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Earlier this month, representatives of the Trans-Pacific Partnership Agreement (TPPA) parties announced they had concluded five years of negotiations by agreeing to final terms. The governments have not yet allowed the public to view the agreement, but a version of the TPPA’s intellectual property chapter published by Wikileaks reveals what I consider a potentially devastating setback to the human right to health.1
Simply put, the TPPA is designed to block the sick and the poor from accessing affordable generic and biosimilar medicines. If the TPPA is ultimately approved by its member nations, it will enshrine a billions-over-millions trade-off: billions of dollars in profits will be made by patent-holding pharmaceutical corporations, and millions of people will needlessly suffer and die.
But the legislative bodies of those member nations, including the US Congress, have not yet signed off on the deal. And many are facing significant pressure not to. That pressure provides an historic opportunity for advocates to not just scuttle a bad trade deal, but to elevate the human right to health.
As it stands, the TPPA is a weapon of mass destruction. The final terms include multiple provisions that extend both the scope and length of patent protections. For example, the agreement guarantees market exclusivity for patented biologic drugs for at least five years in all TPPA countries, and likely eight years of de facto exclusion of more affordable versions of needed medicine.2 Biologic drugs are produced using living systems such as bacteria, or plant and animal cells, and have been particularly effective in response to cancer. Some vaccines are biologics, and in future more diagnostic tests may be developed using biotechnology.
Under current law, the poorest of the TPPA countries, including Malaysia, Mexico, Peru and Vietnam, do not grant monopoly protection for biologic drugs. But the TPPA terms will compel them to do so within just a few years, despite the deadly impact that higher drug prices will inevitably have on their low-income population.3 The TPPA also sanctions “evergreening” of patented medicines at the national level, a process where barriers to generics are extended when new patents are granted for altered uses or slight changes to existing medicines.4
There is much more in the TPPA’s intellectual property chapter, all of it representing the generic-busting wish list of the pharmaceutical corporations that hold monopoly drug patents.5 The TPPA covers 800 million people comprising 40% of the world’s economic activity, but its potential impact is even broader. Supporters and opponents alike agree that the TPPA is designed to be a standard-setter for future trade agreements.
Through the many twists and turns of the TPPA negotiations, several public health advocacy groups and individuals have been heroically fighting for more humane terms. They have reviewed the final agreement, and their verdicts are chilling: “Nothing less than a disaster for global health,” says Deborah Gleeson, LaTrobe University (Australia) professor and peerless analyst of the TPPA.6 “History’s worst trade agreement for access to medicine in developing countries,” says Médicins Sans Frontières.7 Public Citizen bluntly says, “The TPP would cost lives.”8
But there is a silver lining in this dark cloud, and even an historic opportunity to break up the looming menace altogether. The silver lining can be found in the advocacy that prevented the TPPA from becoming an even more formidable barrier to affordable generic drugs. The US Trade Representative pushed for the TPPA to include a 12-year embargo on non-patented biologics, the forbidding length of time the pharmaceutical industry had successfully inserted into the US Affordable Care Act. But the other TPPA countries’ representatives resisted, as they did against multiple US proposals to elevate patent rights over patients’ rights.9 Australia in particular held firm on the biologics issue, even after President Obama leaned on Australian Prime Minister Malcolm Turnbull in the negotiations’ closing hours.10 The US finally blinked, and the five/eight year compromise was reached.
This successful resistance by non-US parties reveals the opportunity for health advocates. Domestic concerns over the TPPA have led to protests in party nations including Australia, New Zealand, Malaysia, and Japan.11 Even in the US, despite the TPPA push by the Obama administration, the leading 2016 presidential candidates from both major political parties have come out against the deal.12 Faith-based advocates oppose the agreement, and labor leaders say the TPPA will cost millions of US jobs.13 Debate in the US Congress promises to be fierce, and approval of the deal is no certainty.
The TPPA has already elevated discussion of the human right to essential medicines.14 And access to medicines advocacy has received an unexpected recent boost by way of breathtaking, headline-producing corporate greed in the US pricing of patented drugs. Patients and policy makers alike have been outraged by a critical hepatitis C drug, developed with government funding, being priced at $1,000 for every pill, manufactured by its patent-holder for about $1.15 Social media exploded in anger when a young pharma CEO arbitrarily raised the cost of a 62-year-old toxoplasmosis drug 5,455% overnight.16 And frustrated cancer physicians have taken to co-authoring articles calling for reform of a system where one in five US cancer patients cannot fill their prescriptions.17
Ironically, if the history of the US Civil Rights movement provides a precedent, these spectacles of avarice, combined with the nakedly profits-over-people terms of the TPPA, may actually save lives. Pharmaceutical corporate overreach can be the ‘Bull Connor’ of the right to health movement. When TV cameras captured Bull Connor, the Birmingham, Alabama, sheriff turning high-powered firehoses on children marching for civil rights in 1963, the world was exposed to the depravity and violence of racial segregation. Reform soon followed.
Today, thanks to the TPPA and shameful price-gouging of essential medicines, the depravity and violence of the patent medicine regime is similarly exposed. The chance to elevate health as a human right is at hand.
Fran Quigley, JD MA, is a clinical professor at Indiana University McKinney School of Law, where he directs the Health and Human Rights Clinic. Please address correspondence to the author at firstname.lastname@example.org.
1 Wikileaks, TPP Treaty: Intellectual Property Rights Chapter (October 5, 2015). Available at https://wikileaks.org/tpp-ip3/
2 Intellectual Property Rights Chapter, Article QQ.E.20, p. 25-26.
3 H. Moir, B. Tenni, D. Gleeson, R. Lopert, Assessing the impact of alternative patent systems on the cost of health care: The TPPA and HIV treatment in Vietnam. Asia-Pacific Innovation Conference, University of Technology Sydney, 2014 November 27-29 [Cited 2015 June 8]. Available at http://ssrn.com/abstract=2536254
4 Intellectual Property Rights Chapter, Article QQ.E.1.2, p. 17.
5 D. Gleeson, Preliminary comments on the competed Trans-Pacific Partnership (TPP) Intellectual Property Chapter (Oct. 10, 2015). Available at http://aftinet.org.au/cms/sites/default/files/Gleeson%20comments%20on%20completed%20IP%20chapter.pdf
7 Médicins Sans Frontières, Statement by MSF on the conclusion of TPP negotiations in Atlanta (October 05, 2015). Available at http://www.doctorswithoutborders.org/article/statement-msf-conclusion-tpp-negotiations-atlanta
8 Public Citizen, Wikileaks publication of complete, final TPP intellectual property text confirms pact would raise costs, put medicines out of reach, (October 9, 2015). Available at http://www.citizen.org/pressroom/pressroomredirect.cfm?ID=5662
9 F. Quigley, “The TPP’s bad medicine,“ Foreign Affairs (July 13, 2015). Available at https://www.foreignaffairs.com/articles/2015-07-13/tpps-bad-medicine
10 A. Behsudi and S. Karlin, “Obama delivers TPP hard sell to pharma CEOs,” Politico (October 8, 2015). Available at http://lists.keionline.org/pipermail/ip-health_lists.keionline.org/2015-October/005490.html
11 F. Quigley, “No news is good news: an update on the Trans-Pacific Partnership Agreement,” Health and Human Rights Journal (August 31, 2015). Available at http://www.hhrjournal.org/2015/08/31/no-news-is-good-news-an-update-on-the-trans-pacific-partnership-agreement/
12 C. Hankla, “The 2016 presidential frontrunners threaten the TPP deal,” Fortune (October 12, 2015). Available at http://fortune.com/2015/10/12/presidential-frontrunners-threaten-ttp-deal/
13 F. Quigley, “Prescription for justice: Catholics must help bring down barriers blocking billions from lifesaving medicine,” National Catholic Reporter (Oct. 9, 2015). Available at http://ncronline.org/news/peace-justice/prescription-justice-catholics-must-help-bring-down-barriers-blocking-billions and AFL-CIO, The Trans-Pacific Partnership Agreement. Available at http://www.aflcio.org/Issues/Trade/Trans-Pacific-Partnership-Free-Trade-Agreement-TPP
14 F. Quigley, “The Trans-Pacific Partnership and Access to Medicines,” Health and Human Rights Journal (June 18, 2015). Available at http://www.hhrjournal.org/2015/06/18/the-trans-pacific-partnership-and-access-to-medicines/
15 M. Sanger-Katz, “$1,000 Hepatitis pill shows why fixing health costs is so hard: critics raise concerns about Sovaldi,” N.Y. Times (August 2, 2014). Available at http://www.nytimes.com/2014/08/03/upshot/is-a-1000-pill-really-too-much.html
16 C. Johnson, “A defining moment in modern health care,” Washington Post (September 23, 2015). Available at http://www.washingtonpost.com/business/economy/a-defining-moment-in-modern-health-care/2015/09/23/d6496468-6229-11e5-b38e-06883aacba64_story.html
17 A. Tefferi et al.,, “In support of a patient-driven initiative and petition to lower the high cost of cancer drugs,” Mayo Clinic Proceedings (August, 2015). Available at http://www.mayoclinicproceedings.org/article/S0025-6196(15)00430-9/pdf Previous publications in HHRJ by Fran Quigley The Trans-Pacific Partnership and Access to Medicines (June 2015) No News is Good News: An Update on The Trans-Pacific Partnership and Access to Medicines (August 2015) SDG SERIES: SDGs vs Trade Agreements: Not a Fair Fight (Sept 2015)
Previous publications in HHRJ by Fran Quigley
Papers in Press
Mechanisms of Accountability for the Realization of the Right to Health in China
Shengnan Qiu and Gillian MacNaughton
The Child’s Right to Protection From Drugs: Understanding Its History to Move Forward
The Case for International Guidelines on Human Rights and Drug Control
Rick Lines, Richard Elliott, Julie Hannah, Rebecca Schleifer, Tenu Avafia, and Damon Barrett
Letter to the Editor: Human Rights, TB, Legislation and Jurisprudence
O. B. K. Dingake
UNstoppable: How Advocates Persevered in the Fight for Justice for Haitian Cholera Victims