In a 6 December 2013 letter, Representative Henry Waxman wrote to USTR Ambassador Michael Froman opposing USTR’s proposal of a term of 12 years of exclusivity for biologics in the Trans Pacific Partnership (TPP). The letter notes,
[w]hile I have worked closely with Senator Hatch on important health issues, including the generic drug law that we co-authored in 1984, I strongly disagreed that the United States should be proposing twelve years of exclusivity.
The Waxman letter highlights the tension between the Obama FY 2014 budget and the proposed USTR language on biologics for the TPP.
The United States only recently established its biosimilars pathway when it enacted the Patient Protection and Affordable Care Act (PPACA) (Pub. L. No. 111-148) and the consequences of PPACA’s mandated twelve years of biologics exclusivity are not yet known. Proposing twelve years of biologics exclusivity would conflict with stated Administration policy, as stated in President Obama’s FY 2014 budget proposal, recommending that the exclusivity period for biologics be reduced to seven years. Were the TPP ultimately to contain a twelve year biologics provision, it would impede the ability of Congress to achieve the President’s seven year change because doing so would run afoul of U.S. trade obligations.
As we have discussed before, it is also critical that USTR ensure that developing countries are not left behind in this agreement. The United States must ensure that the TPP does not result in generic medicines becoming available in TPP developing countries later than in the United States. In addition, the patent flexibilities available to developing countries in the Doha Declaration on Public Health should not be denied or weakened in the agreement.
The full text of Rep. Waxman’s letter to USTR can be found here: http://waxman.house.gov/sites/waxman.house.gov/files/documents/USTR%20Singapore%20Meeting.pdf