[Opinion of the French National Academy of Medicine on the legislative framework for the application of the European Directive on biomedical research in humans].

The French National Academy of Medicine considers that biomedical research in humans is a necessity for Public Health. This research is indispensable to medical progress and public health. It must respect medical ethics, scientific rigor, and should be implemented within a legislative framework. The Academy is concerned by the insufficient French participation in this research, which is largely a result of the small number of patients included in therapeutic trials that are necessary to the progression of knowledge and the improvement of diagnosis and treatment. Such research should be encouraged and unjustified (or useless) constraints should be lifted, particularly those which weigh on studies whose goal is furthering knowledge and are independent from industry. It approves that in the proposed revision of the articles of the law regarding the protection of persons participating in biomedical research, the distinction between research with of without direct individual benefit is removed. It notes that trials known as "non-interventional," meaning tested trials (studies in which the drugs which are used are already authorized or which use tested therapeutic strategies) are not concerned by the directive. The Academy would like these trials to be better defined in order to avoid any ambiguity. It would like to see the creation of a registry of French trials as well as the rapid publication of epidemiological studies or therapeutic trials whose results could have important consequences for Public Health. The realization of large trials requires European cooperation, therefore the harmonization of legislation in the member States of the E.U. is a necessity; this should lead to the creation of a European structure of appeal in this field.