Xenotransplantation or the transplantation into humans of tissues or cells of animal origin for therapeutic purposes was first conceived almost a hundred years ago. There have been sporadic instances of clinical applications in the history of medicine since then but interest was rekindled in the early 90s as a result of progress in the field of biology, the growing shortage of human organs, and the interest shown by industry at that time.

Xenotransplantation raises a large number of ethical, medical, biological and economic questions. In many countries, the scientific community and the health authorities are concerned about the attendant risk of transmitting infectious animal viruses to the receiving patient and, possibly, to the patient's family and friends, or indeed the whole of humankind on an international scale.

On 29 January 1999, the Parliamentary Assembly of the Council of Europe unanimously adopted, in the name of the precautionary principle, Recommendation 1399(1999) on xenotransplantation¹, which among other things called for a legally binding moratorium on all xenotransplantation on humans, including in clinical trials.

The Committee of Ministers of the Council of Europe has not taken a position on the proposed moratorium, but decided to set up a Working Party on xenotransplantation, tasked, under the joint responsibility of the Steering Committee on Bioethics and the European Health Committee, with drawing up draft guidelines on xenotransplantation within three years².

This multidisciplinary Working Party has twelve members, specialists in ethics, law, medical research, clinical practice, epidemiology, immunology and animal protection. It plans to organise several hearings in the near future. It will be working in close co-operation with the Parliamentary Assembly of the Council of Europe and the European Commission, and with other international organisations or states particularly active in this field, including WHO, OECD and Canada, all represented at the Working Party meetings as observers. The international dimension of collaboration in the Working Party is essential given the need to standardise practices, in particular with regard to the regulations governing xenotransplantation and monitoring the health risks.

Accordingly, the Working Party will be looking at xenotransplantation from as wide a perspective as possible, placing particular emphasis on safety aspects. It will certainly be dealing as a matter of priority with the essential preconditions to be fulfilled before any transition to clinical trials and the need to draw up a precise legal framework for clinical trials in whatever form they might take. In this regard, the Working Party shares the views expressed in Parliamentary Assembly Recommendation 1399(1999) and believes that a moratorium on xenotransplantation clinical trials should be declared in any country which does not have appropriate regulation on this matter.

Insofar as choices concerning xenotransplantation affect the whole of society, the Working Party feels that public information and debate should form an essential part of its activities. It will therefore place emphasis on recommendations on informing the public and setting up a debate on the future prospects of xenotransplants, and intends to organise a European Conference dealing with this topic aimed at non-specialists.

Bart WIJNBERG, Chair of the Working Party on Xenotransplantation
Didier HOUSSIN, Vice-Chair of the Working Party on Xenotransplantation Council of Europe
67075 Strasbourg CEDEX
France

¹ Recommendation 1399 (1999) on xenotransplantation, Parliamentary Assembly of the Council of Europe, 29 January 1999
² Reply of the Ministers Deputies of the Council of Europe to the Recommendation 1399 (1999) on xenotransplantation of the Parliamentary Assembly, 662nd meeting, 2-8 March 1999, Document 662/10.1a - Appendix: Terms of reference of the Working Party on xenotransplantation.