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In 1995, the European Union
introduced two procedures for authorizing the marketing
of pharmaceuticals. Experience with the new procedures
was to be evaluated in 2001, and potential amendments
legislated by 2003. This project analyzes the reform as
a political process involving interest representation
and influence in a multi-level, multi-actor framework.
The question is: who behaves in what way in order to
pursue what interests and reform goals, and produce what
political effect? The study tries to identify the
factors that are responsible for the actors’ definition
of interests, for their behavior in the political
process, and for their observable influence on the
political output. It also analyzes what the results of
the reform signify in terms of institutional change in
the context of European integration. The focus will be
on political institutions such as the European
Commission, the Council of Ministers, the Committee of
Permanent Representatives (COREPER), the European
Parliament as well as on interest representatives such
as European-level pharmaceutical associations, external
experts and consumer and patient representatives.
To the furthest extent possible, the
project will rely on primary sources. Therefore, expert
interviews with actors who have been involved, directly
or indirectly, in the review process will be essential. |
