The Undetected Elephant in the Room: An Analysis of DG Competition’s Preliminary Report on the Pharmaceutical Sector Inquiry

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Anthony Dawes, James Killick, Feb 24, 2009

On November 28, 2008, DG Competition’s (“DG COMP”) published its Preliminary Report (“the Report”) on the pharmaceutical sector inquiry. The Report claims that Research & Development (“R&D”)-based pharmaceutical companies (“originator companies” ) have recourse to a toolbox (“toolbox”) of practices in order to delay the entry of generic medicines onto the market and that these practices, where successful, result in significant additional costs for public health budgets and reduce incentives to innovate. The Report also states that originator companies applied defensive patenting strategies, primarily aimed at blocking other originator companies in the development of new medicines. However, when one looks behind these headlines, it becomes clear that the [Pharmaceutical] Report is almost entirely silent on the key issue of causality, i.e. whether there can be said to be a causal link between the potentially anticompetitive practices which the Report identifies and the alleged resulting delays. This article analyzes this issue of causality in an attempt to understand why the Report does not address this fundamental issue.