the issues related to genetic data, ‘distinguish between the different types of data and continue to examine the issue of disclosure of genetic information to third parties’. 8. The Director-General of UNESCO has therefore identified the issue of human genetic data as an area in which the IBC might assist in the elaboration of an instrument addressed to the international community, setting out the principles under which human genetic data should be handled, and this recommendation is contained within the Programme and Budget for 2002-2003 (31 C/5), which was approved by the General Conference of UNESCO in November 2001. The precise form of this instrument remains to be settled, but it has been proposed that ultimately there is a place for a declaration of the same status as the existing Universal Declaration on the Human Genome and Human Rights, sitting alongside it and complementing the principles which it proclaims. 9. The project would not be concerned with some of the broader ethical issues that are dealt with in the Universal Declaration on the Human Genome and Human Rights. Its focus would be on the very specific issue of how genetic information about individual persons, families and populations is collected, processed, stored and used. While this area may

1. These reports have been published in the Proceedings of the Sixth Session of the IBC (Rabat, Morocco, 1999) and are available on Internet (www.unesco.org/ethics).

23 seem narrow in scope, it gives rise to major questions of principle. It is also a central point in the wider debate on how personal information is to be protected in a world in which such information may be gathered and distributed with ever-increasing ease. It therefore addresses fundamental issues of human dignity as well as touching upon the fears that many people have as to how knowledge of some of the most intimate details of their lives might be protected from abuse. The topic is therefore one of considerable human rights significance while at the same time is one of major concern to the public. 10. In order to explore this issue a Working Group of the IBC was set up and met at UNESCO Headquarters on 14 and 15 June 2001 to discuss the possibility of drafting such an instrument (see Composition of the Working Group in Annex). During the course of the meeting, a wide range of issues was examined, beginning with a consideration of whether such an instrument was needed and ending with an attempt to identify, on a preliminary basis, what matters might be included within the instrument.

II. The Need for an Instrument 11. While numerous reports, recommendations, codes and laws dealing with the issue of human genetic data exist, the Universal Declaration on the Human Genome and Human Rights is currently the only universal international instrument. 12. At a regional international level, a prominent instrument is the Council of Europe’s Convention on Human Rights and Biomedicine, several articles of which are directly or indirectly concerned with genetic information. (Work is currently proceeding on the drafting of a genetics protocol to this Convention.) 13. Also at a regional international level, but emanating from non- governmental organisations, there are ethical statements from bodies such as the World Medical Association (Declaration on the Human Genome Project, 1992) and the Ethical Legal and Social Issues Committee of the Human Genome Organization (Statement on DNA Sampling Control and Access, 1998). 14. At a national level, statements and codes have been issued by research funding organisations, national ethical committees or professional bodies. Examples include statements from the Council for Science and Technology of Japan (Fundamental Principles of Research on the Human Genome, 2000), the American College of Medical Genetics (Statement on Storage and Use of Genetics, 1995), the UK Clinical

24 Genetics Society (Guidelines for DNA Banking, 1989) and the Health Research Council of New Zealand (Ethical Considerations for Research in Human Genetics, 1998). There are also national data protection or privacy laws, the effect of which is to establish protection, to a greater or lesser extent, of the confidentiality of human genetic data. 15. Even though there are already many statements, guidelines and codes dealing with the issue of genetic data, the changing conditions in which genetic research is being conducted creates a strong case for a universal international instrument. These changing conditions include the increasing involvement of the private sector, the rapid increase in the number of human genetic databases, the controversial nature of some proposed uses and the international character of genetic research, this latter factor introducing the possibility of variation in the standards applied to research and variation in the regulatory frameworks. In particular, researchers may seek raw genetic data from people living in countries where there may not be an adequate level of protection. The need to recognize the rights of vulnerable populations in respect of genetic data is crucial, and the authorities in such countries may be expected to welcome international guidance on appropriate standards of protection. By virtue of its acknowledged status as guardian of cultural and intellectual patrimonies, UNESCO is better placed to provide this guidance than most other bodies.

III. Definition of Human Genetic Data 16. The human body is made up of a large number of cells with similar characteristics. Each human cell contains a nucleus that contains 23 pairs of chromosomes. One member of each pair of chromosomes in an individual is derived from the father and the other from the mother. Each chromosome contains DNA which carries genetic information in an encoded form. All the DNA contained in all the chromosomes is called the genome. Biological samples from which DNA is commonly extracted are blood, tissue and cells from the inside of the mouth or other body fluids such as semen. Blood samples may include cord blood which is representative of the foetus. 17. A gene is a segment of DNA that contains information for the synthesis of RNA molecules required for synthesis of proteins within the body. The human genome is believed to contain of the order of 30,000 genes, and a complete set of genes is present in every cell of the human body. Genes are discontinuous and include non-coding regions as well as regions coding for proteins. Presently the functions, if any, of most non- coding regions are not known.

25 18. Genetic information is encoded in the DNA as a sequence of nucleotides. This information is passed on from one generation to the next, virtually unmodified. The sequence of nucleotides in the DNA may be determined and stored, for example in a computerized DNA databank. 19. Thus, genetic material and genetic information (the sequence of nucleotides in the DNA) can be separated, and the information can be stored separately from the biological material from which it was determined and thus become available for subsequent research. As such genetic information acquires a status of its own. 20. DNA sequences between two individuals are largely similar, but contain a sufficient number of differences to be able to distinguish them based on their DNA sequences. Often, certain characteristics of the DNA sequences are exploited for easier DNA profiling of individuals. One of these characteristics is that segments, typically non-coding segments, of the DNA contain short sequences of nucleotides that are randomly repeated a large number of times. Often there is variation in the number of repeats across individuals. The number of repeats at many such highly-variable DNA segments provides the DNA profile of an individual. Such DNA profiling data are commonly used in crime detection and forensic medicine and in some countries there are now large databases of DNA profiles. 21. Information about the number and state of the chromosomes, called a karyotope, is also relevant to a person’s genetic identity and may be determined from a laboratory examination of a blood sample. Abnormalities in chromosome structure are generally not conserved through generations. The written description of the karyotope thus constitutes another form of human genetic data. The slides used in the laboratory for karyotope examination may also be stored and therefore also need to be considered. 22. The term human genetic data thus includes karyotope data, DNA sequences and DNA sequence variants (called alleles) such as mutations, single nucleotide polymorphisms, short tandem repeat polymorphisms and insertion/deletion polymorphisms. While this Report is focused on the issues of collection, processing, storage and use of human genetic data, it will also include issues concerning the collection, processing, storage and use of the biological samples from which the human genetic data are derived. 23. In a broader sense, the term human genetic data, when applied to an individual, may be taken to include any information about the heredity of that person. This information may be derived in a number of ways.

26 (a) The taking of a family history through interviews with family members and the analysis of medical records supplied by family members. The information obtained in this way includes written records of names, dates of birth, addresses, history-based descriptions of phenotypes, information about medical conditions and biological inter-relationships among the family members (family pedigrees). In this process, information collected about the presence of genetic conditions in other members of a person’s family enables conclusions to be reached about that person’s genotype. These conclusions, of course, depend on our knowledge of patterns of inheritance and may be confined to statements of possibility. Nonetheless, the statement that a person has a fifty per cent chance of having a particular genetic condition because one of his parents had that condition amounts to genetic information. (Such statements, of course, were possible even before the existence of genes as such was known. At the time that Mendel developed his system, the existence of DNA was undiscovered. All that was known was that there were rules of heredity; the precise operation of the process was not discovered until the twentieth century.)

(b) Direct observation of a person’s phenotype.

Such information would be a written record by the observer of the appearance and characteristics of the person. This may include the results of biochemical analyses of specific substances in the blood, urine or other body fluids/tissues. On the basis of this observation it may be possible to reach a conclusion concerning that person’s genotype or the state of the person’s chromosomes.

(c) A laboratory-based gene products analysis. This type of analysis determine the presence or absence of particular proteins. From this information conclusions can be drawn about the state of the genes that coded for those proteins. For example, the absence of the protein dystrophin indicates Duchenne’s muscular dystrophy and hence indicates an

27 abnormality in the gene coding for this protein. The written record of these proteins thus constitutes another type of genetic information. 24. A decision is therefore required as to whether principles pertaining to human genetic data should include all the above forms of genetic information or whether they should be restricted to direct information about the DNA and the chromosomes. The arguments in favour of each position are: (a) In favour of including all forms of genetic information. Consistency requires that any regime be applied equally to all forms of genetic information, however it is obtained. There is no reason in principle why information about the DNA and the chromosomes should be treated as more significant than other information which is effectively information about DNA, although obtained by a method other than DNA sequencing or DNA profiles. Exclusion of family history information from the scope of any recommendations could mean that protection of a person from breach of confidentiality becomes dependent on the method by which the information was obtained. As a result, an assessment of genetic risk derived from a family history could be used in a discriminatory way in the context of employment or insurance.

(b) Against including all forms of genetic information. DNA testing is capable of disclosing a much greater range of information about an individual than indirect methods. Emerging chip technology will enable tests to be done for tens of thousands of sequences at a time, thus enabling information to be elicited relating to many conditions. DNA sequencing is therefore much more powerful and potentially informative than phenotypical observation or family history-taking. The public perception also is that the results of DNA tests are matters of greater sensitivity than the selective, focused information obtained from, say, family history-taking. A person’s genotype is seen as revealing something about his or her uniqueness as an individual. It therefore falls into a category of particularly personal information, that needs special protection.

28 25. For the purposes of this Report, we recommend that the broader rather than the narrower definition of human genetic data be used i.e. the term ‘human genetic data’ will include all forms of genetic information, irrespective of whether they were obtained directly or indirectly. This is consistent with the position taken in the Report of the IBC on Confidentiality and Genetic Data.

IV. General Issues Concerning Human Genetic Data 26. Human genetic data differs from general medical data about an individual in that they are of direct significance for the health of biological relatives, both living and unborn. Living relatives may, or may not, be aware that this information is being generated. Such family members may have a legitimate interest in the genetic material of their relative or in the information generated from testing. In addition, partners and spouses of family members may also have an interest because of concerns about the health of yet unborn children. 27. Exercise of the right not to know the results of genetic testing also needs consideration. Because families share genes, it can sometimes be very difficult to protect the right of one person to know about his or her genetic future while simultaneously protecting the right of a related person not to know. 28. The ownership of human genetic data requires further consideration. Are human genetic data a national resource or are they to be regarded as the property of the individual, group or community and a resource with economic potential?

V. Processing and Storage 29. The processing and storage of the human samples and genetic information derived from them can be summarized as follows: (a) The samples are labelled on collection and both the sample and the data derived are identified as belonging to a particular person. The sample may be destroyed or kept as agreed with the donor. Disposal should be by a method that is culturally appropriate. (b) The samples are not labelled on collection. (c) The samples are coded on collection and the identity of the person to whom the code relates is stored separately from the samples and derived data. Such samples are referred to as de- identified. Only specified persons have access to the identifying

29 code. Samples are destroyed in a culturally appropriate manner or kept as agreed with the donor. (d) Samples are collected anonymously. There is no linkage between the donor and the genetic data. Note that where human genetic data have been de-identified or anonymized, the opportunity for donors to receive the results of the testing has been lost. Note also that sometimes even when the data have been de- identified or anonymized, the group identity of the person is retained along with the data. This situation needs also to be addressed as the group identity may be used for purposes of group discrimination/stigmatisation. 30. Access to genetic information in computerized databases requires special care to ensure that unauthorized persons do not gain access to it. This would include password protection and procedures for the protection of information during the upgrade and replacement of computers. 31. Access to genetic data after the death of the person from whom it was obtained presents special issues. Who, if anyone, should have access to these data? Such data may be of significance in the diagnosis and genetic counselling of children, grandchildren and other close relatives. A related issue which needs to be addressed concerns the collection of genetic data after the death of a person, for example from exhumed material. 32. Storage of and access to data obtained during prenatal screening also need clarification. 33. Where human genetic data are derived from direct analysis of the DNA, the obtaining of a sample of cells from the person concerned will be required. The ways in which blood, body fluid or tissue are obtained and the conditions in which they are stored or destroyed raise important ethical issues. Any statement of principles will therefore need to deal with the proper handling of the sample itself, as well as the handling of the human genetic data obtained from the sample. 34. Serious issues arise in relation to genetic research performed on archived collections of human samples, for example tissue samples which have been obtained at some time in the past for a different purpose. These historical collections can be important resources for research into human disease, as has been shown by the use in influenza research of samples of lung tissue taken from victims of the influenza epidemics of the early twentieth century. More recent collections raise issues of the rights for donors of tissue who may still be alive.

30 35. The IBC recommends that an instrument on genetic data should include provisions relating to the handling and storage of the human samples from which the data are obtained. This should include provisions dealing with both samples given for the purpose of genetic analysis and tissue originally obtained for other purposes.

VI. Purposes for Collection 36. Genetic information is obtained for a variety of purposes that are not necessarily mutually exclusive. These may be classified as medical, social and research and development as follows:

(a) Medical ƒ Diagnostic testing This refers to the identification of the cause of a disease.

ƒ Pre-symptomatic testing This refers to the identification of healthy individuals who may have inherited a gene for a late-onset disease and if so will develop the disorder if they live long enough (e.g. Huntington disease).

ƒ Predictive/susceptibility testing This refers to the identification of healthy individuals who may have inherited a genetic predisposition that puts them at increased risk of developing a multifactorial disease, such as coronary heart disease or hypertension or monogenic diseases with incomplete penetrance such as breast cancer due to mutations in BRCA1 or BRCA2 genes but who, even so, may never develop the disease in question.

ƒ Carrier testing This refers to the identification of either healthy persons who may have inherited a mutated gene for a particular disease but which is not expressed in those persons or healthy persons who are carriers of balanced chromosomal rearrangements such as translocations and whose offspring are at risk of being affected.

31 ƒ Prenatal testing This refers to the genetic testing of developing foetuses that can be used to diagnose diseases or the likelihood an individual will develop a disease. It should be noted that this information will form part of the health record of the person to whom it pertains and that this raises issues as to the how, and at what age, the information will be communicated.

(b) Social • Identification, for both forensic purposes and for the establishment of the relatedness of individuals, including paternity. • Study of physical and psychological abilities. • Identification of health risks for insurers and employers.

(c) Research and Development ƒ Determination of the sequence of the human genome; ƒ Population studies to establish, for example, genetic relations between different ethnic groups or the distribution of a particular gene; ƒ Determination of the genetic basis of a disease; ƒ Determination of genetic susceptibility/resistance to a disease; ƒ Localisation of disease genes on chromosomes; ƒ Elucidation of the interaction of genes and environmental factors; ƒ Development of new drugs; ƒ Study of individual reaction to drugs. 37. The rationales for health-related testing and screening may be summarized as follows(2): (a) Screen and identify - to treat, - to counsel or educate,

2. Jones D.G., Selected Legal Issues in Genetic Testing: Guidance from Human Rights. For the Health Canada Advisory Committee on Genetic Testing for Late Onset Diseases, 2000.

32 - to isolate or segregate, - to monitor or trace, - to warn or protect third parties, - to exclude, disqualify, transfer, discharge.

(b) Screen and not identify - to count, survey or track diseases, - to study or research.

VII. Providers of Human Genetic Data 38. Persons providing samples for genetic testing may be grouped as follows (included also is an indication of the needs of each group).

(a) Randomly selected individuals:

(i) Information provided for a single purpose, (ii) Information provided for multiple use.

(b) Individuals selected on basis of disease incidence / susceptibility / appearance.

(c) Persons recruited as part of a group defined according to: (i) Ethnic origins, (ii) Geographic origins, (iii) Behavioural attributes, (iv) Chronological age. These groups would, in some countries, include persons taken into custody by the police.

VIII. Principles 39. The substantive principles which will inform the standards to be adopted with respect to the collection, processing, storage and use of human genetic data may be deduced from current human rights standards. These principles include:

33 (a) Respect for Human Dignity

This refers to the intrinsic worth and identity of human beings. It is included in the Charter of the United Nations, in the Universal Declaration of Human Rights and in Articles 1 and 2 of the Universal Declaration on the Human Genome and Human Rights. Genetic testing raises the concern that persons may be viewed as no more than their genetic characteristics. In addition Article 4 of the Universal Declaration on the Human Genome and Human Rights states that ‘the human genome in its natural state shall not give rise to financial gains’.

(b) Autonomy and Freedom

Genetic testing must not be undertaken without free and informed consent and wide-spread discussion for circumstances authorizing non-consensual genetic testing. The Universal Declaration on the Human Genome and Human Rights recognizes this in Article 5 and Article 9.

(c) Privacy and Confidentiality This principle is recognized in Articles 7 and 9 of the Universal Declaration on the Human Genome and Human Rights. The principle is not an absolute one and the justification for the exceptions need to be widely-debated (see in this regard the Report of the IBC on Confidentiality and Genetic Data).

(d) Equality and Non-Discrimination Respect for human dignity means that individuals should not be burdened, mistreated or oppressed due to prejudicial attitudes about such attributes as biological status, race, religion, gender, age, disability. The application of this principle to genetic testing raises important questions concerning the grounds on which an individual is protected against genetic discrimination. It is recognized in Articles 2 and 6 of the Universal Declaration on the Human Genome and Human Rights.

(e) Justice and Solidarity The multiple aspects of justice – ‘distributive’, ‘procedural’ and ‘reparative’ – have direct application to genetic testing. The concept of distributive justice is relevant to how society allocates the risks, benefits and burdens of genetic testing. These range from access to

34 genetic testing services, to unduly burdening populations, to the allocation of genetic testing benefits and burdens between generations and between countries. It is particularly important that research efforts should promote health universally and so include developing countries. Article 17 of the Universal Declaration on the Human Genome and Human Rights draws attention to the need for States to respect and promote the practice of solidarity. The concept of reparative justice refers to the right to just reparations of those aggrieved or otherwise wronged by genetic testing initiatives. This is recognized in Article 8 of the Declaration. Procedural justice refers in part to fair process and procedure for dealing with alleged legal wrongs from genetic testing. It also raises questions about meaningful, inclusive and fair processes of decision-making on genetic testing at the individual, institutional and societal level. 40. Substantive principles alone are not sufficient to determine policy outcomes especially when there are conflicts between principles. An example of this would be conflicts between the principle of solidarity and the principle of confidentiality in relation to genetic information which may be of benefit to other family members. There may be cases in which breaching the right to confidentiality of an individual may appear to be justified in order to avert a serious risk to the life or health of another. Clear processes and fair procedures are essential for addressing, deliberating and mediating such conflicts. From the above discussion, a number of process values can be identified. These include: (a) Transparency of process and procedures, (b) Fairness of process and procedures, (c) Meaningful and inclusive involvement of society in decision- making, (d) Education of society, (e) Quality control (of laboratories undertaking genetic testing) Article 13 of the Universal Declaration on the Human Genome and Human Rights indicates the responsibilities of researchers in carrying out their research. These include meticulousness, caution, intellectual honesty and integrity, (f) Monitoring and evaluation of processes As stated in Article 13, it is important that public and private science policy-makers ensure that there are mechanisms for ensuring that proper processes are being followed.

35 IX Application of the Principles

41. Acceptability of purpose for which human genetic data is collected

Guideline 1 (a) Human genetic data may only be collected, processed, and stored and processed for the following purposes: - the provision of health care; - research intended to further understanding of the structure and function of the human genome; - the identification, in accordance with the provisions of national law, of those suspected of involvement in crime; - the identification in the context of military service or for the purpose of identifying the victims of accidents or disasters, or for any other identification purpose authorized by national law and which is in conformity with the principles of international human rights law. (b) Human genetic data may not be collected, stored or communicated for any purpose which is inconsistent with the principles set out in the Universal Declaration on the Human Genome and Human Rights.

COMMENTARY This initial principle stipulates that human genetic databases should only be established and operated for beneficial purposes. Thus, it would not be acceptable to collect or use genetic data for purposes of pursuing a programme of discrimination against a particular section of the population. Similarly, the collection of human genetic data in order to pursue a eugenic programme would be impermissible under this provision. Research into behavioural genetics might fall under the health grounds stated above. If its focus were criminological or intended to measure and enhance intellectual ability or competence in the performance of tasks, then this might be considered to be research into the workings of the human genome. The acceptability of such work in any particular case would then depend on whether it was linked with an objective prohibited by the Universal Declaration on the Human Genome and Human Rights. The provisions on identification raise issues of some complexity and sensitivity. Many countries now have forensic DNA databases, the aim of which is to link suspects with DNA samples obtained at the scene of a

36 crime. The effectiveness of these databases as a means of apprehending offenders is well-established, but concerns have been expressed over the civil liberties implications of these measures. For this reason, a number of countries limit the circumstances in which samples for DNA testing may be taken or retained on forensic databases. The wording of the principle above recognizes that national laws will differ on this issue. The collection of human genetic data about individuals for insurance or employment purposes is controversial and is the subject of legislative restriction in some countries. The principle stated above would preclude the testing of an individual specifically for these purposes, but would not preclude the communication of information about a genetic test which has been taken in a medical context. This issue will require further consideration. The collection of human genetic data for the provision of health care to an unborn raises issues that also need to be addressed.

42. Transparency of purpose

Guideline 2 The purposes for which human genetic data are collected should be made clear to donors of data-producing samples by those responsible for the collection.

COMMENTARY The aim of this principle is to prevent the building up of databases on the strength of false representations as to purpose or through the concealing of intentions.

43. Role of education

Guideline 3 Those promoting the collection of human genetic data should make every effort to inform the public of the purposes to which their collections may be put and to engage the public in debate over controversial issues. Health authorities, and those communicating with the public on issues of science and health, should endeavour to ensure an adequate level of public understanding of the benefits of the use of human genetic data in the context of health provision and health research before introducing new procedures.

37 COMMENTARY A reasonable level of public understanding of human genetics is important if there is to be better understanding of the objectives of genetic research. This is particularly important in communities in which the public will be invited to participate in long-term research programmes into common illnesses. These research programmes, which could offer substantial benefits for our understanding of disease, require the participation of large numbers of people. An atmosphere of distrust of genetics could seriously affect these research projects. Specific mention is made of the responsibilities of communicators (journalists and others). The irresponsible reporting of science may threaten legitimate research; the responsibilities of journalists to report fairly and accurately need to be stressed.

44. Public consultation and involvement

Guideline 4 The establishment of any collection of human genetic data should be preceded by public consultation at the appropriate level. The views of interested organisations and individuals should be taken into account in the formulation of policies regarding administration and control of the database.

COMMENTARY There is widespread acceptance of the need for public consultation in science policy, even if it is difficult to ensure that consultation is with the public in the wider sense rather than just with a narrow range of interested opinion If science is to enjoy the confidence of the public and if abuses are to be prevented, science policy must be open to public scrutiny and take into account the views of those whose lives it will affect. The prolonged and major disputes over genetically-modified crops provides an example of how secretive or autocratic decisions as to what is best for people may be resented and may not accord with people’s own vision of what is in their best interests. To avoid these misunderstandings, there should be consultation with a wide range of interests in civil society.

Guideline 5 All matters pertaining to the collection of human genetic data and any research which may be carried out on it should be subjected to independent ethical assessment of the same nature as is applied to any other biomedical research involving the use of human research subjects.

38 COMMENTARY The provision relating to independent ethical assessment is an important one. Many countries now have research ethics committees, at national and local level, the function of which is to scrutinize research projects involving the use of human subjects. The collection of biological samples for DNA analysis is a form of research involving human subjects, and should therefore be subject to similar ethical controls. It should be emphasized that this scrutiny should not cease after the collection of data has been made. The subsequent use of the data and also of the samples themselves needs to be subject to ethical scrutiny as does the storage of and access to both the samples and the data. Membership of ethics committees should be diverse, and include members of the community(ies) providing the samples.

45. Cultural issues Guideline 6 (a) The human tissue from which genetic data are obtained, and genetic data itself, may be the subject of moral, social or religious beliefs. Those who collect human genetic data from communities holding such beliefs must give these convictions all due respect, endeavouring to do nothing to or with the genetic data, or the samples from which the data are derived, that would give offence to those from whom the samples and the data have been obtained. (b) National authorities promoting the collection of human genetic data from their populations should take into account the sensitivities of social, religious or ethnic groups within the population at large. Researchers must also observe the laws of the country in which their studies are conducted, as well as implementing the standards under which they work in their own country.

COMMENTARY This principle recognizes that there is considerable cultural sensitivity surrounding human tissue and genetic data. This matter has been substantially debated in the context of what has been called ‘gene prospecting’, the practice of collecting genetic data from isolated or indigenous populations. The genomes of such populations have the attraction to researchers of being relatively homogenous, which means that it may be possible to make a link between a particular genetic mutation and a phenotypical feature commonly observed within the community in question (such as immunity or particular susceptibility to an illness).

39 Community attitudes to these issues vary. Some governments have encouraged the collection of human genetic data in order to make this available to overseas researchers for financial gain. Consent is crucial here, and will be dealt with separately below, but the issue of respect for cultural and other sensitivities is important and it is this issue that the principle seeks to address. The Report of the IBC on Bioethics and Human Population Genetic Research(3) (1995) had dealt with these issues. Particular attention has also been paid to this question by the ELSI Committee of the HUGO project, which has issued a statement setting out the responsibilities of those obtaining human genetic data from other communities.

46. Counselling Guideline 7 (a) The genetic testing of an individual for diagnostic purposes should be accompanied by suitable arrangements for the provision of relevant information both before and after a genetic test is undertaken and also for support in those cases where the test results may have serious implications for either the person tested or for others. (b) Consideration should also be given to methods of ensuring that those to whom genetic information is given are aware of the need to exercise caution in the passing on of this information to relatives who may themselves be affected by it.

COMMENTARY Testing a young person for a devastating monogenetic disorder would be irresponsible if no arrangements were made to explain the implications of such testing and to assist in dealing with the psychological consequences. Parentage testing may also have serious consequences for individuals and for families, and it would be advisable to stipulate a counselling element for this form of testing.

47. Validation and reliability Guideline 8 The obtaining of human genetic data from tissue samples should only be undertaken by persons whose expertise is established. Genetic tests should be properly validated for the purposes for which it is intended to use them.

3. See the Proceedings of the Third Session of the IBC (September 1995).

40 COMMENTARY It is important to ensure that if human genetic data is to be used for the purpose of diagnosis or identification it should be reliable and that claims for its diagnostic weight or its capacity to identify should be justified. This principle would have the effect of encouraging the setting out of laboratory standards. It would also discourage the use of tests supplied direct to the public (over-the-counter tests) unless such tests are approved by the appropriate authorities.

48. Limitation of use

Guideline 9 The genetic analysis of samples should be limited to the purposes for which the information is legitimately acquired.

COMMENTARY The aim of this principle is to prevent the analysis of samples beyond the scope of initially agreed upon purposes. If a person agrees to testing for one disease, it is not necessarily the case that he or she would consent to testing for another disease. Similarly, samples obtained for forensic identification purposes should not be subjected to testing aimed at diagnosing disease or determining behavioural characteristics.

49. Informed consent to diagnostic testing

Guideline 10 (a) In the case of any diagnostic genetic test which may have serious implications for the welfare, psychological health or family relations of the person tested, no test shall be administered unless the person consents after being informed that the test is a genetic one and is informed of its implications. Consent may be given for the future testing of samples should new tests be indicated or become available. (b) Where a person to be tested is unable to give a valid consent on the grounds of minority or on the grounds of mental incapacity, then the consent should be obtained from any person legally authorized to give such consent on behalf of the minor or incapable person after full account has been taken of the present and future impact which the test might have upon the tested person.

41 COMMENTARY Genetic testing is likely to become increasingly common as the genetic component of disease is further identified and as progress is made in pharmacogenetics. Many tests which reveal genetic information will not have a great deal of significance for the person tested (a blood group test, for example, reveals genetic information in that blood grouping is based on genetic factors. Other tests, however, will have major implications, both for the individual and for relatives. The principle stated above sets out the consent requirements. For practical reasons, it would be unrealistic and unnecessary to require that there be specific consent to the genetic component in any test unless the consequences of this are sufficiently serious to justify this.

50. Free and informed consent in research Guideline 11 (a) A research sample may be collected from a person only after the person has first been given a sufficient explanation in an appropriate style and language of: - the purpose for which the sample is collected; - the source of funding for the research; - the type of use which will be made of the sample or any information derived from it; and - any other implications which the collection and subsequent use of the sample might reasonably be expected to have for the person providing it. (b) The consent should be expressed in writing unless there are cultural reasons for not doing so, in which case other possibilities of publicly recording consent should be explored. (c) Donors of samples for research purposes should not be subjected to any pressure or improper inducement in order to secure their consent. A person who refuses to consent should not suffer any adverse consequences as a result of this refusal, and all potential donors should be given an assurance to this effect. (d) Samples donated for research purposes should not be made available for other purposes, such as police use, and national legislation should seek to prevent such use.

COMMENTARY The consent requirements in the research context are more rigorous. A difficult question in this area is whether fresh consent has to be obtained if new research of a different nature is to be conducted on samples

42 originally given for another form of research. A system which required fresh consent would be extremely cumbersome and could seriously inhibit research and it is for this reason that a system of ‘blanket consent’ covering all forms of future medical research might be preferable, provided that the consent given in the first instance explicitly recognizes this. This is envisaged in the wording above which requires that information be given as to the ‘type of research’ involved. It would, of course, be ethically impermissible to carry out non-medical research on samples donated solely for medical purposes.

51. Obtaining research samples from those unable to consent Guideline 12 Where consent to the collection and use of a research sample is sought from a person who is unable to give a valid consent on the grounds of minority or on the grounds of mental incapacity, then the consent should be obtained from any person legally authorized to give such consent on behalf of the minor or incapable person after full account has been taken of the present and future impact which the test might have upon the tested person. Such consent should only be given if any adverse implications for the tested person are negligible and if this conduct of research in these circumstances is permitted by national law.

COMMENTARY There has been considerable discussion in biomedical ethics of the legitimacy of conducting research on minors and people affected by a mental incapacity. While there continues to be some disagreement on the matter, a defensible position is to allow such research to be carried out provided that (a) there is no other way of conducting the research; (b) the research is of clear benefit to the community and, in particular, of benefit to the category of persons from which the subject is drawn (that is, the research is of benefit to minors or to those affected by any condition from which the mentally incapable person suffers); and (c) there is negligible risk or discomfort for the participant.

52. Withdrawal of informed consent Guideline 13 Providing samples and derived data have been stored in an identifiable manner, donors may request that those samples and any human genetic data derived from them be returned to them or destroyed.

43 COMMENTARY This embodies the principle endorsed in the major codes relating to the use of human subjects in research that the subject may withdraw consent at any time during the course of the research. A possible objection to this is the inconsistency which this involves with the principle of donation. An alternative approach would be to treat the giving of a sample as amounting to a donation, thus transferring full ownership and control over the sample to the researcher. In favour of recognizing a continued interest on the part of the provider of the sample is the proposition that people do not wish to relinquish control over genetic information about themselves. If the researcher has complete and ultimate control over the sample, then it might be possible to extract from the sample information which the ‘donor’ might wish to keep confidential.

53. Confidentiality/Anonymity

Guideline 14 Donors of samples for genetic testing, both individuals and communities, should be informed prior to giving consent whether their samples and genetic data will be identified, coded but identifiable, or not identifiable (anonymized), and the meaning of these terms should be clearly explained.

COMMENTARY This recognizes the various forms in which samples might be stored and requires that those be explained to the donor of a sample. Issues concerning a population identifier need further discussion.

54. Fate of material

Guideline 15 Donors of identified samples must consent to whether their samples, extracted DNA, and genetic information will be stored or disposed of. If human samples are destroyed it must be done in a way that takes into account any sensitivities which donors may have regarding this process. If stored, the donor must be told where the sample will be stored. Tissue or DNA should not be exported without the consent of the donor.

44 COMMENTARY The aim of this principle is to prevent subsequent use of samples to which the donor might reasonably have objected. In particular, insensitive destruction of tissue is a matter on which people may have strong views, particularly if the tissue is obtained through post-mortem examination. The exporting of samples is also a matter on which people may be sensitive.

55. Sharing information

Guideline 16 If those conducting research do not envisage informing the donors of samples of any results obtained from testing individual samples, then this fact should be communicated to the donor prior to obtaining consent for the taking of the sample. Where the overall results of research projects can be communicated to the donors, then it is good practice to arrange for this to be done, either individually or through the use of appropriate means of mass communications both to individuals and to families and populations.

COMMENTARY The issue of ‘feedback’ to participants in research is an extremely difficult one. In small research projects, involving relatively few participants, it is desirable that there should be communication to individual participants of any information which emerges which is relevant to their health, provided, of course, they have indicated that they would wish to hear it or, in the particular circumstances, they might reasonably be expected to wish to have this information. This practice, however, is not followed in large- scale epidemiological research projects, as this converts the nature of the exercise from a research one into a mass screening undertaking. The latter might have quite different budgetary and counselling implications and would have the effect of preventing some forms of research from being done in the first place. For this reason, the duty to inform is restricted in this principle.

56. Post-mortem samples

Guideline 17 The taking of samples from the dead for the purposes of obtaining human genetic data should only be undertaken in the following circumstances:

45 (a) the sample is required for the purposes of criminal or civil justice and has been legally authorized for these purposes; (b) the taking of the sample has been authorized by the next-of-kin of the deceased person and there is no evidence that the deceased person might be expected to have objected to the purpose for which the sample is sought; (c) the person from whom the sample is taken has been dead for such a length of time that there is no reasonable prospect of offence being given to identifiable descendants. Where there is a contemporary community which reasonably considers itself to be linked with human remains in this category, then the consent of such community should be obtained before a sample is taken.

COMMENTARY It is generally accepted that the dead should be treated with respect, the content of that respect varying from culture to culture. The DNA testing of the dead is potentially an infringement of privacy rights which the deceased enjoyed during his or her lifetime. There are, however, legitimate purposes which might be served by testing the dead (these may be research purposes or they might be purposes connected with the diagnosis of illness in a person related to the deceased). In these circumstances, unless it is known that the deceased held an objection to the procedure, there might be a presumption of altruistic intent and testing might be permissible. The provisions relating to those who died a considerable time ago recognize that the moral claims which the dead may have are weakened by the passage of the years. At the same time, there are some communities which feel strongly about even very old remains and their feelings should be respected.

57. Historical or archived collections

Guideline 18 The obtaining of human genetic data for medical research purposes from historical collections of human tissue should only be undertaken without the consent of the donor of the sample if the sample is anonymized. If the sample is not anonymized, the consent of the donor should be obtained, provided that the donor can be traced with reasonable effort.

46 COMMENTARY Historical collections of tissue are of great importance in medical research. The denial of these collections to researchers would impede medical progress and for this reason their accessibility to researchers should not be barred. If it is possible to identify the donor and trace him or her without excessive difficulty, then that would be consistent with an approach which recognizes the importance of consent in general. However, in many cases this will not be possible; in which case the samples should be anonymized before being used without consent.

58. Rights of children

Guideline 19 When children are the providers of samples for DNA analysis, investigators must ensure that: (a) the children and their parents, guardians or caregivers have been fully informed, and that the information for children is presented in a style appropriate to their age; (b) where a child has the competence to understand the nature, risks and consequences of the proposed procedures the consent of the child is obtained; (c) where a child lacks the necessary competence: (i) the child’s parents or legal guardian gives permission for the child’s participation; (ii) the child’s assent must be obtained; (iii) the child’s refusal is respected; (iv) presymptomatic testing of children at risk of late onset diseases such as Huntington’s disease is not permitted even when the parents or legal guardian consent to or request this.

COMMENTARY The special vulnerability of children requires that special ethical considerations should be in place for reviewing children’s involvement as providers of genetic data. The recognition that children are persons in their own right with their own unique set of interests requires that particular attention must be paid to the provision of information to children, the gaining of their consent and their right to refuse participation.

47 59. Collection of samples in other countries

Guideline 20 The collection of samples by researchers in a country other than their own, particularly where the researcher(s) are from a developed country and the collection is taking place in a developing country, must only be undertaken after appropriate consultation with the people of that country and according to the laws of both that country and the country of the researcher. Where ethics committees exist in the country where collection is to take place, permission must be sought from the relevant committee as well as an ethics committee in the country of the researcher. The country of origin of the samples should be disclosed in all publications resulting from the research.

COMMENTARY Persons in developing countries are particularly vulnerable to exploitation in the collection of biological samples for genetic testing. The research community must take particular care to ensure that the rights of individuals and communities providing samples are protected. Issues concerning ownership of the information and financial rewards from the use of the information must be considered. In addition, Article 19 of the Universal Declaration on Human Rights and the Human Genome makes it clear that developing countries must benefit from the achievements of scientific and technological research.

60. Collection of samples from indigenous peoples

Guideline 21 The collection of samples from indigenous peoples must only be undertaken after appropriate consultation with those peoples according to their customs and protocols and according to both the laws of their own country and the laws of the country of the researcher.

COMMENTARY Indigenous peoples are particularly vulnerable to exploitation in the collection of biological samples for genetic testing. The research community must take particular care to ensure that the rights of individuals, families and communities providing samples are protected. Issues concerning ownership of the information and financial rewards from the use of the information must be considered.

48 ANNEX

COMPOSITION OF THE WORKING GROUP OF THE IBC ON GENETIC DATA

Chairperson QUESTIAUX (Mrs) Nicole (France) Honorary Chairperson of Section of the State Council Vice-President of the National Consultative Ethics Committee for Health and Life Sciences Former Chairperson of the Permanent European Conference of National Ethics Committees Former Minister of Social Affairs

Rapporteurs RUMBALL Prof. (Mrs) Sylvia (New Zealand) Professor of Chemistry Assistant to the Vice-Chancellor (Equity and Ethics), Massey University Chair of the Massey University Human Ethics Committee Chairperson of the National Ethics Committee on Assisted Human Reproduction Former Dean, Faculty of Science, Massey University

MCCALL SMITH Prof. (Mr) Alexander (United Kingdom) Professor of Medical Law Vice-Chairman of the Human Genetics Commission of the United Kingdom Chairman, Ethics Committee, British Medical Journal

Members of the IBC BERLINGUER Prof. (Mr) Giovanni (Italy) Professor of Medicine Honorary Chairperson of the National Bioethics Committee Former Member of Parliament Former Director of the Department of Human and Animal Biology and of the post-graduate course in Bioethics, University of Rome

49 GALJAARD Prof. (Mr) Hans (The Netherlands) Emeritus Professor of Human Genetics Former Head of the Department of Clinical Genetics, University Hospital Rotterdam

IDA Prof. (Mr) Ryuichi (Japan) Professor of International Law Rapporteur of the Committee of Regional Economic Development Law of the International Law Association

JEAN (Mrs) Michèle (Canada) Adviser in programme development, Faculty of Higher Education, University of Montreal Member of the Commission of Ethics of Science and Technology of Quebec Former Special Adviser to the Minister of Foreign Affairs of Canada to the European Commission Former Vice-Minister of Health

KOSZTOLÁNYI Dr (Mr) György (Hungary) Professor and Chair of the Department of Medical Genetics and Child Development, University of Pecs Vice-President of the Faculty of Medicine of the University of Pecs Former President of the Hungarian Society of Human Genetics

Guests Prof. (Mr) André BOUÉ (France) Emeritus Professor of Medical Genetics, René Descartes University, Paris V Member of the National Consultative Ethics Committee (CCNE)

Dr (Mr) Derek JONES (Canada) Lawyer Lecturer in Health Law and Bioethics, McGill University Senior Research Fellow, Centre for Private and Comparative Law, McGill University

50 Chapter 3

REPORT OF THE IBC ON ETHICS, INTELLECTUAL PROPERTY AND GENOMICS

Rapporteur: Michael Kirby

I. The Problem 1. Immediate background: At the initiative of its Director-General, Mr Koïchiro Matsuura, UNESCO held from 30 January to 1 February 2001 in Paris an International Symposium on ‘Ethics, Intellectual Property and Genomics’, at the closing session of which the participants asked UNESCO to ensure an appropriate follow-up. The International Bioethics Committee (IBC) was entrusted with this task. A Working Group was therefore set up and met at UNESCO Headquarters on 13 and 14 June 2001 (see Composition of the Working Group in Annex). 2. History: The history of intellectual property can be traced back to classical times. Modern legal protection was given by monopolies granted by the Crown in England and France 400 years ago. The first international convention of relevance was the Paris Convention for the Protection of Intellectual Property of 1883. Since then there have been many municipal, regional and international legal developments that together create the network of the world’s intellectual property laws. Instead of more appropriate legal regimes being developed for recent technologies, generally the existing law of intellectual property has been pressed into service, sometimes with less than perfect results. 3. Subject Matter: The genome is not confined to the human genome. Genomics extends to the study of animal, microbial and plant genomes. However, the IBC has decided to single out for primary attention issues presented by patenting and the human genome. This is consistent with the focus of UNESCO’s Universal Declaration

51 on the Human Genome and Human Rights (1997). Nevertheless, some of the conclusions of the IBC will also be relevant, by analogy, to patenting of other genome sequences. 4. Basic Problem: The fundamental issue is how to secure the benefits of the first draft of the human genome sequence for the service of humanity as a whole. The publication of this first draft stimulates consideration of this issue and gives it an element of urgency. 5. Timing: The publication of the first blueprint of the human genome occurred in February 2001 in Science and Nature(1). The genome sequences of many other species have also been published in recent times. 6. Context: The problem must obviously be considered in the context of an accurate understanding of the international, regional and municipal laws on intellectual property and knowledge of practical developments involving the invocation of such laws(2). 7. What is happening: There has been an explosion in the number and variety of applications for patents in respect of the human genome in the United States of America, Europe and elsewhere. Especially controversial have been patents granted in some countries on primary sequences. These developments have given rise to a significant international controversy which the UNESCO Symposium addressed. 8. Benefits of intellectual property: The law on intellectual property serves useful purposes, has a foundation in ethical principles and universal human rights and often contributes to the benefit of humanity. The law protecting intellectual property can facilitate the investments necessary for large and expensive steps in scientific and technological research. Intellectual property protection can also provide an incentive to scientific and technological research and ensure the disclosure of the outcomes of such research to the world at large. Converting discoveries about the human genome from scientific data to beneficial therapies or useful tests is potentially problematic and expensive. Already, private investment in genomics has produced important advances that have accelerated human

1. Science (2001) 291, 1155; Nature (2001) 409, 813. 2. An analysis of existing international and national texts is available at the Division of the Ethics of Science and Technology of UNESCO and on Internet (www.unesco.org/ethics).

52 knowledge that will ultimately be to the benefit of humanity. The IBC recognises these potential advantages of intellectual property protection and the reality that legal protection exists and plays an important part in municipal, regional and international law and in the national, regional and international economies. 9. Concerns: (a) Change in the tradition of open science: Until very recently, almost universally, pure scientific research was substantially funded publicly. It operated in a culture in which individual scientists, universities and foundations did not seek or obtain financial benefits from primary scientific advances. This explains how, between 1920 and 1970, great progress was made in pharmaceutical developments (e.g. penicillin and other antibiotics and vaccines) with little demand for intellectual property protection. This contributed greatly to improvements in public health. In the 1980s, things began to change. An illustration of the change has recently come to light in the development of HIV therapeutic drugs. Although essential to the right to life and health of millions, the intellectual property protections effectively made such drugs mostly unavailable except in developed countries. This led to a public outcry, development of generic drugs, abandonment of court action taken to enforce intellectual property rights in South Africa and widespread public demand for removal of some intellectual property protections in respect of these therapies. Although they are not strictly developments of genomics, they present an illustration of dissatisfaction with the current international, regional and municipal legal regimes as they affect pharmaceuticals and tests vital to human life and health.

(b) Change in the balance of public and private research investment: There is a concern that a decline in public funding for general research is increasing the proportion of research funded by the private sector and hence changing the priorities of that research. Most of the early work on the Human Genome Project itself was, directly or indirectly, publicly funded in many countries. It would not have started without those funds and the insatiable curiosity of scientists unimpeded by large numbers of intellectual property protections.

53 (c) Character of genome as intimate to the human species: Never before in science have individual human participants and groups been so closely involved in, and necessary to, scientific and technological advances. The genomic sequence, from which tests and therapies are developed, begin in every case with a sample provided by an individual human being or samples provided by a group of the population concerned.

(d) Diversion of research priorities: Concern also exists about the potential diversion of research priorities into particular areas by reference to maximum financial rewards rather then those that reflect the greatest human needs.

(e) Premature protection: Concern exists about the rapid growth of intellectual property protection at a time when genome science is in its infancy, with the consequent risk that this coincidence will impede the flourishing of free and uninhibited research that should be possible at this time to take full advantage of the dramatic breakthrough in knowledge about human bio-sciences.

(f) The novelty requirement: Isolation and sequencing of DNA, translation of such DNA sequences to proteins and identification of functions by computer analysis have, to some extent, removed ‘novelty’ (one of the traditional basic criteria for patentability).

(g) Uncertainty about the genome in its ‘natural state’: A question is posed as to how far the ‘natural state’ of the human genome extends. This is referred to in Article 4 of the Universal Declaration on the Human Genome and Human Rights. The answer to that question is still uncertain. This is especially due to the complexity and evolving character of the concept. It can thus be subject to various interpretations. No settled interpretation yet commands universal or general acceptance.

54 (h) ‘Downstream’ use of scientific knowledge for new utility subsequently revealed: A specific concern is a tendency to seek and secure patent rights over genomic sequences of uncertain future utility, leading to a premature accumulation of intellectual property rights that may have a consequence of discouraging unimpeded research in respect of particular genes or in the proteins that they express, because of awareness of a prior intellectual property right with respect thereto. The grant of patents in terms that are unnecessarily wide will have large consequences ‘downstream’ as the subsequent significance of a particular gene – or that gene in interaction with others or with environmental factors – comes to be known.

(i) The duration of present intellectual property: The duration of patent protection of 20 years as a universal rule is arguably excessive having regard to the context of genomic sequences and the rapid advance of knowledge about them.

(j) Implications for developed and developing countries alike: The intellectual property protections already granted and applied for will potentially add greatly to the national health budgets of developed countries. The concerns about the consequences of intellectual property rights have obvious implications for developing countries. They will be burdened by the costs of licensing fees which will be applicable for many years. Such costs may render beneficial therapies or useful tests effectively out of the reach of such countries and most of their people. However, such concerns are not confined to developing countries.

(k) Analogous issues in other spheres: The problems raised by the application of the present intellectual property regime to rapidly evolving scientific fields were discussed, mutatis mutandis, by the COMEST Sub- Commission on the Ethics of Outer Space, in particular

55 concerning inventions, processes and products of the space industry(3).

(l) Equitable benefit sharing: Concern has been expressed about the lack of effective and fair benefit-sharing with many of the developing countries, from which genetic materials are commonly taken and technology transfer to such countries.

(m) Conflicting international rights: The IBC observes that there may be conflicts between the Trade Related Aspects of Intellectual Property Rights Agreement (TRIPs Agreement) and the realisation of internationally protected economic, social and cultural rights. In this regard it refers to Resolution 2000/7 of 17 August 2000 of the Commission on Human Rights which identified these conflicts as, ‘inter alia, impediments to the transfer of technology to developing countries, the consequences for the enjoyment of the right to food of plant variety rights and the patenting of genetically modified organisms, “bio-piracy” and the reduction of communities’ (especially indigenous communities’) control over their own genetic and natural resources and cultural values, and restrictions on access to patented pharmaceuticals and the implications for the enjoyment of the right to health’.

II. The International Framework The foregoing concerns of the IBC must be viewed in an international framework in which an increasing number of initiatives are being taken relevant to the provision of intellectual property protection in respect of human genome sequences. Many of these initiatives have emphasized the imperative need to share the remarkable scientific advances with all of humanity. Amongst these have been: 1. Universal Declaration on the Human Genome and Human Rights, November 1997;

3. See the Report of the Sub-Commission on the Ethics of Outer Space of the UNESCO World Commission on the Ethics of Scientific Knowledge and Technology (COMEST) (July 2000), available from the Secretariat and on the Internet (www.unesco.org/ethics).

56 2. Budapest Declaration on Science and the Use of Scientific Knowledge (non limitation of public funding of sciences), July 1999; 3. Clinton/Blair Statement, 14 March 2000; 4. Statement of the Director-General of UNESCO, May 2000; 5. Statement of G-8 Summit, July 2000; 6. Resolution 2000/7 of the United Nations Sub-Commission on Human Rights, 17 August 2000; 7. Millennium Declaration of Heads of State, September 2000; 8. UNESCO Symposium on ‘Ethics, Intellectual Property and Genomics’ (30 January – 1 February 2001); 9. Resolution 2001/71 of the United Nations Commission on Human Rights, 25 April 2001; 10. Resolution of European Assembly, 25 April 2001; 11. Statement of the Director-General of WHO to World Health Assembly, 14 May 2001; 12. Recommendation 17 of the Second Session of the Intergovernmental Bioethics Committee of UNESCO (IGBC), May 2001.

III. Approach

(A) General Framework It is appropriate to start an approach to the problem under consideration by taking into account a number of general principles: 1. The principles of the Universal Declaration of Human Rights (1948) (e.g. right to health protection and health promotion, right to the protection of the moral and material interests resulting from any scientific production) and the International Covenant on Economic, Social and Cultural Rights (1966); 2. The principles of the Universal Declaration on the Human Genome and Human Rights (1997), noting especially:

Article 1 The human genome underlies the fundamental unity of all members of the human family, as well as the recognition of their inherent dignity and diversity. In a symbolic sense, it is the heritage of humanity.

57 Article 4 The human genome in its natural state shall not give rise to financial gains.

Article 19 a) In the framework of international co-operation with developing countries, States should seek to encourage measures enabling: i) assessment of the risks and benefits pertaining to research on the human genome to be carried out and abuse to be prevented; ii) the capacity of developing countries to carry out research on human biology and genetics, taking into consideration their specific problems, to be developed and strengthened; iii) developing countries to benefit from the achievements of scientific and technological research so that their use in favour of economic and social progress can be to the benefit of all; iv) the free exchange of scientific knowledge and information in the areas of biology, genetics and medicine to be promoted. b) Relevant international organizations should support and promote the initiatives taken by States for the abovementioned purposes.

3. The main task of the IBC being the promotion of bioethical thought, it should be recalled that ultimately law serves the interests of the people and should reflect their ethical concerns. 4. An acceptance of the value of intellectual property law should also guide an informed response, including acceptance of the ethical values which intellectual property law is designed to uphold.

(B) Particular Ethical Principles In addition to the foregoing general principles, there are a number of particular principles specific to the human genome that need to be kept in mind in framing a response to the foregoing concerns: 1. The importance of [free] access to the benefits flowing from scientific knowledge in accordance with Article 27 of the Universal Declaration of Human Rights. It is vital to insist on the transparency of basic science and to a certain extent, Article 27 of TRIPs Agreement could impede this. Arguably, it conflicts with universal ethical principles

58 and with the Universal Declaration of Human Rights and with the Universal Declaration on the Human Genome and Human Rights. This conflict must be resolved. 2. The importance of equitable benefit-sharing, which has a dual aspect: (i) it involves sharing the benefits of research with the contributor of genetic materials and the populations and countries that participated in that research; and (ii) it also involves sharing the benefits with individuals and groups more generally to whom the research is relevant. To some extent presently operating laws, regulations and funding guidelines (e.g. National Institutes of Health Guidelines in the United States of America) promote observance of ethical standards but these need to be strengthened and made more clear and universal in their application. 3. The promotion of international co-operation with developing countries, including technology transfer within the framework of Article 19 of the Universal Declaration on the Human Genome and Human Rights, needs to be translated into action and current intellectual property law does not appear to sufficiently promote this.

4. The regulation of aspects of the human genome (including intellectual property aspects) should be the subject of genuine democratic debate in all countries. This should involve the people generally, indigenous peoples in particular; also special populations and groups subject to particular genetic conditions so that they understand and truly participate in decisions concerning genetic diversity and their future. The IBC recognises that much research on population groups will benefit such groups or the members thereof and patients everywhere subject to genetic conditions disclosed by such research. 5. Informed consent is now a universal ethical principle in research involving human beings, including research connected with the human genome, provision of genetic samples, treatment, etc. It is reflected in Article 5(b) of the Universal Declaration on the Human Genome and Human Rights. It should be scrupulously complied with.

59 6. Ultimately, there is a conflict or tension between ethical principles – those that uphold the right to protection of the creative inventions of the human mind and those that uphold the right to life, the right to health protection and promotion and the solidarity of the entire human family. In the context of intellectual property law it is necessary to resolve this conflict in a just way. The present intellectual property law, municipal, regional and international, falls short of doing this. Hence the IBC turns to consider proposals for future action.

IV. The Way Forward 1. The International Bioethics Committee (IBC) welcomes the Director- General’s initiative of creating of an inter-agency committee on bioethics with the task of improving co-ordination of the activities of participating organisations, and of considering bioethical issues which should give rise to increased co-operation, such as intellectual property related to genomics. It endorses the hosting by UNESCO of its first meeting in Paris on 17 September 2001. The IBC is fully committed to co-operating with the Director-General in this respect. 2. The IBC supports co-operation and consultation with HUGO, scientists, institutes and corporations involved in genomic research and development. 3. As is recommended in the Guidelines for the Implementation of the Universal Declaration on the Human Genome and Human Rights (Item 3.3.1), UNESCO should promote the establishment, where they do not exist, of national and regional bioethical bodies to encourage the participation of peoples generally, indigenous peoples and particular population groups in an informed debate about genomic developments. The political decision-makers and institutions, scientific bodies, universities and other institutions of learning, media, civil society organisations and other relevant bodies have a vital part to play in this dialogue that must go beyond consultation and involve active participation by those interested and affected. 4. The IBC supports the call of the Parliamentary Assembly of the Council of Europe for the widest possible participation by citizens in the discussion on the human genome(4). This discussion should extend to the current state of intellectual property law and practice.

4. Recommendation 15/2 (2001) 1. Para. 9

60 5. The IBC supports the expression of concern of the Director-General of WHO as to the potential risk for research on the human genome to widen the knowledge and technology gap between developed and developing countries and to focus on expensive treatments affordable by developed countries rather than readily marketable tests and therapies available more generally. It calls on UNESCO to work in close co-operation with WHO in its initiatives in this regard. 6. The IBC supports the general idea of benefit-sharing, an illustration of which would be the allocation to participating developing countries of a proportion of the net profits made by pharmaceutical companies(5).

V. Conclusions 1. The International Bioethics Committee (IBC) believes that, in the framework of its review of TRIPS Agreements, the World Trade Organization (WTO) should clarify that, in accordance with the provision of Article 27(2)(6), the human genome is not patentable on the basis of the public interest considerations set out therein, in particular, public order, morality and the protection of human life and health. All concerned institutions such as WTO and WIPO should be informed of UNESCO’s concerns as well as its proposed solutions. 2. The IBC recommends that UNESCO promote urgently the adoption of an international convention on ethical and other issues relating either to intellectual property and genomics, or on living matter including intellectual property and genomics. This convention would, inter alia, clarify that the public interest considerations set out in Article 27(2) of TRIPs Agreement constitute an exception to patentability in respect of the human genome. Alternatively, UNESCO should promote the development of a Code of Conduct addressed to States, natural and juridical persons, and international organisations, by building, inter alia, on the public interest

5. HUGO Ethics Committee Statement on Benefit-Sharing http://www.gene.ucl.ac.uk/hugo/benefit.html or ‘Genetic Benefit Sharing’ Vol. 290 Science (2000) p. 49 6. Article 27.2 of TRIPs Agreement reads: ‘Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or in order to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by their law’.

61 considerations included in the TRIPs Agreement. It should take this initiative in consultation with WTO and WIPO and other relevant interested groups and institutions both to stimulate and promote principled action by such bodies and by the international community. 3. The IBC will keep under consideration the question of an appropriate intellectual property regime either on the basis of its recommendations in paragraphs 1 and 2 or any other basis that takes into account the ethical concerns voiced by the international community and reflected in this Report. While a few members of the IBC had reservations about this conclusion, if no progress is made in this matter, at its next session the IBC will consider the feasibility of recommending that the Director-General of UNESCO propose to the General Conference that appropriate steps be taken towards a global moratorium on the grant of further patents in relation to human genome sequences. 4. UNESCO should consider taking an initiative within the United Nations system towards the establishment of a mechanism, possibly a fund, where necessary to acquire for the benefit of humanity the intellectual property that is privately owned in relation to human genome sequences. This mechanism or fund might be developed by analogy with the World Fund created by WHO for HIV/AIDS therapy and in a way similar to the mechanism or fund proposed by the IBC Report on Solidarity and International Co-operation between Developed and Developing Countries concerning the Human Genome. 5. The advances in genomics are occurring so rapidly that the subject matter of this Report should be kept under constant attention by the IBC. This Report should be reviewed within 1 year of its adoption so that the attention given to the proposals may be assessed and so that any changes made necessary by advances in scientific knowledge or technology can be taken fully into account. The IBC emphasises that it regards the subject matter of this report as both vitally important and extremely urgent. Without action, the current municipal, regional and international intellectual property regimes will continue to apply. More patents will be sought and granted in accordance with such laws. The spiral of patents in relation to human genome sequences will expand. The costs of future therapies and genetic tests will become prohibitive for most human beings and nations. Science will be restrained instead of encouraged. And a remarkable opportunity for humanity to act in a way defensive of the entire human species will be lost.

62 ANNEX

COMPOSITION OF THE WORKING GROUP OF THE IBC ON ETHICS, INTELLECTUAL PROPERTY AND GENOMICS

Chairperson ROBINSON (Mr) Patrick (Jamaica) Judge at the International Criminal Tribunal for the former Yugoslavia Member of the United Nations International Law Commission Former Deputy Solicitor-General Former Chairperson of the Inter-American Commission on Human Rights

Rapporteur KIRBY Justice (Mr) Michael (Australia) Justice of the High Court of Australia Member of the Ethics Committee, Human Genome Organization (HUGO) Former President of the Courts of Appeal of New South Wales and Solomon Islands Former President of the International Commission of Jurists

Members BERLINGUER Prof. (Mr) Giovanni (Italy) Professor of Medicine Honorary Chairperson of the National Bioethics Committee Former Member of Parliament Former Director of the Department of Human and Animal Biology and of the post-graduate course in Bioethics, University of Rome

GALJAARD Prof. (Mr) Hans (The Netherlands) Emeritus Professor of Human Genetics Former Head of the Department of Clinical Genetics, University Hospital Rotterdam

GUESSOUS-IDRISSI Dr (Mrs) Nouzha (Morocco) Professor and Head of Parasitology-Mycology Laboratory, Faculty of Medicine and Pharmacy of Casablanca Founding Member of the Moroccan Organization of Human Rights

63 IDA Prof. (Mr) Ryuichi (Japan) Professor of International Law Rapporteur of the Committee of Regional Economic Development Law of the International Law Association

JEAN (Mrs) Michèle (Canada) Adviser in programme development, Faculty of Higher Education, University of Montreal Member of the Commission of Ethics of Science and Technology of Quebec Former Special Adviser to the Minister of Foreign Affairs of Canada to the European Commission Former Vice-Minister of Health

NOMBELA Prof. (Mr) D. César (Spain) Professor at the Faculty of Pharmacy, Universidad Complutense de Madrid Former President of the Consejo Superior de Investigaciones Científicas Former President of the Federation of European Microbiology Societies

QUESTIAUX (Mrs) Nicole (France) Honorary Chairperson of Section of the State Council Vice-President of the National Consultative Ethics Committee for Health and Life Sciences Former Chairperson of the Permanent European Conference of National Ethics Committees Former Minister of Social Affairs

ROUCOUNAS Prof. (Mr) Emmanuel (Greece) Professor of International Law Chairman, National Commission of Patients’ Rights Member of the Academy of Athens Member of the Institute of International Law, Geneva Former member of the United Nations International Law Commission

RUMBALL Prof. (Mrs) Sylvia (New Zealand) Professor of Chemistry Assistant to the Vice-Chancellor (Equity and Ethics), Massey University Chair of the Massey University Human Ethics Committee Chairperson of the National Ethics Committee on Assisted Human Reproduction Former Dean, Faculty of Science, Massey University

Guests Prof. (Mr) Samir K. BRAHMACHARI (India) Director of the Centre for Biochemical Technology, Delhi University Campus

64 Chapter 4

ADVICE OF THE IBC ON THE PATENTABILITY OF THE HUMAN GENOME (12 September 2001)

The Universal Declaration on the Human Genome and Human Rights states in Article 1 that: ‘The human genome …, in a symbolic sense, is the heritage of humanity’. Article 4 further states that: ‘The human genome in its natural state shall not give rise to financial gains’. The rapid progress of genomics, together with research into pharmaceutical and other applications of this research, has given rise to world-wide debate on the meaning of these provisions. Concern has been expressed both by governments and non governmental organizations, that the patenting of the human genome may inhibit genetic research and, furthermore, allow for the monopolization of this important new scientific knowledge. It is feared that this will deprive many of the world’s peoples of the benefits of therapies which, in their development, have been based on this knowledge of the human genome. To clarify this situation and to assist in the further development of a just system of intellectual property relating to the human genome, the IBC brings the following advice to the attention of the Director-General: (1) The IBC, after considering this issue, is of the view that there are strong ethical grounds for excluding the human genome from patentability; (2) It further recommends that the World Trade Organization (WTO), in its review of the TRIPS Agreement, clarify that, in accordance with the provision of Article 27(2)1, the human genome is not patentable on the basis of the public interest considerations set out therein, in particular, public order, morality and the protection of human life and health.

1. Article 27.2 of TRIPs Agreement reads: “Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or in order to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by their law”. Chapter 5

Speeches at the Eighth Session of the IBC

• Mr Koïchiro Matsuura, Director-General of UNESCO (opening speech)

• Mr Ryuichi Ida, Chairperson of the IBC (opening speech)

• Mrs Anne Fagot Largeault, Professor at the Collège de France (opening speech)

• Mr Ryuichi Ida, Chairperson of the IBC (closing speech) I. Mr Koïchiro Matsuura, Director-General of UNESCO (opening speech)

Mr Chairperson of the International Bioethics Committee,

Excellencies,

Ladies and Gentlemen,

Yesterday’s terrible events have left us all in shock. It was with horror and dismay that I learned, as you all did, of the terrorist attack perpetrated against the United States of America. With the death and wanton destruction it has inflicted on a scale surely unprecedented in time of peace, this attack has caused immense suffering to the American people as a whole. This tragedy will stand out as one of the darkest moments in the history of humanity. Yesterday, on my own behalf and on behalf of UNESCO, I immediately offered my deepest condolences to President Bush and expressed our solidarity with the American people, and I join with Kofi Annan in condemning these attacks outright and reiterating our profound belief that no cause, whatever it may be, can be furthered by terror. These tragic events are not so far removed from the topics that we have to consider today. Forums for ethical reflection like yours are in my opinion places where the defences of peace may truly be constructed. I should therefore like to welcome you to UNESCO Headquarters for the three days of deliberation and debate that will form the substance of your Eighth Session. Although I have not before had the opportunity, since taking up office at the head of this Organization, to participate in your work, I have nevertheless followed it closely, since the ethics of science and technology is one of UNESCO’s five top priorities for the years to come.

69 The process of reflection in which the IBC has been engaged for nearly eight years is truly essential at a time when the boundaries of knowledge are being pushed back at dizzying speed and when our ethical benchmarks sometimes seem blurred by the new prospects opened up daily by scientific discoveries, particularly in the field of medicine. The IBC, chaired first by Ms Lenoir and then Mr Ida, has demonstrated time and again how important it is to have a global forum for reflection of this kind. The Universal Declaration on the Human Genome and Human Rights represents a major step forward in this area, and I can but praise the high quality of the report you published last April on embryonic stem cells. Today, your very full agenda reflects the broad scope of the topics that must be addressed urgently. I should like first to say a few words to the young people who are present here. We were particularly keen to hear your views and we shall listen to you with the utmost interest in a short while, during the Round Table on ‘Education in Bioethics and Youth’ which is to open our debates. This will, I hope, be a good opportunity for you to voice your perceptions and queries, your experiences and expectations. The conclusions and reflections emerging from the Round Table will provide valuable material for UNESCO, which aims to give education in bioethics a leading place in its future programme. As at the two previous sessions, this Eighth Session will also include two state-of-the-art presentations, the first on ‘Ethical Challenges Raised by Brain Research: Cerebral Imaging, Grafts, Implants’ and the second on ‘Ethical Aspects of Proteonomics’. Tomorrow the proposals of the IBC Working Group with a view to the follow-up on the International Symposium on ‘Ethics, Intellectual Property and Genomics’ will be examined. As we move into the post-genomic era, intellectual property issues as related to the genome – and the human genome in particular – are proving to be a thorny issue for which we do not yet have an unequivocal answer. This question was discussed, on my initiative, at an international symposium held here in UNESCO at the end of last January. As you certainly know – for there were many observers from Member States at that expert meeting – the debates were rewardingly open and specific. The patent system, with its advantages and its limitations, the other possible forms of intellectual property management and the specific concerns of developing countries on the subject were studied, without ethical questioning ever being lost from view.

70 After the symposium, I requested the IBC to prepare follow-up proposals. Tomorrow Justice Patrick Robinson will present the conclusions of the Working Group which was set up and met at Headquarters last June. Another question on the agenda of this Eighth Session of the IBC is that of genetic data. The Universal Declaration on the Human Genome and Human Rights does, of course, contain certain relevant provisions concerning the principles to be observed with regard to genetic data, examples being Article 5, which establishes the freedom of each individual to decide whether or not to be informed of the results of genetic examination and the resulting consequences; Article 6, which explicitly concerns discrimination based on the genetic characteristics of the individual; and Article 7 which provides for the need to protect, in the conditions set by law, the confidentiality of genetic data ‘associated with an identifiable person and stored or processed for the purposes of research or any other purpose’. Similarly, ever since its establishment in 1993, the IBC has constantly concerned itself with the question of genetic data, particularly the ethical risks involved in the use that might be made of the results of genetic tests. Several Committee reports in the past have dealt with this subject. However, genetic research is advancing at an increasing pace, opening up possibilities for hitherto undreamed-of applications and raising unprecedented ethical problems – take, for example, the uncertainties and unknown factors involved in the management of genetic databanks, which are proliferating and contain substantial collections; and the questions raised in terms of respect for human rights and fundamental freedoms about the use made of these data, particularly for non-medical purposes, and so on. In order to continue to stimulate the ethical reflection at the global level that should accompany advances in the biomedical sciences, UNESCO might, I think, elaborate an international instrument on the question of genetic data. It was with that in mind that the IBC Working Group chaired by Ms Nicole Questiaux met last June in order to prepare the report which will be submitted to you tomorrow and which seeks to identify the problems relating to the collection, treatment, storage and use of genetic data and the purposes for which such data are collected. The report also outlines the principles that should inform these various operations and endeavours to identify guidelines for their application.

71 A hearing of National Commissioners for the protection of personal data will also be organized during this Eighth Session in order to shed light on the IBC’s work and UNESCO’s future tasks in this area. Foremost among these tasks may be to draft an international instrument on genetic data. This is of course a complex process that may well extend beyond the timeframe of a single biennium, but UNESCO should not miss this opportunity, in the specific field of genetic data, to continue to maintain its role of ethical vigilance and consolidate the moral authority clearly conferred on it by the Universal Declaration on the Human Genome and Human Rights. The Intergovernmental Bioethics Committee (IGBC), established in 1998 by the Statutes of the International Bioethics Committee (IBC) held its second session from 14 to 16 May at UNESCO Headquarters. During that session it examined the most recent reports of the IBC and made recommendations to the Executive Board of UNESCO and the General Conference, including a recommendation that all questions relating to genetic data should continue to be examined. I am happy to have seen the IBC and the IGBC playing their respective roles on this occasion. For while it is necessary to benefit from the advice of independent experts, as is the case in the IBC, it is also essential that States express their determination to commit themselves to the principles and guidelines recommended by the IBC – a role which devolves upon the IGBC. With the tentacular advances in science, bioethics is covering an increasingly vast area. In these circumstances the preparation of a universal instrument on bioethics seems to me to be one of UNESCO’s key priorities for the future. Since the beginning of the 1970s, the field of bioethics – in the broadest sense of the term, i.e. ethics of living matter – has expanded considerably. Today it covers an extraordinarily wide range of questions: research in life sciences and use of the research findings, the participation of human subjects in scientific research, genetically modified organisms (GMOs), donation of organs, tissues or cells, predictive medicine, human reproductive technologies, etc. All these issues, which cover many different fields, are arousing increasingly acute and vociferous concern both among specialists and within civil society and the international community. The international organizations themselves have not remained passive in these debates, nor have political leaders. On 30 March 2001, for example, Mr Chirac, President of the French Republic, speaking at the United Nations Commission on Human Rights, referred to the possibility of preparing a universal instrument on bioethics.

72 This suggestion to draft a comprehensive instrument which would cover the whole range of issues related to bioethics deserves reflection. Faced with ethical problems which often have their roots deep in the cultural, philosophical and religious foundations of the different human communities, what organization better than UNESCO could consider this question and thoroughly appraise the advisability of such an instrument, its possible purposes and coverage? UNESCO, of course, would not embark alone upon such a venture. It would do so in cooperation with the Office of the United Nations High Commissioner for Human Rights, the World Health Organization, the International Labour Organization, the United Nations Food and Agriculture Organization and others. A universal bioethics instrument of this kind would enable Member States to reach agreement on ethical principles that they would then have to reflect in their national legislation. In bioethics, there is indeed a growing awareness of the need for cooperation between the different authorities or even a commitment at international level which might take the form of an instrument of one kind or another. This is why I replied immediately to the Secretary-General of the United Nations, when he sought my views concerning Mr Chirac’s suggestion, that I believed the idea of such an instrument could be studied and even put into effect by UNESCO. The first step towards this concerted action has, moreover, been accomplished, as I have proposed the establishment of an inter-agency committee to ensure better coordination between the activities of the different organizations of the United Nations system concerning bioethics. A preparatory meeting on the subject will be held here at UNESCO Headquarters on 17 September 2001. On the other hand, it did not seem to me appropriate to set up, as proposed by the United Nations Commission on Human Rights, another committee of independent experts to reflect on bioethics and in particular on the follow-up to the Declaration on the Human Genome – the IBC already exists and has demonstrated its excellence. However, since the main controversies arise at the level of political decision-making, the possibility of a high-level group of senior decision- makers did seem worth exploring; this is in fact a suggestion contained in the report which the Secretary-General will be submitting to the General Assembly of the United Nations next week. Without political will, our determination will remain a dead letter. Hence, given the increasing importance of bioethics, I have convened for 22 and 23 October 2001 a round table of Ministers of science on

73 bioethics, which we have entitled ‘Bioethics: International Implications’, and it will be one of the highlights of the General Conference. The four main themes will be as follows:

(a) Basic concepts and principles of bioethics. (b) What are the current issues in bioethics? (c) Institutional and regulatory norms and systems: the rationale for a universal text on bioethics. (d) Consciousness-raising, information, education and public debate. On the basis of the conclusions reached by the round table, I shall propose appropriate follow-up action to the Executive Board.

As you can see, the task is a formidable one and we shall only have these three days to exchange views and reach agreement. UNESCO, I am quite sure, has a unique part to play in bioethics internationally. All too often the norm lags behind the real evolution of societies. This is especially so in the field of bioethics, where the speed of scientific advances and the ‘extraordinary’ character (in the full sense of the term) of their potential applications make reflection and normative action particularly urgent. For in this area, as in others, not to act is in itself a form of action. UNESCO’s comparative advantage in the ethics of science and technology remains indisputable. I therefore hope that Member States will approve the high priority which I propose that they give for the coming biennium to the ethics of science and technology, with bioethics as one of the two main thrusts. Before opening the floor, I should like to express once again my entire confidence in the members of the IBC who are present here and to say how much I am counting on them to put all our plans into operation. I know that the discussions which will follow will be both fruitful and lively.

I should like to welcome the members of the Committee and its Bureau and especially its Chairperson, Mr Ida, and also the observers, representatives of States, representatives of intergovernmental and non- governmental organizations, specialists, experts and young people who are present here today. I should also like to extend special thanks to Professor Anne Fagot-Largeault, who holds the Chair of Philosophy of Biological and Medical Sciences at the Collège de France, for having agreed to give an opening address.

74 Far from indulging in useless self-congratulation, we must consider the future with stoicism and ask ourselves what we can do in concrete terms. Although genetics is certainly not all-powerful, it nevertheless holds out great promise. It is for us to rise to the challenge. Over-enthusiasm often goes hand in hand with lack of discrimination, and predictions for the future are often an excuse for scaremongering. I mistrust those who invoke the name of fatality; it is but another name for resignation. We must not remain passive onlookers of our history. ‘Humanity groans, half-crushed under the weight of the progress it has made. It has not yet fully grasped that its future depends on itself’ wrote Henri Bergson last century. Is it not for UNESCO and the IBC to make humanity aware of this?

75 II. Mr Ryuichi Ida, Chairperson of the IBC (opening speech)

Mr Director-General of UNESCO,

Excellencies,

Ladies and Gentlemen,

The dreadful attacks in the United States yesterday, Tuesday 11 September 2001, have shaken all of us. Only absolute disregard for human life can inspire such despicable acts. In response to these crimes, the ethical ideals for which we work without respite must be more than ever reaffirmed. It is with heavy hearts but with greater determination that we shall continue this mission during the next three days. Before declaring the Eighth Session of the International Bioethics Committee (IBC) open, I should like to ask you to observe one minute’s silence in memory of the victims of the attacks. We are very honoured today by the presence of Mr Koïchiro Matsuura, Director-General of UNESCO. On behalf of the IBC, I should like to commend the excellent initiatives that he has taken to strengthen UNESCO’s action in the field of bioethics and to thank him for the unfailing support that he has given us in our work. Our last session in Paris was the fourth session, which was held in 1996 and was chaired by Ms Noëlle Lenoir. At the time, the Committee was trying to finalize the preliminary draft Universal Declaration on the Human Genome and Human Rights. The following year, the General Conference of UNESCO adopted the Declaration unanimously and by acclamation at its 29th session. At the same time the General Conference adopted the implementing resolution, 29 C/Resolution 17, on which the existence of this Committee is founded. For five years now, advances in the field of the life sciences have been so rapid that it is sometimes difficult for bioethics to keep up. Embryonic stem cell research, in particular, has advanced at a meteoric

77 pace, opening up prospects for treating hitherto incurable diseases. Genetic research has also grown at an unprecedented pace, as the completion of the sequencing of the human genome, thanks to the combined efforts of the Human Genome Project and Celera, shows. Brain research too is opening up prospects for tomorrow’s medicine. But all this scientific and medical progress continually raises ethical questions. In the face of these developments, the ethical debate is continuing. In some countries, including France, national laws and regulations on bioethics are being drafted or revised. In other countries, including the United States of America, the bioethics policy seems to depend on the government’s position on bioethics, or else, as in the Republic of Korea, for example, a national bioethics committee has been or is about to be established. Lastly, national regulations have been introduced in certain leading-edge fields, for example Japan’s Fundamental Principles and Ethical Guidelines on Genome Research. More and more symposia and meetings on bioethics are being held by various international, regional and national bodies (Inter-Parliamentary Union, Pan American Health Organization, Organization of African Unity, etc.). Other international organizations concerned, such as the World Health Organization and the World Medical Association, have taken the initiative of revising existing ethical standards or plan to draw up new ones. Several projects, in Japan and the European Union for example, are being implemented to promote bioethics or to encourage dialogue. In that regard, the establishment of a new UNESCO Club in Portugal is significant because the Club focuses on understanding and promoting bioethics. Efforts are thus being made in each country to promote bioethics. We are happy to welcome the representative of the UNESCO Club in Vila Nova de Gaia in Portugal to the Round Table on ‘Education in Bioethics and Youth’. These initiatives in various regions of the world must not however mask a certain reluctance to espouse bioethics, as in recent, albeit isolated, attempts to launch human reproductive cloning which is clearly rejected by the Declaration and many international and national instruments. Public announcement of a move to begin human reproductive cloning immediately sparked off opposition all over the world. We do not want biomedical technology to be misused in this way. On that score, the joint statement by France and Germany to the United Nations General Assembly on the possibility of drawing up an international convention against human reproductive cloning is noteworthy. UNESCO and the IBC will no doubt closely monitor the outcomes of this initiative.

78 Against that background, I should like to review the activities carried out by the Committee last year, beginning with the work of the IBC’s seventh session in Quito. At the kind invitation of the Government of Ecuador, the seventh session was held from 7 to 9 November 2000. Approximately 170 participants from about 50 countries attended. I should like to renew my thanks to the Ecuadorian authorities, to Professor Edmundo Estevez, a member of the IBC, and to Mr Arvelio Garcia-Rivas, UNESCO’s representative in Quito. The seventh session comprised three working meetings, a round table and a consultation with patients’ associations. The meeting devoted to examining the draft report of the Working Group, chaired by Professor Jacek Zaremba, on the ethical aspects of embryonic stem cell research was chaired by Ms Nouzha Guessous Idrissi. In their report, the two joint rapporteurs, Professor Alexander McCall Smith and Professor Michel Revel, highlighted the difficult nature of the issue. While research on embryonic stem cells can have enormous benefits because of their totipotentiality or pluripotentiality, thus paving the way for the manufacture of organs and tissues for transplantation in patients who are hard or impossible to treat, it comes up against a clear ethical problem since cells can be obtained only from a pre-implantation embryo. ‘Is it ethically acceptable to use embryos for research purposes.’ That, in fact, is the key question. The answer could depend on cultural, philosophical, religious, social and political considerations. The IBC took the view that the supervision of embryonic stem cell research and of embryo research in general should be left to the discretion of each State. The discussion was particularly fruitful and constructive and the IBC decided to hold an additional meeting of the enlarged Working Group in order to finalize its report. After the meeting of the enlarged Working Group (30 January-1 February 2001), the UNESCO International Bioethics Committee adopted conclusions that may be summed up as follows: (1) human embryonic stem cell research is an issue on which there should be a debate at the national level in order to determine each State’s position; (2) measures should be taken to ensure that such research is conducted within a legislative or regulatory framework that gives due regard to ethical considerations and sets appropriate guidelines; (3) other new technologies, such as the use of adult stem cells, should be examined for the purposes of therapeutic research in the field of transplantation.

79 Another working meeting, chaired by Mr Patricio Espinoza del Pozo, Deputy Minister of Health of Ecuador, examined the draft report of the Working Group on solidarity and international cooperation. The report, drawn up by Professor Mohammed Hamdan and Professor Mehmet Öztürk, highlighted the vulnerability of developing countries in comparison with developed countries in the field of genomics. To boost solidarity and international cooperation between developed and developing countries concerning the human genome, the IBC recommended a twofold approach: on the one hand, the promotion of cooperation at different levels (bilateral, multilateral and transnational) and the need to give priority to promoting scientific research and the transfer of technology to these countries and, on the other hand, the creation of a mechanism or an international fund, financed from a proportion of the profits of private and public companies earned from human genome data and from other sources. Noting that people are increasingly aware of the importance of the current issues, the IBC concluded that the need for ethical rules had been accepted and that new forms of cooperation and control were necessary. The latter ought to include both the private and public sectors, as well as non-governmental organizations, as well as States and intergovernmental organizations. The Round Table on bioethics education was moderated by Professor Giovanni Berlinguer, a member of the IBC. The five statements highlighted the vital role of education in the dissemination and practice of bioethical principles. Professor Amnon Carmi described the ‘International Project on Ethics Education in Medical Schools’ and stressed its four objectives, namely: the need to change the focus of curricula in medical schools, the establishment of an ethics education curriculum, training for teachers to whom it will be assigned and the introduction of appropriate teaching tools. Professor Myriam Cotler spoke about the experience gained in medical ethics education in the United States of America and referred to professional dilemmas and difficulties encountered by students. Professor Leonardo de Castro advocated using the media to promote a democratic approach to bioethics, while Mr Fernando Lolas Stepke spoke of the role of the Pan American Health Organization, laying particular emphasis on the work of regional organizations. Professor Darryl Macer said that the effectiveness with which bioethical principles were applied depended on the amount of educational work undertaken, and he developed in particular the idea of ‘bioethical maturity’.

80 Three state-of-the-art reviews were made respectively on research on ageing by Dr Huber Warner of the National Institutes of Health (NIH), on neuroscience research by Dr James Pickel (NIH) and on human genome mapping by Ms Leena Peltonen, a member of the IBC. The three speakers identified current trends and research prospects in those areas. The statements heightened our awareness of the responsibilities entrusted to the IBC. In accordance with Article 24 of the Universal Declaration on the Human Genome and Human Rights and Article 2 of its Statutes, the Committee organized its first ever consultation with patients’ associations, which I had the honour to chair. Respect for human dignity and the protection of rights and fundamental freedoms do indeed demand that the status and situation of vulnerable persons and groups be taken into consideration. The Committee followed the three speakers’ statements most attentively. Ms Anne-Laure Morin of the Association française contre les myopathies (AFM) stressed in particular the principle of sharing the benefits of scientific advances. Ms Ana Mari Del Arco, President of the European Parkinsoniens (Europark), outlined of her Association’s Manifesto. Ms Diane Richler, President of Inclusion International, made useful proposals on the implementation of the Declaration. Their observations and suggestions have enriched the IBC’s reflection and will be taken into account in UNESCO’s action. The working meeting on the economic aspects of human genome research, chaired by Justice Michael Kirby, clarified the various views on the subject. Mr Pascal Brandys, President of France Biotech, set out the position and approach of the pharmaceutical companies involved in genome research. Professor José Maria Cantú described the genome research situation in the developing countries in particular and stressed the need to take the interests of population groups into account and the urgent need for effective international cooperation. Professor Yang Huanming’s statement stressed the need for free access to DNA sequences and protested against the monopolization of scientific advances by private firms. The problem of intellectual property was situated at the intersection of scientific advances, economic interests and bioethical principles. At the end of the seventh session, the IBC adopted two recommendations addressed to the Director-General. First, it welcomed his initiative and support for bioethics and urged its Secretary-General to submit proposals on strengthening the staff and budget so that the Secretariat and the IBC would be able to properly discharge the

81 responsibilities entrusted to them. Secondly, it called for its discussion on bioethics education to be followed up and expressed its constant support for vulnerable persons and groups. Another great event in bioethics occurred after Quito. On the initiative of Mr Matsuura, UNESCO organized an International Symposium on ‘Ethics, Intellectual Property and Genomics’ from 30 January to 1 February 2001. The symposium comprised four meetings: ethics and the protection of intellectual property; current legislation; institutional approaches, and specificity of gene sequence patenting. The debates were so fruitful that the IBC decided to discuss the follow-up to that symposium in one of its two Working Groups in 2001. The second session of the Intergovernmental Bioethics Committee (IGBC) was held from 14 to 16 May 2001 at UNESCO Headquarters in Paris. Thirty-one IGBC States Members took part and 35 other States were represented by observers. The debate opened with an account of initiatives taken by Member States to implement the Declaration. It was important to take stock of national laws and regulations on the subject. Then, after I had the honour to report on the IBC’s work, the IGBC examined our three reports, namely ‘Confidentiality and Genetic Data’, ‘The Use of Embryonic Stem Cells in Therapeutic Research’ and ‘Solidarity and International Cooperation between Developed and Developing Countries concerning the Human Genome’. The IGBC also examined the outcomes of the International Symposium on ‘Bioethics and the Right of the Child’ held in Monaco in April 2000. It commended the IBC’s work and made recommendations that have been widely disseminated. At the end of the session, following a draft recommendation submitted by France, the IGBC expressed its support for the Director- General’s initiative to establish an inter-agency committee. Pursuant to the decision taken in Quito, the IBC established two Working Groups, which met in Paris, on 13 and 14 June and 14 and 15 June 2001 respectively. The first Working Group, on the follow-up to the International Symposium on Ethics, Intellectual Property and Genomics, which was chaired by Judge Patrick Robinson, was entrusted with the task of working out proposals on the follow-up to the symposium. It worked on the basis of a detailed report by Justice Michael Kirby, the Group’s Rapporteur and documents providing a great deal of information. Professor Samir K. Brahmachari (India), an invited expert, and Ms Kathleen Strong of the World Health Organization (WHO) also participated. The discussion was particularly fruitful and instructive, and the Group drew up a draft report that is submitted for consideration to the present session.

82 The second Working Group was requested to examine the different aspects of issues raised by genetic data. The rapid development of genetics, which has led to the growth in numbers and spread of genetic data banks and the use of genetic data for medical and non-medical purposes, raises many ethical issues. The Working Group, chaired by Mrs Nicole Questiaux, examined the main issues at stake in the collection, treatment, storage and use of genetic data. Mr André Boué (France) and Mr Derek Jones (Canada), the Working Group’s two invited experts, proposed a synopsis of the issues involved. The two Rapporteurs, Mrs Sylvia Rumball and Mr Alexander McCall Smith, drew up on that basis an excellent draft report whose thoroughness exceeded our expectations. I now come to the IBC’s Eighth Session. It consists of a Round Table, a state-of-the-art review, a hearing and two working meetings on the draft reports of the Working Groups. Today’s young people will be the main players in the field of bioethics; that is the raison d’être of the Round Table on Education in Bioethics and youth, organized in cooperation with the UNESCO Youth Coordination Unit. The state-of-the-art review will deal with the ethical aspects of research in proteomics. This is an area of prime importance in the post-genomic era. Professor Thierry Rabilloud has graciously agreed to speak on the current state of research in this field. It is essential today to coordinate bioethics activities; several international organizations are responsible for the various aspects of bioethics. To avoid a dispersion of human and financial resources, the Director-General of UNESCO has suggested that an inter-agency committee be set up within the United Nations system. The IBC, as the first and only institution entrusted with all bioethics issues at the international level, obviously supports this initiative. The three Commissioners for the protection of personal data will describe the situation in their own countries. It goes without saying that the two reports of the Working Groups will be submitted to the IBC for consideration on the second and third days of the session. I know that this session, like previous ones, will be a success. I have no doubt that you will join in the debates with your customary zeal and enthusiasm. It is thanks to you, and to the ever growing response that bioethics evokes among all the people of the world, that the IBC can live up to its ambitions and keep its humanist promise.

83 III. Mrs Anne Fagot-Large ault, Professor at the Collège de France (opening speech)

More than 30 years ago, Karl-Otto Apel described the paradoxical situation in which moral philosophy found itself in the twentieth century: under the pressure of advances in science and technology crucially affecting the future of human life on earth, the need for a universal ethics was, he said, strongly felt, but at the same time ‘the philosophical task of creating a universal ethic based on reason has never been so difficult, or even hopeless’ (1). Since the German philosopher wrote those lines, many ethical groups and committees have tackled this ‘daunting’ task in hospitals and laboratories, more recently in national ethics committees, and now in international forums such as the IBC. The scientific and technological advances affecting the destiny of our species and raising urgent ethical issues (survival of the human species, preservation of biodiversity) have been numerous: the standardization of seeds and the creation of genetically modified plant varieties intended for animal or human consumption, the cloning of mammals, the invention of artificial reproduction techniques, human genome sequencing and controversies over the patenting of genetic sequences, the therapeutic hopes raised by research on stem cells and early stage human embryos. At the same time, we have become more receptive to the observation that we do not have a universal ethics, that there are North-South disagreements over intellectual property rights relating to the utilization of materials obtained from the human genome, that there are strong cultural and religious differences about human embryo research, and the removal of organs for transplants. Under the dual effect of democratic freedoms

1. Appel, K.-O., ‘Transformation des Transzendentalphilosophie: das Apriori der Kommunikationsgemeinschaft’, 1967, paragraph 1.1, reproduced in: Transformation der Philosophie, Frankfurt am Main: Suhrkamp, 1973, Vol. 2; Fr. tr: by R. Lellouche & I. Mittmann, L’éthique à l’âge de la science. L’a priori de la communauté communicationnelle et les fondements de l’éthique, Lille: Presses universitaires, 1987.

85 and globalization, we are personally experiencing pluralism and learning from our differences. ‘One must often tolerate on moral grounds that which one must condemn on moral grounds’, wrote the American philosopher Tristram Engelhardt(2), speaking of the duty of solidarity and the controversial limits beyond which obligatory solidarity cannot be imposed. In this pluralistic, even communitarian, environment, one senses at times a certain amount of scepticism about the role of ethics committees and a degree of discouragement among their members. When they go into the details of real problems, it is said that they are turning morality into casuistry and are twisting principles so as to adapt them to the facts; by dint of taking liberties with the most respectable moral rules, bioethics has become a means of acclimatizing scientific practices, this form of research acculturation sets reassuring limits then shifts them at will. One flagrant example of the backsliding in bioethics might be the changes in the rules governing the patenting of genetic engineering products: initially it was said that patenting a living organism was morally inadmissible; then patents were granted for plant varieties while saying that patenting animals would be inadmissible; next they were granted on animals and it was said that patenting a mammal would be unacceptable; after that strains of mice were patented while pledging never to patent parts of the human body; today we can patent human cell lines and it is affirmed that a human being will never be patented. On the other hand, when ethics committees attempt to establish an overall problem-solving framework, they are accused of wishful thinking and of laying down grand principles which are in practice ignored or gaily transgressed since they fail to take practical circumstances into account; besides, they are always lagging behind scientific breakthroughs (focusing on genomics, for instance, while researchers have already moved on to proteomics). I would argue that the situation is not so discouraging and that the challenge is worth taking up. In the first place, accepting pluralism does not necessarily lead to moral nihilism. It is said jokingly that, when in doubt, one should set up a committee. But identifying a problem, and bringing people together to discuss it, people who will adopt a working method and argue for and against (instead of solving the problem purely

2. Engelhardt Jr., H.T., The Foundations of Bioethics, Oxford: Oxford University Press, 1986, Chap. 1: ‘One must often tolerate on moral grounds that which one must condemn on moral grounds. For example … there are limits on the public authority to use force in order to compel charity’.

86 on the basis of their relative strength), is in and of itself a fundamental ethical step. That does not provide the substance of the solution, merely a form – a procedure by which to reach it. Discussing things rather than fighting represents essential moral progress. Of course, in this situation, the solutions found are weak and, to a large extent, arbitrary and tentative since they are the fruit of negotiations that can be challenged as new generations of stakeholders join in the debate. In fact, we have seen over recent years respectable and conscientious ethics committees alter their opinions or change their recommendations (on human cloning, germ-line gene therapies and euthanasia). Is it not troubling that moral rules can change, that what was considered yesterday to be morally reprehensible becomes the standard today, or that yesterday’s standard can be rejected? No, on the contrary, it may mean that we know how to improve our standards as they reveal their defects once put to the test. That is what Karl Popper stressed, observing that the traditional ‘golden rule’ (in its positive form) ‘do as you would be done by’ can be improved on, as one’s knowledge of the other grows, to become: ‘do unto others, as far as possible, as they would wish’. ‘This is the incredible fact: that we can learn by our mistakes and by criticism and that we can learn in the realm of standards just as well as in the realm of facts.’(3) Secondly, we should acknowledge that our major principles do not change so much. And when we modify them (slowly, rarely), it is to clarify or adapt them, not to declare them obsolete and to invent others. The UNESCO International Bioethics Committee drew up a Universal Declaration on the Human Genome and Human Rights which the General Conference of UNESCO adopted in 1997; that declaration was endorsed by the United Nations General Assembly in 1998 (resolution 53/152). ‘Universal’ has several meanings. To begin with, the declaration had been worked on and approved by all the member countries of those international organizations. Then, very few people would disagree with the principles that it sets out. A recent text produced by the United Nations Economic and Social Council, entitled ‘Human Rights and Bioethics’ (4),

3. Popper, Karl, The Open Society and Its Enemies, London: Routledge & Kegan Paul, 1945, 2 vols.; 11th ed. 1977, first addendum (1961), ‘Facts, Standards and Truth’, paragraph 13: ‘This is the incredible fact: that we can learn by our mistakes and by criticism and that we can learn in the realm of standards just as well as in the realm of facts’. Abridged Fr. tr. by J. Bernard & Ph. Monod, La société ouverte et ses ennemis, Paris: Seuil, 1979, 2 vols. 4. United Nations Economic and Social Council, Human rights and bioethics, Commission on Human Rights resolution 2001/71, E/CN.4/RES/2001/71 (25 April 2001).

87 lists the international texts containing material that ‘a life sciences ethics’ is supposed to develop. Very consensual ideals are found in it, such as ‘the ideal of free human beings enjoying freedom from fear and want’; the values of freedom, justice and peace in the world; guiding principles to orient action such as the need to preserve the dignity and integrity of human beings, recognize their ‘equal and inalienable rights’, improve their health, protect them from degrading treatment, protect children against any form of violence, etc. From these general principles recommendations ensue, for example, no biomedical research should prevail over ‘respect for … human rights, fundamental freedoms and human dignity’. The IBC has extended this rule to research on the genome (1997, Art. 10), with a view to ensuring that such research is not a source of discrimination against certain individuals or groups of people. This is an enhancement of the rule, an alteration aimed at adapting it to a new research field. In short, there is a ‘content’, a ‘hard core’(5) in ‘human rights’ as set out in the Universal Declaration (1948) and the International Covenants (1966), that a bioethics committee shares with many other bodies and international commissions. This shared doctrine is not a philosophy in the technical sense of the term because of its syncretic nature. It is the product of composite wisdom, accumulated throughout the history of our species, gathering together strands from diverse philosophical and religious traditions. A bioethics committee has the task of comparing that ‘hard core’ with research data, and testing its solidity by incorporating it in biological and medical practice. Does that mean that it practises applied ethics? Let us rehabilitate applied ethics. Applied ethics is tremendously interesting. Onora O’Neill(6) stresses in a recent article that the role of lofty principles in morality is often misunderstood. We would like moral reasoning to proceed ‘from the top downwards’ so that the solution to every problem could be deduced from lofty principles. It is not the case. On the one hand, ‘principles’ are formulated in very general terms: applying them in real, new situations means clarifying them, bringing out their ambiguities. Thus, we have a ‘principle of respect for the autonomy

5. Fagot-Largeault, Anne, ‘La réflexion philosophique en bioethique’, in: M.-H. Parizeau, ed. Bioethique: méthodes et fondements, Cahiers scientifiques de l’ACFAS, 1989, 66:3-16, Montreal. Repr. In: M.-H. Parizeau, ed., Les fondements de la bioéthique, Brussels: De Boek University, 1992, 11-26. 6. O’Neill, Onora, ‘Practical principles and practical judgment’, Hastings Center Report, July-August 2001, 15-23.

88 of the individual’ – as a moral subject, I am free to decide for myself what I should do, others must respect my freedom of decision and, likewise, I must respect theirs. Who is my ‘other’, though? Does the principle apply in the same way to other adult humans, to children, to foetuses in the womb, to pets and wild animals? On the other hand, the absence of an absolute hierarchy of principles means that, in cases where they cannot be respected simultaneously, there is a sensitive juggling act over which takes precedence. There have been cases where doctors have imposed blood transfusions on ill Jehovah’s Witnesses who were ready to die rather than accept an act that went against their conscience. These doctors considered that the principle of doing good came before that of respecting autonomy. Other doctors respect the refusal of their patients, taking the contrary view that constraint is a worser evil than failure to treat. Health systems differ from one country to the next in terms of the relation between the requirement of solidarity and respect for individual freedoms. UNESCO’s Universal Declaration on the Human Genome and Human Rights sets a fragile equilibrium between freedom of research, the right of individuals not to undergo research and control over the abusive use that could be made of the findings. These standard-setting balances do not proceed from lofty principles. Finally, real situations are a test of the validity of the principles. There are border-line situations where the best moral rules become untenable. Despite the force of the commandment not to kill, it has been necessary over the past 50 years, with technological advances in resuscitation, to gradually integrate the concept of a duty to stop pointless treatment. UNESCO is planning a follow-up to its Universal Declaration on the Human Genome and Human Rights. This is a wise measure. The protection of intellectual property in the area of living cell manipulation, the imperative to exchange freely scientific data and the development of collections of genetic data can all reveal unprecedented moral dilemmas and undermine the rules currently in force. I have attempted to show that the kind of thinking that switches focus from principles to concrete cases and back again to principles and which constitutes the daily routine of ethics committees is noble, creative work. What is referred to as ‘deliberative democracy’’(7) needs ‘intermediary bodies’ which investigate cases, compare arguments, refine principles and anticipate difficulties. It is said that UNESCO is the ‘intellectual arm’

7. Hastings Center Report, July-August 2001, p. 7.

89 of the United Nations, which means that it has a responsibility to the international community which forces it to think at a ‘global’ level about the impact of scientific research. Conducting that debate requires patience, modesty, and intellectual courage. Patience: the work of comparing principles and practice is never finished, it must be repeated over and over again. Modesty: ethics and bioethics committees are advisory, they cannot impose; it is the role of politicians to take any decisions and the path from the IBC to the IGBC and then to the State authorities is a long one. Intellectual courage: this is needed to envisage the future of the planet, and the good of its inhabitants, standing back from the immediate interests of particular groups: doctors, researchers, industrialists, markets and nations. If, as the United Nations projection predicts, there will be 10 billion inhabitants on Earth in 2050, how will their water resources be shared out? If we want more equality worldwide, how can we arrange things so that the sick of poor countries can obtain at a lower price the medicines that the sick of rich countries must continue to buy at top rates? The programme of this session will enable you to address the questions raised by proteonomics and brain transplants. Please accept my sincere wishes for this meeting to be peaceful and creative.

90 IV. Mr Ryuichi Ida, Chairperson of the IBC (closing speech)

Excellencies, Ladies and Gentlemen,

The deep sorrow caused by the ignoble attacks carried out in New York and Washington has cast a shadow over the proceedings of the Eighth Session of the International Bioethics Committee (IBC). Terrorism, which should be classified as a crime against humanity, has blindly struck innocent people once again. Peace and the well-being of humanity must prevail over the many different forms of hate and suspicion. Today, Friday 14 September 2001, is a day of mourning throughout the world. We join in the American people’s grief and express all our sympathy to the bereaved families. This tragedy must not, however, prevent us from continuing our tireless work in favour of bioethics. When he opened this Eighth Session, Mr Koïchiro Matsuura, the Director-General of UNESCO, reminded us of the efforts by UNESCO and the IBC to give greater depth to the reflection on bioethics. The proposals made by the Director-General have been fully taken into account in our discussions. The Director-General’s repeated exhortations have encouraged the IBC in its mission to contribute to universal bioethics. Ms Anne Fagot-Largeault, Professor at the Collège de France, holder of the Chair in the Philosophy of Biology and Medicine, urged us, in her speech, to consider the nature of bioethics, its scope and field of action and what it means for humanity. The first meeting, chaired by Ms Yolande Tano, very recently appointed Ambassador of Côte d’Ivoire to UNESCO, was given over to ‘Education in Bioethics and Youth’. Four youth representatives took part in the meeting and their commitment to promoting bioethics deserves our praise. The subjects they selected for discussion and the diversity of their approaches are illustrative of ongoing experiments and projects in various

91 countries in the field of bioethics education. The idea of a social contract put forward by Ms Catalina Alvarez Irrarragori, the appeal for universal bioethics through education and appropriate regulations made by Ms Natacha Freitas, the importance accorded to bioethics by the International Association of Agricultural Students outlined by Ms Sandra Goritschnig, and also the attention given to the protection of human rights in biotechnologies described by Ms Kwak Young-bin are all evidence of the fact that young people are now taking up the bioethics torch. The second meeting, which was chaired by Professor György Kosztolányi, took stock of the ethical aspects of proteomic research. Professor Thierry Rabilloud from the Laboratory of Cellular and Pathological Bioenergetics of the Atomic Energy Commission (France), Chief Editor of the review Proteomics, gave an admirable presentation based on recent advances in proteomics. He brought out the specificity of proteomic analysis and highlighted both the similarities and the differences between the utilization of genomic research on the one hand and proteomic research on the other. Lastly, he gave an idea of the place that proteomics would occupy in the post-genomics era. The meeting I had the honour to chair dealt with coordination of activities and reflection concerning bioethics carried out by various international organizations. That meeting extended the initiative of the Director-General of UNESCO proposing the establishment of an inter- agency coordination committee on bioethics. Mr Georges Kutukdjian, Secretary-General of IBC, Dr Victor Boulyjenkov of WHO, Ms Barbara Rhode of the European Union and Ms Sandrine Sabatier of the Council of Europe presented their activities in the field of bioethics. They all stressed the need for greater coordination and cooperation. The question now arises of the kind of mechanism needed for this purpose.

The first meeting of the second day, chaired by Professor Hans Galjaard, focused on the proposal by the Working Group on the follow-up to the International Symposium on ‘Ethics, Intellectual Property and Genomics’. Judge Patrick Robinson, Chairperson of the Working Group, explained the draft report drawn up by Justice Michael Kirby. The three basic documents, namely the draft report, the report of the symposium compiled by Justice Kirby, and the reference document concerning this subject, prepared by the Secretariat, are of the utmost importance. The contents of the draft report and its conclusions were endorsed by all the participants. The speakers’ attention focused mainly on the section pertaining to the conclusions, particularly its paragraph 7, which

92 constitutes the cornerstone. On the basis of the discussions, the IBC adopted by consensus the Advice on the Patentability of the Human Genome.

The following meeting was devoted to the problem of genetic data. That meeting included the hearing of three commissioners for the protection of personal data. Mr Joël Boyer, Secretary-General of the Cmmission national française ‘Informatique et Libertés’, presented the functioning of the French standard-setting system for the collection, analysis and utilization of genetic data. Ms Bénédicte Havelange, Secretary-General of the Belgian Commission for the Protection of Privacy, described briefly the present situation in Belgium, based on an analysis of the law of 1999. She stressed, in particular, that the question of protecting genetic data, with regard to the protection of privacy, was an eminently political choice for society. Mr George Radwanski, Privacy Commissioner of Canada, urged the drawing-up of an international instrument on genetic data. He made suggestions with a view to the preparation of such an instrument on the strength of the Canadian experience. The considerations of a practical nature that they developed are all elements to be taken into consideration when formulating an international instrument on genetic data, which is an initiative of the Director-General. The meeting which has just come to an end, chaired by Professor Roberto Andorno, was based on the draft report of the Working Group on genetic data. This detailed draft, which outlines challenging objectives, was the outcome of the joint work by Professors Sylvia Rumball and Alexander McCall Smith. It comprises a general part relating to the topicality of the subject, the definition of the problem and the objectives pursued by the document. A second standard-setting part includes proposed guidelines and standards for the collection, treatment, storage and use of genetic data. All the observations and comments made by the participants have proved to be practical and precise. They will certainly provide input for the revision of the draft report with a view to its finalization. In any event, they have fully demonstrated the relevance of the Director-General’s initiative and the need for UNESCO to draw up an international instrument on genetic data. The IBC will be selecting the topics for inclusion in its programme of work during this afternoon’s restricted meeting. The programme of work will be made public and widely disseminated, notably on UNESCO’s Internet site.

93 Ladies and Gentlemen, Dear Colleagues,

The eighth session of the IBC has been so fruitful in terms of the discussions and the results that we have become more aware of our responsibility and our hope in the future of universal bioethics has been reinforced. I wish to thank you for having participated so actively in our discussions. I should like to express my appreciation to all the members of the Secretariat and to all those who have worked behind the scenes for the success of this session, not forgetting the interpreters whose work was particularly effective work: without them our multilingual and multicultural discussions would have been impossible. I hereby declare the Eighth Session of the UNESCO International Bioethics Committee closed.

94 Chapter 6

COMPOSITION OF THE INTERNATIONAL BIOETHICS COMMITTEE OF UNESCO (IBC) IN 2001

NAME TERM OF OFFICE

AL-SWAILEM Dr (Mr) Abdulaziz Mohammed (Saudi Arabia) 2000-2003 Director at the King Abuldaziz City for Science and Technology (KACST)

ANDORNO Dr (Mr) Roberto Luis (Argentina) 1998-2001 Professor of Civil Law

BARTHOLOMEW Prof. (Mr) Courtenay (Trinidad and Tobago) 2000-2003 Emeritus Professor of Medicine of the University of the West Indies Director of the Medical Research Foundation, Trinidad and Tobago Former Chairman of the National Institute of Higher Education, Research, Science and Technology Former Member of the World AIDS Foundation (WAF)

BERLINGUER Prof. (Mr) Giovanni (Italy) 2000-2003 Professor of Medicine President of the National Bioethics Committee Former Member of Parliament Former Director of the Department of Human and Animal Biology and of the Post-graduate Course in Bioethics, University of Rome

CANÇADO TRINIDADE Prof. (Mr) Antonio A. (Brazil) 1998-2001 Professor of International Law President of the Inter-American Court of Human Rights

95 DE CASTRO Dr (Mr) Leonardo (Philippines) 2000-2003 Professor of Philosophy President of the Philippine Health Social Science Association Vice-Chairman of the Forum for Ethics Review Committees in Asia and the Pacific Member of the National Ethics Committee

ESTEVEZ Prof. (Mr) Edmundo (Ecuador) 2000-2003 Professor of Biochemistry and Molecular Biology and Neuroscience Director of Biomedical Centre and Medical School, Central University of Ecuador

FOX Prof. (Mr) Maurice (United States of America) 2000-2003 Lester Wolfe Professor of Molecular Biology Member of the National Academy of Science

GALJAARD Prof. (Mr) Hans (The Netherlands) 1998-2001 Professor of Human Genetics Head of the Department of Clinical Genetics, University Hospital Rotterdam

GROS ESPIELL Prof. (Mr) Héctor (Uruguay) 1998-2001 Professor of International Law Chairperson of the UNESCO Consultative Committee on the Teaching of Human Rights, Culture of Peace, Tolerance and Democracy Former Ambassador of Uruguay in France and to UNESCO Former Minister of Foreign Affairs of Uruguay Former President of the Inter-American Court of Human Rights

GUESSOUS-IDRISSI Dr (Mrs) Nouzha (Morocco) 2000-2003 Professor and Head of Parasitology-Mycology Laboratory, Faculty of Medicine and Pharmacy of Casablanca Founding Member of the Moroccan Organization of Human Rights

HAMADE (Mr) Marwan (Lebanon) 2000-2003 Minister for Displaced Persons Member of the Higher Council of the Lebanese Press Former Member of Parliament Former Minister of Health

96 HAMDAN Dr (Mr) Mohammad (Jordan) 1998-2001 Rector of the Arab Open University, Riyadh, Saudi Arabia President, Jordanian National Bioethics Committee Former President of the Hashemite University Former Minister of Education and Higher Education

IDA Prof. (Mr) Ryuichi (Japan) 2000-2003 Professor of International Law Rapporteur of the Committee of Regional Economic Development Law of the International Law Association

JEAN (Mrs) Michèle (Canada) 1998-2001 Adviser in programme development, Faculty of Higher Education, University of Montreal Former Special Adviser to the Minister of Foreign Affairs of Canada to the European Commission Former Vice-Minister of Health

KIRBY Justice (Mr) Michael (Australia) 1998-2001 Justice of the High Court of Australia Member of the Ethics Committee, the Human Genome Organization (HUGO) Former President of the Courts of Appeal of New South Wales and Solomon Islands Former President of the International Commission of Jurists

KOSZTOLÁNYI Dr (Mr) György (Hungary) 2000-2003 Professor and Chair of the Department of Medical Genetics and Child Development, University of Pecs Vice-President of the Faculty of Medicine, University of Pecs Former President of the Hungarian Society of Human Genetics

MCCALL SMITH Prof. (Mr) Alexander (United Kingdom) 1998-2001 Professor of Medical Law Vice-Chairman of the Human Genetics Commission of the United Kingdom Chairman, Ethics Committee, British Medical Journal

97 NOMBELA Prof. (Mr) D. César (Spain) 2000-2003 Professor at the Faculty of Pharmacy, Universidad Complutense de Madrid Former President of the Consejo Superior de Investigaciones Científicas Former President of the Federation of European Microbiology Societies

ÖZTÜRK Prof. (Mr) Mehmet (Turkey) 1998-2001 Professor and Chair of the Department of Molecular Biology and Genetics, Bilkent University Member of the Third World Academy of Science

PAK Prof. (Mrs) Un-jong (Republic of Korea) 2000-2003 Professor of Law President of the Korean Association of Legal Philosophy Vice-President, Korean Bioethics Association

PELTONEN Prof. (Mrs) Leena (Finland) 2000-2003 Professor and Chair of the Department of Human Genetics, University of California Chairperson of the European Medical Research Council

PETROV Academician (Mr) Rem V. (Russian Federation) 1998-2001 Vice-President of the Academy of Sciences Co-Chair of the National Bioethics Committee Member of the Russian Academy of Medical Sciences

POGNON (Mrs) Elisabeth (Benin) 1998-2001 Magistrate Former President of the Constitutional Court of Benin

QUESTIAUX (Mrs) Nicole (France) 2000-2003 Honorary Chairperson of Section of the State Council Vice-President of the National Consultative Ethics Committee for Health and Life Sciences Chairperson of the Permanent European Conference of National Ethics Committees Former Minister of Social Affairs

98 REICH Prof. (Mr) Jens (Germany) 1998-2001 Professor of Genetics Former co-editor of the European Journal of Biochemistry

REVEL Prof. (Mr) Michel (Israel) 1998-2001 Professor of Molecular Genetics, Weizmann Institute of Science Israeli Prize for Medicine (1999) Chief Scientist, Interpharm President of the National Committee for Biotechnology

ROBINSON (Mr) Patrick (Jamaica) 1998-2001 Judge at the International Criminal Tribunal for the former Yugoslavia Member of the United Nations International Law Commission Former Deputy Solicitor-General Former Chairperson of the Inter-American Commission on Human Rights

ROUCOUNAS Prof. (Mr) Emmanuel (Greece) 2000-2003 Professor of International Law Chairman, National Commission of Patients’ Rights Member of the Academy of Athens Member of the Institute of International Law, Geneva Former member of the United Nations International Law Commission

RUMBALL Prof. (Mrs) Sylvia (New Zealand) 2000-2003 Professor of Chemistry Assistant to the Vice-Chancellor (Equity and Ethics), Massey University Former Dean, Faculty of Science, Massey University

RWEGERA (Mr) Damien (Rwanda) 2000-2003 Anthropologist Technical Adviser UNAIDS Former Director of the Pan-African Organization Against AIDS (OPALS) Former Professor of Anthropology and Sociology, National University of Rwanda

99 SACHS Justice (Mr) Albie (South Africa) 2000-2003 Judge of the Constitutional Court of South Africa Honorary Professor of the Faculty of Law, University of Cape Town

TADJUDIN Prof. (Mr) Muhammad Kamil (Indonesia) 1998-2001 Professor of Biology President of the National Accreditation Board of Higher Education Former Rector of the University of Indonesia

TANO BOUAH Prof. (Mrs) Yolande Evelyne (Côte d’Ivoire) 1998-2001 Professor of Law Vice-Chairperson of the University of Abobo-Adjamé

YANG Prof. (Mr) Huanming (China) 1998-2001 Professor of Genetics Director of the Human Genome Center, Chinese Academy of Sciences Secretary General of the Chinese Human Genome Project

ZAREMBA Prof. (Mr) Jacek Stanislaw (Poland) 2000-2003 Professor, Head of Department of Genetics, Institute of Psychiatry and Neurology President of the Neurogenetics Commission of the Polish Academy of Science Vice-President of the Polish Society of Human Genetics

100 Chapter 7

LIST OF PARTICIPANTS

I. Members of the IBC AL-SWAILEM Dr (Mr) Abdulaziz Mohammed (Saudi Arabia) Director at the King Abuldaziz City for Science and Technology (KACST)

ANDORNO Dr (Mr) Roberto Luis (Argentina) Professor of Civil Law

BARTHOLOMEW Prof. (Mr) Courtenay (Trinidad and Tobago) Emeritus Professor of Medicine of the University of the West Indies Director of the Medical Research Foundation, Trinidad and Tobago Former Chairman of the National Institute of Higher Education, Research, Science and Technology Former Member of the World AIDS Foundation (WAF)

DE CASTRO Dr (Mr) Leonardo (Philippines) Professor of Philosophy President of the Philippine Health Social Science Association Vice-Chairman of the Forum for Ethics Review Committees in Asia and the Pacific Member of the National Ethics Committee

ESTEVEZ Prof. (Mr) Edmundo (Ecuador) Professor of Biochemistry and Molecular Biology and Neuroscience Director of Biomedical Centre and Medical School, Central University of Ecuador

FOX Prof. (Mr) Maurice (United States of America) Lester Wolfe Professor of Molecular Biology Member of the National Academy of Science

GALJAARD Prof. (Mr) Hans (The Netherlands) Professor of Human Genetics Head of the Department of Clinical Genetics, University Hospital Rotterdam

GROS ESPIELL Prof. (Mr) Héctor (Uruguay) Professor of International Law Chairperson of the UNESCO Consultative Committee on the Teaching of Human Rights, Culture of Peace, Tolerance and Democracy Former Ambassador of Uruguay in France and to UNESCO Former Minister of Foreign Affairs of Uruguay Former President of the Inter-American Court of Human Rights

101 GUESSOUS-IDRISSI Dr (Mrs) Nouzha (Morocco) Professor and Head of Parasitology-Mycology Laboratory, Faculty of Medicine and Pharmacy of Casablanca Founding Member of the Moroccan Organization of Human Rights

HAMADE (Mr) Marwan (Lebanon) Minister for Displaced Persons / Member of Parliament Member of the Higher Council of the Lebanese Press Former Minister of Health

HAMDAN Dr (Mr) Mohammad (Jordan) Rector of the Arab Open University, Riyadh, Saudi Arabia Vice-Chairperson of the Jordanian National Bioethics Committee Former President of the Hashemite University Former Minister of Education and Higher Education

IDA Prof. (Mr) Ryuichi (Japan) Professor of International Law Rapporteur of the Committee of Regional Economic Development Law of the International Law Association

JEAN (Mrs) Michèle (Canada) Adviser in programme development, Faculty of Higher Education, University of Montreal Former Special Adviser to the Minister of Foreign Affairs of Canada to the European Commission Former Vice-Minister of Health

KOSZTOLÁNYI Dr (Mr) György (Hungary) Professor and Chair of the Department of Medical Genetics and Child Development, University of Pecs Vice-President of the Faculty of Medicine of the University of Pecs Former President of the Hungarian Society of Human Genetics

MCCALL SMITH Prof. (Mr) Alexander (United Kingdom) Professor of Medical Law Vice-Chairman of the Human Genetics Commission of the United Kingdom Chairman, Ethics Committee, British Medical Journal

NOMBELA Prof. (Mr) D. César (Spain) Professor at the Faculty of Pharmacy, Universidad Complutense de Madrid Former President of the Consejo Superior de Investigaciones Científicas Former President of the Federation of European Microbiology Societies

ÖZTÜRK Prof. (Mr) Mehmet (Turkey) Professor and Chair of the Department of Molecular Biology and Genetics, Bilkent University Member of the Third World Academy of Science

PETROV Academician (Mr) Rem V. (Russian Federation) Vice-President of the Academy of Sciences Co-Chair of the National Bioethics Committee Member of the Russian Academy of Medical Sciences

102 POGNON (Mrs) Elisabeth (Benin) Magistrate Former President of the Constitutional Court of Benin

QUESTIAUX (Mrs) Nicole (France) Honorary Chairperson of Section of the State Council Vice-President of the National Consultative Ethics Committee for Health and Life Sciences Chairperson of the Permanent European Conference of National Ethics Committees Former Minister of Social Affairs

REVEL Prof. (Mr) Michel (Israel) Professor of Molecular Genetics, Weizmann Institute of Science Israeli Prize for Medicine (1999) Chief Scientist, Interpharm President of the National Committee for Biotechnology

ROBINSON (Mr) Patrick (Jamaica) Judge at the International Criminal Tribunal for the former Yugoslavia Member of the United Nations International Law Commission Former Deputy Solicitor-General Former Chairperson of the Inter-American Commission on Human Rights

ROUCOUNAS Prof. (Mr) Emmanuel (Greece) Professor of International Law Chairman, National Commission of Patients’ Rights Member of the Academy of Athens Member of the Institute of International Law, Geneva Former member of the United Nations International Law Commission

RUMBALL Prof. (Mrs) Sylvia (New Zealand) Professor of Chemistry Assistant to the Vice-Chancellor (Equity and Ethics), Massey University Former Dean, Faculty of Science, Massey University

RWEGERA (Mr) Damien (Rwanda) Anthropologist Technical Adviser UNAIDS Former Director of the Panafrican Organization Against AIDS (OPALS) Former Professor of Anthropology and Sociology, National University of Rwanda

TADJUDIN Prof. (Mr) Muhammad Kamil (Indonesia) Professor of Biology President of the National Accreditation Board of Higher Education Former Rector of the University of Indonesia

TANO BOUAH Prof. (Mrs) Yolande Evelyne (Côte d’Ivoire) Professor of Law Vice Chairperson of the University of Abobo-Adjamé

103 YANG Prof. (Mr) Huanming (China) Professor of Genetics Director of the Human Genome Center, Chinese Academy of Sciences Secretary General of the Chinese Human Genome Project

ZAREMBA Prof. (Mr) Jacek Stanislaw (Poland) Professor, Head of Department of Genetics, Institute of Psychiatry and Neurology President of the Neurogenetics Commission of the Polish Academy of Science Vice-President of the Polish Society of Human Genetics

II. Special Guests Mrs Anne Fagot-Largeault Professor at the Collège de France Chair of Philosophy of biological and medical sciences Mr Thierry Rabilloud Laboratory of Cellular and Pathological Bioenergetics (BECP-DBMS – CEA – Grenoble), CR1 CNRS Senior Editor of Proteomics

III. Round Table on Education in Bioethics and Youth Mrs Yolande Tano Bouah Professor of Law Vice-President of the University of Abobo-Adjamé Côte d’Ivoire Miss Catalina Alvarez Irarragori Centre of Genetic Engineering and Biotechnology Cuba Miss Natasha Isabel de Freitas Chairperson of the Youth Council of the UNESCO Club V.N. of Gaya Portugal Miss Sandra Goritschnig National Director of the International Association of Agricultural Students (IAAS) Austria Miss Kwak Young-bin Department of International Relations, Seoul National University Republic of Korea

IV. Hearings of Commissioners for the Protection of Personal Data Mr Joël Boyer Secretary-General of the Commission nationale de l’informatique et des libertés (CNIL) France

104 Mrs Bénédicte Havelange Secretary-General of the Belgian Commission for the Protection of Privacy Belgium Mr Georges Radwanski Privacy Commissioner of Canada Canada

V. Representatives of the United Nations Organization and Organizations of the United Nations System

UNITED NATIONS ORGANIZATION (UNO) Mr Hassen Fodha Director of the Information Centre of the United Nations Paris Mr Abdul Dieng Information Centre of the United Nations Paris

WORLD HEALTH ORGANIZATION (WHO) Mr Victor Boulyjenkov Human Genetics Office

UNITED NATIONS UNIVERSITY (UNU) Ms Caterina Casullo Head of the UNU Office at UNESCO Ms Lynn K. Mytelka Director United Nations University Institute for New Technologies (NU/INTECH) Maastricht The Netherlands

INTERNATIONAL CENTRE FOR GENETIC ENGINEERING AND BIOTECHNOLOGY (ICGEB) Mr Decio Ripandelli Programme and Administrative Coordinator Trieste Italy

VI. Observers from Intergovernmental Organizations

EUROPEAN COMMISSION Ms Barbara Rhode Head of Unit Research

105 Mrs Christiane Bardoux Secretary of the European Group on Ethics in Science and New Technologies

COUNCIL OF EUROPE Ms Sandrine Sabatier Bioethics Division

ORGANIZATION FOR ECONOMIC CO-OPERATION AND DEVELOPMENT (OECD) Ms Elettra Ronchi Co-ordinator Health and Biotechnology Activities Biotechnology Unit

VII. Observers from International Non-Governmental Organizations

ARAB LEAGUE EDUCATIONAL, CULTURAL AND SCIENTIFIC ORGANIZATION (ALECSO) Mrs Saida Charfeddine Representative to UNESCO

B’NAI B’RITH Mrs Rita Thalmann Deputy Permanent Representative to UNESCO Mrs Norma Anav Paris Mrs Irène Orès Paris

COUNCIL FOR INTERNATIONAL ORGANIZATIONS OF MEDICAL SCIENCES (CIOMS) Mr Juhana Idänpään Heikkilä Secretary-General Dr James Gallagher Senior Adviser

DISABLED PEOPLE’S INTERNATIONAL Mr Jean-Luc Simon Vice-President of the European Region

EUROPEAN ACADEMY OF ARTS, SCIENCES AND HUMANITIES Mr Raymond Daudel President

106 INCLUSION INTERNATIONAL Mrs Nancy Breitenbach Director-General Mrs Françoise Jan Adviser

INTERNATIONAL ASSOCIATION OF AGRICULTURAL STUDENTS (IAAS) Mr Els Martens Vice-President

INTERNATIONAL ASSOCIATION OF UNIVERSITIES Mr Franz Eberhard Secretary-General and Executive Director

INTERNATIONAL COUNCIL FOR SCIENCE (ICSU) Mr Tish Bahmani Fard Assistant Executive Director

INTERNATIONAL COUNCIL OF WOMEN Mrs Françoise Bouteiller Permanent Representative to UNESCO

INTERNATIONAL COUNCIL OF JEWISH WOMEN Mrs Gabrielle Voignac

INTERNATIONAL FEDERATION OF MEDICAL STUDENTS’ ASSOCIATION (IFMSA) Mr Youri Yordanov Issy-les-Moulineaux France

INTERNATIONAL OFFICE OF CATHOLIC EDUCATION (IOCE) Mr Yannick Gainche Deputy Permanent Representative to UNESCO

PAX CHRISTI INTERNATIONAL Mrs Colette Petit Permanent Representative to UNESCO

PAX ROMANA Mr Jean Bussac Permanent Representative to UNESCO

107 WOMEN’S INTERNATIONAL LEAGUE FOR PEACE AND FREEDOM (WILPF) Mrs Simone Landry Secretary-General, French Section

WORLD ASSOCIATION OF GIRL GUIDES AND GIRL SCOUTS Mrs Martine Lévy Co-ordinator

WORLD ASSOCIATION OF CHILDREN’S FRIENDS (AMADE) Mr Jean Michaud Member of the Administration Council

WORLD FEDERATION OF SCIENTIFIC WORKERS (WFSW) Mr André Jaegle President Mr Jean-Pierre Bazin Researcher at Inserm

VIII. Observers from Member States, Permanent Missions of Observation and National Commissions for UNESCO

ARAB REPUBLIC OF EGYPT Ms Menha Bakhoum Counsellor Permanent Delegation to UNESCO

ARGENTINA Mrs Claudia A. Zampieri Adviser Permanent Delegation to UNESCO

AUSTRIA Ms H. Baumgartner Assistant Professor Department of Biochemical Pharmacology University of Innsbruck Vice-Chairman – Faculty Ethics Committee

AZERBAIJAN Mr Namig Aliev Director of the Institute of Medical Prophylaxis Baku

108 Mr Akif Alizada Director of the Institute of Geology Azerbaijan National Academy of Sciences Baku Mr Rovshan Mustafayev Director of the Institute of Human Rights Azerbaijan National Academy of Sciences Baku Mr Rasulova Nigar Institute of Human Rights Baku

BRAZIL

Mr Joăo Lanari Bo Adviser Permanent Delegation to UNESCO

CHILE Mr Jorge Vera-Castillo Scientific Attaché Permanent Delegation to UNESCO

COLOMBIA Mrs Carolina Lorduy First Secretary Permanent Delegation to UNESCO

CROATIA

Mrs Daša Bradiþic Deputy Permanent Delegate to UNESCO Mrs Biserka Belicza Bioethics Institute Zagreb

FINLAND Mr Arto Kosononen Ministry for Foreign Affairs Ms Tehri Hermanson Senior Medical Officer Ministry of Social Affairs and Health Ms Salla Lötjönen Secretary-General National Research Ethics Council of Finland

109 Ms Rina Subra Stagiaire Permanent Delegation to UNESCO

FRANCE Mrs Sylvie de Bruchard Deputy Permanent Delegate to UNESCO

GERMANY Mr Stefan Weckbach Deputy Permanent Delegate to UNESCO

HUNGARY Ms Judit Sandor Associate Professor Central European University Budapest

ICELAND Ms Bryndis Kjartansdottir First Secretary Permanent Delegation to UNESCO

IRAN (ISLAMIC REPUBLIC OF) Mr Mohammed Kashani Deputy Permanent Delegate to UNESCO Mr Mahmoud Abbasi Centre for Biomedical Ethics Tehran Mr Mohammad-Mehdi Golmakani Chief of the Centre of Study and Research on Medical Ethics Tehran

IRAQ H. E. Mr Ali Almashat Ambassador Permanent Delegate to UNESCO Mr Iyad Aflak Adviser Permanent Delegation to UNESCO

JAPAN Mr Keisuke Otani First Secretary Permanent Delegation to UNESCO

110 LEBANON Mr Khalil Karam Professor at the Faculty of Dental Medicine Beirut Mrs Carla Jazzar Chargée d’affaires Permanent Delegation to UNESCO

LITHUANIA Mr Darius K. Mereckis First Secretary Permanent Delegation to UNESCO

MEXICO H. E. Mr Javier Barros Ambassador Permanent Delegation to UNESCO Mr Adolfo Martinez Palomo Director General of the Centro de Investigación y Estudios Avanzados (CINESTAV) del Instituto Politécnico Nacional Mexico Mr Ismael Madrigal Permanent Delegation to UNESCO Mr Diego Simancas Third Secretary Permanent Delegation to UNESCO

NIGERIA Mr Young Nwafor Deputy Permanent Delegate to UNESCO

PAKISTAN Mr Rukhsana Zia Deputy Permanent Delegate to UNESCO

PALESTINE Mr Bilal Ghareeb Palestinian National Commission for Education, Culture and Science

PERU Mr Alfredo Picasso de Oyague Adviser for Scientific and Technological Cooperation Permanent Delegation to UNESCO

111 POLAND Ms Mazgorzata Dziedvszycha Permanent Delegate to UNESCO Ms Katarzyna Brzeczek Permanent Delegation to UNESCO

PORTUGAL Mrs Ana Zacarias Deputy Permanent Delegate to UNESCO

SYRIAN ARAB REPUBLIC Mr Abd Al Gabar Aldahhak Dean of Science Damascus University

REPUBLIC OF KOREA Mr Jong-Goo Yeo First Secretary Permanent Delegation to UNESCO

RUSSIAN FEDERATION Mr Andrei Skachkov First Secretary Permanent Delegation to UNESCO

SLOVENIA

Mrs Vlasta Moþnik Drnovšek Counsellor to the Government Ministry of Health

THE NETHERLANDS Mrs Marjan Romain Attachée Permanent Delegation to UNESCO Ms Paula Schinderler Internship Permanent Delegation to UNESCO

UKRAINE Mr Olexander Demianiuk Permanent Delegate a.i. to UNESCO

112 UNITED REPUBLIC OF TANZANIA Mr Mohammed S. Sheya Deputy Permanent Delegate to UNESCO

IX. Guests Mrs Ladan Abbasian Henri Mondor Hospital, Créteil France Mr Ali Abdelfattah Founding President International Association of Psychiatry and Psychotherapy France Mr Hassan Abelhamid Professor of Law Ain Chams University, Cairo Egypt Rev. Emmanuel Agius Bioethics Committee of Malta Malta

Mr Salah AL-Ateequi Islamic Organization for Medical Sciences Kuwait Mr Abdulrahman Alatawi Assistant Professor Department of Medical Biochemistry Arabian Gulf University Bahrain Ms Jessica de Alba Research, University of Paris Sud XI Paris Mr André Albert Magistrate Paris Mr Carlos Alonso-Bedate Centre of Molecular Biology ‘Severo Ochoa’ Faculty of Science Madrid Spain Mr Abbas Ameur Faculty of Law and Political Science University of Oran Algeria

113 Mrs Irma Arnoux University of Bordeaux 3 France Mrs Geneviève Augendre Former member of the Conseil de l’Ordre des Avocats à la Cour de Paris Paris Mrs Laurence Azoux-Bacrie Institut de formation en droits de l’homme du Barreau de Paris Paris Mr Néji Baccouche Faculty of Law University of Sfax Tunisia Mr Jean Bacou μInstitute of Health Sciences Paris Mr Mark Bale Secretary, Human Genetics Commission Department of Health London United Kingdom Mr Dominique Beaufils Secretary of the Orthodox Association of Bioethical Studies Hirson France Mrs Nicole Becarud French National Council of Engineers and Scientists Paris Mrs Zelina Ben-Gershon Senior Scientific Director Chief Scientist’s Office Jerusalem Israel

Ms Caroline Bidon DESS d’ingénierie génomique fonctionnelle University of Paris 7 Denis Diderot Paris

Ms Martine Boiteux Ministry of Research Paris

Mr Dalil Boubakeur Rector of Muslim Institute Paris

114 Ms Catherine Bourdinn Paris Mr Jacques Brunschwig President, Association pour la morale agnostique Bar le Duc France Mr Christian Byk Magistrate Paris Ms Marie-Madeleine Cance Lawyer Paris Ms Elvira Carvajal Professor State University of rio de Janeiro Brazil Mr Maurice Cassier RESEARCH OFFICER at the CNRS Centre of Research, Medicine, Science, Health and Society (CERMES) Paris Ms Laurence Cate Ministry of Health Paris Mr Maurice Cauchi Chairman Bioethics Consultative Committee Malta

Mr Jean-Paul Caverni Conference of University Presidents National Consultative Bioethics Committee Paris

Rev. P. Fernando Chomali Centre of Bioethics Santiago de Chile Chile

Mr Abram Coen Psychiatrist Saint-Denis France

Ms Carla Correia UNESCO Club V.N. de Gaya Viana do Castelo Portugal

115 Mr Ricardo Cruz-Coke Department of Genetics, Hospital Clinico University of Chile Chile Mr Pierre Cüer Co-ordinator Bioethics Training European Federation of Networks for Scientific and Technological Cooperation France Mr Rimas Cuplinskas German Reference Centre for Ethics in the Life Sciences Bonn Germany Mr Chekhe Dem Honorary President International Federation of Training Centres for Methods of Active Educztion Paris Ms Danièle Demonchy Maître de conférences, Bioethics and Pharmacology University René Descartes Paris V Paris Mrs Marie Agnes Dillies-Peltier DESS d’ingénierie génomique fonctionnelle Université Paris 7 Denis Diderot Paris Mrs Thomais Douraki Legal Counsellor Greece Mr Alain Drouard Director of Research at the CNRS Paris

Ms Drula-Guignard France

Ms Fatima El Kebir Professor University of Oran Es Senia Algeria

Mrs Isabelle Erny Legal Councillor Ministry of Health Paris

Mr Georges Fauré Maître de conférences, Law Faculty of Amiens Paris

116 Ms Marie-Laure Fouché Montrouge France

Mr Norio Fujiki Emeritus Professor of Fukui Medical University Japan

Mr Kjell Fuxe Department of Neuroscience Karolinska Institute Stockholm Sweden

Mr Philippe Garabiol Head of the Office of Ethics and Law Ministry of Health Paris

Mrs Beatriz Garcia Autonomous University Barcelona Spain Mr Michael Geier Wetzlar Germany

Ms Marion Girer Mionnay France

Ms Grete Gjertsen Adviser Ministry of Health Norway

Ms Geneviève Grangy Paris

Mr Yves-Marie Granjon Psychoanalyst - Psychotherapist France

Mr Pierre Greiveldinger Paris

Mrs Laura Guidoni Physics Laboratory High Institute of Health Rome Italy

117 Mr Farid Hakkou Professor of medicine Bioethics Committee Casablanca Morocco Mr Alix Halm DESS d’ingénierie génomique fonctionnelle Paris 7 Denis-Diderot University Paris Mr Bechir Hamza President of the National Medical Ethics Committee Tunisia Ms Florence Hardy University de Cergy-Pontoise France Ms Nicole Heine Institut für Wissenschaft und Ethik Bonn Germany Mr Fayçal Hentati Department of Neurology National Institute of Neurology La Rabt - Tunis Tunisia Ms Claire Honigman La Voix de l’Enfant Paris Mr Ram Ishay Chairman The Israel Society of Medical Ethics Ramat-Gen Israel Ms Françoise Jan Union nationale des associations de parents et amis de personnes handicapées mentales (UNAPEI) Paris Ms Brigitte Jansen Research Center, Biotechnology and Law Lüneberg Germany Ms Lena Jonsson Director, Special Expert Ministry of Health and Social Affairs Sweden

118 Ms Claire Jourdan Lawyer Paris Mr R. R. Kishore President, Indian Society for Health Laws and Ethics New Delhi India Mr Abderrahim Kounda Sidi Othman Laboratory Casablanca Morocco Ms Isabelle de Lamberterie Director of Research National Centre of Scientific Research Ivry France Ms Chantal Lebatard Union nationale des associations familiales (UNAF) Paris Mr Georges Lienard Secretary-General European Humanist Federation Belgium Mr Tor Lezemore Assistant Director Nuffield Council on Bioethics London United Kingdom Ms Susanne Lundin Swedish Gene Technology Advisory Board Solna Sweden Mr Pedro Nuno Machado UNESCO Club de Gaya Porto Portugal Mr Thomas Mackenzie Executive Director Interdisciplinary University of Paris Paris Mrs Marianne Maman Head, Medicine and Society Novartis Clinical R&D Basle Switzerland

119 Mr George Maniatis National Bioethics Committee Greece

Ms Catherine Manuel Laboratory of Public Health Medical Faculty of Marseille France

Mr Eric Martinent Institut de formation et de recherche sur les organisations sanitaires et sociales et leurs réseaux (IFROSS) Faculty of Law of Lyon France

Ms Marie Cécile Masure Operational Committee for Ethics National Centre for Scientif Research Paris

Mrs Elizabeth McPherson Genetics Ethics Advisor GlaxoSmith Kline Research Triangle Park NC United States of America

Mr Eddy Mhlanga Director Maternal, Child and Women’s Health Department of Health Pretoria South Africa

Mr Andy Miah De Montfort University Bedford United Kingdom

Ms Anne-Laure Morin Jurist Association française contre les myopathies (AFM) France

Mgr Jean-Marie Mpendawatu Pontifical Council for Health Vatican City

Mrs Josette Perrouin Fédération internationale des mouvements d'adultes ruraux catholique (FIMARC) France

120 Mr Lazare Poame Vice-Dean University of Bouake Côte d’Ivoire Miss Cristina Portuondo Spanish Society of Bioethics Madrid Spain Mr Salvatore Privitera Istituto Siciliano di Bioetica Acireale Italy Mr Bracha Rager Professor of Microbiology and Immunology Ben-Gurion University Chief Scientist Ministry of Health Israel Mrs Carmen Rauch Department of Medical Genetics Timone Enfants Hospital Marseille France

Mrs Nathalie Rauffer-BRUYERE National Institute of Industrial Property Paris Mr Jean-Pierre Raugel Yerres France Mr João Paulo Remédio Marques Professor of Law Centre for Biomedical Law Faculty of Law of the University of Coimbra Portugal Mrs Gemma Revuelta Deputy Director, Observatory of Scientific and Medical Communication of Pompeu Fabra University Barcelone Spain Ms Laurence Ricci DESS d’ingénierie génomique fonctionnelle University Paris 7 Denis-Diderot Paris Ms Ragnhild Riis Member of Ethics Board Copenhagen Denmark

121 Mr Pío Rodriguez Paris Mr Claude Saint Upery National Adviser Syndicat national professionnel des médecins du travail (SNPMT) France Mr Peter Schroeder Zentrum für Medizinische Ethik Ruhr University, Bochum Germany Mr Vladimir de Semir Councillor for the City of Knowledge Barcelona Spain Mr Drasko Serman Professor of Biology University of Zagreb Medical School Croatia Ms Ann-Charlotte Smedler Secretary of the National Council on Medical Ethics Stockholm Sweden Mr Michel Somville Bioethics Consultative Committee Belgium Mrs Sheila Stonehouse Pugwash UK United Kingdom Mr Claude Sureau Theramex Institute Bioethics, Women’s Health and Society Paris Mr Gérard Teboul Professor at the University of Paris XII Paris Ms Patricia Terrell Corona del Mar United States of America Mrs Gwen Terenoire National Ethics Consultative Committee Paris Mr Eduardo Tibiriçá Laboratory of Neuro-Cardiovascular Pharmacology Oswaldo Cruz Institute, Rio de Janeiro Brazil

122 Mr Ayako Tokoro Hosei University Tokyo, Japan Ms Françoise Touraine-Moulin Pierre Wertheimer Neurological and Neuro surgical Hospital Lyon France Mrs Jocelyne Vaysse Paris Mr Gaston Verdonk Bioethics Consultative Committee Belgium Mr Patrick Verspieren Director of the Biomedical Ethics Centre Sèvres Paris Mr Nuno Vicente Agronomic Engineer Lisbon Portugal Mr Vladimir Viklicky Institute of Molecular Genetics CAS Czech Republic Ms María Dolores Vila-Coro Director UNESCO Chair in Bioethics Madrid Spain Ms Marilena Villela Corrêa Professor of Human Reproduction and Bioethics State University of Rio de Janeiro Brazil Mr François Vittecoq President Association des centres de rééducation pour déficients mentaux (A.C.R.) Paris Mr P. Efrén Vivar Reinoso Universidad Politecnica Salesiana Guayaquil, Ecuador

IX. Communication Mr Pierre Atallah An-Nahar Lebanon

123 Mr Jacques Bonneau Gazette du Palais Paris Mr Michel Fargeon SEAEMY-Productions Paris Ms Sylvie O’Dy Editor-in-Chief L’Express

Mr Antoine Schoen ARTE Paris

X. UNESCO

Mr Koïchiro Matsuura Director-General Mr Pierre Sané Assistant Director-General for Social and Human Sciences Mr Georges B. Kutukdjian Secretary-General of the IBC Director, Division of Human Sciences, Philosophy and the Ethics of Science and Technology Ms Maria-Elena Henriques-Mueller Chief of Unit Unit for Youth Ms Sabina Colombo Assistant Programme Specialist Division of Human Sciences, Philosophy and the Ethics of Science and Technology Ms Sabine Detzel Programme Specialist Unit for Youth Mr Rok Vogric Senior Programme Specialist Programme for the Freedom of Expression, Democracy and Peace Mr Emile Glele Assistant Legal Officer Arts and Copyright Section

124 Ms Orio Ikebe Associate Expert Division of Human Sciences, Philosophy and the Ethics of Science and Technology Ms Jeannette Blom Division of Human Sciences, Philosophy and the Ethics of Science and Technology Mrs Léonie Treguer Documentation Division of Human Sciences, Philosophy and the Ethics of Science and Technology Ms Aïssata Boundy Administration Division of Human Sciences, Philosophy and the Ethics of Science and Technology

125 ACTES

COMITE INTERNATIONAL DE BIOETHIQUE DE L’UNESCO (CIB) neuvième session

*****

PROCEEDINGS

INTERNATIONAL BIOETHICS COMMITTEE OF UNESCO (IBC) Ninth Session

Volume II Les idées et opinions exprimées dans cette publication sont celles des auteurs et ne reflètent pas nécessairement les vues de l’UNESCO.

Les appellations employées dans cette publication et la présentation des données qui y figurent n’impliquent de la part de l’UNESCO aucune prise de position quant au statut juridique des pays, territoires, villes ou zones, ou de leurs autorités, ni quant à leurs frontières ou limites.

***

The ideas and opinions expressed in this publication are those of the authors and do not necessarily represent the views of UNESCO.

The designations employed and the presentation of material throughout the publication do not imply the expression of any opinion whatsoever on the part of UNESCO concerning the legal status of any country, territory, city or area or of its authorities, or concerning its frontiers or boundaries.

United Nations Educational, Scientific and Cultural Organization Division of the Ethics of Science and Technology, Bioethics Section Social and Human Sciences Sector SHS/EST/02/CIB-9/3

© UNESCO, 2003

II Table des matières * * * Table of Contents

CHAPITRE / CHAPTER 1 TABLE RONDE SUR « LA BIOETHIQUE AU MIROIR DES VALEURS ET TRADITIONS SPIRITUELLES DE L’HUMANITE » / ROUND TABLE ON ‘BIOETHICS IN THE LIGHT OF SPIRITUAL VALUES AND TRADITIONS OF HUMANITY’ Buddhism and Bioethics Noritoshi Aramaki ...... 3 La bioéthique au miroir des valeurs et traditions spirituelles de l’humanité Bernard Kanovitch ...... 5 Bioethics and the Eastern Spiritual Traditions Sehdev Kumar ...... 9 La bioéthique dans la tradition chrétienne catholique / Bioethics in the Catholic Christian Tradition Mgr Jean-Marie Mpendawatu ...... 13 Points of Convergence in Bioethics among Christians and Muslims Hisham Nashabe ...... 29 Vers une conception politique de la bioéthique Daniel Weinstock ...... 31

CHAPITRE / CHAPTER 2 VERS UNE DECLARATION INTERNATIONALE SUR LES DONEES GENETIQUES HUMAINES / TOWARD AN INTERNATIONAL DECLARATION ON HUMAN GENETIC DATA Présentation de l’Esquisse de la déclaration internationale sur les données génétiques humaines Georges B. Kutukdjian ...... 37

III CHAPITRE / CHAPTER 3 ETAT DES LIEUX / STATE-OF-THE-ART PRESENTATION Neurosciences and Brain Research State of the Art and Neuroethics Rémi Quirion ...... 59

CHAPITRE / CHAPTER 4 PREDISPOSITIONS, SUSCEPTIBILITES ET RECHERCHES GENOMIQUES : QUELS ENJEUX POUR L’AVENIR ? / PREDISPOSITIONS, SUSCEPTIBILITY AND GENOMIC RESEARCH : WHAT IMPLICATIONS FOR THE FUTURE? Genomics and Society Claude Laberge ...... 67 The Ethical Issues Raised by Behavioural Genetics in Humans Michel Revel ...... 81 A Patrimony to be Preserved Francisco Mauro Salzano ...... 95

IV Chapitre / Chapter 1

TABLE RONDE SUR « LA BIOETHIQUE AU MIROIR DES VALEURS ET TRADITIONS SPIRITUELLES DE L’HUMANITE » * * * ROUND TABLE ON ‘BIOETHICS IN THE LIGHT OF SPIRITUAL VALUES AND TRADITIONS OF HUMANITY’

• Prof. Noritoshi Aramaki (Japon / Japan)

• Dr Bernard Kanovitch (France)

• Dr Sehdev Kumar (Canada)

• Mgr Jean-Marie Mpendawatu (Saint Siège / Holy See)

• Dr Hisham Nashabe (Liban / Lebanon)

• Prof. Daniel Weinstock (Canada) BUDDHISM AND BIOETHICS

Noritoshi Aramaki (Japan), Department of Buddhist Studies Otani University, Kyoto

Within the comparatively short period since the birth of bioethics, say fifty years at the most, bioethicists have consistently been confronted with those new questions which are beyond itself. Between the 1960s and the 1970s it emerged as an independent discipline to question medical-professions and medical-education; whether physicians trained in the increasingly technical specialities; could behave with responsibility in their clinical realities so as to protect the human rights of patients; whether nurses employed in profit-oriented hospitals and institutions could behave with a warm bedside manner so as to satisfy the human dignity of patients, etc. These questions are beyond bioethics itself because they demand not only ethical standards of medicine but also the humanity essentially rooted in the spiritual values of respective cultures. The 1970s and 1980s saw heated discussions about life and death questions: whether an artificially inseminated human egg or a pre- embryonic conglomeration of human cells should be treated as an inorganic object, thereby disgracing the bliss of beginning life; whether the internal organs of a living or brain-dead person should be transacted as merchandise thereby humiliating the solemnity of dying life, etc. These questions are beyond bioethics itself, because they demand not only the ethical justification of those therapeutic necessities but also the meaning of life itself defined according to the religious traditions of humanity. Between the 1980s and the turn of the century bioethicists have been involved in the mysterious and enigmatic enterprise of asking genome- ethical questions: whether each individual’s genome and its coded products, RNA and protein, should be recombined and manipulated thereby interfering with the evolution of life itself; whether each individual’s genome and its coded products, RNA and protein, should be exploited and mass-produced

3 technologically and commercially thereby influencing the future of life itself, etc. These questions are beyond bioethics itself, because they demand not only ethical guidelines or controls of those therapeutic and pharmaceutic necessities, but also the truth of life itself that can be experienced only through religious experiences. Thus, bioethics has raised new and urgent questions at each stage and efforts to answer them have brought the discipline nearer to touching life itself, namely: - the first stage: a physician’s and a nurse’s behaviour; - the second stage: an artificially inseminated human egg and the internal organs for transplantation; - the third stage: a human genome and its coded products, RNA and protein, but has never been able to experience life itself. Has any human being been able to experience life itself as such here and now? I am of the opinion that all philosophical and religious traditions are attempts to experience life itself as such. A truly creative thinker in the respective traditions must have experienced life itself as such here and now, but even though Indian religious traditions are centred around their practice to experience life itself here and now (yoga dhyăna, samădi, Zenor etc.), the Buddhist message seems to be most cogent in our contemporary contexts. Put simply, it runs as follows: 1. Concentrate on life here and now and be desireless and selfless so that your old body will create new culture; 2. Concentrate on life here and now and be free and creative so that your new body will communicate new culture and communalise a new cultural community. Thus Buddhism teaches that life itself here and now is creative and communal, not individualized and internalised within each body. If bioethics were to be founded on this principle of life in the here and now that is creative and communal, what would its agenda be? Bioethics must encourage selfless creativity of biological science, but not to the point of selfish profitability of biological technology, especially with regard to patented monopolies. Bioethics must be able to contribute to culturally and ecologically recovering diverse communities on earth, but not to the point of enforcing mono-cultural capitalistic products especially with regard to gene- technological interference with the evolution of life itself.

4 LA BIOETHIQUE AU MIROIR DES VALEURS ET TRADITIONS SPIRITUELLES DE L’HUMANITE

Bernard Kanovitch (France), Directeur de la Chaire d’éthique Rothschild Professeur de médecine à l’Université de Paris XI

Dans une conférence restée célèbre, Max Weber (1864-1920) avait en 1919 distingué l’éthique de la conviction et l’éthique de la responsabilité. La première est fondée sur des principes intangibles tels ceux du sermon sur la montagne où le Christ énonce à ses disciples les huit béatitudes. La seconde est par excellence celle d’un métier, la politique, qui laisse une place aux compromis et tient compte des conséquences possibles de nos actes. Cette distinction très souvent utilisée depuis, reste valable. Nous en ferons l’analyse du point de vue notamment, des partisans de l’éthique de conviction. Quelques principes fondamentaux entre autres représentent les fondements d’une approche religieuse de l’éthique biomédicale, notamment les religions monothéistes. L’éthique religieuse en matière biomédicale considère qu’il y a : • du sacré dans l’homme, • du sacré dans la relation de l’homme à l’homme, • du sacré dans la relation de l’homme à Dieu. Après des considérations sur le droit pour le médecin d’intervenir dans le dessein divin, c’est-à-dire de soigner : « Et il fera guérir. Exode XXI-9 » la mention du Dieu guérisseur, Adonaï fait écho à la guérison opérée par l’adoucissement de l’eau (Mara) dans diverses traditions. Ainsi, Philon d’Alexandrie raconte comment au milieu des merveilles accomplies devant eux, les enfants d’Israël commencent à se lamenter sur leur propre sort lors de la traversée du désert.

5 Parmi les textes fondamentaux, le célèbre « Tu choisiras la vie. Nombre XXX-9 » ainsi que le commandement de ne pas rester : « Ne restes pas indifférent au sang de ton prochain. Lévitique XIX-6 ». L’ensemble érige en principe de vie, la dialectique permis interdit en référence à Celui qui est saint.

La vie humaine est sacrée, chaque instant de l’existence est aussi précieux que de longues années de vie. En application de ces principes : • interdiction de provoquer ou de hâter la fin de la vie d’un être humain ne serait-ce que pour abréger ses souffrances ou pour se servir d’une partie de son corps en but de sauver un autre malade ; • le corps conserve un caractère sacré même après la mort. La rigueur de ces principes étant corrigée par la priorité donnée à la vie lorsque celle-ci est en danger, où beaucoup d’interdits sont alors levés. L’a priori de la vie peut être établie sur cette sourate du Coran « C’est Dieu qui donne la vie et la retire » et, dans la Bible hébraïque, « Tu ne tueras point ». L’ensemble des religions monothéistes s’appuiera sur cet aphorisme du Talmud, « Ne pas porter atteinte à la vie que Dieu a rendu sacrée, tuer un homme car il a été créé unique, c’est tuer toute l’humanité ». La procréation médicalement assistée et les nombreuses méthodes utilisées dans cet objectif, reposent sur ce principe (que toutefois, tout humaniste partage avec une mentalité religieuse) c’est moins la maîtrise des techniques biomédicales que la maîtrise de cette maîtrise qui est en jeu. Ecrit en 1990, le principe de responsabilité (Hans Jonas) introduit l’idée d’une éthique pour la civilisation technologique, éthique de l’hétéronomie, celle-ci suivant les termes de l’auteur est fondée sur un heuristique de la peur avec la triple relation de cette responsabilité à la manière des textes fondamentaux précédents : • père/fils • politiciens/citoyens • médecins/malades.

6 Ceci nous conduit en relaté au deuxième principe de Max Weber, l’éthique de responsabilité. A savoir, la prise en compte des conséquences des choix et décisions. Voir le récit de la Genèse III-9 : « L’Eternel appela l’homme et lui dit ‘où es-tu ?’ » Car après l’interdiction de manger de l’arbre de la connaissance, du bien et du mal dans le jardin d’Eden, la question posée à l’homme suivant les sage du Talmud doit se comprendre ainsi : non pas « où es-tu ? » mais « où en es-tu ? » appelant ainsi à réfléchir à sa propre référence par rapport au créateur, par rapport à autrui et par rapport à soi-même, fondements de la loi juive suivant la Bible hébraïque.

7 BIOETHICS AND THE EASTERN SPIRITUAL TRADITIONS

Sehdev Kumar (Canada), Emeritus Professor Director of the Forum for Dialogue between Science and Religion, Toronto

It would be easy to proclaim that the religious traditions, whether in the East or the West, have had the answer to all bioethical challenges that now so stare us in the face. Traditions – religious, cultural or philosophical – are not a fixed repository of answers, but a reminder that in our Faustian thrust for newness, how we are tempted to betray what is truly noble and nourishing about life. The powers of science are now immense; we are literally in a position to move the mountains, change the course of rivers, and alter the heart of nature. In our hubris, sometimes we proclaim that we have the power of gods. But do gods have unfettered power? And do they have only power? And power to do what? In July 1945, when the fierce and utterly unknown genie of nuclear power was first released on Point Zero in a desert in New Mexico, as the scientists and others watched the desert lit ‘by a searing light with an intensity many times that of the midday sun’, Robert J. Oppenheimer, the father of the atom bomb, is said to have been reminded of a passage from the Bhagavad Gita, the sacred epic of the Hindus: If the radiance of a thousand suns Were to burst into the sky, That would be like the The splendour of the Mighty One. As the sinister and gigantic cloud rose in the far distance, he was reminded yet of another line from the epic: I am become Death, the shatterer of worlds.

9 In the Hindu epic, the words are of Sri Krishna, the Exalted One, Lord of the fate of the mortals. On the tongue of humans, however, the same words became menacing and foreboding. Man was now in possession of a blazing new instrument of darkness. As the years and decades have shown since then, we are all doomed now to live in morbid fear of annihilation by our own instruments of creation! We think of the power of scientists to be like that of gods. Whatever else we may imagine God and gods to be, it would be imprudent to regard them as wielding only unbridled power. If God is all powerful, in all of our religious traditions, she is also merciful and wise, forgiving and loving, truthful and compassionate, just and attentive. If God were only powerful, and little else, his immense and abiding hold on our hearts and minds, and on our imagination and creative exuberance would be minimal. If we humans are indeed created in the image of God, we must learn to aspire to be touched by the fragrance of that Being in all its glories. In a thousand different ways, and on every turn of our lives – in laboratories and classrooms, in courtrooms and chambers of power, in our homes and prisons, in our temples and churches – we have too often been drawn to betray that calling. Often times, as Oppenheimer acknowledged himself, the scientists are seduced by ‘the lure of the technically sweet’, where concerns for ethics and the nourishment of life seem empty idealistic illusions. ‘It is my judgement in these things,’ he said, as he felt tormented by the ‘devil’s work’ that he and many of his distinguished scientists did in the Manhattan Project, ‘that when you see something that is technically sweet you go ahead and do it and you argue about what to do about it only after you have had your technical success. That is the way it was with the atomic bomb.’ We are faced with equally momentous challenges in the biological laboratories today. Over fifty years ago, as a family of nations and peoples, we created a Universal Declaration of Human Rights. In these decades, even as we have often failed to uphold these rights in many places in the world, we have felt increasingly drawn to define the quality of our civilization in terms of the success or failure of these rights. Today time has come to create a new charter of human ethical duties and responsibilities, universally upheld. Such a charter will undoubtedly be guided by our sense of life and well being that is encompassing of the body and the spirit together, for otherwise we will continue to be engulfed in a world-wide ecological crisis and intractable problems of bioethics on one hand, and simmering plague of depression and inward disgrace on another.

10 Ethics, both personal and social, has always been a matter of choice. But not only of choice but of wise choice, vivek. Such choices don’t come easy; one has to learn to choose wisely. No other life form on this planet is endowed with this special gift of reason and choice. We humans alone, among the multitudinous diversity of life, have this unique capacity to place ourselves in an ever-growing circle of compassion. Science has increasingly brought us within the laws of nature and has made our world natural. There is no retreat from this magnificent achievement. Still, human freedom, tangled though it is in the passions of our own making has left us the difficult choice of determining what it is in our nature to be: To remain God’s glorious creatures or to make ourselves gods. Perhaps that is the meaning of the ancient story of the Garden and the Fall. In scientific circles there is a story told about one of the chief architects of the atomic bomb. On a walk in the woods with a friend once, he saw a tiny tortoise and picked it up, hoping to amuse his children with it. He had, however, not gone very far when he decided to turn back. Carefully he retraced his steps and put the small creature in its place to let it wander on its way again. ‘It struck me,’ he said, ‘that perhaps, for one man, I have tampered enough with the universe.’ It was a small gesture in a vast universe but it was the wisest recognition by a man of science that science alone is not enough for man and that the way back to the Garden is through the heart and splendours of life itself. In the Hindu epic Bhagavad Gita, it is the voice of Sri Krishna that speaks to the great warrior Arjuna in the battlefield. Though he is the greatest of the warriors, Arjuna is paralyzed and driven into despair. He can no longer choose. He must seek guidance from higher powers. Today, in a secular world, any guidance from a transcendental being is acceptable, at best, only at the most personal level. For all our collective decisions and ethics, we must turn to our own human devices, however fallible and fractured. Not to harm or injure, to serve the greatest good of the greatest number, to nourish and respect all beings, to let be and to let the wisdom of nature prevail, have not been easy ethical lessons to accept and honour. The Faustian urge to alter and control is far too strong in us to be easily curtailed. The ‘lure of the technical sweet’ lurks in every test tube; the awards of fame and fortune are far too large to allow us to listen to any other voices. This is the pride of man, and it is a harbinger of fall and destruction. Our mythology has alluded to such fall in a hundred

11 different fables and parables. It tells us again and again that every human being must always remain a student all his life; indeed the greatest warrior Arjuna chose Krishna to be his charioteer and a teacher in the battlefield. The greatest teacher, however, is life itself, with all its disquietudes and dilemmas, and its glories and graces. If a scientist or a technician aspires to be a god in a laboratory, let him learn the face of mercy and compassion that is of god’s, and of god’s powers to nourish and heal, create anew and forever, with hope. All else is arrogance and hubris and is doomed to self destruct. These are some of the ways in which the great spiritual traditions speak to us, never directly, never vociferously, but from the corner of an eye, with a whisper. In our search to unravel the mysteries of nature, we can’t truly afford to be driven by the lure of the technically sweet, but only by the sweetness of life itself, in all its luxuriant fecundity. That is an ethics and an oath by which all of us – and the scientists foremost among us – must choose to learn to live, thus truly touching upon hope.

12 LA BIOETHIQUE DANS LA TRADITION CHRETIENNE CATHOLIQUE

Mgr Jean-Marie Mpendawatu (Saint-Siège), Conseil Pontifical pour la Pastorale de la Santé

I. Cadre de référence historique/épistémologique

1. Genèse On peut situer, de manière à peu près certaine, la naissance de la bioéthique au sein de l’éthique médicale qui a été développée par le serment d’Hippocrate(1). Le célèbre serment est une œuvre tripartite qui comprend : • l’invocation des divinités comme témoins de l’acte important ; • l’accomplissement des obligations du médecin ; • les sanctions de la divinité : bénédictions à celui qui est fidèle et malédictions à celui qui ne respecte pas la parole donnée. Le serment d’Hippocrate est le texte moral le plus important de toute la tradition médicale occidentale. Ensuite, il sera transmis aux mondes romain et chrétien.

2. Origine du terme En 1970, le terme de bioéthique fut « inventé » aux États-Unis d’Amérique par le cancérologue Van Reusselaer Potter(2). Pour Potter, la biologie doit se poser des questions éthiques sur son action ; l’homme est invité à s’interroger sur l’importance morale de son intervention sur la vie. D’où la demande pressante de Potter afin de

1. Hippocrate de Cos (Grèce) a vécu de 460 à 377 J.C. 2. Cf. Potter V.R., Bioethics : The Science of Survivals in « Perspectives in Biology and Medicine » XIV (1970) 127-153, ID., Bioethics. A Bridge to the Future, 1971.

13 dépasser la tendance pragmatique de l’homme moderne qui applique immédiatement le savoir, sans une médiation rationnelle et encore moins morale. En effet, l’application de toute connaissance scientifique peut comporter des conséquences imprévisibles pour l’humanité, en raison de la concentration du pouvoir technologique entre les mains de quelques personnes seulement.

3. Eléments de définition « La bioéthique est une discipline de recherche qui, en utilisant une méthodologie interdisciplinaire, a pour objet l’examen systématique du comportement humain dans le domaine des sciences de la vie et de la santé, en ce sens que ce comportement est examiné à la lumière de valeurs et de principes moraux, selon la définition acceptée de l’Encyclopedia of Bioethics (1978). Sa spécificité découle du type de problèmes qu’elle aborde, de la nature des instances éthiques et de la méthodologie utilisée. »(3) Les finalités « consistent dans l’analyse rationnelle des problèmes moraux liés à la biomédecine et de leur connexion avec les disciplines du droit et des sciences humaines. Elles impliquent l’élaboration de lignes éthiques fondées sur les valeurs de la personne et sur les droits de l’homme, respectueuses de toutes les confessions religieuses, avec un fondement rationnel et méthodologique scientifiquement adapté »(4). « Les instruments d’étude de la bioéthique résultent de la méthodologie interdisciplinaire spécifique qui se propose d’examiner, de manière approfondie et mise à jour, la nature du fait biomédical (moment épistémologique), d’en relever les implications au niveau anthropologique (moment anthropologique), de déterminer les « solutions » éthiques et les justifications de nature rationnelle qui étayent ces solutions (moment d’application). »(5) La bioéthique en tant qu’éthique normative ne peut négliger d’établir un dialogue avec les différentes disciplines scientifiques, en posant des questions et en écoutant les réponses, afin d’obtenir des connaissances toujours plus exhaustives sur la réalité. On pourra alors faire démarrer le

3. Sgreccia E., Manuale di Bioetica - Fondamenti ed Etica biomedica, Vita e Pensiero, Nuova edizione aggiornata e ampliata, Rome 1988, p.51. 4. Idem. 5. Idem.

14 processus d’évaluation sur les données empiriques et anthropologiques dans le but de formuler le jugement moral sur chaque action particulière qui se rapporte à la vie. En résumé, on peut définir la bioéthique comme une réflexion éthique/normative de la philosophie et de la théologie morales dans laquelle un simple problème opérationnel est assumé, pour rechercher un jugement moral et indiquer au monde de la médecine, de la politique, de l’économie et à toute la société l’orientation morale à donner à l’activité humaine et au projet du futur(6).

II. Axiologie de référence pour la bioéthique de tradition chrétienne catholique

1. Une anthropologie personnaliste de référence 1.1. Pour la tradition théologique/morale, la solution des différents « cas » éthiques a toujours eu recours à une série de principes : de totalité, du moindre mal, de l’action à double effet, de l’epichea, etc. L’orientation personnaliste fait partie de cette tradition. Elle identifie dans la vie humaine la valeur fondamentale de la personne, élabore un principe de liberté et de responsabilité, un principe thérapeutique (nouvelle proposition du « principe de totalité » classique) et le principe de socialité et de subsidiarité. Bien plus que des clés d’interprétation de toute la réalité bioéthique, ils assument les traits de la tradition de certaines valeurs fondamentales inhérentes à la personne en termes de « principes », afin de pouvoir être plus facilement utilisés dans la solution de « cas » bioéthiques spécifiques. 1.2. La bioéthique ne peut être conçue simplement comme le résultat de positions éthiques présentes dans la société et dans la culture, elle doit suggérer des valeurs de référence et des lignes de choix opérationnels et s’engager à donner des réponses objectives concernant certains critères valables au point de vue rationnel. La comparaison est sacro-sainte, mais dans un contexte de discussion critique et d’orientation normative. D’où l’exigence d’une anthropologie de référence « dans laquelle la valeur de la vie physique, corporelle, de l’amour conjugal et de la procréation, de la souffrance et de la maladie, de la mort et de la manière de mourir, du rapport liberté-responsabilité, individu et société, trouvent leur

6. Cf. Leone S., Privitera S., « Bioetica » in Dizionario di Bioetica, EDD-ISB 1994, Bologne, pp. 89-98.

15 encadrement et leur valorisation éthique. La pensée personnaliste, d’un personnalisme fondé ontologiquement, trouve dans cette réflexion un point de confrontation culturelle et d’enrichissement. Répondre aux problèmes posés par les progrès scientifiques que nous avons rappelés et à ceux de l’organisation sociale, de la médecine et du droit signifie proposer à nouveau la question sur la valeur de la personne, sur ses prérogatives et sur ses devoirs »(7). 1.3. « La valeur fondamentale de la vie, la valeur transcendante de la personne, la conception intégrale de la personne qui apparaît comme synthèse humanitaire de valeurs physiques, psychologiques et spirituelles, le rapport de priorité et de complémentarité entre personne et société, une conception personnaliste et de communion de l’amour conjugal forment l’axiologie de référence de la bioéthique ainsi que de toute l’éthique humaine et sociale. Ces valeurs devront être examinées et confrontées aux problèmes issus du développement de la science biomédicale, science qui, aujourd’hui, semble avoir pris l’envol de l’enthousiasme, en laissant pratiquement de côté les grands défis des maladies non éradiquées, de la prévention de maux provoqués par la société technologique elle-même et engendrés par l’exploitation écologique. »(8)

2. L’amour pour la vie comme pont bioéthique entre la raison humaine et le mystère de Dieu 2.1. La lumière de la révélation chrétienne, interprétée par le magistère, constitue un point de référence non seulement important au point de vue sociologique, les chrétiens sont des citoyens à part entière, mais également par sa conception de la personne humaine soumise à des réductions idéologiques et biologiques et menacées toujours plus d’être instrumentalisée. La personne est le critère moral objectif pour juger les options concrètes dans le domaine bioéthique, parce qu’elle a en soi quelque chose de grand : création, incarnation et rédemption sont les trois actes de l’histoire du salut à la lumière desquels apparaît la valeur de l’homme. La raison elle-même reconnaît et affirme le respect de la personne comme condition indispensable d’une société civile qui ne s’adonne pas à des actes de barbarie. Le visage de l’homme est le reflet du visage trinitaire, voilà pourquoi son sens profond (logos) se trouve dans la

7. Cf. Sgreccia E., ibid., p. 53. 8. Sgreccia E., ibid., p. 54.

16 rationalité qui le pousse à s’exprimer selon une double réalité de communion et de don. Par conséquent, toute éthique normative comportera ces caractéristiques fondamentales ; elle jaillira de la structure même de la personne (intériorité), elle sera soumise au crible de la raison (rationalité) et exprimera le bien authentique de la personne (humanisation). 2.2. « Le personnalisme chrétien reçoit l’élan et la force des textes récents du magistère qui soulignent la grandeur et la dignité de l’homme dans sa référence au Christ. »(9) Le Concile Vatican II déclare que « en réalité, le mystère de l’homme ne s’éclaire vraiment que dans le mystère du Verbe incarné. Adam, en effet, le premier homme, était la figure de celui qui devait venir, le Christ Seigneur. Nouvel Adam, le Christ, dans la révélation même du mystère du Père et de son amour, manifeste pleinement l’homme à lui- même et lui découvre la sublimité de sa vocation » (Gaudium et Spes, 22). Dans sa première encyclique, Jean Paul II écrit à ce sujet : « L’homme qui veut se comprendre lui-même jusqu’au fond ne doit pas se contenter pour son être propre de critères et de mesures qui seraient immédiats, partiaux, souvent superficiels et même seulement apparents ; mais il doit, avec ses inquiétudes, ses incertitudes et même avec sa faiblesse et son péché, avec sa vie et sa mort, s’approcher du Christ. Il doit « s’approprier » et assimiler toute la réalité de l’incarnation et de la rédemption pour se retrouver soi-même » (Redemptoris Hominis, 10). De là, l’invitation de Jean Paul II à l’homme moderne en ces termes : « il convient que l’homme d’aujourd’hui se tourne de nouveau vers le Christ pour recevoir de lui la réponse sur ce qui est bien et sur ce qui est mal » (Veritatis Splendor, 8). Enfin, dans la grande Charte sur la vie, le Souverain Pontife parlant du rapport entre la vérité et la vie s’exprime en ces termes : « C’est donc à partir de la parole, de l’action, de la personne même de Jésus, que la possibilité est donnée à l’homme de ‘connaître’ la vérité tout entière sur la valeur de la vie humaine ; c’est de cette source qu’il reçoit notamment la capacité de faire parfaitement la vérité; ou d’assumer et d’exercer pleinement la responsabilité d’aimer et de servir la vie humaine, de la défendre et de la promouvoir. » (Evangelium vitae, 29)

9. XXX, Introduzione alla bioetica, Ellenici, Turin 2000, p. 69.

17 « La personne humaine existe par le Christ et est constituée par lui comme enfant. De cette vérité jaillissent deux éléments : sa vocation qui consiste à agir dans le monde de manière filiale et sa dignité, qui exige qu’il soit traité comme enfant de Dieu. »(10) 2.3. La vie humaine peut être un terrain fertile de dialogue entre peuples, cultures et religions et favoriser le rapprochement de nos sociétés menacées par la désintégration et l’isolement. La vie humaine est d’abord une valeur naturelle, raisonnable, connue de tous ceux qui font usage de la raison ; la valeur de la personne humaine est rendue plus précieuse par la grâce et le don du Saint-Esprit, mais elle ne cesse d’être pour tous, croyants ou incroyants, une valeur inestimable. La tradition chrétienne affirme la valeur de la raison et la légitimité de l’éthique rationnelle, appelée également naturelle. Comme illustration, on peut mentionner le problème de l’avortement (ou comme disent les scientifiques, l’interruption volontaire de grossesse - IVG) qui ne constitue pas un problème de foi ou d’absence de foi ; la vie humaine est telle pour tous les hommes ; l’obligation de la respecter est un devoir de l’homme en tant qu’homme, non seulement en tant que croyant ; le croyant aura des raisons de réconfort surnaturel, mais ces raisons ne doivent pas être utilisées pour dispenser tous les hommes de bonne volonté et de raison saine de réfléchir sur les faits à la lueur de la raison. Le dialogue entre science et foi ne peut advenir que par l’intermédiaire de la raison qui est comme la référence de l’une pour l’autre.

III. Quelques exemples de jugements éthiques/moraux

1. Le clonage 1.1. Le clonage humain représente une violation de deux principes fondamentaux sur lesquels reposent tous les droits de l’homme : le principe de parité entre les êtres humains et le principe de non- discrimination. 1.2. La violation du premier principe mène à une forme de domination de l’homme sur l’homme et la discrimination se réalise par tout le processus de sélection eugéniste inhérent à la logique du clonage (Académie pontificale pour la Vie, Réflexions sur le clonage, 1997).

10. XXX, Introduzione alla bioetica, p. 70.

18 2. La production et l’usage scientifique et thérapeutique des cellules souches embryonnaires humaines 2.1. Il est moralement illicite de produire et/ou d’utiliser des embryons humains vivant pour la préparation de cellules souches parce que l’embryon humain vivant est, à partir de la fusion des gamètes, un sujet humain avec une identité bien définie, qui commence ainsi son développement coordonné, propre, continu et progressif, de manière qu’à aucun stade ultérieur il ne puisse être considéré comme un simple agglomérat de cellules. Il s’ensuit qu’en tant qu’être humain, « il a droit à sa vie », c’est pourquoi toute intervention qui ne serait pas en faveur de l’embryon même serait préjudiciable de ce droit. L’ablation de la masse cellulaire (ICM) de la blastocyste est un acte hautement immoral et, donc, gravement illicite. 2.2. De même, il est moralement illicite d’effectuer ce que l’on appelle le « clonage thérapeutique », car on retombe dans le problème éthique exposé précédemment. Aucune fin, même considérée bonne, ne peut justifier cette intervention. 2.3. Il est moralement illicite d’utiliser des cellules souches et les cellules différenciées de celles obtenues, éventuellement fournies par d’autres chercheurs ou trouvées dans le commerce car, au-delà du partage, formel ou non, de l’intention moralement illicite de l’agent principal, dans le cas considéré, il y a une coopération matérielle du producteur ou fournisseur (Académie pontificale pour la Vie, Déclaration sur la production et sur l’usage scientifique et thérapeutique des cellules souches embryonnaires humaines, 2000).

3. La perspective des xénogreffes 3.1. L’Académie pontificale pour la Vie, institution de référence de l’Église en matière de bioéthique, indique une ligne de conduite pour orienter le parcours de recherche et de développement des xénogreffes. Lorsque le moment sera venu : 3.2. Il sera correct, au point de vue éthique, de présenter la proposition, dans le respect des règles sur le consentement informé, d’abord et uniquement à des groupes restreints de malades dans l’incapacité - étant donné la contingence - d’effectuer une greffe allogénique, toujours dans la perspective qu’une meilleure alternative ne soit pas disponible pour eux. 3.3. il sera moralement nécessaire d’assurer une surveillance attentive et programmée des sujets ayant reçu une greffe, surveillance qui pourra durer également toute la vie, en étant attentif à chaque signal d’infection éventuelle due à des agents pathogènes connus ou inconnus.

19 3.4. En outre, il faudra que chaque expérience clinique soit menée dans des centres extrêmement spécialisés, avec une expérience certaines des modèles pré-cliniques, cochon/primate, spécifiquement autorisés et contrôlés par les autorités sanitaires compétentes. 3.5. Les résultats obtenus, s’ils sont incontestablement positifs, constitueraient alors la base d’un élargissement de la pratique des xénogreffes comme thérapie chirurgicale définitive. D’où l’importance et l’opportunité d’une coordination réelle, à différents niveaux, de la convergence substantielle de la législation internationale en la matière ; elle doit établir les règles pour la poursuite de la recherche scientifique, en garantissant sa validité et sa sécurité, mais aussi en veillant sur la santé des citoyens concernés et sur les risques potentiels (surtout de nature infectieuse) liés aux xénogreffes (Académie pontificale pour la Vie, La perspective des xénogreffes : aspects scientifiques et considérations éthiques, 2001). Conclusion Le dialogue entre les sciences, les cultures et les peuples dans le domaine de la bioéthique est possible ; mieux, il est souhaitable et je crois que cela constitue précisément l’intention de cette table ronde. Afin que celui-ci soit bénéfique et marque un tournant de qualité, il convient de dépasser les différents réductionnismes éthiques qui ont pour nom : moralisme, relativisme, intégrisme, prohibitionnisme etc. en vue d’accéder à une approche bioéthique qui tienne toujours compte du bien de l’homme compris comme personne particulière et comme communauté. Je termine en reprenant le concept de Potter sur la bioéthique comme pont (bridge), concept que le cardinal F. Angelini, dans son allocution aux participants à la seconde assemblée de l’Académie pontificale pour la Vie, synthétise dans l’amour de la vie, en ces termes : L’amour pour la vie, défendue et promue de manière scientifique et religieuse, constitue le pont le plus large jeté par Dieu entre la raison humaine et le mystère, sur lequel peuvent se rencontrer tous les hommes, même ceux qui proviennent des rives opposées.(11) Cette pensée résume parfaitement ce que nous pourrions appeler la « bioéthique chrétienne catholique ».

11. Angelini F., Actes de la 2e Assemblée de l’Académie pontificale pour la Vie, La cause de la vie. Libreria editrice vaticana, Cité du Vatican, 1995, p. 17

20 BIOETHICS IN THE CATHOLIC CHRISTIAN TRADITION

Mgr Jean-Marie Mpendawatu (Holy See), Pontifical Council for Health Pastoral Care

I. The Historical-Epistemological Frame of Reference

1. Genesis One can reasonably locate the birth of bioethics in the medical ethics that developed from the Hippocratic oath(1). This famous oath was a work in three parts which involved: • calling upon the gods to be witnesses to this important act; • the taking on of duties by the medical doctor; • rewards and punishments imposed by the gods: blessings for those who are loyal and maledictions for those who did not honour their word. The Hippocratic oath is the most important moral text of the whole of the Western medical tradition. Subsequently, it entered the Roman world and Christian culture.

2. The origins of the Term The term ‘bioethics’ was coined in the United States of America in 1970 by the oncologist Van Renssalaer Potter(2). For Potter, biology must ask itself ethical questions about its own activity; man is invited to ask himself about the moral relevance of his intervention in relation to life. Hence the pressing request made by Potter to overcome the pragmatic tendency of modern man who immediately applies knowledge without a rational, and even less a moral, mediation.

1. Hippocrates of Cos (Greece) lived between 460 and 377 BC. 2. Cf. V.R. Potter, ‘Bioethics: the Science of Survival’, Perspectives in Biology and Medicine, XIV (1970), 127-153; idem, Bioethics. A Bridge to the Future (1971).

21 The application of every form of scientific knowledge can, in fact, have unpredictable consequences for mankind, as a result, as well, of the concentration of biotechnological power in the hands of a few people.

3. Elements for a Definition ‘Bioethics is an area of research which makes use of an interdisciplinary methodology and has as its aim (according to the accepted definition of the Encyclopaedia of Bioethics, 1978) ‘the systematic analysis of human behaviour in the field of the life sciences and health, where this behaviour is examined in the light of moral values and principles’. Its specific character derives from the kinds of issues it addresses, from the nature of its ethical questions, and from the methodology it uses.’(3).

Its aims ‘lie in the rational analysis of the moral questions and issues connected with biomedicine and their connection with the fields of law and the human sciences. Such aims involve the drawing up of ethical guidelines based upon the values of the person and upon human rights, respecting all religious confessions, with a scientifically adequate rational and methodological foundation’.(4)

‘The instruments of study of bioethics arise from the specific interdisciplinary methodology proposed to examine in a detailed and up- to-date way the nature of the biological fact in question (the epistemological moment), to bring out its implications at an anthropological level (the anthropological moment), and to identify the ethical ‘solutions’ and the justifications of a rational kind that support such solutions (the applicative moment).’(5)

As normative ethics, bioethics cannot but enter into dialogue with the various scientific disciplines, raising questions and listening to answers, in order to obtain forms of knowledge about reality that are always complete. Taking the empirical-anthropological facts as a basis, one can then set in motion the processes of assessment in order to arrive at the formulation of a moral judgement on every individual action connected with life.

3. E. Sgreccia, Manuale di Bioetica – Fondamenti ed Etica biomedica (Vita e Pensiero, new and up-dated edition, Rome, 1988), p. 51. 4. Ibidem. 5. Ibidem.

22 To summarise: one can define bioethics as a ethical-normative reflection of moral philosophy and moral theology in which an individual operative question is taken into consideration in order to look for a moral judgement and to indicate to the worlds of medicine, of politics and of economics, and to society as a whole, the moral direction that should be impressed upon human activity and the planning of the future(6).

II. The Axiology of Reference for Bioethics of the Catholic Christian Tradition 1. A Personalist Anthropology of Reference 1.1 For the theological-moral tradition, solving various ethical ‘cases’ has always involved referring to a series of principles: the principle of totality, the principle of the lesser evil, the principle of the action with a dual effect, the principle of epichea, etc. The personalist approach belongs to this tradition. It sees human life as the fundamental value of the person and draws up a principle of freedom and responsibility, a therapeutic principle (a return to the classic ‘principle of totality’) and a principle of sociality and subsidiarity. More than keys of interpretation for the whole of bioethical reality, they take on the connotations of the personalist tradition of certain fundamental values inherent in the person, in the form of ‘principles’, so as to be able to be more easily employed in solving specific ‘bioethical’ cases. 1.2. Bioethics cannot be simply conceived as the outcome of ethical positions present within society and culture. It must suggest values of reference and operative guidelines for choices, and be involved in providing objective answers based on rationally valid criteria. Dialogue is sacrosanct, but within a framework of critical discussion and normative orientation. Hence the need for an anthropology of reference ‘within which the value of physical life, corporeal life, conjugal love and procreation, pain and illness, death and dying, the relationship between freedom and responsibility, the individual and society, find their framework and their ethical appreciation. The personalist way of thinking, the way of thinking of an ontologically based personalism, finds in this reflection a point of cultural dialogue and enrichment. To respond to the questions and issues raised by the scientific advances that we have referred to, and to those connected with social organisation, medicine and law, means to pose anew the question of the value of the person, his prerogatives and his tasks’(7).

6. Cf. S. Leone, ‘Bioetica’, in Dizionario di bioetica (EDD-ISN, Bologna), pp. 89-98. 7. Cf. E. Sgreccia, op. cit., p. 53.

23 1.3 ‘The fundamental value of life, the transcendent value of the person, the overall conception of the person who should be seen as a human synthesis of physical, psychological and spiritual values, the relationship of priority and complementariness between the person and society, and a personalist and communion approach to conjugal love, form the axiology of reference for bioethics, no less than for the whole of human and social ethics. These values should be addressed and arranged in relation to the emergent questions and issues of the development of biomedical science, a science that today seems to have risen high on the wings of enthusiasm, almost placing in the shade the great challenges posed by illnesses that have not been mastered and by the prevention of evils wanted by technological society itself and generated by ecological exploitation.’(8)

2. Love for Life as a Bioethical Bridge between Human Reason and the Mystery of God 2.1 The light of Christian Revelation, interpreted by the Magisterium, is a point of reference which is not only relevant at a sociological level: after all, Christian believers are citizens to the full. It is also relevant because of its vision of the human person, who is constantly subject to ideological and biological reductions and is increasingly threatened by various forms of exploitation. The person is the objective moral criterion by which to judge concrete choices in the bioethical field. This is because the person has in himself something that is great: creation, incarnation and redemption are the three acts of the history of salvation in the light of which the value of man emerges. Reason itself recognises and affirms that respect for the person is the shared approach that cannot be dispensed with if we want to ensure that society is civilised and does not fall into forms of barbarity. The face of man is the reflection of the face of the Trinity and for this reason his deep meaning (logos) lies in his relational nature, which leads him to express himself (ethos) according to a dual reality of communion and donation. As a result, each ethical norm must have the following fundamental characteristics: it springs from the very structure of the person (intrinsicalness); it is subjected to the examination of reason (rationality); and it expresses the authentic good of the person (humanisation).

8. E. Sgreccia, op. cit., p. 54.

24 2.2. ‘Christian personalism receives impetus and energy from the recent texts of the Magisterium, which emphasise the greatness and the dignity of man in his reference to Christ’.’(9) Vatican Council II stated that: ‘The Truth is that only in the mystery of the Incarnate Word does the mystery of man take on light. For Adam, the first man, was the figure of Him who was to come, namely Christ the Lord. Christ, the final Adam, by the revelation of the very mystery of the Father and his love, makes man fully manifest to himself and brings to light his exalted vocation (Gaudium et Spes, 22). In his first encyclical, John Paul II made the following observations: ‘The man who wishes to understand himself thoroughly –and not just in accordance with immediate, partial, often superficial, and even illusory standards and measures of his being – he must with his unrest, uncertainty and even his weakness and sinfulness, with his life and death, draw near to Christ. He must, so to speak, enter into him with all his own self, he must ‘appropriate’ and assimilate the whole of the reality of the Incarnation and Redemption in order to find himself’ (Redemptoris hominis, 10). Hence John Paul II’s invitation to modern man expressed in the following terms: ‘People today need to turn to Christ once again in order to receive from him the answer to their questions about what is good and what is evil’ (Veritatis Splendor, 8). Lastly, expressing himself in the Magna Carta on Life on the relationship between truth and life, the same Pontiff says: ‘Through the words, the actions and the very person of Jesus, man is given the possibility of ‘knowing’ the complete truth concerning the value of human life. From this ‘source’ he receives, in particular, the capacity to ‘accomplish’ this truth perfectly (cf. Jn 3:21), that is, to accept and fulfil completely the responsibility of loving and serving, of defending and promoting human life’ (Evangelium Vitae, 29). ‘The human person exists from Christ and by him he is made a son: from this truth spring two facts – his vocation, which lies in acting in the world in a filial way, and his dignity, which requires him to be treated as a son of God.’(10)

9. XXX, Introduzione alla bioetica (Ellenici, Turin, 2000), p. 69. 10. XXX, Introduzione alla bioetica, p. 70.

25 2.3 Human life can be a fertile field for dialogue between peoples, cultures and religions and foster the drawing near of our societies, which are threatened by disintegration and closure. Human life is first and foremost a natural value, rationally known by all those who make use of reason. The value of the human person is made even more precious by the grace and the gift of the Holy Spirit, yet it does not cease to be an intangible value for all people, both believers and otherwise. It is in the tradition of the Church to affirm the value of reason and the legitimacy of rational ethics, also known as natural ethics. As an illustration of this, one can mention the question of abortion (or as scientists say ‘the voluntary interruption of pregnancy’ – VIP) which is not a question of faith or of not having faith. Human life is such for all men; the obligation to respect it is a duty of man as man and not only because he is a believer: the believer will have reasons which have a supernatural backing but these reasons must not be used to release all men of good will and upright reason from reflecting on facts in the light of reason. The dialogue between science and faith can take place solely with the intermediary of reason, which is a reference point for them both.

III. Some Examples of Ethical Moral Judgments

1. Cloning 1.1 Human cloning represents a violation of the two fundamental principles on which all human rights are based: the principle of equality among human beings and the principle of non-discrimination. 1.2 The violation of the first principle leads to a form of domination of man over man and discrimination comes about through the whole of the selective-eugenic dimension inherent in the logic of cloning (Pontifical Academy for Life, Riflessioni sulla clonazione, 1997).

2. The Production and Scientific and Therapeutic Use of Human Embryonic Stem Cells 2.1 It is morally illicit to produce and/or use living human embryos for the preparation of stem cells because the living human embryo is – from the moment of the union of the gametes – a human subject with a well defined identity, which from that point begins its own co-ordinated, continuous and gradual development, such that at no later stage can it be considered as a simple mass of cells. From this it follows that as a human

26 individual it ‘has a right to its own life’, and therefore every intervention which is not in favour of the embryo is an act which violates that right. The ablation of the inner cell mass (ICM) of the blastocyst is a gravely immoral act and thus gravely illicit.

2.2 It is equally morally illicit to carry out so-called ‘therapeutic cloning’ for there is present the ethical problem examined above. No end considered good can justify such an action. 2.3 It is morally illicit to use stem cells, and the differentiated cells obtained from them, supplied by other researchers or commercially available because, beyond the formal or otherwise sharing in the morally illicit intention of the principal agent, in the case in question there is a proximate material co-operation by the producer or supplier (Pontifical Academy for Life, Dichiarazione sulla produzione and sull’uso scientifico e terapeutico delle cellule staminali embrionali umane, 2000).

3. The Prospects for Xenotransplantation 3.1 The Pontifical Academy for Life, the reference institution for the Church in questions of bioethics, has set out an operative guideline to direct the path of research and development of xenotransplantation applied to man. When the moment arrives: 3.2 It will be ethically correct, respecting the rules of informed consent, to involve initially only a restricted groups of patients, patients who cannot be chosen – in the given circumstances – for allotransplantation and for whom no better alternative treatment is available. 3.3 It will be morally necessary to ensure a careful and planned monitoring of the subjects who have undergone such transplants, which could foreseeably continue for the rest of the patient’s life, watching for any sign of possible infection caused by known and unknown pathogenic agents. 3.4 It will be necessary, in addition, for every experimental clinical trial to be carried out in highly specialised centres with proven experience in pre- clinical pig-to-primate models; these centres should be authorised and supervised by the competent health care authorities. 3.5 The results thus obtained, if unequivocally positive, could constitute the basis for extending the practice of xenotransplantation, making it an accepted surgical therapy.

27 3.6 Hence the importance and the advisability of real co-ordination at the different levels to ensure a substantial convergence of international legislation in this area. Such legislation must establish the rules for the continuing of scientific research, guaranteeing its validity and safety, and in addition watching over the health of the citizens involved and the potential risks (especially infective) connected with xenotransplantation (Pontifical Academy for Life, La prospettiva degli xenotrapianti: aspetti scientifici e considerazioni etiche, 2001).

Conclusion Dialogue between the sciences, cultures and peoples within the sphere of bioethics is possible, indeed, it is to be welcomed, and I believe that this roundtable has precisely this intention. For this dialogue to be fruitful and to constitute a qualitative leap forward, we need to overcome the various forms of ethical reductionism, whose names are ‘moralism’, ‘relativism’, ‘fundamentalism’, ‘prohibitionism’ etc., in order to reach a bioethical approach that always bears in mind the good of man understood as an individual person and a community. I would like to conclude by going back to Potter’s concept of bioethics as a bridge, which Cardinal F. Angelini in his speech to those taking part in the second assembly of the Pontifical Academy for Life summarised as love for life. These were the words he then employed: ‘love for life, scientifically and religiously defended and promoted, is the longest bridge there is that God has thrown between human reason and mystery, the bridge on which all men, including those who come from different sides, can meet each other’(11). What thought better captures what we could call ‘Catholic Christian Bioethics’?

11. F. Angelini, Atti 2a Assemblea della Pontificia Accademia per la Vita, La causa della vita (Libreria Editrice Vaticana, Vatican City, 1995), p. 17.

28 POINTS OF CONVERGENCE IN BIOETHICS AMONG CHRISTIANS AND MUSLIMS

Hisham Nashabe (Lebanon), Director of Institutes for Higher Studies, Makassed Association Beirut

We all agree that in the fields of biological and technological research, application and practice, the following principles ought to be adhered to: I. General principles: 1. That human life and dignity should be respected in matters of biological and technological research, application and practice. 2. That man, as God’s vice-regent on earth and the noblest of his creations, should seek to respect nature, protect it from abuse and preserve its equilibrium; 3. That all research as well as application should aim to promote life and the family institution and to encourage practices leading thereto. Consequently, all research or practices that may endanger life and the family institution must be prohibited; 4. That the benefits of biological and technological research should be equitably distributed among all the people of the world so that these benefits might serve to improve their quality of life. II. More specifically: 1. That organ transplantation among human being is an approved practice provided it is not in any way subject to commercial exploitation and that the life of the donor or the receive of an organ is not seriously endangered by the transplantation. The human body is not a property that one may dispose of as such; 2. That abortion is an approved practice only when it is applied to save life; 3. That sexual intercourse, that cannot lead to procreation is a perversion and must be strictly prohibited;

29 4. That man cannot dispose of his life or lives of others, as he pleases; rather, it is man’s obligation to preserve life and act as a custodian thereof. Because life is a gift from God; 5. That contraception and artificial insemination ought to be used for the well-being of individuals and of human societies at large and should be resorted to only with this aim in mind; 6. In the use of animals for research purposes, the lives of animals must be protected from abuse and the pain inflicted on them during experimentation must be minimized; 7. Experimentation and research in the field of biology must neither aim nor achieve to substitute the natural method of procreation by other artificial methods. If discovered, such methods must not be resorted to if they jeopardize family life in any way; 8. Cloning must be limited to organs that may benefit man or help cure disease and disabilities. The cloning of whole human beings must be prohibited because it disrupts family life and opens possibilities of procreation contrary to the ways of nature. The cloning of animals may, however be permitted only if it helps to improve the quality of life in human societies; 9. The genes of every individual are his own. No one has the right to dispose of the genes of another individual or to disclose their composition (DNA) or any other information pertaining thereto, without the written consent of the individual concerned.

30 VERS UNE CONCEPTION POLITIQUE DE LA BIOETHIQUE

Daniel Weinstock (Canada), Chaire de recherche en éthique et en philosophie politique Directeur, Centre de recherche en éthique de l’Université de Montréal Professeur titulaire, Département de philosophie, Université de Montréal

La bioéthique touche aux questions existentielles les plus fondamentales. Qu’est-ce que l’humain ? Qu’est-ce qui le distingue du non-humain ? À partir de quel moment dans son développement la vie humaine revêt-elle l’importance morale que nous avons tendance à lui attribuer ? Les grandes traditions religieuses, spirituelles et philosophiques répondent à ces questions de manières souvent fort différentes, voire diamétralement opposées. Elles ont donc par rapport aux questions de la bioéthique des points de vue fort différents. Comment une société pluraliste devrait-elle gérer les différends en matière de bioéthique qui naissent de ces points de départ divergents sur les questions les plus fondamentales ? C’est à cette question que je voudrais consacrer ce bref texte. Commençons par écarter deux réponses que l’on pourrait être tenté de donner à cette question. La première, c’est celle de l’hégémonie. Il pourrait sembler raisonnable pour un individu convaincu de la vérité incontestable de telle ou telle doctrine religieuse ou spirituelle que la meilleure chose serait que ce soit son point de vue qui devienne dominant dans sa société et qui vienne à guider la formulation de la politique publique sur les questions de bioéthique. Il pourrait alors décider de rendre son point de vue dominant, soit par des moyens politiques, en tentant par exemple de s’accaparer les postes décisionnels stratégiques en la matière, soit en tentant de convaincre les tenants d’autres points de vue de leurs erreurs. Cette première réponse est de toute évidence à rejeter, pour au moins trois raisons. Premièrement, dans le contexte de sociétés pluralistes, elle va à l’encontre de la conception que la grande majorité des citoyens ont de leur société comme ouvertes à la diversité de ce que l’on pourrait appeler les « conceptions de la vie bonne », qu’elles soient

31 religieuses ou non. Deuxièmement, l’histoire nous apprend que les institutions; qui protègent la liberté de penser et d’expression ont tendance à exacerber plutôt qu’à modérer le problème de la diversité. La diversité religieuse et philosophique est donc un aspect permanent de nos sociétés et il est probablement utopique au sens péjoratif du terme de penser que la discussion et la délibération entre traditions réduiront ces écarts. Et troisièmement, elle est instable, pour des raisons que voyait déjà le philosophe anglais du XVIIe siècle Thomas Hobbes : si je pense que mon voisin tente de me dominer, je ferai la même chose à son endroit et il en découlera pour tous les deux une situation qui est moins favorable pour tous les deux que si nous avions tenté de réaliser un compromis. (Il peut sembler inutile dans le contexte d’une réunion comme celle-ci de consacrer ne serait-ce que l’une des quelques précieuses minutes qui m’ont été octroyées pour tenter d’exclure la solution de l’hégémonie. Mais quiconque connaît un tant soit peu la littérature en bioéthique doit bien se rendre compte à quel point ces principaux protagonistes sont encore motivés, qu’ils le reconnaissent ou non, par des visées hégémoniques.) La deuxième solution qu’il convient de rejeter est celle de la simple tolérance. La tolérance implique dans son acception la plus commune le fait d’accepter de coexister avec des individus dont nous ne partageons pas les croyances et les pratiques, dont les croyances et pratiques nous répugnent à la limite, et de ne pas user du pouvoir dont nous disposons à leur endroit pour faire de sorte qu’ils cessent de se livrer aux pratiques dont nous désapprouvons. La tolérance comme stratégie institutionnelle peut fonctionner dans des domaines où il est impensable que tous les membres d’une société diverse viennent à partager les mêmes opinions, mais où rien n’oblige qu’ils partagent les mêmes institutions et les mêmes lois. Un cas classique, souvent discuté parmi les juristes de nos jours, est le plurijuridisme dans des domaines comme celui du droit familial. Certains communautés religieuses ont des conceptions et des pratiques relative au mariage et au divorce qui diffèrent de celles de la majorité. Pour certains juristes, le respect de la différence culturelle exige de créer des poches de « quasi-souveraineté » à l’intérieur desquelles ces communautés peuvent gérer certaines dimensions de leur existence collective selon leurs propres traditions. Il y a là tolérance institutionnalisée : les différents groupes rejettent les conceptions du mariage de leurs voisins, mais ils acceptent que ces derniers organisent leur vie interne eu égard au mariage comme bon leur semble, à condition qu’ils ne tentent pas d’imposer leur conception à autrui.

32 Le problème des principaux problèmes de la bioéthique est qu’ils ne se prêtent pas aussi bien à cette espèce de séparation institutionnelle qu’appelle la tolérance. Nous partageons nos institutions de santé à l’intérieur d’une société même très plurielle, et il est difficile d’imaginer, tant pour des raisons philosophiques et économiques que pour des raisons relevant de la santé publique, que nous puissions créer des « enclaves » juridiques en matière d’administration de la santé qui seraient analogues aux enclaves en matière de droit familial que nous considérions il y a un instant. Nos sociétés sont donc caractérisées par des différends irréductibles en matière de bioéthique et nous ne pouvons pas contourner ces différends en optant pour la séparation institutionnelle. Alors, que faire ? La stratégie de la tolérance nous indique à mon avis au moins en partie le chemin à adopter. Elle transforme en effet une question morale (par exemple, quelle est la bonne manière de gérer l’institution du mariage ?) en une question politique et institutionnelle (quelles sont les institutions que nous devons mettre en place étant donné que nous ne pourrons jamais nous mettre d’accord en matière d’éthique sexuelle, de rapports entre les sexes, etc. ?). La réponse précise qu’offre la stratégie de la tolérance ne peut pas être simplement adaptée aux problèmes de la bioéthique, pour des raisons que nous n’avons fait qu’esquisser plus haut. Mais la question est la bonne. Nous devons à mon avis traiter les questions de différends moraux irrésolvables qui se produisent dans des contextes où nous devons néanmoins en arriver à des solutions communes comme des problèmes institutionnels, touchant cette fois-ci aux institutions et aux procédures que nous devons mettre en place pour en arriver à des décisions qui, même si elles ne correspondent parfaitement aux idéaux de qui que ce soit, peuvent néanmoins être vus par tous comme émanant de procédures dans lesquelles elles ont été traitées avec respect. Si nous ne pouvons avoir de consensus sur le fond, il nous faut établir des consensus sur les institutions nous permettant de vivre avec nos différends permanents. À quoi ressembleraient de telles institutions ? Je ne peux dans le contexte de ce bref texte qu’esquisser six principes qui me semblent devoir sous-tendre leur architecture précise : 1) Le principe de la représentativité : le poids institutionnel des différentes voix présentes dans un tel corps ne peut pas être simplement le reflet de leurs poids relatifs dans la population, à défaut de quoi de telles institutions risqueraient simplement d’institutionnaliser la tyrannie de la majorité.

33 2) Le principe de la raison publique : même si elles émanent ultimement de leurs convictions religieuses et spirituelles les plus profondes, les participants dans de telles institutions doivent présenter leurs positions en évoquant des considérations que leurs interlocuteurs sont en mesure d’apprécier, sinon de partager. 3) Le principe de la fidélité conversationnelle : les participants doivent éviter toute caricature et toute démonisation du point de vue de leurs interlocuteurs. 4) Le principe du compromis : les participants doivent tenter d’identifier des compromis qui permette de minimiser la mesure dans laquelle l’un ou l’autre des participants est forcé de sacrifier ses convictions les plus fondamentales. 5) Le principe du consensus non-thématisé : les participants doivent tenter d’identifier des passerelles entre les différentes traditions et conceptions, des points où des accords ponctuels sont possibles, même si ils n’y viennent pas pour les mêmes raisons. 6) Le principe majoritaire : toute institution doit se doter d’un processus majoritaire permettant de trancher ce qui demeure comme différend après que des processus de discussion gouvernés (au moins) par les principes 1 à 5 ont été épuisés. Seules des institutions décisionnelles gouvernées par des principes relevant de la procédure sur lesquelles il peut y avoir consensus nous permettront de découvrir des principes en matière de bioéthique pouvant faire l’objet de compromis honorables, là où aucun consensus substantiel n’est possible.

34 Chapitre / Chapter 2

VERS UNE DECLARATION INTERNATIONALE SUR LES DONEES GENETIQUES HUMAINES

* * *

TOWARD AN INTERNATIONAL DECLARATION ON HUMAN GENETIC DATA

• Mr Georges B. Kutukdjian PRESENTATION DE L’ESQUISSE DE LA DECLARATION INTERNATIONALE SUR LES DONNEES GENETIQUES HUMAINES

Georges B. Kutukdjian, Membre du Groupe de rédaction du CIB Ancien Secrétaire général du CIB

I. Introduction Les données génétiques humaines revêtent une importance capitale pour les progrès de la science et de la médecine et elles sont fréquemment produites en vue de leurs utilisations à des fins non médicales. En premier lieu, l’analyse des données génétiques contribue à une meilleure connaissance de l’évolution du génome humain, notamment en ce qui concerne les interactions entre ce dernier et l’environnement. En deuxième lieu, elles permettent à la recherche biomédicale appliquée, par exemple menée par l’industrie pharmaceutique, de mettre en évidence d’éventuelles prédispositions génétiques à réagir à des traitements ou à des produits pharmaceutiques. En troisième lieu, elles peuvent constituer pour la recherche épidémiologique une source d’information utile pour la santé publique et les services sociaux. En quatrième lieu, elles sont fondamentales en matière de diagnostic génétique individuel et familial, qu’il s’agisse de tests révélant une mutation génétique délétère ou de tests prédictifs de susceptibilité ou de prédisposition génétique à d’éventuelles pathologies. En dernier lieu, elles sont également utilisées à des fins non médicales et sont devenues des outils précieux pour la médecine légale, par exemple pour identifier le corps de soldats morts au combat, et la justice, notamment en matière de procédures civiles, par exemple pour une identification parentale, ou en matière de procédures pénales, par exemple pour identifier un criminel. Toutes ces pratiques produisent une masse considérable de collections d’échantillons d’ADN dont l’analyse génère des données génétiques humaines qui sont par la suite traitées et conservées. Le

37 terme de données génétiques humaines recouvre les informations phénotypiques et les informations génotypiques générées à la fois à partir du caryotype et des séquences d’ADN et de leurs polymorphismes. Les données génétiques en question, qu’elles aient été recueillies à des fins scientifiques, médicales ou autres, doivent être utilisées à des fins licites et dans le respect des droits de l’homme, des libertés fondamentales et de la dignité humaine. En effet, les données génétiques, surtout si elles sont nominatives, c’est-à-dire reliées à une personne identifiable, pourraient être détournées de leurs buts fondamentaux et conduire à des stigmatisations de personnes, de familles ou de groupes entiers, à des discriminations à leur égard et à des violations de la vie privée, notamment si elles sont communiquées à des tiers qui ne sont pas autorisées à les détenir. Aussi, cette question fait- elle l’objet d’une vive préoccupation au sein de la communauté scientifique internationale et de la société civile. La communauté scientifique internationale au cours des deux dernières années, à diverses reprises, s’est prononcée en faveur de cette initiative(1). La préparation de l’instrument international sur les données génétiques humaines constitue une suite logique de la Déclaration universelle sur le génome humain et les droits de l’homme. En effet, le futur instrument international applique les principes énoncés dans la Déclaration universelle aux données génétiques humaines, domaine essentiel pour le respect des droits de l’homme, des libertés fondamentales et de la dignité humaine. Un Groupe de travail du CIB, dont le professeur Ryuichi Ida, Président du CIB, a rappelé le mandat et la composition, s’est réuni à trois reprises à Paris en février, avril et juillet 2002. L’Esquisse que j’ai l’honneur de vous présenter aujourd’hui en est le fruit. Elle s’inspire des rapports du CIB sur « Confidentialité et données génétiques » (1999) et sur « Données génétiques humaines : étude préliminaire du CIB sur leurs collectes, leurs traitements, leurs stockages et leurs utilisations » (2002) et, d’une manière générale, s’appuie sur l’ensemble des rapports élaborés par le Comité international de bioéthique de l’UNESCO (CIB) depuis 1992.

1. Citons, par exemple, la Déclaration de Bogotá, adoptée le 10 août 2002 lors du IIe Congrès international de l’éthique de la recherche scientifique, qui stipule au point VII qu’il est « essentiel que les pays adoptent une position internationale commune en matière de protection des données génétiques, car elles peuvent avoir des répercussions sur la personne en ce qu’elle a de plus intime » (traduit de l’espagnol). La question a été abordée également lors de la Deuxième Conférence internationale de bioéthique (Gijón, Espagne, 30 sept. – 4 oct. 2002).

38 Un certain nombre de pays se sont dotés de législations, ont pris des mesures réglementaires, ou ont adoptés des normes éthiques, inspirées par des rapports circonstanciés de comités nationaux d’éthique, portant quelquefois spécifiquement sur les données génétiques humaines, plus généralement sur les données médicales, les données personnelles et les données sensibles(2). L’Esquisse se fonde également sur une analyse du corpus législatif ou réglementaire dans ces pays. Elle tient compte des dispositions adoptées et des rapports établis par des organisations internationales universelles - en particulier l’Organisation des Nations Unies (ONU), l’Organisation internationale du travail (OIT), l’Organisation mondiale de la santé (OMS)(3) et l’Organisation des Nations Unies pour l’éducation, la science et la culture (UNESCO)(4) - et régionales - tels que le Conseil de l’Europe(5), l’Organisation pour la

2. Les données sensibles couvre les informations sur l’origine ethnique ou raciale d’une personne, ses opinions politiques, ses convictions religieuses, philosophiques ou autres, son état de santé (physique et mental), sa vie sexuelle, son appartenance à un syndicat ou à une association. Cependant, cette définition n’est pas exhaustive comme attestée par une analyse des législations de quelques pays qui utilisent cette notion, tels que l’Autriche, le Danemark, l’Estonie, la Finlande, la France, la Grèce, la Hongrie, l’Islande, l’Italie, la Norvège, les Pays- Bas, le Portugal, la République tchèque, le Royaume-Uni et la Suisse. En Espagne, la loi organique de 1990 se réfère à des données « spécialement protégées », tandis qu’un avant-projet de loi en Allemagne parle de données « particulières ». Dans quelques pays, par exemple l’Autriche, l’Estonie, l’Islande, la Norvège, le Portugal, et la Suisse, les données génétiques se subsument sous la notion de données sensibles. La Convention du Conseil de l’Europe pour la protection des personnes à l’égard du traitement automatisé des données à caractère personnel (Convention 108/1981) et la Directive européenne relative à la protection des personnes physiques à l’égard du traitement des données à caractère personnel et à la libre circulation de ces données (Directive 95/46/CE) se réfèrent également à des « catégories particulières de données ». 3. Voir en particulier le récent rapport établi en 2002 par M. Dan Brocke et Mme Chee Heng Leng pour l’Organisation mondiale de la santé (OMS) et le débat auquel il a donné lieu au VIe Congrès mondial de bioéthique (Brasilia, Brésil, 30 oct. – 3 nov. 2002). Le Rapport est disponible en anglais sur le site Internet de l’OMS. 4. En particulier le flux fransfrontière des données personnelles a été traitée dans un ouvrage intitulé « Privacy and Human Rights », James Michael, Paris/Londres, UNESCO/Dartmouth, 1994. (Date ???) 5. Voir en particulier la Convention européenne du 28 janvier 1981 pour la protection des personnes à l’égard du traitement automatisé des données à caractère personnel (Convention 108/1981) et la Recommandation N° R(81)1 du Conseil des Ministres relative à la réglementation applicable aux banques de données médicales automatisées.

39 coopération et le développement économiques (OCDE)(6) et l’Union européenne(7). L’Esquisse suit une logique d’énoncés de principes et de normes établissant ainsi un équilibre entre des dispositions trop générales et des dispositions trop précises qui ne conviendraient qu’à un instrument ayant un caractère contraignant (par exemple, une convention). Etant donné que les diverses étapes du maniement des données génétiques humaines posent des questions distinctes, la future déclaration internationale les différencie clairement en des sections qui abordent successivement la collecte, le traitement, l’utilisation et la conservation des données considérées. De plus, conformément à la pratique désormais en vigueur à l’UNESCO et dans d’autres organisations internationales, chaque article comporte un titre qui en présente l’objet(8). Le titre de l’Esquisse indique que la déclaration internationale porte sur les données génétiques humaines. Cependant, il faut souligner que la déclaration internationale s’applique également aux données qui en sont ou qui pourraient en être dérivées. Ce point est important, car différentes bases de données, par exemple les données protéomiques, vont se constituer rapidement dans les années à venir et il serait opportun que la déclaration internationale anticipe de tels développements.

II. La future déclaration internationale sur les données génétiques humaines Les données génétiques humaines étant tout à la fois des données scientifiques, notamment médicales, des données personnelles et des données sensibles, le Préambule rappelle en la matière les instruments internationaux et régionaux pertinents, les législations, les réglementations et les textes de portée éthique nationaux ainsi que les documents adoptés par des organisations internationales non

6. Voir en particulier les « Principes directeurs gouvernant la protection de la vie privée et le flux transfrontière des données de caractère personnel » du 23 septembre 1980. 7. Directive 95/46/CE du Parlement européen et du Conseil des ministres relative à la protection des personnes physiques à l’égard du traitement des données à caractère personnel et à la libre circulation de ces données (24 octobre 1995). 8. Voir par exemple la Déclaration universelle sur la diversité culturelle adoptée en 2001 par la Conférence générale de l’UNESCO.

40 gouvernementales. Par exemple l’Assemblée générale des Nations Unies a examiné à plusieurs reprises les principes directeurs devant réglementer les données personnelles (résolution 44/132 du 15 décembre 1989 et résolution 45/95 du 14 décembre 1990). Le Préambule décrit la spécificité des données génétiques humaines. Leur complexité tient à leur double nature, dans la mesure où elles fournissent à la fois des informations médicales et des informations personnelles, parce qu’elles caractérisent une personne et peuvent en constituer pour ainsi dire sa carte d’identité. Dans les deux cas, ces informations demeurent pertinentes tout au long d’une vie, en particulier en matière médicale parce que ces données contiennent non seulement des informations sur l’état de santé d’une personne mais peuvent avoir également un caractère prédictif. Mais cette complexité tient également au fait qu’elles constituent des informations potentielles sur la fratrie (les frères et les sœurs), les descendants et, d’une manière générale, le groupe auquel appartient une personne. Le Préambule insiste aussi sur la nécessité de collecter et de traiter les données génétiques humaines et de les constituer en bases de données. Il est essentiel de rappeler les différents domaines dont le développement est intrinsèquement tributaire de la capacité d’analyse qui s’attache aux données génétiques humaines. En bref, les données génétiques sont essentielles pour : • la recherche fondamentale ; • la recherche biomédicale appliquée ; • la recherche épidémiologique ; • la connaissance sur l’état de santé d’une personne ou sur les risques qu’elle ou sa famille peuvent encourir ; • la médecine légale et la justice. Le Dispositif est composé de six (6) sections et de vingt-sept (27) articles.

A. Objet et portée La première section traite de l’objet de la future déclaration internationale et énonce des principes transversaux qui constituent la clé de voûte de l’Esquisse. En effet, certains principes s’appliquent aux données génétiques humaines dans leur ensemble avant d’aborder les différentes étapes de leurs maniements.

41 L’article premier affirme que la personne humaine forge son identité à partir de relations sociales, culturelles et symboliques ; l’identité n’est pas mécaniquement déterminée par un substrat naturel. En effet, il serait dangereux de naturaliser l’identité d’une personne. C’est l’exercice de la liberté qui permet à toute personne de devenir le sujet de son histoire et non de la subir en raison de ses caractéristiques génétiques. L’article 2(b) de la Déclaration universelle sur le génome humain et les droits de l’homme réfutait déjà le réductionnisme et le déterminisme génétiques. L’Esquisse propose d’étendre cette réfutation à l’identité d’une personne et aux liens de filiation. Toutes les cultures du monde attestent - et même quelquefois s’ingénient à affirmer - que la famille, dans ses différentes acceptions, est fondée sur des relations sociales et non sur des relations biologiques. L’article 2 précise la double nature, médicale et personnelle, des données génétiques humaines ainsi que les incidences qu’elles peuvent avoir sur la famille et même sur l’ensemble du groupe auquel appartient l’intéressé(e). Le terme de groupe est compris au sens d’une communauté ethnique ou d’une population. En effet, si une mutation génétique est décelée chez un homme sans qu’il ne présente de pathologie, par exemple dans le cas du syndrome X-fragile, ces informations peuvent intéresser ses frères et sœurs ou encore ses filles qui ont un risque élevé d’avoir des fils malades. De plus, certaines prédispositions génétiques décelées sur des personnes appartenant à un même groupe, communauté, ou population, peuvent indiquer qu’il s’agit de prédispositions qui sont prévalentes dans le groupe en question. En outre, l’article 2, à l’alinéa (b), insiste sur la teneur culturelle et symbolique que revêtent les données génétiques pour de nombreuses personnes. Qu’il s’agisse du sang ou d’autres éléments du corps humain qui peuvent servir d’échantillons pour produire des données génétiques, des valeurs culturelles ou spirituelles s’y attachent, souvent en fonction des représentations culturelles des personnes ou de leurs convictions religieuses ou philosophiques. Aussi est-il nécessaire que les milieux professionnels et les instances chargées de la gestion des données génétiques humaines en soient conscientes et les manient en sachant ce qu’elles représentent pour autrui. L’article 3 a pour objectif de définir les finalités pour lesquelles les données génétiques humaines peuvent être collectées, traitées, utilisées et conservées. Il s’agit principalement de :

42 • la recherche scientifique ; • les soins de santé ; • la médecine légale ; • les besoins de la justice. Certes, il pourrait y avoir sans doute d’autres finalités légitimes pour collecter, traiter, utiliser et conserver des données génétiques, comme par exemple les recherches généalogiques qui sont prisées à l’heure actuelle dans certains pays. Si tel était le cas dans un pays, cette finalité devrait faire l’objet d’une mention explicite dans le cadre de la législation nationale qui devrait également prévoir les conditions dans lesquelles la collecte, le traitement, l’utilisation et la conservation des données génétiques pourraient s’effectuer. L’article 4 énonce les conditions générales dans lesquelles les données génétiques humaines devraient être collectées, traitées, utilisées et conservées, quelques soient leurs finalités visées : recherche, soins de santé, médecine légale et justice. Cet article précise également que ce processus doit faire une place à un débat largement ouvert sur le plan international et assurant la libre expression de différents points de vue. Ainsi, l’alinéa (a) précise les trois conditions constitutifs des procédures à mettre en place, à savoir : • la transparence dans les finalités de la production des données génétiques humaines et de leur gestion ; • la participation de la société, aux différentes étapes de production, de gestion, de contrôle et d’évaluation des bases de données ; • l’éducation et l’information de la société, afin de garantir un réel exercice démocratique sur la collecte, le traitement, l’utilisation et la conservation des données - s’agissant notamment de populations entières - et de manière à s’assurer que la participation est éclairée, fondée sur des connaissances et des faits scientifiques et non motivée par des peurs et des préjugés. L’alinéa (b) spécifie que les comités d’éthique indépendants, pluridisciplinaires et pluralistes devront être consultés et que l’examen de la collecte, du traitement, de l’utilisation et de la conservation des données se fondera sur l’instrument international considéré lors de la constitution de données génétiques humaines. Un comité d’éthique n’est pas une instance décisionnelle et ne peut ni ne devrait se substituer à un

43 organe exécutif ou législatif. Il s’agit en l’occurrence de le consulter pour s’assurer, par exemple, qu’un hôpital, qui accumule au fil du temps des données issues de tests génétiques, suit des normes et des règles qui sont conformes aux principes énoncés dans la future déclaration internationale. De même, si par exemple toute une population est invitée à fournir des échantillons en vue de la constitution d’une banque de données génétiques, cas de figure qui a tendance à se renouveler, est-il nécessaire de consulter un comité d’éthique. Les trois critères énoncés, à savoir l’indépendance, la pluridisciplinarité et le pluralisme, sont déjà inscrits à l’article 16 de la Déclaration universelle sur le génome humain et les droits de l’homme(9). Le critère d’indépendance signifie que les membres d’un comité d’éthique siègent en leur nom propre. Ils ne doivent pas représenter le point de vue d’instances publics ou privés, même quand il s’agit d’institutions qui les y ont proposés. A fortiori ne doivent-ils pas y défendre des intérêts étatiques ou privés. Leur légitimité tient à l’autorité que leur confèrent leurs connaissances, leurs compétences et leur expérience et non aux instances qu’ils y représenteraient. Le critère de pluridisciplinarité est essentiel afin que les aspects éthiques ne soient pas uniquement abordés sous l’angle d’une seule pratique professionnelle. Ainsi, si l’apport des chercheurs scientifiques et des cliniciens est crucial, celui des anthropologues, des juristes, des philosophes, des sociologues, etc. l’est autant, afin de saisir les enjeux éthiques, sociaux et juridiques dans leur complexité. Le troisième critère du pluralisme garantit au sein du comité d’éthique la nécessaire expression des différents courants de pensée et de convictions et les diverses sensibilités constitutives d’une société donnée. L’article 5 stipule la nécessité pour les Etats d’adopter une législation et une réglementation appropriées relatives aux données génétiques humaines afin d’éviter toute stigmatisation d’une personne, d’une famille ou d’un groupe et tout traitement discriminatoire] à leur égard. Il faut signaler que l’article 2 (a) et l’article 6 de la Déclaration universelle sur le génome humain et les droits de l’homme consacraient

9. « Article 6. Les Etats devraient reconnaître l'intérêt de promouvoir, aux différents niveaux appropriés, la création de comités d'éthique indépendants, pluridisciplinaires et pluralistes, chargés d'apprécier les questions éthiques, juridiques et sociales soulevées par les recherches sur le génome humain et leurs applications. »

44 déjà le principe de non-discrimination(10). L’article 5 de l’Esquisse spécifie que le principe de non discrimination doit également s’appliquer aux données génétiques humaines et il introduit la notion de non stigmatisation d’une personne, d’une famille ou d’un groupe. Il faut reconnaître qu’en plus d’une éventuelle discrimination, le problème de la stigmatisation se trouve au cœur même de l’utilisation des données génétiques humaines recueillies à l’occasion de dépistages génétiques ou des études de génétique des populations.

B. Collecte La deuxième section traite de la collecte d’échantillons qui serviront à la production de données génétiques humaines. En effet, les données génétiques humaines ne peuvent être produites qu’à partir du prélèvement sur une personne d’un échantillons de cellules (sanguines ou autres) ou de tissus, selon une pratique invasive (par exemple une prise de sang) ou non invasive (cheveu avec le bulbe capillaire). L’article 6 porte sur le consentement lors de la collecte des données génétiques humaines. L’alinéa (a) précise que le consentement doit être préalable, libre, éclairé et exprès. • Le consentement est préalable lorsque la personne concernée sait d’avance et a compris que l’échantillon est destiné à produire des données génétiques humaines. • Il est libre, lorsque la personne concernée ne subit aucune contrainte physique ou psychologique, n’encourt aucune sanction matérielle ou morale et ne reçoit pas en échange une récompense financière injustifiée. • Il est éclairé, lorsque la personne concernée comprend les raisons pour lesquelles les données génétiques humaines sont collectées, les avantages et les inconvénients éventuels et comprend les garanties de protection dont les données en question sont entourées, notamment en ce qui concerne la confidentialité vis-à-vis des tiers.

10. « Article 2a). Chaque individu a droit au respect de sa dignité et de ses droits, quelles que soient ses caractéristiques génétiques. » « Article 6. Nul ne doit faire l'objet de discriminations fondées sur ses caractéristiques génétiques, qui auraient pour objet ou pour effet de porter atteinte à ses droits et à ses libertés fondamentales et à la reconnaissance de sa dignité. »

45 • Enfin, le consentement est dit exprès lorsque la personne qui fournit l’échantillon donne son accord à la finalité pour laquelle la collecte de données est effectuée. Le consentement préalable, libre, éclairé et exprès devrait être obtenu par écrit sur la base d’informations écrites remises à l’intéressé(e), accompagnées d’explications orales. En effet, souvent des explications orales sont nécessaires pour la compréhension des documents écrits, d’autant plus que la terminologie utilisée n’est pas accessible pour tous. Dans le cas de personnes illettrées, un consentement oral peut être envisagée, à condition qu’une personne puisse s’en porter témoin. En tout état de cause il est opportun de prévoir l’archivage de la documentation, écrite ou sur bande magnétique, prouvant qu’un consentement écrit ou un consentement oral (notamment dans le cas d’une personne illettrée) a été recueilli. L’alinéa (b) porte sur les conditions de consentement dans les cas où une personne n’est pas en mesure de la donner. Il peut s’agir d’un(e) mineur(e) ou d’un(e) adulte handicapé(e) mental ou juridiquement incapable, pour une période donnée ou de manière permanente. Dans ces circonstances, il est prévu de se conformer à la législation nationale et d’obtenir une autorisation de la justice. De telles démarches devront être guidées par l’intérêt supérieur de l’intéressé(e). Cette formulation est conforme à l’article 5 b) de la Déclaration universelle sur le génome humain et les droits de l’homme(11). L’article 7 stipule qu’une personne qui a accordé son consentement préalable, libre éclairé et exprès peut le retirer. Le cas de figure du retrait d’un consentement se pose dans la recherche médicale (par exemple, un dépistage volontaire d’une population) ou scientifique (par exemple, la participation volontaire à un projet de recherche). En premier lieu, l’article 7 prévoit que, dans de telles circonstances, un délai devrait être spécifié à l’intéressé(e) pour le retrait de son consentement. En second lieu, passé un tel délai, le retrait ne serait possible que pour autant que les données génétiques n’ont pas été anonymisées de manière irréversible. En tout état de cause, l’intéressé(e) ne devrait en aucun cas être pénalisé(e) ou subir un désavantage en raison du retrait de son consentement.

11. « Article 5b). Dans tous les cas, le consentement préalable, libre et éclairé de l'intéressé(e) sera recueilli. Si ce(tte) dernier(e) n'est pas en mesure de l'exprimer, le consentement ou l'autorisation seront obtenus conformément à la loi, guidé par son intérêt supérieur. »

46 A l’instar de l’article 7, toujours dans le cadre de la recherche médicale et scientifique, le consentement préalable, libre éclairé et exprès devra prévoir une rubrique laissant le choix à l’intéressé(e) d’être informé ou non des résultats de la recherche médicale ou scientifique. La Déclaration universelle sur le génome humain et les droits de l’homme utilise une formulation analogue à l’article 5 c)(12). S’agissant de collecte des données génétiques humaines ayant pour finalité les soins de santé, notamment tout test génétique, individuel et familial, l’article 9 précise, qu’en plus du consentement préalable, libre, éclairé et exprès, le conseil génétique sera proposé à l’intéressé(e). Cette question avait déjà été examinée par le CIB lors de ses discussions sur les rapports portant sur « Le dépistage et les tests génétiques » et sur « Le conseil génétique ». En effet, avant même un dépistage et un test génétiques, toute personne doit bénéficier du conseil génétique, afin de comprendre la nature d’un tel examen, le sens de ses résultats, les limites de son interprétation, etc. De même, la présentation des résultats d’un test génétique qu’il soit positif ou négatif, et dont les répercussions psychologiques peuvent être importantes, doit se faire dans le cadre du conseil génétique. Cependant, au moment de la prise de décision, la personne peut souhaiter s’y soustraire. Même si le conseil génétique est fondamentalement non directif, la personne peut craindre d’être influencée dans ses choix. Aussi, n’est-il pas opportun de rendre le conseil génétique obligatoire, afin de respecter l’autonomie de la personne et sa liberté. L’article 10 traite de la collecte des données génétiques humaines, in vivo ou post mortem, à des fins d’identification. Dans le cadre d’une instruction judiciaire ou de l’identification d’un cadavre ou de restes humains (dont l’identification est impossible autrement que par une analyse d’ADN), il convient de préciser que seule une décision de justice, en conformité avec le droit international des droits de l’homme, peut demander une telle collecte. Dans le cadre d’une procédure civile, il faut en effet éviter que des laboratoires d’analyses génétiques procèdent, par exemple, à des tests d’identification de filiation en l’absence de la décision d’un juge. L’article 10 précise d’ailleurs que dans l’hypothèse d’une identification parentale, la décision du juge doit être prise en fonction de l’intérêt supérieur de l’enfant ou du mineur. Dans le cadre d’une procédure pénale, en cas de viol ou de meurtre, il est évident que la décision doit également être prise par un juge.

12. « Article 5 c). Le droit de chacun de décider d’être informé ou non des résultats d’un examen génétique et de ses conséquences devrait être respecté. »

47 C. Traitement La qualité et la sécurité sont au centre des préoccupations en matière de traitement des données génétiques humaines. La troisième section est composée de trois articles.

L’article 11 précise que les milieux professionnels concernées et les instances chargées du traitement des données génétiques humaines ont l’obligation de remplir certaines conditions. Les garanties qui sont demandées sont au nombre de quatre.

• L’exactitude des données génétiques est une exigence scientifique.

• La fiabilité porte par exemple sur l’origine des données génétiques qui ne doit point être douteuse.

• La qualité des données génétiques suppose de s’assurer qu’elles ont été recueillies dans le respect du consentement préalable, libre, éclairé et exprès et suivant les normes édictées en la matière.

• La sécurité impose de protéger les données génétiques par exemple du piratage.

L’article met aussi l’accent, à l’instar de l’article 13 de la Déclaration universelle sur le génome humain et les droits de l’homme(13), sur leurs responsabilités particulières, notamment de rigueur, de prudence, d’honnêteté intellectuelle et d’intégrité dans le traitement des données génétiques humaines. Il faut rappeler que la Recommandation concernant la condition des chercheurs scientifiques, adoptée par la Conférence générale de l’UNESCO le 20 novembre 1974, affirme que : « la recherche scientifique exige des chercheurs qui l’accomplissent des qualités d’intégrité et de maturité alliées à d’éminentes .qualités morales et intellectuelles »(14).

13. « Article 3. Les responsabilités inhérentes aux activités des chercheurs, notamment la rigueur, la prudence, l'honnêteté intellectuelle et l'intégrité, dans la conduite de leurs recherches ainsi que dans la présentation et l'utilisation de leurs résultats, devraient faire l'objet d'une attention particulière dans le cadre des recherches sur le génome humain, compte tenu de leurs implications éthiques et sociales. Les décideurs publics et privés en matière de politiques scientifiques ont aussi des responsabilités particulières à cet égard. » 14. Section III intitulée « L’éducation et la formation initiales des chercheurs scientifiques », paragraphe 10.

48 Dans le cas de données génétiques humaines recueillies à des fins de recherche scientifique, l’article 12 précise que les données génétiques humaines devront être anonymisées. L’anonymisation peut être irréversible ou réversible. • Dans le cas d’une anonymisation irréversible, le logiciel attribue un numéro aux données génétiques correspondant à une personne selon une formule stochastique dont l’aléatoire ne permet plus d’identifier cette personne. • Dans le cas d’une anonymisation réversible, le logiciel qui attribue un numéro aux données génétiques correspondant à une personne permet de restituer au besoin l’identité de l’intéressé(e). Or, dans le cadre de recherches portant sur plusieurs générations de membres d’une ou de plusieurs familles, il peut être nécessaire de resituer des personnes dans les lignées familiales, par exemple pour calculer la pénétrance d’une mutation génétique sur plusieurs générations. Aussi, l’article 12 précise-t-il que si l’anonymisation est réversible, les précautions nécessaires devront être prises pour assurer la confidentialité des données génétiques vis-à-vis de tiers, en vue du respect des droits de l’homme, des libertés fondamentales et de la dignité humaine. L’article 13 porte spécifiquement sur la confidentialité des données génétiques associées à une personne, à une famille ou à un groupe identifiable. Cet article prolonge la disposition prévue à l’article 7 de la Déclaration universelle sur le génome humain et les droits de l’homme(15). Il appartient aux milieux professionnels concernés et aux instances chargées du traitement des données en question de l’assurer.

D. Utilisation La quatrième section porte sur les utilisations multiples des données génétiques humaines à des fins médicales ou non médicales. Les utilisations les plus problématiques sont peut-être celles qui ont des finalités non médicales. En raison de la complexité de la question, cette section comporte huit articles.

15. « Article 7. La confidentialité des données génétiques associées à une personne identifiable, conservées ou traitées à des fins de recherche ou dans tout autre but, doit être protégée dans les conditions prévues par la loi. »

49 L’article 14 exclut l’utilisation des données génétiques humaines - recueillies dans le cadre d’un test, d’un dépistage, d’une recherche ou d’une procédure civile ou pénale - à des fins discriminatoires ou de manière à stigmatiser une personne, une famille ou un groupe. Les programmes de dépistage menés dans certains pays du monde démontre à l’évidence que la crainte la plus souvent exprimée, à juste titre, par les intéressé(e)s est l’utilisation qui sera faite des résultats de telles recherches. Par conséquent, la réussite ou l’échec de tels programmes tient souvent à la perception qu’ont les personnes, les familles ou les groupes intéressés de leur possible stigmatisation dès lors que les résultats du dépistage seront divulguées. A plus forte raison craignent-ils que des mesures discriminatoires soient prises à leur égard, par exemple des restrictions de naissance. Les affirmations qui précédent sont étayées sur les résultats d’enquêtes effectuées dans plusieurs pays d’où il ressort que jusqu’à 75% des personnes interrogées refuseraient un test génétique si le résultat devait être divulgué à des tiers. Cet article insiste en outre sur la nécessité à ne pas avancer des interprétations hasardeuses auxquelles les résultats des études génétiques du comportement humain pourraient donner lieu. Dans ce domaine également des personnes présentant une structure génétique donnée pourraient faire l’objet de discrimination ou de stigmatisation. L’article 15 précise que des données génétiques humaines collectées, traitées, utilisées ou conservées en vue de l’une des finalités énoncés à l’article 3, peuvent être utilisées en vue d’une autre finalité à condition de s’assurer à nouveau auprès de la personne, de la famille ou du groupe concernés de son (ou de leur) consentement préalable, libre, éclairé et exprès. L’article 16 exclut l’accès de tiers à des données génétiques associées à une personne identifiable, à une famille ou à un groupe, sauf dans les cas prévus par la loi et conformément au droit international des droits de l’homme. L’article mentionne nommément les employeurs, les compagnies d’assurance et les institutions éducatives, sans toutefois que cette énumération soit restrictive. Un rapport du Ministère du travail des Etats-Unis d’Amérique fait état d’une enquête menée en 1989 qui indiquait déjà que 5% des entreprises consultées procédaient à un dépistage ou un contrôle (=monitoring) génétique auprès de leurs salariés. En 1997, le pourcentage est de 6%. En dépit de ces pourcentages relativement bas, ce qui est plus révélateur c’est la tendance de ces pourcentages à augmenter rapidement. Il est vrai que des employeurs pourraient avancer comme argument la nécessité

50 d’avoir accès à des données génétiques associées à une personne afin de ne pas l’assigner à un poste de travail qui pourrait mettre sa santé en danger ou mettre en danger la vie d’autrui. Les compagnies d’assurance observaient jusqu’à présent un moratoire en la matière. Dans quelques pays, la tendance s’inverse et elles estiment qu’elles devraient être informées des résultats de tests génétiques ou devraient pouvoir les demander. Certaines arguent du fait qu’une bonne évaluation des coûts éventuels qu’elles pourraient encourir, par exemple en assurant des personnes ayant eu des accidents cardio- vasculaires, leur ont permis d’accepter de couvrir ces personnes, alors qu’elles les auraient refusées il y a vingt ans. Elles considèrent par conséquent que mutatis mutandis la situation est analogue. De même, les institutions éducatives pourraient estimer que c’est dans l’intérêt d’un enfant - par exemple pour tenir compte de ses éventuelles difficultés présentes ou futures - qu’elles puissent avoir accès à certaines données génétiques. L’article 16 précise que, le cas échéant, de telles situations peuvent être prévues par la législation nationale ou la réglementation, conformément au droit international des droits de l’homme. L’article 17 porte sur les obligations d’un médecin traitant qui entend communiquer des données génétiques humaines à une instance qui s’y intéresse. En effet, les médecins traitants sont quelquefois démarchés par des organismes publics ou privés pour communiquer des données génétiques humaines, soit associées à une personne, une famille ou un groupe soit même anonymisées. L’Esquisse prévoit qu’une telle communication est possible à la condition que le médecin traitant recueille le consentement préalable, libre, éclairé et exprès de la(les) personne(s) intéressée(s) et qu’il précise les conditions dans lesquelles il se propose de les transmettre, les utilisations qui en seront faites et les conditions de cette transmission. L’article 18 traite des bienfaits découlant de l’utilisation des résultats de la recherche scientifique, y compris des études de génétique des populations. Cette question a déjà été traitée par le CIB à deux reprises, dans le cadre de ses rapports sur « Bioéthique et recherches en génétique des populations humaines » (1995) et sur « La solidarité et la coopération internationale entre pays développés et pays en développement concernant le génome humain » (2001). Par exemple, il est important qu’ils soient informés avant tout autre de l’existence éventuelle de mutations génétiques particulièrement prévalentes dans le groupe considéré. En outre, l’article 18 stipule que les bienfaits de

51 l’utilisation des données génétiques humaines collectées dans le cadre de la recherche médicale et scientifique, seront partagés avec les personnes et les groupes y ayant participé. L’article 19 aborde la question de l’utilisation des données génétiques humaines issues d’échantillons historiques collectées dans le cadre de soins de santé ou d’échantillons archivés. Cette question se pose dans plusieurs pays du monde depuis plus d’une dizaine d’années. L’article 19 pose le principe que leurs utilisations doivent faire l’objet d’un consentement préalable, libre, éclairé et exprès. Cependant, dans certaines circonstances, l’application de se principe peut s’avérer difficile. La raison est double : les données génétiques contenues dans les collections en question sont parfois déjà anonymisées de manière irréversible ; et/ou les personnes concernées peuvent être décédées ou s’être déplacées. C’est pourquoi l’article 19 prévoit leur utilisation seulement si elles présentent un intérêt indéniable pour la recherche ou pour la santé publique et à condition qu’elles aient été anonymisées de manière irréversible. Il reviendra bien entendu aux comités d’éthique de décider si les collections d’échantillons historiques ou archivés présentent effectivement un intérêt indéniable pour la recherche ou pour la santé publique. L’article 20 porte sur la libre circulation des données génétiques anonymisées. Il souligne qu’il convient de l’encourager entre chercheurs afin de favoriser le partage des connaissances scientifiques. Toutefois, il indique que cette libre circulation ne peut avoir lieu qu’entre chercheurs ayant un respect scientifique réciproque et partageant la même éthique et à condition qu’ils respectent également tous les principes énoncés dans le présent instrument international. L’article 21 concerne spécifiquement l’utilisation transnationale des données génétiques humaines. Il dispose que les Etats réglementent leur flux transfrontière afin de favoriser la coopération internationale et d’assurer un accès équitable aux données génétiques humaines. Cependant, les Etats doivent s’assurer que les données génétiques humaines ne soient utilisées par un autre Etat que dans le respect du droit international des droits de l’homme et des principes énoncés dans la présente déclaration internationale.

E. Conservation La conservation des données génétiques humaines est l’objet de la cinquième section. Si leur conservation dans de nombreux pays du monde pouvait sembler pour l’heure ne pas poser de problèmes trop

52 aigus, l’accumulation rapide de ces données, leurs multiples utilisations éventuelles, leurs différentes formes d’anonymisation, etc. rendra la question de leur conservation particulièrement ardue. Cette section comporte trois articles. L’article 22 aborde l’instauration au niveau national d’un régime de gestion des données génétiques humaines. En effet, les données génétiques humaines doivent bénéficier d’une protection spéciale, étant donné leur spécificité exposée à l’article 2 et compte tenu des risques inhérents aux systèmes informatisés. Il est clair qu’un tel régime de gestion suppose qu’une instance soit chargée de se prononcer sur la production, la gestion et le suivi des bases de données génétiques humaines. Elle ne peut s’acquitter de cette fonction en respectant les droits de l’homme, les libertés fondamentales et la dignité humaine que si elle est instaurée sur la base de principes démocratiques quant à sa légitimité, sa représentativité et sa crédibilité. L’article 22 propose également que qu’il tel régime de gestion fixe le cadre de la reconnaissance de la souveraineté nationale sur les ressources génétiques humaines. Ce membre de phrase est indiqué entre crochets car il mérite une réflexion approfondie, en raison de la reconnaissance implicite qu’il pourrait comporter d’un droit patrimonial des pays sur les ressources génétiques humaines. L’article 23 porte sur la destruction des données génétiques humaines et distingue entre celles qui sont collectées au cours d’une enquête criminelle et celles qui le sont dans une action en procédure civile. C’est sans doute l’un des articles les plus importants pour la protection des libertés fondamentales. En effet, les données génétiques humaines recueillies au cours d’une enquête criminelle ne devraient plus être conservées, dès lors qu’un jugement définitif a été rendu et que l’individu concerné soit n’est pas accusé d’un délit, soit est déclaré non coupable. Afin de les conserver en dépit de tout, certains avancent souvent l’argument que les analyses d’identification portent sur l’ADN dit non codant. Toutefois, il apparaît de plus en plus clairement que même l’ADN non codant recèle d’importantes informations personnelles et médicales. Aussi, rien ne justifie la conservation des données génétiques d’une telle personne. En revanche, en cas de condamnation définitive d’une personne pour un crime assorti de violences, ses données génétiques pourront être conservées et ainsi conservées dans un fichier afin de faciliter l’identification des délinquants par la police judiciaire, par exemple les fichiers d’ADN pour les délinquants sexuels.

53 Dans une action en procédure civile, qu’il s’agisse d’une identification à des fins de filiation ou de l’identification de soldats morts au combat, les données génétiques ne devraient être conservées que pour la durée nécessaire à la poursuite de l’action. L’article 24 porte également sur l’une des garanties les plus essentielles pour le respect des libertés fondamentales. Afin de respecter la lettre et l’esprit du consentement préalable, libre, éclairé et exprès et afin d’éviter toute possibilité de discrimination ou de stigmatisation, les recoupements entre données génétiques ne doivent être autorisés que pour autant qu’elles ont été collectées en vue d’une même finalité. En revanche, les données génétiques collectées en vue de la recherche médicale et les soins de santé d’une part, et celles qui ont été collectées pour les besoins de la justice, d’autre part, ne devraient pas être recoupées entre elles. Par exemple, le recoupement des données génétiques humaines recueillies en vue d’un diagnostic génétique avec des données génétiques humaines conservées dans des fichiers de personnes condamnées pour des actes criminels constituerait une violation de la confidentialité des données génétiques vis-à-vis de tiers.

F. Promotion et mise en oeuvre La dernière section de la déclaration internationale, qui comporte trois articles, porte sur sa promotion et sa mise en œuvre. L’article 25 prévoit que les Etats prendront des mesures appropriées, afin de donner effet aux principes énoncés dans la déclaration internationale dans leur législations ou réglementations. Dans de nombreux domaines, l’expérience prouve que des lois ou des règlements ne sont effectivement appliqués que s’ils sont appuyés par une action en matière d’éducation, de formation et d’information. Aussi, l’article insiste-t-il autant sur l’aspect législatif ou réglementaire que sur l’aspect d’éducation et d’information. L’article 26 porte sur la diffusion des principes énoncés dans la déclaration internationale et sur les responsabilités exercées par le Comité international de bioéthique de l’UNESCO (CIB) et le Comité intergouvernemental de bioéthique de l’UNESCO (CIGB) quant à sa mise en œuvre. Ils sont tous deux chargés, en concertation, du suivi de sa mise en œuvre, notamment de la formulation de tout avis ou proposition susceptible d’en favoriser l’effectivité.

54 Enfin, inspiré de l’article 30 de la Déclaration universelle des droits de l’homme(16) et de l’article 25 de la Déclaration universelle sur le génome humain et les droits de l’homme(17), l’article 27 de l’Esquisse vise à prévenir tout détournement des principes énoncés dans la déclaration internationale.

16. « Article 30. Aucune disposition de la présente Déclaration ne peut être interprétée comme impliquant pour un Etat, un groupement ou un individu un droit quelconque de se livrer à une activité ou d’accomplir un acte visant à la destruction des droits et des libertés qui y sont énoncés. » 17. « Article 25. Aucune disposition de la présente Déclaration ne peut être interprétée comme pouvant être invoquée de quelque façon par un Etat, un groupement ou un individu pour se livrer à une activité ou accomplir un acte visant à des fins contraires aux droits de l'homme et aux libertés fondamentales y compris, notamment, les principes énoncés dans la présente Déclaration. »

55 Chapitre / Chapter 3

ETAT DES LIEUX

* * *

STATE-OF-THE-ART PRESENTATION

• Dr Rémi Quirion (Canada) NEUROSCIENCES AND BRAIN RESEARCH (∗) STATE OF THE ART AND NEUROETHICS

Rémi Quirion (Canada), Scientific Director of the Institute for Neurosciences, Mental Health and Addiction Canadian Institutes for Health Research

My Research Loves • The Alzheimer’s Puzzle Cross-talks / neuroprotection-cognition

• Neuropeptide Y Food and sex Cognition

• Calcitonin Gene-related Peptide Pain Tolerance to opiates

Canadian Institutes of Health Research (CIHR) CIHR has 13 Institutes : Health systems and Policy Research, Circulatory and Respiratory Health, Aboriginal Peoples’ Health, Cancer Research, Muscoloskeletal Health and Arthritis, Nutrition, Metabolism and Diabetes, Neurosciences, Mental Health and Addiction, Human Development, Child and Youth Health, Population and Public Health, Genetics, Healthy Aging, Gender and Health, Infection and Immunity.

∗. Dr Quirion used a power point presentation. This text presents a summary of this presentation.

59 Four Research Pillars of CIHR • Biomedical • Clinical • Health services and Health systems • Health of populations, societal and cultural dimensions of health and environmental influences on health

Institute of Neurosciences, Mental Health and Addiction (INMHA) Advisory Board Members (16)

Our Mission – INMHA To foster excellence in innovative, ethically responsible research in Canada that aims to increase our knowledge of the functioning and disorders of the brain and the mind, the spinal cord, the sensory and motor systems, as well as mental health, mental illnesses and all forms of addictions. To translate this new knowledge into improved health outcomes, health promotion, healthcare services and a better quality of life for all Canadians.

Research in Bioethics The institute of Neurosciences, Mental Health and Addiction (INMHA) will work with Canadian Institutes of Health Research (CIHR) in building capacity in health care ethics to address the ethical challenges associated with research in the domains covered by INMHA (INMHA Strategic Plan 2001-2005).

INMHA Strategic Initiatives • Nicotine addiction and tobacco abuse • Co-occurrence of brain disorders with other health problems • First episodes in neurological and mental illnesses, and in addictions • Regenerative medicine • Discrimination and stigma

60 The Economist, 25 May 2002 ‘People already worry about genetics. They should worry about brain science too.’ ‘A public debate over the ethical limits to (such neurosciences is long overdue).’

Neuroethics

Traditional issues Emerging issues • Informed consent • Enhancement of normal functions • Privacy rights to results of • Court-ordered CNS testing intervention • Design of optimal clinical • Brain reading trials and the use of placebo • Use of fetal tissues, stem cells or cloning

Enhancement of normal functions • Mood • Cognitive abilities - attention - memory • Vegetative functions - Sleep - Appetite - Sex

Might drugs and CNS interventions make normal people ‘better than normal’? • The line between healthy and sick is fuzzy • Diagnostic thresholds move downward • Patients are likely to be treated prophylactically, even when symptom free

61 Ethical issues of enhancement • Will enhancement have serious side effects for the individual, including long term and delayed effects? • Will enhancement be fairly distributed? • Will widespread enhancement raise our standard of normalcy? • Is there a risk of mitigating diversity through medication?

Forensic Neuroscience Altering brain function under court-ordered rehabilitation • Addiction • Aggression • Impulse control • Sex drive • Parenting behaviour • How can we reconcile notions of free will with mechanistic views of the causation of behaviour • Is self determination merely an unscientific fiction? • How can the role of self control in ethical and legal thought be reconciled with facts about mental illness and brain dysfunction • Prophylactic treatment of ‘future’ offenders

Brain reading • fMRI, PET scan, EEG to visualize brain regions associated with: - violent behaviour - gambling and addiction - memory sensitivity to stress - lie detection - etc. • fMRI of a detoxified cocaine user (image) • Brain Fingerprinting Laboratories - ‘A new paradigm to counter terrorism’

62 Plusieurs publications récentes font état de découvertes intéressantes: Mark W. Gilbertson et al. ‘Smaller hippocampal volume predicts pathologic vulnerability to psychological trauma’, Nature, Neuroscience, vol. 15, no 11, November 2002

Neuroethics: the next challenge? ‘Fixing your brain’ Newsweek, June 24, 2002 ‘The future of mind control’, The Economist, May 25 2002

Ethical and Legal Questions Genetics: How much screening should be allowed? Who should access this information? What will happen when those traits can be modified?

Neuroethics Traditional issues Informed consent Privacy rights to results of testing Design of optimal clinical trails and the use of placebo Use of fetal tissues, stem cells or cloning

Issues peculiar to neuroethics Subjects have brain disorders that affect their decision making ability What guidelines should be in place for treatment of experimental participation? We also take for granted that patients will choose what is in their best interests

Two examples: The National Placebo Initiative The mandate is to provide a recommendation to Health Canada and CIHR on a common placebo policy To advance the debate on placebos both nationally and internationally

63 To conduct stakeholder and public consultations on what constitutes appropriate placebo use To reach a Canadian consensus on what constitutes ethical and scientifically appropriate use of placebos To prepare a Report that reflects that debate and consensus

Privacy in Health Research CIHR workshop held 14-15 November 2002: ‘Sharing perspective and paving the way forward’ Objectives: Harmonize privacy legislation and data access policy Develop best practices for health researchers Clarify and strengthen the role and responsibilities of ethics research boards Engage the public in a broader and more meaningful debate.

64 Chapitre / Chapter 4

PREDISPOSITIONS, SUSCEPTIBILITES ET RECHERCHES GENOMIQUES : QUELS ENJEUX POUR L’AVENIR ?

* * *

PREDISPOSITIONS, SUSCEPTIBILITY AND GENOMIC RESEARCH : WHAT IMPLICATIONS FOR THE FUTURE

• Dr Claude Laberge (Canada)

• Prof. Michel Revel (Israël / Israel)

• Prof. Francisco Mauro Salzano (Brésil / Brazil) GENOMICS AND SOCIETY

Claude Laberge (Canada), Professeur de Medicine Paediatrics at the University Laval Director of the Network of Applied Genetic Medicine of Quebec

Je tiens d’abord à remercier les organisateurs de me donner l’occasion de présenter des choses qui sont connues, mais auxquelles je crois pouvoir donner une perspective nouvelle, sinon inhabituelle. We’re going to talk about genomics, which is supposedly a laboratory science, about health which is the political responsibility of States and about society which is in the crucible of the eventual application of genomics to the domain of public health. The larger theme of my presentation is the notion of predisposition and susceptibility and of genomic research and what the implication will be for the future. Before we talk about the future, we have to remind ourselves about what is going on. We have sequenced the human genome. What will be the definition of health within a genomic framework? What about the application of genomics to health care and what are the international implications of the research ahead of us? Over the last three years, there have been all kinds of promises about the future of medicine. Everybody talks about personalized medicine and how genomics is going to change medicine. The provisional sequence of the genome that was reported a year and a half ago gives you the first detailed map on which we can now do association studies and this is important in terms of susceptibility and predisposition. However, all we have is the anatomy book. It doesn’t tell us how it works. It used to be that the function, the physiology, was seen in terms of metabolic pathways and this is typical of modern medicine – it’s linear thinking. What we find with the genomes is that nothing is linear, everything is part of a complex interactive system; and what is important remains the output. If you can get the output going, whatever is wrong with the pathway doesn’t really matter. It brings us to complex systems. A

67 complex system must be analysed through different topologies and the topology of this human genome, in terms of scale-free networks, is just beginning to come out in terms of mathematics. By comparing our genome with that of other species, we find that we are not alone in the world, we are co-evolving with all forms of life, even with plants. We use different species to understand homology of sequence with the human and we now have a user guide to the genome, just like for your car – you can go on to the web and play with the genome and find any genes that you want – and even see it in 3D in Amsterdam, because the general aspect of a complex system is better seen by an holistic approach than by a sequencer approach. So that is where we now are in genomics. The answer to our quest is extremely complex and we’re just beginning to understand the depth of this complexity – so using only one gene to do or prevent something is out of the question, at least for the next generation.

Health is a continuum and, in terms of genetics, depends on a phenotype equation (P=G*E) and again, categorization such as susceptibility, monogenic, polygenic and so on, depends on the environment and on the perspicacity of observation. According to the World Health Organization, health is a state. According to modern genetics, health is a dynamic state of personal and temporary (instantaneous) adaptation to the environment that confronts the given individual. This latter definition makes it so that if you modify the environment you can modify health. Basically and genetically speaking, health is only adaptation in the moment.

The confines of all diseases reside within a triangular surface of interaction between the genotype (G), the environment (E) and gene interaction with this environment (*). Under the mantle of environment, the typical one is scurvy – vitamin C deficiency. There is no metabolic disease related to vitamin C – if you don’t take vitamin C, you get scurvy – thus, a completely environmental disease that completely disappeared, because we put Vitamin C in our foodstuff.

So the confine of health and disease is not a normal curve where (P) health and non-health ‘determinants’ are distributed in a ‘Bell’ curve against a background of environmental (E) pressures – it is skewed toward the ‘disease’ spectrum, because of the health care services systems that seeks out ‘diseases’. Nobody goes to see a doctor if one feels that one is in better health that one’s neighbour.

68 There are more people that are going to be sick than people that are going to be eternal. So the definition of the phenotype we use in medicine is the resultant of the unique genome of that individual and his own environment. You can multiply this complexity in terms of the different times of our own life cycles. (P=G*E) is an equation that reluctantly works from our fertilization event to the event of our own personal death. Charles Scriver in Montreal has demonstrated that there is no way you can predict the phenotype of PKU from the genotype one may have. So, even the most monogenic disease is not simple – it’s a complex disease – but however, easily treated if you modify the environment, if you take the phenylalanine (an essential amino-acid) out the children’ diet, so that their eventual mental development revert to normal. In Quebec we have a distribution of PKU phenotypes that is stratified in the general population and that is different from the distribution of benign hyperphenylalanimia (HyperPhe), that does not require dietary treatment. So, the same gene has different expressions and, qualitatively, we can demonstrate a different distribution in our own population after 30 years of newborn screening for PKU. Consequently, we have historical stratification and our prevalent genetic diversity is exposed in our own population. No population is free of ‘diversity’. Diversity is where we came from, what we are all about, and how we will survive. At another level of perception would be the paradigm of ‘predisposition’. The classical demonstration of such is Huntington’s disease, but it is a bad example. The best example of the paradigm of predisposition should be myotonic dystrophy (Steinert’s disease, a form a muscular dystrophy of the adult) which is a dynamic mutation ( a repeat of a stuttering triplets of CAG). The phenotype, although it is correlated with the number of repeat triplets (the ‘mutation’) and the gradation of clinical symptoms from no symptoms to moving around in a wheelchair, however is not 100% in terms of prediction of the disease state that one has. However, there is anticipation (which means that the disease state gets more serious from one generation to the next. If we intervene in terms of prevention and stop its generational spread by DNA testing, the grandchildren of the ‘predisposed’ grandparent will not ‘phenotype’ the disease. However, we cannot predict the outcome for a given individual in the population depending only on his/her genotype. Another genetic ‘predisposition’ would be familial hypercholesterolemia (FHC) which is a recessive and fatal disease in homozygous children. Here in Quebec, we have at least four different mutations for FHC. From this fact, we did some population studies and we

69 were able to establish a different distribution for different mutations at different places in the social geography. Even though your cholesterol levels are high, it does not mean that you are going to have a cardiac infarct at exactly 45 years’ old. Levels of cholesterol (the bad one!) can be modified by juggling the environment or by using ‘one-shot’ drugs. A complementary example to topologies such as ‘susceptibility’ and/or ‘predisposition’, is the dormant polymorphism (diversity). Such dormant polymorphism, which is neither ‘susceptibility’ nor ‘predisposition’, suddenly becomes ‘out of the blue’ a very important emergent genetic state in terms of delaying the AIDS phenotype in Caucasians. That is because 10% of them carry a (bad?) mutation. Something went wrong in our remote past within the CCR5 gene that spawn a ‘mutation’ in the genetic information for making a normal cell- surface receptor. Such ‘mutants’ could not produce an ‘essential(?)’ receptor on the surface of the cell (for what purpose we do not yet know! An ancient epidemic? 25,00 years ago?). However, this particular receptor is necessary for the HIV virus to come, hook to the CD4 receptor and ‘salto’ into the CCR5 domain so as to progress within the cell and there, multiply by the millions … and infest other cells .. and so on. People with a mutation in the CCR5 gene, they resist infection for 50% longer than people without the ‘mutation’. The geographical problem is that the mutation occurred only after the ‘out of Africa’ migration to the modern world of ‘homo sapiens’ and that gradient took the road towards the North of Europe. The ‘more Viking’ you are, you should feel more ‘safe’ because you have only a 10% chance of being protected against early AIDS being a carrier or a homozygote for this ‘random’ mutation. Native Americans, Asians, Africans do not harbour that mutation. So sometimes and without teleology, being a carrier gives you an advantage! How does this come about? It comes about solely because populations move and, they do not move in blocks, they move by small families’ founder effect and folk’s bottlenecks so the present population, here, possesses only a definite part of the genomes of the peoples in the population where they came from the past. That is how ‘fractalization’ of genetic diversity is accomplished. On the other hand, a phenotype as neutral as the ABO blood group (everybody wants to carry it in a ‘MedicAlert’ bracelet) does not show openly (as in ‘up your face’) – one can’t tell your blood group just by looking at you, but depending on circumstances, if you have a transfusion, you better be compatible … or else your may die! Is this susceptibility or is it predisposition? Neither, it is just a neutral polymorphism, until you are

70 put in a situation where it becomes essential knowledge to your survival. However, depending on circumstances, what was neutral may become beneficial or even dangerous. A snowman presents itself in a general practitioner’s office. It is the beginning of Spring and 20Cº in the doctor’s office. Is the snowman predisposed or susceptible to thawing and melting? Yes, if it stays in the sun (or the GP’s office) but if he moved to Antarctica, maybe it would have a chance not to die. So, you should not believe everything that you are told about this or that gene, a ‘gene’ supposedly responsible for that behaviour or whatever else – it is SO much more complex than that! Now, what kind of research is going on in terms of health and genomics? Well we are beginning to be able to handle very large genetic databases on a total population basis, we are supposedly in a position to ‘transfer’ this knowledge into preventive medicine as soon as possible, we have many hundreds of ‘gene hunting labs’ looking for whatever genes, but we have but a few societies (populations, communities) doing genomic epidemiology per se. There is no forwardness, no view of the long-term in order to contribute to the common heritage of humankind in terms of public good and commons. The day’s focus is on diseases, treatment, SNP’s, pharmacogenomics and … so on. We supposedly have an ‘eventual’ personal preventive medicine scheme in the making and the Venter’s dream of everybody having his genome-CD or his DNA-chip and going to the doctor, to find if (s)he is susceptible to, or predisposed to … something? If you find a gene in a research setting, you will eventually (presumably) have to apply its prevalence to a random sample to see if it is significant and maybe important. Population genomics is the inverse of that. You have to do good environmental epidemiology first and you put the ‘genetics’ in it, instead of doing genetics and then trying afterwards to work the epidemiology in. We are indeed poised for a new ‘genomic’ epidemiology. In the Province of Quebec in Canada, we have such a visionary project. Fifty thousand individuals — one per cent of the adult population between 25 and 74 years old — would be recruited at random, in order to apply all the different genomic variations implicated in susceptibilities to diseases (not many yet for protection against such diseases) as announced and published by researchers here and there around the world. We have drafted a Statement of Principles of ethical conduct that will explain to the population what we are going to do in order to act ethically even before and all the while we are doing this type of population genomics research. We

71 think that such a Statement should be of interest to those who are doing the same kind of human genetic research involving populations and that it could even become of universal acceptance1).( In this Statement, based on principles that are evolving from the individuality to the universality of the human species, we have drafted recommendations and procedures that stem out of these principles concerning consultation, recruitment, consent, confidentiality, governance, communication and research, commercialisation and contribution to the welfare of the population and of humanity in general. In conclusion, ‘heritability’ is hidden all the while. If everybody was in the perfect environment, eating the perfect things and doing everything as prescribed all the time, there still would be some of the people who would get sick, and eventually die. It is evident that as we try to understand what we are doing (ourselves, all researchers of some kind), we are just beginning to realize and understand, eventually and hopefully, what and why it is, we are doing, playing in the ‘secret of life’. We do not, as yet, have the topological map of ‘susceptibilities’ or ‘predispositions’. There are no simplistic categories of health risks. We have to be very careful and cautious because genetics is only a human science, developed by men and women through the scientific endeavour over the centuries and such science does belong to all the people (humanity), because its knowledge affects everybody who was ever born. So, if we are in a new Garden of Eden, we at least have to decide how to use it for the good or for the bad. We have to try to perceive and forecast what we, as a society, are going to ban, or accept in the long- term for the human race. The implications of genomics applied to health, applied to society, applied to populations, is much more urgent. It has to involve society in all its interventions as well as the decision-makers and the unaware public. Population genomics is an absolute necessity, otherwise we are at the mercy of the gene hunters. The contribution of the developed countries that can pay millions of dollars to do these big population studies is important because they are the only ones in the world that can afford them, for their own presumed benefit. However, if they could get together and harmonize their researches, the human genomic information could become available to everybody in the world - even those who are in communities that do not have the means of doing such costly studies.

1. This proposed Statement can be found as Annex to this paper.

72 Accordingly, it would be important to have some kind of coordinating international body for those public programmes that use state infrastructures or money (public population genomics programmes), so that they could serve and contribute to the common heritage of mankind. More and more research, … and more, is needed and we do not always know beforehand where to look for the answers. Because of Galileo Galilei who started our modern science by looking at the sky with a telescope while hoping to sell the technology to help the; merchants of Venetia to look for their ships before they did enter the harbour, we ended up going to the stars and seeing our own planet Earth with our own eyes (at least in photo from the astronauts). Whatever, what we have to unravel is the deconstruction of the background that has been there since the very beginning of Humanity, right in front of our eyes, Nature. We are the ‘observers’. We are the ‘explorers’. We have to go where no one has gone before!

73 ANNEX

RMGA (QUEBEC NETWORK OF APPLIED GENETIC MEDICINE) Statement of Principles on the Ethical Conduct of Human Genetic Research Involving Populations Geneviève Cardinal, Mylène Deschênes, Bartha Maria Knoppers, Thomas Hudson, Damian Labuda, Gérard Bouchard, Éric Racine, Claudine Fecteau, Simone Truong and Claude Laberge.

This Proposed Statement of Principles on the Ethical Conduct of Human Genetic Research Involving Populations is based on a framework of ten fundamental principles giving rise to specific recommendations and procedures for their implementation.

Population genetic research implies research projects that investigate the dynamics and the structures of genetic variation in either subsets or populations generally defined by their geography, ethnicity, language, religion, etc. It is the intention of the Quebec Network of Applied Genetic Medicine (RMGA) that this Statement is to be interpreted consistent with its previous Statement of Principles: Human Genome Research (2000) on DNA sampling and banking in individuals and families. In the following Statement, the expression ‘genetic data’ means genetic material as well as information derived therefrom. Furthermore, RMGA recognizes the fundamental principles of bioethics: respect for persons, beneficence, non-maleficence and justice as well as those relevant to genetic research from the following international organizations: United Nations Educational, Scientific and Culture Organization (UNESCO), Human Genome Organization (HUGO) and the World Health Organization (WHO).

All human rights and ethical principles flow from the respect of the inherent dignity of the person. Population research is impossible without the trust of participants. RGMA members consider participants as research partners.

1. This Statement has been approved by the board of directors of the RMGA: Gérard Bouchard, Bernard Brais, Alessandra Duncan, Daniel Gaudet, Thomas Hudson, Edward Khandjian, Bartha Maria Knoppers, Claude Laberge, Damian Labuda, Jack Puymirat, Guy A. Rouleau, Francois Rousseau, Rima Rozen, Jacques Simard, and Marc Tremblay. We wish to thank the members of the Genetics and Society Project, especially Martin Letendre for their valuable assistance.

74 FRAMEWORK OF PRINCIPLES

Individuality: Recognition of the uniqueness of the person mandating respect for the autonomy of the individual within a given group.

Diversity: Recognition and respect for difference through the fostering of a multidisciplinary approach.

Complexity: Interpretation of genetic information that recognizes its multi- variable nature and expression.

Reciprocity: Mutual exchange through consultation and communication. Solidarity: Protection from discrimination and from stigmatization.

Security: Confidentiality of genetic data and strict control in the use or exchange thereof.

Accountability: Adherence both to the recognized body of legal and ethical norms applying to research as well as to transparency and representation of the population in decision-making.

Equity: Fairness in participation, access, and in the sharing of benefits.

Citizenry: Contribution to the public good and to the health of the population.

Universality: Knowledge dissemination and international collaboration. These ten fundamental principles lay the foundations for the following recommendations and procedures.

RECOMMENDATIONS

1. Consultation Respecting the principles of reciprocity, diversity and accountability requires that research on a given population be based upon open dialogue between the population and the research team. A guiding mechanism for population genetic research is prior and ongoing public consultation.

Implementation • Education, consultation and information should be offered to the population before recruitment begins. • The role of the population in the process should be clarified at the outset.

75 • Continuous, meaningful dialogue should be maintained throughout the project. • The diverse values and cultural worldviews of the population should be taken into account at every stage of the research. • The possible risks and benefits of research for the general public good as well as for the population studied should be discussed.

2. Recruitment Genetic information about a population is a social and community resource that must be protected. Taking into account the principle of equity, recruitment should ensure a process for participation that spreads the risks and benefits.

Implementation • Researchers should provide the rationale for the chosen methods of sampling, banking and dissemination of genetic data. • Recruitment should be organized so as to respect privacy. • Over-recruitment of any given population should be avoided.

3. Consent Each individual carries a unique copy of the human genome. Yet, genes are shared by all humans as a species, as the common heritage of humanity. Research on any population should neither lose sight of the individuality of the person nor of the universality of the human genome.

Implementation Autonomy of the person (individual consent) • Even in a population study, free, informed, and written consent of each individual is required, with legislative exceptions (for the surveillance of disease prevalence in a population, for example). It should be made clear to participants in a population research project that they are considered as a representative of their population. • Consent is a continuing process and must be reconfirmed for instance in the case of significant changes to the research protocol, to the conditions of banking, in the research partnerships, and in the management of the bank. • In all population studies, the individual retains the right of withdrawal except in the case of anonymization or where the law foresees otherwise.

76 Group interests (population support) • The right of expression (of both those who participate and those who do not) should be recognized through: ¾Support of representative and legitimate group(s) or absence of significant opposition; ¾Withdrawal by the population of its support for the research through mechanisms determined at the outset of the research.

4. Confidentiality Mutual confidence between the researcher and the population is essential to reciprocity. To respect this confidence, the researcher should ensure the security and confidentiality of population data.

Implementation • Regardless of the size of the data bank, measures must be instituted to ensure the safe conservation of the information. • Management and exchange of information should be protected by appropriate mechanisms of confidentiality, such as coding or anonymizing the samples, confidentiality agreements binding the users, etc. • Confidentiality and access mechanisms should be communicated to the population. • An independent authority should oversee the overall protection of personal information.

5. Governance The creation of a genetic data bank and its use in population genetic research should respect current legal and ethical norms. Accountability to the public and to a research ethics board is mandatory.

Implementation • A banking policy should be created and made public (see Statement, 2000). • Evaluation of the overall population research project by an independent research ethics board must precede recruitment. This ethics board should collectively be knowledgeable in genetics and population research. Its composition should be multidisciplinary and include representatives from the population studied. The research ethics board should also approve and monitor any research projects using the population bank as well as other requests for access.

77 • A committee should also be set up to oversee the creation and management of the bank. It should ensure that the rules established for access and use are respected. This committee will provide for the long- term adherence to the policy. The composition of this committee could include for example: a representative of the population studied, a participant from the group under study, a databank manager, a representative of the social sciences and humanities, and experts in human genetics and computer sciences. • In the case of international partnerships, the highest ethical standards in force among the countries involved should apply, taking into account their values.

6. Communication of research results Reciprocity implies that researchers will regularly share information out of respect for the participation of the population. Researchers should exercise caution in the communication and interpretation of their results due to the complexity of genetic information and its personal, familial, and social impact. They should adopt a multidisciplinary approach to reflect the values of the population and avoid misleading the public in the interest of solidarity.

Implementation Communication of general results • Results should be made public. • By communicating results in a timely and diligent fashion, researchers contribute to a better understanding of the determinants of health. • It is reasonable to expect that researchers should communicate with the population and the relevant governmental authorities regarding results that are pertinent to the improvement of health and/or the prevention of disease. • Where appropriate, researchers, in collaboration with the population concerned, should facilitate the development and the implementation of a follow-up plan.

Interpretation of the results • The population studied should be made aware of possible socio- economic discrimination or group stigmatization as a result of perceptions of genetic risks. The population should also be informed of the means taken to minimize the risks.

78 • To avoid misleading or unrealistic expectations, the researchers should make the limits of the results and their applicability known.

7. Commercialization Researchers and those responsible for the bank do not own the genetic material collected but may aspire to the acquisition of intellectual property rights over inventions derived from genetic data. The research team should be transparent in its operations. For the sake of equity, population research should promote the attribution of benefits to the population.

Implementation Benefit Sharing • The eventual sharing of any benefits with the population should be discussed at the outset. This sharing could take different forms such as: an access to medical care, to future treatments or drugs developed; a contribution of a portion of the benefits to a humanitarian organization; support for local needs, or support for technological infrastructures or health services to the population, etc. • Benefit sharing cannot be limited to the individuals who participated. The research must, in consideration of the principle of equity, provide advantages for the whole population.

Freedom of Research • Freedom of research should be promoted by respecting the principle of public access to the bank.

Conflict of Interests • All perceived or real conflicts of interest should be disclosed. • An independent body should be created to determine and to manage conflicts of interests rising from the commercialization of products derived from research or otherwise.

8. Contribution to the welfare of the population Population genetic research should endeavour to promote health and prevent disease, especially for the population studied. The principle of citizenry requires the recognition of participation in health research. Given the complexity of population genetic research, a multidisciplinary approach is essential.

79 Implementation • The research team should possess proven expertise in the field of population research. • Partnerships with local research teams should be established and copies of samples must remain in the province/state/country of origin. • Research should serve the interests of the population and be used for peaceful means. • The goals of the study should be to improve health.

9. Contribution to the welfare of humanity The universality of the human genome mandates the sharing of knowledge at an international level.

Implementation • Collaboration with researchers from other countries should be encouraged and results should be broadly disseminated. • Scientists should also be encouraged to pursue research on all types of populations including those with rare or endemic diseases.

80 THE ETHICAL ISSUES RAISED BY BEHAVIOURAL GENETICS IN HUMANS

Michel Revel (Israel), Professor of Molecular Genetics Weizmann Institute of Science

What is Behavioural Genetics Let us try first to define what is behavioural genetics. How does it differ from other areas of human genetics? The Nuffield Council on Bioethics recently issued a report on ‘Genetics and human behaviour: the ethical contex’(1), of which our IBC colleague Prof. A. McCall Smith is one of the authors. Much of my presentation to this session of the IBC is based on this report. Behavioural genetics is an attempt to locate specific genes or groups of genes associated with behavioural traits and to understand the complex relationship between genes and the environment. Complex, because in most cases multiple genes will interact to fashion our behavioural tendencies. Complex, because in all likelihood, the lessons of behavioural genetics will not be understood without referring to the environment in which a human lives. Examples of the aspects of human personality under study are intelligence (elaborated on below), musical abilities, sexual orientation, susceptibility to aggressiveness or other anti social conducts and tendencies towards extraversion or novelty seeking. There are of course many other types of behaviour that can be studied in the human species, some being found also in animals thereby raising the question of how much we humans are determined by our biological nature and how much of our behaviour can be controlled by human freewill and intellect. Intelligence encompasses probably one of the more specific aspect of human behaviour, but one which cannot be separated from the influence of education and environment.

1. http://www.nuffieldbioethics.org/behaviouralgenetics/index.asp

81 Distinction from Medical Genetics A second characteristic of behavioural genetics, as defined here, is that it differs from research into the genetic bases of diseases and disorders. In the case of behavioural genetics researchers investigate aspects of our personalities not actually diseases or disorders; it is important to stress this difference, because there are diseases of behaviour that are investigated in the framework of medical genetics, but behavioural genetics deals with non-pathological variance. The meaning of genetic variation between humans is best illustrated by a bell-shape curve describing the distribution of a trait over an entire population. There are some cognitive traits which are ‘species universals’ – for example language learning. Every human knows to speak (excluding again pathological conditions) and this can be defined as a non-varying trait (or genetic characteristic). Then there are rare disorders, which are clustered at one very extreme end on the bell curve, affecting only a very small part of the population. Examples may be severe retardation and early- onset Alzheimer’s disease. Pathologies due to mutation in a single gene may give a similar extreme bias in distribution. Next, there are traits which are more frequent and be found in a sizeable part of the population on one side or the other of the bell curve, these may be called common mild disorders, such as mild retardation or learning disabilities – and are likely to result from multiple genes. But, as already stated, behavioural genetics deals with the normal distribution of traits, for example cognitive abilities, that vary within the normal range from one end of the curve to the other. One attempts to assign a quantitative value to each group over the curve, thereby defining quantitative traits. The gene loci that may affect them are quantitative trait loci or QTLs. This affords a quantitation of behaviour (as one would quantify height or weight). But it is a normal variation and what is being studied is actually where in this variance one or another individual in a population would be. Two methodological remarks may be useful. First, the analogy with height and weight are in place because there are upper and lower limits to what is considered as the normal range. Moreover, these limits vary with the epoch: a child with short stature that in the past may have been considered normal may today receive growth hormone treatment, and the limit at which obesity is considered pathological and requiring treatment is lower than it was before. The definition of the normal range is not absolute, but nevertheless there is a normal range in which a medical intervention would be considered improper. These considerations apply of course to the definition of the normal range of behaviours as well.

82 A second remark is that research on the genetics of QTLs is rapidly evolving thanks to the advent of genetic ‘association’ studies(2). These make use of large-scale, population based DNA collections which allow associating genetic polymorphisms (variations among individual genomes) with diseases but also with normal phenotypic characteristics (including behaviours). Using such a collection, the Israeli company IdGene compared genome-wide scans for single nucleotide polymorphisms (SNPs) on almost 1,000 DNA from schizophrenia patients to 3,000 controls and discovered a significant association between schizophrenia and a given form of catechol-O-methyltransferase, an enzyme producing a neurotransmitter(3). However, the probability of diseases such as schizophrenia is the result of many genes (multigenic) and also of interactions with the environment (multifactorial). Two other genes were already found associated with schizophrenia(4). Studies done before by linkage analyses on small families or groups could not show these associations because they lacked the statistical power provided by the large numbers of DNA samples. As of today, there are population based large collections of DNA samples in several countries(5), the UK Biobank aiming to collect 500,000 samples. These advances will most likely be instrumental in the attempts to identify genes that vary with behaviour. Simply as an example, a genetic association was claimed for cigarette smoking(6), clearly only one of the many different factors, both genetic and environmental, that influence smoking behaviour. To reiterate, behavioural genetics is distinct from genetics of human disease because it deals with non-pathological variance within the normal range. There are diseases of behaviour but these pathologies are being studied as part of clinical genetics and, as explained above, the genetic basis for diseases of behaviour is different from just a variation in abilities over the population.

2. Bird T. et al (2001), Genetic association studies. Neurology 57, 1153-1154. 3. Shifman S. et al (2002), A highly significant association between a COMT haplotype and Schizophrenia. Am. J. Hu. Genet. 71, 1296-1302. 4. Chumakov I. et al (2002), Genetic and physiological data implicating the new human gene G72 and the gene for D-amino acid oxidase in Schizophrenia. Proc. Natl. Acad. Sci. USA 99, 13675-17221. 5. See http://www.weizmann.ac.il/bioethics: Reports of the Bioethics Committee of the Israel Academy of Sciences and Humanities: Population-Based Large-Scale Collections of DNA Samples and Databases of Genetic Information. 6. Sue Z. et al (1999), A genetic association for cigarette smoking. Health Psychology 18, 7-13.

83 General Ethical Issues in Behavioural Genetics A critical view of behavioural genetics cannot ignore that it raises ethical issues. The central topic of behavioural genetics is the heritability of variance among individuals, and of course between groups, implying an inescapable social impact of the research. In a sense, it is assigning a value, a certain quantity, and inevitably a certain quality, to the uniqueness of the individual. In ethical terms, to the statement that every human being is unique, we might have to add that some are more unique than others, some are better than others as a result of the QTLs assigned to their personnality. However, it is not the study of behavioural genetics that may poses the main ethical queries but the applications that these studies may have. If the scientific enquiry is justified, there are likely to be outcomes deserving a serious ethical reflection. One purpose of knowing about the genetic basis of behaviour could be intervention or treatment, for example preventing aggressive behaviour by using medication or by attempts to change the socioeconomic environment. A more problematic purpose might be that of selection, for example using prenatal genetic testing or even PGD in order to test or screen for certain behavioural traits in the unborn child. Next we may want to stream children in school on the basis of intelligence and aptitude as we predict them from a genetic test. This surely should switch on some ethical red lights. Other purposes may be the screening of employees or job seekers to exclude those with traits that the employers consider undesirable. Insurers may seek genetic information about behaviour and personality traits in order to estimate the risk of giving an insurance policy. Yet another purpose may be to claim diminished legal responsibility for one’s actions or to mitigate punishment for criminal behaviour by saying; ‘I was made like that’, ‘I was born like that’ and therefore I am not responsible for my action, I do not bear moral responsibility. These implications of behavioural genetics, distinguish it not only from the genetics of diseases but also from social application of genetics such as geographic genetics or study of the movement of human populations, etc. Clearly there are some words of caution which need to be said about behavioural genetics. First of all, it is important to say clearly that it is a legitimate area of research. Certainly one should let this research go on and investigate the genetic basis for various human behaviours – range of behavioural skills and even intelligence (IQ). But at the same time it is capital to say that

84 extreme care is required in the interpretation of the results. Quoting Lewis Wolpert(7): ‘Scientists have the obligation to examine the social implications of their work. It matters a great deal if complex behavioral characteristics are treated as being controlled by genes and behavioral influences are ignored. Scientists have an obligation to make the reliability of their views in these sensitive social areas clear to the point of overcautiousness’. The social implications of behavioural genetics are very powerfull and the interpretation of the results is often careless. We see how quick is the press to speak of ‘the gene for aggressiveness’ or ‘the gene for criminality’ or the ‘alcoholism gene’, even I read once of a ‘gene for monogamy’ based on the length of time a male mouse spends copulating with the same female. Indeed, scientists have an obligation to make the reliability of their views in these sensitive social areas clear to the point of over-cautiousness – it is not even enough to be cautious. When scientists identify a genetic variation that affects behaviour, they must tell us how much it affects the behaviour, how much of the variance among the human population is accounted for by the gene variation and whether the effect of the gene is likely to be influenced by environment, education, socioeconomic status, etc. This all the more because the interpretation may depend on; social outlook and may influence political decisions.

Heritability of Intelligence: The Ethical Context A good example of these dilemmas is the heredity of intelligence in all its implications. Evidence for a heritable component in intelligence or IQ level is rather strong (monozygotic twin studies indicating a heritability(8) of 0.5-0.7), and the hunt for QTLs of cognition is underway(9). But the question is whether one should try to improve intelligence by genetic changes and selection or by better education and living conditions? As a matter of fact, the hereditarian theory of IQ did not wait for the human genome project to be born. It came out of the 19th century

7. Wolpert L. (1994), The Unnatural Nature of Science. Harvard University Press 8. Heritability is the proportion of variation in the population which is attributable to genetic influences. A value of 0.6 means that 60% of the variation in a trait across a population (bell-shape curve) is the result of differences in their genotypes. 9. Gottesman I.I. (1997), Twins: Enroute to QTLs for cognition. Science 276, 1522-1523.

85 eugenic movement and, in 1904, Charles Spearman invented a value called ‘g’ for general intelligence or general cognitive ability, a single parameter claiming to correlate various mental tests that often produce different scores on children or adults. This g factor was used by the eugenic movement and in 1940 the controversial British scientist Cyril Burt made political use of g by screening to assess children, as a result of which 20% of the children were sent to grammar school preparing for university while 80% were relegated to technical or secondary modern school as unfit for higher education. Such prospective screening makes a socio-political statement, namely that it is better to make a selection of children than to invest in trying to educate those who may have difficulties in the education system. Burt’s approach was opposed in particular by L. Thurstone who showed that there is not one dominant innate g, but rather multiple primary mental abilities (PMA), making it much harder to predict success or failure. However, he was not really believed. In 1979, the American scientist Arthur Jensen revived the g factor in a book ‘Educability and Group Differences’ claiming that children from some ethnic groups are innately unfit for education. In the same vein are many of the ideas developed by Hernstein and Murray in ‘The Bell Curve: Intelligence and Class Structure in American Life’(10) where African Americans are reported to have an average lower IQ than white Americans. Many critics pointed out that this may be due to the fact that the IQ testing is biased by culture and environment. A most outspoken opponent to the misuses of research on heritability of intelligence, as outlined above, has been Stephen Jay Gould, one of the greatest expert on evolution and biology in the 20th century. In his book ‘The Mismeasure of Man’(11), Gould criticizes the hereditarian theory of IQ and especially the g factor, depicting it as ‘a reification of a single number used to rank people on a unilinear scale of intellectual worth’. Nevertheless the concept of an innate and genetically based g survives and was reaffirmed in a December 2001 Nature Neurosciences article(12) coauthored by Robert Plomin, a leading expert on behavioural genetics. This article is a comment on a study by

10. Hernstein R.J. and Murray C. (1995), The Bell Curve: Intelligence and Class Structure in American Life, Simon & Schuster Adult Publishing Group. 11. Gould S.J. (1996), The Mismeasure of Man. Norton, W. W. & Company, Inc. 12. Plomin R. and Kosslyn S.M. (2001), Genes, Brain and Cognition. Nature Neurosciences 4, 1153-1154.

86 Thompson et al(13) published in the same issue comparing by magnetic resonance the volume of gray matter areas in the brain of genetic (monozygotic) twins versus non-genetic twins, and correlating these volumes with the g value. Gray matter volume in several areas of the brain cortex showed a much higher correlation in genetic twins leading the authors to conclude that there is a high heritability for gray matter volume. Given a correlation between brain volume and g of about 0.4 (40% of individuals with larger brains have higher g scores) it is proposed that ‘given the high heritability of variance of gray matter volume in the new paper, it seems likely that its association with g is also mediated genetically rather than environmentally’. Plomin favors the ‘hypothesis of genetic g’ - that the same genetic factors affect diverse cognitive abilities. Whether this study really takes into account environmental influences on g and IQ remains debatable. The genetic and non-genetic twins were matched for duration of cohabitation and parental social class. An important question is whether the correlation with IQ would still be significant if the twins were raised apart since IQ of genetic twins are different if adopted in families of different socioeconomic environment (see below). Another conclusion drawn by Plomin from the similarity in gray matter volume in genetic twins is that the density of neurons, the gray matter, may not be easily modified by experience. This contrasts with the views of many neurobiologists who, like Jean-Pierre Changeux, consider that the connections (synapses) between neurons are very much influenced by learning and training, that neuron connections are made and destroyed all the time and therefore are not genetically predetermined. Yes, there is a ‘genetic envelope’ but the neuron connections are malleable, mostly made by learning and destroyed if there is no learning. Even if the numbers of neurons are genetically determined that does not mean that the functions of the brain (related to the connections between the neurons) are pre-determined. It certainly does not mean that the cognitive functions could not be changed by better education. The Report of the Nuffield Council for Bioethics1 addresses the issue of the heritability of brain volume and its implication for cognitive abilities: ‘The only securely replicated correlation is that between IQ and the overall volume of the brain - where the correlation is about 0.4. But we do not know

13. Thompson P.M. et al (2001), Genetic influences on brain structure. Nature Neurosciences 4, 1253-1258.

87 whether that effect is genetic: improved nutrition and a more stimulating environment will both cause a significant increase in the volume of the rat’s brain and improve their learning ability, and it is entirely possible that these and other environmental variables have a similar impact on the human brain’ (14). As a matter of fact, it appears unlikely that the volume of the brain is affected solely by genes because in animals the brain becomes bigger if the animals are trained and are given a lot of exercise. Even with the important study of Thompson et al(12) showing that the volume of certain cortical areas correlates better with intelligence, it is reasonable to say that this area of genetic research requires considerably more detailed studies before firm conclusions can be drawn. Medical genetics has made very important discoveries on the genetic basis of diseases affecting intelligence, such as mental retardation due to fragile X chromosome and others. But it is important to note that, despite a better understanding of mental retardation, not a single gene involved in the development of mental retardation has been shown to be associated with the normal variation in IQ. The basis for the observed normal range of IQ variance cannot be reduced to a single cause. This emphasizes further the necessary distinction between medical genetics and behavioural genetics.

Ethical Debate: Is it All in Our Genes? The complexity of the concept of ‘heritability’ for intelligence and IQ has been particularly emphasized by Richard Lewontin et al in ‘Not in our Genes’(15). This book examines in detail the meaning of heritability, i.e. genetic variance divided by the total variance (genetic plus environmental). For IQ, most studies show that the genetic variance contributes about 50% of the IQ variance. But one often makes the mistake to believe that heritability means unchangeability. In fact, adoption can increase IQ - on the average - from 86 points to 117 points, most likely as a result of a change in familial and socioeconomic environment. Non-adopted siblings of low socio-economic level fail a year of school at a rate of 56%, compared to failure rates of 13% for adopted siblings. Even for children who are genetics twins and have a similar IQ,

14. Renna J.M. and Rosenzweig M.R. (1987), Enriched and impoverished environments. Springer-Verlag, New York. 15. Lewontin R.C., Rose S. and Kamin L.J. (1985), Not in Our Genes. Knopf Publishing Group.

88 where they are educated has a major influence on their success in school. The real question is then: if IQ levels are heritable, is this heritage also irreversible? Lewontin makes the interesting remark that the heritability of arithmetic skills has been changed by the pocket calculator– you may be unable to calculate rapidly but once you are given a pocket calculator there is no difference between you and a very gifted arithmetician. Environment can change intelligence. As noted by Plomin(12), even the heritability of g measured in twin studies changes from infancy (20%) to childhood (about 40%) to adulthood and old age (about 60%). Could that be related to higher learning capacities and higher receptivity to environmental clues in the young – we don’t know. Gould in the Mismeasure of Man(11) further points out fundamental difficulties in the concept of IQ heritability. One is that human uniqueness lies in the flexibility of what our brains can do: ‘what is intelligence if not the ability to face problems in an unprogrammed manner?’. When we say that the innate IQ predicts human intelligence, we overlook the fact that flexibility, creativity, much more than a given ability, are the hallmark of human intelligence. We are not born with a fixed capacity but we have flexible potentials. The question, says Gould, is not the classical opposition of biological nature versus cultural nurture. Rather it is that in the study of man’s biological nature there are two conflicting theories: one of biological potentiality versus another claiming biological determinism. Both are biological theories. There is nothing compelling in the theory of genetic determinism. Genes do not determine but give potentials and this is particularly true for the interaction of brain with environment. There is nothing compelling in the theory that personality traits and cognitive ability are genetically determined. Data on twins with identical genomes indicate that genes account for 0.5 of the variance in general cognitive ability, while shared and non-shared environmental agents account for 0.33 and 0.17 of the variance (with an error of measurement of 0.1)(9). Thus, genetic twins are correlated 50% in their intelligence, but still the environment contributes another 50%. A 50% correlation is high, it is more than fraternal twins (~ 25%) but it is by far not 100%: genetic twins are not the same person. If one could safely clone two individuals they would not be the same person, not have the same personality traits, not more than genetic twins. Great caution must be taken to understand what these percentages mean: the influences of the genes and of the environment cannot be compared by such statistics, because they are of different nature. Enough to say that genes beneficial in one environment may be poor in another.

89 The fundamental issue at stake is: how much are we determine by our genes? For behavioural genetics this is indeed a crucial question. Attempting to simplify genetic data which are obviously complex, the media often propagate the idea that there is a gene for aggressiveness, a gene for criminality and so on for different human behaviours. What the data really say at best is that having a certain form of a gene contributes X percent to predisposition to a certain behaviour, most genes affecting behaviour having only small effects (usually up to 5%). Furthermore the effects of two genes are in general not additive, that is to say that inheriting two genes that act on a certain behavioural trait does not mean that the effect of one will be added on top of the effect of the other. In one of the seminal studies on behavioural genetics authored by Israeli and USA researchers(16), a certain form of a gene encoding a receptor for the neurotransmitter dopamine was found associated with novelty seeking (curiosity, impulsiveness, as based on a self-reported yes/no questionnaire) so that this genotype accounted for 3-4% of the overall variation in novelty seeking. Confusion can occur when such important results are reviewed under the title ‘Genes for personality traits’(17), which may be understood by laypersons in a deterministic sense. The same can be said for association between a serotonin transporter gene and neuroticism(17) or a dopamine transported and the post-traumatic stress syndrome(18). In the latter case the contribution to behaviour was 3-8% and the Israeli psychiatrist who made this discovery said that the help of the family or the social worker may be more important than the genetic contribution. Such statements are very important for the general public to escape the delusion of genetic determinism and are not less important when speaking of genes associated with alcoholism, aggressiveness or other personality traits. A feature of behaviour which should be stressed is that genetically- based differences in behaviour are nevertheless malleable. In a classical experiment by the anthropologist Franz De Waal, two species of aggressive and of peaceful macaque were clustered in the same cage. When the peaceful Bonono macaques had a fight, their characteristic

16. Benjamin J. et al (1996), Population and familial association between the D4 dopamine; receptor gene and measures of Novelty Seeking. Nat.Genet. 12, 81-84. 17. Benjamin J. et al (1998), Genes for personality traits: implications for psychopathology. Int. J. Neuropsychopharmacol. 1, 153-168. 18. Segman R.H. et al (2002), Association between the dopamine transporter gene and posttraumatic stress disorder. Mol. Psychiatry 7, 903-907.

90 behaviour was to end the fight very quickly by having instead sexual contacts, what we would call love-making. The aggressive macaques learned quickly, in about six months, and began to behave in this peaceful way. Hence, even if genetics establishes that a behaviour - including aggressivness - is related to certain genes, this does not mean that it is determined and unchangeable by learning.

Sociobiology and Human Cultural Values Contemporary thoughts about behaviour have been much influenced by sociobiology and Edward O. Wilson’s(19) theory that many of the human behaviours, noble ones such as altruism and the will to defend the weaker, but also male domination and xenophobia, are rooted in biology and Darwinian selection, rather than being the results of culture and ideologies. To explain the natural selection of altruism, in which the altruist individual would be unable to transmit the genes which caused him to sacrifice his life for the sake of others, sociobiology proposes that the selection acts at the level of the whole group because altruism benefits the collective. Similarly, homosexuality - implying as well no gene transmission - would benefit the group by increasing the number of adults who can protect the progeny of others. Feeling that extending observations on animal societies to human nature may overlook important aspects of human culture, Gould(11) among many others presents arguments to escape the determinism of sociobiology, that our biology determines our social behaviour(20): ‘Human behaviour is adaptive. But adaptation in humans may arise by the alternative route of non-genic, cultural evolution’. In Life’s Grandeur he writes (21): ‘The most impressive contrast between natural evolution and cultural changes lies embedded in the major fact of our history. We have no evidence that the modal form of human bodies or brains has changed at all in the past 100,000 years [..] but cultural change, on a radical other hand, is potentially Lamarckian in basic mechanism. Any cultural knowledge acquired in one generation can be directly passed to the next by what we call, in a most noble way, education. This uniquely and distinctively Lamarckian style of human culture inheritance gives our technological history a directional and

19. Wilson E.O. (1988), On Human Nature. Harvard University Press. 20. Some would extend the ‘bio’ too far: even bioethics is understood by some as meaning that ethics is the result of our biology and controlled by genes. 21. Gould S.J. (1996), Life’s Grandeur, Vintage edition, chapter 15.

91 cumulative character that no natural Darwinian evolution can possess.’ On behaviour, Gould(11) asks for holding the middle road: ‘Modern biology provides a model standing between the despairing claim that biology has nothing to teach us about human behaviour and the deterministic theory that specific items of behaviour are genetically programmed by the action of natural selection.’ The much heralded Human Genome Project may itself encourage reductionist views of human nature, as Lewontin(22) forewarns: ‘The inherent ethical issue to the whole human genome project is to escape a determinism, categorizing of humans according to their genetic makeup ... or say when we know the molecule that makes up all our genes, we will know what it is to be human’. Philosophers and men of religion have, over the centuries labored on attempts to define the human with its interfacing intellect, spirit and physical body. Paleohistory, structural analysis of myths and psychoanalysis have sketched a complex image of the human mind and soul. Genetic determinism would be a poor substitute indeed. Even our forefathers had a better understanding of the limits of inborn fate. There is in the Talmud(23) a discussion about astrology or horoscopes and the belief that man’s fate is determined at birth: ‘... a man born under the sign of Mars will be blood lusty (violent, aggressive). Rabbi Ashi says he may become a barber (surgeon of that time), or a murderous brigand, or [he may become] a butcher or a circumciser’. That is he can use his bloodlust for good purposes or for bad purposes. A commentary on this text in the fourteenth century(24) gives it a truly modern meaning with implications for human behavioural genetics: ‘If all is fate, where is moral responsibility? But innate fate only predisposes, it does not determine. Man’s spirit can either overcome the drive or use it for good and not for evil’. Genetic may predispose some to a toughened, more aggressive, temper but man has free will, moral responsibility, and he can decide to use his predisposition to be a surgeon and not a murderer. In ‘Not in our Genes’ (15) the same thought is expressed in this way: ‘Human actions are consequences of immense arrays of interacting causes ... [if] constrained by a single cause … we are no longer free’.

22. Lewontin R. (1992), The Doctrine of DNA. Penguin Books. 23. Jewish Babylonian Talmud. Tractate Shabbat. Folio 156a. 24. Rabeinou Nissim. Derashot Ha-Ran. Hadroush hashemini.

92 Bioethics and the Genetics of Man and His Behaviour The Universal Declaration on the Human Genome and Human Rights has given, I believe, the right platform on which to approach the complexity of human behavioural genetics, by clearly stating that genes alone do not suffice to define a human being. Thus, in Article 2a: ‘Everyone has a right to respect for their dignity and for their rights regardless of their genetic characteristics’. There should be no discrimination based on genetics, and that should apply to use of behavioural genetics for streaming children in schools, and other kinds of discriminations. Furthermore in Article 2b: ‘That [human] dignity makes it imperative not to reduce individuals to their genetic characteristics and to respect their uniqueness and diversity’. The behaviour of any human being can similarly not be reduced to his genetic make-up but depends on his intellect and freewill. Culture, education and social environment have a major impact as indicated in Article 3: ‘The human genome, which by its nature evolves, is subject to mutations. It contains potentialities that are expressed differently according to each individual’s natural and social environment including the individual’s state of health, living conditions, nutrition and education’. There may be few areas where an in-depth bioethical reflection is more needed than the application of human genetics to behavioural traits. The power to analyze the influence of genes on personality and behavioural tendencies is almost at hand. There will be a growing demand for using genetic screening methods in order to produce design babies, along parent’s or society’s wishes. It is capital to keep a comprehensive view of human life, an encompassing experience of complex interactions. Not only do genes and environment interact, but the human brain in its flexible predisposition is the centre where culture and nature meet to shape behaviour.

In conclusion: 1) Behavioural Genetics is a legitimate area of research but the interpretation of the results must be over-cautious. 2) Is human behaviour predictable by genetics? And by how much? The answer is still far from us, but few would doubt that mankind is endowed of moral responsibility; he ought not to hide from responsibility by saying ‘I was made like that’.

93 3) Education, improvement of living conditions are the best ways to influence and change human behaviour. I have doubts whether we should use genetics, when it is not for a medical indication. 4) Should we allow wide-scale screening for genotype, or should we restrict genetics only to voluntary testing. This is a subject to which the IBC should give more thought, as we consider non-medical genetics. Let us not forget that the dangers of eugenics are still with us. We have seen how societies imposed sterilization programmes, even in modern democratic states. The Nazi atrocities began by the elimination of the feeble minded in 1938, leading to the Shoah genocide and the murder of 6,000,000 ‘inferior’ human beings. Eugenics starts when society wants to impose a selection of heredity, screening for genetic characteristics. The use of genetics should be entirely an individual decision, for the benefit of the individual, with informed consent and with genetic counselling to avoid misunderstanding of genetics, for example to select behaviour or other non-pathological traits. Above all, there is no ideal genome. Being in Montreal, it is proper to end by quoting the beautiful statement of the Quebec Genetic Group: ‘Our genetic heritage is imperfect – it is important to conceive man in his complexity and originality to recognize that all humans carry abnormal recessive genes and susceptibility genes (5-30 in each of us). No-one can be qualified as genetically sane or genetically deficient’. There is no ideal genome, no ideal behaviour, and hence no ideal behavioural genetics.

94 A PATRIMONY TO BE PRESERVED

Francisco Mauro Salzano (Brazil), Emeritus Professor Institute of Biosciences of the Federal University of Rio Grande do Sul

We all inherited from our ancestors a type of environment that had been variously subjected to change. These modifications may have been caused by physical and/or biotic factors, but one of the most important agents of change is the human species itself. We are almost everywhere in the planet, and although presently it is impossible to predict our evolutionary future, it is certain that we are a tremendously dominant form of life. Some numbers about the value of this patrimony may be presented. For instance, Garcia (1995) asked the question, What is the value of a cubic meter of air, or of water, or of biodiversity? Exact answers, of course, cannot be given. But he added that while the price of a gram of gold is estimated at about 12 dollars, one gram of raw chlorophyll is worth 700 dollars, and one gram of purified chlorophyll 20,000 dollars. As for biodiversity (Erlich and Wilson, 1991), about 1.4 million species of plants, animals and microorganisms have been described, but it is estimated that they may number 100 million. The most numerous forms of life are the flowering plants (with 220 thousand species described), and their coevolutionary partners, the insects (with 750 thousand species). The spatial distribution of this organic diversity is most variable. For instance, 300 species of trees were found in just one hectare in Peru, while only 700 of them had been described in the whole of North America (Erlich and Wilson, 1991). Brazil can be classified as a megadiversity country. Its tropical forests, covering 3.57 million km2, are the largest in the world, representing 30% of those present on earth. Around 10% of all described species occur in Brazil (Mittermeier et al., 1992).

95 Life quality Why should we worry about the maintenance of this biodiversity? Erlich and Wilson (1991) indicate at least three basic reasons. The first is ethic and esthetic. As a dominant species we have a moral responsibility of protecting our biological relatives (if there is one lesson that we learned from molecular genetic evolutionary studies, it is that all forms of life constitute an immense family). All of us, also, enjoy gratifying feelings in contact with nature. Another reason is that economic benefits had already been obtained from this diversity, in the form of food, medicines and industrial products. Much more, however, could be earned. For instance, just a small fraction of the plant species has been tested in relation to their pharmaceutical value; and while we have used about seven thousand species as food, the number of those with edible parts are several orders of magnitude higher. Finally, natural ecosystems ensure the stability of climates, waters, soils and nutrients, protection from pests and pollination agents. The biosphere is an integrated whole, and changes in even the most simple organism may lead to imbalance. The picture that we presently observe is however quite distressing. There is a continuing irreversible loss of species, and by 2100 this loss may reach one-third of all species now living. Loss of soil productivity, which is causing extensive land abandonment, is a widespread consequence of current practices in agriculture and animal management. Since 1945, 11 per cent of the earth’s vegetated surface has been degraded, an area larger than India and China combined,; and per capita food production in many parts of the world is decreasing (Union of Concerned Scientists, 1997).

Ethics and the Environment How can we justify the fact that we can feed an astronaut in remote space and build tremendously expensive instruments of death and destruction (for instance, the cost of just one military airplane is equivalent to the annual budget of the World Health Organization for research in tropical diseases!) but are incapable of feeding or vaccinating Third World children, or those at the periphery of large cities? Perhaps the worst environmental contamination is that of a mental nature (Shrader- Frechette, 1991).

96 The relationship between homo sapiens and the environment is of course modulated by culture and socioeconomic factors. When humans based their subsistence on hunting and gathering, they influenced the environment in a much less drastic way than after they developed agriculture and industrialization. The influence of religion, on the other hand, cannot be minimized. White (1967) characterized christianism in its occidental version as ‘the most anthropocentric religion ever created’.

Genomics and the Environment Genetic knowledge experienced tremendous progress in recent times, mainly due to developments in the areas of laboratory testing and informatics. Presently we can do anything we want with DNA (the genetic material): pieces of it can be cut, introduced in the DNA of another species (for instance, microorganisms), multiplied, and then turned back to its original carrier. Whole genomes of many organisms have been totally mapped, including that of our species. Therefore a new branch of science has been developed, comparative genomics. In which way can this knowledge be used to deal with environmental problems? Answers to these questions can be obtained in Table 1. Eight items related to the relationships between genomics and biotic conservation are listed in that table. The key word in relation to all of them is variability. A clear understanding about its inter and intrapopulation components should exist. In addition, data about population size and its variation between generations are important. Reductions in the number of individuals can lead to restriction in variability, with a concomitant loss of adaptive plasticity (like the ability to resist predators and parasites) or even extinction. On the other hand, the sheer artificial increase in a given population by the addition of individuals raised in captivity is not enough, since these individuals are not adapted to life in nature. Drastic changes in the environment can be disastrous to certain species, and high mutation rates can lead to unbearable genetic loads (by an increase in the frequency of deleterious genes). In the case of pollution monitoring, questions related to the environment to be monitored, types of polluting agents, methods of detection, and traits to be studied should be considered. Fish and planarians should be used for water monitoring, while fossoreal mammals could be useful for soil quality control. Radiation effects may differ from those induced by chemical agents, and methods of detection and their indicators have variable efficiency.

97 Technological applications of genetic knowledge have increased enormously in the last years, and our life is being much influenced by products and services directly or indirectly connected with genetics. Applications are present in industry, agriculture, food production, and medicines, developed to assure the well-being of humans and domestic animals. The possibilities of use of genetically modified microorganisms are manifold, and include mineral retrieval and lixiviation, as well as the degradation of oil spilled in the ocean by ships.

Biotechnology, Agriculture and Animal Breeding Any technological advance in the area of agriculture and animal breeding should be carefully evaluated, since it will involve large numbers of persons and extensive areas of cultivation. ‘Clean’ technologies are necessary, involving the dialectical cost-benefit relationship. Before the advent of agriculture 2,500 hectares were necessary to feed one person. Presently, with high technology, 250 hectares yield food which can feed 3,600 persons (Paterniani, 1999). Despite this progress, it is estimated that about 800 million people (18% of the population in the developing world) do not have sufficient food (Pinstrup-Anderson et al., 1999). Malnutrition plays a significant role in nearly 6 million deaths which occur each year among children under five years of age in these countries (UNICEF, 1998). Although these problems are mainly caused by lack of appropriate wealth distribution, it is clear that new techniques of plant breeding and improvement may at least minimize this terrible situation. Since prehistory homo sapiens is performing gene transfer from one species into another. Transgenic processes are not new. What happened is that the methods of such transfer had been improved, making them more efficient. Present research with transgenic crops aims selectively to alter, add or remove a given character in a plant, bearing in mind regional needs and opportunities. A whole range of traits are involved, from pest and herbicide resistance to improved proteins and other substances, as well as higher yield. On the other hand, horizontal DNA transfer between species is very common among microorganisms, and there are evaluations that about one- half of our genetic material is derived from transposable elements, which originated in a different species. We are all transgenic (Bushman, 2002). The estimated global area in which transgenic (GM) crops are grown, for 2002, is 58.7 million hectares, under the care of 5.5 to 6.0 million farmers in sixteen countries. This area represents more than 5% of

98 the total land area of China or the United States of America, or almost two and half times the land area of the United Kingdom. A sustained rate of annual growth of more than 10% per year has been achieved for these cultures every year for the last six years, since the introduction of large- scale production of transgenic plants in 1996. The main producers of GM crops are the United States of America (66% of total), Argentina (23%), Canada (6%), and China (4%). The remaining 1% is being produced in a large number of including developing countries (James, 2002). No human health problems associated specifically with the ingestion of transgenic crops or their products have been identified (Working Group, National and Third World Academies of Sciences, 2000). What is the reason, therefore, for the world hysteria against GM crops? The answers can only be: (a) ferocious conservatism; (b) ideological positions against the large multinational companies (but transgenic techniques are available to all interested researchers); (c) irrational fear to anything that is new; (d) antiscience preconceived ideas in general.

The Future Table 2 presents two contrasting views of the world’s future, one pessimistic and the other optimistic. There is no doubt that with the present economic globalization process there is a real danger that the pessimistic picture will prevail. The easiest way of escape possessed by oppressed people against their rulers is to resort to some kind of mystical or mythical belief. This, coupled with ignorance, resent, and lack of understanding of the potential role of science for the improvement of life conditions, may lead to a gloomy world in which misery will necessarily coexist with scandalous wealth. Against this tendency, an effort should be directed for the equalization of opportunities between individuals and nations. Science has already contributed to a substantial improvement in the life conditions all over the world. But to reach the conditions indicated by the optimistic world view, science is not enough. Vigorous political action in favor of those in need of help is necessary.

Acknowledgements Our research is financed by Programa de Apoio a Núcleos de Excelência (PRONEX), Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq), Fundação de Apoio à Pesquisa do Estado do Rio Grande do Sul (FAPERGS), and Pró-Reitoria de Pesquisa, Universidade Federal do Rio Grande do Sul (PROPESQ/UFRGS).

99 REFERENCES ƒ Bushman, F. 2002, Lateral DNA Transfer. Mechanisms and Consequences. Cold Spring Harbor Laboratory Press, Cold Spring Harbor. ƒ Erlich, P.R. and Wilson, E.O. 1991, Biodiversity studies: science and policy. Science 253: 758-762. ƒ Garcia, E.S. 1995, Biodiversidade, biotecnologia e saúde. Cadernos de Saúde Pública 11: 495-500. ƒ Jackson, D.A. 1995, DNA: template for an economic revolution. Annals of the New York Academy of Sciences 758: 356-365. ƒ James, C. 2002, Global status of commercialized transgenic crops: 2002. ISAAA Briefs no. 27 (available at www.isaaa.org). ƒ Lynch, M. 1995, A quantitative-genetic perspective on conservation issues. In: Avise, J.C. and Hamrick, J.L. (eds.), Conservation Genetics. Chapman and Hall, New York, pp. 471-501. ƒ Mittermeier, R.A., Werner, T., Ayres, J.M. and Fonseca, G.A.B. 1992, O país da megadiversidade. Ciência Hoje 14(81): 20-27. ƒ Ozorio de Almeida, A.L. 1984, Biotecnologia e Agricultura: Perspectivas para o Caso Brasileiro. Vozes e Biomatrix, Petrópolis. ƒ Paterniani, E. 1992, A ciência dos transgênicos. Revista do Incor Fev.: 38- 40. ƒ Pinstrup-Andersen, P., Pandya-Lorch, R. and Rosegrant, M.W. 1999, World Food Prospects: Critical Issues for the Early Twenty-First Century. International Food Policy Research Institute, Washington, D.C. ƒ Salzano, F.M. 1990, Genética e Farmacia. Editora Manole, São Paulo. ƒ Shrader-Frechette, K. 1991, Etica y medio ambiente. Foro Mundial de la Salud 12: 329-339. ƒ UNICEF. 1998, The State of the World’s Children. Oxford University Press, New York. ƒ Union of Concerned Scientists. 1999, World Scientists’ Warning to Humanity. Union of Concerned Scientists, Cambridge. ƒ Vogel, F. and Motulsky, A.G. 1997, Human Genetics: Problems and Approaches. Springer-Verlag, Berlin. ƒ White, L. Jr. 1967, The historical roots of our ecological crisis. Science 155: 1203-1207. ƒ Working Group, National and Third World Academies of Sciences. 2000,Transgenic Plants and World Agriculture. National Academy Press, Washington, D.C.

100 Table 1. Areas of contact between genetic knowledge and environmental problems

1. Conservation (Lynch, 1995) 1.1. Intra and interspecific variability levels 1.2. Minimum effective population level 1.3. Maximum rate of sustainable evolution 1.4. Effect of population reductions (‘bottlenecks’) 1.5. Deleterious genes in the ancestral population 1.6. New deleterious mutations in an isolated population 1.7. High levels of mutation 1.8. Increase in population size based on individuals maintained in captivity 2. Pollution monitoring (Salzano, 1980; Vogel and Motulsky, 1997) 2.1. Environments to be monitored 2.1.1. Air 2.1.2. Water 2.1.3. Soil 2.2. Types of inducing agents 2.2.1. Radiation 2.2.2. Chemical substances 2.3. Methods of detection 2.3.1. Organisms 2.3.1.1. Humans 2.3.1.2. Others (eukaryotic) 2.3.1.3. Microorganisms 2.3.2. Cell culture 2.4. Traits monitored 2.4.1. Gene mutations 2.4.2. Chromosome aberrations 3. Technological applications (Ozorio de Almeida, 1984; Jackson, 1995) 3.1. Fermentation processes 3.2. Tissue culture 3.3. Products (in the areas of inorganic and organic chemistry, energy, mining, agriculture, food, medical/veterinary/pharmaceutical applications, forensic, and public health services)

101 Table 2. Two contrasting views of the world’s future

1. The pessimistic view 1.1. Accentuation of the present gap which separates rich and poor individuals or nations. 1.2. A world dominated by technology, with monotonous repetition of the same patterns of culture and environment. Extinction of all wild species. 1.3. Triumph of mystical and mythical beliefs in social life. 2. The optimistic view 2.1. Health for all, individualized protection against diseases and food intoxication, appropriate science education, end of mystical and mythical beliefs. 2.2. Population control, scientifically established areas of conservation and management of endangered species, sophisticated techniques of environmental monitoring and appropriate pollution control. 2.3. Adequate wealth distribution – the maximum of happiness for the largest number of people.

102