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The WTO–TRIPS Flexibilities on Public Health: A Critical Appraisal of the East African Community Regional Framework

  • OLUFEMI SOYEJU (a1) and JOSHUA WABWIRE (a2)
Abstract
Abstract

Over the years, many developing countries have attempted to make policies utilizing the WTO–TRIPS flexibilities to address the public health needs of their populations. A common strategic trend in these policies has been the tendency to attempt to increase access to medicines through price reduction, achieved by weakening patent protection. This paper, using the policy that has recently been adopted by the East African Community (EAC) member states as a case study, demonstrates the inappropriateness of this strategy. The core argument is that weakening patent protection will hinder further research and invention, which are necessary to ensure the availability of medicines. For developing countries, especially those in Africa, such as the EAC member states, the problem is aggravated by the fact that pharmaceuticals, due to commercial considerations, have already ignored investing in developing medicines for diseases predominant in these countries, hence the need to strengthen rather than weaken, patent protection.

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Corresponding author
*Email: femi.soyeju@up.ac.za/olusoyej@yahoo.co.uk.
**Email: wabwirejoshua@yahoo.com.
References
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1 Boldrin M. and Levine D. K., ‘Does Intellectual Monopoly Help Innovation?’, 5:3 Review of Law and Economics (2009) 991 , at 991.

2 Forman L., ‘Trade Rules, Intellectual Property, and the Right to Health’, 21:3 Ethics and International Affairs (2007) 337 , at 339.

3 Helfer L. R. and Austin G. W., Human Rights and Intellectual Property Mapping the Global Interface (Cambridge: Cambridge University Press, 2014), at 90; Matthews D., ‘Intellectual Property Rights, Human Rights and the Right to Health’, in Grosheide W. (ed.), Intellectual Property Rights and Human Rights: A Paradox (2009), http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1414900 (accessed 10 July 2016).

4 Quoted in Sterckx S., ‘Patents and Access to Drugs in Developing Countries: An Ethical Analysis’, 4 Developing World Bioethics (2004) 59 , at 59; Cullet P., ‘Patents and Medicines: The Relationship Between TRIPS and the Human Right to Health’, 1 International Affairs (2003) 79 , at 160.

5 Wu C. F., ‘Transnational Pharmaceutical Corporations' Legal and Moral Human Rights Responsibilities in Relation to Access to Medicines’, 7 Asian Journal of WTO and International Health Law and Policy (2012) 77 , at 79; Grover A., Citro B., Mankad M., and Lander F., ‘Pharmaceutical Companies and Global Lack of Access to Medicines: Strengthening Accountability under the Right to Health’, 40:2 Journal of Law, Medicine and Ethics (2012) 234 , at 234; Lucyk S., ‘Patents, Politics and Public Health: Access to Essential Medicines under the TRIPS Agreement’, 38 Ottawa Law Review (2006) 193 , at 193.

6 Watson A. G., ‘International Intellectual Property Rights: Do TRIPS' Flexibilities Permit Sufficient Access to Affordable HIV/AIDS Medicines in Developing Countries?’, 32 Boston College International and Comparative Law Review (2009) 143 , at 143.

7 The Regional Intellectual Property Policy on the Utilisation of Public Health Related WTO–TRIPS Flexibilities and the Approximation of National Intellectual Property Legislation (hereafter the Policy) http://www.cehurd.org/wp-content/uploads/downloads/2013/05/EAC-TRIPS-Policy.pdf (accessed 10 July 2016).

8 The Policy, supra note 7, para 2.3.

9 Wu, supra note 5.

10 Forman, supra note 2.

11 Aplin T. and Davies J., Intellectual Property Law: Text, Cases, and Materials (Oxford: Oxford University Press, 2013), at 551; Tuosto C., ‘The TRIPS Council Decision of August 30, 2003 on the Import of Pharmaceuticals under Compulsory Licences’, 26:12 European Intellectual Property Review (2004) 542 , at 543.

12 Sell S. K., ‘TRIPS-Plus Free Trade Agreements and Access to Medicines’, 28 Liverpool Law Review (2007) 41 , at 50.

13 Hassim H. A., Heywood M., and Berger J. (ed.) Health and Democracy (South Africa: Siber Ink, 2007), at 436.

14 Hettinger E. C., ‘Justifying Intellectual Property’ (1989) 18 Philosophy and Public Affairs 36 , at 47; Sterckx, supra note 4, at 62; Lindberg Van, Intellectual Property and Open Source: A Practical Guide to Protecting Code (California: O'Reilly Media, 2008), at 15.

15 See, for instance, Lemley M. A., ‘Faith-Based Intellectual Property’, 62 UCLA Law Review 1328 , at 1331–1334.

16 Boldrin and Levine, supra note 1, at 991.

17 Aplin and Davies, supra note 11, at 11.

18 Adila et al., supra note 13, at 436.

19 Final Act Embodying the Results of the Uruguay Round of Multilateral Trade Negotiations, 15 April 1994, Legal Instruments–Results of The Uruguay Round Volume 1, 33 ILM 1125 (1994).

20 Tuosto, supra note 11, at 542.

21 TRIPS Art. 2 (1).

22 Lalitha L., ‘Doha Declaration and Public Health Issues’, 13 Journal of Intellectual Property Rights (2008) 401 , at 401; Mercurio B. C., ‘TRIPS, Patents, and Access to Life-Saving Drugs in the Developing World’, 10:2 Marquette Intellectual Property Law Review (2004) 211 , at 211.

23 Zainol Z. A., Amin L., Jusoff K., Zahid A., and Akpoviri F., ‘Pharmaceutical Patents and Access to Essential Medicines in Sub-Saharan Africa’, 10 African Journal of Biotechnology, 10 (2011) 12376, at12376.

24 Bass N., ‘Implications of the TRIPS Agreement for Developing Countries: Pharmaceutical Patent Law in Brazil and South Africa in the 21st Century’, 34 George Washington International Law Review (2002) 191 , at 205.

25 Drahos P. and Brathwaite J., Information Feudalism: Who Owns the Knowledge Economy? (Taylor & Francis, 2002), at 10.

26 Gutowski R., ‘The Marriage of Intellectual Property and International Trade in the TRIPS Agreement: Strange Bedfellows or a Match Made in Heaven?’, 47 Buffalo Law Review (1999) 754 , at 754.

27 Ibid.; Braga C., Fink C., and Sepulveda C., ‘Intellectual Property Rights and Economic Development’, in Maskus K. E. (ed.), The WTO, Intellectual Property Rights and the Knowledge Economy (Cheltenham: Edward Elgar Publishing, 2004), at 245.

28 George E., ‘The Human Right to Health and HIV/AIDS: South Africa and South–South cooperation to Reframe Global Intellectual Property Principles and Promote Access to Essential Medicines’, 18:1 Indiana Journal of Global Legal Studies (2011) 167 , at 175.

29 Watson, supra note 6, at 146.

30 Gathii J. T., ‘The Legal Status of the Doha Declaration on TRIPS and Public Health under the Vienna Convention on the Law of Treaties’, 15 Harvard Journal of Law and Technology (2002) 292 , at 292.

31 TRIPS, supra note 20, Arts. 7 and 8; see the findings on the role of Arts. 7 and 8 in Canada – Patent Protection of Pharmaceutical Products WT/DS114/R 17 March 2000.

32 J. T. Gathii, supra note 30, at 298.

33 Ibid.

34 Drahos P., ‘Developing Countries and International Intellectual Property Standard Setting’, 5:5 Journal of World Intellectual Property (2002) 781 , at 781; Mercurio, supra note 22, at 228–229.

35 Doha Declaration, para. 6.

36 The 30 August 2003 Decision.

37 Matthews D., ‘Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health: A Solution to the Access to Essential Medicines Problem?’, 7(1) Journal of International Economic Law (2004) 82 , at 82.

38 Ibid.

41 Attaran A., ‘The Doha Declaration on the TRIPS Agreement and Public Health, Access to Pharmaceuticals, and Options under WTO Law’, 12 Fordham Intellectual Property, Media and Entertainment Law Journal (2002) 859 , at 869.

42 Forman, supra note 2, at 350; Zainol et al., supra note 23, at 12383.

44 J. V. Mwapachu, ‘EAC: Past, Present and Future’ (2010), www.firstmagazine.com/downloadspecialistpublicationdetail.480.ashx (accessed 10 July 2016).

45 Treaty Establishing the East African Community (adopted 30 November 1999, entered into force 7 July 2000) 2144 UNTS 255 (the Treaty).

46 Ibid., Art. 5(1).

47 Ibid., Art. 5(2).

49 The Treaty, supra note 45, chapters 11–27.

50 The Protocol on the Establishment of the East African Community Common Market (the Common Market Protocol), Art. 2.

51 Ibid., Arts. 5(3) k and 43.

52 The Protocol, para. 10 of the preamble.

53 The Policy, supra note 7, para. 2.2.

54 Ibid., para. 2.3.

55 TRIPS, supra note 21, Art. 66.1.

56 Declaration on the TRIPS Agreement and Public Health, adopted on 14 November 2001 WT/MIN (01)/DEC/220 November 2001 (01-5860) para. 7; Decision of the Council for TRIPS of 27 June 2002 Extension of the Transition Period under Article 66.1 of the TRIPS Agreement for Least-Developed Country Members for Certain Obligations with Respect to Pharmaceutical Products IP/C/25 1 July 2002 (02-3664); https:// www.wto.org/english/tratop_e/trips_e/ldc_e.htm (accessed 10 July 2016).

57 TRIPS, supra note 21, Art. 66.1.

58 Ibid., Art. 65.

59 A. Hold and B. C. Mercurio, ‘After the Second Extension of the Transition Period for LDCs: How Can the WTO Gradually Integrate the Poorest Countries into TRIPS?’, Swiss National Centre for Competence in Research Working Paper No. 2013/42/July 2013(2013), at 7.

60 Ibid.

62 Ibid.

63 The Policy, supra note 7, para. 3.1.

64 Ibid.

65 TRIPS, supra note 21, Art. 70.8.

66 Ho C. M., Access to Medicine in the Global Economy: International Agreements on Patents and Related Rights (Oxford University Press, 2011), at 85.

67 Hold and Mercurio, supra note 59.

68 Supra note 56.

69 Tanzania Patents (Registration) Act of 1994; Uganda Patents Act Cap 216 of 1993.

70 Law 1/13 of 2009 Relating to Industrial Property in Burundi arts 17 and 381; Law 31 of 2009 on the Protection of Intellectual Property in Rwanda Art. 18.8.

71 See section 4.2.2 below.

72 The Policy, supra note 7, para. 3.2.

73 Ibid.

74 Ibid.

75 Ibid.

76 The Policy, supra note 7, para. 3.3.

77 Ibid.

78 Correa C. M., ‘Pharmaceutical Innovation, Incremental Patenting and Compulsory Licensing’, 41 South Centre Research Paper (2011), at 5; Gopakumar K. M., ‘Product Patents and Access to Medicines in India: A Critical Review of the Implementation of TRIPS Patent Regime’, 3:2 The Law and Development Review (2010) 326 , at 332; Kondro W., ‘Supreme Court Rules Against Drug Patent “Evergreening”’, 175 Canadian Medical Association Journal (2006), at 1508.

79 Kapczynskiti A., ‘Harmonization and Its Discontents: A Case study of TRIPS Implementation in India's Pharmaceutical Sector’, 97 California Law Review (2009) 1571 , at 1590.

80 Correa, supra note 78, at 2.

81 Ibid.

82 Ibid., at 3.

84 Under TRIPS, supra note 21, Art 66.1, it can be extended further.

85 E. Ferrara, ‘Access to Medicine: Patent, Price Regulation and Prizes’, Washington College of Law International Legal Studies Programme (2009), at 16.

86 Ibid.

87 Singham S. A., ‘Competition Policy and the Stimulation of Innovation: TRIPS and the Interface between Competition and Patent Protection in the Pharmaceutical Industry’, 26 Brooklyn Journal of International Law (2000) 363 , at 383; Forman, supra note 2, at 350.

88 Sell, supra note 12, at 50.

89 Azam M. M. and Richardson K., ‘Pharmaceutical Patent Protection and Trips Challenges for Bangladesh: An Appraisal of Bangladesh's Patent Office and Department of Drug Administration’, 22.2 Bond Law Review , at 4.

90 Correa, supra note 78, at 2.

91 The Policy, supra note 7, para. 3.4.

93 The Policy, supra note 7, para. 3.4.

94 Ibid.

95 Supra notes 85 and 86.

96 The Policy, supra note 7, para. 3.4.

97 Correa, supra note 77, at 2.

98 The Policy, supra note 7, para. 3.4.

99 Ibid.

101 The Policy, supra note 7, para. 3.5.

102 Canada – Patent Protection of Pharmaceutical Products, supra note 31, at para. 7.48.

103 Ibid., para. 7.45.

104 Ibid.

105 TRIPS, supra note 21, Art. 30.

106 Canada – Patent Protection of Pharmaceutical Products, supra note 31, at para. 7.50.

108 The Policy, supra note 7, para. 3.6.

109 Scafidi S., ‘The “Good Old Days” of TRIPS: The US Trade Agenda and the Extension of Pharmaceutical Test Data Protection’, 4:2 Yale Journal of Health Policy, Law, and Ethics (2013) 341 , at 346.

110 Skillington G. L. and Solovy E. M., ‘The Protection of Test and Other Data Required by Article 39.3 of the TRIPS Agreement’, 24:1 Northwestern Journal of International Law and Business (2003), at 6.

111 Ibid., at 8.

112 Ibid.

113 Scafidi, supra note 109, at 343.

114 Skillington and Solovy, supra note 110, at 10.

115 Ibid.

116 The Policy, supra note 7, para. 3.6.

117 Ibid.

118 Ibid.

119 Correa C. M., ‘Unfair Competition under the TRIPS Agreement: Protection of Data Submitted for the Registration of Pharmaceuticals’, 3 Chicago Journal of International Law (2002) 69 , at 78.

120 Scafidi, supra note 109, at 346.

121 Skillington and Solovy, supra note 110, at 10.

122 Ferrara, supra note 85.

123 Correa, supra note 119.

124 The Policy, supra note 7, para. 3.6.

125 Ibid.

126 Supra notes 85 and 86.

127 The Policy, supra note 7, para. 3.7.

128 Ibid.

129 Ibid.

130 H. MacQueen et al., Contemporary Intellectual Property: Law and Issues (2010), at 378.

131 Ibid.

132 See, for instance, the Industrial Property Act cap 509 Laws of Kenya sec. 103; the Patents Act cap 216 Laws of Uganda sec. 36; the Tanzania Patents (Registration) Act sec. 64; UK Patents Act 1977 sec. 14(3) & 72(1).

133 Cornish W. R., Intellectual Property: Patents, Copyright, Trademarks and Allied Rights (Sweet & Maxwell, 1999), at 135.

134 Valensi v. British Radio [1973] RPC 337; Ibid, at 231.

135 The Policy, supra note 7 para. 3.7.

136 See section 4.2.3.

137 See section 4.2.2.

138 Gopakumar, supra note 78, at 345.

139 C. Correa and D. Matthews, ‘The Doha Declaration: Ten Years on and Its Impact on Access to Medicines and the Right to Health’, UNDP Discussion Paper 29 (2011), http://www.undp.org/content/dam/undp/library/hivaids/Discussion_Paper_Doha_Declaration_Public_Health.pdf (accessed 11 July 2016).

140 Ibid.; Gopakumar, supra note 78.

141 Ibid., at 346.

142 The Policy, supra note 7, para. 3.11.

143 TRIPS, supra note 21, Art. 8.2.

144 Ibid., Art. 40.

145 The Policy, supra note 7, para. 3.11.

146 Correa and Matthews, supra note 139.

147 Ibid.

148 Mercurio, supra note 22, at 242; Sell, supra note 88, at 61.

149 Barfield C. and Groombridge M., ‘Parallel Trade in the Pharmaceutical Industry: Implications for Innovation Consumer Welfare, and Health Policy’, 10 Fordham Intellectual Property, Media and Entertainment Law Journal (1999) 185 , at 185.

150 Gopakumar, supra note 78, at 343.

151 Whobrey B., ‘International Patent Law and Public Health: Analyzing TRIPS’ Effect on Access to Pharmaceuticals in Developing Countries’, 45 Brandeis Law Journal (2007) 623 , at 632.

152 Zainol et al., supra note 23, at 12385; Gopakumar, supra note 78, at 343.

153 TRIPS, supra note 21, Arts. 6 and 28.

154 Correa and Matthews, supra note 139, at 9.

155 Ibid.; Helfer L. R. and Austin G. W., Human Rights and Intellectual Property: Mapping the Global Interface (Cambridge: Cambridge University Press, 2014), at 121.

156 The Policy, supra note 7, para 3.9.

157 Ho C. M., ‘A New World Order for Addressing Patent Rights and Public Health’, 82 Chicago-Kent Law Review (2007) 1469 , at 1501.

158 Sherman P. B. and Oakley E. F. III, ‘Pandemics and Panaceas: The World Trade Organization's Efforts to Balance Pharmaceutical Patents and Access to AIDS drugs’, 41 American Business Law Journal (2004) 353 , at 375.

159 Barfield and Groombridge, supra note 149, at 224.

160 Watson, supra note 6, at 154.

161 Harrelson J. A., ‘TRIPS, Pharmaceutical Patents, and the HIV/AIDS Crisis: Finding the Proper Balance between Intellectual Property Rights and Compassion’, 7 Widener Law Symposium Journal (2001), at 154.

162 See section 4.2.2.

163 Lazzarini Z., ‘Making access to Pharmaceuticals a Reality: Legal Options under TRIPS and the Case of Brazil’, Yale Human Rights and Development Law Journal (2003) 103 , at 136.

164 Whobrey, supra note 151, at 633.

165 Sherman and Oakley III, supra note 158, at 375.

166 Snyder D. B., ‘South Africa's Medicines and Related Substances Control Amendment Act: A Spoonful of Sugar or a Bitter Pill to Swallow?’, 18 Dickinson Journal of International Law (1999) 175 , at 191.

167 Ford S. M., ‘Compulsory Licensing Provisions under the TRIPS Agreement: Balancing Pills and Patents’, 15:4 American University International Law Review (2000) 941 , at 945; Bass, supra note 24, at 198.

168 TRIPS, supra note 21 Art. 31; Weissman R., ‘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’, 17 University of Pennsylvania Journal of International Economic Law (1996) 1069, at 1099.

169 Mercurio, supra note 22, at 222; Ferreira L., ‘Access to Affordable HIV/AIDS Drugs: The Human Rights Obligations of Multinational Pharmaceutical Corporations’, 71:3 Fordham Law Review (2002) 1133 , at 1135.

170 Bombach K. M., ‘Can South Africa Fight AIDS? Reconciling the South African Medicines and Related Substances Act with the TRIPS Agreement’, 19 Boston University International Law Journal (2001) 273 , at 276.

171 Lybecker K. M. and Fowler E., ‘Compulsory Licensing in Canada and Thailand: Comparing Regimes to Ensure Legitimate Use of the WTO Rules’, 37:2 Journal of Law, Medicine and Ethics (2009) 222 , at 235; Watson, supra note 6, at 150.

172 Tuosto, supra note 11, at 543.

173 Matthews, supra note 37, at 82.

174 The Policy, supra note 7, para 3.10.

176 Forman, supra note 2, 341.

177 Attaran, supra note 41, at 869.

178 Ibid.

179 Singham, supra note 87, at 392.

180 Watson, supra note 6, at 153.

181 Mercurio, supra note 22, at 250.

182 Bird R. C., ‘Developing Nations and the Compulsory License: Maximizing Access to Essential Medicines While Minimizing Investment Side Effects’, 37:2 Journal of Law, Medicine and Ethics (2009) 209 , at 210.

183 Ferrara, supra note 85, at 15.

184 The Policy, supra note 7, para. 310.

185 See Section 4.2.2.

186 Greenbaum J. L., ‘TRIPS and Public Health: Solutions for Ensuring Global Access to Essential AIDS Medication in the Wake of the Paragraph 6 Waiver’, 25 Journal of Contemporary Health Law and Policy (2008) 142 , at 151.

187 Aginam O., ‘Global Health Governance, Intellectual Property and Access to Essential Medicines: Opportunities and Impediments for South–South Cooperation’, 4:1 Global Health Governance (2010), at 4; Watson, supra note 6, at 151.

188 Harrelson, supra note 161, at 175; Sherman and Oakley III, supra note 158, at 398.

189 Mercurio, supra note 22, at 250.

190 Lybecker and Fowler, supra note 172, at 225.

191 Bird, supra note 183, at 213.

192 Mercurio, supra note 22, at 250.

193 Ibid.; Bird, supra note 183, at 214.

194 See for instance, the Public Health, Innovation and Intellectual Property Rights, Report of the Commission on Intellectual Property Rights, Innovation and Public Health, Geneva: World Health Organization, 2006, http://www.who.int/intellectualproperty/documents/thereport/ENPublicHealthReport.pdf (accessed 10 July 2016).

195 Whitt L. A., ‘Part One: Interdisciplinary Perspective: Indigenous Peoples, Intellectual Property and the New Imperial Science’, 23 Oklahoma City University Law Review (1998) 215 , at 215.

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