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Advancing healthcare policy


Pharmacovigilance: In brief

  Public health disasters are a constant reminder of the need for independent and proactive pharmacovigilance. Yet under the recent reorganisation of European pharmacovigilance, this crucial public health mission is increasingly outsourced to drug companies.

To protect patients, it is essential to evaluate drugs properly before they are placed on the market, and to ensure effective pharmacovigilance once they are marketed.

New regulations reorganising pharmacovigilance at the European level were adopted in late 2010, then revised in 2012 in the wake of the Mediator° disaster in France.

The worst  has been avoided. The European Commission's original proposals, released in 2008, would have meant a major regression in the protection afforded to European citizens, in particular by facilitating over-hasty drug authorisations.

Advocacy to protect patients' interests helped secure improvements to the regulations that were eventually adopted: greater transparency over pharmacovigilance data; strengthened authority for the European Pharmacovigilance Risk Assessment Committee (PRAC); and extension in all Member States of patients' right to report adverse drug reactions directly to health authorities, without having to go through a health professional.

However, one major regression persists: the central role given to pharmaceutical companies in the collection and interpretation of reports of adverse drug reactions, despite their conflict of interest.

Regional and national health authorities have an important role to play in bringing safety signals to the attention of Europe's decision-making bodies.

And for robust pharmacovigilance, it is crucial to encourage healthcare professionals, patients and their carers and family members to report adverse drug reactions. Spontaneous reporting remains the foundation of pharmacovigilance.

©Prescrire November 2014