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Pharmacovigilance: the European Commission loses sight of the public interest

A mission of vital public interest is farmed out to pharmaceutical companies, while misplaced priorities and conflicts of interest threaten to slow down decision-making in matters affecting public health.

In December 2008, the European Commission published its proposed Directive and Regulation concerning pharmacovigilance.

Despite the recent public health disasters due to adverse drug effects, many of the proposed measures would weaken the European pharmacovigilance system, instead of reinforcing it: the spread of premature marketing authorisations; an end to the requirement that pharmacovigilance activities be publicly funded; strengthening of pharmaceutical companies' stranglehold on the intepretation and also the gathering of data, which could threaten the member states' public pharmacovigilance systems with extinction; organising the dilution of data, centralised at the European level in an unusable "megabase", etc.

The Commission's proposals must be very significantly amended in order to reorient them toward serving the public interest.

©Prescrire September 2009

Source: "Pharmacovigilance : la Commission européenne oublie l'intérêt général" Rev Prescrire 2009; 28 (311): 696-702.
Based on the Joint statement by AIM, HAI Europe, ESIP, MiEF and ISDB, June 2009.

> Click here to download the Joint Position signed by Prescrire and other members of the Medicines in Europe Forum, "EU Commission’s proposals on pharmacovigilance dismantle the entire system" (pdf, 245 Ko)

>Click here for Prescrire's online Dossier "Medicines in Europe", including "Pharmacovigilance: a crucial issue for the health and safety of all Europeans".

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