On June 2 and
3, 2003, the European Council of Health Ministers examined the draft
Directive and Regulation on medicines for human use.
Despite
strong pressure by big pharmaceutical companies and an obliging
Enterprise Directorate-General of the European Commission, the Council
agreed with the Parliament on three points:
-Transparency of European institutions, including the European medicines
agency;
-True revision of all marketing authorisations 5 years after drug
release;
-Confirmation of the ban on direct-to-consumer advertising for prescription
drugs.
A
number of points are a source for concern, such as the prolongation
of 'data protection' that would hinder generic development.
Next
step: second reading by the Parliament in the fall of 2003.
©La revue Prescrire, for the Medicines
in Europe Forum 15 June 2003
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