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Regulatory Europeanization, national autonomy and regulatory effectiveness: Marketing authorization for pharmaceuticals

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  • Feick, Jürgen

Abstract

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.

Suggested Citation

  • Feick, Jürgen, 2002. "Regulatory Europeanization, national autonomy and regulatory effectiveness: Marketing authorization for pharmaceuticals," MPIfG Discussion Paper 02/6, Max Planck Institute for the Study of Societies.
    • Handle: RePEc:zbw:mpifgd:p0027
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    1. Schmidt, Susanne K., 1996. "Sterile Debates and Dubious Generalisations: European Integration Theory Tested by Telecommunications and Electricity," Journal of Public Policy, Cambridge University Press, vol. 16(3), pages 233-271, September.
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    3. Scherer, F.M., 2000. "The pharmaceutical industry," Handbook of Health Economics, in: A. J. Culyer & J. P. Newhouse (ed.), Handbook of Health Economics, edition 1, volume 1, chapter 25, pages 1297-1336, Elsevier.
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    1. Demortain, David, 2008. "Institutional polymorphism: the designing of the European Food Safety Authority with regard to the European Medicines Agency," LSE Research Online Documents on Economics 36534, London School of Economics and Political Science, LSE Library.
    2. Corinne Sauer & Robert Sauer, 2007. "Is it possible to have cheaper drugs and preserve the incentive to innovate? The benefits of privatizing the drug approval process," The Journal of Technology Transfer, Springer, vol. 32(5), pages 509-524, October.

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