IDEAS home Printed from https://ideas.repec.org/a/eee/socmed/v222y2019icp76-83.html
   My bibliography  Save this article

Changing standards for drug approval: A longitudinal analysis of conditional marketing authorisation in the European Union

Author

Listed:
  • Hoekman, Jarno
  • Boon, Wouter

Abstract

Drug regulatory agencies around the world increasingly implement expedited regulatory pathways allowing for approval of medicines that intend to address unmet medical needs based on lower evidentiary standards than would be conventionally required. Few studies have investigated how companies and regulators utilise these pathways. We therefore conducted a longitudinal analysis of the emergence and implementation of the conditional marketing authorisation (CMA) instrument in the European Union. Drawing on archival documents, procedural data and interviews, we show that there was substantial ambiguity among regulators and companies about how to strike a new balance between evidentiary requirements and patient needs. As ambiguities were left unresolved, parties became reluctant to use CMA and in the majority of procedures did not use the pathway in a prospectively planned fashion. Rather, CMA became an option for regulators and companies to apply when submitted data were not strong enough to justify standard approval. Particularly, incumbent companies profited from this. The results stress the challenges of realising institutional change in drug regulation by showing how interest-driven actors can act upon ambiguities in attempts to shape regulatory outcomes and stretch rule interpretations.

Suggested Citation

  • Hoekman, Jarno & Boon, Wouter, 2019. "Changing standards for drug approval: A longitudinal analysis of conditional marketing authorisation in the European Union," Social Science & Medicine, Elsevier, vol. 222(C), pages 76-83.
  • Handle: RePEc:eee:socmed:v:222:y:2019:i:c:p:76-83
    DOI: 10.1016/j.socscimed.2018.12.025
    as

    Download full text from publisher

    File URL: http://www.sciencedirect.com/science/article/pii/S0277953618307081
    Download Restriction: Full text for ScienceDirect subscribers only

    File URL: https://libkey.io/10.1016/j.socscimed.2018.12.025?utm_source=ideas
    LibKey link: if access is restricted and if your library uses this service, LibKey will redirect you to where you can use your library subscription to access this item
    ---><---

    As the access to this document is restricted, you may want to search for a different version of it.

    References listed on IDEAS

    as
    1. George J. Stigler, 1971. "The Theory of Economic Regulation," Bell Journal of Economics, The RAND Corporation, vol. 2(1), pages 3-21, Spring.
    2. Christoph Ossege, 2015. "Driven by Expertise and Insulation? The Autonomy of European Regulatory Agencies," Politics and Governance, Cogitatio Press, vol. 3(1), pages 101-113.
    3. Carpenter, Daniel P., 2004. "Protection without Capture: Product Approval by a Politically Responsive, Learning Regulator," American Political Science Review, Cambridge University Press, vol. 98(4), pages 613-631, November.
    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. Anna Chorniy & James Bailey & Abdulkadir Civan & Michael Maloney, 2021. "Regulatory review time and pharmaceutical research and development," Health Economics, John Wiley & Sons, Ltd., vol. 30(1), pages 113-128, January.
    2. Shai Mulinari & Andreas Vilhelmsson & Emily Rickard & Piotr Ozieranski, 2020. "Five years of pharmaceutical industry funding of patient organisations in Sweden: Cross-sectional study of companies, patient organisations and drugs," PLOS ONE, Public Library of Science, vol. 15(6), pages 1-19, June.
    3. Vokinger, Kerstin Noëlle & Kesselheim, Aaron S., 2019. "Characteristics of trials and regulatory pathways leading to US approval of innovative vs. non-innovative oncology drugs," Health Policy, Elsevier, vol. 123(8), pages 721-727.

    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. Rebecca L. Perlman, 2020. "For Safety or Profit? How Science Serves the Strategic Interests of Private Actors," American Journal of Political Science, John Wiley & Sons, vol. 64(2), pages 293-308, April.
    2. Persson, Torsten & Tabellini, Guido, 2002. "Political economics and public finance," Handbook of Public Economics, in: A. J. Auerbach & M. Feldstein (ed.), Handbook of Public Economics, edition 1, volume 3, chapter 24, pages 1549-1659, Elsevier.
    3. Scott Gehlbach & Konstantin Sonin & Ekaterina Zhuravskaya, 2010. "Businessman Candidates," American Journal of Political Science, John Wiley & Sons, vol. 54(3), pages 718-736, July.
    4. Thomas Wyrick & Roger Arnold, 1989. "Earmarking as a deterrent to rent-seeking," Public Choice, Springer, vol. 60(3), pages 283-291, March.
    5. Pavel Ciaian & Ján Pokrivčák & Dušan Drabik, 2008. "Prečo sú niektoré sektory v tranzitívnych ekonomikách menej reformované ako ostatné? prípad výskumu a vzdelávania v oblasti ekonómie [Why some sectors of transition economies are less reformed than," Politická ekonomie, Prague University of Economics and Business, vol. 2008(6), pages 819-836.
    6. Kris James Mitchener & Matthew Jaremski, 2014. "The Evolution of Bank Supervision: Evidence from U.S. States," NBER Working Papers 20603, National Bureau of Economic Research, Inc.
    7. Masciandaro, D. & Nieto, M. & Prast, H.M., 2007. "Financial Governance of Banking Supervision," Other publications TiSEM 65d7ff26-dca3-4da3-86ff-6, Tilburg University, School of Economics and Management.
    8. J. Mark Ramseyer & Eric Rasmusen, 2013. "Lowering the Bar to Raise the Bar: Licensing Difficulty and Attorney Quality in Japan," Working Papers 2013-12, Indiana University, Kelley School of Business, Department of Business Economics and Public Policy.
    9. Grant H. Lewis, 2017. "Effects of federal socioeconomic contracting preferences," Small Business Economics, Springer, vol. 49(4), pages 763-783, December.
    10. Rausser, Gordon C. & de Janvry, Alain & Schmitz, Andrew & Zilberman, David D., 1980. "Principal issues in the evaluation of public research in agriculture," Department of Agricultural & Resource Economics, UC Berkeley, Working Paper Series qt74v9m7dh, Department of Agricultural & Resource Economics, UC Berkeley.
    11. Arvind Magesan & Matthew A. Turner, 2008. "The Value of Information in Public Decisions," Working Papers tecipa-345, University of Toronto, Department of Economics.
    12. Arblaster, Margaret & Zhang, Chrystal, 2020. "Liberalisation of airport air traffic control: A case study of Spain," Transport Policy, Elsevier, vol. 91(C), pages 38-47.
    13. Deniz Igan & Prachi Mishra & Thierry Tressel, 2012. "A Fistful of Dollars: Lobbying and the Financial Crisis," NBER Macroeconomics Annual, University of Chicago Press, vol. 26(1), pages 195-230.
    14. Elert, Niklas & Henrekson, Magnus, 2017. "Entrepreneurship and Institutions: A Bidirectional Relationship," Working Paper Series 1153, Research Institute of Industrial Economics, revised 05 May 2017.
    15. Schnellenbach, Jan & Schubert, Christian, 2015. "Behavioral political economy: A survey," European Journal of Political Economy, Elsevier, vol. 40(PB), pages 395-417.
    16. Hahn, Robert & Evans, Lewis, 2010. "Regulating Dynamic Markets: Progress in Theory and Practice," Working Paper Series 4052, Victoria University of Wellington, The New Zealand Institute for the Study of Competition and Regulation.
    17. Sauro Mocetti & Giacomo Roma & Enrico Rubolino, 2022. "Knocking on Parents’ Doors: Regulation and Intergenerational Mobility," Journal of Human Resources, University of Wisconsin Press, vol. 57(2), pages 525-554.
    18. Koichi Hamada & Asahi Noguchi, 2005. "The Role of Preconceived Ideas in Macroeconomic Policy: Japan's Experiences in the Two Deflationary Periods," Working Papers 908, Economic Growth Center, Yale University.
    19. Fernando Borraz & Juan Dubra & Daniel Ferrés & Leandro Zipitría, 2009. "Supermarket Entry and its effect on small stores in Montevideo, 1998 to 2007," Documentos de trabajo 2009005, Banco Central del Uruguay.
    20. Matthias Finger & Rolf W. Künneke (ed.), 2011. "International Handbook of Network Industries," Books, Edward Elgar Publishing, number 12961.

    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:eee:socmed:v:222:y:2019:i:c:p:76-83. 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: Catherine Liu (email available below). General contact details of provider: http://www.elsevier.com/wps/find/journaldescription.cws_home/315/description#description .

    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.