Ministers’ Deputies
CM Documents

CM(2009)20 27 January 20091
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1050 Meeting, 11 March 2009
10 Legal questions


10.3 Steering Committee on Bioethics (CDBI)

Abridged report of the 35th meeting (Strasbourg, 2-5 December 2008)2

Item to be prepared by the GR-J at its meeting of 17 February 2009

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The Steering Committee on Bioethics (CDBI) held its 35th meeting in Strasbourg from 2 to 5 December 2008. The meeting agenda is appended to this abridged report.

ITEMS SUBMITTED TO THE COMMITTEE OF MINISTERS FOR INFORMATION

Developments in the field of bioethics in member states, other states, international organisations and other Council of Europe bodies
· One delegation informed the CDBI about the progress made at national level in procedures towards ratification of the Convention on Human Rights and Biomedicine.

Announcement by Spain of an initiative under its chairmanship of the Committee of Ministers
· As part of its current chairmanship of the Committee of Ministers of the Council of Europe, Spain considers it important to initiate a ministerial conference on research ethics in countries with emerging or developing economy. It wishes to invite Council of Europe member states as well as observers to draw up a charter of ethical principles for biomedical research conducted in third states, particularly in countries with emerging or developing economy.

· The following events would be arranged:

    v a meeting of the organising committee (10 experts, Madrid, April 2009)
    v a launch meeting (delegations and experts, spring 2009)
    v the conference itself (ministers responsible for research, Madrid, 2nd half of 2010)

Each of these events would last two days.

· Through the Carlos III Health Institute, the Spanish Ministry of Science and Innovation would cover the costs of the preparatory meeting (to be held at the Carlos III Institute’s headquarters) and the ministerial conference itself.

· As Chair of the Group of Specialists on Biomedical Research, Professor Elmar Doppelfeld said he greatly welcomed this initiative.

· After a number of other contributions, the Chair of CDBI summarised the Committee’s position as follows: the Committee regarded ethical aspects of biomedical research in third countries as an extremely important issue; it considered that the general principle on the subject set out in Article 29 of the Additional Protocol concerning Biomedical Research needed to be developed. Accordingly, the Committee welcomed the approach taken in the Spanish initiative, aiming at the adoption of a declaration of ethical principles, which would be common to member states and observer states of the Council of Europe, and which the relevant international organisations – particularly the European Union – and experts from countries with emerging or developing economy would also be invited to help draft. The CDBI would be glad to contribute to the implementation of this initiative.

Predictivity, genetic testing and insurance
· The CDBI had instructed the Working Party (Group of Specialists) on Predictivity, Genetic Testing and Insurance (CDBI-CO-GT4) to explore the various issues surrounding the concept of predictivity, without focusing exclusively on genetic testing. The Committee examined the conclusions of the meeting of the CDBI-CO-GT4 held on 6 and 7 November 2008.

· Delegations supported the Working Party’s conclusions, particularly the need to consider both genetic and non-genetic testing with a view to drafting a legal instrument on the use of the results of such tests/examinations in the insurance field.

· It was agreed that, at its next meeting, the Working Party should focus on insurance company risk assessments. It was also agreed that a human rights expert, if possible possessing an in-depth knowledge of the case-law relating to discrimination issues, should join the Working Party from its next meeting.

Biomedical research: preparation of a guide for research ethics committee members
· The CDBI held an initial discussion on the guide for research ethics committee members prepared by the Working Party (Group of Specialists) on Biomedical Research (CDBI-CO-GT2guide).

· It was agreed that a revised version of the guide would be prepared in the light of the comments to be forwarded by the delegations by 1 March 2009. That revised version would be submitted to the CDBI with a view to making it public for consultation.

Pre-implantation and pre-natal genetic tests: background paper to be prepared by the Secretariat
· The Secretariat informed the CDBI of its progress on the background paper the Committee had asked it to prepare on pre-implantation and pre-natal testing. The Secretariat intended to present the updated sections on clinical practices and the legal framework, along with the new section on ethics, to the CDBI in spring 2009 with a view to its publication. It foresaw the finalisation of the section on the principles that might be applicable by November 2009.

Legislative developments on nuclear transfer and their relationship with Article 18.2 of the Convention
· The Secretariat presented the CDBI with a paper summarising the information provided by the delegations regarding legislative developments on nuclear transfer and their relationship with Article 18.2 of the Convention. It was agreed that the paper should be updated regularly.

DEBRA Project
· At the request of the Moldovan authorities, a seminar on ethical and organisational aspects of organ transplantation had been held in Chisinau on 3 and 4 July 2008. In addition, at the request of the Ukrainian authorities, a seminar on ethical reviews of biomedical research was planned to be held in Kiev on 15 and 16 December 2008.

· The CDBI took note of two requests for 2009:

    - a request from the Slovakian Delegation for the organisation of a regional conference on “the impact of the Oviedo Convention in central and east European countries”, on the occasion of the 10th anniversary of the Convention on Human Rights and Biomedicine;
    - a request from the Serbian authorities for the organisation of a seminar on genetic testing.

Election of the Bureau
· The CDBI elected four members of the Bureau: Professor Eugenijus Gefenas (Lithuania), Ms Ritva Halila (Finland) and Professor Pavel Martasek (Czech Republic) were elected, with Ms Lisette Geldof Van Doorn (Netherlands) re-elected for a second term.

Seminar on decisions relating to medical treatment in end-of-life situations
· At its 34th meeting, the CDBI had agreed to hold a seminar in 2010 on decisions relating to medical treatment in end-of-life situations. The CDBI discussed the preparation of the seminar, which could be held in the first semester 2010.

· It was agreed that the Bureau of the CDBI would act as a steering group for the organisation of the seminar, and that its Chair, Ms Isabelle Erny, would co-ordinate the preparations.

· The decision was reiterated to focus the Seminar on decisions relating to medical treatment, and consequently not to cover the issues of euthanasia or assisted suicide.

Future activities and the CDBI’s working methods
Committee of Ministers questionnaire on relevance and added value
· The CDBI was informed of a request from the Committee of Ministers to those committees whose terms of reference were due to expire in 2009. The Committee of Ministers asked delegations to the CDBI to reply to a questionnaire on the relevance and added value of the latter’s work (doc. CDBI (2008) 35) by 20 December 2008.

Elaboration of an additional protocol on the protection of the human rights and dignity of persons with mental disorders
· On the basis of a document prepared by the Secretariat at the CDBI’s request, the majority of the delegations welcomed the proposed approach for a possible additional protocol to the Convention on Human Rights and emphasised the need for greater protection for persons with mental disorders. The CDBI agreed to continue exploring the advisability of elaborating an additional protocol, with the aim of taking a decision in Spring 2009. Furthermore, before taking any decision as to whether a proposal should be made to the Committee of Ministers on the elaboration of an additional protocol, it was agreed that the Steering Committee for Human Rights (CDDH) and the European Committee for the Prevention of Torture and Inhuman or Degrading Treatment or Punishment (CPT) should be asked for their opinions on the desirability of such an instrument. Lastly, the delegations would be sent a short questionnaire on the impact in their countries of Recommendation (2004) 10 concerning the protection of the human rights and dignity of persons with mental disorder.

Elaboration of guidelines on access to medical records
· At its 34th meeting, the CDBI had agreed to keep this subject on the list of possible future activities. Wishing to ensure the added value of any new activities envisaged, it had asked the Secretariat to supplement the information already provided about any work under way at EU level.
The Secretariat had been invited to present the CDBI’s work at the 67th plenary meeting of the Article 29 Working Party (advisory group set up under Article 29 of EU Directive 95/46/EC - Data protection). The Working Party had shown considerable interest in the CDBI’s activities. The possibility of co-operation with the CDBI might be explored in 2009.

Dates of the next meetings
· The CDBI agreed to hold its next plenary meeting in Madrid (Spain) from 27 to 29 April 2009, at the invitation of the Spanish authorities.

· The Bureau of the CDBI would meet in Strasbourg on 2 and 3 April 2009.

Anniversaries
· The possibility of holding a Conference focusing on the Oviedo Convention on the occasion of the 10th anniversary of the entry into force of the Convention was welcomed by the Slovenian authorities who will collaborate with the CDBI to organise this event under the Slovenian chairmanship of the Committee of Ministers. The aim of the conference would be to discuss the Convention’s impact and relevance and the enduring nature of the principles it had established.

· The Bureau of the CDBI would act as the steering group for the conference; the Vice- Chair, Ms Tina Garani-Papatos (Greece), would co-ordinate the various events organised to mark the anniversary of the Convention’s entry into force, both at the Council of Europe and in member states.

· The conference, scheduled for 3 November 2009, would also contribute to the Council of Europe’s 60th anniversary celebrations.

Other business
· The delegations to the CDBI proceeded to an exchange of views on the draft Recommendation on principles concerning continuing powers of attorney and advance directives for incapacity (doc. CJ-FA-GT2(2008)10 rev), drawn up by the Committee of Experts on Family Law (CJ-FA). The delegations’ comments would be passed on to the CJ-FA.

Appendix

Agenda

1. Adoption of the Agenda

2. Chart of signatures and ratifications of the Convention on Human Rights and Biomedicine, the Protocol on the Prohibition of Cloning Human Beings, the Protocol concerning Transplantation of Organs and Tissues of Human Origin, the Protocol concerning Biomedical Research and the Protocol concerning Genetic Testing for Health Purposes

3. Developments in the field of bioethics in member states, other states, international organisations, and other Council of Europe bodies

4. Strategic approach to the Council of Europe’s (public) health and related issues

5. Predictivity, genetic testing and insurances

6. Biomedical research: Elaboration of a guide for research ethics committee members

7. Prenatal genetic tests: background paper to be prepared by the Secretariat

8. Legislative developments on nuclear transfer and their relationship with Article 18.2 of the Convention

9. Cooperation program (DEBRA)

10. Election to the Bureau

11. Seminar on decisions relating to medical treatment in end-of-life situations

12. Future activities and working methods of the CDBI

13. Relations with other international bodies

14. Dates of the next meeting

15. Anniversaries

16. Other business

Note 1 This document has been classified restricted until examination by the Committee of Ministers.
Note 2 The complete report is reproduced in document CDBI/RAP35 and can be obtained from DGIII – Social Cohesion.


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