JOURNAL OF HEALTH DIPLOMACY
Human Rights Impact Assessment Of Trade-Related
Intellectual Property Rights: A Key Strategy In Post-2015
Efforts To Improve Access To Safe And Accessible
Medicines
Lisa Forman*
Citation: Forman, L. (2013). Human Rights Impact Assessment Of Trade-Related Intellectual Property Rights: A
Key Strategy In Post-2015 Efforts To Improve Access To Safe And Accessible Medicines. Journal of Health
Diplomacy. Published online June 12, 2013.
Editor: Rachel Irwin, Stockholm International Peace Research Institute
Managing Editor: Mark Pearcey, Carleton University
Published: June 12, 2013
Type: Commentary
This is an open-access article distributed under the terms of the Creative Commons Attribution License, which
permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are
credited.
* Lisa Forman, Lupina Assistant Professor, Dalla Lana School of Public Health, Director, Comparative Program on
Health and Society, Munk School of Global Affairs, University of Toronto
Human Rights Impact Assessment Of Trade-Related
Intellectual Property Rights: A Key Strategy In Post-2015
Efforts To Improve Access To Safe And Accessible
Medicines
Abstract
Lisa Forman*
In 2013, more than half the world’s poor continue to lack access to essential medicines, despite a multitude of global health diplomacy efforts to increase access to affordable medicines in low and middle-income countries. This failure is exemplified
in Millennium Development Goal (MDG) Target 8E which aims to increase access
to affordable medicines, yet fails to address key causes of unaffordability, including
trade-related intellectual property rights under World Trade Organization (WTO) and
bilateral and regional free trade agreement rules. This commentary argues that addressing these price impacts is key to effectively advancing access to medicines and
that such measures should be incorporated into goals to replace the MDGs after they
expire in 2015. One way to do so is through the use of human rights impact assessment (HRIA) of trade-related intellectual property rights to mitigate the price impacts
of these rights and realize state duties in order to provide access to affordable essential medicines. An HRIA requires policy makers to assess the impacts of trade-related
intellectual property rights on medicine affordability and access, and to accordingly
remedy any negative impacts on medicines access. Multiple global health and human
rights actors and institutions endorse their use, and significant attention has been
brought to developing effective, robust and user-friendly methodologies. Global policy makers formulating post-2015 access-to-medicine goals should ensure that HRIAs
are adopted as a pragmatic and widely agreed upon means of protecting drugs from
a key structural determinant of inaccessibility, and realizing universal access as a prioritized aspect of the right to health..
Introduction
In 2013, more than half the world’s poor continue to lack access to essential medicines (World Health
Organization, 2004), despite a multitude of diplomacy efforts to increase access to affordable medicines in developing countries. While inadequate access to medicines is multi-causal, an overwhelming policy consensus has emerged regarding the price impacts of international trade rules such as
* Lisa Forman, Lupina Assistant Professor, Dalla Lana School of Public Health, Director, Comparative Program on
Health and Society, Munk School of Global Affairs, University of Toronto, Rm. 406, 155 College Street, Toronto, Ontario, M5T 3M7, Canada, Tel: 416-978-3087, Email: [email protected]
Journal of Health Diplomacy
Online First - June 12, 2013
Forman
the World Trade Organization’s (WTO) Agreement on Trade-Related Aspects of Intellectual Property
Rights (TRIPS) and the even stronger “TRIPS-plus” intellectual property rights proliferating in bilateral and regional free trade agreements (FTAs). Yet this legal and political context is entirely absent
from Millennium Development Goal (MDG) Target 8E which aims to increase access to affordable
essential medicines in cooperation with pharmaceutical companies, and which has been largely ineffective. As the MDGs move towards expiration in 2015, there is a considerable focus at the international level on formulating their replacement goals. At present, discussions are focused on adopting
an overarching health goal of healthy life expectancy, with universal health coverage as a subsidiary
target (Editorial, 2013; United Nations, 2013). If the goal of universal health coverage is to effectively
advance access to affordable medicines as a fundamental component of essential health care services,
I argue that it must address the price impacts of trade-related intellectual property rights. One pragmatic and highly endorsed means of doing so is via human rights impact assessment (HRIA) of traderelated intellectual property rights, whereby policy makers assess and remedy the potential or actual
impacts of trade-related intellectual property rights on access to medicines. This tool is recognized
as offering a pragmatic mechanism for advancing the efficacy of global health diplomacy efforts (Lee,
Ingram, Lock, & McInnes, 2007; Scott-Samuel & O’Keefe, 2007), and advancing access to affordable
medicines. Multiple global health and human rights actors and institutions endorse the use of HRIA
in relation to trade-related intellectual property rights, and significant attention has been brought to
developing user-friendly methodologies to conduct HRIA.
Accordingly, this commentary will outline why HRIA should be adopted within post-2015 goals for
medicines in the following way: first, by overviewing the current MDG target on medicines; second,
by outlining the impact of TRIPS and TRIPS-plus trade rules on the affordability of medicines; and
third, by locating the current proposal within the emerging global consensus regarding the use of
HRIA in relation to TRIPS-plus intellectual property rights.
The MDGs and Access to Medicines
In September 2000, 189 heads of state meeting at the United Nations (UN) headquarters in New York
issued the Millennium Declaration where they committed to global action to advance peace, the environment, good governance and development (United Nations, 2000, para. 11, 19-20). These commitments precipitated the creation of the MDGs: eight human development goals to be met by 2015 in
relation to poverty, hunger, water, education, gender equality, child and maternal mortality, infectious
disease, the environment and development (United Nations, 2000). Medicines are addressed in MDG
8, which aims to develop a global partnership for development through increased aid, non-discriminatory trade, debt relief, and improved access to medicines and information and communication
technologies. Target 8E aims to, “in cooperation with pharmaceutical companies, provide access to
affordable essential drugs in developing countries,” measured via a corresponding indicator of “the
proportion of the population with access to affordable essential drugs on a sustainable basis” (United
Nations Statistics Division, 2013).
MDG 8E is distinctive from other goals for its lack of time-bound or quantifiable components. For
example, other MDGs aim to achieve measurable results by 2015, such as reducing the maternal mortality ratio by three quarters or achieving universal access to treatment for HIV/AIDS for all those
who need it (United Nations Statistics Division, 2013). The formulation of MDG 8E without such measurable or time-bound outcomes gives little guidance on how to evaluate progress under this target.
© Journal of Health Diplomacy 2013
2
Journal of Health Diplomacy
Online First - June 12, 2013
Forman
Moreover, it is unclear what advancing access to affordable essential medicines “in cooperation with
pharmaceutical companies” requires. On one level, this terminology may be understood to extend to
cooperative ventures such as public-private partnerships (PPP) between governments and pharmaceutical companies, which may positively enable drug access. Yet on another level, the implication
of the language of MDG 8E is that using a measure like compulsory licensing to produce or import
generic versions of patented medicines without the authorization of corporate patent holders could
be viewed as an “uncooperative” approach to advancing access to affordable medicines, despite the
legality of such measures under TRIPS.
Little progress has been made in increasing access to affordable essential medicines. A 2012 study
shows that in many low and middle-income countries, the average availability of essential medicines
remains low in the public health sector, at around 50.1 percent, versus 67 percent in the private sector (MDG Gap Task Force, 2012, 61). Many essential medicines, especially for chronic diseases, continue to be prohibitively priced in low and middle-income countries: often 2.6 and five times higher in
the public and private sectors respectively than international reference prices (MDG Gap Task Force,
2012, 62-64). The global drug gap—two billion people who lack regular access to essential medicines—continues largely unabated (World Health Organization, 2004; MDG Gap Task Force, 2012).
TRIPS and TRIPS-Plus Rules
While access to medicines is determined by several factors, such as rational use, adequate infrastructure, and sustainable financing (World Health Organization, 2004, 24), drug pricing can have
a disproportionate impact on access (Scherer, 2000; Caves, Whinston, & Hurwitz, 1991). Patents are
the primary determinants of drug prices, and are protected internationally under the WTO’s TRIPS
agreement. The TRIPS agreement requires 20-year patents for pharmaceuticals which give exclusive
rights to patent holders to prevent non-consensual use. These rights are subject to extensive domestic and international enforcement including at the WTO’s dispute settlement mechanism. The TRIPS
agreement permits exceptions to patenting in the interests of public health and social welfare (including compulsory licensing and parallel importing). However, governments may face considerable
obstacles to the use of these “TRIPS flexibilities” including corporate litigation, unilateral trade pressures, and “TRIPS-plus” intellectual property rules adopted in bilateral and regional FTAs. “TRIPSplus” rules limit the use of TRIPS flexibilities and are recognized as significantly limiting the capacity
of states to increase access to affordable medicines (Smith, Correa, & Oh., 2009; Grosse Ruse-Khan,
2010). In response, developing countries successfully pushed for a confirmation of the legality of
TRIPS flexibilities in the 2001 Doha Declaration on the TRIPS Agreement and Public Health (World
Trade Organization, 2001). Despite the confirmation in the Doha Declaration that countries are legally entitled to use TRIPS flexibilities, governments that do so remain subject to significant economic
and legal pressure, and the use of TRIPS flexibilities remains rare (MDG Gap Task Force, 2012, 67).
A Growing Consensus on Human Rights Impact Assessment
Trade-related intellectual property rights threaten the realization of a range of human rights including the right to health. This right is protected extensively in international law, with its most authoritative articulation contained in the International Covenant on Economic, Social and Cultural Rights
(ICESCR) (United Nations, 1976). The right to health has been interpreted to impose a state duty to
provide universal access to essential medicines as a core and hence prioritized duty under this right
© Journal of Health Diplomacy 2013
3
Journal of Health Diplomacy
Online First - June 12, 2013
Forman
(United Nations Committee on Economic, Social and Cultural Rights (UNCESCR), 2000, para. 43d).
Growing concerns about the impact of trade rules on state duties to realize access to affordable essential medicines has seen a rising consensus that policy makers should take the right to health into
account when entering trade agreements. For example, several UN treaty-monitoring committees
have called on countries to conduct assessments of the effect of international trade rules on the right
to health (UNCESCR, 2004; 2006; 2008; UN Committee on the Rights of the Child, 2004; United Nations Committee on the Elimination of Discrimination Against Women, 2006a; 2006b; and 2007). A
similar call has been made in relation to TRIPS-plus rules (albeit without a specifically human rights
approach) by the United Nations MDG Gap Task Force, appointed by the UN Secretary-General in May
2007 to improve monitoring of MDG 8. In 2012 the MDG Gap Task Force suggested, “developing countries should carefully assess possible adverse impacts on access to medicines when adopting TRIPS
plus provisions as part of bilateral or regional trade agreements” (MDG Gap Task Force, 2012, 72).
These global calls draw in significant part from the emergence of impact assessments over the last
40 years as a major policy approach in relation to the social, environmental and health impacts of
governmental and private projects, programs and policies (Walker, 2009, 3; Harrison, 2011, 3; Kemm,
2003, 387). The primary objective of impact assessment is to improve knowledge about the potential
impact of a policy or program, and facilitate adjustment to mitigate the negative and maximize the
positive impacts (Gothenburg Consensus Paper, 1999, 1). Impact assessments do this by enabling
policy makers to predict the consequences of decisions and inform decision making accordingly
(Kemm, 2003). At the same time, there has been a significant growth in methodologies and scholarship exploring human rights impact assessments related to health (Hunt & MacNaughton, 2006;
Humanist Committee on Human Rights, 2006; NORAD, 2001) and the impact of TRIPS and FTAs on
access to medicines (Wu, 2010; Walker, 2009; Shaffer & Brenner, 2009; IFARMA, 2009; Faunce et al.,
2005; Kessomboon et al., 2010; Rovira, Abbas, & Cortas, 2009; Oxfam International, 2007). Indeed,
scholars widely view impact assessment as offering a practical tool to minimize the negative health
impacts of foreign policy and trade agreements on health and human rights (Lee et al., 2007; ScottSamuel & O’Keefe, 2007; Walker, 2009; Harrison, 2011).
Walker has developed a detailed human rights methodology for trade-related intellectual property
rights (Walker, 2009; 2011), and Rovira has developed a simulation model to assess the impact of
intellectual property rights that is being widely used (Rovira et al., 2009). In addition, international expert consultations have produced principles to guide flexible, robust and user-friendly human
rights impact assessments of trade and investment agreements (Berne Declaration, 2010; United Nations General Assembly, 2011). These consultations and prior experiences suggest that HRIA should
engage an interdisciplinary research team that would follow a step-by-step methodology to impact
assessment. These steps include: (1) screening a prospective trade agreement for potential impacts,
(2) scoping for potential its impact against a baseline of the current enjoyment of access to medicines,
(3) analysing impacts, (4) drawing up conclusions and recommendations, and (5) conducting ongoing evaluation and monitoring of impacts (Walker, 2009; Berne Declaration, 2010; United Nations
General Assembly, 2011, 14).
The policy guidance issued by these consultations reinforces global consensus about the practical
contribution of HRIA in the realm of trade. Yet they go further, and suggest that conducting HRIA is
itself a human rights duty, and that “all states should prepare human rights impact assessment prior
© Journal of Health Diplomacy 2013
4
Journal of Health Diplomacy
Online First - June 12, 2013
Forman
to the conclusion of trade and investment agreements” (United Nations General Assembly, 2011, 5).
The time is therefore ripe for the wide-scale adoption of HRIA in order to protect access to affordable
essential medicines against a key determinant of inaccessibility.
Conclusion
The limited success of MDG Target 8E in increasing access to medicines should inform global health
diplomacy efforts to formulate post-2015 goals for increasing access to affordable medicines. A growing consensus recognizes the causal impact of TRIPS and TRIPS-plus rules in sustaining and increasing medicine prices, and in limiting policy options for governments to increase access to essential
medicines. The policy imperative is to take feasible and practical steps to protect state capacities to
realize their duty to increase access to affordable essential medicines. Human rights impact assessment of trade-related intellectual property rights offers one pragmatic tool capable of mitigating the
price impacts of trade-related intellectual property rights on access to medicines, and enabling states
to realize their human rights duties. Accordingly, a post-2015 goal on medicines that prioritizes public health needs as much as corporate interests should require policy makers to conduct HRIA when
negotiating or implementing trade-related intellectual property rights in order to mitigate any negative price impacts.
Acknowledgements
I am grateful to Rebekah Sibbald for research assistance.
© Journal of Health Diplomacy 2013
5
Journal of Health Diplomacy
Online First - June 12, 2013
Forman
References
Agreement on Trade-Related Aspects of Intellectual Property Rights. (1994). Annexure 1C to the
Marrakesh Agreement Establishing the World Trade Organization, signed in Marrakesh, Morocco, on
April 15,1994.
Bakker, S., Van Den Berg, M., Duzenli, D., & Radstaake, M. (2009). Human rights impact assessment in
practice: The case of the Health Rights of Women Assessment Instrument (HeRWAI). Journal of Human Rights Practice, 1(3), 436-458.
Berne Declaration, Canadian Council for International Co-operation, & Misereor. (2010). Human
rights impact assessment for trade and investment agreements. Report of the Expert Seminar, June
23-24, 2010, Geneva, Switzerland.
Cameron, A., Ewen, M., Auton, M., & Abegunde, D. (2011). The world medicines situation 2011: Medicine prices, availability and affordability. Geneva: World Health Organization.
Caves, R.E., Whinston, M.D., & Hurwitz, M.A. (1991). Patent expiration, entry, and competition in the
US pharmaceutical industry. Brookings Papers on Economic Activity Special Issue, 1–62.
Editorial. (2013). Health and the post-2015 development agenda. The Lancet, 381, 699.
Faunce, T., Doran, D., Henry, D., Drahos, P., Searles, A., Pekarsky, B., & Neville, W. (2005). Assessing the
impact of the Australia-United States free trade agreement on Australian and global medicines policy.
Globalization & Health, 1(15), 1.
Grosse Ruse-Khan, H. (2010). From TRIPS to ACTA: Towards a new “gold standard” in criminal IP enforcement. Max Planck Institute for Intellectual Property, Competition and Tax Law Research Paper
Series No. 10-06.
Harrison, J. (2011). Human rights measurement: Reflections on the current practice and future potential of human rights impact assessment. Journal of Human Rights Practice, 3(2), 162-187.
Humanist Committee on Human Rights. (2006). Health rights of women assessment. Humanistisch
Overleg Mensenrechten, Utrecht.
Hunt, P., & MacNaughton, G. (2006). Impact assessments, poverty and human rights: A case study using the right to the highest attainable standard of health. Health and Human Rights Working Paper
Series No. 6, World Health Organization and UNESCO.
IFARMA. (2009). Impact of the EU-Andean trade agreement on access to medicines in Peru. Available
at http://www.haiweb.org/11112009/ReportIFARMAImpactStudyPeru(EN).pdf
Kessomboon, N., Limpananont, J., Kulsomboon, V., Maleewong, U., Eksaengsri, A., & Paothong, P.
(2010). Impact on access to medicines from TRIPS-plus: A case study of Thai-US FTA. Southeast Asian
Journal of Tropical Medicine and Public Health, 41(3), 667.
Kemm, J. (2003). Perspectives on health impact assessment. Bulletin of the World Health Organization, 81(6), 387.
Lee, K., Ingram, A., Lock, K., & McInnes, C. (2007). Bridging health and foreign policy: The role of
health impact assessment. Bulletin of the World Health Organization, 85(3), 207-211.
Millennium Development Goal Gap Task Force. (2012). Millennium Development Goal 8: The global
partnership for development: making rhetoric a reality: MDG Gap Task Force Report 2012. New York:
United Nations.
Norwegian Agency for Development Cooperation (NORAD). (2001). Handbook in human rights
assessment.
Available
at
http://www.norad.no/en/tools-and-publications/publications/
publication?key=109343
Oxfam International. (2007). All costs, no benefits: How TRIPS-plus intellectual property rules in the
US-Jordan FTA affect access to medicines. Oxfam Briefing Paper.
Rovira, J., Abbas, I., & Cortas, M. (2009). Guide to the IPRIA (Intellectual Property Rights Impact Aggregate) Model. Available at http://ictsd.org/downloads/2010/03/guide-to-the-ipria-model.pdf
© Journal of Health Diplomacy 2013
6
Journal of Health Diplomacy
Online First - June 12, 2013
Forman
Scherer, F.M. (2000). The pharmaceutical industry. In A.L. Culyer & J.P. Newhouse (Eds.), Handbook of
health economics (pp. 1322–1324). New York: Elsevier Science B.V.
Scott-Samuel, A., & O’Keefe, E. (2007). Health impact assessment, human rights and global public
policy: A critical appraisal. Bulletin of the World Health Organization, 85(3), 212-217.
Shaffer, E., & Brenner, J. (2009). A trade agreement’s impact on access to generic drugs. Health Affairs,
957.
Smith, R.D., Correa, C., & Oh, C. (2009). Trade, TRIPS and pharmaceuticals. The Lancet, 373: 687.
United Nations. (1976). International covenant on economic, social and cultural rights, December 26,
1966, 993 U.N.T.S. 3, 6, I.L.M. 360 (1967) (entered into force January 3, 1976).
_____. (2000). Millennium declaration. Resolution 55/2, adopted by the United Nations General Assembly.
_____. (2013). High level dialogue on health in the post-2015 development agenda. Meeting report.
Gaborone, March 4-6, 2013.
United Nations Committee on Economic, Social, and Cultural Rights. (2000). General comment No. 14:
The right to the highest attainable standard of health. UN Doc E/C.12/2000/4.
_____. (2004). Concluding observations of the Committee on Economic, Social and Cultural Rights:
Ecuador. E/C.12/1/Add.100, June 7, 2004.
_____. (2006). Concluding observations of the Committee on Economic, Social and Cultural Rights:
Morocco. E/C.12/MAR/CO/3, September 4, 2006.
_____. (2008). Concluding observations for Costa Rica. UN Doc. E/C.12/CRI/CO/4, January 4, 2008.
United Nations Committee on the Elimination of Discrimination against Women. (2006a). Concluding comments of the Committee on the Elimination of Discrimination against Women: Guatemala.
CEDAW/C/GUA/CO/6, June 2, 2006.
_____. (2006b). Concluding comments of the Committee on the Elimination of Discrimination against
Women: Philippines. CEDAW/C/PHI/CO/6, August 25, 2006.
_____. (2007). Concluding comments of the Committee on the Elimination of Discrimination against
Women: Colombia. CEDAW/C/COL/C0/6, February 2, 2007.
United Nations Committee on the Rights of the Child. (2004). Consideration of reports submitted by
states parties under article 44 of the convention—Concluding observations: El Salvador. CRC/C/15/
Add.232, June 4, 2004.
United Nations Statistics Division. (2013). Official list of MDG indicators. http://mdgs.un.org/unsd/
mdg/Host.aspx?Content=Indicators/OfficialList.htm
Walker, S. (2009). The future of human rights impact assessments of trade agreements. Brussels:
Intersentia.
Walker, S. (2011). The United States-Dominican Republic-Central American free trade agreement and
access to medicines in Costa Rica: A human rights impact assessment. Journal of Human Rights Practice, 3(2), 188-213.
World Health Organization. (2004). WHO medicines strategy: Countries at the core 2004–2007. Geneva: World Health Organization.
World Trade Organization Ministerial Conference. (2001). Declaration on the TRIPS agreement and
public health. Doha, November 9-14, 2001. WT/MIN(01)/DEC/2 (November 20, 2001).
Wu, C. (2010). Raising the right to health concerns within the framework of international intellectual
property law. Asian Journal of WTO and International Health Law and Policy, 5(1), 141.
© Journal of Health Diplomacy 2013
7