WASHINGTON - 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.”

“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 near-failure 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.”