english.prescrire.org > Spotlight > Archives : 2010 > Final proposals on pharmacovigilance: Some progress, but a missed opportunity to genuinely strengthen patient safety

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Final proposals on pharmacovigilance: Some progress, but a missed opportunity to genuinely strengthen patient safety

In a joint communiqué, HAI Europe, the Medicines in Europe Forum and the International Society of Drug Bulletins analyse the pharmacovigilance proposals that were adopted by the Ministers for Health of the Member States on 29 November 2010.

Despite several improvements to the original proposals made by members of the European Parliament, two major backward steps remained, including :

  • Member States will no longer be required to provide public funding for pharmacovigilance systems, which will jeopardise the independence of pharmacovigilance systems ;
  • pharmaceutical companies will code adverse effects and enter this data directly into the European Eudravigilance database, with the risk that clinical cases will be distorted and therefore difficult to interpret.

If the safety of European patients is to be genuinely reinforced, the European Commission’s priorities must be :

  • to improve the quality of the evaluation of medicines before they are granted marketing authorisation
  • to increase the independence of drug regulatory authorities, to enable them to better fulfil their public health remit, particularly when evaluating and reviewing the harm-benefit balance of medicines.

> Click here to download the Joint Press Release (pdf, 141 Ko)

> Click here for the online Dossier "Pharmacovigilance: a crucial issue for the health and safety of all Europeans"

©Prescrire 7 December 2010

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Joint Press Release
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Pharmacovigilance: a crucial
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