Regulatory Developments in Xenotransplantation in France


Responsible Ministry/Agency: Établissement Français des Greffes

In 1995, the Etablissement Français des Greffes, the French national transplantation agency, formed an expert committee on xenotransplantation. In 1996, the committee produced a first draft document on "Good Practice Guidelines for the Production of Pigs". Ethical aspects of xenotransplantation are presently being considered by another committee, the French National Advisory Ethics Committee.

On 14 January 1998, the French Parliament adopted a draft law on new "Health and Safety Regulations", which includes a statement on xenotransplantation. This law stipulates that research on xenotransplantation will be regulated by existing biomedical research legislation and that applications for clinical trials will need approval of both the newly formed health safety agency (Agence Française de Sécurité Sanitaire des Produits de Santé) and the Ministry of Health. The text, however, seems to suggest that clinical trials will only be considered after the establishment of a national mechanism for long-term epidemiological surveillance.

Source: Julvez, NY'98.


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