Drug Reformulation Regulatory Gaming in Pharmaceuticals: Enforcement & Innovation Implications

This article examines drug reformulation regulatory gaming as a vehicle for analyzing the way in which European courts and the Commission are currently approaching innovation issues in the pharmaceutical sector. First, the economics literature regarding pharmaceutical innovation is briefly summarized. Next, the phenomenon of regulatory gaming is introduced, followed by an analysis of the two primary theories of harm being used to address drug reformulations as a competition concern. In comparing the recent General Court decision in AstraZeneca to earlier U.S. court cases addressing similar conduct, it is asserted that these approaches differ in significant ways with regards to preservation of innovation incentives as well as on the basis of institutional and evidentiary concerns. Finally, this discussion is then placed into the broader context of the ongoing debate regarding pharmaceutical innovation that first surfaced in the Syfait cases—in particular, the desirability of sector-specific competition law analysis of pharmaceutical innovation.