english.prescrire.org > Spotlight > Archives : 2009 > Pharmacovigilance in Europe: soon to be placed in the hands of pharmaceutical companies?

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Pharmacovigilance in Europe: soon to be placed in the hands of pharmaceutical companies?

The European Commission is proposing to entrust pharmaceutical companies with the post-marketing monitoring of their own drugs – entailing the risk that firms will cover up evidence of adverse effects that might harm sales.

Adverse drug effects are a nuisance to patients – sometimes a deadly one. They are a nuisance to healthcare professionals, who have to deal with the damage they cause. They are a nuisance to pharmaceutical companies, as they hurt sales. They are a nuisance to governments, since they represent a failure to protect public safety.

Confronted with this fundamental problem, rather than attack the causes (including inadequate risk evaluation before drugs are approved), the European Commission has proposed a dangerous reform of the pharmacovigilance system. The Commission plans to turn the problem over to the very parties who have a strong direct interest in burying it: pharmaceutical companies.

Drug companies are already in charge of evaluating on their own, prior to receiving marketing authorisation, the drugs upon which their fortunes depend, with the attendant risk that they will suppress crucial information. Instead of addressing this conflict of interest, the Commission is proposing to give the pharmaceutical industry the additional responsibility of post-marketing monitoring. Instead of strengthening the existing network of pharmacovigilance centres, the Commission is proposing to bypass it. Instead of improving information for patients and healthcare professionals, the Commission is giving drug companies a monopoly on gathering, analysing and disseminating sensitive data.

By handing over the responsibility for pharmacovigilance to pharmaceutical companies, the European Commission, and those who allow it to have its way, are letting the firms get away with murder.

©Prescrire December 2009

"Putting temptation in their path" Prescrire Int 2009; 18 (104): 240 (pdf, free).

> Click here for Prescrire's online Dossier "Medicines in Europe"

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