Revue Prescrire, article en une, Medicines in Europe Directive April 2003 (2)
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Medicines in Europe:
Areas in which the Directive remains to be reinforced
 
The Medicines in Europe Forum demands that the Directive be reinforced in the following areas.
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Areas in which the draft Directive remains to be reinforced, as of 7 April 2003
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Medicines in Europe: campaigning goes on!
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Data protection: ambiguous texts will lead to conflicts

The Commission rejects amendment 40 article 1 point 7, and recommends a maximal data protection period of 10 years for all drugs, plus a year for each new indication. It opposes amendments that seek a compromise between countries that protect data for 6 years and those that protect them for 10 years (amendments 34 and 202 article 1 point 7). However, any lengthening of the data protection period would hinder the development of the generics market and have a negative impact on member states' health spending.
The viewpoints of all member states must be taken into account, and an acceptable compromise on the data protection period must be found.

We welcome the Commission's proposal to withdraw the poorly defined term "biosimilar", which it used in the Directive in an attempt to overprotect biotech drugs. But the Commission has not yet eliminated ambiguity: it recommends that clinical and preclinical trials be required for drug generics that do not meet "some conditions" defining generics.
An article as vague as article 10 (3a) has no place in a Directive, which must be perfectly clear if it is to be strictly applied in all member states. Article 10 (3a) must be rejected.

©La revue Prescrire, for the Medicines in Europe Forum 7 April 2003