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