House Democrats and health care advocates blasted drug patent provisions in a current draft of the Trans-Pacific Partnership agreement on Friday, criticizing the Obama administration for advancing policies that could drive up drug global drug costs.
Reps. Jan Schakowsky (D-Ill.) and Rosa DeLauro (D-Conn.), together with health advocates and a representative of the generic drug maker Mylan, called on the Obama administration to change aspects of the 12-nation Pacific Rim trade pact that would strengthen pharmaceutical patent monopolies. Speaking to reporters on a conference call, they said the measures would make it harder for generic drugs to come to market in countries that sign the agreement, including the United States.
The TPP agreement's chapter on intellectual property for drugs “confirms some of the worst fears of health care advocates,”said DeLauro, who has access to the agreement's classified draft text. If the current draft of TPP becomes law, she warned, “You can freeze cheaper generic drugs out of the market.”
In addition to the impact this could have on lower- and middle-income countries involved in TPP negotiations, like Vietnam, the provisions “will mean increased costs for Medicare and Medicaid, which will have a devastating effect on seniors" in the U.S., DeLauro said.
One thing fueling critics' concerns is a mandatory “patent linkage” provision in the draft text, which would prevent governments from approving generic drugs if there is any possibility that they violate a patent. This could dissuade generic drug makers from entering poorer or smaller countries, since overcoming stringent patent barriers has less of a payoff than in larger or wealthier nations like the United States.
Although the United States already has mandatory “patent linkage” requirements in place, the requirements in the current TPP draft are broader, said Nawel Rojkjaer, senior director of international affairs for Mylan. Currently, generic drug makers are only required to notify the Food and Drug Administration (FDA) about patent disputes. TPP’s patent linkage would preclude them from entering the market entirely if a pharmaceutical company argues that they are violating a patent, she said.
HIV/AIDS advocates are particularly worried that TPP could limit access to generic drugs made in developing nations, which have been crucial to fighting HIV/AIDS.
“We have achieved the target of having 15 million people in on treatment by 2015,” said Brian Honermann, senior research advisor at amfAR, the Foundation for AIDS Research. “That goal would never have been able to be achieved if we did not have access to generic drugs. If the intellectual property standards that are being proposed in the TPP were the standards in 2002 and 2003, it would have prohibited India and Thailand from creating the generic drugs we have been relying on to treat HIV.”
The advocates consider the current pharmaceutical patents component of TPP a repudiation of the so-called “May 10th” agreement of 2007, which the George W. Bush administration negotiated with House Democrats to clear passage for trade deals. In addition to unprecedented protections for labor and environmental rights, the accord ensured greater flexibility on patent protections for developing countries.
The TPP deal would depart from the May 10th agreement's high standards, argues Rep. Sander Levin (D-Mich.), who helped negotiate the 2007 agreement.
Friday's call precedes the next round of TPP negotiations in Maui, Hawaii, which will take place from July 24 to 27. Schakowsky said the meeting could be “the last chance we have to protect the public health.”
The public first caught wind of the drug patent protections in a May 11 draft of the TPP’s intellectual property chapter, leaked to Politico in late June. The Obama administration has since insisted that the draft is still being negotiated and remains subject to change.
"The negotiations on intellectual property are complex and continually evolving,” Trevor Kincaid, a spokesman for the U.S. Trade Representative, told Politico. “On pharmaceutical products, we are working closely with stakeholders, Congress, and partner countries to develop an approach that aims to make affordable life-saving medicine more widely available while creating incentives for the development of new treatments and cures. Striking this important balance is at the heart of our work.”
But Schakowsky said “virtually nothing that has been suggested by members of Congress in a very thoughtful and serious way" has been incorporated into the evolving draft text.
“I have been very public about my concerns on the pharma chapter and have had no response at all from the U.S. Trade Representative about it,” she added.
Congress granted Obama trade promotion authority in late June, enabling the TPP and any other trade deals to be passed in an up-or-down vote in the next 6 years, without the possibility of filibusters and amendments.
But the president only received the fast-track authority after a prolonged legislative battle that exposed a bitter rift between the administration and House Democrats. After Democratic lawmakers helped defeat a companion bill key to the passage of trade promotion authority in the Senate, Obama circumvented them entirely, negotiating final passage with House Republican leadership.
Still, Schakowsky argues that public health advocates have leverage over the Obama administration on the issue of drug affordability, since many of the 11 other nations involved in TPP negotiations have also objected to the patent protections.
The protections for pharmaceutical patent monopolies reflect the U.S. negotiating position “virtually exclusively,” Schakowsky said. “Having looked at the document, it is filled with the names of countries objecting to the U.S. position.”