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French drug regulatory agency and health authority: insufficient transparency

The French drug regulatory agency and health authority, slow to enforce transparency obligations, are ducking their responsibilities.

The 27 February 2007 law on medicines and the decree dated 25 March 2007 have transposed into French law transparency obligations that will apply to the French Health Products Safety Agency (AFSSAPS) and the National Authority for Health (HAS).

The AFSSAPS’s administrative and scientific database is due to make information on drug marketing authorisations delivered before 1st January 1999 available to the public, "by 31 December 2008 at the latest", i.e. three years after the EU deadline.

The Marketing Authorisation Committee has also delayed putting its reports online. Available on the AFSSAPS’s website since 3 March 2006, these reports are sometimes very brief. The sketchy summaries of decisions often do not even specify the amendments made to marketing authorisations.

In practice, much remains to be done to achieve full transparency. The Association Mieux Prescrire and Prescrire's editorial board have sent an open letter to the directors of the AFSSAPS and the HAS, asking them how and when they plan to implement their transparency obligations.

©Prescrire June 2007

Source: "Transposition. Jour J+540 : lenteurs et faux-semblants de transparence" Rev Prescrire 2007 ; 27 (284) : 423.

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