[Ip-health] TPP: Waxman letter to USTR opposing 12 year term of biologics exclusivity

Thiru Balasubramaniam thiru at keionline.org
Sat Dec 7 03:43:36 PST 2013


In a 6 December 2013 letter, Representative Henry Waxman wrote to USTR
Ambassador Michael Froman
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:


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