Revue Prescrire, article en une, Medicines in Europe: Appeal to EU Ministers March 2003 (5)

Medicines in Europe:
Appeal to EU Ministers: don't forget the fundamentals!

The working party preparing the decisive meeting of the Council of Ministers on 2-3 June 2003 is meeting regularly and productively, but several key matters concerning public health have not yet been taken into account.

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Areas in which the draft Regulation remains to be improved, as of 4 February 2003
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Medicines in Europe: campaigning goes on!
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Composition of the marketing authorisation Committee: scientific evaluation must not be overlooked

According to the current draft of article 54, the Committee responsible for scientific evaluation of marketing applications (CPMP) would only comprise one representative per Member State, instead of two at present. The European Commission considers this necessary to limit the size of the CPMP after European enlargement. In addition, each expert will be chosen on the basis of his/her role and experience in evaluation (…) and will represent the competent national authorities.

The danger is that the marketing authorisation Committee will end up consisting mainly of administrators from national agencies who may have little clinical experience or scientific expertise.

To preserve a minimum of clinical expertise, the Medicines in Europe Forum recommends that article 54 be modified to provide for two representatives per Member State (one administrative representative of each national agency, and one independent expert); the two representatives would have a single vote.




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