Saturday, August 4, 2012
Abuse of Regulatory Procedures in the Pharmaceutical Sector—Developments Since the General Court's Judgment in AstraZeneca
Posted by D. Daniel Sokol
Kristina Nordlander & Patrick Harrison (Sidley Austin) address Abuse of Regulatory Procedures in the Pharmaceutical Sector—Developments Since the General Court's Judgment in AstraZeneca.
ABSTRACT: In June 2005, the European Commission issued a decision finding that AstraZeneca had breached Article 102 TFEU by engaging in conduct aimed at blocking or delaying market access for generic alternatives to its blockbuster Losec product. The decision was highly controversial at the time, and the Commission acknowledged that it was making "novel" findings of abuse of regulatory procedures, but, in July 2010, the EU's General Court handed down a judgment largely upholding the Commission's decision. Many commentators-including the authors of this article-thought at the time that the terms of the General Court's judgment might embolden the Commission and the EU Member States' National Competition Authorities in their enforcement of Article 102 TFEU in the pharmaceutical sector.
This article explores key developments in the concept of abuse as applied in the pharmaceutical sector since the General Court's landmark July 2010 judgment in AstraZeneca. The article focuses on: (i) the April 2011 decision of the Office of Fair Trading in relation to Reckitt Benckiser; (ii) the January 2012 Autorità Garante della Concurrenza e del Mercato decision in relation to Pfizer Italy; and (iii) the May 2012 Opinion of Advocate General Mazak in the appeal to the European Court of Justice of the General Court's AstraZeneca judgment itself.
The authors conclude that NCAs do indeed appear to have been emboldened in their enforcement of Article 102 TFEU in the pharmaceutical sector and that in subtle, but important, ways, recent NCA decisions may have expanded the notion of abuse of regulatory procedures which lay at the heart of the Commission's seminal AstraZeneca case. Indeed, it even appears from the Pfizer Italy decision, that NCAs may be using the observations made by the Commission in its 2008-2009 Pharmaceutical Sector Inquiry as a means of further expanding the concept of abuse as set out in AstraZeneca. Before addressing these developments, it may be helpful to summarize the key findings in the AstraZeneca case itself.