HEALTH ACTION INTERNATIONAL (EUROPE) RESPONSE TO THE
EUROPEAN COMMISSION'S CONSULTATION ON PHARMACOVIGILANCE

 

Recent drug debacles - notably with SSRI antidepressants, Vioxx, Lipobay - have focused attention on the need for improved monitoring of drugs in clinical practice (pharmacovigilance). The need for better pharmacovigilance is further underlined by:

• growing awareness of the limited value of pre-marketing clinical trials data

• more direct promotion of medicines to consumers (especially via the internet)

• the pressure to speed up drug approval times

• the switching of prescription-only medicines to over-the-counter availability, and

• the extension of prescribing rights to nurses and pharmacists.

This paper by HAI(E) - a response to the European Commission’s (DG Enterprise) consultation on pharmacovigilance in the EU - concludes that "The present European pharmacovigilance control system is not merely weak. The extent to which it helps to sustain the illusion that drug benefits to health hugely outweigh the harms, leads us to believe that its overall impact on health is positively dubious." Read on

 

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