Recommendation 1399 (1999)1
Xenotransplantation
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).
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