Actors and Networks database

The Committees on Ethics in Animal Experimentation (Comités d’éthique en expérimentation animale – C2EA) are independent bodies responsible for evaluating research projects involving the use of animals for scientific purposes. Their main role is to examine authorisation applications to ensure compliance with ethical principles, particularly those of the 3Rs (Replacement, Reduction, Refinement), in order to limit the impact on animals. To this end, they carry out prospective and retrospective evaluations of projects and issue ethical opinions, which are essential for obtaining ministerial authorisation for projects. Their activities are the subject of an annual report produced by the National Committee for Ethical Reflection on Animal Experimentation (CNREEA).

The Departmental Directorates for the Protection of Populations (DDPP), of which there are 51 in France, play an essential role in the control and application of regulations relating to animal experimentation at local level. They issue approvals to establishments that breed, supply and use animals for scientific purposes, and carry out regular checks and inspections to ensure compliance with animal welfare standards. In particular, they check housing conditions, staff training and the implementation of ethical principles. In the event of non-compliance, they can take corrective measures to ensure that animals are used in accordance with current regulations.

The CEPS is an interministerial body primarily responsible by law for setting prices for medicines and tariffs for medical devices for individual use covered by compulsory health insurance. The latter will negotiate a conditional price based on conventional indicators defined as part of the framework agreement, with the implementation of post-marketing surveillance, the results of which are expected to provide sufficient clinical data for longer-term evaluation in a real-life context. As part of these missions, the CEPS may enter into agreements with companies or groups of companies relating to the price of medicinal products and its development, rebates, companies‘ commitments concerning the proper use of medicinal products and sales volumes, and the terms and conditions of companies’ participation in the implementation of ministerial guidance.

The High Authority for Health (HAS) is the independent public authority responsible for evaluating medicines, medical devices and professional procedures in order to decide on prices and reimbursement. It is also responsible for recommending good professional practice, and for measuring and improving the quality of care and patient safety in health establishments, outpatient clinics and social and medico-social facilities.

The ‘Medical Establishment Commissions’ are hospital medical committees. They are present at local level, in each hospital. They are responsible for deciding which medicines are available in the hospital's internal pharmacy, based on the list of medicines authorised for use by the Ministries of Health and Social Security.

The Ministry of Agriculture ensures compliance with national and European regulations, in particular Directive 2010/63/EU. It issues approvals to establishments that breed and supply animals for research purposes, as well as authorisations to structures that conduct experiments on animals, via the Departmental Directorates for the Protection of Populations (DDPP). It exercises veterinary and health control through inspections carried out by the departmental veterinary services, in order to guarantee compliant housing conditions and prevent animal suffering. It also plays a role in training, approving training courses for people involved in animal experimentation (breeders, suppliers and users of animals for experimentation) on the advice of the CNEA, to ensure that professionals have the necessary skills in animal welfare and alternative methods.

The Armed Forces Biomedical Research Institute (Institut de Recherche Biomédicale des Armées – IRBA) is an organisation attached to the Armed Forces Health Service (Service de Santé des Armées – SSA) of the French Ministry of Defence. It is responsible for conducting research in the field of biomedicine to meet the specific needs of the French armed forces. As such, the Ministry of Defence is subject to the same obligations in terms of experimentation as any other research organisation, and is responsible for ensuring compliance with the regulations in force in this field. It also has its own animal experimentation ethics committee (called “C2A-SSA”) and is represented on the CNEA.

The French Ministry for Ecological Transition receives applications for authorisation to deliberately release genetically modified organisms into the environment for clinical trials.

It is the responsibility of the Minister for Health to make the final decision in the health technology assessment process. All the opinions and data obtained through the various High Authority for Health (HAS) and Economic Committee for Health Products (CEPS) committees are used to decide whether or not to include a medicinal product intended for hospital use on the ‘liste en sus’. The Ministry of Health is also responsible for deciding whether or not a medicine should be reimbursed. If the decision is to reimburse, the Economic Committee for Health Products (CEPS) is then asked to negotiate the price. The final decision on whether or not a medicine should be reimbursed falls within the remit of the Ministers of Health and Social Security, and is published in the Official Journal of the French Republic.

The Ministry of Higher Education and Research receives declarations of preservation and preparation for scientific purposes of tissues and cells from the human body for the needs of research programmes, as well as requests for authorisation for preservation and preparation with a view to their transfer for scientific use. In addition, any contained use of Genetically Modified Organism is subject to a request for authorisation or a declaration to the Ministry. Finally, the Ministry receives applications for authorisation to import/export human body parts and products for scientific purposes. / In the field of animal experimentation, the Ministry evaluates and authorises animal experimentation projects both prospectively and retrospectively. It ensures compliance with national and European regulations. It carries out the statistical tasks required by Directive 2010/63/EU, collecting and analysing data on the use of animals for scientific purposes. It also promotes the 3Rs principles (Replacement, Reduction, Refinement) to limit and improve the use of animals in research, while encouraging the development of alternative methods. Finally, it works with ethics committees and national and European authorities to ensure the responsible and controlled use of animals for scientific purposes.