Revue Prescrire, article en une, Medicines in Europe: Appeal to EU Ministers March 2003 (2)

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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Medicines in Europe: campaigning goes on!
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The Medicines in Europe Forum recalls the areas in which the European draft Regulation on human medicines must be improved.

• Centralised marketing authorisation procedure: a minimum guarantee of transparency
• An incompressible 90-day period for scientific evaluation: a minimum guarantee of safety
• The notion of "added therapeutic value": a key element of transparency
• Five-year re-evaluation of marketing authorisation: not a simple formality
• Duration of data protection: precisely worded texts to limit abuses
• Direct adverse event reporting by patients: medicines agencies must listen
• Functioning of the Agency: transparency and document access are no longer optional extras
• Composition of the marketing authorisation Committee: scientific evaluation must not be overlooked
• Composition of the management board: civil society must be represented
• Funding the European Medicines Evaluation Agency: guaranteeing a minimum of independence
• Compassionate use: adopt the necessary means




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