The initial
drafts of the Directive and Regulation on medicinal products, prepared
by the European Commission, were extensively amended by the European
Parliament in its vote of 23 October 2002. Most of the adopted amendments
oppposed items that favoured drug companies' vested interests over
public health concerns.
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The
European Council of Health Ministers, involved in the co-decision
procedure, started by examining the draft Regulation, at its meeting
of 2 December 2002. The Council only managed to reach a consensus
on a few points (including the important principle of five-year
marketing authorisation re-evaluation), and decided to pursue its
work at the next meeting on 2-3 June 2003 under Greek presidency.
In the meantime discussions continue within the Council working
group on pharmaceuticals.
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After
Parliament's amendments and the Council's initial reflections, the
Commission published a modified draft Regulation on 10 December
2002. Publication of a modified draft Directive is due for mid-January
2003.
Overall,
the Commission rejected a large number of amendments voted by Parliament,
including important measures supported by the Medecines in Europe
Forum, of which la revue Prescrire is an active member. More information:
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Health
professionals and patients throughout the European union must remain
fully committed and remind the European Commission that, even when
industrial competitiveness is at stake, drugs are not just another
consumer product.
©La revue Prescrire 15 January 2003
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