Revue Prescrire, article en une, Medicines in Europe: Appeal to EU Ministers March 2003 (7)

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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Compassionate use: adopt the necessary means

Both the Parliament and the Council accepted the principle that promising drugs that have not yet been granted marketing authorisation should be made available for "compassionate use" by patients with no therapeutic alternative.

However, article 73 does not mention the possibility for patient representatives and health professionals to seek the opinion of the CPMP on compassionate use of a given drug. Moreover, the question of who will pay for compassionate treatment is not clearly dealt with. Article 73-6, states that such treatments should be provided free of charge, but fails to specify whether the costs should be met by the company, national health authorities, or the European Union.




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