Drug Reformulation Regulatory Gaming: Enforcement and Innovation Implications

"First, I briefly recount the standard narrative regarding the nature of the pharmaceutical industry and the economics of drug innovation (section B). Next, I briefly summarise the Commission’s approach to enforcement in the pharmaceutical sector (section C). I present the AstraZeneca case and the two primary approaches to regulatory gaming, and offer a critique on the basis of their probable impact on innovation, in section D. I then introduce the ongoing debate over the proper role for industry-specific characteristics in competition law enforcement, and discuss the ways in which the common story regarding the nature of pharmaceutical innovation has come into question (section E)."