The « Agence de la biomédecine »
L’Agenzia francese di biomedicina (“Agence de la Biomedicina”), istituito nell’agosto 2004 dalla Legge di Bioetica, opera in quattro settori chiave della biologia umana e della medicina: tecniche di riproduzione assistita, la diagnosi prenatale e genetica, embrioni e ricerca sulle cellule staminali, e l’approvvigionamento e trapianto di organi, in particolare grazie alla regolamentazione e il sostegno degli uffici-tessuti e cellule
The French Agency of biomedicine (“Agence de la biomedecine”), established in August 2004 by the Law of Bioethics, operates in four key areas of human biology and medicine : assisted reproductive technologies, prenatal and genetic diagnosis, embryos and stem cell research, and the procurement and transplant of organs –notably thanks to regulation and support offices– tissues and cells.
These medical activities present major therapeutic, health and ethical issues. Interacting nation-wide, the Agency provides professionals and researchers with collective answers, guarantees equity of access,
ethics and transparency for the activities under its responsibility, organises information and awareness campaigns and publishes an annual activity report. Additionally, the head office also entails a training and information centre.
Moreover, by closely following the development of knowledge and technologies, the Agency regularly raises authorities’ awareness and issues recommendations, provides advice in drafting rules and regulations and to the development of new strategies to organise health care, and promotes research as well as international cooperation in its fields of activity.
Drawing on the skills of medical and scientific experts, the Agency works with professionals to develop guidelines for harmonizing and developing best medical practices, contributes to the development of homogeneous quality and safety treatments accessible to all, issues recommendations, approvals and authorizations, and ensures their application and the respect of legal provisions notably regarding consent, anonymity and donation criteria for organs, tissues, cells, gametes and embryos. The Agency guarantees that patients throughout France benefit from the highest levels of safety and quality care. In this regard, the Agency also evaluates medical activities and makes these evaluations available to the government, parliament and professionals and to the public at large.
The “Agence de la biomedecine” is the only Agency in Europe covering the four areas of transplantation, procreation, embryology and genetics. It has forged close links with Transplant medical teams and patients; thanks to its 24/7 operational role of managing transplants waiting list and the non-donor registry, and allocating transplantable organs.
The field of transplantation:
Donation, procurement and transplantation of organs and tissues have been raised as a “national health priority”, with the 2004 bioethics law. This public health priority has been clearly reaffirmed in 2012 with the adoption of a national plan to increase transplantation of organs, tissues and hematopoietic stem cells.
The Agency’s role:
– In procurement and transplantation of organ and tissue
- Manage the national waiting list of patients awaiting an organ or a cornea
- Manage the national registry of refusals
- Manage the registry of pairs of donors and recipients as part of the programme of cross over donation
- Elaborate rules of allocation and distribution of organs
- Coordinate organ procurement activities, and ensure the national and international allocation and distribution of grafts
- Monitor the report of incidents as part of the Biovigilance system
- Evaluate procurement and organ transplantation activities
- Organize expert committees that allow organ donation from living donors
- Manage the registry of living donors
- Raise awareness by promoting campaign to increase organ and tissue donation
- Organise the training of health professionals involved in procurement activities.
- Develop international cooperation in the field of organs, tissues and cells.
– In donation, procurement and transplantation of hematopoietic stem cells
- Management and development of the national registry of bone marrow (haematopoietic stem cells) donors
- Evaluation of activities and results of transplantation
- Raise awareness by promoting campaign to recruit bone marrow (haematopoietic stem cells) donors
The « Agence de la biomédecine »