Foreign policy is linked to global health in a variety of ways, including funding (e.g., development assistance for health), programming (e.g., PEPFAR) and trade. This post is going to explore one element of U.S. trade policy, bilateral free trade agreements, and the potential impact on health in impoverished countries.
Brief Background on TRIPS, Intellectual Property Rights and Access to Medicine
The Agreement on Trade-Related Aspects of Intellectual Property Rights, or TRIPS, administered by the World Trade Organization, governs minimum intellectual property protection standards, including copyright, trademarks and patents. Medicine is subject to patent law, which in this case grants a pharmaceutical company the rights to make, use, sell, import and offer for sale drugs and other products that it invents or owns for a minimum period of 20 years.
The implementation of TRIPS raised concerns, particularly among developing countries, regarding access to essential medicines. These were not unfounded. For instance, the U.S. government invoked TRIPS against attempts by Brazil, India, South Africa and Thailand to produce low-cost AIDS medications, at the behest of the pharmaceutical industry. It has also effectively applied political pressure to countries for the same purpose.
In 2001 the WTO adopted the Doha Declaration on the TRIPS Agreement and Public Health, reconfirming the flexibilities contained within TRIPS that relate to the domain of health care. It states, “We agree that the TRIPS Agreement does not and should not prevent Members from taking measures to protect public health. Accordingly, while reiterating our commitment to the TRIPS Agreement, we affirm that the Agreement can and should be interpreted and implemented in a manner supportive of WTO Members’ right to protect public health and, in particular, to promote access to medicines for all.”
“TRIPS-Plus”: Free Trade Agreements
Although the Doha Declaration recognized that TRIPS should not compromise public health, the patent regulations still serve to limit access to medicine for the poorest people because of the lack of generic competition, which ends the monopoly power of patents and is a decisive factor in lowering the prices of drugs. Moreover, industrialized countries led by the United States have taken measures and negotiated bilateral free trade agreements (FTAs) requiring even stricter property protection than mandated by TRIPS, which undermines the principle and global consensus of the Doha Declaration and (intentionally) circumvents its public health protections.
The “Trips-Plus” measures vary by agreement; common provisions have tended to include the following: increase the term of patents beyond 20 years in order to offset delays in obtaining marketing approval; sometimes limit compulsory licensing, a flexibility contained in TRIPS to safeguard public health that enables a manufacturer to produce generic versions of patented medicines locally as long as the patent holder is compensated; prohibit exports of products created using the licenses in all circumstances, thusly undermining a 2003 decision by the WTO to allow developing countries to export products to those without pharmaceutical manufacturing capacity; and limit use of pharmaceutical test data relating to the effectiveness and safety of a drug, which delays the possibility of compulsory licensing.
In 2007, the U.S. Congress created the “May 10 Agreement” to address concerns about several aspects of FTAs, including “TRIPS-Plus” provisions. The Agreement makes patent extensions voluntary and eliminates some of the barriers to compulsory licensing. It applied only to three FTAs in development at the time, but created hope that it might “mark an important political shift in U.S. trade policy toward greater sensitivity to public health concerns in global IP rules.”* This remains to be seen. The 2011 Trade Policy Agenda acknowledged the importance of the Doha Declaration, public health protections and access to medicines, but in the same paragraph emphasized supporting and strengthening intellectual property rights.
Ultimately, TRIPS and stricter TRIPS-Plus standards strain governments with limited resources and effectively price treatment and therefore health out of reach for the most vulnerable populations. According to a United Nations report, TRIPS and other intellectual property standards serve to “advance global markets. But there has been much less progress in strengthening rules and institutions to promote universal ethics and norms – especially human rights to promote human development and to empower poor people and poor countries.”**
Aginam O. 2010. Intellectual Property and Access to Medicines. Global Health Governance, IV(1), Fall. http://www.ghgj.org/Aginam_final.pdf
Correa CM. 2006. Implications of bilateral free trade agreements on access to medicines. Bulletin of the World Health Organization, 84(5).
*Elliot KA and Fink C. 2008. Tripping Over Health: U.S. Policy on Patents and Drug Access in Developing Countries. CGD Policy Brief. Center for Global Development. http://www.cgdev.org/files/967265_file_TRIPS_Web.pdf
Fink C and Reichenmiller P. 2006. “Tightening TRIPS: Intellectual Property Provisions of U.S. Free Trade Agreements” in Trade, Doha, and Development: A Window into the Issues. Editor: Richard Newfarmer. World Bank. http://siteresources.worldbank.org/INTRANETTRADE/Resources/Pubs/Trade_Doha_Devt_A_Windo_into_the_Issues.pdf#page=292
Shaffer ER, Waitzkin H, Brenner J and Jasso-Aguilar R. 2005. Global Trade and Public Health. American Journal of Public Health, 95(1), 22-34.
**United Nations Development Program. 1999. Human Development Report, 1999. New York: Oxford University Press for UNDP. Pg. 35.