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Transparency of the drug regulatory agency:
France drags its feet

The incorporation of a major EU Directive on medicines into French law has been delayed. This delay particularly affects measures aimed at improving the transparency of the French drug regulatory agency’s activities and decisions.

The legal framework regulating medicines in Europe was significantly modified by an EU Directive in 2004, which was supposed to be incorporated into member states’ national legislation by 30 October 2005. In France, as at 7 November 2005, only a few provisions of use to the drug companies and the drug regulatory agencies had been introduced in compliance with the Directive.

Many aspects of the Directive that are of interest to health professionals and patients have not yet been incorporated into French legislation. This applies particularly to measures concerning the transparency of the French drug regulatory agency (AFSSAPS) and patient information.

Most importantly, the Agency is required to publish the assessment report and the reasons for granting a marketing authorisation to a new drug. The agendas and minutes of the Agency’s meetings as well as explanations of the votes leading to the decisions must also be published.

These measures, which will benefit public health, are eagerly awaited. All the more so, since they are now late in coming.

©Prescrire December 2005

Source: "Transposition de la 2004/27/CE sur le médicament : la France en retard" Rev Prescrire 2005 ; 25 (267) : 817-818.

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