The Generic Pharmaceutical Association (GPhA) is beefing up its government relations muscle in response to growing concerns about intellectual property provisions in recent free trade agreements (FTAs). GPhA's interests will be represented by a trio of experts in international trade at the Washington, DC lobbying firm Greenberg Taurig.
GPhA has concerns that some recently negotiated FTAs include provisions affecting generic drugs that "appear to contradict, both explicitly and in spirit, commitments made by the United States in the World Trade Organization, and several appear inconsistent with US law."
Officials at the association said that GPhA is worried that these provisions could block generic drug exports abroad, substantially delay the timely access to affordable pharmaceuticals in those territories, and create the means to delay generic competition in the United States. Specific FTA provisions raising concerns among US generic-drug industry leaders include patent-restoration extensions for products that are not new chemical entities and the omission of a mandatory Bolar provision allowing generic companies to conduct research prior to the expiration of a patent.
Additionally, GPhA has raised objections to FTA provisions providing patented drugs with a minimum of 5 years of market exclusivity with no foreseeable cap.