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Conflicts of interest within the French drug regulatory agency: much remains to be done

It is imperative that French drug regulatory agency experts remain impartial in fulfilling their public service role.

The French Health Products Safety Agency (AFSSAPS) calls upon outside experts to help it fulfil its public service role of monitoring the drugs market. These experts are legally obliged to declare any interests they have, especially financial, in the pharmaceutical companies regulated by the AFSSAPS. The reason they must do so is to prevent conflicts of interest and to avoid, for example, an expert being involved in a decision regarding a pharmaceutical firm with which he has close ties.

Prescrire reviewed the conflicts of interests declared between 1997 and 2005 by 1034 AFSSAPS experts. 135 experts (12%) have never completed a declaration of interests. 283 experts (24%) declared they had no links with any companies, while there were 77 declarations of financial interests and 281 declarations of long-term or permanent relationships with firms.

The AFSSAPS distinguishes between "minor interests" and "major interests". But there is nothing to prove that a minor interest does not influence an expert. More generally, there are no convincing assurances that monitoring of conflicts of interest is comprehensive, no report on prevention of conflicts involving identified interests, and transparency is lacking in some committee reports, etc. Much still remains to be done to reassure the public regarding the impartiality of the AFSSAPS experts.

©Prescrire December 2006

Source: "Conflits d'intérêts à l'Agence française des produits de santé : il reste beaucoup à faire" Rev Prescrire 2006 ; 26 (278) : 857-861.

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