Legal framework

The Agency participates in the development of regulations governing gamete donation and medically assisted procreation. It issues opinions to regional health agencies, which are responsible for issuing activity authorizations to establishments carrying out these activities. The Agency issues authorizations for the transfer of embryos to and from France. It also issues gamete import and export authorizations to establishments, organizations, health cooperation groups and laboratories authorized to carry out medically assisted procreation activities.

The Agency monitors, evaluates and controls medically assisted procreation, and ensures the transparency of this activity. To this end, it regularly publishes the results of the activities of assisted reproduction centers. The Agency draws up rules of good practice and formulates recommendations for healthcare professionals. It also implements vigilance measures in the field of medically assisted procreation. As such, it proposes rules for the allocation of gametes and embryos.

The Agency assesses the possible consequences of medically assisted procreation on the health of those who have recourse to it, oocyte donors and the children born from them.

The Agency manages national registers, including the gamete and embryo donor register and the register of medically assisted procreation activities.

The Agency supports medical and scientific research, and keeps Parliament and the Government informed of developments in knowledge and techniques of medically assisted procreation.

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

In France, gamete 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 gamete 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 gamete collection, without having to justify his or her decision;
• free donation: no payment may be demanded or made in exchange for the donation, in accordance with the principle of non-commercialization of the human body;
• anonymity between donor and recipient: information enabling the identification of the donor or recipient cannot be communicated. Only persons born of a donation may, at the age of majority and if they so wish, access non-identifying data and the donor's identity by contacting the Commission d'Accès des Personnes nées d'une Assistance médicale à la procréation aux Données des tiers Donneurs (CAPADD).

These principles are supplemented by provisions designed to guarantee :

• the safety and quality of practices, through the implementation of regulated protocols including gamete traceability and vigilance in medically assisted procreation ;
• fair access to donations, based on transparently defined medical and ethical criteria;
• respect for human dignity and the fundamental rights of donors, recipients and children born of assisted reproduction.

The missions and legal framework of gamete donation and medically assisted procreation 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.