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…

The Agence de la biomédecine draws up an annual activity report which is made public and which it sends to Parliament, which refers it to the Parliamentary Office for the Evaluation of Scientific and Technological Choices, to the Government and to the National Consultative Ethics Committee for Life Sciences and Health. This report sets out the main developments in knowledge and techniques for the activities within its remit and in…

In order to carry out the tasks provided for in 4°, 10°, 11° and 14° of article L. 1418-1, the Agency shall appoint inspectors from among its staff to carry out the relevant checks and investigations and may ask the competent State administrative authorities or public establishments concerned to call in their staff authorised to monitor the application of legislative and regulatory provisions designed to protect human health. These inspectors…

The Agency is administered by a Board of Directors and managed by a Chief Executive Officer. In addition to its Chairman, the Board of Directors of the Agency is made up of: 1° A majority of representatives of : a) The State; b) Health insurance organisations; c) National public administrative health establishments and public research establishments concerned by the Agency’s activities; 2° Qualified persons chosen for their expertise in the…

The Agency has a Steering Committee which ensures the quality of its medical and scientific expertise, taking into account any ethical issues that may arise. This board must be consulted by the Director General on applications for the authorisations referred to in b of 10° of article L. 1418-1 and on issues relating to medical or scientific research that fall within the remit of the Agency. It also defines the…

The Director General and the Policy Board may refer any question raising an ethical issue to the National Consultative Ethics Committee for Health and Life Sciences. They may be consulted by this committee on any matter falling within their respective areas of competence.

The Agency’s staff are governed by the provisions of articles L. 5323-1 to L. 5323-4. The members of the Agency’s Board of Directors and any other persons in possession of information held by the Agency are bound by professional secrecy under the conditions and subject to the penalties laid down in articles 226-13 and 226-14 of the French Penal Code. In addition, members of the Steering Committee, groups of experts…

The Agency’s resources include : 1° Subsidies from the European Union or international organisations; 2° A contribution from compulsory health insurance schemes, paid and distributed in accordance with conditions laid down by decree; 3° Taxes and fees created for its benefit; 4° Miscellaneous income, gifts and bequests; 5° Loans.

The procedures for applying the provisions of this chapter shall be determined by decree in the Conseil d’Etat, which shall in particular lay down : 1° The administrative, budgetary, financial and accounting system of the Agency and the State control to which it is subject; 2° The rules applicable to the Agency’s contract staff; 3° The private activities which, by reason of their nature, contract staff of the agency who…