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Single market regulation between technocratic independence and political control: the European Agency for the Evaluation of Medicinal Products and the authorisation of pharmaceuticals
[working paper]
Corporate Editor
Bamberger Centrum für Empirische Studien (BACES)
Abstract "The paper explores the successful European scheme for the authorisation of
pharmaceuticals within the Single Market. Theoretically, it argues that successful regulation requires the exclusion of parochial interests from the decision process and the strict limitation of the agency's opportunities to... view more
"The paper explores the successful European scheme for the authorisation of
pharmaceuticals within the Single Market. Theoretically, it argues that successful regulation requires the exclusion of parochial interests from the decision process and the strict limitation of the agency's opportunities to adopt arbitrary decisions. Empirically, it holds that these conditions are fulfilled in the European authorisation scheme. The European Agency for the Evaluation of Medicinal Products (EMEA) enjoys a strong agenda-setting power, while it is locked into a control arrangement that precludes arbitrary decisions. Moreover, all actors involved in the decision-making process are bound to a coherent and detailed set of legally binding decision-making criteria as well as subject to judicial review." (author's abstract)... view less
Keywords
domestic market; steering; pharmaceutical; decision making
Classification
European Politics
Health Policy
Method
documentation
Free Keywords
Europäische Union
Document language
English
Publication Year
2004
City
Bamberg
Page/Pages
21 p.
Series
BACES Discussion Paper, 4
Licence
Deposit Licence - No Redistribution, No Modifications
Data providerThis metadata entry was indexed by the Special Subject Collection Social Sciences, USB Cologne