Committee of Ministers

Comité des Ministres

Strasbourg, 6 August 1998

Restricted

CM(98)139

For consideration at the 641^st meeting

of the Ministers’ Deputies

(15 September 1998, B level, item 10.4)

STEERING COMMITTEE ON BIOETHICS (CDBI)

ABRIDGED REPORT OF THE 14^TH MEETING OF THE CDBI

Strasbourg, 9–12 June 1998

1. The Steering Committee on Bioethics (CDBI) met from 9 to 12 June 1998 at the Palais de l’Europe in Strasbourg.

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 the Additional Protocol on the prohibition of cloning human beings

3. The delegations from Cyprus, Poland and Russia said that a decision on the signing of the Convention was due to be taken this year. The Swiss delegation hoped that the Convention would be signed next year. The German delegation welcomed the progress achieved in Germany but said that the matter had been postponed until after the elections in September 1998. The question of the signature of the Convention had also been postponed in Bulgaria.

4. The delegations from France, Lithuania, Moldova, Slovenia, Turkey and Ukraine informed the CDBI that the ratification procedure for the Convention and the Protocol was under way. The Portuguese delegation said that the question of the ratification of these two texts would be looked at this year.

5. Italy had deferred ratification of the Convention until the adoption of a law on medically assisted procreation. Latvia had deferred ratification because of elections.

Working Party on Organ Transplantation (CDBI-CO-GT1)

a. Examination of the Recommendation of the CDBI-CO-GT1 on xenotransplantation

6. The CDBI considered the Recommendation of the CDBI-CO–GT1 on xenotransplantation (see Appendix III) and was asked either to approve this text advocating the setting up of a specific Working Party on xenotransplantation, or to decide to address the issue of xenotransplantation in the Protocol on organ transplantation.

7. Several delegations felt it would be wrong to incorporate xenotransplantation into the Protocol on transplantation since the latter dealt exclusively with transplantations between human beings and that it was, moreover, on the point of being finalised. They stressed that xenotransplantation raised issues which were far removed from those addressed in the current draft Protocol, such as animal protection.

8. The CDBI approved the Recommendation of the CDBI-CO-GT1 and decided that:

- the draft Protocol on organ transplantation would not address the issue of xenotransplantation;

- it did not foresee the preparation of a specific Protocol on xenotransplantation;

- a specific working party would be set up to consider xenotransplantation;

- the CDBI-CO-GT1 was instructed to draw up at its next meeting (12-14 October 1998), in close collaboration with the CDSP, draft terms of reference for the Working Party on Xenotransplantation, which would be placed under the joint authority of the CDBI and the CDSP;

- the draft terms of reference should be adopted at the next CDBI meeting (7-9 December 1998). If appropriate the draft terms of reference would then be submitted, in a joint approach with the CDSP, to the Committee of Ministers for adoption.

b. Examination of the draft Protocol on Organ Transplantation (See Appendix IV)

9. Dr BJARNASON (Iceland), Chair of the Working Party on organ transplantation (CDBI-CO-GT1) presented the latest version of the draft additional Protocol on Organ Transplantation. The Committee decided that, for legal reasons, a Protocol should not contain a global reference to another Protocol. However, reference to other Protocols could be made in the explanatory report.

10. The Committee looked at the CDBI-CO-GT1’s proposed change of title aimed at excluding xenotransplantation from the scope of the Protocol, namely "Draft Protocol on organ and tissue transplantation of human origin". Following other proposed titles, the Committee asked the Working Party to reconsider the matter.

11. The terms of Article 2 concerning exclusions from the scope of the Protocol were made more explicit.

12. With regard to embryo and foetal tissues, the Committee agreed that their removal should not be covered in the Protocol (this question would be dealt with by the Protocol on the protection of the human embryo and foetus). The Working Party was asked to tell whether the Protocol would nevertheless apply to their implantation.

13. The Committee discussed whether the Protocol should contain a definition of organs and tissues. Some delegations felt it absolutely essential that the Protocol contain such definitions since this was a text which stipulated what states could and could not do. Other delegations, however, felt it inadvisable to include definitions since the latter depended on current scientific knowledge and could therefore subsequently prove to be obsolete.

14. The Chair of the Working Party concluded that in accordance with the wishes of the vast majority of the Committee, it would be wiser to include definitions of tissues and organs in the explanatory report and not in the text of the Protocol.

15. One delegation raised the question of the approach to be adopted to newborn babies with anencephaly for whom general guidelines would be required. Since this issue had already been raised by the CDBI, it was restated that the Protocol would apply to anencephalics even though there might not be a provision dealing specifically with them. Consequently, if anencephalics were alive, the provisions relating to the removal of organs from living donors would apply; in cases where the death of anencephalics was declared in accordance with Article 14, the chapter on the removal of organs from deceased persons would apply. The explanatory report could contain the necessary clarifications.

16. Articles 1 (Object), 3 (Transplantation system), 8 (Evaluation of risks for the donor), 9 (Information), 10 (Consent of the living donor), 11 (Potential donors), 12 (Protection of persons not able to consent to organ and tissue removal) 14 (Declaration of death), 15 (Consent and authorisation), 17 (Disposal of a removed organ or tissue) and 19 (Confidentiality) also prompted observations from delegations. These would be taken into account by the Working Party at its next meeting.

17. Given that the draft Protocol on Organ Transplantation was almost completed, the Committee wondered about the advisability of organising a hearing of patients’ associations prior to its being adopted as there was a risk that adoption would be delayed whereas in principle it was due to take place next December. Nevertheless, in view of the fact that a hearing would enable a text on such a sensitive subject as organ transplants to be better understood, and thus accepted, the CDBI reserved the right to take a decision on this matter at a later date.

Examination of the draft Protocol on Biomedical Research (CDBI-CO-GT2) (see Appendix V)

18. Dr Boothman (Ireland), Chair of the Working Party on Biomedical Research (CDBI-CO-GT2), presented the latest version of the draft additional Protocol on Biomedical Research, and the most recent progress made by the Working Party at its 5th meeting held from 24 to 26 March 1998. In particular, she referred to the questions raised by the Working Party on which the CDBI’s opinion was required.

19. Following an indicative vote, the CDBI supported the principle of including in the scope of the Protocol provisions on the regulation of research on personal data. The Secretariat stated that when these additional provisions were being drafted, consideration should be given to the advisability of making a distinction in the Protocol between biological materials and data in the strict sense of the term. The Committee decided to invite an expert from the CJ-PD to take part in the Working Party’s meeting when it discussed this issue.

20. Dr Boothman said that the Working Party would like to receive written submissions from the CDBI delegations on minimal risk and minimal burden.

21. The CDBI approved the work plan of the Working Party (CDBI-CO-GT2) in 1998-1999 and its proposal to hold its next meeting in Porto, Portugal, in conjunction with the European Conference of National Ethics Committees in November 1998.

Working Party on the protection of the human embryo and foetus (CDBI-CO-GT3)

22. Prof. SERRÃO (Portugal), Chair of the Working Party on the protection of the human embryo and foetus (CDBI-CO-GT3) pointed out that each member of the Working Party had been asked to present a report on several of the subjects to be addressed in the draft Protocol. He stated that these reports (Doc CDBI-CO-GT3 (97) 7) reflected the personal views of the authors and not necessarily the position of the states from which the experts came.

23. He also stated that in accordance with the CDBI’s decision, the Working Party would not address issues preceding the creation of the embryo and that a large proportion of the Protocol would concern protection of the embryo in vitro.

24. Discussions between the CDBI delegations highlighted divergences between countries on the issues addressed by the Working Party. These differences of opinion concerning the number of embryos to be created in IVF procedures, the definition of embryo and the philosophical view of the question, prompted a reminder that the aim of the Protocol was to set out common practical standards and the suggestion that it would be preferable to concentrate on the values which the CDBI wished to protect in order to reach agreement on the level of protection to be given to embryos.

Working Party on Human Genetics (CDBI-CO-GT4)

25. Dr Winter (Germany), Chair of the Working Party on Human Genetics (CDBI-CO-GT4) said that the first meeting of the Working Party, initially scheduled for April 1998, had not taken place because of insufficient staff resources in the Secretariat. He confirmed that the first meeting of the Working Party would take place on 14, 15 and 16 September next.

26. He presented two initiatives which had provided the Working Party with relevant information which would help them in preparing the draft Protocol.

27. The first was a workshop held in Leuven on 21 and 22 April 1998 attended by a number of scientific experts. Financed and organised by the European Commission, it focused on medical, ethical and social aspects of new developments in genetic research (Document CDBI-CO-GT4 (98) 2 prepared by the Secretariat contains a summary of the workshop). The following themes were amongst those addressed: genetic screening of populations, developments in prenatal and pre-implantation diagnosis, gene therapy, the Human Genome Programme and education of the public in this field.

28. The second initiative was a hearing held on 8 June last in Strasbourg at which 9 European patients’ organisations were able to express their views on the various topics to be addressed by the Working Party on human genetics (a summary of the hearing and a complete report are available in documents CDBI-CO-GT4 (98) 4 and CDBI-CO-GT4 (98) 5 respectively). The travel and subsistence expenses of the representatives who attended were borne by the Interpharma association (Switzerland).

29. Following the above two meetings, the Working Party concluded that it was necessary to draw up a legal instrument offering a sufficiently flexible framework so as to take account of future developments in human genetics.

Presentation by Mr MOREAU (expert with the CJ-PD) on the use of genetic databases for identification purposes in criminal investigations

30. Mr MOREAU (Belgium), invited to the Project Group on Data Protection (CJ-PD) as expert on new technologies, gave a presentation on the use of genetic databases for identification purposes in criminal investigations.

31. He said that in the light of the gradual setting up of genetic databases for identification purposes in criminal investigations (advocated by both the European Commission and Interpol), it would be appropriate to review some of the solutions advanced in Council of Europe Recommendation R (92) 1 on the use of analysis of DNA within the framework of the criminal justice system which had not foreseen the problem of such databases.

32. He added that the CJ-PD would be discussing the matter at the meeting of its Bureau, scheduled for 30 September to 2 October next, and it was hoped that the CDBI would be represented at the meeting.

33. The CDBI appointed the following to attend the meeting: Dr Winter, Chair of the Working Party on Human Genetics, and Mr Michaud, Chair of the CDBI and the French Committee responsible for authorising the practice of genetic fingerprinting who would already be in Strasbourg on 30 September to attend the meeting of the CDBI-CO-GT3.

Working Party on the harmonisation of autopsy rules (CDBI-AR)

34. Prof. ANDRE (Belgique), Chair of the Working Party on the harmonisation of autopsy rules (CDBI-AR), presented the draft Recommendation on the harmonisation of medico-legal autopsy rules (see the full report: Document CDBI/RAP 14). He stressed the importance of harmonising regulations in this field.

35. He said that the draft had been submitted for opinion to various Steering Committees. Once these opinions had been examined, the draft Recommendation had been adopted by the CDBI-AR at its first reading.

36. Prof. ANDRE added that the draft explanatory memorandum had also been examined and provisionally adopted by the Working Party (Doc CDBI-AR (98) 2 rev. 1).

37. The CDBI examined the draft Recommendation on the harmonisation of medico-legal autopsy rules, placing particular emphasis on its scope and technical provisions.

38. With regard to the scope of the draft Recommendation, discussions focussed primarily on the need to retain the possibility of removing organs from victims of road accidents or suicides, on autopsies following medical errors and examination of the placenta and umbilical cord.

39. Concerning the technical aspects of autopsies, the Committee considered the provisions concerning the participation of two physicians in an autopsy (Principle II), the qualifications of experts required to carry out genetic identification (Principle III. 5) and the need for testimonies from individuals known to the victim.

40. The CBDI took note of all items submitted to it by the CDBI-AR and set out in the last meeting report (Doc. CDBI-AR (98) 16), and approved, subject to renewed scrutiny by the CDBI-AR, the items discussed at the current meeting:

- (i) the section of the draft Recommendation concerning "the scope of the Recommendation", listing the specific cases in which medico-legal autopsy ought to be performed, and

- (ii) the decision to draw up high-level technical rules for carrying out medico-legal autopsy that member states, where necessary, should gradually incorporate into practice and domestic law.

41. Following this discussion, the Chair of the CDBI-AR asked the delegations to forward their written observations to the Secretariat by the end of September 1998 at the latest. The CDBI-AR was to submit the final version of the draft Recommendation once it had held its last meeting in October next.

Working Party on psychiatry and human rights (CDBI-PH)

a. Presentation of the work of the CDBI-PH

42. Dr KINGDON (United Kingdom), Chair of the Working Party on psychiatry and human rights (CDBI-PH) presented to the CDBI the first draft guidelines to be incorporated in a preliminary draft Recommendation to ensure the protection of the human rights and dignity of persons suffering from mental disorder, especially those placed as involuntary patients in psychiatric establishment (see document CDBI-PH (98) 13). He stressed that this first draft was based on the conclusions drawn by the CDBI-PH at its three meetings and would be examined in detail by the Working Party at its 4th meeting (20-22 October 1998).

43. Several delegations raised various questions, in particular on the parts of the text relating to biomedical research^1, involuntary placement of minors, permanent infringement with the individual’s capacities to procreate and the confidentiality of patients’ files.

44. Delegations were asked to submit their written comments to the Secretariat in time for the next CDBI-PH meeting (20-22 October 1998).

^{1 The Chair of the CDBI-PH pointed out that the Working Party had not yet examined this question in detail and that a joint meeting with the CDBI's Working Party on Biomedical Research was scheduled for 1999.}

b. Election of 3 experts to the CDBI-PH

45. The CDBI appointed Prof. H E REMSCHMIDT (Germany), and Dr M. MULCAHY (Ireland) as members of the CDBI-PH.

46. With regard to the third member to be appointed and given the needs expressed by the CDBI-PH, the Committee agreed that the French delegation should nominate as soon as possible a psychiatrist with wide experience as expert with the courts. This nomination would be forwarded to the Chair of the CDBI-PH, who, in contact with the CDBI Chair and the Secretariat, would be able to take a decision on this question. This expert should be able to take part in the work of the CDBI-PH from its next meeting.

Working Party for the preparation of the Biotechnology Conference (CDBI-GT-TECH)

47. The CDBI examined the draft programme of the International Conference on the ethical issues arising from the application of biotechnology (see Appendix VII) drawn up by the Working Party responsible for the preparation of this event (CDBI-GT-TECH). The Conference would be based on case studies aimed at illustrating the full range of ethical questions raised by the various fields of applied biotechnology.

48. In response to comments from the CDBI, a number of clarifications were made in connection with the tasks assigned to the rapporteurs in order to ensure that the results of the Conference corresponded to the terms of reference given to the CDBI by the Committee of Ministers following suggestions from the Parliamentary Assembly.

49. Lastly, the CDBI agreed on the need to postpone the Conference initially scheduled for December 1998, in order to derive maximum benefit from the results of the studies currently being carried out, with the support of the European Commission, on the ethical problems of biotechnology and to ensure that the event was properly organised. It was decided that the Conference would be held from 16 to 19 May 1999.

50. In accordance with the decision of the Committee of Ministers (620th meeting of the Ministers' Deputies, 12 February 1998), the Conference would be held in Oviedo (Spain) at the invitation of the Spanish Government.

51. Consequently, the CDBI asked the Committee of Ministers to carry over to the 1999 Budget the appropriations set aside in the 1998 budget for the Conference. Following an exchange of letters between the Secretary General of the Council of Europe and the President of the European Commission, it had been arranged that the Commission would make a financial contribution to the organisation of the Conference. There would also be funding from the Oviedo local authorities and the Asturias government.

Participation of a sufficient number of experts from Central and Eastern Europe in the CDBI’s working parties

52. Following the Committee of Ministers’ decision to ensure that a sufficient number of experts from central and Eastern Europe participated in the working parties, the CDBI considered the nominations submitted by the Russian Federation and Ukraine and appointed the following experts:

- CDBI-CO-GT2: Prof. Z SHKIRYAK-NYZHNYK (Ukraine)

- CDBI-CO-GT3: Prof. L KURILO (Russia)

- CDBI-CO-GT4: Prof. V IVANOV (Russia).

53. No changes were made to the composition of CDBI-CO-GT1 as it would be holding only one more meeting prior to completing its task. Nevertheless, Prof. V GHUMAKOV (Russian Federation) would be invited by the Chair of the Working Party to submit his written comments.

54. However, the CDBI wished to point out that because of their limited number of members, no country had an automatic right to nominate an expert in the working parties and it was necessary to look at the progress made in each working party before deciding to add a member. It was also pointed out that participation by the above experts during the current financial year was subject to the availability of budgetary resources.

Demo droit – Ethical Review of Biomedical Research in Europe (DEBRA)

55. The Secretariat presented a report on the most recent seminars held in 1998 as part of the DEBRA project and emphasised that dates had been chosen for future bilateral seminars in the Czech Republic, Hungary, Poland and Romania.

56. The Committee expressed its gratitude to the European Commission for its support and to Norway for its support for further DEBRA activities in the Baltic countries. The Secretariat explained that the second bilateral stage of DEBRA had been proposed in 1999-2000 for the six countries not taking part in the first bilateral stage.

57. The Secretariat mentioned that future activities related to psychiatry and human rights in Central and Eastern Europe and the halting the spread of tuberculosis in prisons of the Russian Federation were currently being discussed.

European Conference of National Ethics Committees (Cometh)

58. Prof. Serrão, member of the Conference Bureau provided details of the next meeting of the European Conference of National Ethics Committees (Cometh) to be held on 9 and 10 November 1998 in Porto (Portugal).

59. The Conference would be divided into two parts (see Appendix VIII). The first day (the scientific day) would be devoted to "international biomedical research" and the second day would focus more specifically on the functioning of national ethics committees.

60. Prof. Serrão pointed out that the aim of the Conference, a non-governmental body, was to prompt debate on major ethical questions and to promote discussion on these items.

Joint meeting of the Group of Specialists on Incapable Adults (CJ-S-MI) and certain members of the CDBI concerning the draft Recommendation on principles concerning the legal protection of incapable adults

61. Following the decision taken at the 13th meeting of the CDBI, in response to the request from the Group of Specialists on Incapable Adults (CJ-S-MI) for an opinion on the above draft Recommendation, an exchange of views had been held on 9 June 1998 between the members of the CJ-S-MI and certain members of the CDBI. Dr GADD (United Kingdom) gave a report on this exchange of views.

62. She mentioned the generally favourable opinion of the text. All were agreed on the need for it to be compatible with the Convention on Human Rights and Biomedicine and on the fact that a Recommendation on incapable adults was essential in a society with an ever increasing number of incapable adults, resulting from ageing of the population.

Conference on Health and Human Rights organised by the "Nordic School of Public Health" (Sweden)

63. The Secretariat outlined the Conference on Health and Human Rights to be organised by the Nordic School of Public Health (Sweden), under the patronage of the Secretary General of the Council of Europe, in March 1999. CDBI delegations were asked to make proposals for the Conference programme and rapporteurs.

Sterilisation of the mentally disabled

64. The Committee examined the preliminary draft Report on the sterilisation of the mentally disabled written by a consultant (Doc. CDBI (98) 9). The report stated that only 9 countries out of 40 had replied to the questionnaire which was to serve as a basis for the report and the consultant asked for those states which had not yet replied to do so as quickly as possible.

Developments in the field of bioethics in member states, other states and international organisations

65. The delegations from Finland, France, Italy, the Netherlands, Poland, Portugal, Romania and Turkey provided information on recent legislation, draft legislation or legislative changes under way in the field of bioethics.

Information on the joint CDBI-CDSP Bureau meeting

66. The Chair reported on the results of the meeting held on 29 May 1998 between the CDBI Bureau and the Chair and two other representatives of the CDSP.

67. With regard to the draft Recommendation on medical examinations preceding employment or private insurance, the Chairs of the two Steering Committees observed that there was a divergence of opinion between the two Bureaus.

68. The CDSP felt that the draft recommendation, a non-binding text, not only would not pose an obstacle to the adoption of the Protocol on Human Genetics later, but would stimulate it. The Bureau of the CDBI felt that the overall draft Recommendation was useful, but that the provisions relating to genetic testing which took a stand on a delicate and very controversial issue requiring further discussion of all its various aspects, were inopportune and should be removed from the draft.

69. The CDBI supported the position of its Bureau and reiterated that the draft Recommendation should not contain provisions on genetic testing. Although two delegations could accept that the part referring to genetic testing prior to employment be maintained, the Committee felt that both sections on employment and insurance should be removed.

70. Consequently, the CDBI invited the CDSP to remove from the draft Recommendation the provisions relating to genetic testing and pointed out that the CDSP, like the CJ-PD, had been invited to take part in the work of the Working Party responsible for a draft Protocol on Human Genetics, in accordance with the terms of reference given by the Committee of Ministers.

71. The CDBI also took note of the plan to set up a Working Party on Xenotransplantation which would be under the joint authority of the CDBI and the CDSP.

Dates of future meetings

72. The CDBI’s next meeting would be held in Strasbourg from 7 to 10 December 1998. The CDBI Bureau would meet from 19 to 20 November 1998. The CDBI would hold its following meeting in Oviedo (Spain) in May 1999, following the Biotechnology Conference.

Programme of activities for 1999

73. The CDBI examined the draft intergovernmental programme of activities for 1999 concerning bioethics (Doc CDBI (98) 7). For the most part, this draft represented a continuation of the 1998 programme, subject to the following changes.

74. For CDBI-CO-GT2 (Biomedical Research), CDBI-CO-GT3 (Protection of the Human Embryo and Foetus) and CDBI-CO-GT4 (Human Genetics), one further expert had been added.

75. It was noted that in 1999 both the draft Protocol on Organ Transplantation and the draft Recommendation on the Harmonisation of Autopsy Rules were to be adopted and that the preliminary draft Protocol on Biomedical Research could be finalised for discussion.

76. It was also planned to set up a Working Party on Xenotransplantation which would be under the joint authority of the CDBI and the CDSP.

77. The Committee, taking note of the large number of tasks to be carried out by the Secretariat, repeated its request to the Committee of Ministers and the Secretary General for additional staffing resources.

Other business

78. The Secretariat presented the "Digest of selected national and European case-law in bioethical matters", published provisionally in document CDBI/INF (98) 7 under the title "Digest of selected medical law and bioethics cases in 5 countries". It had taken the initiative of producing this document since in bioethical matters it was often the courts, long before legislation, which were required to address and decide on problems posed by new technologies (for example with regard to medically assisted procreation) or to reconsider more traditional problems (in particular concerning consent to a medical act). The digest did not set out to be exhaustive but was confined to the most emblematic decisions, either because they established a case-law doctrine or because of their innovative character. This was a first attempt and thus was restricted to only a few countries, but the intention was to extend it to other states. It was also planned to compile a thematic index to make it easier to locate decisions on any given issue.

79. Many delegations expressed their appreciation of this document. The Committee hoped that it would be extended to include the case-law of the other European countries and the European Court of Human Rights and the Court of Justice of the European Communities. It was also suggested that it include, if possible, the case-law of observer countries to the Committee. The CDBI also hoped that it would be available in soft-copy format to enable computerised searching by theme.

80. It was also stressed that work should be continued on setting up a database of bioethics documents in the Council of Europe and making it available on Internet.

APPENDIX I

Agenda

1. Adoption of the Agenda

2. Chart of signatures and ratifications to the Convention on Human Rights and Biomedicine and to the Protocol on the prohibition of cloning human beings

3. Examination of the draft Protocol on organ transplantation (CDBI-CO-GT1)

a. Examination of the Recommendation of the CDBI-CO-GT1 on xenotransplantation

b.

Presentation of the draft Protocol on organ transplantation by Mr. Örn BJARNASON (Iceland), Chair of the CDBI-CO-GT1, and discussion

c.

Organisation of the future work of the CDBI-CO-GT1, including:

- Proposal to organise a hearing for associations before adoption of the draft Protocol

- Publication of the draft Protocol

 

4. Examination of the draft Protocol on biomedical research (CDBI-CO-GT2)

a. Presentation of the draft Protocol on biomedical research by Dr. Rosemary BOOTHMAN (Ireland), Chair of the CDBI-CO-GT2, and discussion

b. Proposal to hold the next meeting of the CDBI-CO-GT2 in Oporto (Portugal), following the European Conference of National Ethics Committees, on 9 and 10 November 1998

c. Organisation of the future work of the CDBI-CO-GT2

5. Work of the Working Party responsible for the preparation of the draft Protocol on the protection of the human embryo and foetus (CDBI-CO-GT3)

-

Presentation of the work of the Working Party by Professor Daniel SERRÃO (Portugal), Chair of the CDBI-CO-GT3, and discussion

 

6. Work of the Working Party responsible for the preparation of the draft Protocol on Human Genetics (CDBI-CO-GT4)

- Report of the genetics workshop (Brussels, 21-22 April 1998) by Stefan WINTER (Germany), Chair of the CDBI-CO-GT4, and discussion

7. Working Party on harmonisation of medico-legal autopsy rules (CDBI-AR)

- Presentation of the work of the CDBI-AR and of the draft Recommendation on the harmonisation of medico-legal autopsy rules

8. Working Party on psychiatry and human rights (CDBI-PH)

a. Presentation of the work of the CDBI-PH

b. Election of 3 experts of the CDBI-PH

9. Working Party for the preparation of the Biotechnology Conference (CDBI-GT-TECH)

a.

Examination of the proposal to set the date of the Biotechnology Conference for 16-19 May 1999

b.

Examination of the programme of the Biotechnology Conference

10. Participation of a sufficient number of experts from Central and Eastern Europe in the CDBI's working parties

11. DEBRA project

- Presentation by Peteris ZILGALVIS on the first three completed seminars (Latvia, Estonia and Lithuania)

-

Confirmation of dates of meetings by certain Central and Eastern European countries

12. European Conference of National Ethics Committees (ComEth)

- Presentation by Professor Daniel SERRÃO (Portugal) of the programme of the 4th Conference to be held in Oporto (Portugal) on 9 and 10 November 1998 and which will focus on:

• 1st day: "International biomedical research: ethical controversies"

• 2nd day: Round table on the functioning of ethics committees

13. Joint meeting of the Group of Specialists on Incapable Adults (CJ-S-MI) and certain members of the CDBI concerning the draft Recommendation on principles concerning the legal protection of incapable adults

a. Information on the joint meeting (9 June 1998, 9:00 am to 1:00 pm)

b. Comments by CDBI delegations on the draft Recommendation on principles concerning the legal protection of incapable adults

14. Conference on Health and Human Rights organised by the Nordic School of Public Health (Sweden)

a. Information on the Conference which will held in Strasbourg, in principle in early 1999, under the auspices of the Secretary General of the Council of Europe

b. Examination of the subjects to be dealt with and proposed experts

15. Sterilisation of the mentally disabled

-

Examination of the preliminary draft report on sterilisation of the mentally disabled, written by Ms Corinne DROUIN, expert consultant

16. Developments in the field of bioethics in member states, other states and international organisations

17. Information on the CDBI-CDSP joint Bureau meeting

18. Dates of future meetings

- Next meeting of the CDBI: 7-9 December 1998

- Meeting for 1999: Oviedo, May 1999 (together with the Biotechnology Conference)

19. Programme of activities for 1999

20. Other business

a. Digest of selected national and European case-law in bioethical matters.

b. Delay in the reception of certain documents.

APPENDIX II

List of participants

MEMBER STATES

Albania

Andorra

Austria

Belgium

Mme Sylviane FRIART, Conseiller Juridique Adjoint, BRUXELLES

M. Peter MENU, Attaché, Bruxelles

Bulgaria

Croatia

Cyprus

Czech Republic

Denmark

Ms Jette MERSING, Deputy Permanent Secretary, COPENHAGEN

Mr Peter SAUGMANN-JENSEN, MD, Senior Medical Officer, COPENHAGEN

Estonia

Finland

France

Mme Isabelle ERNY, Attachée d'Administration, Direction générale de la Santé au Secrétariat d'Etat à la Santé, PARIS

Mme Catherine MARCHI-UHEL, Magistrat détaché à la Sous-Direction des Droits de l'Homme, PARIS

M. Jean MICHAUD (CHAIR/PRESIDENT) Vice-Président du Comité Consultatif National d'Ethique, PARIS

Germany

Prof. Dr. phil., Ludger HONNEFELDER, Philosophisches Seminar der Universität Bonn, BONN

Ms Cornelia RUDLOFF-SCHÄFFER, Regierungsdirektorin, Bundesministerium der Justiz, BONN

Dr. Stefan WINTER (VICE-CHAIR/VICE-PRESIDENT) Regirungsdirektor, Bundesministerium für Gesundheit, BONN

Greece

Hungary

Iceland

Ireland

Italy

Prof. Claudio ZANGHI, Ministère des Affaires Etrangères, ROMA

Latvia

Liechtenstein

Lithuania

Luxembourg

Malta

Moldova

Netherlands

M. B. WIJNBERG, Ministry of Health, Welfare and Sport, RIJSWIJK

Norway

Ms Sylvi STORAAS, Assistant Director of Department, OSLO

Poland

Portugal

Romania

Russia

San Marino

Slovakia

Slovenia

Spain

Mr Antonio CUETO ESPINAR, Professeur de Santé Publique, ASTURIES,

Sweden

Switzerland

Mme Rafaella MARTINELLI, Office fédéral de la santé publique, BERNE

"The Former Yugoslav Republic of Macedonia" - Mrs Violeta Malinska PETRUSEVSKA, Social Medicine Specialist, SKOPJE

Turkey

Ukraine

United Kingdom

Parliamentary Assembly

European Community

M. José ELIZALDE-PEREZ, Chef de l'Unité XII.E.5, "Aspects éthiques et juridiques-Science du vivant", BRUXELLES

Working Party on the harmonisation of autopsy rules (CDBI-AR)

Working Party on psychiatry and human rights (CDBI-PH)

OBSERVATEURS

Australia

Canada

Ms Doris COOK, Analyste des politiques, Direction de l'information et de la politique de santé, OTTAWA

Holy See

Japan

USA

International Commisssion on Civil Status (CIEC)

European Science Foundation (ESF)

OECD

UNESCO

World Health Organisation

CDSP

CDDH

EECCS – European Ecumenical Commission for Church and Society

Mme Mireille JEMELIN, OLLON

STUDY VISITORS

Melle Corinne DROUIN

Mme Vassiliki LEONTIS

Mme Marie-Rose LOZANO

SECRETARIAT

Directorate of Legal Affairs

M. Carlos de SOLA, Secretary of the Steering Committee on Bioethics/Secrétaire du Comité directeur pour la bioéthique, Principal Administrative Officer, Administrateur Principal

M. Péteris ZILGALVIS, Administrative Officer/Administrateur

Mme Muriel DECOT, Attaché/Attaché

Melle Sandrine SABATIER, Attaché/Attaché

M. Philippe PFRUNNER, Attaché/Attaché

Mme Terry JOURNIAC, Assistant/Assistante

Mlle Christelle PERRIN, Assistant/Assistante

APPENDIX III

RECOMMENDATION OF THE WORKING GROUP ON

ORGAN TRANSPLANTATION (CDBI-CO-GT1)

ON XENOTRANSPLANTATION

(adopted on 3 March 1998)

The Working Party,

Considers that because organ and tissue transplantation are accepted and well-established treatments, whereas xenotransplantation remains unproven, it would not be appropriate to include both in the same protocol,

Has taken note of the progress made with research already under way on xenotransplantation, and is aware that stopping this research would jeopardise the hopes founded on this technique,

Considers that research on xenotransplantation must continue, so that the feasibility and risks can be evaluated,

Has taken note of the various texts on transplantation adopted by national and international bodies, including the Council of Europe, and particularly Committee of Ministers Recommendation No. R (97) 15 on xenotransplantation, the provisions of which are still valid,

The Working Party on Organ Transplantation, at its sixth meeting (2-4 March 1998), unanimously recommends:

- that no provisions to regulate xenotransplantation be inserted in the protocol on organ and tissue transplantation of human origin which is at present being prepared;

- that each member state to provide a regularly update on any work being done on xenotransplantation in their country. Reports should cover both relevant experimental or clinical project and development of regulatory frameworks;

- that any clinical trials carried out concerning xenotransplantation be closely monitored at national level;

- that a public debate, involving the various Council of Europe sectors concerned with xenotransplantation (CDBI, CDSP and animal welfare), the other relevant international organisations (European Union, WHO, OECD,¼ ) and the public at large, be organised at European level, with a view to achieving the broadest possible consensus on this issue;

- that a specific working party, comprising in particular members appointed by the CDBI, the CDSP and an animal welfare committee, be set up on xenotransplantation. Answerable to the CDBI and the CDSP, this working party should have about twelve members with the various types of expertise required (animal welfare, medical research, clinical, epidemiological, ethical, legal and policy-making).

APPENDIX IV

DRAFT PROTOCOL ON TRANSPLANTATION

OF ORGANS AND TISSUE OF HUMAN ORIGIN

Preamble

The Member States of the Council of Europe, the other States and the European Community signatories to this additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine,

Considering that the aim of the Council of Europe is the achievement of greater unity between its members and that one of the methods by which this aim is pursued is the maintenance and further realisation of human rights and fundamental freedoms;

Considering that progress in medical science, in particular in the field of organ and tissue transplantation, contributes to saving lives and improving their quality;

Considering that transplantation of organs is a specific but important part of the comprehensive health services offered to the population;

Considering that due to the shortage of organs, the number of donors must be enlarged by the implementation of an information policy on the significance of organ transplantation and by the promotion of the European co-operation in the field of organ transplantation;

Considering the ethical, psychological and the socio-cultural problems inherent in the transplantation of organs;

Considering that the aim of the Convention on human rights and biomedicine, in particular Article 1, is to protect the dignity, the identity and the integrity of all persons;

Conscious that the misuse of organ transplantation may lead to acts endangering human dignity;

Concerned that organ transplantation should take place under conditions that ensure the rights and freedom of donors, potential donors and recipients of organs;

Agreeing that in facilitating the transplantation of organs in the interest of patients in Europe, there is a need to protect individual rights and freedoms and to avoid the commercialisation of organ procurement, exchange and transplantation activities;

Taking into account Resolution (78) 29 on the harmonisation of legislation in the member states relating to the removal, grafting and transplantation of human substances, adopted by the Committee of Ministers of the Council of Europe on 11 May 1978;

Resolving to take such measures as are necessary to safeguard human dignity and the fundamental rights and freedoms of the individual with regard to the application of organ transplantation;

Have agreed as follows:

Chapter I

(Object and scope)

Article 1

Parties shall protect the dignity and identity of everyone and guarantee, without discrimination, respect for his or her integrity and other rights and fundamental freedoms with regard to organ and tissue transplantation of human origin.

Article 2

This protocol applies to the transplantation of organs and tissue of human origin carried out for therapeutic purposes.

This protocol does not apply to blood, blood constituents[, or germ tissue^*]. The protocol does not apply to the removal of embryonic and foetal organs or tissue.

For the purposes of this Protocol:

- the term "transplantation" covers the removal from one person of an organ or tissue and the grafting of that organ or tissue into another person including any procedure of preservation and/or storage;

- unless otherwise indicated, the term "removal" refers to removal for the purposes of transplantation.

Chapter II

(General provisions)

Article 3 (Transplantation system)

1. Each Party shall guarantee that a system exists to provide equitable access to transplantation services for patients which ensures that organs and tissue are allocated according to transparent criteria which are duly justified.

The persons or bodies responsible for the allocation decision shall be designated within this framework.

2. Without prejudice of provision of Article 19 regarding confidentiality, the transplantation system ensures an adequate transmission of information necessary for the traceability of organs and tissue.

Article 4

Any intervention in the field of organ or tissue transplantation must be carried out in accordance with relevant professional obligations and standards.

Organ or tissue grafting shall only be performed for medical indications for the recipient.

Article 5

All professionals involved in organ or tissue transplantation shall take all reasonable measures to minimise the risks of transmission of any disease to the recipient and to avoid any action which might affect the suitability of an organ for grafting.

Article 6

The Parties shall provide information for health professionals and for the public in general on the need for organs and tissue. They shall also provide information on the conditions relating to removal and grafting of organs and tissue, including systems of consent or authorisation, in particular with regard to removal from deceased persons.

Chapter III

(Organ removal from living persons)

Article 7 (General rule)

Removal of organs or tissue from a living person may be carried out solely for the therapeutic benefit of a recipient and where there is no suitable organ or tissue available from a deceased person and no other alternative therapeutic method of comparable effectiveness.

Article 8

Before organ and tissue removal, appropriate medical investigations and interventions shall be carried out to evaluate and reduce risks to the health of the donor.

The removal may not be carried out if there is an unacceptable risk to the life or health of the donor.

Article 9

The donor shall be given beforehand appropriate information as to the purpose and nature of the removal as well as on its consequences and risks.

He or she shall also be informed of his/her rights and the safeguards prescribed by law for his or her protection. In particular he or she shall be informed of his or her right to have access to independent advice about such risks by health professional having appropriate experience and who is not involved in the organ or tissue removal or subsequent transplantation procedures.

Article 10

Subject to Article 12 below, an organ or tissue may be removed from a living donor only after the person concerned has given free, informed and specific consent to it either in written form or before an official body.

The person concerned may freely withdraw consent at any time.

Article 11

Organ removal from a living donor shall only be carried out for the benefit of a recipient with whom the donor has an appropriate relationship as defined by law, or otherwise with the approval of an appropriate independent body.

Article 12

1. No organ and tissue removal may be carried out on a person who does not have the capacity to consent under Article 10.

2. Exceptionally and under the protective conditions prescribed by law, the removal of regenerative tissue from a person who does not have the capacity to consent may be authorised provided the following conditions are met:

- there is no compatible donor available who has the capacity to consent;

- the recipient is a brother or sister of the donor;

- the donation must have the potential to be life-saving for the recipient;

- the authorisation of his or her representative or an authority or a person or body provided for by law has been given specifically and in writing [and with the approval of the competent body];

[- an appropriate independent body has given its approval;]

- the potential donor concerned does not object.

Chapter IV

(Organ Removal from deceased persons)

Article 13

In response to the shortage of organs and tissue, the Parties shall take all appropriate measures to promote the procurement of organs and tissue from deceased persons in accordance with the provisions laid down in this Protocol.

Article 14

Organs or tissue shall not be removed from the body of a deceased person unless that person has been declared dead in accordance with the law.

Doctors having responsibilities for the care of potential organ or tissue recipients, or who participate directly in removal of organs or tissue from a donor or subsequent transplantation procedures, shall be other than from those establishing the death of the potential donor.

Article 15 (Consent and authorisation)

Organs or tissue shall not be removed from the body of a deceased person unless consent or authorisation required by law has been obtained.

The removal may not be carried out if the deceased person had objected to it.

If the wishes of the deceased are not sufficiently established, the team in charge of the removal of organs or tissue must beforehand endeavour to obtain testimony from relatives of the deceased.

Article 16

In transplantation the human body must be treated with respect and all reasonable measures shall be taken to restore the appearance of the corpse.

Chapter V

(Disposal of a removed organ or tissue)

Article 17

When an organ or tissue is removed for a purpose other than transplantation, it may be used for the purpose of transplantation only if this is done in conformity with appropriate information and consent procedures.

Chapter VI

(Prohibition of financial gain)

Article 18

1. The human body and its parts shall not, as such, give rise to financial gain or comparable advantage.

The aforementioned provision shall not prevent payments which do not constitute a financial gain or a comparable advantage, in particular:

- compensation of living donors for loss of earnings and any other justifiable expenses caused by the removal or by the related examinations;

- payment of a justifiable fee for legitimate medical or related technical services rendered in connection with transplantation;

- compensation in case of undue damage resulting from the removal on living persons.

2. Advertising the need for, or availability of, organs, with a view to offering or seeking financial gain or comparable advantage, shall be prohibited.

Chapter VII

(Confidentiality)

Article 19

The identity and any other personal data relating to either donor or recipient shall be considered as confidential and treated according to the rules relating to protection of private life.

This provision shall be interpreted without prejudice to the provisions making access possible to the identity of the donor or the recipient of organs insofar as this is required for medical purposes.

Chapter VIII

(Infringements of the provisions of the Protocol)

Article 20

The Parties shall provide appropriate judicial protection to prevent or to put a stop to an unlawful infringement of the rights and principles set forth in this Protocol at short notice.

Article 21 (Compensation for undue damage)

The person who has suffered undue damage resulting from transplantation procedures is entitled to fair compensation according to the conditions and procedures prescribed by law.

Article 22

Parties shall provide for appropriate sanctions to be applied in the event of infringement of the provisions contained in this Protocol.

Chapter IX

(Co-operation between Parties)

Article 23

The Parties shall take appropriate measures to ensure that there is efficient co-operation between them on organ transplantation, inter alia through information exchange.

In particular they shall undertake appropriate measures to facilitate the rapid and safe transportation of organs to and from their territory.

Chapter X

(Final provisions)

Article 24

As between the Parties, the provisions of Articles 1 to 23 of this Protocol shall be regarded as additional articles to the Convention, and all the provisions of the Convention shall apply accordingly.

Article 25

This Protocol shall be open for signature by Signatories of the Convention. It is subject to ratification, acceptance or approval. A Signatory may not ratify, accept or approve this Protocol without previously or simultaneously ratifying the Convention. Instruments of ratification, acceptance or approval shall be deposited with the Secretary General of the Council of Europe.

Article 26

1. This Protocol shall enter into force on the first day of the month following the expiration of a period of three months after the date on which 5 States have expressed their consent to be bound by the Protocol in accordance with the provisions of Article 25.

2. In respect of any State which subsequently expresses its consent to be bound by it, the Protocol shall enter into force on the first day of the month following the expiration of a period of three months after the date of the deposit of the instrument of ratification, acceptance or approval.

Article 27

The Secretary General of the Council of Europe shall notify the member States of the Council of Europe, any Party and any other State which has been invited to accede to the Convention of:

a. any signature;

b. the deposit of any instrument of ratification, acceptance or approval;

c. any date of entry into force of this Protocol in accordance with Article 26;

d. any other act, notification or declaration relating to this Protocol.

In witness whereof the undersigned, being duly authorised thereto, have signed this Protocol.

Done at Strasbourg, this …, in English and French, both texts being equally authentic, in a single copy which shall be deposited in the archives of the Council of Europe. The Secretary General of the Council of Europe shall transmit certified copies to each member State of the Council of Europe, to the non-member States which have participated in the elaboration of this Protocol and to any State invited to accede to the Convention.

APPENDIX V

DRAFT PROTOCOL ON BIOMEDICAL

CHAPTER I

General provisions

Article 1

Parties to this Protocol shall protect the dignity and identity of all human beings and guarantee everyone, without discrimination, respect for their integrity and other rights and fundamental freedoms with regard to any research in the field of biomedicine.

Article 2

This Protocol covers the full range of research activities on human beings in the field of biomedicine, from research into molecular and cellular mechanisms in health and disease to the study of individuals and populations in the environments in which they live or work. The scope of this Protocol extends to cover research based on personal data or biological materials of human origin, that can be attributed to an identifiable person or group.

This Protocol does not apply to research on embryos or foetuses¹.

Article 3

The interests and welfare of the human being participating in research shall prevail over the sole interest of society or science.

Article 4

Biomedical research shall be carried out freely, subject to the provisions of this Protocol and the other legal provisions ensuring the protection of the human being.

Article 5

Research on a person may only be undertaken if there is no alternative of comparable effectiveness to research on humans.

Article 6

The risks to which a person may be exposed to through participating in research must not be disproportionate to the potential benefits of the research. Where research is undertaken on women in the reproductive stage of their lives, particular consideration must be given to the possible impact on the health of the embryo, foetus (or child).

This provision is without prejudice to the stricter requirements of Article 17.

When in the course of the research unforeseen adverse events arise, the research shall be evaluated and the protocol shall be revised, if necessary, before any decision for continuation.

Article 7

The protection of persons participating in research and the advancement of knowledge in the field of biomedicine require that all such research meet appropriate quality standards.

Research involving interactions or interventions on persons shall be carried out under the direction of a doctor or person who exercises clinical responsibility and who possesses the necessary knowledge and qualifications to respond appropriately to any clinical contingency.

^{1 An additional Protocol on the Protection of the Human Embryo and Foetus is under preparation under the authority of the CDBI.}

CHAPTER II

Research Project

Article 8

Every research project must be documented. Clear information shall be provided as the basis for ethical evaluation (assessment) of each research project on the following namely:

i) the name of the responsible researcher

ii) qualifications and experience of researchers and responsible clinicians, where appropriate

iii) the aim and justification for the research documented by an updated survey of relevant scientific literature

iv) objectives of the research project

v) methods and procedures envisaged

vi) arrangements for cumulative data monitoring – including criteria for modifying or discontinuing the research project

vii) potential benefits from the research project

viii) the researchers’ own ethical considerations

ix) the categories of persons who would participate in the research project and how they are to be recruited

x) a comprehensive summary of the research project in lay language for the ethics committee

xi) justification for inclusion of any persons in special situations or persons not able to consent to research

xii) the nature and degree of any foreseeable risks and arrangements to react to such risks

xiii) arrangements for recording, evaluating, and reacting to unforeseen events

xiv) justification for a placebo or control group, alternative methods of treatment, or non-treatment if included

xv) documentation for consent or, in the case of persons not able to consent, authorisation for participating in the research project

xvi) details of adequate and explicit information to be provided to potential participants in the research project and the means proposed for provision of said information

xvii) arrangements to guarantee the confidentiality of personal data

xviii) arrangements for guaranteeing compensation for injury, including no fault injury, which may occur as a result of participation in the research project

xix) the funding arrangements including details of payments or other rewards to be given to health authorities, researchers and persons participating in the research project

xx) any potential conflicts of interest affecting the independence of the researcher

xxi) the bodies, including an ethics committee, to which the research project shall be submitted for an assessment or approval

xxii) a record of previous submissions, combined with a list of the bodies, including an ethics committee, to which the research project has been submitted for assessment or approval, a record of concurrent submissions of the proposal and the decisions, if any, taken

Article 9

Every research project shall be submitted to the authorised bodies for independent examination of the necessary scientific merit and ethical acceptability.

The primary function of the examination of the ethical acceptability, assuming that the condition of scientific quality has been met, is to protect the safety and rights of the research participants in conformity with the highest ethical standards, including scientific quality.

The ethical evaluation should draw on a broad range of expertise and experience reflecting adequate professional, lay, gender, and cultural views.

For the protection of persons participating in research the researcher shall inform the committee or committees in charge of ethical evaluation of progress, unforeseen events giving rise to new ethical issues, and final report of the research. It shall be ensured that the results of research projects be made available to participants.

CHAPTER III

Consent

Article 10

The persons asked to participate in a research project shall be given adequate information in a comprehensible format on the purpose, overall plan and methods to be applied in the research project, including the decisions of the ethics committee and competent bodies, according to national law. They shall also be informed (before participating in research):

i. of the foreseeable risks and burdens to them of the proposed research project as well as arrangements for compensation in case of loss or injury suffered because of the research,

ii. of their rights and the safeguards prescribed by law for their protection,

iii. of their right to withdraw consent at any time,

iv. arrangements to guarantee the confidentiality of personal data.

They shall be informed immediately of any relevant developments, in particular of any risks which have become apparent in the course of the research.

Article 11

It shall be ascertained by ethics committees that no undue influence will be exercised on persons to participate in research.

Article 12

1. No research involving interventions, including interactions, on persons may be carried out without the informed, free, express, specific and documented consent of the person undergoing it. Refusal to participate in research shall not prejudice the right of the individual to receive appropriate and timely medical care.

2. Such consent may be freely withdrawn by participants at any phase of the research without prejudice to their right to future medical care.

CHAPTER IV

Safety

Article 13

Research may be only carried out provided that all necessary preconditions as to its safety have been fulfilled.

Article 14

The researcher shall check the state of health of potential participants in research, including a medical examination if the research involves direct intervention, to ensure that individual participants who may be at increased risk in relation to a specific project be excluded.

Article 15

In research associated with treatment, patients assigned to control groups shall be assured of the established method of treatment.

Placebo treatment may be used in cases where there is no treatment of proven effectiveness, or where withdrawal or withholding of active treatment does not present unacceptable risk or burden.

CHAPTER V

Protection of persons not able to consent to research

Article 16

1. Research on a person without the capacity to consent to research may be undertaken only if all the above applicable conditions and all the following conditions are met:

i. the results of the research have the potential to produce real and direct benefit to his or her health;

ii. where appropriate, the persons undergoing research have been informed of their rights and the safeguards prescribed by law for their protection;

iii. research of comparable effectiveness cannot be carried out on individuals capable of giving consent;

iv. the necessary authorisation has been given specifically and in writing by the legal representative or an authority, person or body provided for by national law.

v. the person concerned does not object to participating in the research.

2. Exceptionally and under the protective conditions prescribed by law, where the research has not the potential to produce results of direct benefit to the health of the person concerned, such research may be authorised subject to the conditions above and to the following additional conditions:

i. the research has the aim of contributing, through significant improvement in the scientific understanding of the individual’s condition, disease or disorder, to the ultimate attainment of results capable of conferring benefit to the person concerned or to other persons in the same age category or afflicted with the same disease or disorder or having the same condition;

ii. the research entails only minimal risk and minimal burden for the individual concerned.

Under the protective conditions provided by law, the opinion of the minor shall be taken into consideration as an increasingly determining factor in proportion to his/her age and degree of maturity.

Article 17

1. For the purposes of Article 16 paragraph 2 it shall be considered that research bears a minimal risk if it is to be expected that, in terms of the nature and scale of the intervention, it will be associated, in the individual case, at the most with very slightly detrimental and temporary effects on the health of the person concerned.

2. Research within the meaning of Article 16 paragraph 2 only bears a minimal burden if it is to be expected that the symptoms or unpleasantness possibly associated with the intervention in the individual case will be felt by the person concerned to be, at the most, temporary and very slight. Where appropriate, persons enjoying the special confidence being a close relation of the person concerned shall be called in to evaluate the burden.

3. Any balancing of minimal risk and burden against expected benefits may not result in an increased level of risk or burden.

Article 18

Subject to the provisions of Articles 16 and 17, in recognised emergency situations research may be carried out on patients who are not able to give their consent on the condition that:

i. whenever possible, the relatives of the patients or persons close to them shall be consulted in order to ascertain the wishes of the patient. If there are indications that the patient would not agree, the research shall not be undertaken.

ii. the authorisation which is contemplated in Article 16, paragraph 1.iv has been provided under the specific protective conditions prescribed by internal law.

iii. the research has the aim of contributing, through significant improvement in the scientific understanding of the individual’s condition, disease or disorder, to the ultimate attainment of results capable of conferring benefit to the health of the persons participating or to other persons in comparable emergency situations.

iv. the research project has been approved by the competent body and authority as research to be carried out in emergency situations.

 

CHAPTER VI

Special situations

Article 19

Research may not be undertaken on pregnant or nursing women where their health or that of the foetus or child would not potentially benefit directly unless this research is aimed at benefiting other foetuses or children or women who are in the same position and the same scientific results cannot be obtained by research on women who are not pregnant or nursing.

Article 20

It shall be ascertained by ethics committee that no undue influence will be exercised on dependent persons and vulnerable groups in society.

Article 21

Research may only be undertaken on persons deprived of liberty exceptionally and under the protective conditions prescribed by law if all of the following conditions are met:

i. it has the potential to produce a significant benefit to their health or of people in the same situation

ii. the conditions of Article 20 are fulfilled, and

iii. the necessary authorisation has been given by the competent body provided for by national law.

 

CHAPTER VII

Confidentiality

Article 22

Any information of a personal nature obtained during biomedical research shall be considered as confidential and treated according to the rules relating to the protection of private life.

Information collected on their health shall be made accessible to participants in research, in conformity with the provisions of Article 10 of the Convention².

Article 23

1. Whenever possible, personal data collected or used for biomedical research purposes shall be anonymised.

2. However, if such anonymisation would make the biomedical research project impossible or impracticable and the project were to be carried out for legitimate purposes, it could be carried out with personal data on condition that:

a. the data subject has given his/her consent for that or further research purposes; or

b. disclosure of data for the purpose of a defined biomedical research project concerning an important interest has been authorised by the body or bodies designated by domestic law, but only if:

i. the data subject has not expressly opposed disclosure; and

ii. despite reasonable efforts, it would be impracticable to contact the data subject to seek his consent; and

iii. the interests of the research project justify the authorisation; or

c. the scientific research is provided for by law and constitutes a necessary measure for public health reasons.

3. Personal data used for biomedical research may not be published in a form which enables the data subject to be identified, unless they have given their consent for the publication and publication is permitted by law.

CHAPTER VIII

Reimbursement of expenses

Article 24 (Reimbursement of expenses)

Persons participating in research shall not be offered any financial or other inducement which may influence their free consent.

Expenses and any financial loss involved in participation in research may be refunded.

If persons undergoing research are legally incapacitated, their legal representatives shall not receive any form of remuneration whatever.

CHAPTER IX

Research in states not party to this protocol

Article 25

Promoters of research based in the territory of a Party to this Protocol and researchers who are nationals of states Party to it who envisage to carry out research in a state not Party to this protocol, shall satisfy both the conditions applicable in the state in the territory of which research is to be carried out and the fundamental ethical standards and safety guarantees laid down in this protocol.

Such researchers shall:

- submit research projects to ethics committees in their home countries, and

- inform of research to be carried out in States not Party to this Protocol.

CHAPTER X

Infringement of the provisions of the Protocol

Article 26

The Parties shall provide appropriate judicial protection to prevent or put a stop to an unlawful infringement of the rights and principles set forth in this Protocol at short notice.

Article 27

Persons participating in research and where appropriate their dependants shall be adequately compensated for loss and/or injury caused by the research.

Article 28

Parties shall provide for appropriate sanctions to be applied in the event of infringement of the provisions contained in this Protocol.

CHAPTER XI

Relation between this Protocol and other provisions

Article 29

(The Working Party envisaged including an article like the following (cited from the Convention), but it did not have time to consider it)

1. No restrictions shall be placed on the exercise of the rights and protective provisions contained in this Convention other than such as are prescribed by law and are necessary in a democratic society in the interest of public safety, for the prevention of crime, for the protection of public health or for the protection of the rights and freedoms of others.

2. The restrictions contemplated in the preceding paragraph may not be placed on Articles provisional recommendation of the Secretariat: 1 to 19.

Article 30

None of the provisions of this protocol shall be interpreted as limiting or otherwise affecting the possibility for a Party to grant persons participating in research a wider measure of protection than is stipulated in this protocol.

CHAPTER XII

Final provisions

Article 31

As between the Parties, the provisions of Article 1 to 26 shall be regarded as additional articles to the Convention, and all the provisions of the Convention shall apply accordingly.

Article 32

This Protocol shall be open for signature by States which have signed the Convention. It is subject to ratification, acceptance or approval. A State Signatory] may not ratify, accept or approve this Protocol without previously or simultaneously ratifying the Convention. Instruments of ratification, acceptance or approval shall be deposited with the Secretary General of the Council of Europe.

Article 33

1. This Protocol shall enter into force on the first day of the month following the expiration of a period of three months after the date on which 5 States have expressed their consent to be bound by the Protocol in accordance with the Provisions of Article 28.

2. In respect of any State which subsequently expresses its consent to be bound by it, the Protocol shall enter into force on the first day of the month following the expiration of a period of three months after the date of the deposit of the instrument of ratification, acceptance or approval.

Article 34

The Secretary General of the Council of Europe shall notify the member states of the Council of Europe, any Party and any other State which has been invited to accede to the Protocol of:

a. any signature;

b. the deposit of any instrument of ratification, acceptance or approval;

c. any date of entry into force of this Protocol in accordance with Article 29;

d. any other act, notification or declaration relating to this Protocol.

In witness whereof the undersigned, being duly authorised thereto, have signed this Protocol.

Done at Strasbourg, this …., in English and French, both texts being equally authentic, in a single copy which shall be deposited in the archives of the Council of Europe. The Secretary General of the Council of Europe shall transmit certified copies to each member State of the Council of Europe, to the non-member States which have participated in the elaboration of this Protocol and to any State invited to accede to the Convention.

APPENDIX VI

INTERNATIONAL CONFERENCE ON THE ETHICAL ISSUES ARISING FROM THE APPLICATION OF BIOTECHNOLOGY

DRAFT PROGRAMME OF THE CONFERENCE

SUNDAY 16 MAY 1999

6.00 pm Opening of the Conference

6.30 pm General introduction

7.30 pm Cocktail

MONDAY 17 MAY 1999

9.00 am ENVIRONMENT (three case studies)

11.30 am Break

12.00 am FOOD (three case studies)

1.30 pm Lunch

3.30 pm RESEARCH (two case studies)

5.00 pm Break

5.30 pm RESEARCH (two case studies)

7.00 pm End of Day

TUESDAY 18 MAY 1999

9.00 am HUMAN HEALTH (three case studies)

10.30 am Break

11.00 am INDUSTRY (four case studies)

1.00 pm Lunch

3.00 pm ANIMAL WELFARE (three case studies)

4.30 pm Break

5.00 pm NORTH/SOUTH - EAST/WEST (four case studies)

7.00 pm End of Day

WEDNESDAY 19 MAY 1999

9.00 am PUBLIC PERCEPTION - MEDIA (four case studies)

11.30 am Break

12.00 am Legal overview

12.15 am General rapporteur

1.00 pm Closing speech

1.30 pm END OF CONFERENCE

APPENDIX VII

EUROPEAN CONFERENCE OF NATIONAL ETHICS COMMITTEE

Provisional Programme

Sunday 8 November 1998

Reception at 8pm

Hotel Meridien

Avenida da Boavista

Porto

Monday 9 November 1998

International Biomedical Research

9:00 am Opening session

Mr Jose Mariano Gago (Portuguese Minister of Science)

(to be confirmed)

Mr Daniel Tarschys (Secretary General of the Council of Europe)

Mr Luis Archer (Chair of the National Portuguese Ethics Committee)

Ms Nicole Questiaux (Chair of the Conference)

9:30 am General introduction

Session Chair: Mr Jean Michaud (France)

Mr P. Riis (Denmark)

- double standard of therapy

- research ethics committees

Representative of the National Bioethics Advisory Commission of the United States of America

- AIDS research

10:00 am

10:45 am

11:05 am Pharmaceutical research

Session Chair: Mr Georges Binamé (Belgium)

Mr W. Osswald (Portugal)

Mr J. Reden (European Federation of Pharmaceutical Industry Associations)

11:35 am

11:55 am Central and Eastern Europe

Session chair: Mr Elmar Doppelfeld (Germany)

Mr Y. Lopukhin (Russian Federation)

Mr E. Gefenas (Lithuania)

Mr P. Zilgalvis (Council of Europe)

12:40 pm

1:00 pm

2:45 pm "Orphan bioethics¹"

Session Chair: Mr Eugenijus Gefenas (Lithuania)

Mr M. Gentilini (France)

Mr P. Effa (Cameroun)

3:15 pm

3:35 pm Developing countries: research partners or research subjects?

Session Chair: Mr Daniel Serrão (Portugal)

Ms C. Bomtempo Ducca de Freitas (Brazil)

Mr P. Cleaton-Jones (South Africa)

Mr A. Berbich (Morocco)

4:20 pm

4:45 pm

(to be confirmed)

5:00 pm

5:20 pm Back to ethics

Session Chair: Ms Linda Nielsen (Denmark)

Ms R Boothman (Chairperson of the Working Party on biomedical research - Council of Europe)

Ms E. Cresson (Commissioner - European Commission)

(to be confirmed)

6:00 pm Closing session

Session Chair: Ms Nicole Questiaux (France)

Mrs Maria de Belém (Portuguese Minister of Health)

Representative of the Parliamentary Assembly of the Council of Europe

^{1 Research on diseases and treatments with little or no commercial potential due to the 0rarity of the disease and/or the relative poverty of those who may contract it.}

Tuesday 10 November 1998

Round table on the functioning of national ethics committees

10:00 am Composition of the Committee and conditions

11:10 am

11:30 am

12:30 am

2:00 pm

3:00 pm

3:15 pm

4:15 pm

4:30 pm

5:30 pm

8: 00 pm Diner

N. B.: