Last week, in a letter sent to the U.S. Trade Representative, Ambassador Michael Froman, the AARP asked that the U.S. not sign onto the Trans-Pacific Partnership Agreement (TPP) if the trade agreement includes a 12-year data exclusivity period for biologics. The TPP is a multilateral free trade agreement currently being negotiated by Australia, Brunei, Chile, Malaysia, New Zealand, Peru, Singapore, the United States, and Vietnam (Canada, Japan, the Philippines, South Korea, and Taiwan have also expressed interest in participating in the agreement).
Indicating that it was the AARP's "understanding that market exclusivity is one of the outstanding issues negotiators are working to resolve with the goal of completing the trade agreement before the end of the year," the letter declares that the AARP "strongly believes the final trade agreement should not bind the U.S. to a 12-year market exclusivity period for brand-name biologic drugs" (emphasis in original). The group notes that its support for a shorter exclusivity period is based on the high cost of biologic therapeutics, which "can put these treatments out of reach for those who need them most, even for those with comprehensive health insurance." The letter points out that "[t]he daily costs associated with biologics are approximately 22 times higher than the daily costs associated with small-molecule drugs."
Although the AARP notes that the Patient Protection and Affordable Care Act (ACA) recognized that "there was a need for less expensive follow-on biologics, or biosimilars, both to help ensure access to biologic drugs and to reduce the economic burden they impose," the group also acknowledges that the PPACA created a 12-year data exclusivity period for biologics. However, the letter indicates that the Federal Trade Commission "concluded that no additional exclusivity beyond the term of the patent was necessary to maintain innovation and competition in the industry" (see "No One Seems Happy with Follow-on Biologics According to the FTC"), and that the Obama Administration proposed reducing the exclusivity period from 12 years to 7 years in its most recent budget (see "Senators Back 12-Year Data Exclusivity Period for Biosimilars and President Obama (Once Again) Does Not"). The AARP concludes the letter by expressing its strong support for the President's proposal, as well as the group's belief that "increasing the availability of biosimilars will be a critical element of any comprehensive effort to contain health care costs."
For additional information regarding this and other related topics, please see:
• "White Paper Asserts That Existing Trade Agreements Provide No Data Exclusivity for Biologics," August 26, 2013
• "BIO Reiterates Support for 12-Year Data Exclusivity Period for Biologics," August 20, 2013
• "Senators Back 12-Year Data Exclusivity Period for Biosimilars and President Obama (Once Again) Does Not," May 9, 2013
• "U.S. Negotiators on TPP -- Don't Trade Away the Biopharmaceutical Research Sector," September 30, 2012
• "Senators Support Inclusion of 12-Year Exclusivity Period in Free Trade Agreement," September 12, 2011
• "House Legislators Lobby to Exclude 12-Year Data Exclusivity Period from Free Trade Agreement," August 11, 2011