L'adoption de la loi Jardé modifie l'encadrement juridique de la recherche clinique en France

The Jardé law is adopted further to the Public Health Act No. 2004-806 which transposed into French law the Directive 2001/20/EC on clinical trials of medicinal products, made effective by the implementing Decree 2006-477 of April 26, 2006. The main novelty introduced by the Jardé law is to unify all “research organized and practiced on human beings for the development of biological or medical knowledge” and to facilitate its effective conduct, without however excluding from the scope of the law routine care and non-interventional research. The favorable opinion of the French Ethical Research Committee (comité de protection des personnes or “CCP”) will now be required before launching any research on human beings, after validation of the risk/benefit ratio of said research. Applicable requirements and procedures - including information and consent - are adapted to each category of clinical research. New provisions are adopted to address special situations, previously forgotten. Finally, if Ethics committees were up until now freely chosen, they will, in two years' time, be randomly assigned. Thus, the Jardé law amends substantially the legal framework of clinical research in France. The question is whether these new national provisions will be compatible with those from the next revision of the so called “clinical trials” directive 2001/20/EC. In any case, the Jarde law will only come into force when all required implementing measures have been adopted.