[Ip-health] TPP: Senator Hatch to USTR, 12 years of IPR for Biologics test data, no restrictions on cross border data flows | Knowledge Ecology International

Jamie Love james.love at keionline.org
Tue Dec 3 12:51:57 PST 2013


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 in 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

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]"
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.

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