As TPP Ministers Meet, NGOs Make Urgent Push For Public Interest

Trade ministers negotiating the Trans-Pacific Partnership (TPP) agreement meet this week in Maui, Hawaii to try to finish the deal. Along with them are numerous public interest groups strenuously lobbying to steer the deal away from single-minded corporate interest.

The TPP ministers are meeting from 28-31 July.

Below are several of the statements. There may be more from other participating countries.

Decision Time on Biologics Exclusivity: Eight Years Is No Compromise

Public Citizen published an opinion piece in the Intellectual Property Watch Inside Views column today entitled, Decision Time on Biologics Exclusivity: Eight Years Is No Compromise.

It states: “As the Trans-Pacific Partnership (TPP) negotiations approach their endgame, biologics exclusivity is still considered “one of the most difficult outstanding issues in the negotiation.”[2] Pharmaceutical companies seek longer data and marketing exclusivities to further delay market entry of cost-saving biosimilar drugs. Data exclusivity prevents follow-on pharmaceutical developers from relying on originators’ test data submitted for marketing approval while seeking such approval for its own product. The World Trade Organization’s (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) requires some protection against unfair competition for this sort of data, but it does not require countries to adopt rules conveying exclusive rights over it in the same way as it does regarding patents.[3] Currently, the US provides 12 years of exclusivity for new biological products under the Biologics Price Competition and Innovation Act (BPCIA).[4] The provision providing 12 years exclusivity was buried inside the 20,000-page healthcare law, The Patient Protection and Affordable Care Act. A robust debate over what would be an appropriate exclusivity period, if any, was overshadowed by other controversial aspects of the bill commonly referred to as Obamacare.

“There is much confusion surrounding the statutory interpretation of the BPCIA. Many scholarly articles and blog posts as well as industry-funded sources state that the United States allows for 12 years of data exclusivity. However, this is not the case. The law actually provides only four years of data exclusivity for biologic drugs, while the remaining eight years function as market exclusivity.”

See (IPW, Inside Views, 27 July 2015) for the full article.

 

TPP Negotiators Must Fix the Most Damaging Trade Agreement Ever for Global Health, MSF Says

“Trade negotiators must remove damaging access to medicines provisions in the Trans-Pacific Partnership (TPP) trade deal or risk locking in high drug prices and endangering the health of millions of people for decades to come,” Médecins Sans Frontières (MSF, Doctors without Borders) said in a statement.

MSF said: “If approved in its current form, the TPP, which is being negotiated between the US and 11 other Pacific Rim countries, will have a devastating impact on global health. It would strengthen, lengthen and create new patent and regulatory monopolies for pharmaceutical products that will raise the price of medicines and reduce the availability of price-lowering generic competition.

“Some of the most concerning provisions in the TPP center on so-called ‘patent evergreening,’ which would force TPP governments to grant pharmaceutical companies additional patents for changes to existing medicines, even when those changes provide no therapeutic benefit to patients.

“US negotiators have also aggressively pushed for 12 years of ‘data exclusivity’ for biologic medicines, which include vaccines and drugs to treat conditions such as cancer and multiple sclerosis. Data exclusivity blocks government regulatory authorities from allowing price-lowering generic competitors to enter the market with previously generated clinical data.

“If pharmaceutical companies get their way, brand-name drugs and vaccines would not face direct competition for excessively long periods of time while patients, medical providers like MSF, and people in TPP countries endure unnecessarily high prices.

“The provisions demanded by US negotiators break past US government commitments to global health, including a 2007 agreement in which the US agreed to include key public health safeguards in future free trade deals with developing countries.”

 

USTR Proposal Violates State Immunity, KEI Says

Washington, DC-based Knowledge Ecology International produced a video asserting that a proposal in the TPP by the US Trade Representative’s office would undermine state sovereign immunity for patents, copyrights, and expose US taxpayers to fines under investor-state dispute settlement (ISDS) procedures. It states:

“This is a video produced by Zack Struver and Tazio De Tomassi, on July 26, 2015, during the negotiations on the intellectual property and investment chapters of the Trans Pacific Partnership (TPP) trade agreement,” it said. “USTR is ignoring 1999 US Supreme Court Decisions, see: FLORIDA PREPAID v COLLEGE SAVINGS (98-531) 527 U.S. 627 (1999) , which held that US states cannot be sued for patent, trademark (or copyright) infringement, under the provisions of the 11th Amendment to the US constitution. USTR’s proposals on remedies make the US government liable for such infringements, under the TPP private sector arbitration provisions in the Investor State Dispute Settlement (ISDS).”

 

TPP’s Copyright Trap

The Electronic Frontier Foundation (EFF) issued an analysis on the negative impact of copyright provisions in the TPP, which it called:

“Our Last Stand Against Undemocratic International Agreements That Ratchet up Term Lengths and Devastate the Public Domain”

It stated: “Few arguments around copyright are as self-evidently fact-free as the length of its term. Defying economic reasoning, the astonishingly long period of restrictions has only grown over the years, and frequently the newer, longer terms have been retroactively applied to earlier works. The argument against term extension, and retroactive term extension in particular, is so obvious that the Nobel Prize winning economist Milton Friedman reportedly agreed to sign a Supreme Court brief opposing the most recent extension only on the condition that it used the word “no-brainer.”

 

Public Knowledge Urges USTR to Protect Fair Use and Public Domain

Public Knowledge sent a letter to United States Trade Representative Michael Froman urging him to protect the rights of American consumers of intellectual property goods.

“Public Knowledge remains concerned that provisions in the secretive Trans-Pacific Partnership trade agreement could harm Americans by weakening exceptions and limitations available under US law, including fair use,” it said.

 

Ways and Means Democrats Press USTR to Protect Anti-Tobacco Public Health Measures

Separately, the Democratic members of the US House of Representatives Ways & Means Committee urged USTR Froman to protect public health measures against tobacco. They said:

“All 15 Ways and Means Committee Democratic Members today sent a letter to US Trade Representative (USTR) Michael Froman pressing him to ensure the Trans-Pacific Partnership (TPP) negotiations clearly protect legitimate public health measures related to tobacco.

“Countries around the world – including those engaged in TPP negotiations – have put in place substantive measures to help prevent and reduce tobacco consumption. Despite these efforts, the tobacco industry has continued to work to undermine these laws through international trade disputes. In their letter, Democratic Members urged Ambassador Froman to lead efforts to make sure these public health commitments are not weakened by unwarranted challenges under the TPP agreement.”

 

House Democrats Supporting Fast Track Write USTR about Medicine IPR

Knowledge Ecology International also circulated a letter from House Democrats cautioning USTR on health-related provisions in the TPP. In a blog post, KEI states:

“Eleven of the 28 House Democrats who supported the Trade Promotion Authority (TPA) Fast Track legislation have sent a letter to Ambassador Froman at the USTR on the topic of intellectual property rights and medicine in the TPP. The letter, which is moderate and cautious in substance, but overall helpful given where negotiations stand, closes by telling Ambassador Froman that “As members who support trade done right, we strongly believe that TPP must not inhibit access to lifesaving medicines.”

“The letter endorses “strong protections for marketing exclusivity for test data,” but does not mention a specific term for biologic drugs. While not specifically addressing the need for and importance of having space for exceptions to the test data rights, the letter notes that:

“Additionally, we think it is critical a final TPP agreement include language ensuring IP obligations do not prevent member countries from taking measures to protect public health, and in particular, to promote access to all.”

The letter also states:

“We are concerned that the TPP would fail this scrutiny if it does not meet or exceed the standards set under the May 10th Agreement, reached by House Democrats and the Bush White House in 2007, with respect to timely access to affordable medicines in developing countries.”

 

The Trans-Pacific Partnership — Is It Bad for Your Health?

In a related item, Yale Law Professor Amy Kapczynski article in the New England Journal of Medicine raises questions about the public health implications of TPP provisions.

The article, “The Trans-Pacific Partnership — Is It Bad for Your Health?” states:

“International trade deals once focused primarily on tariffs. As a result, they had little direct effect on health, and health experts could reasonably leave their details to trade professionals. Not so today. Modern trade pacts have implications for a wide range of health policy issues, from medicine prices to tobacco regulation, not only in the developing world but also in the United States.

“The Trans-Pacific Partnership Agreement (TPP) is a case in point. A massive trade deal now reportedly on the verge of completion, the TPP has nearly 30 chapters. A draft chapter on intellectual property (IP) alone runs 77 single-spaced pages.

“The full health implications of the TPP are hard to judge, not only because its provisions are complex but also because the draft text is a closely held secret. Even members of the U.S. Congress can see it only if they agree not to talk publicly about it and if they leave their pens and phones (and, until recently, their expert staffers) at the door. But several key chapters have recently been leaked and reveal that the TPP could have a substantial impact on health.”