Working Paper

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


  • Heuer
  • A.
  • Mejer
  • M.
  • Neuhaus
  • J.
Publication Date

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.


JEL Classification
I11, I18, L51

Key Words

  • New chemical entity
  • Parallel trade
  • Pharmaceuticals
  • Regulation
  • Regulierung