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The National Regulation of Pharmaceutical Markets and the Timing of New Drug Launches in Europe

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Author Info

  • Alexander Heuer
  • Malwina Mejer
  • Jennifer Neuhaus

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.

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Bibliographic Info

Paper provided by Kiel Institute for the World Economy in its series Kiel Advanced Studies Working Papers with number 437.

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Length: 24 pages
Date of creation: Mar 2007
Date of revision:
Handle: RePEc:kie:kieasw:437

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Keywords: pharmaceuticals; regulation; new chemical entity; parallel trade;

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  1. Brekke, Kurt R. & Grasdal, Astrid L. & Holmås, Tor Helge, 2006. "Regulation and Pricing of Pharmaceuticals: Reference Pricing or Price Cap Regulation?," Working Papers in Economics 14/06, University of Bergen, Department of Economics.
  2. Kurt R. Brekke & Ingrid Königbauer & Odd Rune Straume, 2006. "Reference Pricing of Pharmaceuticals," CESifo Working Paper Series 1825, CESifo Group Munich.
  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 R. Lichtenberg & Tomas J. Philipson, 2002. "The Dual Effects of Intellectual Property Regulations: Within- and Between- Patent Competition in the US Pharmaceuticals Industry," NBER Working Papers 9303, National Bureau of Economic Research, Inc.
  5. Tom Stargardt & Jonas Schreyogg, 2006. "Impact of Cross-Reference Pricing on Pharmaceutical Prices: Manufacturers' Pricing Strategies and Price Regulation," Applied Health Economics and Health Policy, Springer Healthcare | Adis, vol. 5(4), pages 235-247.
  6. 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.
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Cited by:
  1. Garcia Marinoso, Begona & Jelovac, Izabella & Olivella, Pau, 2011. "External referencing and pharmaceutical price negociation," Economics Papers from University Paris Dauphine 123456789/5987, Paris Dauphine University.
  2. Ulrich Kaiser & Susan J. Méndez & Thomas Rønde & Hannes Ullrich, 2013. " Regulation of Pharmaceutical Prices: Evidence from a Reference Price Reform in Denmark," Working Papers 330, University of Zurich, Department of Business Administration (IBW).
  3. 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.

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