Published online by Cambridge University Press: 25 March 2011
In perpetuating and exacerbating restricted access to essential medicines, current trade-related intellectual property rules on medicines may violate core human rights to health and medicines. In this light, their impact on the global disease burden raises serious questions about their necessity, and their justification should be critically assessed from the perspective of human rights standards. These standards require that international trade rules on medicines be justified to the fullest extent possible, and permitted only to the extent to which they can be justified. In this article I explore the impact of trade rules on medicines access, and the growing force of the human right to health. I argue that the limited justification for strong patents in poor countries suggests the need for significant reform of trade-related intellectual property rights. I argue further that human rights standards may offer both normative and practical tools for achieving this reform and for challenging trade rules on medicines at various levels.
1 World Health Organization, WHO Medicines Strategy: Countries at the Core 2004–2007(Geneva: World Health Organization, 2004), p. 3.
3 World Health Organization, UNAIDS, UNICEF, Towards Universal Access: Scaling Up Priority HIV/AIDS Interventions in the Health Sector: Progress Report, April 2007(Geneva: WHO, 2007), p. 5.
4 World Health Organization, Public Health, Innovation and Intellectual Property Rights: Report of the Commission on Intellectual Property Rights, Innovation and Public Health(Geneva: World Health Organization, 2006), p. 20.
5 UNAIDS and World Health Organization, AIDS Epidemic Update December 2005, UNAIDS/05.19E (Geneva: UNAIDS and World Health Organization, 2005), p. 2.
6 World Health Organization, “HIV/AIDS: Report by the Director-General,” Fifty-third World Health Assembly, A53/6, March 22, 2000, para. 3.
7 J. Salomon, et al., “Integrating HIV Prevention and Treatment: From Slogans to Impact,” PLoS Medicine 2, no.1, e16 (2005), pp. 50–53.
8 World Health Organization, Public Health, Innovation and Intellectual Property Rights, p. 13.
9 Ibid., p. 24.
10 G. Velásquez, Y. Madrid, and J. Quick, “Health Reform and Drug Financing, Selected Topics,” Health Economics and Drugs, DAP Series no. 6, WHO/DAP/98.3 (Geneva: World Health Organization, 1998).
11 Many African countries continue to rely on chloroquine, an outdated drug, to treat malaria because the newer, more effective artemisinin-based treatment costs as much as twenty times more. Médecins Sans Frontières, “Will the Lifeline of Affordable Medicines for Poor Countries be Cut? Consequences of Medicines Patenting in India,” Briefing document, February 2005, p. 2.
12 R. Loewenson, “Essential Drugs in Southern Africa Need Protection from Public Health Safeguards under TRIPS,” Bridges 4, no.7 (2000), p. 3.
13 On the global HIV/AIDS treatment access battle, see Ellen ’t Hoen, “TRIPS, Pharmaceutical Patents and Access to Essential Medicines: A Long Way from Seattle to Doha,” Chicago Journal of International Law 3, no.2 (2002), p. 27; and E. Cameron and A. Gupta, “Global Access to Treatment,” Canadian HIV/AIDS Policy and Law Review 7, no.1 (2002); available at http:\\www.aidslaw.ca/Maincontent/otherdocs/Newsletter/vol7no12002/accesstotreatment.htm.
14 Médecins Sans Frontières, “Will the Lifeline of Affordable Medicines for Poor Countries be Cut?” p. 2
15 See the World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), arts. 6, 30, 31, and 41; available at http:\\www.wto.org/english/docs_e/legal_e/legal_e.htm#TRIPs.
16 TRIPS, arts. 31(b) and (k). Compulsory licensing is allowed in cases of national emergencies or other circumstances of extreme urgency, for public noncommercial use, or where usage is intended to remedy a practice determined after judicial or administrative processes to be anticompetitive.
17 See World Health Organization, “Globalization, TRIPS, and Access to Pharmaceuticals,” Policy Perspectives on Medicines No. 3 (March 2001).
18 S. Chaudhuri, P. K. Goldberg, and P. Jia, “The Effects of Extending Intellectual Property Rights Protection to Developing Countries: A Case Study of the Indian Pharmaceutical Market,” National Bureau of Economic Research Working Paper No. 10159, December 2003; available at http:\\www.nber.org/papers/W10159.
19 F. M. Scherer, “The Pharmaceutical Industry,” in A. L Culyer and J. P. Newhouse, eds., Handbook of Health Economics, vol. 1 (New York: Elsevier Science B.V., 2000), pp. 1322–24.
20 R. E. Caves, M. D. Whinston, and M. A. Hurwitz, “Patent Expiration, Entry, and Competition in the U.S. Pharmaceutical Industry,” Brookings Papers on Economic Activity Special Issue (1991), pp. 1–62.
21 Médecins Sans Frontières, “Will the Lifeline of Affordable Medicines for Poor Countries be Cut?” p. 3.
22 F. M. Scherer and J. Watal, “Post-TRIPS Options for Access to Patented Medicines in Developing Countries,” Commission on Macroeconomics and Health Working Paper No. WG 4, no. 1, June 2001, p. 13.
23 World Trade Organization, Doha Declaration on the TRIPS Agreement and Public Health, para. 4; available at http:\\www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.htm.
24 Ibid., para. 5.a.
25 Ibid., para. 5.b.
26 See World Trade Organization General Council, “Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health: Decision of the General Council of 30 August 2003,” WT/L/540, September 1, 2003, paras. 2 (a) (ii), (iii), (b) (i) and (ii), and paras. 4 and 5; available at http:\\www.wto.org/English/tratop_e/trips_e/implem_para6_e.htm.
27 L. Forman, “Trading Health for Profit: Bilateral and Regional Free Trade Agreements Affecting Domestic Property Rules on Intellectual Property Rules on Pharmaceuticals,” in J. C. Cohen, U. Schuklenk, and P. Illingsworth, eds., The Power of Pills: Social, Ethical, and Legal Issues in Drug Development, Marketing, and Pricing (London: Pluto Press, 2006), p. 190.
29 J. R. Sanjuan, “Pfizer is Suing Philippine's Government Officials in their Personal Capacity in Order to Stop Parallel Trade,” IP-Health Mailing List, March 31, 2006.
30 Forman, “Trading Health for Profit,” p. 193.
32 Peter Drahos, “Developing Countries and International Intellectual Property Standard-Setting,” Commission on International Property Rights background paper no. 8; available at http:\\www.iprcommission.org/papers/pdfs/study_papers/sp8_drahos_study.pdf
33 United Nations Press Release, “U.S.-Peru Free Trade Pact Negotiations: Special Rapporteur on Right to Health Reminds Parties of Human Rights Obligations,” July 13, 2005; available at http:\\www.unhchr.ch/huricane/huricane.nsf/view01/502C4F87F9FF119BC125703D00396440?opendocument.
34 For a thorough discussion of the normative framework and associated state obligations, see A. E. Yamin, “Not Just a Tragedy: Access to Medications as a Right under International Law,” Boston University International Law Journal 21 (2003), p. 325.
35 T. W. Pogge, “Human Rights and Global Health: A Research Program,” Metaphilosophy 36, no. 1–2 (2005), pp. 182, 194.
36 See, e.g., United Nations, International Covenant on Economic, Social and Cultural Rights (ICESCR), December 16, 1966, 993 U.N.T.S. 3, art. 2.
37 Other core duties include ensuring nondiscriminatory access to health facilities, goods, and services; access to food, basic shelter, housing, sanitation, and water; ensuring equitable distribution of all health facilities, goods, and services; and adopting a national public health strategy and plan of action addressing the health concerns of all.
38 United Nations, ICESCR, paras. 50 and 39.
39 Committee on Economic, Social and Cultural Rights (CESCR), General Comment 14, para. 42, August 11, 2000; available at http:\\www.ohchr.org/english/bodies/cescr/comments.htm.
40 Ibid., para. 39.
41 Office of the United Nations High Commissioner for Human Rights, “Status of Ratifications of the Principal International Human Rights Treaties, as of 16 June 2006”; available at http:\\www.ohchr.org/english/bodies/docs/RatificationStatus.pdf.
42 See, for instance, United Nations, International Convention on the Rights of the Child, November 20, 1989, U.K.T.S. 1992 No. 44, 28 I.L.M. 1448 1989, art. 24(1); United Nations, International Convention on the Elimination of All Forms of Racial Discrimination, December 21, 1965, 660 U.N.T.S. 195, 5 I.L.M. 352 1966, art. 5(e)(iv); United Nations, Convention on the Elimination of All Forms of Discrimination Against Women, December 18, 1979, U.K.T.S. 1989 No. 2, 19 I.L.M. 33 1980, arts. 11(1)(f) and 12; Council of Europe, The European Social Charter, October 18, 1961, 529 U.N.T.S. 89, art. 11; African Charter on Human and People's Rights, June 27, 1981, O.A.U. Doc. CAB/LEG/67/3 rev. 5, 21 I.L.M. 58 (1982), art. 16; and Additional Protocol to the American Convention on Human Rights in the Area of Economic, Social, and Cultural Rights (Protocol of San Salvador) (1988), art. 10.
43 E. D. Kinney and B. A. Clark, “Provisions for Health and Health-Care in the Constitutions of the Countries of the World,” Cornell International Law Journal 37 (2004), pp. 285, 287.
44 See, e.g., Paschim Banga Khet Mazdoor Samity v. State of West Bengal (1996) 4 S.C.C. 37; and Eldridge v. British Columbia (Attorney General) (1997) 3 S.C.R. 624.
45 See, e.g., Minister of Health and Another v. Treatment Action Campaign and Others (2002) 5, South African Law Report 721 (South African Constitutional Court); Viceconti v. Ministry of Health and Social Welfare (Argentina, Poder Judicial de la Nación, Causa no. 31.777/96, June 2, 1998); and Cruz Bermudez et al v. Ministerio de Sanidad y Asistencia Social (Supreme Court of Justice of Venezuela, Case No. 15.789, Decision No. 916, July 15, 1999).
46 Hans V. Hogerzeil, Melanie Samson, Jaume Vidal Casanovas, and Ladan Rahmani-Ocora, “Is Access to Essential Medicines as Part of the Fulfilment of the Right to Health Enforceable through the Courts?” Lancet 368 (2006), p. 306.
47 Hazel Tau & Others v. GlaxoSmithKline and Boehringer Ingelheim, Competition Commission of South Africa.
48 Another twenty-five countries are WTO observers, which means that they are required to initiate the WTO accession process within five years of becoming an observer. Of these, twenty-one are ICESCR members, meaning that within five years the total number of countries that will have ratified the ICESCR and are WTO members will increase to 143, or 82 percent of all WTO members.
49 It is notable that of the four WTO members that are not parties to a human rights treaty, one is the European Communities which cannot ratify treaties, although its individual member states have all ratified relevant human rights treaties. The other three are countries under Chinese control (Hong Kong, Chinese Taipei [Taiwan], and Macau).
50 See, e.g., United Nations, The Charter of the United Nations, June 26, 1945, Can. T.S. 1945 No. 7 (entered into force on October 24, 1945), sec. 103; and World Conference on Human Rights, Vienna Declaration and Program of Action, June 14–25, 1993, A/Conf.157/23, July 12, 1993.
51 For example, the International Covenant on Civil and Political Rights (ICCPR) allows the restriction of certain rights (e.g., free movement, religion, peaceful assembly, association and press freedom) to protect collective interests (such as national security, public order, public health or morals, the rights and freedoms of others, or public emergency). The ICCPR also enables countries to derogate from human rights in the event of public emergencies that threaten the life of the nation (and that are officially proclaimed), although public emergencies cannot justify derogations from rights to life or freedom from torture and slavery. International Covenant on Civil and Political Rights G.A. res. 2200A (XXI), 21 U.N. GAOR Supp. (No. 16) at 52, U.N. Doc. A/6316 (1966), 999 U.N.T.S. 171, entered into force March 23, 1976.
52 United Nations Economic and Social Council, UN Sub-Commission on Prevention of Discrimination and Protection of Minorities, Siracusa Principles on the Limitation and Derogation of Provisions in the International Covenant on Civil and Political Rights, UN Doc.E/CN.4/1984/4 (1984).
53 United Nations Committee on Economic, Social and Cultural Rights, General Comment 17 (2005): The right of everyone to benefit from the protection of the moral and material interests resulting from any scientific, literary or artistic production of which he or she is the author (art. 15, para. 1(c), of the Covenant), January 12, 2006, UN Doc. E/C.12/GC/17, at para. 1.
54 Ibid., paras. 22–24, and 35.
55 Ibid., para. 35.
56 See, e.g., H. Grabowski, “Patents, Innovation, and Access to New Pharmaceuticals,” Journal of International Economic Law 5, no.4 (2002), pp. 849–53; and Pharmaceutical Research and Manufacturers of America (PhRMA), Pharmaceutical Industry Profile 2003 (Washington, D.C.: PhRMA, 2003), p. 6.
57 For example, the International Federation of Pharmaceutical Manufacturers Association contends that “compulsory licensing is a threat to good public health by denying patients around the world the future benefits of R&D capabilities of the research-based industry from which new therapies come.” International Federation of Pharmaceutical Manufacturers Association, “Access to Medicines: The Right Policy Prescription,” paper distributed at the WTO in 2001, quoted in ’T Hoen, “TRIPS, Pharmaceutical Patents and Access to Essential Medicines.”
58 “How Much Does It Really Cost to Manufacture a Drug?” Guardian Special Report: AIDS, February 18, 2003.
59 The Pharmaceutical Manufacturer's Association and Others v. The President of the Republic of South Africa, case no. 4183/98, Trans. Prov. Div., Treatment Action Campaign Replying Affidavit, Supporting Affidavit of James Packard Love, at para. 29.
60 A. D. So, A. K. Rai, and R. M. Cook-Deegan, “Intellectual Property Rights and Technology Transfer: Enabling Access for Developing Countries,” Commission on Intellectual Property Rights, Innovation, and Health Study.
61 “How Much Does It Really Cost to Manufacture a Drug?” Guardian.
62 N. Pattison and L. Warren, “2002 Drug Industry Profits: Hefty Pharmaceutical Company Margins Dwarf Other Industries,” Public Citizen, Congress Watch (June 2003); available at http:\\www.citizen.org/documents/Pharma_Report.pdf.
63 For instance, in the United States, Merck opposed efforts to disclose its R&D costs to congressional investigators for nine years, culminating in a Supreme Court victory in Bowsher v. Merck & Co., 460 U.S. 824 (1983). See Sara Joseph, “Pharmaceutical Corporations and Access to Drugs: The ‘Fourth Wave’ of Corporate Human Rights Scrutiny,” Human Rights Quarterly 25 (2003), p. 433. In South Africa, GlaxoSmithKline and Boehringer Ingelheim settled a Competition Commission complaint alleging that its pricing of AIDS drugs was excessive and anticompetitive, which would have required it to disclose its pricing structures. See Hazel Tau & Others v. GlaxoSmithKline and Boehringer Ingelheim, Competition Commission of South Africa.
64 World Health Organization, Public Health Innovation and Intellectual Property Rights, p. 28.
66 J. O. Lanjouw and William Jack, “Trading Up: How Much Should Poor Countries Pay to Support Pharmaceutical Innovation?” Center for Global Development Brief 4, no. 3 (2004), p. 6.
67 Médecins Sans Frontières, “Doha Derailed: A Progress Report on TRIPS and Access to Medicines” (2003), p. 6; available at http:\\www.accessmed-msf.org/documents/cancunbriefing.pdf. The Global Forum for Health Research focuses on methods of correcting the 10/90 gap; see Global Forum for Health Research, The 10/90 Report on Health Research 2001–2002 (Geneva: Global Forum for Health Research, 2002), and http:\\www.globalforumhealth.org for other annual reports on this topic.
68 P. Trouiller, et al., “Drug Development for Neglected Diseases: A Deficient Market and a Public Health Policy Failure,” Lancet 359 (2002), p. 2188.
69 World Health Organization Commission on Intellectual Property Rights, Innovation and Public Health, Framework Paper, July 2004, p. 1; available at http:\\www.who.int/intellectualproperty/documents/en/Framework.paper.pdf.
70 World Health Organization, Public Health, Innovation and Intellectual Property Rights, p. 34.
71 There are, however, critiques about the limited nature of innovation in wealthy markets as well. For example, in the United States between 1981 and 1991, “less than five percent of drugs introduced by the top twenty-five pharmaceutical companies were therapeutic advances.” Carlos Correa, “Public Health and Intellectual Property Rights,” Global Public Policy 2, no. 3 (2002), p. 265, quoting UNDP, Human Development Report (New York: Oxford University Press, 1999).
72 World Health Organization, Public Health, Innovation and Intellectual Property Rights, p. 202.
73 See “Medical Research and Development Treaty (MRDT), Discussion Draft 4,” January 2005, art. 1; available at http:\\www.cptech.org/workingdrafts/rndtreaty4.pdf.
74 See, for example, Gabrielle Marceau, “WTO Dispute Settlement and Human Rights,” European Journal of International Law 13 (2002), pp. 753–814.
75 See D. Black, “The Long and Winding Road: International Norms and Domestic Political Change in South Africa,” in T. Risse, S. C. Ropp, and K. Sikkink, The Power of Human Rights: International Norms and Domestic Change (Cambridge, England: Cambridge University Press, 1999), p. 78; and A. Klotz, Norms in International Relations: The Struggle Against Apartheid (Ithaca, N.Y.: Cornell University Press, 1995), p. 6.
76 UNAIDS and World Health Organization, AIDS Epidemic Update: Special Report on HIV/AIDS December 2006, UNAIDS.06.29E (Geneva: UNAIDS and World Health Organization, 2006), p. 17. UNAIDS indicates that in South Africa in 2005, an estimated 5.5 million people were living with HIV, 18.8% of adults (15–49 years) were living with HIV, and in 2004 almost one in three pregnant women attending public antenatal clinics had HIV.
77 See, e.g., R. Howse, “Conference: Linking Trade and Sustainable Development: Roundtable Discussion,” American University International Law Review 18 (2003), p. 1324.
78 Hazel Tau & Others v. GlaxoSmithKline and Boehringer Ingelheim, Competition Commission of South Africa.
79 World Health Organization, Public Health, Innovation and Intellectual Property Rights, p. 19.