In a December 2, 2013 letter, Senator Orrin Hatch wrote to USTR’s Michael Froman, suggesting TPP exclude any countries that do not meet “high levels of ambition.” According to Hatch, these high ambitions include agreeing to 12 years of exclusive rights for IPR in biologic drug test data, and the elimination of barriers to cross border data flows (a privacy issue). A copy of the Hatch letter is attached below.
The timing of the Hatch letter is designed to pressure countries meeting in Singapore on December 7-10 in the TPP negotiation, on these two contentious issues.
Ironically, the Obama FY 2014 budget is on record opposing the 12 years of exclusive rights for biologic drugs.
“The Budget also proposes to accelerate access to affordable generic biologics by modifying the length of exclusivity on brand name biologics. Beginning in 2014, this proposal would award brand biologic manufacturers seven years of exclusivity, rather than 12 years under current law, and prohibit additional periods of exclusivity for brand biologics due to minor changes in product formulations, a practice often referred to as “evergreening.” The proposal will result in $3 billion in savings over 10 years to Federal health programs including Medicare and Medicaid [FY 2014 Budget, Page 40]”
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Who actually wrote the Hatch letter? Part was probably written by Greg Kalbaugh, the Deputy Vice President at PhRMA. What was Kalbaugh’s previous job? He was “International Trade Counsel” for the Senate Finance Committee, working for Senator Hatch.
Some additional context:
Ben Goad, AARP warns trade deal could lock in high drug prices, the Hill. October 23, 2013.
Donald Zuhn, AARP Seeks Reduced Data Exclusivity Period in TPP, Patent Docs, October 31, 2013.