Legal framework

The Agency oversees bone marrow and cord blood donation and transplantation activities. It manages national registries, including the voluntary bone marrow donor registry (also known as France Greffe de Moelle), which registers volunteers, requests queries from all national and international donor registries and placental blood banks, and organizes collections for transplant physicians; and the French Placental Blood Network. The Agency is also responsible for monitoring the health of bone marrow and cord blood donors.

The Agency reports to Parliament and the Government on the development of knowledge and techniques for bone marrow and cord blood collection 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 the development of regulations governing bone marrow and cord blood collection 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 bone marrow and cord blood collection 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 bone marrow and cord blood donation, in collaboration with healthcare professionals, institutional partners and associations, through communication campaigns designed to raise public awareness.

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

• voluntary and informed consent: all bone marrow and cord blood donations are based on the donor's prior, free and informed consent. The donor may change his or her mind at any time prior to the donation, without having to justify his or her decision;
• free donation: no payment may be demanded or made in exchange for donation, in accordance with the principle of non-commercialization of the human body;
• anonymity between donor and recipient: information enabling the donor or recipient to be identified may not be communicated, except in the case of strictly regulated exceptions, such as intra-family donations or certain specific situations.

These principles are supplemented by provisions designed to guarantee :

• the safety and quality of transplants, through the implementation of regulated protocols including transplant traceability and biovigilance ;
• fair access to transplants, based on medical criteria established transparently by national and international registries;
• respect for human dignity and the fundamental rights of donors and recipients.

The missions and legal framework of bone marrow and cord blood 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.