Dr. Jürgen Feick
National and European pharmaceuticals' regulation
Pharmaceutical products and their development, production and distribution are traditionally subject to national regulation. On the other hand, pharmaceutical firms depend on the opportunity to market their products internationally in order to recover increasingly high development costs. The European Commission has been trying for years to install centralized regulatory procedures, to harmonize national regulations and to foster mutual recognition. International standardization activities within a wider framework (International Conference on Harmonization) are supposed to facilitate the latter approach. While the EU has been successful recently in institutionalizing centralized systems for licensing and pharmacovigilance, economic and social regulation concerning, for example, pricing, distribution and financing of pharmaceuticals have remained almost completely national. In a first step, the development and present state of pharmaceuticals' regulation in France, Great Britain, and Germany will be compared, and the processes of Europeanization and internationalization described. Secondly, analysis will focus on the interdependencies and interactions between national and international systems. The analysis of regulatory relationships between national and European institutions and the functioning of each of these systems within the larger regulatory network will be the final step, which should include an assessment of the impact of these regulations on the development of a single European market for pharmaceuticals.
- Marketing authorization for pharmaceuticals in the European Union (2007)
- Learning and interest accommodation in policy and institutional change: EC risk regulation in the pharmaceuticals sector (2005)
- Regulatory Europeanization, National Autonomy and Regulatory Effectiveness: Marketing Authorization for Pharmaceuticals (2002)
Interest Representation and Influence in the Reform of European Pharmaceuticals Regulation 2001-2004
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.
The 2001-2004 Review of European pharmaceuticals authorization and regulatory Europeanization (2005)
The Impact of Modern Information and Communication Technologies on Governability and Governing Capacity
Modern information and communication technologies (ICT) can be regarded as resources for actors. Organizationally they facilitate the establishment and coordination of networks, thus extending networks' reach across territorial and systemic borders. Their utilization enhances the functional complexity of modern societies, promoting interdependency between societies and within them. Eliminating or transcending some barriers does not mean complete openness or generalized access, since new demarcations tend to emerge. From a regulatory perspective, the decreasing importance of territorial and systemic borders that results from these technologies has a significant influence on the institutionalization and implementation of collectively binding rules, particularly on the governability of sectors and the governing capacity of regulatory bodies. The project examines this aspect of the impact of the utilization of modern ICTs. From a policy-oriented point of view, does the utilization of these technologies create new problems calling for rule-making? Or do the regulatory conditions in regulated sectors change in a way that puts pressure on institutions that are supposed to provide and implement collectively binding rules? Not limited to governmental institutions in the narrower sense, this kind of collectively binding regulation or governance also includes configurations based on private rule-making or private-sector participation.
- New publication:
Jürgen Feick and Raymund Werle (2010) Regulation of Cyberspace. In: Richard Baldwin, Martin Cave and Martin Lodge (eds) The Oxford Handbook of Regulation, Oxford, Oxford University Press
Demokratische Partizipation im Zeitalter des Internets (2007)
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