Council of Europe, Committee of Ministers, Recommendation No. R (97) 15 on Xenotransplantation

Council of Europe, Committee of Ministers, Recommendation No. R (97) 15 on Xenotransplantation (Sept. 30, 1997).

(Extract from the Official Gazette of the Council of Europe – January 1999)

1. The advancement of transplantation technology has allowed considerable success in human-to-human organ transplants (allotransplantation) and is promising a radical breakthrough for the transplantation of animal cells, tissues, and organs into humans (xenotransplantation).

2. Whereas rejection problems and the transfer of diseases can be satisfactorily controlled in allotransplantation, these risks remain today uncontrollable for xenotransplantations. Research to solve these problems should be stepped up prior to any clinical trial.

3. The transmission of animal retroviruses and prions into humans through xenotransplants may cause diseases which, if transmitted to other humans, may cause major pandemics.

4. The health risks of xenotransplantation must therefore be weighed up against their estimated benefits and methods must be found to eliminate any such risks.

5. There are considerable scientific, medical, ethical, social and legal problems that should be answered before clinical xenotransplantations proceed. The ethical problems include the acceptability of xenotransplantations as regards both humans and animals.

6. The Assembly, noting Recommendation No. R (97) 15 of the Committee of Ministers to member states on xenotransplantation, recommends that the Committee of Ministers:

i. work for the rapid introduction in all member states of a legally-binding moratorium on all clinical xenotransplantations, and consider the feasibility of elaborating a second 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: Convention on Human Rights and Biomedicine (European Treaty Series No. 164), on xenotransplantation;

ii. take steps to make this moratorium a worldwide legal agreement;

iii. ask its European Health Committee and Steering Committee on Bioethics to work out, in co-operation with the World Health Organisation, a strategy for balancing the ethical, medical, scientific, legal, social and public health aspects of xenotransplantation, before the scientific and medical establishment is permitted to proceed with clinical trials on humans.

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1. Assembly debate on 29 January 1999 (8th Sitting) (see Doc. 8166, report of the Committee on Science and Technology, rapporteur: Mr Plattner, and Doc. 8264, opinion of the Social, Health and Family Affairs Committee, rapporteur: Mr Dees).

Text adopted by the Assembly on 29 January 1999 (8th Sitting).