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EU Regulation of Medical Devices and Pharmaceuticals in Comparative Perspective

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  • Christa Altenstetter
  • Govin Permanand

Abstract

This paper provides a comparison of European Union regulatory policy for pharmaceuticals and medical devices. The discussion highlights key similarities and differences in regulatory approach for the two sectors. More importantly, it explores the balance that has been struck between public health, health care, and industrial policy as “competing” objectives within the respective regulatory regimes. It is argued that, despite both sectors being affected by the same institutional rules and constraints at the EU level, and both being central to the delivery of high‐quality health care in Europe, there are a surprising number of differences between the regulatory frameworks. That this stems in part from their different “launch” times, hence different institutional conditions of regulation, and commensurate political climates, as well as reflecting different aims and goals among member‐state and EU‐level policy makers, are among the paper's main conclusions.

Suggested Citation

  • Christa Altenstetter & Govin Permanand, 2007. "EU Regulation of Medical Devices and Pharmaceuticals in Comparative Perspective," Review of Policy Research, Policy Studies Organization, vol. 24(5), pages 385-405, September.
    • Handle: RePEc:bla:revpol:v:24:y:2007:i:5:p:385-405
    DOI: 10.1111/j.1541-1338.2007.00291.x
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    Cited by:

    1. Carsten Strøby Jensen, 2020. "While We Are Waiting for the Superbug: Constitutional Asymmetry and EU Governmental Policies to Combat Antimicrobial Resistance," Journal of Common Market Studies, Wiley Blackwell, vol. 58(6), pages 1361-1376, November.
    2. Kale, Dinar, 2019. "Mind the gap: Investigating the role of collective action in the evolution of Indian medical device regulation," Technology in Society, Elsevier, vol. 59(C).
    3. Jean-Pierre Galland, 2017. "Big Third-Party Certifiers and the Construction of Transnational Regulation," The ANNALS of the American Academy of Political and Social Science, , vol. 670(1), pages 263-279, March.

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