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Advancing healthcare policy


Pharmacovigilance: the status of the reorganisation (end 2014)

Where things stand at the end of 2014 on the reorganisation of pharmacovigilance in Europe, following the adoption of new EU Regulations in 2010 and 2012.
New EU regulations on pharmacovigilance were adopted in 2010 and at the end of 2012, following the Mediator° disaster in France. Do these new regulations better protect patients? What are the practical consequences for the various actors in the healthcare system?

The first part of a two-part review examining these questions appears in the December 2014 issue of Prescrire International. The second part will follow in early 2015.

Part 1 - European pharmacovigilance: increasingly outsourced to drug companies

A quantitative approach is favoured, at the risk of endangering the clinical and pharmacological analysis of signals made spontaneously by independent teams, especially by pharmacovigilance centres, whose financing is weakened; monitoring of adverse effects is left up to pharmaceutical companies, who are put in a position of having to police themselves. 


  • New regulations reorganising pharmacovigilance at the European level were adopted in late 2010, then revised in 2012 in the wake of the Mediator° (benfluorex) disaster.
  • The European Commission’s original proposals, released in 2008, would have represented a major step backwards in the protection afforded to European citizens, in particular by facilitating earlier marketing authorisations.
  • Thanks to the mobilisation of civil society, the Members of the European Parliament have improved these proposals, supported by EU health ministers.
    • The role of the new European Pharma covigilance Risk Assessment Committee (PRAC) has been strengthened.
    • Patients in every Member State have the right to report adverse drug effects directly to health authorities.
    • EU drug regulatory agencies are required to provide greater transparency, and public access to information about adverse effects has been improved.
  • However, one major regression persists: the central role given to pharmaceutical companies in the collection and interpretation of reports of adverse drug effects, despite their conflicts of interest.
    • Drug companies are asked to record the adverse effect reports of which they are aware in a vast European centralised database, Eudravigilance, without going through drug regulatory agencies.
    • Pharmaceutical companies remain responsible for producing "a scientific evaluation of the risk-benefit balance" of their drug, as part of the periodic benefit-risk assessment reports they are required to submit to drug regulatory agencies. These reports are now analysed for the entire EU by two Member States (one rapporteur and one co-rapporteur), so that harmonised decisions can be taken. But these decisions are still based on data preanalysed by the drug companies.
    • In addition, the independence of the European Medicines Agency is undermined by its financial reliance on the fees paid by pharmaceutical companies in exchange for these assessments.
  • In 2012, following France’s Mediator° disaster, several modest measures were added to the European regulations adopted in late 2010. They were mainly concerned with harmonising urgent decisions taken by Member States in response to drug safety issues arising from pharmacovigilance data.
  • In each Member State, 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 relatives to report adverse effects.
  • Finally, it is vital that, in developing a centralised quantitative approach to pharmacovigilance, the clinical and pharmacological analysis of spontaneous reports by independent teams, especially in pharmacovigilance centres, is not abandoned.

"European pharmacovigilance: increasingly outsourced to drug companies" Prescrire Int 2014; 23 (155): 302-307. > Pdf, subscribers only
©Prescrire 1 December 2014