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Advancing healthcare policy


Pharmacovigilance: Actions
Prescrire's response to the EMA public consultation on good pharmacovigilance practices and risk management programmes (May 2016)

Paris, 30 May 2016

To improve patient safety, the priority should be patients, not companies

> Click here to download Prescrire's response (pdf, 74 Ko)


In late February 2016 the European Medicines Agency released for public consultation a revised module on good pharmacovigilance practices on risk management systems.

Over the years Prescrire has advocated for strong and independent pharmacovigilance systems in the European Union and for the European Medicines Agency to play a proactive role in defending patient safety and protecting the population from avoidable drug-induced harm.

Citizens should not be exposed to the adverse effects of drugs that have been released onto the market prematurely. The very high human and financial costs of adverse drug reactions end up being borne by the patients who experience them and by society at large. Yet, instead of strengthening pharmacovigilance in Europe, the EMA proposal falls short in three fundamental aspects:

  1. It sustains weak marketing authorisation practices;
  2. It tightens marketing authorisation holders’ stranglehold on pharmacovigilance;
  3. It maintains a lack of transparency.

©Prescrire 2016

> Click here to download Prescrire's response (pdf, 74 Ko)