The Trans-Pacific Partnership and Access to Medicines

Fran Quigley

Representatives of Pacific Rim nations are negotiating a trade agreement that could negatively impact the health of millions. But the high-profile discussion about the proposed Trans-Pacific Partnership Agreement (TPPA) also presents an opportunity for health advocates. This Perspective essay first reviews key proposed terms of the TPPA that would extend the flawed pharmaceutical patent regime and violate multiple human rights commitments. Second, the social movement to ensure access to antiretroviral medicines is presented as an object lesson in successful advocacy for health as a human right. Finally, this essay argues that the attention paid to the TPPA by media, lawmakers, and social justice activists, particularly in the US, creates an ideal platform for advocacy in support of the human right to essential medicines.

Introduction: The Trans-Pacific Partnership Agreement

Negotiations on the Trans-Pacific Partnership Agreement (TPPA) include 12 countries whose economies encompass nearly 40% of the world’s gross domestic product.[1] The TPPA talks are conducted in secret, with no proposed terms officially disclosed. But representatives of the pharmaceutical industry have had access to the process, and leaked drafts reveal that the US Trade Representative is pushing for expanded patent protection for medicines and delayed access to generic alternatives.[2][3]

Specific provisions reportedly include allowing new patents for minor revisions and new uses of old medicines, a process known as “evergreening.” Other provisions would delay proposed generic alternatives from accessing information needed to allow their entry into the market, a barrier known as data exclusivity. Both evergreening and data exclusivity have the effect of extending the patent holders’ monopoly power over medicines, which leads to higher prices.[4]

The draft TPPA also reportedly includes investor-state dispute settlement provisions that would allow pharmaceutical and medical device corporations to force a government into arbitration over state pharmaceutical policies. Similar terms in the North American Free Trade Agreement (NAFTA) enabled Eli Lilly and Company to file a $500 million challenge to Canada’s invalidation of two Lilly drug patents, despite court rulings that upheld the Canadian government’s decisions.[5]

The TPPA could also undercut ongoing successful efforts to increase access to medicines. For example, the Pharmaceutical Management Agency (PHARMAC) in New Zealand keeps medicine costs low by conducting price negotiations with patent-holding pharmaceutical companies and through therapeutic reference pricing, which sets the cost paid for medicines by comparing them with other medicines with similar therapeutic benefits. PHARMAC is widely considered to be a model approach that can be followed by developing nations seeking to ensure access to medicines.[6]

Ominously, the US Trade Representative has labeled New Zealand’s reimbursement policies as unfair to patent holders and criticized the “negative aspects of the overall climate for innovative medicines in New Zealand.”[7] The most recent leak of draft TPPA terms suggests that country parties are poised to reduce New Zealand’s flexibility in medicine pricing and formulary choices, in part by forcing PHARMAC to open its decision-making process to accommodate corporate lobbying.[8]

Medicine patents and human rights

These proposed TPPA terms demonstrate a fundamental conflict between the human right to health and the regime of intellectual property, in particular the process of granting patents to medicines. A patent awards its holder the exclusive right to manufacture and sell a product for a defined period, set at a minimum of 20 years by the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights, known as TRIPS.[9] In theory, these monopoly rights and the accompanying high product pricing represent a justifiable investment in spurring the process of discovery.[10]

But research and development costs shouldered by pharmaceutical corporations turn out to be far less substantial than the sums those companies spend on sales and marketing.[11] Many of the most important research gains in medicines have been funded directly or indirectly by governments, not private companies.[12] And the patent system provides little incentive for profit-motivated corporations to address diseases that primarily affect people living in poverty. Of 1556 new chemical entities marketed between 1975 and 2004, only 21 were for tropical diseases and tuberculosis.[13]

The results are devastating. WHO estimates that one-third of the world’s population has no access to necessary medicines, and the first UN Special Rapporteur on the right to health, Paul Hunt, reported in 2008 that the lack of medicine leads to 10 million deaths each year.[14]

The patent system’s failures stand in stark contrast to the human right to access essential medicines. Dating back to the WHO Constitution and the Universal Declaration of Human Rights, the highest attainable standard of health has long been recognized as a fundamental right.[15] The International Covenant on Economic, Social and Cultural Rights (ICESCR) imposes in its Article 12 the obligation for state parties to take steps to achieve full realization of the right to health.[16] General Comment 14 by the UN Commission on Economic, Social and Cultural Rights affirms that ensuring access to essential medicines is a core and immediate obligation of ICESCR state parties.[17]

Most countries have explicitly recognized this human right to the highest attainable standard of health, whether through binding international and regional treaties or in their national constitutions.[18] Many courts across the globe, usually responding to a robust social movement supporting litigation, have issued rulings recognizing the right to health, including the right to access to medicine, and have ordered the right’s fulfillment by state parties.[19]

The social movement for access to essential medicines

The movement for access to essential medicines can claim one of the great triumphs in human rights history. In 2000, the high cost of patented antiretroviral medicines created such an imposing barrier that just one of every 1,000 Africans infected with HIV had access to the treatment.[20] The TRIPS Agreement had recently bolstered the global strength of those patents, creating a sense of fatalism among some global health actors.[21] But civil society organizations proved unwilling to sacrifice HIV patient lives for the benefit of patent protection.

Determined activism in Brazil caused its government to implement a national program of ARV treatment in 1997, initially relying on the domestic manufacture of medicines that were patented elsewhere.[22] In South Africa, following an advocacy model developed previously in the US, persons living with HIV/AIDS came together under the banner of the Treatment Action Campaign (TAC) to use direct action, political lobbying, and litigation to demand the human right to access medicines. [23] Pressure on the ARV patent holders was increased when community-based activists recruited international allies to help aggressively “name and shame” both the companies and the US elected officials who defended them.[24]

In 2001, the pharmaceutical industry stood down. Corporations dropped litigation contesting parallel importation of low-cost generic ARVs in South Africa, and the US Trade Representative withdrew its complaint against Brazil’s compulsory licensing of ARVs. Later that year, governments at the WTO Ministerial Conference adopted the Doha Declaration on TRIPS and Public Health, affirming that the TRIPS Agreement must be interpreted “in a manner supportive of WTO members’ right to protect public health and, in particular, to promote access to medicines for all.”[25] The Doha Declaration’s powerful message led to 50-plus developing countries taking advantage of TRIPS flexibilities to bypass patents to procure lower-cost generic medicines for their populations.[26]

But the pharmaceutical patent empire has since struck back, pushing for so-called “TRIPS-Plus” trade agreements negotiated by the US and the European Union with middle- and low-income countries. Those countries are being pressured to agree to terms that undercut the TRIPS flexibilities for access to essential medicines.[27]

A social movement response to TPPA

Opposition to TRIPS-Plus has been concentrated in low- and middle-income countries whose governments are being pushed to increase patent protection, while most TRIPS-Plus proposals have generated little attention in the US.[28] But US-based resistance to the TPPA mounted by labor unions, faith-based organizations, and environmental groups has raised the profile of the agreement’s likely negative effects on the social determinants of health.[29] That resistance led to recent Congressional votes that denied for the moment President Obama’s effort to push for trade promotion authority that would allow amendment-free, expedited approval of the TPPA.[30]

This debate provides multiple opportunities for access to medicine advocates. They can forge with other TPPA resisters the kinds of alliances that have proven to be critical to the success of social movements.[31] The bright TPPA spotlight can also accommodate renewed discussions about the many creative non-monopoly approaches to induce medicine research and development, along with affordable pricing. Those approaches include open source collaboration, patent pools, prize schemes, and a research and development treaty.[32]

As the historic movement to gain access to ARVs demonstrated, such advocacy is most impactful when it frames access to medicines as a human right, rather than a charitable endeavor.[33] A US audience can particularly benefit from a message that reinforces health as a human right, since the US population is less accustomed than others in the global community to viewing economic and social needs through the human rights lens.

International organizations including Médecins Sans Frontières, Public Citizen, and Oxfam, working in alliance with access to medicines campaigns based in low- and middle-income countries, are using the TPPA as a platform to deliver this message.[34] The stage is set for the access to medicines movement to make significant progress, so these efforts deserve the support of all who support the human right to health.

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 quigley2@iupui.edu.

References

[1] Office of the US Trade Representative, Trans-Pacific Partnership: Summary of U.S. objectives (Washington, DC: Executive Office of the President of the US, 2015). Available at https://ustr.gov/tpp/Summary-of-US-objectives.

[2] E. Palmberg, “The insider list,” Sojourners (June 29, 2012). Available at http://sojo.net/blogs/2012/06/29/insider-list.

[3] Public Citizen, What’s new in the 2014 WikiLeaks TPP intellectual property text? (October 16, 2014). Available at http://www.citizen.org/documents/highlights-of-section-e.pdf; WikiLeaks, Trans-Pacific Partnership Agreement Transparency Chapter Annex on Transparency and Procedural Fairness for Pharmaceutical Products and Medical Devices (June 10, 2015).

[4] E. t’Hoen et al., “Driving a decade of change: HIV/AIDS, patents and access to medicines for all,” Journal of the International AIDS Society 14/15 (2011), p. 8.

[5] B. Baker, “Threat of pharmaceutical-related IP investment rights in the Trans-Pacific Partnership Agreement: An Eli Lilly v. Canada case study,” Investment Treaty News (International Institute for Sustainable Development, September 2013), pp. 8-10. Available at https://www.iisd.org/itn/2013/09/20/threat-of-pharmaceutical-related-ip-investment-rights-in-the-trans-pacific-partnership-agreement-an-eli-lilly-v-canada-case-study/

[6] D. Gleeson, R. Lopert, and P. Reid, “How the Trans-Pacific Partnership Agreement could undermine PHARMAC and threaten access to affordable medicines and health equity in New Zealand,” Health Policy 112/1 (2013), pp. 227-233.

[7] United States Trade Representative, 2012 Special 301 Report (Washington DC: Executive Office of the President of the US, 2012), p. 21. Available at https://ustr.gov/sites/default/files/2012%20Special%20301%20Report.pdf.

[8] D. Gleeson, The TPP’s healthcare transparency annex: commentary on the leaked TPP Transparency Chapter Annex on Transparency and Procedural Fairness for Pharmaceutical Devices dated December 17, 2014 and released by Wikileaks in June 2015.

[9] Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), 33 I.L.M. 1197 (1994). Available at https://www.wto.org/english/tratop_e/trips_e/t_agm0_e.htm.

[10] Pharmaceutical Research and Manufacturers of America, Intellectual property protections are vital to continuing innovation in the biopharmaceutical industry (2015). Available at http://www.phrma.org/innovation/intellectual-property.

[11] D. Light and R. Warburton, “Demythologizing the high costs of pharmaceutical research,” BioSocieties (2011), pp. 1-17; R. Anderson, “Pharmaceutical industry gets high on fat profits,” BBC News (November 6, 2014). Available at http://www.bbc.com/news/business-28212223.

[12] B. Sampat and F. Lichtenberg, “What are the respective roles of the public and private sectors in pharmaceutical innovation?” Health Affairs 30/2 (2011), pp. 332–339.

[13] P. Chirac and E. Torreele, “Global framework on essential health R&D,” The Lancet 367/9522 (2006), pp. 1560-1561.

[14] World Health Organization, The world medicines situation 2011: Access to essential medicines as part of the right to health (Geneva: WHO, 2011), p. 1; Paul Hunt, Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of physical and mental health, Human Rights Guidelines for Pharmaceutical Companies in relation to the Access to Medicines, UN Doc. No. A/63/263 (2008), p. 15. Available at http://www.who.int/medicines/areas/human_rights/A63_263.pdf.

[15] Constitution of the World Health Organization, UN Doc. E/155 (1946), Preamble. Available at http://www.who.int/governance/eb/who_constitution_en.pdf . Universal Declaration of Human Rights (UDHR), G.A. Res. 217A (III) (1948), Art.25. Available at http://www.un.org/en/documents/udhr/.

[16] International Covenant on Economic, Social and Cultural Rights (ICESCR), G.A. Res.

2200A (XXI), Art. 12. (1966). Available at http://www.ohchr.org/EN/ProfessionalInterest/Pages/CESCR.aspx

[17] Committee on Economic, Social and Cultural Rights, General Comment No. 14, The Right to the Highest Attainable Standard of Health, UN Doc. No. E/C.12/2000/4 (2000), paras. 12, 43(d). Available at http://docstore.ohchr.org/SelfServices/FilesHandler.ashx?enc=4slQ6QSmlBEDzFEovLCuW1AVC1NkPsgUedPlF1vfPMJ2c7ey6PAz2qa
ojTzDJmC0y%2b9t%2bsAtGDNzdEqA6SuP2r0w%2f6sVBGTpvTSCbiOr4XVFTqhQY65auTFbQRPWNDxL

[18] S. Perehudoff, R. Laing, and H. Hogerzeil, “Access to essential medicines in national constitutions,” Bulletin of the World Health Organization 88 (2010), p. 800.

[19] H. Hogerzeil et al., “Is access to essential medicines as part of the fulfillment of the right to health enforceable through the courts?” The Lancet 368 (2006), pp. 305-311; Global Health Justice Partnership, A human rights approach to intellectual property and access to medicines, (New Haven, CT: Yale Law School and Yale School of Public Health, September 2013), pp. 11-24.

[20] B. Gellman, “An unequal calculus of life and death: as millions perished in pandemic, firms debated access to drugs,” Washington Post (December 27, 2000). Available at http://www.washingtonpost.com/wp-dyn/content/article/2006/06/09/AR2006060901287.html

[21] Karen DeYoung, “Global AIDS Strategy May Prove Elusive,” Washington Post (April 23, 2001). Available at http://www.globalaging.org/health/world/strategy.htm.

[22] Tina Rosenberg, “Look at Brazil,” New York Times (January 28, 2001). Available at http://www.nytimes.com/2001/01/28/magazine/look-at-brazil.html

[23] Mark Heywood, “South Africa’s Treatment Action Campaign: Combining law and social mobilization to realize the right to health,” Journal of Human Rights Practice 1/1 (2009), pp. 17-21.

[24] S. Adrangi, “Patent on Yale’s AIDS drug relaxed,” Yale Daily News (March 19, 2001). Available at http://yaledailynews.com/blog/2001/03/19/patent-on-yales-aids-drug-relaxed; C. Babcock and C. Connolly, “AIDS activists badger Gore again,” Washington Post (June 18, 1999). Available at http://www.washingtonpost.com/wp-srv/politics/campaigns/wh2000/stories/gore061899.htm.

[25] World Trade Organization, Ministerial Declaration of 14 November 2001, WT/MIN(01)/DEC/1, 41 I.L.M. 746 (2002), para. 4. Available at https://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.htm

[26] E. t’Hoen, The global politics of pharmaceutical monopoly power: drug patents, access, innovation, and the application of the WTO Doha Declaration (Diemen, The Netherlands: AMB Press, 2009), pp. 44-62.

[27] M. El Said, World Health Organization & International Center for Trade & Sustainable Development, Public Health Related TRIPS-Plus Provisions in Bilateral Trade Agreements: A Policy Guide for Negotiators and Implementers in the WHO Eastern Mediterranean Region (Geneva: WHO, 2010), pp. 128,144. Available at http://applications.emro.who.int/dsaf/dsa1081.pdf

[28] S. Sell, “TRIPS-Plus free trade agreements and access to medicines,” Liverpool Law Review 28 (2007), p.p. 64-74.

[29] AFL-CIO, Trans-Pacific partnership (2015). Available at http://www.aflcio.org/Issues/Trade/Trans-Pacific-Partnership-Free-Trade-Agreement-TPP . (April 30, 2015); Oxfam America, Fast track and TPP bad for development, (April 30, 2015). Available at http://www.oxfamamerica.org/press/fast-track-and-tpp-bad-for-development/; Sierra Club, Trans-pacific partnership (2015). Available at http://www.sierraclub.org/trade/trans-pacific-partnership

[30] J. Weisman, “House rejects trade measure, rebuffing Obama’s dramatic appeal,” New York Times (June 12, 2015). Available at http://www.nytimes.com/2015/06/13/us/politics/obamas-trade-bills-face-tough-battle-against-house-democrats.html.

[31] J. Jenkins and C. Perrow, “Insurgency of the powerless: farm worker movements (1946-1972),” American Sociological Review 42 (1980), p. 251; C. Colvin and S. Robins, “Social movements and HIV/AIDS in South Africa,” in P. Rohleder et al. (eds.), HIV/AIDS in South Africa 25 years on (New York: Springer, 2009), p. 159.

[32] J. Love and T. Hubbard, “Prizes for innovation of new medicines and vaccines,” Annals of Health Law 18/2 (2009), pp. 155-186.

[33] Y. Vawda and B. Baker, “Achieving social justice in the human rights/intellectual property debate: Realising the goal of access to medicines,” African Human Rights Journal 13 (2013).

[34] Médecins Sans Frontières, Spotlight on Trans-Pacific Partnership Agreement (August 18, 2013). Available at http://www.msfaccess.org/spotlight-on/trans-pacific-partnership-agreement; Public Citizen, Trans-Pacific Partnership (TPP): job loss, lower wages and higher drug prices (2015). Available at http://www.citizen.org/TPP;Oxfam America, Trans-Pacific Partnership Free Trade Agreement (March 30, 2014). Available at http://policy-practice.oxfamamerica.org/work/in-action/trans-pacific-partnership-free-trade-agreement; Public Citizen, Country actions (2015). Available at http://www.citizen.org/Country-Actions; Treatment Action Campaign, Fix the patent laws (2015). Available at http://www.fixthepatentlaws.org.