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Medicines and public health risks: the European Commission is not demanding enough

The European Commission has adopted a minimalist definition of the risk posed to public health by insufficiently evaluated drugs.

The marketing authorisation for drugs on sale in France may have been issued by the European Medicines Agency, a national regulatory agency, or through the mutual recognition procedure that accepts an authorisation issued by another member state. European legislation permits a Member State to refuse to recognise a marketing authorisation issued by another Member State only in the event of a potentially "serious risk to public health". However, the Commission is careful to ensure that this clause does not hinder the "free movement of goods", and has published draft "guidelines" defining this serious risk to public health.

This interpretation of risk wilfully ignores all the current major drug evaluation shortcomings. In practice, for the European Commission, a drug must be accepted without protest by a member state even if it has been evaluated solely against placebo, in adults with no particular risk factor, or if its performance compared with other already available drugs in the same class has not been measured and its optimum dose is not known. French health authorities should be more stringent, and should oppose mutual recognition if necessary, in the best interests of patients.

©Prescrire January 2006

Source: "AMM et santé publique : les recommandations minimalistes de la Commission européenne" Rev Prescrire 2006 ; 26 (268) : 63-64.

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