Ethics at the Agency

As part of its role, the Agence de la biomédecine relies on the work and recommendations of committees, boards and working groups involving nearly 1,000 external experts. It must ensure that the fundamental principles of independence, impartiality and transparency of its expert assessments are complied with, both by its agents and by the members of the various expert groups. Measures have been introduced to ensure that these principles are complied with.

The French Law of 29 December 2011 on the strengthening of the health security of medicines and health products harmonized and extended to all persons involved in the field of public health and health security the obligation to make a public declaration of interests. The agency applies the principles of the Health Expertise Charter, as required by law: each expert must read the charter and submit a declaration of interest form on the Ministry of Health’s DPI Santé website.

The conflict of interest assessment is carried out by the head of each working group and its chair. In order to facilitate the analysis of the declarations and to ensure that all situations are assessed consistently, the agency has classified interests as either major interests or other interests in a guide on analyzing declared interests. The agency’s Expert Ethics Unit (Cedex) systematically analyzes each declaration of interest using this guide in order to avoid any conflicts of interest.

The agency collects and processes whistleblower reports in its areas of expertise. It ensures that the identity of whistleblowers, who benefit from a protective framework provided for by law, will remain strictly confidential.