French Govt Launches Generics Decree

The French authorities have now launched their long-awaited decreeintended to promote the development and use of generic drugs. The regulation will make it easier for copies of original drugs to be manufactured as it will, under certain conditions, exempt drug manufacturers from undertaking costly bioavailability and bioequivalence studies involving clinical testing in man.

The decree establishes the basis of a future right of substitution which will authorize pharmacists to replace one product with another. It envisages a regime set up through the national drugs agency, in which drug specialties are grouped in generic categories, each group headed by a "specialty of reference" of which the other products will be copies. Doctors and pharmacists will thus have available a sort of catalogue which will indicate clearly which specialties can be substituted among themselves.

Lists Still Being Drawn Up The decree is partly inoperative at present because lists of comparable specialties which underpin the new regime are still being drawn up. The drug regulatory authority's commission has examined an initial range of 20 active principles and 259 specialties, and a listing of these will be published shortly.