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