May 10 Agreement

Subject: Trade deal leaked, would endanger public health
For Immediate Release:
Oct. 9, 2015
Contact: Peter Maybarduk, [email protected], +1 (202) 588-7755
Burcu Kilic, [email protected], +1 (202) 588-7792
David Rosen, [email protected], +1 (202) 588-7742
WikiLeaks Publication of Complete, Final TPP Intellectual
Property Text Confirms Pact Would Raise Costs, Put Medicines
Out of Reach
Final Deal Rolls Back Bush-Era “May 2007” Access to Medicine Protections
WASHINGTON, D.C. – WikiLeaks’ publication today of the final Trans-Pacific Partnership
(TPP) Intellectual Property chapter text verifies that the pact would harm public health by
blocking patient access to lifesaving medicines, Public Citizen said today. The latest leak of a
secret TPP text reveals how the TPP would roll back the “May 10 Agreement” reforms brokered
in 2007 between Democratic congressional leaders and the George W. Bush administration. It
also reveals the contentious “death sentence” clause on biologics, or biotech drugs, which roiled
TPP talks in Maui and Atlanta.
“If the TPP is ratified, people in Pacific Rim countries would have to live by the rules in this
leaked text,” said Peter Maybarduk, director of Public Citizen’s Global Access to Medicines
program. “The new monopoly rights for big pharmaceutical firms would compromise access in
TPP countries. The TPP would cost lives.”
The leak comes the morning after a White House meeting with pharmaceutical executives who
are dissatisfied that the deal did not provide them even greater monopoly rights.
“The monopolist pharmaceutical industry has won a lot with the TPP, at the expense of people’s
health,” said Burcu Kilic, policy director for Public Citizen’s Global Access to Medicines
program. “They should stop crying crocodile tears.”
WikiLeaks published the complete TPP Intellectual Property Chapter, dated Monday, October 5,
2015 – the date that the 12 Pacific Rim nations announced a final TPP deal. The leaked text does
not contain negotiating country brackets, indicating rules are no longer subject to debate, but
rather are the final version subject only to a legal “scrub.”
Read the full release.
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“These final TPP rules would lengthen, strengthen and broaden special patent and data
protections, which pharmaceutical companies use to delay generic competition and keep drug
prices high,” said Maybarduk.
The text shows that TPP rules do not even conform to the Bush-era May 10 access to medicines
standards that many congressional Democrats had insisted be further improved. In contravention
of the May 10 standard, TPP imposes patent term extensions and additional and longer
marketing exclusivities, as shown in Public Citizen’s analysis (PDF). Unlike the May 10
Agreement standard, the TPP would require developing countries to quickly transition to the
same rules that apply to developed countries, which provide extreme monopoly rights for the
pharmaceutical industry and limit access to affordable medicines.
“From very early on in the TPP negotiations, and to the ire of health advocates, it became
apparent that the Office of the U.S. Trade Representative (USTR) was abandoning the May 10
Agreement template,” said Maybarduk. “With today’s publication of the final version of the TPP
IP chapter by WikiLeaks, for the first time the public can see precisely which rules negotiators
agreed to and, importantly, how far beyond the May 10 Agreement the provisions extend
pharmaceutical intellectual property obligations in developing countries.”
Pharmaceutical intellectual property and access to medicines have been especially contentious
issues in the TPP talks, contributing to years of delay in the Obama administration’s timeline for
completing a TPP deal. While various new monopoly rights for drug firms were agreed to by
participating nations, confrontations over a special exclusivity rule for biologics – medical
products derived from living organisms, including many new and forthcoming cancer treatments
– contributed to the meltdown of the August ministerial in Hawaii and the double-overtime nearfailure in Atlanta.
Biologics exclusivity is separate from and independent of patent protection, though the
protections may overlap. The USTR initially supported a twelve- and then an eight-year
minimum monopoly period, while a majority bloc of negotiating countries would not consider
more than five years’ exclusivity. (Five countries provide no special biologics exclusivity rule at
all in their laws.) A Public Citizen analysis of the biologics provisions is available here (PDF).
The final document imposes a minimum mandatory five-year period. It also subjects the issue to
future discussions of a “TPP Commission” and efforts “to deliver a comparable effective
period.” This reflects a USTR effort to impose eight-year monopolies over countries’ refusal.
“That purposefully ambiguous language is meant to provide USTR a means to harass countries
in the future, and keep pushing for longer monopolies and industry profits at the expense of
people’s health,” said Kilic.
The USTR has indicated its solution to medicine access would include transition periods for
developing countries. Yet the leaked text shows that transition periods would last only three to
ten years and apply to only a few of the rules under discussion. A Public Citizen analysis of the
transition periods in the leaked text is available here (PDF).
“Forcing expansive pharmaceutical monopoly rules on countries that can scarcely afford high
drug prices has not always been U.S. trade policy, and in the past U.S. policymakers have
recognized that the needs of developing countries should not always be subordinate to U.S.
pharmaceutical industry profits,” said Maybarduk. “Some rare public servants from TPP
countries fought back and stood for health in this negotiation. Their efforts saved lives,” said
Maybarduk. “Yet in the end, the TPP will still trade away our health.”
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