Recherche clinique : mise au point sur l'encadrement législatif en France

A key element of medical progress, clinical research, is ruled by specific legislation in France. The first law on clinical research was the Huriet-Serusclat law of 1988, which introduced ethical committees - called committees on the protection of persons participating in biomedical research. It was adapted to a European directive on drug research in 2004. The Public Health Law, which is part of the Public Health code, states the conditions for biomedical research in France, not only regarding medication, as it applies to all research areas. Its main points are analysed in this paper. Legislation is still changing at a European level with the vote of a regulation on drug research, but also in France where the Jardé law is being implemented.