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French drugs regulatory agency still
dragging its feet on transparency

The French drugs regulatory agency is dragging its feet with regard to its obligations to be transparent. But the delay in implementing the European Directive into French law does not exonerate the agency from its obligations, since European Directives are deemed to have a "direct effect" in the countries that are late in incorporating them.

The European legislative framework on drugs voted in 2004 has given rise to a great deal of hope concerning drugs regulatory agencies. The European and national drugs regulatory agencies now have clear obligations as regards public access to the documents they hold, both relating to their decision-making procedures, the decisions themselves and the rationale behind them. The French agency has begun to take steps to implement these new obligations, but it is still a long way from providing the requisite degree of transparency. The Agency can not hide behind the fact that the European Directive has not yet been incorporated into French law, even though the deadline was 30 October 2005. European jurisprudence has constantly confirmed that a Directive acquires a "direct effect" after the time limit for its incorporation into national law has passed. In short, the French drugs regulatory agency had better apply the Directive, even if it has not yet been adopted into French law.

©Prescrire February 2006

Source: "Accès à l'information : Jour J + 75" Rev Prescrire 2006 ; 26 (269) : 103.

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