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COUNCIL OF EUROPE

COMMITTEE OF MINISTERS

________

RECOMMENDATION No. R (97) 15

OF THE COMMITTEE OF MINISTERS TO MEMBER STATES

ON XENOTRANSPLANTATION

(Adopted by the Committee of Ministers on 30 September 1997

at the 602nd meeting of the Ministers' Deputies)

Provisional version

 

The Committee of Ministers, under the terms of Article 15.b of the Statute of the Council of Europe,

Considering that the aim of the Council of Europe is to achieve greater unity between its members and that this aim may be pursued, inter alia, by the adoption of common action in the health field;

Taking into account Resolution (78) 29 on the harmonisation of legislation of member States relating to removal, grafting and transplantation of human substances, the Final Text of the 3rd Conference of European Health Ministers (Paris, 16-17 November 1987) and Articles 19 and 20 of the Convention on Human Rights and Biomedicine;

Considering that xenotransplantation, that is, the use of living organs, tissues and/or cells from animals, whether genetically modified or not, for transplantation into humans, may become a practicable therapeutic intervention in the very near future.

Aware that there is a risk of transmission of disease as a result of xenotransplantation procedures,

Recommends that Governments of member States should establish a mechanism for the registration and regulation of the following aspects of xenotransplantation with a view to minimising the risk of transmission of known or unknown diseases and infections to either the human or animal population:

i.     basic research and clinical trials;

ii.     the source and care of animals for use in xenotransplantation;

iii.     xenotransplantation programmes;

iv.     long term follow-up and review of xenograft recipients and the xenograft source animals.

 

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