english.prescrire.org > Spotlight > Archives : 2010 > Conflicts of interest at the French drug regulatory agency: progress too slow

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Conflicts of interest at the French drug regulatory agency:
progress too slow

Transparency in declaring experts’ connections with pharmaceutical companies is essential. But it is not sufficient to guarantee the impartiality of the agency’s decisions.

The French Health Products Safety Agency (Afssaps) calls on outside experts for its drug evaluation activities. These individuals must declare any links they have with healthcare product manufacturers and abstain from participating in decisions concerning these companies’ products.

Each year, Afssaps publishes the list of its outside experts’ conflicts of interest, as well as a report on their management.

In 2008, only 77% of declarations of interests were dated 2008 or 2007. Moreover, Afssaps does not have any mechanism enabling it to verify its experts’ declarations of interest.  Afssaps considers interests below  5000 euros or a 5% stake in a company’s capital as a "minor interest" -- as if such sums could not influence the person concerned. And lastly, more than half the experts with a major conflict of interest (more than  5000 euros or a stake of over 5%) do not leave the meeting as required by the Agency’s regulations.

At least Afssaps is transparent about its own inadequate performance, but it really must enforce the regulations more rigorously. Most importantly, a premium must be placed on independent expert advice and experts must be able to do their work without having to depend on money from pharmaceutical companies.

©Prescrire August 2010

"Conflicts of interest with the Afssaps French regulatory agency: more progress needed" Prescrire Int 2010; 19 (108):186-187 (pdf, subscribers only).
 
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