IDEAS home Printed from https://ideas.repec.org/p/zbw/mpifgd/p0027.html
   My bibliography  Save this paper

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

Author

Listed:
  • 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
    as

    Download full text from publisher

    File URL: https://www.econstor.eu/bitstream/10419/43181/1/359456413.pdf
    Download Restriction: no
    ---><---

    References listed on IDEAS

    as
    1. 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.
    2. Abraham, John & Lewis, Graham, 1999. "Harmonising and competing for medicines regulation: how healthy are the European Union's systems of drug approval?," Social Science & Medicine, Elsevier, vol. 48(11), pages 1655-1667, June.
    3. Schmidt, Susanne K., 1996. "Sterile debates and dubious generalisations: An empirical critique of European integration theory based on the integration processes in telecommunications and electricity," MPIfG Discussion Paper 96/5, Max Planck Institute for the Study of Societies.
    4. 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.
    5. Hirschman,Albert O., 1981. "Essays in Trespassing," Cambridge Books, Cambridge University Press, number 9780521282437, October.
    Full references (including those not matched with items on IDEAS)

    Citations

    Citations are extracted by the CitEc Project, subscribe to its RSS feed for this item.
    as


    Cited by:

    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.

    Most related items

    These are the items that most often cite the same works as this one and are cited by the same works as this one.
    1. Grossman, Gene M & Helpman, Elhanan, 1995. "The Politics of Free-Trade Agreements," American Economic Review, American Economic Association, vol. 85(4), pages 667-690, September.
    2. Samuel, Sajay & Manassian, Armond, 2011. "The rise and coming fall of international accounting research," CRITICAL PERSPECTIVES ON ACCOUNTING, Elsevier, vol. 22(6), pages 608-627.
    3. Paolo Crestanello & Giuseppe Tattara, 2006. "Connections and Competences in the Governance of the Value Chain. How Industrial Countries Maintain their Competitive Advantage," Working Papers 2006_48, Department of Economics, University of Venice "Ca' Foscari".
    4. Muhamad, Goran M. & Heshmati, Almas & Khayyat, Nabaz T., 2021. "How to reduce the degree of dependency on natural resources?," Resources Policy, Elsevier, vol. 72(C).
    5. Beckert, Jens & Ebbinghaus, Bernhard & Hassel, Anke & Manow, Philip (ed.), 2006. "Transformationen des Kapitalismus: Festschrift für Wolfgang Streeck zum sechzigsten Geburtstag," Schriften aus dem Max-Planck-Institut für Gesellschaftsforschung Köln, Max Planck Institute for the Study of Societies, volume 57, number 57.
    6. Antonio Savoia & Kunal Sen, 2021. "The Political Economy of the Resource Curse: A Development Perspective," Annual Review of Resource Economics, Annual Reviews, vol. 13(1), pages 203-223, October.
    7. Mauro Boianovsky, 2010. "A View from the Tropics: Celso Furtado and the Theory of Economic Development in the 1950s," History of Political Economy, Duke University Press, vol. 42(2), pages 221-266, Summer.
    8. Antonio Cabrales, 2003. "Pharmaceutical generics, vertical product differentiation and public policy," Economics Working Papers 662, Department of Economics and Business, Universitat Pompeu Fabra.
    9. Wegenast, Tim & Krauser, Mario & Strüver, Georg & Giesen, Juliane, 2019. "At Africa’s expense? Disaggregating the employment effects of Chinese mining operations in sub-Saharan Africa," World Development, Elsevier, vol. 118(C), pages 39-51.
    10. Akhand Akhtar Hossain, 2009. "Central Banking and Monetary Policy in the Asia-Pacific," Books, Edward Elgar Publishing, number 12777.
    11. Fernando Rugitsky, 2016. "Growth, distribution, and sectoral heterogeneity: Reading the Kaleckians in Latin America," Economia, ANPEC - Associação Nacional dos Centros de Pós-Graduação em Economia [Brazilian Association of Graduate Programs in Economics], vol. 17(3), pages 265-278.
    12. Yin, Nina, 2023. "Pharmaceuticals, incremental innovation and market exclusivity," International Journal of Industrial Organization, Elsevier, vol. 87(C).
    13. Brekke, Kurt R. & Holmas, Tor Helge & Straume, Odd Rune, 2011. "Reference pricing, competition, and pharmaceutical expenditures: Theory and evidence from a natural experiment," Journal of Public Economics, Elsevier, vol. 95(7), pages 624-638.
    14. Cyrille Sardais & Martin Blom & Josée Lortie, 2021. "Exit, voice, loyalty, and … disobedience: When a CEO opposes his principal," Corporate Governance: An International Review, Wiley Blackwell, vol. 29(2), pages 188-207, March.
    15. Jose Antonio Alonso & Ana Luiza Cortez & Stephan Klasen, 2014. "LDC and other country groupings: How useful are current approaches to classify countries in a more hetergeneous developing world?," CDP Background Papers 021, United Nations, Department of Economics and Social Affairs.
    16. Karolien De Bruyne & Wouter Bam & Denis Engelbrecht, 2023. "South Africa's titanium industrial policy: A product space perspective," South African Journal of Economics, Economic Society of South Africa, vol. 91(1), pages 3-27, March.
    17. Leonardo Baccini, 2010. "Explaining formation and design of EU trade agreements: The role of transparency and flexibility," European Union Politics, , vol. 11(2), pages 195-217, June.
    18. Vahabi, Mehrdad, 2005. "Destructive power, enforcement and institutional change," MPRA Paper 13236, University Library of Munich, Germany, revised Jan 2006.
    19. Tim Legrand & Diane Stone, 2021. "Governing global policy: what IPE can learn from public policy? [Review article: What is policy convergence and what causes it?]," Policy and Society, Darryl S. Jarvis and M. Ramesh, vol. 40(4), pages 484-501.
    20. David Hulme & John Toye, 2006. "The case for cross-disciplinary social science research on poverty, inequality and well-being," Journal of Development Studies, Taylor & Francis Journals, vol. 42(7), pages 1085-1107.

    More about this item

    Statistics

    Access and download statistics

    Corrections

    All material on this site has been provided by the respective publishers and authors. You can help correct errors and omissions. When requesting a correction, please mention this item's handle: RePEc:zbw:mpifgd:p0027. See general information about how to correct material in RePEc.

    If you have authored this item and are not yet registered with RePEc, we encourage you to do it here. This allows to link your profile to this item. It also allows you to accept potential citations to this item that we are uncertain about.

    If CitEc recognized a bibliographic reference but did not link an item in RePEc to it, you can help with this form .

    If you know of missing items citing this one, you can help us creating those links by adding the relevant references in the same way as above, for each refering item. If you are a registered author of this item, you may also want to check the "citations" tab in your RePEc Author Service profile, as there may be some citations waiting for confirmation.

    For technical questions regarding this item, or to correct its authors, title, abstract, bibliographic or download information, contact: ZBW - Leibniz Information Centre for Economics (email available below). General contact details of provider: https://edirc.repec.org/data/mpigfde.html .

    Please note that corrections may take a couple of weeks to filter through the various RePEc services.

    IDEAS is a RePEc service. RePEc uses bibliographic data supplied by the respective publishers.