Legal framework

The agency oversees organ and tissue procurement and transplantation activities and manages national registries, including the national transplant waiting list, the national refusal registry, the living donor follow-up registry, the cross-donor registry, as well as the corneal transplant database and the voluntary bone marrow donor registry.

The agency coordinates organ procurement, distribution and allocation of transplants, and ensures that the transplants procured are allocated to patients awaiting transplants in accordance with medical criteria and the principles of fairness. It is also responsible for monitoring the state of health of organ donors.

The agency reports to Parliament and the government on the development of knowledge and techniques for organ and tissue procurement and transplantation. It also supports medical and scientific research in this field.

It is responsible for monitoring, evaluating and controlling medical and biological activities, particularly those related to nanobiotechnologies, and for ensuring the transparency of these activities.

The agency is involved in shaping the regulations governing organ and tissue procurement and transplantation. It draws up rules of good practice and recommendations for healthcare professionals, and issues opinions on the authorization of healthcare establishments carrying out organ and tissue retrieval and transplantation activities. The agency assesses and controls the quality and safety of these activities by implementing biovigilance systems, analyzing reported incidents and publishing professional recommendations to improve practices.

Finally, it promotes organ and tissue donation, in collaboration with healthcare professionals, institutional partners and associations, through communication campaigns designed to raise public awareness.

In France, organ and tissue donation is governed by the bioethics laws, which are based on three main principles enshrined in the Public Health Code:

• presumed consent: all persons are considered donors after their death, unless they are registered on the National Register of Refusals or their next of kin express opposition;
• free donation: no payment may be demanded or made for a donation or transplant;
• anonymity between donor and recipient: information enabling the donor or recipient to be identified may not be communicated, except in the case of exceptions strictly defined by law.

These principles are supplemented by provisions designed to guarantee:

• fairness in the allocation of transplants, based on precise medical criteria and transparently established priorities ;
• safety and quality of care, ensured by protocols defined by law, including traceability of transplants and biovigilance;
• respect for human dignity and the integrity of the human body.

The missions and legal framework for organ and tissue donation and transplantation are set out in articles L. 1418-1 to L.1418-8 of the French Public Health Code. These provisions are set out in detail in decrees, orders and circulars. The Agence de la biomédecine oversees the implementation of these texts, supports healthcare professionals and provides resources to ensure optimum compliance with regulations.