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Risk regulation and interest accommodation in European pharmaceuticals' licensing

Speaker: Dr Jürgen Feick, Max Planck Institute for the Study of Societies
: 20 May 2003
Time: 1:00pm - 2:30pm
Venue: CARR Seminar Room, H615


Pharmaceuticals are considered one of or even the most densely regulated products, market entry licensing being a strategically important regulatory subfield. Close to the phase of marketing, licensing is the first decisive hurdle to be crossed by a pharmaceutical enterprise in order to recover its research, development and regulatory costs for a new product. Furthermore, regulatory bodies thus determine the medicinal arsenal available to the medical profession, the therapeutical spectrum to be offered to potential patients and the risks patients have to take when consuming pharmaceuticals. Indirectly regulatory outcomes can have important effects on national pharmaceutical industries. Thus, pharmaceuticals' licensing - and pharmaceuticals' regulation in general - has high political salience not only in terms of health policy, but also of economic and industrial policy.

What, in hindsight, seems to be an almost logical regulatory development resulting from rational problem solving behaviour, is in fact the result of historical struggles for social reputation, regulatory power and economic gains. And what can be viewed today as an assessment and decisions-making process largely driven by scientific and technical considerations, making this regulatory field an especially convincing candidate for international conversion or even - as in the case of the EU - supranational regulatory institutions, actually allows much leeway for the discretionary utilisation of regulatory authority and the influence of diverse interests.

The European Community is a good example to illustrate these tensions between the scientification of regulatory decision-making, convergence under the heading of harmonisation and integration, and the influence of political and economic interests in shaping policy outputs and their implementation. The current simultaneous existence of three different regulatory procedures for pharmaceuticals' licensing within the European Community is a case in point: They are the result of interest-driven political influence and are accommodating a diverse universe of interests.