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
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