The French Agency of Biomedicine is a public institution created by the 2004 Bioethics Law.
We oversee four medical areas that are particulary sensitive :
Our mission is to evaluate, supervise, support and provide information on related treatments to improve the quality of care for patients. This requires expertise in medical, scientific, legal and ethical issues on which the agency is the authority in France.
Our responsibilities are diverse and include managing national organ donor and transplant registers, certifying practitioners, authorizing embryonic and stem cell research, implementing biomonitoring systems, advising government authorities, and promoting organ, tissue, egg, sperm and bone marrow donation.
Is it dangerous to donate bone marrow ?’ ‘What happens to the body of a deceased donor after the organs are removed ? ‘Is egg donation painful ?’ There are wide-ranging issues in the fields of health and ethics that legitimately concern the public. We attempt to provide clear and accurate answers to these complex questions.
Our role is to guarantee equal access to care for all patients in all our fields of expertise. We ensure, for example, that donated organs are equitably distributed via a national transplant database with a score-based rating system. The goal is to provide quality, safe care for all.
Medical and research activities using human body tissues raise ethical questions, which are regulated by French law. The regularly updated Bioethics Law governs medical research that applies to human subjects, guaranteeing respect for human dignity. It is the origin of the agency, which promotes free, fully consensual, anonymous organ donation.
The agency’s mission is to improve patients’ access to treatment
and their quality of life in six key areas :
From newborns to the elderly, many patients have had their lives saved or dramatically improved thanks to organ or tissue transplant.
Bone marrow or umbilical cord blood donation enhances the recovery chances of patients suffering from serious blood diseases such as leukaemia or lymphoma.
Medically assisted procreation techniques, including egg and sperm donation, allow thousands of infertile couples to become parents every year.
Strictly regulated by the Bioethics Law, this type of research advances knowledge about human development and paves the way to new therapeutic practices.
Prenatal diagnosis allows certain serious conditions to be identified during pregnancy and treated accordingly. For parents who are carriers of incurable genetic conditions, preimplantation screening can allow them to conceive a healthy infant.
Medical genetics involves the diagnosis and management of hereditary disorders. To date, 6000 genetic diseases have been identified.
Under the auspices of the French Ministry of Health, the missions of the Agency of Biomedicine also extend outside of France. The agency helps to draft European rules, represents France in numerous international bodies, ensures international monitoring, participates in working groups and conferences, publishes in international scientific journals, and contributes to the development of good practices.
Internationally, the agency is also involved in projects on the ground to improve access to transplantation and to establish national regulatory and ethical frameworks. Our policy approach is based on cooperation, with the goal of promoting the development of local expertise. Working with institutional partners, we collaborate on priority projects at the request of national authorities, the French Ministry of Foreign Affairs or international organisations. A key focus is on helping emerging countries, particularly in the development of kidney and tissue transplantation.
In practice, this involves a multitude of actions including
• Developing the expertise of local procurement and transplantation teams (by sending French experts to provide advice and training on site, and/or inviting professionals to be trained in France) ;
• establishing donation and transplant registers ;
• creating information systems and tissue banks ;
• strengthening the capacities of local agencies to supervise and develop procurement and transplantation ;
• training in promoting organ donation ;
• guidance on evaluating ;
• regulating and auditing authorized establishments ;
• and ensuring the safety of substances of human origin in line with European standards.
A number of international initiatives are underway, supported by outside funding, particularly from the Ministry of Foreign Affairs and the French Development Agency. Currently, the agency is collaborating on projects in Morocco, Tunisia, Algeria (as well as supporting cooperation between these Maghreb countries), Lebanon, Moldavia, French Polynesia and New Caledonia.
In Europe, the agency is a partner in a joint project to develop a portal for organ exchange within the European Union. The FOEDUS platform has been operational since 2015, allowing the exchange of organs between 25 EU countries. We also represent France on the Council of Europe’s Committee on Organ Transplantation, a group of experts that works on recommendations and technical documents for member states, and we participate in the development of directives to standardize quality and safety standards for the EU.
Globally, the agency has long been engaged in the World Health Organization (WHO), in particular on the challenges of organ donation at the international level. At any given time, there are also a number of ad hoc bilateral relationships with foreign health agencies or ministries concerning specific requests for information or expertise on patient cases.