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662nd meeting - 2-8 March 1999

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APPENDIX 13
(item 10.2b)

TERMS OF REFERENCE

WORKING PARTY ON XENOTRANSPLANTATION

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1. Name of Committee: Working Party on Xenotransplantation (CDBI/CDSP-XENO)

2. Type of Committee: Working Party

3. Source of terms of reference: European Health Committee (CDSP) and Steering Committee on Bioethics (CDBI)

4. Terms of reference:

Under the responsibility of the Steering Committee on Bioethics (CDBI) and the European Health Committee (CDSP), taking into account Parliamentary Assembly Recommendation 1399 (1999) on xenotransplantation, the Working Party is instructed:

a. - to monitor developments in the field of xenotransplantation in member States and in other States, in particular in co-operation with other international organisations, currently addressing the issue (including the WHO, OECD and EU),

- to collect and make available information concerning regulations and research, clinical trials and current practice in this field,

- to make, at appropriate intervals, a report on the state of the art, for the attention of the Council of Europe member States.

To this end, the Group may, through experts from the CDBI and the CDSP, ask authorities of each member State to regularly provide any relevant information on xenotransplantation, in particular concerning experimental and clinical projects and evolution of (draft) regulations;

b. - to consider, in the light of the work undertaken under (a), and taking into account the various interests involved, (in particular the fundamental rights of the patients, the public health goals, the priorities in health care, the animal protection and the interests of industry), the implications of xenotransplantation for the member States of the Council of Europe, concerning:

(i) respect of ethical and legal principles;

(ii) protection of safety and quality regarding xenotransplantation, not only at short term, but also at long term (intergenerational aspects), including environmental aspects, in particular:

- medical aspects: safety and quality of organs and tissue from animals, breeding of animals and using conditions of organs and tissue of animal origin, antibody-based immune responses, physiological behaviour and risks of transmission of viruses or infections, consequences from a physiological point of view, long term follow-up and review of recipients,

- questions relating to international movement of organs and tissues of animal origin;

(iii) efficiency and cost-effectiveness, taking into account alternative solutions;

(iv) protection of animals;

c. to make recommendations on informing the public and media about xenotransplantation including organising a European Conference if appropriate;

d. on the basis of the above-mentioned items, to prepare draft guidelines on xenotransplantation, taking into account the activities carried out by other bodies, in particular international, and the necessity of world-wide co-operation.

5. Membership:

a. The Working Group shall be composed after mutual consultation of 5 members designated by the CDBI including at least 1 member of the CDBI; 5 members designated by the CDSP including at least 1 member of the CDSP; 2 members designated by the Multilateral Consultation of the Parties to the European Convention for the protection of vertebrate animals used for experimental and other scientific purposes, in consultation with the Chairmen of the other relevant Committees;

b. the Working Party will appoint its Chairman and its Vice-Chairman;

c. desirable qualifications of persons serving on the Working Party: specialists in the fields covered by the terms of reference, in particular in the field of ethics and law, medical research, clinical practice, epidemiology, immunology as well as animal protection;

d. the European Commission, WHO and OECD can send a representative to meetings of the Working Party, without the right to vote or defrayal of expenses;

e. the United States, as well as others States under invitation of the Working Party may send a representative, without the right to vote or defrayal of expenses;

f. the Parliamentary Assembly can also be represented in the CDBI/CDSP-XENO;

g. in order to discharge its functions, the Working Party or its Chair may seek the advice of experts. The experts may, at the request of the Working Party or its Chair, take part in the work of the Working Party.

6. Working structure and methods:

Two meetings per year.

7. Duration:

These terms of reference will expire on 31 December 2001.

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