Nouvelle législation portant sur les soins courants : rappel des difficultés passées

Summary Objective The regulatory framework of clinical research in France was recently modified substantially, in part to transpose into French law directive 2001/20/EC of the European Parliament and Council, which concerns only drug trials. The revision also covered research on “human beings” (Public Health L. 2004-806, 2006-450), on biological samples (revision of bioethics, L. 2004-800) and on data (the so-called CNIL act, L. 2004-801). The value of this set of texts (statutes, decrees, and regulations) is that it diversifies and clarifies the different forms of clinical research. Methods This article describes the painful progression of important public health studies, most often with “academic” sponsors. Results The 5 studies described here managed to overcome a variety of obstacles posed by the pre-2004 regulations. Comments To understand the new provisions, it is useful to recall the difficulties, imprecision and inaptness of the earlier regulations.