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French drug regulatory agency:
the battle for transparency

Transparency is making slow progress at the French Health Products Safety Agency … and some bad habits are coming to light.

In 2004, a major EU Medicines Directive introduced crucial advances concerning the improved transparency of national and European drugs regulatory agencies' procedures and decisions. By April 2006, five months after the deadline, this Directive had still not been incorporated into French law.

AFSSAPS, the French Health Products Safety Agency, has however taken a few steps forward in applying some of the Directive's provisions concerning transparency. For example, the agency has now posted the internal regulations of the Marketing Authorisation Committee and the minutes of meetings of the national pharmacovigilance committee on its web site.

The minutes reveal that an important rule governing the operation of the drugs regulatory agency has been ignored. The law stipulates that committee members must not take part in discussions or in votes concerning firms with which they have links that might lead to a conflict of interest (remuneration, shareholdings, relatives employed by the firm, etc.). AFSSAPS publishes the register of conflicts of interest which committee members must declare each year.

According to this register, several members of the pharmacovigilance committee broke the law by taking part in discussions and even voting on matters concerning firms where they had a conflict of interest. This disclosure confirms the practical value of transparency. Watch this space.

©Prescrire June 2006

Source: "Conflits d'intérêts à l'Afssaps : la transparence progresse et dévoile les mauvaises habitudes" Rev Prescrire 2006 ; 26 (272) : 382.

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