Comments of the Generic Pharmaceutical Association on the Anti- Counterfeiting Trade Agreement
March 21, 2008
The Generic Pharmaceutical Association (GPhA) supports efforts to secure the U.S. drug supply from counterfeit medicines. Currently, due in great part to the vigilance of the U.S. Food and Drug Administration (FDA), the quality of America’s prescription medicines is the highest in the world. However, the abundance of counterfeit medicines in the global market and the increasing presence of such medicines in our domestic market threaten to undermine the standards of quality and security that the American public has come to rely upon. Pharmaceuticals represent the fastest-growing area of IPR seizures by U.S. Customs and Border Protection (CBP), accounting for 6 percent by value in FY 2007, up from only 1.5 percent the previous year. Moreover, pharmaceuticals accounted for 40 percent of the domestic value of IPR “Import Safety” Commodities seized by CBP in FY 2007, making it far and away the #1 public health and safety concern with respect to imported counterfeit goods.1
GPhA believes that the problem of counterfeit medicines raises a very significant public health concern that must be addressed systemically on a range of levels—from local to global, and throughout the drug supply chain. GPhA applauds the initiative of the Office of the United States Trade Representative (USTR) to pursue an Anti- Counterfeiting Trade Agreement (ACTA) with like-minded countries to establish a common standard for IPR enforcement in terms of international cooperation, enforcement practices, and the legal framework for IPR enforcement. We offer these comments to ensure that the ACTA addresses the growing threat of counterfeit drugs to the security of our drug supply in a balanced, appropriate and effective way, taking account of the IPR peculiarities of the U.S. pharmaceutical sector. In our view, anti-counterfeiting strategies should be centered on strong enforcement of the rights and systems currently in place and the cultivation of proper legal framework in nations where it may be inadequate.
In its Federal Register Notice of February 15, 2008, USTR stated that a principle goal of the ACTA would be to establish a common standard for IPR enforcement “to combat global infringements of IPR particularly in the context of counterfeiting and piracy ….” (Emphasis added.) As an initial matter, especially given the importance of this undertaking, GPhA urges USTR not to allow the rising momentum behind a global
1 “Intellectual Property Rights, Seizure Status: FY 2007”, U.S. Customs and Border Protection (CBP), December 2007.
anti-counterfeiting strategy to be diffused by deviating into expanded IP protection and enforcement with respect to patents and data exclusivity.
While this may seem a stretch at first glance, the fact is, some confusion does exist regarding just what IP rights are violated by counterfeiting. This may not be too surprising when you consider that the terms “counterfeiting and piracy” are often used in conjunction, just as USTR did in this announcement. Because patent infringement is a form of piracy, some erroneously conclude that counterfeiting is also a form of patent infringement, particularly in the area of counterfeit medicines. Thus, for example, Wikipedia in the opening paragraph of its entry on “Counterfeit,” inaccurately states, “