Revue Prescrire, article en une, Medicines in Europe: Appeal to EU Ministers March 2003 (10)
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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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Funding the European Medicines Evaluation Agency: guaranteeing a minimum of independence

European members of parliament recommended that EMEA's core tasks be publicly funded. The Commission continues to argue that sensitive tasks such as evaluating marketing authorisation applications are "services rendered to the pharmaceutical industry" and can therefore be financed by the same industry.

The Council seems ready to adopt the principle of public funding for pharmacovigilance activities (article 60-1), but offers no other guarantees.

The Medicines in Europe Forum considers that scientific evaluation of marketing applications, and the management of registers containing all sensitive data on medicinal products (especially clinical trials, assessment reports, Committee reports, pharmacovigilance surveys, etc.), must be publicly funded. The management of administrative files can be covered by the fees manufacturers pay for EMEA assessment.

Articles 60 and 61 should be reconsidered, taking into account the growing international criticism of industry funding of medicines agencies.

©La revue Prescrire for the Medicines in Europe Forum 1 March 2003