12 January 1995

Doc. 7210

REPORT

giving an opinion on the draft Bioethics Convention 1

[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. This convention should allow codification of existing but fragmented work and fill a legal vacuum. The Assembly is aware that the incorporation of certain principles into the European Convention on Human Rights, which affords better protection, albeit limited to the member states, should be borne in mind for 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 draft 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.       The Assembly therefore recommends that the Committee of Ministers review thoroughly the text of the draft Bioethics Convention as transmitted to the Assembly and set out in Doc. 7124, and amend it as indicated below before opening it for signature:

i.       At the end of Article 1, add the following new sentence:

      "They shall introduce the substantial provisions of this convention into their national legislation".

ii.       In Article 4, add a new paragraph to read as follows:

      "Services offered to the public involving the use of the biomedical services and techniques shall be subject, in the interest of the protection of the persons concerned, to control of their quality".

iii.       Amend Article 5, paragraph 1, to read as follows:

      "No intervention may be carried out in the health field without the informed, free, express and specific consent of the person undergoing it".

iv.       Replace Article 6 by the following text:

      "Interventions may be carried out on persons who have no legal capacity to give consent and those who, though legally capable to give consent have a reduced capacity of understanding, only for their direct benefit and with the consent of their legal representative, or an authority or an individual authorised or designated under his national law.

      A legally incapacitated person may not undergo medical research unless it is expected to produce a direct and significant benefit to his health.

      Any refusal by the incapacitated person must always be respected.

      For the purposes of this convention, "incapacitated persons" means:

      - persons who have a reduced capacity of understanding;

      - persons whose capacity to possess rights and to be bound by obligations is limited, either for reasons of age or because of mental illness;

      - persons having a de facto incapacity".

v.       In Article 7, at the end of paragraph 2, add the following words:

      "and also the free and informed consent of the parent(s) or legal guardian(s) is necessary".

vi.       In Article 15, paragraph 1, after "such research may only be permitted in the case of ", add "non viable" before "embryos".

vii.       In Article 15, paragraph 2, delete the word "solely".

viii.       Replace Article 16 with the following text:

      "An intervention on the human genome may only be undertaken for preventive, therapeutic or diagnostic purposes without any intervention in the human germ cell line".

ix.       In Article 20, delete "according to the conditions and procedure prescribed by law".

x.       In Article 26, paragraph 2 (and elsewhere), replace "European Community" by "European Union".

xi.       In Chapter V, add a new Article worded as follows:

      "For the purpose of observing the application of the Convention on the territory of the Contracting Parties and of interpreting the text of the Convention a monitoring body in connection with the European Court of Human Rights is hereby set up".

xii.       In Article 28, paragraph 1, delete "and by the unanimous vote of the representatives of the Contracting States entitled to sit on the Committee of Ministers".

xiii.       In Article 30, at the end of the first paragraph add "No reservations may be made in respect of Articles 15 and 16".

9.       The Assembly therefore recommends that the Committee of Ministers

i.       invite member states and non-member states (according to the procedure provided for in Articles 27 and 28 of the draft convention) to sign and ratify the reviewed and amended convention and to implement it as soon as possible;

ii.       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, in the light of the opinion of the Parliamentary Assembly;

iii.       transmit for opinion to the Parliamentary Assembly each draft protocol as soon as it is finalised.

II. Explanatory Memorandum

by Mr PALACIOS

CONTENTS

A.       Why, in spite of the controversial nature of the issues

      involved, is there a need for a convention?       5

B.       Background       7

C.       Human rights and bioethics       8

D.       Observations on the text of the convention       9

E.       Concluding remarks       12

Appendix:        List of Council of Europe documents

      on bioethics       14

A.       Why, given the controversial nature of the issues involved, is there a need for a convention?

1.       An initial discussion on the draft convention took place on Wednesday 5 October 1994 in Strasbourg. The Assembly, in its wisdom, gave itself additional time for reflection by referring the report to the committee. Indeed, the subject needs to be handled as carefully as possible and giving the question further thought cannot but be of benefit to Europeans. This is the reason for this revised report and the few proposed changes to the draft which we are submitting to the Committee of Ministers.

2.       Despite over 15 years of discussions, colloquies, debates and various texts adopted in this field, a number of concepts are still as complex and controversial as ever for many of us. There is nothing strange in this; the applications of biology and medicine which we call "bioethics" are a relatively recent and multidisciplinary field which has its own highly technical terminology and which furthermore is developing at a phenomenal rate. All this serves to make bioethics a mysterious discipline, and one viewed with some suspicion. The initial reaction from public opinion and, consequently, from policy-makers is one of extreme caution, if not hostility.

3.       This situation should not however hide the fact that a number of applications have already become accepted and that millions of people benefit from them, eg artificial procreation. It is very likely that other research currently under way will pave the way for treating genetic diseases, hitherto considered beyond the scope of human intervention.

4.       However, as is often the case in the history of civilisation, legal rules have once again lagged behind reality and practice. In other words, except in the very few countries which have introduced legislation on the matter, bioethical research and its applications take place in a total legal vacuum at national level. The situation is no better at international level. Admittedly, some basic texts do provide protection and guarantees of a general nature, but they do not contain any specific provisions to help grasp the complexity of scientific advances and guide further developments.

5.       Democratic societies first of all need an overall view, and then the corresponding written principles. Policy-makers must take responsibility for decisions on matters which are occasionally extremely complex and controversial. In the absence of such commitment, scientists and doctors are left with a task which is not normally theirs to perform, namely social and ethical leadership in society. Furthermore, as there are no clear rules, the courts too are put in a difficult position in dealing with delicate situations which have far-reaching implications.

6.       Consequently, I subscribe to the view that the time is right to bring together several years of work in a document forming a framework within which a balance will be struck between respect for the individual and the hopes placed in advances in biomedicine. News from across the Atlantic concerning an imminent liberalisation with regard to embryo research, authorising for example the creation of embryos in vitro exclusively for research purposes, strengthens us in our belief that if we continue to delay agreeing on rules of conduct, such incursions into dangerous areas could soon become irreversible practices.

7.       The criticisms made of the draft convention as presented to us focus mainly on two points: Article 6 (persons lacking capacity) and Article 15 (research on embryos in vitro). It must be admitted that these are two sensitive points which must be handled with particular care. Taken as a whole and in its spirit, the proposed text is in harmony with both national practices in the majority of our member states and with previous texts adopted by the Parliamentary Assembly and by the Committee of Ministers of the Council of Europe. I refer in particular to Assembly Recommendations 1046 on the use of human embryos and foetuses for diagnostic, therapeutic, scientific, industrial and commercial purposes and 1100 on the use of human embryos and foetuses in scientific research. Recommendation R (90) 3 of the Committee of Ministers on medical research on human beings, although limited in scope, was the logical and desired consequence to the Assembly's initiatives. The draft convention does not run counter to the substance of these texts in respect of the two points mentioned above, but the wording could be improved.

8.       Accordingly, in Article 6, we propose that interventions on a subject lacking capacity with no direct benefit to him or her be limited to the removal of regenerative tissues for transplantation purposes between persons of the same family, subject, as always, to the protection afforded by national legislation and in accordance with the principles of consent stipulated in Article 7.

      In Article 15, by insisting that research on embryos in vitro be limited to "non-viable" embryos, ie those which appear to have have no chance of developing, we are remaining in line with the thinking followed by the Assembly thus far and are significantly limiting the scope for abuse.2

      With regard to the question of "fourteen days" which has quite rightly aroused so much feeling, here again we are following the positions previously adopted by the Assembly. Amongst the various criteria proposed, the 14th day seems to have achieved the greatest degree of consensus.

      Finally, we feel it is essential to exclude Articles 15 and 16 (the latter relating to protection of the germ cell line) from the scope of Article 30, ie possible reservations by signatory states. This could serve as an additional guarantee to dispel all fear of chimeras, eugenics or other interventions on the genetic heritage.

B.       Background

9.       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 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.

10.       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.

11.       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.

12.       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 adopted definitively and unanimously by the Standing Committee, acting on behalf of the Parliamentary Assembly, as Recommendation 1160.

13.       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.

14.       The preliminary draft convention was discussed at a Meeting on Bioethics in Strasbourg on 7 February 1992, which was attended by representatives of the CDBI and of various Parliamentary Assembly committees (Committee on Science and Technology, Social, Health and Family Affairs Committee, Sub-Committee on Health, Family Affairs and Bioethics, Committee on Legal Affairs and Human Rights), representatives of the European Parliament and of certain national parliaments, and representatives of Non-Governmental Organisations, such as Mr Merminod from the European Ecumenical Commission for Church and Society (see AS/Science (43) PV 9).

15.       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 then 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.

C.       Human rights and bioethics

16.       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 draft convention.

17.       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.

18.       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.

19.       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 which does not include a definition of these terms. 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.

D.       Observations on the text of the draft convention3

20.       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.

21.       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 including research 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 decision. 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 Medical Research Council - EMRC (Professor Danielsson) over many years, and a Hearing in Paris on this and other matters, attended by Professors Lincoln, Rubellin-Devichi, 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. In principle, discoveries are not patentable.

-       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.

E.       Concluding remarks

22.       Six years have passed since the adoption of Doc. 5943 which proposed 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 draft 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 part of a complex and difficult process, the outcome of which will be of major significance for Europe and, indeed, the whole world.

23.       Following our acceptance of this text and its approval by the Committee of Ministers, it 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 it. 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 this document, 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.

24.       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 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.

25.       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.

26.       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 this proposal will be accepted.

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 1235 on psychiatry and human rights

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 adopted by the committee on 9 January 1994 by 19 votes against 0 and 8 abstentions.

Members of the committee: M. Roseta (Chairman), Mrs Terborg (Vice-Chairperson), Mrs Baastrup, MM. Bartodziej, Bauer, Berger, Birraux, Bogár, Borderas, Mrs Brenden (Alternate: Mr Lie), MM. Caccia, Cunliffe (Alternate: Lord Newall), De Decker, Dees, Del Gaudio, Dumont, Galley, Golu, Hurta, Inönü, Ivanov, Johansson, Mrs Kaliska, MM. Konecny, Konstandinidis, Leers, Lekberg, Lenzer, López Valdivielso (Alternate: Palacios), Luczak, Metelko, Mitchell, Mitolo, Mocioi, Moran, Panov, Pecriaux, Poças Santos, Požéla, Probst, Mrs Ragnarsdóttir, Mrs Stiborova, MM. Szabó, Tabladini (Alternate: Lorenzi), Theis, Sir Donald Thompson, MM. Jack Thompson, Tiuri, Vrettos, Yürür.

The names of the members present at the meeting are printed in italics.

Secretaries to the committee: Mr Perin and Mrs Theophilova.


1 1See Doc. 7124

2 1       I shall deal with this question in greater detail in section D of my report "Observations on the text of the convention".

3 1       The draft Convention and its explanatory report are set out in Document 7124 as transmitted to the Assembly on 21 June 1994.