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Drug Reformulation Regulatory Gaming in Pharmaceuticals: Enforcement & Innovation Implications

Battaglia, Lauren E. (2011) Drug Reformulation Regulatory Gaming in Pharmaceuticals: Enforcement & Innovation Implications. [Conference Proceedings]

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    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.

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    Item Type: Conference Proceedings
    Subjects for non-EU documents: EU policies and themes > Policies & related activities > industrial policy
    Subjects for EU documents: UNSPECIFIED
    EU Series and Periodicals: UNSPECIFIED
    EU Annual Reports: UNSPECIFIED
    Conference: European Union Studies Association (EUSA) > Biennial Conference > 2011 (12th), April 23-25, 2011
    Depositing User: Phil Wilkin
    Official EU Document: No
    Language: English
    Date Deposited: 28 Oct 2016 10:11
    Number of Pages: 14
    Last Modified: 28 Oct 2016 10:11

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