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Supranational regulatory agencies between independence and control: the EMEA and the authorization of pharmaceuticals in the European Single Market
[journal article]
Abstract "The European Medicines Agency (EMEA) represents a new type of
supranational regulation. Formally, it merely advises the Commission and a member
state committee on the authorization of pharmaceuticals. In practice, however, it
dominates decision-making and operates much like an independent agency. B... view more
"The European Medicines Agency (EMEA) represents a new type of
supranational regulation. Formally, it merely advises the Commission and a member
state committee on the authorization of pharmaceuticals. In practice, however, it
dominates decision-making and operates much like an independent agency. Based
upon a brief discussion of the merits of independent regulation and the necessity
to control regulatory activities, the article explores the institutional arrangement in
which the EMEA is embedded and seeks to explain how tight oversight is compatible
with quasi-independent action. It argues that the multi-tiered oversight mechanism
restricts the non-scientific actors involved in the authorization of pharmaceuticals
more than the agency – as long as the agency adheres to its mandate of producing
scientifically convincing decisions." (author's abstract)... view less
Keywords
control; pharmaceutical industry; regulation; pharmaceutical; delegation of tasks
Classification
European Politics
Free Keywords
EMEA; pharmaceuticals; regulatory agencies; Single Market regulation
Document language
English
Publication Year
2007
Page/Pages
p. 208-226
Journal
Journal of European Public Policy, 14 (2007) 2
DOI
https://doi.org/10.1080/13501760601122407
Status
Published Version; reviewed
Licence
Deposit Licence - No Redistribution, No Modifications
Data providerThis metadata entry was indexed by the Special Subject Collection Social Sciences, USB Cologne