Arbeitspapier
Regulatory Europeanization, national autonomy and regulatory effectiveness: Marketing authorization for pharmaceuticals
The EC harmonized market entry regulation for pharmaceuticals from the early sixties on, but it achieved neither its goal of uniform national regulatory decisions nor that of automatic mutual recognition. Subsequent attempts to Europeanize the procedures themselves resulted in two alternatives in 1995: a Centralized Procedure for innovative pharmaceutical products implemented at the EU level, and a Decentralized Procedure which tries to assure mutual recognition. First, the paper analyzes the distinctive modes of Europeanization employed in these regulatory alternatives, examining both their impact on the effectiveness of European governing and the balance they strike between European interventionism, national participation and national autonomy. Second, it tries to assess whether Europeanization furthers the goals of pharmaceutical market entry policy as defined in European regulations - public health protection, creation of a single market and the reduction of regulatory costs to industry. There is little evidence that the public's health is less well protected when regulation is Europeanized. Only the Centralized Procedure contributes significantly to the goal of establishing a single market. Regulatory costs in terms of approval time did go down especially for pharmaceutical firms using the Centralized Procedure, mainly because of efficiency-enhancing legal provisions and institutionally induced regulatory competition between national authorities.
- Language
-
Englisch
- Bibliographic citation
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Series: MPIfG Discussion Paper ; No. 02/6
- Classification
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Sozialwissenschaften, Soziologie, Anthropologie
- Subject
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Arzneimittelrecht
EU-Recht
Gesundheitspolitik
EU-Binnenmarkt
EU-Staaten
- Event
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Geistige Schöpfung
- (who)
-
Feick, Jürgen
- Event
-
Veröffentlichung
- (who)
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Max-Planck-Institut für Gesellschaftsforschung
- (where)
-
Köln
- (when)
-
2002
- Handle
- Last update
-
10.03.2025, 11:41 AM CET
Data provider
ZBW - Deutsche Zentralbibliothek für Wirtschaftswissenschaften - Leibniz-Informationszentrum Wirtschaft. If you have any questions about the object, please contact the data provider.
Object type
- Arbeitspapier
Associated
- Feick, Jürgen
- Max-Planck-Institut für Gesellschaftsforschung
Time of origin
- 2002
Other Objects (12)
Regulatory Europeanization, national autonomy and regulatory effectiveness : Marketing authorization for pharmaceuticals
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The National Impact of EU Regulatory Policy : three Europeanization Mechanisms
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Regulatory Europeanization, national autonomy and regulatory effectiveness : Marketing authorization for pharmaceuticals
Regulatory Europeanization, national autonomy and regulatory effectiveness: marketing authorization for pharmaceuticals
Regulatory Europeanization, national autonomy and regulatory effectiveness : marketing authorization for pharmaceuticals
Medical product regulatory affairs : pharmaceuticals, diagnostics, medical devices
Medical product regulatory affairs : pharmaceuticals, diagnostics, medical devices
The National Impact of EU Regulatory Policy : three Europeanization Mechanisms
Transatlantic Regulatory Divergence in Pharmaceuticals: Exploring economic and cultural explanations
Regulatory agencies and regulatory risk
Regulatory agencies and regulatory risk
Differential Europeanization in Eastern Europe : The Impact of Diverse EU Regulatory Governance Patterns
Driven by expertise and insulation?: the autonomy of European regulatory agencies
Regulatory autonomy and multilateral disciplines: The dilemma and a possible resolution
Regulatory Europeanization, national autonomy and regulatory effectiveness : Marketing authorization for pharmaceuticals
Regulatory Europeanization, national autonomy and regulatory effectiveness: marketing authorization for pharmaceuticals
Regulatory Europeanization, national autonomy and regulatory effectiveness : marketing authorization for pharmaceuticals
Medical product regulatory affairs : pharmaceuticals, diagnostics, medical devices
Medical product regulatory affairs : pharmaceuticals, diagnostics, medical devices
The National Impact of EU Regulatory Policy : three Europeanization Mechanisms
Transatlantic Regulatory Divergence in Pharmaceuticals: Exploring economic and cultural explanations
Regulatory agencies and regulatory risk
Regulatory agencies and regulatory risk
Differential Europeanization in Eastern Europe : The Impact of Diverse EU Regulatory Governance Patterns
Driven by expertise and insulation?: the autonomy of European regulatory agencies