Boston University School of Law

Import Safety Rules Should Not Hinder Legitimate Generic Drug Markets
Kevin Outterson

Appearing in IMPORT SAFETY: REGULATORY GOVERNANCE IN THE GLOBAL ECONOMY (Cary Coglianese, Adam Finkel, & David Zaring, eds., 2009) (The University of Pennsylvania Press)

Boston University School of Law Working Paper 09-25

Abstract

Trade agreement negotiations are routinely cloaked in secrecy, a model that may have suited the Eighteenth Century, but has no place in modern democracies. Transparency deficits have led to capture by powerful industries, sometimes to the detriment of public health. This is a standard account of the WTO TRIPS Agreement, but the pattern is being repeated, in a new regime, in the Anti-Counterfeiting Trade Agreement (ACTA) and related efforts. In the context of pharmaceuticals, ACTA should be limited to deliberate trademark violations and should not be expanded to encompass other intellectual property rights such as patent infringement. Recent seizures of generic medicines by Dutch authorities highlight the danger to legitimate and valuable global generic drug markets from overzealous enforcement of border control regimes.

Keywords: counterfeit, drug, pharmaceutical, Anti-Counterfeit Trade Agreement, ACTA, IMPACT

SSRN Accepted Paper Series

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Suggested Citation:

Kevin Outterson, Appearing in IMPORT SAFETY: REGULATORY GOVERNANCE IN THE GLOBAL ECONOMY (Cary Coglianese, Adam Finkel, & David Zaring, eds., 2009) (The University of Pennsylvania Press)

Kevin Outterson Contact Information

Boston University School of Law
765 Commonwealth Avenue
Boston, MA 02215

Email address: mko@bu.edu

Office Phone: (617) 353-3135

 

 

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