Revue Prescrire, article en une, Medicines in Europe Directive May 2003 (4)
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European Directive on Medicines:
We must remain vigilant!
On 2-3 June 2003 the European Council of health ministers will give an opinion on the Directive and Regulation that will form the legal framework for human medicines throughout the European Union in years to come. The wording of these texts will have enormous implications for patients, health professionals, and health insurance systems (social security and mutual insurance).
More information

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Areas in which the draft Directive remains to be reinforced, as of 1 May 2003
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Medicines in Europe: campaigning goes on!
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The Council has examined the amendments to the drafts that were voted by the European Parliament at the first reading on 23 October 2002 (For further information: The European Parliament opts for public health at first reading Click here). It is currently examining the responses of Enterprise Directorate-General of the European Commission to these amendments. The Commission prepared the initial draft texts and is actively seeking to influence the final documents.

The Commission's responses to the proposed amendments to the draft Regulation were drafted rapidly, as they were made public on 10 December 2002. The Medicines in Europe Forum analysed these responses and informed the Council of Ministers of its concerns in a public alert dated 20 February 2003 (For further information: The European Commission counter-attacks with its second draft Regulation Click here).

The Commission has taken far longer to release its responses to the proposed amendments to the draft Directive. They have been submitted to the Council of Ministers (1) rendered public on 25 April 2003 (For further information: The European Commission counter-attacks with its second draft Directive (pdf, 313 Ko): Click here).

We therefore have less than two months to examine the Commission's opinion and to offer our own views; this is very short, given that the Commission is challenging some principles of public health that were endorsed by the European Parliament.

The Commission has reached a favourable opinion on several important measures, such as non acceptance of data from clinical trials conducted in developing countries unless the local population is likely to derive a direct benefit; re-evaluation of marketing authorisation after five years (this is crucial, given the limitations of the initial marketing procedure); unannounced inspection of company premises; validation of patient information leaflets by groups of potential users; the principle that companies must guarantee uninterrupted supplies of their drugs; and advance announcement of marketing withdrawals, etc.

But the Commission is intending to reject key measures essential to maintain quality of care. As usual, the Commission's main concern seems to be the interests of drug companies.

©La revue Prescrire, for the Medicines in Europe Forum 1 May 2003
1-Commission of the European Communities "Modified draft directive of the European Parliament and Council on medicinal products for human use" 2001/0253 (COD), 3 April 2003: 28 pages.