Patents and medicines: The relationship between TRIPS and the human right to health

International Affairs

Volumn 79, Issue 1, 2003, Pages

  Cullet, Philippe ^a  

^a UNIVERSITY OF LONDON   (United Kingdom)

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EID: 0041376523     PISSN: 00205850     EISSN: None     Source Type: Journal    
DOI: 10.1111/1468-2346.00299     Document Type: Review

References (124)

1. See WTO, Declaration on the TRIPS Agreement and Public Health, Ministerial Conference. Fourth Session, WTO Doc. WT/MIN(01)/DEC/2 (2001) [hereafter Doha Health Declaration].
2. Over 95% of people living with HIV/AIDS are in developing countries. See UNICEF-UNAIDS-WHO/HTP/MSF. Sources and prices of selected drugs and diagnostics for people living with HIV/AIDS (May 2001) [hereafter Drug Price Report).
3. International Covenant on Economic, Social and Cultural Rights, New York. 16 Dec. 1966, repr. in International Legal Materials 6: 360, 1967 [hereafter ICESCR].
4. Agreement on Trade-Related Aspects of Intellectual Property Rights, Marrakesh, 15 Apr. 1994, repr. in International Legal Materials 33: 1197, 1994 [hereafter TRIPS Agreement].
5. See e.g. Martha C. Nussbaum, 'Capabilities, human rights and the universal declaration', in Burn H. Weston and Stephen P. Marks, eds, The future of international human rights (Ardsley, NY: Transnational, 1999).
6. See e.g. Guido Calabresi and A. Douglas Melamed, 'Property rules, liability rules, and inalienability: one view of the cathedral', Harvard Law Review 85, 1972, p. 1089.
7. ICESCR; International Covenant on Civil and Political Rights, New York, 16 Dec. 1966, repr. in ILM 6, 1967, p. 368 [hereafter ICCPR].
8. Cf. preamble of the ICESCR.
9. See article I of the Vienna Declaration and Programme of Action, Vienna, 25 June 1993, UN Doc. A/CONF. 157/24 (Part 1), which states that '[h]uman rights and fundamental freedoms are the birthright of all human beings; their protection and promotion is the first responsibility of Governments'.
10. See e.g. Frédéric M. Scherer. 'Le système des brevets et l'innovation dans le domaine pharmaceutique', Revue internationale de droit économique 110: 1, 2000, Note also that intellectual property protection is also considered essential in influencing investment decisions, including in developing countries. See Ida Madieha Azmi and Rokiah Alavi, 'TRIPS, patents, technology transfer, foreign direct investment and the pharmaceutical industry in Malaysia', Journal of World Intellectual Property 4, 2001, p. 948, concerning Malaysia.
11. See e.g. Frédéric M. Scherer. 'Le système des brevets et l'innovation dans le domaine pharmaceutique', Revue internationale de droit économique 110: 1, 2000, Note also that intellectual property protection is also considered essential in influencing investment decisions, including in developing countries. See Ida Madieha Azmi and Rokiah Alavi, 'TRIPS, patents, technology transfer, foreign direct investment and the pharmaceutical industry in Malaysia', Journal of World Intellectual Property 4, 2001, p. 948, concerning Malaysia.
12. See e.g. Harvey E. Bale, Jr, 'The conflicts between parallel trade and product access and innovation: the case of pharmaceuticals', Journal of International Economic Law 1, 1998, p. 637; Thomas B. Cueni, 'Industrial property protection: lifeline for the pharmaceutical industry', in Thomas Cottier and Peter Widmer, eds, Strategic issues of industrial property management in a globalizing economy: abstracts and selected papers 13 (Oxford: Hart. 1199).
13. See e.g. Harvey E. Bale, Jr, 'The conflicts between parallel trade and product access and innovation: the case of pharmaceuticals', Journal of International Economic Law 1, 1998, p. 637; Thomas B. Cueni, 'Industrial property protection: lifeline for the pharmaceutical industry', in Thomas Cottier and Peter Widmer, eds, Strategic issues of industrial property management in a globalizing economy: abstracts and selected papers 13 (Oxford: Hart. 1199).
14. See e.g.John H. Barton, Differentiated pricing of patented products, Commission on Macroeconomics and Health Working Paper Series no. WG4: 2, 2001.
15. See e.g. Carlos Correa, Integrating public health concerns into patent legislation in developing countries (Geneva: South Centre, 2000).
16. For Switzerland, see Loi fédérale sur les brevets d'invention, 25 June 1954, Recueil officiel des lois fédérales 1955, p. 893 and amendment of 17 Dec. 1976, Recueil officiel des lois fédérales 1977, p. 1990, Note also that the trigger for this change in some European countries was the adoption of the European Patent Convention more than internal pressure to change the laws. See Friedrich-Karl Beir, 'The European Patent system', Vanderbilt Journal of Transnational Law 14, 1981, p. 1.
17. For Switzerland, see Loi fédérale sur les brevets d'invention, 25 June 1954, Recueil officiel des lois fédérales 1955, p. 893 and amendment of 17 Dec. 1976, Recueil officiel des lois fédérales 1977, p. 1990, Note also that the trigger for this change in some European countries was the adoption of the European Patent Convention more than internal pressure to change the laws. See Friedrich-Karl Beir, 'The European Patent system', Vanderbilt Journal of Transnational Law 14, 1981, p. 1.
18. For Switzerland, see Loi fédérale sur les brevets d'invention, 25 June 1954, Recueil officiel des lois fédérales 1955, p. 893 and amendment of 17 Dec. 1976, Recueil officiel des lois fédérales 1977, p. 1990, Note also that the trigger for this change in some European countries was the adoption of the European Patent Convention more than internal pressure to change the laws. See Friedrich-Karl Beir, 'The European Patent system', Vanderbilt Journal of Transnational Law 14, 1981, p. 1.
19. World Health Organization, Globalizaition, TRIPS and access to pharmaceutical, WHO Policy Perspectives on Medicines no. 3, 2001 [hereafter WHO Policy Perspectives].
20. See India Patents Act 1970, See also Justice N. Rajagopala Ayyangar. Report on the Revision of the Patents Law, Sept. 1959.
21. Pradeep Agrawal and P. Saibaba, 'TRIPS and India's pharmaceuticals industry', Economic and Political Weekly 36, 2001, p. 3787.
22. See e.g. World Bank, Global economic prospects 2002 (Washington DC: World Bank, 2001).
23. The Commission on Intellectual Property Rights, Integrating intellectual property rights and development policy (London: CIPR, 2002) [hereafter CIPR Report] notes at p. 33 that all the evidence examined concerning the role that intellectual property protection plays in stimulating R&D on diseases prevalent in developing countries 'suggests that it hardly plays any role at all, except for those diseases where there is a large market in the developed world'.
24. WHO Policy Perspectives.
25. See e.g. John H. Barton, 'Intellectual property rights and innovation', in Nicholas Imparato, ed., Capital for our time: the economic, legal, and management challenges of intellectual capital (Stanford, CA: Hoover Institution Press, 1999), pp. 123 at p. 132, arguing that the intellectual property rights system generally favours large firms over small ones and in the final analysis stifles innovation rather than promotes it. As a result, the intellectual property system may contribute to an unnecessarily concentrated industrial structure.
26. See e.g. Commission on Human Rights, Resolution 2001/33, 'Access to medication in the context of pandemics such as HIV/AIDS', in Report on the 57th Session, 19 March-27 April 2001, UN Doc. E/2001/ 23-E/CN.4/2001/167.
27. See e.g. German Velásquez and Pascale Boulet, 'Globalization and access to drugs: implications of the WTO/TRIPS Agreement', in Globalization and access to drugs - perspectives on the WTO/TRIPS Agreement 2, WHO doc. WHO/DAP/98.9 (1998). See also United Nations Development Programme, Human development report 2001 (Oxford: Oxford University Press, 2001), p. 3, estimating that about 2 billion people do not have access to low-cost essential drugs.
28. See e.g. German Velásquez and Pascale Boulet, 'Globalization and access to drugs: implications of the WTO/TRIPS Agreement', in Globalization and access to drugs - perspectives on the WTO/TRIPS Agreement 2, WHO doc. WHO/DAP/98.9 (1998). See also United Nations Development Programme, Human development report 2001 (Oxford: Oxford University Press, 2001), p. 3, estimating that about 2 billion people do not have access to low-cost essential drugs.
29. See e.g. Germán Velásquez, 'Médicaments essentiels et mondialisation'. Revue internationale de droit économique 37: 1, 2000.
30. See e.g. World Health Organization and World Trade Organization Secretariats. Report of the workshop on differential pricing and financing of essential drugs, Høsbjør, Norway, 8-11 April 2001.
31. See e.g. Jérome Dumoulin, 'Les brevets et le prix des médicaments', Revue internationale de droit économique 45: 1, 2000. In the case of Malaysia, see Azmi and Alavi, 'TRIPS, patents'.
32. See e.g. Jérome Dumoulin, 'Les brevets et le prix des médicaments', Revue internationale de droit économique 45: 1, 2000. In the case of Malaysia, see Azmi and Alavi, 'TRIPS, patents'.
33. See e.g. Drug Price Report, p. 5, indicating that factors related to affordability include patents, limited volume, limited competition, import duties and tariffs. local taxes and mark-ups for wholesaling, distribution and dispensing.
34. Drug Price Report.
35. See e.g. Jean O. Lanjouw, The introduction of pharmaceutical product patents in India: 'Heartless exploitation of the poor and suffering'?, NBER Working Paper no. 6366, 1999.
36. Government of India, Department of Chemicals and Petrochemicals, Annual Report 1999-2000.
37. Shekhar Chaudhri, 'The evolution of the Indian pharmaceutical industry', in Greg Felker et al., eds, the pharmaceutical industry in India and Hungary: policies, institutions, and technological development (Washington DC: World Bank, 1997), p. 6.
38. Note also that the Patents Act 1970 was not the only element in the Indian health policy aimed at containing health costs. It was supplemented by other important tools such as the Drug Prices Control Order. The latest version of the latter is the Drug (Price Control) Order, 1995.
39. See section 53 of the Indian Patents Act 1970.
40. See sections 86ff. of the Indian Patents Act 1970, which authorized the government to force patent holders to provide licences to any applicant who made an application. While licences of right were to be authorized only in specific cases for normal patents, the Act provided that process patents for inventions relating to medicines were automatically subjected to these provisions.
41. Article 27.1 of the TRIPS Agreement.
42. Article 7 of the TRIPS Agreement (emphasis added).
43. Cf. statement by the Committee on Economic, Social and Cultural Rights on Human Rights and Intellectual Property, in Committee on Economic, Social and Cultural Rights. Report on the 25th, 26th and 27th Sessions, UN Doc. E/2002/22-E/C. 12/2001/17, Annex XIII [hereafter CESCR IP Statement).
44. See Brazil, Industrial Property Code. Law 5772/71, 21 Dec. 1971.
45. Article 7 of the TRIPS Agreement.
46. Article 8 of the TRIPS Agreement. However, it would be difficult to justify an exception not foreseen in TRIPS under article 8 unless it were an exception to a right which is not protected under TRIPS.
47. World Trade Organization, Communication from India, WTO Doc. IP/C/W/195 (2000).
48. In principle, all inventions, whether product or processes, in all fields of technology are patentable. See article 27 of the TRIPS Agreement.
49. See article 31 of the TRIPS Agreement.
50. As confirmed by the Doha Health Declaration.
51. Cf. section 87 of the Indian Patents Act 1970 providing in derogation of the general regime that all food-and medicine-related inventions should be deemed to be endorsed with the rubric 'licence of right'.
52. See e.g. Jayashree Watal, Intellectual property rights in the WTO and developing countries (New Delhi: Oxford University Press, 2001); Robert Weissman, 'A long, strange TRIPS: the pharmaceutical industry drive to harmonize global intellectual property rules, and the remaining WTO legal alternatives available to Third World countries', University of Pennsylvania Journal of International Economic Law 17, 1996, p. 1069. Cf Daniel Gervais, The TRIPS Agreement: drafting, history and analysis (London: Sweet & Maxwell, 1998).
53. See e.g. Jayashree Watal, Intellectual property rights in the WTO and developing countries (New Delhi: Oxford University Press, 2001); Robert Weissman, 'A long, strange TRIPS: the pharmaceutical industry drive to harmonize global intellectual property rules, and the remaining WTO legal alternatives available to Third World countries', University of Pennsylvania Journal of International Economic Law 17, 1996, p. 1069. Cf Daniel Gervais, The TRIPS Agreement: drafting, history and analysis (London: Sweet & Maxwell, 1998).
54. See e.g. Jayashree Watal, Intellectual property rights in the WTO and developing countries (New Delhi: Oxford University Press, 2001); Robert Weissman, 'A long, strange TRIPS: the pharmaceutical industry drive to harmonize global intellectual property rules, and the remaining WTO legal alternatives available to Third World countries', University of Pennsylvania Journal of International Economic Law 17, 1996, p. 1069. Cf Daniel Gervais, The TRIPS Agreement: drafting, history and analysis (London: Sweet & Maxwell, 1998).
55. See Section 5(c) of the Doha Health Declaration.
56. Organization of African Unity, Abuja Declaration on HIV//AIDS, tuberculosis and other related infectious diseases, 27 April 2001, OAU Doc. OAU/SPS/ABUJA/3 (3001).
57. The understanding of what amounts to 'working' the patent has changed over time and industrial use is not required any more. Cf. Carlos M. Correa, Intellectual property rights and the use of compulsory license: options for developing countries, Working Paper no. 5 (Geneva: South Centre, 1999).
58. On parallel imports, see generally Frederick M. Abbott, 'First report (final) to the Committee on International Trade Law of the International Law Association on the subject of parallel importation', Journal of International Economic Law 1, 1998, p. 607.
59. See e.g. Frederick M. Abbott, 'The TRIPS Agreement, access to medicines, and the WTO Doha ministerial conference', Journal of World Intellectual Property 5, 2002, p. 15.
60. Cf. David P. Fidler, International law and infectious diseases (Oxford: Oxford University Press, 1999).
61. See article 12 of the ICESCR. On the right to health, see generally Brigit C. A. Toebes, The right to health as a human right in international law (Antwerp: Intersentia, 1999).
62. See Committee on Economic, Social and Cultural Rights, General Comment no. 14, The right to the highest attainable standard of health, UN Doc. E/C. 12/2000/4 (2000) [hereafter General Comment 14].
63. ICESCR.
64. General Comment 14.
65. General Comment 14.
66. See article VII of the Declaration of Alma-Ata, 12 Sept. 1978. repr. in Report of the International Conference on Primary Health Care (Geneva: World Health Organization. 1978).
67. World Health Assembly, 'HIV/AIDS: confronting the epidemic'. Resolution WHA53:14 (Genoa: World Health Organization, 2000).
68. Commission on Human Rights, 'Access to medication in the context of pandemics such as HIV/AIDS', Resolution 2001/53 (23 April 2001).
69. General Comment 14.
70. See e.g. CESCR IP Statement, para. 12, which states specifically that 'any intellectual property regime that makes it more difficult for a State parry to comply especially with its core obligations in relation to health, food, education or any other right set out in the Covenant, is inconsistent with the legally binding obligations of the State party.'
71. Universal Declaration of Human Rights, 10 Dec. 1948, UN General Assembly Resolution 217 (III) A, Official Records of the Third Session of the General Assembly, Part 1, 21 Sept.-12 Dec. 1948, Resolutions.
72. Article 15.1(c) of the ICESCR.
73. Draft Covenant on Economic, Social and Cultural Rights, Commission on Human Rights, Report of the 10th Session, ECOSOC, 18th Session, Suppl. 7, Doc E/2573-E/CN.4/705 (1954). Note that article 15 was article 16 in the 1954 draft, References in this article are all to article 15.
74. For the text of the proposed amendment, see UN Doc. A/C.3/L.636/Rev.1 (1957).
75. Draft International Covenant on Human Rights, Report of the 3rd Committee, UN Doc. A/3764 (1957).
76. United Nations, Third Committee Summary Record of Meetings, UN Doc. A/C.3/SR.797 (1957).
77. Note that the amendment was accepted by 39 states, including most west European and Latin American countries, and rejected by nine countries from the communist bloc. Twenty-four countries abstained, including the United States. See Draft International Covenant on Human Rights, Report of the 3rd Committee, UN Doc. A/3764 (1957).
78. United Nations, Third Committee Summary Record of Meetings, UN Doc. A/C.3/SR.796 (1957).
79. See United Nations, Report of the 3rd Session of the Commission on Human Rights, UN Doc. E/800 (1948). Note that article 27 of the final text was article 25 in the draft Declaration. References in this article are all to article 27.
80. See article 13 of the American Declaration of the Rights and Duties of Man, repr. in United Nations, human rights: a compilation of international instruments, vol. II: Regional instruments, UN Doc. ST/HR/1/ Rev. 5 (Vol. II). 1997; United Nations, Draft International Declaration of Human Rights - Mexico: amendment to article 45 of tin draft declaration, UN Doc. A/C.3/266 (1948).
81. See article 13 of the American Declaration of the Rights and Duties of Man, repr. in United Nations, human rights: a compilation of international instruments, vol. II: Regional instruments, UN Doc. ST/HR/1/ Rev. 5 (Vol. II). 1997; United Nations, Draft International Declaration of Human Rights - Mexico: amendment to article 45 of tin draft declaration, UN Doc. A/C.3/266 (1948).
82. United Nations, Third Committee Summary Record of Meetings. UN Doc. A/C.3/SR.150 (1948).
83. See e.g. the statements, of the Dominican Republic supporting the amendment, UN Doc. A/C.3/ SR.798 (1957), and India, which abstained, UN Doc. A/C.3/SR.798 (1957).
84. See Resolution 2001/21, 'Intellectual property and human rights', United Nations Sub-Commission on Human Rights. UN Doc. E/CN.4/Sub.2/RES/2001/21 (2001).
85. CESCR IP Statement.
86. Cf United Nations Development Programme, Human development report 2000 (Oxford: Oxford University Press, 2000), which mentions that TRIPS raises issues of compatibility with human rights and international environmental law.
87. Sub-Commission on the Promotion and Protection of Human Rights, The impact of the Agreement on Trade-Related Aspects of Intellectual Property Rights on human rights, UN Doc. E/CN.4/Sub.2/2001/13 (2001).
88. Cf. ibid
89. See CESCR IP Statement, section 6.
90. US Executive Order no. 13,155, 'Access to HIV/AIDS pharmaceutical and medical technologies', Federal Register 65, 2000, p. 30,521. Note, however, that under this executive order, beneficiary countries can benefit from its provisions only if they provide adequate and effective intellectual property protection.
91. In South Africa, the dispute concerned the Medicines and Related Substances Control Amendment Act, 1997 (Republic of South Africa, Government Gazette. 12 Dec. 1997). See The Pharmaceutical Manufacturers' Association of South Africa et al. v. The President of the Republic of South Africa et al., Notice of Motion. High Court of South Africa (Transvaal Provincial Division), 18 Feb. 1998 and The Pharmaceutical Manufacturers' Association cf South Africa et al. v. The President of the Republic of South Africa et al., Joint Statement of Understanding (2001). In Brazil, the dispute concerned the Industrial Property Law, Law No 9.279 of 14 May 1996. See Brazil: measures affecting patent protection - notification of mutually agreed solution, WTO Doc. WT/DS:99/4 (2001).
92. The United States indicated as it was challenging Brazil in the WTO that it made a clear distinction between the health and other sectors. See United States Trade Representative. 2001 Special 301 Report (Washington DC: USTR, 2001).
93. Para. 4 of the Doha Health Declaration. See also Paul Vandoren. 'Médicaments sans frontières? Clarification of the relationship between TRIPS and public health resulting from the WTO Doha ministerial declaration', Journal of World Intellectual Property 5, 2002, p. 4.
94. Cf. Abbott, 'The TRIPS Agreement', p. 38, suggesting more generally that measures adopted by developing and least developed countries to address public health should be presumed to be consistent with TRIPS and that any member challenging them should bear the burden of proof.
95. See e.g. CIPR Report, p. 35.
96. The Doha Health Declaration has not tackled this problem but required the TRIPS Council to provide a solution within a limited time frame (see para. 6 of the declaration).
97. This constitutes the definition of 'public interest' under article 1 of the Brazilian Presidential Decree on Compulsory Licensing, Decree no. 3, 201, 6 Oct. 1999. On this point, see also Paul Champ and Amir Attaran, 'Patent rights and local working under the WTO TRIPS Agreement: an analysis of the US-Brazil patent dispute', 27 Yale Journal of International Law 27, 2002, p. 365.
98. See Medicines and Related Substances Control Amendment Act 1997, Republic of South Africa, Government Gazette, 12 Dec. 1997.
99. As argued by the World Bank; see Global economic prospects 2002, p. 148.
100. See above, p. 136.
101. Similarly, the fact that developed countries in general can 'afford' the costs involved in patent-protected drug research does not imply that all individuals in those countries are in a position to benefit from the system.
102. See Indian Patents Act 1970 and Brazilian Presidential Decree on Compulsory Licensing, Decree no. 3,201, 6 Oct. 1999.
103. Committee on Economic Social and Cultural Rights, General Comment no. 3, 'The nature of states parties obligations (art, 2, para. 1 of the covenant)', in Compilation of general comments and general recommendtions adopted by human rights treaty bodies, UN Doc. HR1/GENV 1/Rev.4 (2000).
104. I b i d.
105. Cf. World Bank. The Bank would rather see public funds used to purchase drugs or licences than essential drugs removed from patentability; see Global economic prospects 2002, p. 148.
106. Note that a conflict occurs if the fulfilment of one obligation leads to the violation of another commitment. A conflict can also arise where the only way to reconcile two treaties is to apply the one providing stricter obligations. On this point see joost Pauwelyn, 'The role of public international law in the WTO: How far can we go?', American Journal of International Law 95, 2002, p. 535.
107. See article 26 of the Convention on the Law of Treaties, Vienna, 23 May 1969, repr. in International Legal Materials 8, 1969, p. 679 [hereafter Vienna Convention 1969].
108. This makes reliance on the intention of the parties difficult. Cf. Pauwelyn, The role of public international law in the WTO', p. 543.
109. See article 22 of the Understanding on Rules and Procedures Governing the Settlement of Disputes, Marrakesh, 15 April 1994, repr. in International Legal Materials 33, 1994, p. 1226.
110. See also Pauwelyn, 'The role of public international law in the WTO', p. 549, who concludes that the modification of human rights treaties by WTO treaties may have difficulties passing the test required by article 41.1(b) of the Vienna Convention 1969.
111. See Vienna Convention 1969.
112. See e.g. Dominique Carreau, Droit international, 7th edn (Paris: Pédone, 2001).
113. See article 103 of the UN Charter.
114. Cf. Jean-Pierre Cot and Alain Pellet, eds, La charte des Nations Unles: Commentaire article par article, 2nd edn (Paris: Economica, 1991).
115. See e.g. Lauri Hannikainen, Peremptory norms (jus cogens) in international law: historical development, criteria, present status (Helsinki: Finnish Lawyers' Publishing, 1989). See also Teraya Koji, 'Emerging hierarchy in international human rights and beyond: from the perspective of non-derogable rights', European Journal of International Law 12, 2001, p. 917.
116. See e.g. Lauri Hannikainen, Peremptory norms (jus cogens) in international law: historical development, criteria, present status (Helsinki: Finnish Lawyers' Publishing, 1989). See also Teraya Koji, 'Emerging hierarchy in international human rights and beyond: from the perspective of non-derogable rights', European Journal of International Law 12, 2001, p. 917.
117. Article 53 of the Vienna Convention 1969.
118. Carreau, Droit international
119. See e.g. article 4 of the ICCPR.
120. Some authors agree, however, that human rights are jus cogens. See e.g. Hannikainen, Peremptory norms, p. 429, noting that '[i]n my view there is no doubt that contemporary international law has reached a stage in which it has the prerequisites for the existence of peremptory obligations upon States to respect basic human rights.'
121. Paras 3 and 5 of Resolution 2001/21, 'Intellectual property and human rights'.
122. Para. 18 of the CESCR IP Statement.
123. On this point, see e.g. Louise de la Fayette, 'United States: import prohibition of certain shrimp and shrimp products; recourse to article 21.5 of the DSU by Malaysia'. American Journal of International Law 96, 2002, p. 685.
124. See text accompanying note 94 above, p. 140-41.