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Ministers' Deputies CM Documents  679 Meeting, 15[-16] September 1999 10 Legal Questions
10.1 Steering Committee on Bioethics (CDBI)
CM(99)119 13 August 1999
Introduction 1. The Steering Committee on Bioethics (CDBI) met from 19 to 21 May 1999 at the Palace of Congresses in Oviedo (Spain). 2. The agenda and the list of participants are set out in Appendices I and II to this report respectively. Chart of signatures and ratifications of the Convention on Human Rights and Biomedicine and of the Protocol on the Prohibition of Cloning human beings 3. The Spanish delegation stated that the Government of its country has presented to the Parliament the law to ratify the Convention. 4. The delegations from Denmark, Finland, Portugal, Luxembourg, Romania and from Estonia said that the Convention might be ratified in their respective countries before the end of this year. Developments in the field of bioethics in member States, other States and international organisations. 5. The delegations from Finland and Poland noted that in order to take into account the provisions of the Oviedo Convention, their respective laws on organ transplantation are being amended. 6. Other delegations such as Finland, France, Greece, Slovenia and Switzerland stressed the existence of new laws or draft laws related to bioethics. 7. The Secretariat noted a document containing the contributions of some countries relating to developments in bioethics (document CDBI (99) 4). Working Party on Organ Transplantation (CDBI-CO-GT1) 8. The delegations are invited to submit any comments on the draft Protocol on Transplantation of Organs and Tissues of Human Origin and on its draft Explanatory report before 15 June (both texts have been declassified by the Committee of Ministers for consultation purposes). 9. The CDBI agreed to leave consideration of a possible hearing for non-governmental organisations to the Working Party’s Chair, in consultation with the Chair of the CDBI and the Secretariat. A written consultation with non-governmental organisations is in progress. 10. The draft Protocol has also been submitted for an opinion to the Parliamentary Assembly, from which three Committees have been solicited. Working Party on Xenotransplantation (CDBI/CDSP-XENO) 11. The CDBI took note of the written report prepared by the Secretariat ( document CDBI/CDSP-XENO RAP 1.99) on the first meeting of the Working Party on Xenotransplantation, and of the oral presentation made by the Chair of the Working Party, Mr Bart Wijnberg. 12. The CDBI approved:
13. The CDBI approved the decision taken by the Working Party to grant observer status to the Office International des Epizooties (OIE) and to the International Society for Xenotransplantation. It noted that Canada would also participate as an observer. Working Party on Biomedical Research (CDBI-CO-GT2) Presentation of the work of the Group on Biomedical Research 14. Dr. R. Boothman (Ireland), Chair of the Working Party on Biomedical Research, presented the report of the 7th meeting of the CDBI-CO-GT2 (CDBI-CO-GT2 (99) RAP7) including the most recent draft of the Protocol. 15. The Chair reported that at the meeting the Working Party had discussed a proposed rearrangement of the draft Protocol divided into separate sections applying to research on persons, biomedical data, and biological materials, but had found it overly repetitive. She stressed that the Secretariat had offered to prepare an alternative Protocol framework of general chapters applicable to all research followed by separate chapters addressing research on persons, data, and biological materials prior to the 8th meeting of the Working Party (14-16 September 1999). 16. The Secretariat also offered to prepare a comparison of the draft Protocol, the International Conference on Harmonisation (ICH) Guidelines on Good Clinical Practice, and the proposed European Union Directive on Good Clinical Practice, keeping in mind that the Protocol is intended to have a much broader scope than just the pharmaceutical research addressed in the other two instruments. Presentation of the hearing for Icelandic experts on the law on health sector database 17. The chairperson of the Working Party on Biomedical Research presented a summary of the meeting held on 1 March with Icelandic experts to discuss the Law on a Health sector database (report CDBI-CO-GT2 (99) 10). She also presented the worries expressed by several members of the Working Party and by the experts of the Working Party on Human Genetics (CDBI-CO-GT4) and by the experts of the Project Group on Data Protection (CJ-PD). 18. The CDBI thought that it is not empowered to give a formal opinion on a law which has not been formally submitted to it. On the other hand, it considered that it would be appropriate to study the general principles, which should govern the constitution and the use of medical databases of the type established by Icelandic law. Therefore, it agreed to ask the Working Party on Biomedical Research, in collaboration with the other relevant Groups of the Council of Europe, to formulate such general principles in order to present them to the CDBI next December. Working Party on the Protection of the Human Embryo and Foetus (CDBI-CO-GT3) 19. The Committee discussed the guidance relating to the division of the related issues (research on pregnant woman, research on embryo and foetus in vivo, and research on embryonic and foetal cells and tissues) between the Protocol on Biomedical Research and the Protocol on the Protection of the Human Embryo and Foetus (Document CDBI (99)12). 20. The Committee invited the two concerned Working Parties to hold a joint meeting in order to consider this question and address it. 21. Professor D. SERRÃO presented the report of the last meeting (document CDBI-CO-GT3/RAP9). He presented specifically the preliminary draft of principles relating to the constitution and destination of embryos in vitro (appendix IV of the document CDBI-CO-GT3/RAP9). He asked the delegations to send the Secretariat their comments on these principles. Working Party on Human Genetics (CDBI-CO-GT4) 22. Dr S. WINTER presented the report of the second meeting of the Working Party, held last January (document CDBI-CO-GT4/RAP2), and put forward the draft organisation of the Protocol, found in appendix III of the meeting report. 23. Concerning the possible revision of Recommendation R(92) 1 relating To the use of analysis of DNA within the framework of the criminal justice system, the Secretariat informed the Committee that Professor B. Ludes, consultant expert (an expert in forensic medicine, he has legal capacity to undertake procedures to determine the identification of individuals by means of genetic fingerprinting within the framework of both civil and criminal legal proceedings) will submit a study on the identification techniques of persons by DNA, for September 1999 (see document CDBI-CO-GT4 (99)6). Working Party on Psychiatry and Human rights (CDBI-PH) 24. The CDBI took note of the progress made by the Working Party and decided, after examination of the draft "White Paper" (see appendix VII of the document CDBI/RAP 16), to postpone its declassification, in order to allow the Working Party to add provisions pertaining to penal psychiatry, and to take into account the comments of the delegations, prior to declassification. Biotechnology Conference (CDBI-GT-TECH) 25. The CDBI proceeded to exchange views on the organisation and results of the Biotechnology Conference, and congratulated Dr Quintana and the Working Party for the preparation of the Conference and for its success. The CDBI warmly thanked the Spanish authorities for their welcome and assistance to the Conference. 26. The follow-up to the Conference was discussed within the CDBI. It agreed that Dr Quintana, the Chair of the CDBI, the General Rapporteur of the Conference, the Secretariat and, if possible, a representative of the Parliamentary Assembly, would work in order to elaborate a draft Proposal of follow-up to the Conference. An opinion on Recommendation 1213 would then be transmitted by the CDBI to the Committee of Ministers. Recommendation No. R... on the right to free choice in matters of sexuality and reproduction 27. The CDBI adopted an opinion in regard to this draft Recommendation, in which the Committee invited the CDEG to consider the possibility of circulating this text, after amendment, in the form of a report rather than a Recommendation (see appendix III). DEBRA project 28. The Committee took note that the next multilateral meeting of the DEBRA project will be held on 8 and 9 next November, at the Bureau of the Council of Europe in Paris. Conference on Health and Human Rights organised by the Nordic School of Public Health 29. The CDBI took note of the oral report made by Dr Winter, member of the CDBI and General Rapporteur of the Conference. Future activities of the Council of Europe in the field of health 30. Taking into account the proposals submitted to the Committee of Ministers by Denmark and the Netherlands, the CDBI discussed the future activities of the Council of Europe in the field of health. 31. All the delegations which took the floor felt that the activities of the CDBI fit into the first aim of the Council of Europe, which is normative activity in the field of Human rights. There was also agreement that the CDBI had the task of preparing the Protocols to the Convention and that the current composition of the CDBI (legal, policy, ethical, and medical) was well designed to fulfil this work programme. 32. All the delegations which addressed the proposed merger stated their opposition to merging the CDBI and the CDSP saying that the issues before the two committees were fundamentally different, and that such a merger would not be conducive to fulfilling the CDBI’s work programme. Several delegations added that given the role of the Council of Europe in Human rights it would be unthinkable for it to be without a multidisciplinary committee specifically dealing with bioethics. 33. In regard to health activities in the Council of Europe in general, the delegations emphasised the need to enhance efficiency and avoid duplication both within the Council of Europe and with other international organisations. It was noted that the health activities to be undertaken by the World Health Organization, and the European Union under the Treaty of Amsterdam needed to be taken into account. Delegates noted that within the Council of Europe issues such as access to health care and technical matters in the health field had links with the activities carried out in the Committee on Social Cohesion and in the relevant partial agreement, respectively. 34. Several delegations also expressed scepticism in regard to the use of an outside consultant to evaluate the health activities of the Council of Europe as they felt that this was mainly a political, not organisational question. Election of the Chair, Vice-Chair and Bureau 35. The CDBI elected Ms Elaine GADD (United Kingdom) as Chair and Ms Ruth REUSSER (Switzerland) as Vice-Chair of the Committee. 36. Mr Stefan WINTER (Germany) was elected member of the Bureau. Ms ŠIMONOVIC (Croatia) was also elected as a member of the Bureau, subject to the confirmation that Mr Ferenc OBERFRANK (Hungary) will be unable to continue as a Bureau member due to his new functions as Secretary of State for Health. Dates of future meetings 37. The next meeting of the Bureau of the CDBI will be held on 9 and 10 November 1999 in Paris. The next meetings of the plenary Committee will be held on 6 to 9 December 1999, and on 5 to 8 June 2000, in Strasbourg. Other business
38. The Secretariat stated that the Chair of the European Ethics Group of the European Commission had been contacted with the view of jointly establishing, a Bioethics documentation centre which would be computerised and accessible on the Internet. He underlined that the idea is to provide for reliable information, in English and in French, on legislation and case-law, while avoiding duplication with existing centres. On the other hand, this European centre could associate existing official centres (for example those which depend of national parliamentary offices). Additional information would be forthcoming when the proposal was further advanced. - Item of information on proposed co-operation to combat tuberculosis in the Russia prison system
39. The Secretariat informed the Committee that, following the request made by the Russian authorities, an exploratory meeting devoted to the problem of tuberculosis in the penitentiary system had been held in Moscow at the beginning of March 1999 with the participation of Russian authorities, international and non governmental organisations, and the Directorate of Legal Affairs of the Council of Europe. Additional information on further developments in this project would be given to the Committee.
40. On behalf of the Committee and also speaking personally, the Vice-Chair expressed gratitude to Mr Michaud for all that he had achieved for the CDBI during his period in office. Mr de Sola also referred to Mr Michaud's body of achievements in the bioethics field within the Council of Europe, particularly his contribution to the Protocol on the prohibition of cloning human beings. 41. Mr Michaud told all the members of the Committee of his gratitude and his great affection for their activities. He also thanked the Secretary of the Committee and all members of the Secretariat for their help. APPENDIX I List of participants
MEMBER STATES Albania – Mr Orion GLOZHENI, Président du Comité National d’Ethique, Tirana
Andorra - Austria - Dr Renate FALLY-KAUSEK, Referatsleiterin, Wien
Dr Michael STORMANN, Director, Wien Belgium - Mme Sylviane FRIART, Conseiller juridique adjoint, Bruxelles M. Peter MENU, Attaché, Bruxelles Bulgaria - Ms Silvia TOMOVA, conseiller juridique, Sofia
Croatia - Dr Ines ROMER, Adviser, Zagreb Dr Dubravka ŠIMONOVIC, Minister Plenipotentiary, New York Cyprus – Mrs Rena PETRIDOU, Senior Counsel, Nicosia
Czech Republic – Mr Jan PAYNE, MD, PhD, President of the Czech Central Ethics Committee, Praha Denmark - Ms Inger-Marie CONRADSEN, Head of Section, Copenhagen
Estonia - M. Arvo TIKK, Member of Bioethics Committee, Tartu Finland – Mrs Ritva HALILA, Secretary General, Helsinki
Dr Terhi HERMANSON, Senior Medical Officer, Helsinki France - M. André ALBERT, Magistrat, Paris M. Pierre BOUSSAROQUE, Secrétaire des Affaires Etrangères, Paris Mme Isabelle ERNY, Attachée d'Administration, Paris M. Jean MICHAUD (PRESIDENT) Vice-Président du Comité Consultatif National d'Ethique, Conseiller à la Cour de Cassation, Paris Georgia –
Germany – Dr Birgit-Maria BORN, Ministerialrätin, Bonn Prof. Dr. med. Elmar DOPPELFELD, Association de Comités d'Ethique, Köln Prof. Dr. Phil. Ludger HONNEFELDER, Philosophisches Seminar der Universität Bonn, Bonn PD Dr Stefan WINTER, Regierungsdirector, Köln Greece - Mrs Panagiota DALLA-VORGIA, Associate Professor, Athens
Hungary - Iceland - Dr Örn BJARNASON MD, DPH, Chief Physician and Director, Reykjavik
Ireland - Dr Rosemary BOOTHMAN, Deputy Chief Medical Officer, Dublin Italy - M. le Professeur Adriano BOMPIANI, Président, Ospedale Pediatrico "Bambino Gesù", Roma
Mme Adriana LORETI BEGHE, Roma Latvia - Dr Laima RUDZE, Deputy Head of Health care Supervision unit, Riga Liechtenstein -
Lithuania - M. Romualdas LEKEVICIUS, Professor of Genetics, Vilnius Luxembourg - M. Raymond MOUSTY, premier conseiller de gouvernement, Luxembourg
Malta - Prof. Maurice CAUCHI, Dept of Health, Merchant’s street, Malta Moldova - Mr Valery RUDIC, Director of Institute of Microbiology, Chisinau
Netherlands – M. Bart WIJNBERG, Ministry of Health, Ej Den Haag Mr Henriquez DE WAAL, Ministry of Health, Ej The Haghe Norway - Mrs Grete GJERTSEN, Adviser, Oslo
Ms Sylvi STORAAS, Assistant Director of Department, Oslo Mrs Anne Louise VALLE, Assistant Director General, Oslo Poland - Prof. Andrzej RZEPLINSKI, Head of Human Rights Research Centre, Warsaw Portugal - Dr Daniel SERRÃO, Professeur d'Ethique médicale, Porto
Romania - M. Vladimir BELIS, Président de la Commission roumaine pour la Bioéthique, Bucarest Russia - Mr Boris YOUDIN, Vice-Director of the Institute of Human Studies, Moscow
San Marino – M. Pietro BERTI, Medical Doctor, San Marino Slovakia - Prof. MD Ladislav SOLTES, Head of Institute of Medical Ethic and Bioethics, Bratislava
Slovenia - M. Joze V. TRONTELJ, National Medical Ethics Committee, Ljubljana Spain – Dr Octavi QUINTANA, Adjoint au Directeur Général de Insalud, Madrid
Sweden - Ms Lena JONSSON, Deputy Director, Stockholm Switzerland - Mme Ruth REUSSER, Directrice suppléante de l’Office fédéral de la Justice, Berne
"the Former Yugoslav Republic of Macedonia" - Turkey - M. Ergun ÖZSUNAY, Professor of Civil and Comparative Law, Istanbul
Ukraine - Mrs Zoreslava SHKIRYAK-NYZHNYK, Head of Department of Medical and Social Problems of Maternity and Childhood, Kyiv United Kingdom – Dr Elaine GADD, Senior Medical Officer, London
Parliamentary Assembly – M. Jean-François MATTEI, Marseille M. Gian-Reto PLATTNER, Ständerat, Basel European Community –
OBSERVERS Australia -
Canada – Mr Bernard STARKMAN, Senior Counsel, Ottawa Holy See – Dr Axel CARLBERG, Sweden
Rev. Prof. Maurice DOOLEY, Ireland Japan – M. Masahiro NISHIMORI, Director for planning, Tokyo USA - Dr Duane ALEXANDER, Director of the National Institute of Child Health and Human Development, USA
International Commission on Civil Status (CIEC) – Apologised European Science Foundation (ESF) - Dr David EVERED, Checkendon
OECD - UNESCO – Apologised
World Health Organisation (WHO) - CDSP - Prof. Dr. H. ROSCAM ABBING, Professor of Health Law, Ej Den Haag
CDDH - M. E ROUCOUNAS, Professor, Athens KEK – Church and Society Commission of the Conference of European Churches – Pasteur Richard FISCHER, Secrétaire Exécutif, Strasbourg
M. Egbert SCHROTEN, Gk Driebergen SECRETARIAT Directorate of Legal Affairs M. Carlos de SOLA, Secretary of the Steering Committee on Bioethics, Principal Administrative Officer M. Péteris ZILGALVIS, Administrative Officer Melle Sandrine SABATIER, Attaché Mme Martine GABOLDE, Attaché APPENDIX II AGENDA
1. Adoption of the Agenda 2. Chart of signatures and ratifications to the Convention on Human Rights and Biomedicine and the Protocol on the Prohibition of Cloning Human Beings 3. Developments in the field of bioethics in member States, other States and international organisations 4. Working Party on Organ Transplantation (CDBI-CO-GT1) a. Advancement of the national consultations on the draft Protocol on the Transplantation of Organs and Tissues of Human Origin
5. Working Party on Xenotransplantation (CDBI/CDSP-XENO)
6. Working Party on Biomedical Research (CDBI-CO-GT2)
7. Working Party on the Protection of the Human Embryo and Foetus (CDBI-CO-GT3)
8. Working Party on Human Genetics (CDBI-CO-GT4)
Appraisal of :
- the discussions during the meeting of the Bureau of the CJ-PD (Strasbourg, 18 March 1999) - the Working meeting with Professor Bertrand LUDES ( Expert consultant) 9. Working Party on harmonisation of medico-legal autopsy rules (CDBI-AR) Information concerning the adoption by the Committee of Ministers of the Recommendation R (99) 3 on the harmonisation of medico legal autopsy rules. 10. Working Party on Psychiatry and Human Rights (CDBI-PH)
11. Working Party for the preparation of the Biotechnology Conference (CDBI-GT- TECH)
13. DEBRA project
14. Conference on Health and Human Rights organised by the Nordic School of Public Health
15. Future activities of the Council of Europe in the field of health 16. Election of the Chair, Vice-Chair and Bureau To elect • Chair • If the occasion should arise, Vice-Chair • If the occasion should arise, a member of the Bureau 17. Dates of future meetings Next meeting of the Bureau of the CDBI:
Next CDBI meetings:
18. Other business a. Information on a European bioethics documentation centre b. Information on the tuberculosis in Russian prisons
APPENDIX III Opinion of the CDBI on the draft Recommendation on the right to free choice in matters of sexuality and reproduction
1. Having been requested to provide an opinion on the draft Recommendation on the right to free choice in matters of sexuality and reproduction, the CDBI has reviewed the draft Recommendation and has come to the following conclusions. 2. The Steering Committee on Bioethics (CDBI) recognised the importance of the subject matter dealt with, and noted the developments made at the International Conference on Population and Development in Cairo and the Fourth World Conference on Women in Beijing in this context. The CDBI also noted the further developments made at the Hague International Conference in February 1999 and suggests that these are taken into account. 3. The CDBI noted many useful aspects of the draft Recommendation on the right to free choice in matters of sexuality and reproduction. In particular, the CDBI welcomed the acknowledgement that choices in sexuality can only be exercised while respecting the rights of others, but felt that this aspect of the work needed to be strengthened, particularly in regard to human dignity, minors, and persons not able to consent. 4. The CDBI finds that measures provided for in clause III, section A(a) of the draft Recommendation In the field of family planning and contraception (with the exception of the paragraph on sterilisation) meet the requirements of the Convention in regard to information. The measures provide useful details in regard to providing information to men and women in this field. 5. Further, the CDBI noted that the draft Recommendation encouraged support for the work of non governmental organisations (NGOs), and the signature, ratification, and implementation of existing international instruments in these areas. 6. The CDBI also approved of clause III, section A(b) 12. to 15., which foresees the creation of a suitable environment for children in all areas of society, noting the importance of men in childcare, and sufficient childcare facilities. 7. The measures listed in clause III, section A(e) which seek to prevent sexual violence and to protect the physical integrity of the individual were also found to be useful by the CDBI. 8. While noting the many positive aspects of the draft Recommendation, the CDBI has also come to the conclusion that the draft Recommendation addresses a subject matter of great sensitivity, and that caution must be exercised in drafting legislation in this field. 9. The CDBI is concerned that free choice in matters of sexuality and free choice in matters of reproduction are treated jointly as if they constitute one and the same right. The CDBI finds that the interests at stake regarding the two rights are not comparable, as reproduction, unlike sexuality, concerns the bringing into existence of a third party. 10. The CDBI wishes to emphasise that a free choice in matters of sexuality and reproduction cannot be unlimited. Consequently, it expresses concern that the draft Recommendation puts too much weight on the rights of the individual to free choice in these areas in contrast to safeguards designed to protect the interests of the child, the individual, and the family, for instance. In particular, the problems related to paedophilia receive insufficient attention. Also, the treatment of adoption in the draft Recommendation seems to place insufficient emphasis on the protection of the interests of the child. 11. The CDBI expresses its concern that the draft Recommendation, in clause I., seems to confer the status of a fundamental right to the wish to enjoy the highest attainable level of physical and mental health in matters of sexuality and reproduction. As there is no general recognised legal right, no such legal right should be conferred on a single area of health, 12. In general, the CDBI considers that the draft Recommendation seeks to direct Member States in respect to their legal priorities in regard to the organisation of their national health care systems. While acknowledging the importance of the issues dealt with in the draft Recommendation, the CDBI notes that any legal prioritisation of health care measures must take into account existing resources and other health care needs. This is acknowledged in Article 3 of the Convention on Human Rights and Biomedicine, which addresses equitable access to health care. The CDBI notes that Article 3 does not afford priority even to life threatening diseases in the allocation of resources, thus making it especially difficult to accord such priority to reproductive and sexual health. 13. The CDBI notes that the provisions of the draft Recommendation addressing sterilisation and medically assisted reproduction may not be compatible with the existing legislation and policies of a number of Member States. In the case of adoption of the Recommendation, this could elicit a significant number of reservations, thus weakening the authority of the text. 14. For the aforementioned reasons, the CDBI considers that certain parts of the text would be very difficult to implement in the framework of a Recommendation, which is a legal instrument. Noting that there are many positive and useful aspects to the text, the CDBI recommends that the CDEG consider the possibility of disseminating it in the more suitable form of a report, after amendment. Should the CDEG wish to develop this text further, the CDBI would welcome the opportunity for further dialogue. |