Days after secretive negotiations on the Trans-Pacific Partnership concluded, WikiLeaks has published the complete chapter on intellectual property. The leaked text shows the TPP would expands monopoly rights for pharmaceutical companies to help protect against competition from generic drug manufacturers.
According to an analysis by Public Citizen, the text also “requires TPP countries to stop generic versions of biologic medicines (‘biosimilars’) from being available to patients, even when there is no patent.” This effectively means lifesaving medicines will be more expensive and harder for sick people in TPP countries to afford and access.
Twelve countries—Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, the United States, and Vietnam—negotiated the TPP.
Although U.S. officials, like Pentagon chief Ash Carter, have made claims TPP would promote government transparency, the deal has been shrouded in secrecy. It will not be made available to the public until some time around November 7.
Before President Barack Obama can sign and send the deal to Congress, he must wait 90 days after notifying Congress. A full text of the agreement has to be made public for 60 days during this period.
WikiLeaks released multiple drafts of TPP chapters throughout negotiations. The information contributed significantly to the public’s understanding of the process that has been unfolding behind closed doors. Without WikiLeaks’ efforts, it would have been even harder to reasonably speculate about what pharmaceutical companies and other corporations were trying to specifically gain through this shadowy trade agreement.
In analysis of the final text of the TPP intellectual property chapter, Burcu Kilic and Peter Maybarduk of Public Citizen note pharmaceutical companies are granted market exclusivity of at least three years for any medicines discovered to have new uses.
For example, the HIV medicine zidovudine was discovered in 1964 as an anti-cancer medicine. In 1987, the U.S. Food and Drug Administration approve the drug for treatment of HIV. When it was introduced, AZT cost $7,000 person at the “monopoly price” for HIV treatment. The price of the generic version for treating cancer was $70 person by June 2013.
“This is an example of the kind of price differences, which could occur in TPP countries if they choose this implementation option of providing three-year monopolies for new indications,” according to Kilic and Maybarduk.
There also is a rule that would grant pharmaceutical companies five years of exclusivity if a “known product were combined with a new chemical entity that has not been previously approved.”
As Kilic and Maybarduk note:
…Kaletra, a second line combination HIV medicine (lopinavir and ritonavir) is sold as a single tablet by Abbott. Ritonavir was originally marketed on its own under the brand name Norvir by Abbott in 199618. Later Abbott worked on lopinavir and the combination of the two medicines was approved for marketing in 2000 by the U.S. FDA.19 In recent years generics have been available in some middle-income countries at about 10-20% the price of Abbott’s monopolized products in countries of comparable income levels.
The U.S. Trade Representative aimed to defeat the practice in some countries of exclusivity periods ending when a patent term elapsed by incorporating a provision into the TPP that states exclusivity and patent terms are independent from one another.
When it comes to biologic medicines, which can be vaccines, cancer medicines or therapies produced through biotechnology, the TPP could have profound implications [PDF].
According to Kilic and Sanya Smith of Public Citizen, under the TPP there would be 8 years of market exclusivity from the date the biologic is approved in a country or 5 years from the date the biologic is approved in the country, if other measures are in place to “deliver a comparable market outcome.”
Biologics are a “growing share of medicines and can cost tens or even hundreds of thousands of dollars per patient per year, and are often needed for a lifetime,” Kilic and Smith explain. “This is unaffordable even for the U.S. government. The Obama administration has repeatedly proposed in its budget reducing its current 12 years of biologics exclusivity to 7 years.”
Additionally, the TPP requires countries to join the International Convention for the Protection of New Varieties of Plants 1991 [PDF]. This convention favors seed company rights over the rights of farmers. Smith and Kilic point out it requires intellectual property protection be granted to “all species,” for 20 to 25 years, and imposes prohibitions against farmers who exchange seeds for the purpose of crop rotation.
Brunei, Malaysia, Mexico, and New Zealand are not members of this convention and would have to comply with the terms.
Finally, as analysis by Public Citizen advocates highlight, forcing monopoly rules on countries represents an abandonment of an agreement established between Democrats in the House of Representatives and President George W. Bush’s administration on May 10, 2007.
In this agreement, there was an attempt to recognize developing countries should not “always be subordinate to Big Pharma. The impact of including “stringent” intellectual property rules was paid attention for the first time. However, the Obama administration trampled all over this agreement and made forcing monopoly rights on countries a larger component of U.S. trade policy.
“If TPP is ratified, people in the Pacific-Rim countries would have to live by the rules in this leaked text,” said Maybarduk concluded. “The new monopoly rights for big pharmaceutical firms would compromise access to medicines in TPP countries. The TPP would cost lives.”