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The national regulation of pharmaceutical markets and the timing of new drug launches in Europe

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  • Heuer, Alexander
  • Mejer, Malwina
  • Neuhaus, Jennifer

Abstract

We analyze the impact of national pharmaceutical regulation on the launch delay of new chemical entities approved by the EMEA's centralized procedure. We find that direct price control regimes have a significantly negative impact on the launch timing. These results cannot be found when investigating the impact of indirect price controls. Our results show that Germany (65%) has the highest probability of experiencing an early launch, while it is the lowest in southern European countries (18% for Portugal and 19% for Greece). This difference accrues from both price regulation and market attractiveness, since southern European countries generally have lower prices. Due to the possibilities for parallel trade within the EU, pharmaceutical companies, by acting strategically, may further increase launch delays.

Suggested Citation

  • Heuer, Alexander & Mejer, Malwina & Neuhaus, Jennifer, 2007. "The national regulation of pharmaceutical markets and the timing of new drug launches in Europe," Kiel Advanced Studies Working Papers 437, Kiel Institute for the World Economy (IfW).
  • Handle: RePEc:zbw:ifwasw:437
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    References listed on IDEAS

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    1. Patricia M. Danzon & Y. Richard Wang & Liang Wang, 2005. "The impact of price regulation on the launch delay of new drugs-evidence from twenty-five major markets in the 1990s," Health Economics, John Wiley & Sons, Ltd., vol. 14(3), pages 269-292.
    2. Brekke, Kurt R. & Grasdal, Astrid L. & Holms, Tor Helge, 2009. "Regulation and pricing of pharmaceuticals: Reference pricing or price cap regulation?," European Economic Review, Elsevier, vol. 53(2), pages 170-185, February.
    3. Lopez-Casasnovas, Guillem & Puig-Junoy, Jaume, 2000. "Review of the literature on reference pricing," Health Policy, Elsevier, vol. 54(2), pages 87-123, November.
    4. Frank Lichtenberg, 2005. "The Impact of New Drug Launches on Longevity: Evidence from Longitudinal, Disease-Level Data from 52 Countries, 1982–2001," International Journal of Health Economics and Management, Springer, vol. 5(1), pages 47-73, January.
    5. Ganslandt, Mattias & Maskus, Keith E., 2004. "Parallel imports and the pricing of pharmaceutical products: evidence from the European Union," Journal of Health Economics, Elsevier, vol. 23(5), pages 1035-1057, September.
    6. Frank R. Lichtenberg & Tomas J. Philipson, 2002. "The Dual Effects of Intellectual Property Regulations: Within- and Between-Patent Competition in the U.S. Pharmaceuticals Industry," Journal of Law and Economics, University of Chicago Press, vol. 45(S2), pages 643-672.
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    Cited by:

    1. repec:trp:01jefa:jefa0008 is not listed on IDEAS
    2. Begoña Garcia Mariñoso & Izabela Jelovac & Pau Olivella, 2011. "External referencing and pharmaceutical price negotiation," Health Economics, John Wiley & Sons, Ltd., vol. 20(6), pages 737-756, June.
    3. Kaiser, Ulrich & Mendez, Susan J. & Rønde, Thomas & Ullrich, Hannes, 2014. "Regulation of pharmaceutical prices: Evidence from a reference price reform in Denmark," Journal of Health Economics, Elsevier, vol. 36(C), pages 174-187.
    4. Joan Costa-Font & Alistair McGuire & Nebibe Varol, 2015. "Regulation effects on the adoption of new medicines," Empirical Economics, Springer, vol. 49(3), pages 1101-1121, November.
    5. Nebibe Varol & Joan Costa-i-Font & Alistair McGuire, 2011. "Explaining Early Adoption on New Medicines: Regulation, Innovation and Scale," CESifo Working Paper Series 3459, CESifo Group Munich.
    6. Abdulkadir Civan & Michael Maloney, 2015. "Launch Decisions of Pharmaceutical Companies," European Journal of Economic and Political Studies, Fatih University, vol. 8(2), pages 35-58.

    More about this item

    Keywords

    pharmaceuticals; regulation; new chemical entity; parallel trade;

    JEL classification:

    • I11 - Health, Education, and Welfare - - Health - - - Analysis of Health Care Markets
    • I18 - Health, Education, and Welfare - - Health - - - Government Policy; Regulation; Public Health
    • L51 - Industrial Organization - - Regulation and Industrial Policy - - - Economics of Regulation

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