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Press Release - DTCA & Pharmaceutical package

Pharmacovigilance: a crucial issue for the health and safety of all Europeans

Prescrire and its partners continue in their campaign to reorient the European Commission’s proposals on pharmacovigilance toward public health and a real reinforcement of safety for European citizens.

Pharmacovigilance in Europe: the European Commission’s proposals endanger the population

Summary

A series of public health disasters (from thalidomide in the 1960s to rofecoxib (Vioxx°) at the beginning of this century) have served to remind us of the crucial nature of pharmacovigilance. To this end, the European Commission’s proposed legislative changes represent a serious regression in the protection of European citizens.

Among the key issues of concern:

• the spread of weak marketing authorisation practices, justified by post-authorisation safety studies and ’risk management’ programmes that would allow inadequately evaluated medicines to reach the market;
• the withholding of adverse drug reactions data, the collection and interpretation of which are abandoned to pharmaceutical companies, despite the fact that these companies have a vested interest in delaying pharmacovigilance decisions;
• the increased financial and intellectual dependency of health authorities on pharmaceutical companies (due to the end of public funding obligation for pharmacovigilance activities, and to the hierarchical dependency of pharmacovigilance authorities on marketing authorisation committees), which leads to an opaque and increasingly biased decision-making process.

Member States are responsible for the protection of their populations

They cannot accept the exposure of their populations to adverse drug reactions from medicines that have been marketed prematurely. Neither should they support the delegation of tasks that are the responsibility of public pharmacovigilance systems to pharmaceutical companies.

Concrete recommendations

The EU Commission proposals on pharmacovigilance can still be refocused in defence of public interest, provided they are profoundly amended in order to end to the conflation of roles. Read our 15 concrete recommendations on page 6 of the Joint Analysis available for download below.

Download the Joint Analysis "Pharmacovigilance in Europe: the European Commission’s proposals endanger the population" (314 KB)