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19 September 1994
Doc. 7156
RAPPORT
giving an opinion on the draft Bioethics Convention
[draft Convention for the Protection of Human Rights
and Dignity of the Human Being with regard to the
Application of Biology and Medicine]
(Rapporteur: Mr PALACIOS,
Spain, Socialist Group)
Summary
The ethical, social and legal implications of the applications of scientific and technological advances in human biomedicine and biotechnology have been kept constantly under review by the Council of Europe, which has sponsored numerous debates on this subject and produced many documents and recommendations over a period of almost 20 years.
In view of the need to go beyond purely national approaches and harmonise on a universal basis the principles and norms governing activities in the field of bioethics, it was proposed in the Parliamentary Assembly of the Council of Europe that a European Bioethics Convention be drafted. In this report the Rapporteur presents a positive appraisal of that document.
I. Draft Opinion
1. The Assembly has undertaken a considerable amount of work since 1976 with regard to the bioethical aspects of human biotechnology and biomedicine.
2. This work, based on principles designed to protect human dignity and the corresponding fundamental human rights relating to human biology and medicine, led to Recommendations 1100 (1989) and 1160 (1991) which contained proposals for the preparation of a comprehensive European bioethics convention intended as a legal instrument open to non-member states.
3. Resolution No. 3 of the 17th Conference of European Ministers of Justice (1990), recommended that the Committee of Ministers instruct the CAHBI (now the CDBI, the Steering Committee on Bioethics) to examine the possibility of preparing a framework convention and, if so decided, to draft it.
4. The Assembly considers that Recommendation 1160 proposes a convention of a general nature and a series of protocols on specific subjects that can be extended to other subjects if this is considered to be advisable and necessary in the future.
5. The Assembly has closely followed the various stages in the drafting of the texts of the convention and of the protocols within the CDBI, in which the Parliamentary Assembly has been represented since 1990, and its contributions and suggestions have been largely taken into account and incorporated into the texts.
6. There has been excellent co-operation between the Parliamentary Assembly and the CDBI and the latter has carefully considered the work carried out by the Parliamentary Assembly over the last 20 years, which largely inspired the text of the convention.
7. The Assembly notes the fact that the Committee on Science and Technology, the Social, Health and Family Affairs Committee, and the Committee on Legal Affairs and Human Rights have been kept permanently informed by their representative in the CDBI during these years of drafting the convention.
8. It urges the relevant committees of the Council of Europe to continue their activities in the field of bioethics, which have formed an extremely important part of the work of this international institution for many years.
9. The Assembly therefore recommends that the Committee of Ministers:
i. adopt the text of the draft Bioethics Convention as transmitted to the Assembly and set out in Doc. 7124, and to open it for signature before the end of 1994;
ii. invite member states and non-member states (according to the procedure provided for in Article 27 and 28 of the draft convention) to sign and ratify the convention and to implement it as soon as possible;
iii. invite the CDBI to continue with the preparation of the four draft protocols concerning medical research, organ transplantation, protection of the human embryo and foetus, as well as genetics;
iv. transmit for opinion to the Parliamentary Assembly each draft protocol as soon as it is finalised.
II. Explanatory Memorandum
by Mr PALACIOS
CONTENTS
A. Background 5
B. Human rights 6
C. Observations on the text of the Convention 7
D. Concluding remarks 10
Appendix: List of Council of Europe documents
on bioethics 12
A. Background
1. We have repeatedly called attention in the most varied forums to the enormous amount of work that the Council of Europe has been carrying out for many years on the complex aspects - not only legal or economic aspects, but also those of a humanist nature -of advances in science and technology, especially as regards animal and plant life and, of course, with particular reference to human beings.
For 18 years now the concerns and efforts of the Council of Europe regarding the legal, social or ethical implications of scientific and technological progress have been reflected in a multitude of resolutions, recommendations, directives, agreements, charters etc. In order to avoid repetition here, reference is made to document AS/Soc/Bio (44) 1 (Rapporteur: Mr Palacios), which contains a detailed chronological account of the Assembly's work and some observation on the background (see also the Appendix). It also contains some texts of great interest prepared by the CDBI (previously the CAHBI) or adopted by the Committee of Ministers.
2. In 1987 in document AS/Science (39) 4 and in 1988 in the subsequent Doc. 5943 (Rapporteur: Mr Palacios) a comprehensive recommendation was for the first time addressed to the Committee of Ministers to "provide for joint action by all Council of Europe member states, together with non-member states, so that in addition to purely national action they should contribute to the framing of a common legal instrument, such as a European convention on biomedicine and human biotechnology, which would be open to non-member states also" (paragraph 19 C). This was a proposal for a Bioethics Convention of a universal nature, not fragmented or partial, covering human biomedicine and biotechnology as a whole. Document 5943 was to give rise to Recommendation 1100 (1989) on the same subject, which reproduced the text containing the idea for the Convention as proposed by the Rapporteur.
3. In response to Resolution No. 3 of the 17th Conference of European Ministers of Justice (1990), which stated that the rights of the individual should not be threatened by the development of biomedical sciences and expressed a preference for a framework Convention, the Committee of Ministers instructed the CDBI to study the possibilities of drafting such a text. This decision showed that there were some difficulties within the committee.
4. This Rapporteur (the representative of the Parliamentary Assembly in the CDBI since 1990) informed the Committee on Science and Technology of the situation regarding this matter in the CDBI. As a result, and in view of the fact that the idea of a Convention had first been raised within the Parliamentary Assembly, I was given the task of presenting a "Report on the preparation of a convention on bioethics" (Doc. 6449 of 1991) which was examined for the first time at the meeting of that committee in March 1991. It was accepted by the CDBI as a valid working document and, subsequently, by the committee, to be approved definitively and unanimously by the Standing Committee, acting on behalf of the Parliamentary Assembly, as Recommendation 1160.
5. That Recommendation 1160 envisages a framework Convention with (a) a general part or Convention as such, concerning respect for human rights with regard to the applications of biology and medicine and their technologies, and (b) a specific part, with 5 protocols concerning respectively organ donations and transplants; research on the human body, including the structures of embryonic development; assisted reproduction; genetic technology and, finally, the privacy of genetic data for other than medical purposes. The CDBI (in which, as has already been remarked, the Parliamentary Assembly had been represented since December 1990 by this Rapporteur, so that from that date onwards relations between the two parties, Assembly and committee, took a very positive direction) regarded this proposal for a Convention as satisfactory and its working groups intensified their drafting work. Except when unforseen events supervened, I attended the meetings of the CDBI and I should like to express my gratitude to all its members, represented by its Chairmen, Mrs Kokonen and Mr Quintana, for the freedom and frankness with which we jointly analysed and discussed these texts, for their respect for, and recognition of, the value of the Parliamentary Assembly's efforts, which were a great inspiration to them in their work, and for the sensitivity they showed in accepting amendments and suggestions by the representative of the Parliamentary Assembly in the committee for inclusion in the texts produced during this period of time.
6. The preliminary draft Convention was discussed at a Meeting on Bioethics in Strasbourg on 7 February 1993 (documents AS/Science (43) PV 9 and AS/Soc (43) PV 10), which was attended by representatives of the CDBI, the Committee on Science and Technology, the Social, Health and Family Affairs Committee, the Sub-Committee on Family Affairs, Health and Bioethics and the Committee on Legal Affairs and Human Rights of the Parliamentary Assembly, as well as by representatives of the Committee on Energy, Research and Technology of the European Parliament (Mrs Breyer, Mr Linkhor and Mr Pompidou), by Mrs Gebhard on behalf of the Bundestag and by Mrs Merminod on behalf of the Ecumenical Commission for Church and Society to the European Community.
7. The Committee on Science and Technology, the Social, Health and Family Affairs Committee and the Sub-Committee on Family Affairs, Health and Bioethics were kept regularly informed by the Rapporteur either verbally or in writing (see the reports and documents cited) about the progress of work in the CDBI and the contributions made. In addition, there was a Hearing (1 February 1993) organised by the two committees together with the Committee on Legal Affairs and Human Rights, at which I presented a report and which was attended by the Secretary General of the Council of Europe, Mrs Lalumičre, whose contribution gave further impetus to our work on these matters, emphasising both the scope of the intensive work of the Parliamentary Assembly and the work carried out by the CDBI.
B. Human rights and bioethics
8. The principles of freedom, equality and safety are satisfactorily dealt with both in the statement of principles and in the preambular part and, in greater detail, in the substantive part of the Convention.
9. The ethical principles applicable to life in general and to human life in particular cannot reflect the attitudes of a particular individual or group, but must be understood as universal, involving mutual respect for different opinions. Furthermore, the ethical principles that should guide conduct in human biomedicine and biotechnology often strongly influence legislation and thus should find their main source in the Universal Declaration of Human Rights, the Convention for the Protection of Human Rights and Fundamental Freedoms and the constitutions of various democratic countries.
10. Any intervention concerning a human being through the use of biological and medical science and technology involve two kinds of fundamental rights which need to be harmonised and protected, so as not to halt or hinder arbitrarily the advances of science and technology and so as not to cause any possible harm to human beings: the right of the individual to dignity, together with the fundamental and inviolable rights derived from that dignity, and the right to participate in and benefit from scientific and technological progress as part of the heritage of all mankind. The Bioethics Convention reflects the need to strike a balance between them, since, while its principles are clearly open to progress, it is equally clear that possible abuses of their application are firmly opposed.
11. In short, the Universal Declaration of Human Rights (1948), the Rome Convention for the Protection of Human Rights and Fundamental Freedoms (1950), and other international conventions, covenants or treaties, form part of the constitutions of democratic countries and guide their legal and legislative arrangements, and their principles are endorsed in the Bioethics Convention. The interpretation which the European Commission of Human Rights places on such terms as "human life", "person", "everyone", etc. should facilitate the acceptance of the text of the Bioethics Convention; otherwise, given the philosophical, scientific, ethical and religious implications, we might become involved in an interminable debate, which would reveal our inability to address rationally and respond adequately to a dynamic situation in which science and technology increasingly enter into the activities of everyday life. This has not been the case in preparing this Convention and any such difficulties have been avoided.
C. Observations on the text of the convention1
12. The generic term "Bioethics Convention" is a convenient abbreviation, although it is perfectly clear in the preamble that, in the light of our proposal of 1986-87 and Recommendation 1160, it deals with human biomedicine and biotechnology. This observation may be helpful in suggesting to other committees of the Council of Europe that they might take steps towards the preparation of a convention relating to the application of technologies in animals, plants and micro-organisms.
13. The contents of the "biotechnical" part of the Convention may be summarised as follows:
- The purpose and object of the Convention are to protect the dignity and identity of all human beings and guarantee everyone, without discrimination, respect for their integrity and other rights with regard to the application of biology and medicine.
- The interests and welfare of the human being shall prevail over the sole interest of science and society.
- Any intervention in the health field must meet relevant professional obligations and standards.
- Everyone should have equitable access to the uses of biology and medicine for medical purposes taking into account health needs and available resources.
- No intervention may be carried out in the health field without the free and informed consent of the person undergoing it.
- Interventions may be carried out on legally incapacitated persons and those who, though legally capable, have a reduced capacity of understanding, only for their direct benefit and under protective conditions recognised by national law.
Exceptions are allowed in the case of the transplantation of regenerative tissues between persons having close personal or family relations, provided that sufficient protection is guaranteed and that there is no other possible donor nor any equally effective alternative method.
As far as possible, the incapacitated person shall be involved in the consenting procedure. The age and capacity for discernment of the incapacitated persons should be taken into account proportionately and in relation to the protection recognised by national legislation.
- In an emergency situation and for the immediate benefit of the health of the individual concerned any medically necessary intervention may be carried out, even though the appropriate consent cannot be obtained.
- The previously expressed wishes relating to a medical intervention by a patient shall be taken into account.
- National law shall prescribe the conditions for medical intervention on a patient with mental disorders, taking into account his consent, the urgency of the situation and supervisory, control and appeal procedures.
- The human body and its parts have dignity and shall not, as such, give rise to financial gain.
- Everyone has the right to privacy in the health field and is entitled to know any information collected about his health.
- A part of the human body cannot be used for a purpose other than that for which it was removed, in conformity with appropriate information and consent procedures.
- Scientific research in the field of biology and medicine shall be carried out freely in accordance with legal provisions ensuring the protection of the human being.
- The creation of human embryos solely for research purposes is prohibited.
- When research on embryos in vitro is allowed by law, such research may only be permitted in the case of embryos less than fourteen days old.
- An intervention on the human genome shall only be undertaken for diagnostic or therapeutic purposes and as long as the aim is not to interfere with the germ cell line.
- Predictive tests may only be performed for purposes of treating genetic diseases or for scientific research.
- The communication of the results of genetic testing for purposes other than health or scientific research shall only be allowed if prescribed by law when there is an overriding interest.
- The Parties shall provide appropriate judicial protection to prevent unlawful infringement of the principles set forth in the Convention.
- The person who has suffered undue damage resulting from an intervention is entitled to fair compensation.
- The states shall provide for appropriate sanctions to be applied in the event of the infringement of the aforementioned provisions.
- Each Party shall have the right to grant a wider measure of protection than is stipulated in the Bioethics Convention.
- In keeping with the spirit of the Convention, I insisted on some matters of particular importance both at the preparatory meetings to draft the text of the Convention and the protocols and in the numerous suggestions and amendments put forward.
- The prohibition of creating pre-embryos or pre-implantation embryos for purposes other than human procreation.
Having been withdrawn from the text, this prohibition (which appears in both Recommendation 1046 (1986) and Recommendation 1100) has since been definitively incorporated into the Convention, which, moreover, limits interventions on such embryos to the first 14 days of life, this being the criterion set by the Parliamentary Assembly of the Council of Europe. It is worth noting that this subject gave rise to a long and passionate debate in the Assembly, to meetings and exchanges of documents between the Sub-Committee on Family Affairs, Health and Bioethics and the President of the European Science Foundation (Professor Danielsson) over many years, and a Hearing in Paris on this and other matters, attended by Professors Cohen, Wilkinson, Egozcúe, Bigozzi etc and with the active participation of members of the committees. After careful analysis of these matters and subsequent discussions in the committees of the Council of Europe, it was thought necessary to keep the text of Recommendation 1046 (1986) in this regard, which prohibits the creation of embryos in vitro for purposes of research. Subsequently, however, in Recommendation 1100 (1989) research and experimentation were authorised on pre-embryos, but only in the case of non-viable pre-implantation embryos that is to say, embryos which having been created for the purpose of procreation cannot be used for that purpose on account of damage or their intrinsic defects, so that they are not suitable for procreation in either scientific or human terms. For scientific purposes, provided that they are dying of their own account (and not through the will of the researcher), there should be no objection to research on them.
- The principle that the human body or its parts should not be used for financial gain or patented is of particular importance.
In this context, in relation to biology, we should note the difference in European culture between invention and discovery. Research on the human body (including genetic molecules) does not involve any invention on our part; we discover merely what we did not previously know, not because it had not been in the human body for many thousands of years and had to be invented, but simply because our ignorance prevented us from knowing about it.
- The principles of equality and justice are particularly evident in the right of equal and equitable access for all to health care and scientific and biomedical treatment, although clearly in each case the type and scope of treatment desired and that can be provided has to be balanced against the availability of resources within the country.
- The importance of informed consent has always been upheld by the Parliamentary Assembly and is reflected in the Convention in the form of a requirement covering particular situations, which are regulated and protected, such as those of minors, the legally incapacitated, prisoners, emergency situations, the mentally ill and, in certain circumstances pregnant women.
Particular emphasis is given to persons undergoing a bio-medical intervention, whether for diagnostic or therapeutic purposes or for purposes of research-experimentation, it being stressed that consent has to be easily comprehensible, complete (concerning all the circumstances involved in the intervention, its advantages and forseeable risks, ethical, legal or economic aspects, etc), expressed prior to the biomedical intervention (except in emergency situations) and, preferably, in writing.
D. Concluding remarks
14. Six years have passed since I proposed in Doc. 5943 the preparation of a comprehensive Bioethics Convention that would cover all the aspects and implications of human biomedicine and biotechnology, and not just some of them and would be a legal instrument open to non-member states of the Council of Europe, and it is three years since a draft of what was to become the future Recommendation 1160 was submitted in a report to the Committee on Science and Technology. It is the text of that Convention that now form the basis of our discussions. The work carried out by the Parliamentary Assembly during those and previous years and the invaluable contribution of the CDBI have been complex and difficult, but highly gratifying and extremely satisfactory and with great practical consequences for Europe and, indeed, the whole world.
15. Following our acceptance of these texts and their approval by the Committee of Ministers, they will be opened for signature by the member states of the Council of Europe and by any non-member states that wish to accede to them. That will mark the end of an extraordinary chapter, but also the beginning of an even more important chapter with the implementation of the principles set forth in these documents, leading to widespread harmonisation and standardisation of the laws of many countries in such sensitive fields and superseding as far as possible differences in national regulations.
16. In conclusion, although it is not usual to make such remarks in a report of this kind, I would like to take this opportunity to express my sincere gratitude for the confidence bestowed on me, the constant stimulation and support received and the calm, but positive way in which disagreements have been expressed, although I am aware that the members of the Assembly, experts and others involved in this task have at no time sought such recognition, believing that in carrying out this work they are only doing their duty.
I should like to thank the Presidents of the Parliamentary Assembly (MM. Jung, Björg and Martínez) and the Secretaries General (Mr Oreja and Mrs Lalumičre), who have encouraged and followed our work and helped on occasions to resolve particular difficulties, thereby endorsing and enhancing the scope of the activities of the Assembly.
I should also like to thank all the following: the chairmen of the Committee on Science and Technology (MM. Petterson, Lenzer, Bassinet and Roseta), of the Social, Health and Family Affairs Committee (MM. Foschi and Pini and Mrs Havik), and those of the Sub-Committee on Family Affairs, Health and Bioethics (Mr Worrel and Mrs Morf), of which I have been a member since my arrival at the Council of Europe.
And all those who, in one way or another, lent their assistance, which was sometimes unobtrusive but always valuable. My appointments as Chairman of the Sub-committee on Family Affairs, Health and Bioethics and as General Rapporteur of the Parliamentary Assembly for Bioethics are honours for which I am deeply grateful and in my unsparing efforts to carry out these duties I hope I have fulfilled the hopes placed in me.
17. I wanted to acknowledge this crucial role played by the Council of Europe and I believe that my remarks will not be considered out of place and that my feelings are in fact widely shared since, ultimately, the efforts of any one individual are likely to be wasted without reasonable criticism and support from all those people, as in the Council of Europe, who ensure the success of the work, for the benefit of the general public.
18. Finally, in view of the fact that the preliminary draft of the Convention was first submitted to the Committee on Science and Technology in the Principality of Asturias, in Spain, I suggest that the signing of the Convention take place there and I trust that the Parliamentary Assembly will adopt it.
APPENDIX
Among other documents related to bioethics adopted by the Council of Europe, it should be mentioned:
Parliamentary Assembly:
1976 - Recommendation 779 and Resolution 613 on the rights of the sick and dying
1977 - Recommendation 818 on the situation of the mentally ill
1982 - Recommendation 934 on genetic engineering
1983 - Resolution 812 on the acquired immune deficiency syndrome (AIDS)
1986 - Recommendation 1046 on the use of human embryos and foetuses for diagnostic, therapeutic, scientific, industrial and commercial purposes
1989 - Recommendation 1100 on the use of human embryos and foetuses in scientific research
1989 - Recommendation 1116 on AIDS and human rights
1991 - Recommendation 1159 on the harmonisation of autopsy rules
1991 - Recommendation 1160 on the preparation of a convention on bioethics
1994 - Recommendation 1240 on the protection and patentability of material of human origin
Committee of Ministers (texts adopted or published with its authorisation):
1978 - Resolution (78) 29 on harmonisation of legislations of member states relating to removal, grafting and transplantation of human substances
1979 - Recommendation R (79) 5 concerning international exchange and transportation of human substances
1981 - Recommendation R (81) 1 on regulations for automated medical data banks
1983 - Recommendation R (83) 2 concerning the legal protection of persons suffering from mental disorder placed as involuntary patients
1983 - Recommendation R (83) 10 on the protection of personal data used for scientific research and statistics
1984 - Recommendation R (84) 16 concerning notification of work involving recombinant deoxyribonucleic acid (DNA)
1987 - Final text of the 3rd Conference of European Ministers for Health on organ transplantation (Paris, 16-17 May 1987), Revision of Resolution (78) 29
1987 - Recommendation (87) 15 regulating the use of personal data in the police sector
1987 - Recommendation (87) 25 concerning common European public health policy to fight the acquired immunodeficiency syndrome (AIDS)
1989 - Recommendation (89) 4 on the collection of epidemiological data on primary health care
1990 - Recommendation R (90) 3 concerning medical research on human beings
1990 - Recommendation R (90) 13 on prenatal genetic screening, prenatal genetic diagnosis and associated genetic counselling
1992 - Recommendation R (92) 1 on the use of analysis of deoxyribonucleic acid (DNA) within the framework of the criminal justice system
1992 - Recommendation R (92) 3 on genetic testing and screening for health care purposes
Reporting committee: Committee on Science and Technology.
Budgetary implications for the Assembly: none.
Reference to committee: Doc. 7124 and reference No. 1956 of 28 June 1994.
Draft opinion unanimously adopted by the committee on 12 September 1994.
Members of the committee: Mr Roseta (Chairman), Mr Meszáros, Mrs Terborg (Vice-chairpersons), Mr Alemyr, Mrs Arnold, MM. Bartodziej, Bauer, Berger, Birraux, Borderas (Alternate: Palacios), Mrs Brenden (Alternate: Mr Lie), MM. Fulvio Caccia, Cunliffe, De Decker, Del Gaudio, Dees, Dumont, Galley (Alternate: Decagny), Golu, Hurta, Inönü, Ivanov, Mrs Kaliska, MM. Konecny, Konstandinidis, Leers, Lenzer, López Valdivielso, Lotz, Luczak, Metelko, Mitchell, Mitolo, Mocioi, Moran, Panov, Pecriaux, Poças Santos, Požela, Probst, Mrs Ragnarsdóttir, Mr Regenwetter, Mrs Saint Cyr (Alternate: Mrs Fleetwood), Mrs Stiborova, MM. Tabladini (Alternate: Lorenzi), Sir Donald Thompson, Mr Jack Thompson (Alternate: Lord Newall), MM. Tiuri, Vrettos, Yürür.
N.B. The names of the members present at the meeting are printed in italics.
Secretary to the committee: Mr Perin
1 1 The draft Convention and its explanatory report are set out in Document 7124 as transmitted to the Assembly on 21 June 1994.