Chapter VIII: Biomedicine

The Agence de la biomédecine is a public administrative establishment under the supervision of the Minister for Health.

It is responsible for transplants, reproduction, embryology and human genetics. In particular, it is responsible for

1° To participate in the development and, where appropriate, the application of regulations and rules of good practice and to make recommendations for activities within its remit;

2° To provide Parliament and the Government with ongoing information on the development of knowledge and techniques for the activities within its remit, and to propose to them the guidelines and measures they require;

3° Promoting health quality and safety, as well as medical and scientific research, for the activities within its remit;

4° Monitoring, evaluating and, if necessary, controlling medical and biological activities, particularly those related to nanobiotechnologies, within its remit and ensuring the transparency of these activities; to this end, it will receive the annual activity reports from the establishments and organisations within its remit; in particular, it will evaluate the possible consequences of medically assisted procreation on the health of the persons who have recourse to it and on that of the children born from it. It provides for the regular publication of the results of each medically assisted procreation centre according to a methodology that takes into account the characteristics of their patient base and in particular the age of the women; in the light of this data, it carries out support and advisory missions in certain centres, and even proposes recommendations for numerical indicators to certain centres;

4° bis Ensure the implementation of biovigilance and medically assisted procreation systems. To this end, it proposes rules for the allocation of gametes and embryos in application of the last paragraph of article L. 2141-1 ;

5° Promoting the donation of organs, tissues and cells from the human body, as well as the donation of gametes;

6° Implementing monitoring of the state of health of organ, oocyte and haematopoietic stem cell donors, in order to assess the consequences of donation on the donors' health;

7° Registering patients waiting for transplants on the list mentioned in article L. 1251-1, managing this list and that of the register of pairs of living donors and potential recipients who have consented to cross-organ donation, as well as allocating transplants, whether they have been taken in France or outside national territory, and drawing up the rules for distributing and allocating transplants, taking into account the emergency nature of certain indications, which rules are approved by order of the Minister for Health;

8° Managing the register of voluntary donors of haematopoietic cells or peripheral mononuclear cells for patients who cannot receive a related transplant; it also searches international registers and organises the provision of transplants;

9° Providing the public with information on the use of freely available genetic tests;

10° To issue the authorisations provided for in :

a) Articles L. 2141-9 and L. 2141-11-1;

b) VIII of article L. 2131-1, the penultimate paragraph of article L. 2131-4 and articles L. 2131-4-1, L. 2151-5, L. 2151-8 and L. 2151-9;

11° Approving the practitioners mentioned in articles L. 1131-3 and L. 2131-4-2;

12° Issuing opinions to the administrative authorities for activities within its remit;

13° Managing the processing of data relating to the third-party donors mentioned in Article L. 2143-1, their donations and the children born from these donations, with the exception of medical data collected after the donation;

14° Receiving declarations of research protocols on human embryonic stem cells and induced pluripotent stem cells;

15° Providing Parliament and the Government with ongoing information on the development of knowledge and techniques in the field of neuroscience.

It may be consulted by medical or scientific academies or learned societies, by the associations mentioned in article L. 1114-1, under conditions defined by decree, and by the social affairs committees of the National Assembly and the Senate.

The Director General and the Chairman of the Orientation Council of the Agence de la biomédecine may ask to be heard by the Office parlementaire d'évaluation des choix scientifiques et technologiques if the development of knowledge and techniques in the activities falling within the remit of the agency or in the field of neuroscience is likely to raise new ethical issues.