Hostname: page-component-89b8bd64d-46n74 Total loading time: 0 Render date: 2026-05-10T19:34:37.672Z Has data issue: false hasContentIssue false
  • English
  • Français

IPRs, Public Health, and International Trade: An International Law Perspective on the TRIPS Amendment

Published online by Cambridge University Press:  29 April 2016

WENWEI GUAN
Get access Rights & Permissions [Opens in a new window]

Abstract

This article critically examines the dynamics between public health, intellectual property, and international trade in the context of the TRIPS Amendment and its theoretical implications in international law. The article suggests that international efforts in the TRIPS 2003 Waiver and 2005 Amendment addressing public health concerns have not been very successful due to the birth defect of TRIPS, i.e., hoping a private-rights-in-nature regime could accommodate public interests in health concerns. TRIPS’ birth defect further reveals itself in post-TRIPS development and contributed to the failure of the TRIPS Waiver and Amendment due to the resulting practice fragmentation and procedural hurdles in domestic compulsory licensing administration. Moreover, the TRIPS Amendment raised a fundamental theoretical issue, i.e., how the WTO as an international organization in public international law can regulate compulsory licensing of intellectual property rights as private rights – in particular the proprietary right to remuneration – while recognizing that TRIPS grants no positive rights. The paper suggests that the key to the issue is the treatment of private rights in public international law. It is submitted that the TRIPS Amendment has no legal basis in international law due to its unwarranted intrusion into members’ domestic affairs and individuals’ private proprietary rights. The article thus calls for alternative thinking about the TRIPS Amendment, in particular to leave administration of compulsory licensing fully with domestic authorities as it is in the Paris Convention.

Keywords

WTOTRIPS amendmentpublic healthprivate rightscompulsory licensing

Information

Type
INTERNATIONAL LAW AND PRACTICE
Information
Leiden Journal of International Law , Volume 29 , Issue 2 , June 2016 , pp. 411 - 440
Copyright
Copyright © Foundation of the Leiden Journal of International Law 2016 

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

Article purchase

Temporarily unavailable

References

1 UN General Assembly, ‘Letter dated 12 January 2015 from the Secretary-General addressed to the President of the General Assembly’ (A/69/720), 19.

2 See EMA News, ‘Speeding up development of Ebola treatments and vaccines (20/10/2014)’, available at www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2014/10/news_detail_002190.jsp&mid=WC0b01ac058004d5c1 (accessed 10 March 2015). Human Ebola virus species, compositions and methods thereof have been patented by the US Government in 2009 (US20120251502, PCT/US2009/062079). All Ebola therapies and vaccines, however, are still in various stages of development, and none of them have been approved for human use so far.

3 The WTO's Paragraph 6 System refers to the ‘waiver’ allowing generic medicines to be made through compulsory licenses exclusively for exporting to countries that have no capacity in producing the medicines themselves. The system is developed under Paragraph 6 of the 2001 Doha Declaration on the TRIPS Agreement and Public Health by removing the exportation limit under compulsory licenses in Art. 31(f) of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

4 The Amendment refers to the WTO's amendment to TRIPS proposed in December 2005. See General Council, ‘Amendment of the TRIPS Agreement’, WT/L/641, Decision of 6 December 2005 (hereafter the TRIPS Amendment). The TRIPS Amendment is an attempt to legalize the 2003 TRIPS Waiver, ‘Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health', which offers temporary suspension of certain TRIPS compulsory licensing obligations as a solution to public health crises. For details of the TRIPS Waiver and Amendment, see discussion in Section 2.2.

5 Dreyfuss, R.C. and Lowenfeld, A.F., ‘Two Achievements of the Uruguay Round: Putting TRIPS and Dispute Settlement Together’, (1997) 37 Virginia Journal of International Law 275Google Scholar, at 276–7.

6 Yu, P.K., ‘The Objectives and Principles of the TRIPS Agreement’, (2009) 46 Houston Law Review 979Google Scholar, at 980; see also, Dinwoodie, G.B. and Dreyfuss, R.C., ‘Designing A Global Intellectual Property System Responsive to Change: the WTO, WIPO, and Beyond’, (2009) 46 Houston Law Review 1187Google Scholar, at 1188.

7 See, e.g., Weissman, R., ‘Long Strange Trips: The Pharmaceutical Industry Drive to Harmonize Global Intellectual Property Rules, and the Remaining WTO Legal Alternatives Available to Third World Countries’, (1996) 17 University of Pennsylvania Journal of International Economic Law 1069Google Scholar; Ford, S.M., ‘Compulsory Licensing Provisions Under the TRIPS Agreement: Balancing Pills and Patents’, (2000) 15 American University International Law Review 941Google Scholar; Abbott, F.M., ‘The TRIPS-Legality of Measures Taken to Address Public Health Crises: A Synopsis’, (2001) 7 Widener Law Symposium Journal 71Google Scholar; Rein, J., ‘International Governance Through Trade Agreements: Patent Protection for Essential Medicines’, (2001) 21 Northwestern Journal of International Law and Business 379Google Scholar; Garcia-Castrillón, C.O., ‘An Approach to the WTO Ministerial Declaration on the TRIPS Agreement and Public Health’, (2002) 5 Journal of International Economic Law 212Google Scholar; Matthews, D., ‘WTO Decision on Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health: A Solution to the Access to Essential Medicines Problem?’, (2004) 7 Journal of International Economic Law 73CrossRefGoogle Scholar; Shaffer, G., ‘Recognizing Public Goods in WTO Dispute Settlement: Who Participates? Who Decides? The Case of TRIPS and Pharmaceutical Patent Protection’, (2004) 7 Journal of International Economic Law 459CrossRefGoogle Scholar; Abbott, F.M., ‘The WTO Medicines Decision: World Pharmaceutical Trade and the Protection of Public Health’, (2005) 99 The American Journal of International Law 317CrossRefGoogle Scholar.

8 See Weissman, supra note 7, 1075–85; see also, Rein, supra note 7, at 381.

9 J.H. Jackson, Sovereignty, The WTO, and Changing Fundamentals of International Law (2006) 247

10 Rein, supra note 7, at 381.

11 The 52nd World Health Assembly (WHA), Revised Drug Strategy (WHA52.19, 24 May 1999), 1.(2) and 1.(3).

12 J.N. Bhagwati, In Defense of Globalization: With a New Afterword by the Author (2007) 185.

13 First recital of the Preamble, Agreement Establishing the World Trade Organization.

14 Jackson, supra note 9, at 247.

15 Ibid.

16 Art. XX(b), General Agreement on Tariffs and Trade 1994 (GATT 1994).

17 Last recital of the Preamble, the TRIPS Agreement.

18 UNCTAD-ICTSD, Resource Book on TRIPS and Development (2005) 13–14.

19 Art. 6, the TRIPS Agreement.

20 Para. 5(d), the Doha Declaration on the TRIPS Agreement and Public Health (WT/MIN(01)/DEC/2, adopted at the Fourth WTO Ministerial Conference in Doha, Qatar on 14 November 2001, the 2001 Doha Declaration).

21 C.M. Correa, Integrating Public Health Concepts into Patent Legislation in Developing Countries (2000), 72–3; See also S.F. Musungu et al., Utilizing TRIPS Flexibilities for Public Health Protection through South-South Regional Frameworks (2004) 13–14.

22 Art. 31, the TRIPS Agreement.

23 Ibid.

24 UNCTAD-ICTSD, supra note 18, 461–2.

25 Art. 7, the TRIPS Agreement.

26 Art. 8.1, the TRIPS Agreement. Emphasis added.

27 N. Pires de Carvalho, The TRIPS Regime of Patent Rights (2010), 223. Carvalho suggests (at 225) that Art. XX(a) of the GATT 1994 is a provision ‘of relevance to the understanding and application of Article 8.1 [of the TRIPS Agreement]’.

28 European Communities – Protection of Trademarks and Geographical Indications for Agricultural Products and Foodstuffs (EC - Trademarks and Geographical Indications (Australia)), Panel report (WT/DS290/R, 15 March 2005), para. 7.210.

29 Art. 27.2, the TRIPS Agreement.

30 The WTO Ministerial Conference suggests that the TRIPS Council's work ‘shall be guided by the objectives and principles set out in Articles 7 and 8 of the TRIPS Agreement and shall take fully into account the development dimension.’ See para. 19, Ministerial Declaration, adopted at the Fourth Session of the Ministerial Conference at Doha on 14 November 2001, WT/MIN(01)/DEC/1.

31 Para. 5(a), the 2001 Doha Declaration.

32 Canada–Patent Protection of Pharmaceutical Products (Canada–Pharmaceutical Patents), Panel Report (WT/DS114/R, 17 March 2000), para. 7.26.

33 Jackson, supra note 9, at 247.

34 Brazil – Measures Affecting Imports of Retreaded Tyres (Brazil – Retreaded Tyres), Appellate Body Report (WT/DS332/AB/R, 3 December 2007), para. 210.

35 Abbott, F.M., ‘The Doha Declaration on the TRIPS Agreement and Public Health: Lighting A Dark Corner at the WTO’, (2002) 5 Journal of International Economic Law 469CrossRefGoogle Scholar, at 470.

36 Ibid., 471–2.

37 Ibid., 480–1.

38 Ibid., 470.

39 Para. 4, the 2001 Doha Declaration.

40 Ibid., para. 6.

41 Ibid., para. 5(b).

42 Ibid., para. 5(c).

43 Art. 5A, Paris Convention for the Protection of Industrial Property (Paris Convention), as amended on 28 September 1979. For more details on the compulsory licensing mechanism in the Paris Convention, see Section 3.3.

44 WTO General Council, ‘Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health’, WT/L/540 and Corr.1, 1 September 2003 (hereafter the TRIPS Waiver).

45 Para. 2, the TRIPS Waiver. For the TRIPS obligation, see Art. 31(f), the TRIPS Agreement.

46 Para. 3, the TRIPS Waiver.

47 Ibid. For the TRIPS obligation, see Art. 31(h), the TRIPS Agreement.

48 Vandoren, P. and Van Eeckhaute, J.C., ‘The WTO Decision on Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health: Making it Work’, (2003) 6 The Journal of World Intellectual Property 779CrossRefGoogle Scholar, at 780.

49 Para. 1(a), the TRIPS Waiver.

50 Abbott, supra note 7 (2005), 327–32. According to Abbott, countries like the US, Japan, and Switzerland supported the limited view of the scope of diseases for the purpose of ‘limit[ing] the number of patented technologies subject to compulsory licensing for export.’ Ibid., 329.

51 Vandoren & Eeckhaute, supra note 48, at 785.

52 Bill C-9, An Act to amend the Patent Act and the Food and Drugs Act (The Jean Chrétien Pledge to Africa), passed at the 3rd Session of the 37th Parliament of Canada, assented to 14 May 2004. Under section 21.02 of the Act, pharmaceutical products under the TRIPS Waiver system are limited to those 56 patented pharmaceutical products listed in Schedule 1 of the Act. For the debates on the legislation in Canada, see Abbott, supra note 7 (2005), 332–3.

53 Paras. 1(b) and 2(a)(ii), the TRIPS Waiver. Of course, this limitation makes sense theoretically as those countries with sufficient manufacturing capacity do not need the waiver. However, singling out those countries with insufficient or no manufacturing capacity together with the procedural and good faith limitations (discussed next in the same paragraph) clearly reflects the TRIPS Waiver's intention of limiting the use of the waiver system as much as possible.

54 Abbott, supra note 7 (2005), at 331, 335.

55 Para. 2(a), the TRIPS Waiver.

56 Vandoren and Eeckhaute, supra note 48, 785–6.

57 WTO General Council, Minutes of Meeting held in the Centre William Rappard on 25, 26, and 30 August 2003 (WT/GC/M/82, 13 November 2003), para. 29. The Chairman's statement also makes a clear reference to transparency (Ibid., para. 29) that:

To promote transparency and avoid controversy, notifications under paragraph 2(a)(ii) of the Decision would include information on how the Member in question had established, in accordance with the Annex, that it has insufficient or no manufacturing capacities in the pharmaceutical sector.

58 Abbott, supra note 7 (2005), 343; See also, Vandoren and Eeckhaute, supra note 48, at 780.

59 WTO General Council, Amendment of the TRIPS Agreement.

60 Para. 1, Protocol Amending the TRIPS Agreement.

61 Ibid., paras. 2, 3.

62 WTO General Council, ‘Amendment of the TRIPS Agreement – Fifth Extension of the Period for the Acceptance by Members of the Protocol Amending the TRIPS Agreement’ (WT/L/965, Decision of 30 November 2015).

63 WTO, ‘Members Accepting Amendment of the TRIPS Agreement’, available on the WTO official site: www.wto.org/english/tratop_e/trips_e/amendment_e.htm (accessed 20 February 2016).

64 Art. X.1, Marrakesh Agreement Establishing the World Trade Organization (the WTO Agreement).

65 L.R. Helfer and G.W. Austin, Human Rights and Intellectual Property: Mapping the Global Interface (2011), 124.

66 Thapa, R., ‘Waiver Solution in Public Health and Pharmaceutical Domain under TRIPS Agreement’, (2011) 16 Journal of Intellectual Property Rights 470Google Scholar, at 472.

67 By July 2014, only Rwanda notified the Council for TRIPS as the importer and Canada notified the Council for TRIPS as the exporter under the paragraph 6 system. See Rwanda, ‘Notification under Paragraph 2(a) of the Decision of 30 August 2003 on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health’ (IP/N/9/RWA/1, 19 July 2007); Canada, ‘Notification under Paragraph 2(c) of the Decision of 30 August 2003 on the Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health’ (IP/N/10/CAN/1, 8 October 2007).

68 G. Moretti, ‘Better be safe than sorry: should the regulation on patent compulsory licensing for exportation be reconsidered?’ Queen Mary Journal of Intellectual Property online posts, 23 December 2014. Available at qmjip.wordpress.com/2014/12/ (accessed 10 March 2015).

69 See discussion in Section 4.

70 Fourth Recital of the Preamble, the TRIPS Agreement.

71 F.M. Abbott, ‘Technology and State Enterprise in the WTO’, in World Trade Forum: State Trading in the Twenty-First Century (1998), at 144, footnote 11.

72 Enforcement of Intellectual Property Rights, Hong Kong Submission to Negotiating Group on Trade-Related Aspects of Intellectual Property Rights, including Trade in Counterfeit Goods (MTN.GNG/NG11/W/54, 7 December 1989), para. 6 (p. 2). Emphasis added.

73 Ibid., at para. 9 (p. 2). Emphasis added.

74 China – Measures Affecting the Protection and Enforcement of Intellectual Property Rights (China – Intellectual Property Rights), Panel Report (WT/DS362/R, 26 January 2009), para. 7.247. According to the Panel:

The Panel also observes that a common feature of Sections 2, 3 and 4 of Part III of the TRIPS Agreement is that the initiation of procedures under these Sections is generally the responsibility of private right holders. . . This is consistent with the nature of intellectual property rights as private rights, as recognized in the fourth recital of the preamble of the TRIPS Agreement. Acquisition procedures for substantive rights and civil enforcement procedures generally have to be initiated by the right holder and not ex officio.

75 EC - Trademarks and Geographical Indications (Australia), Panel report, para. 7.602.

76 Ibid., para. 7.611, footnote 558. Emphasis added.

77 Ibid., para. 7.210. Emphasis added.

78 See discussion in Section 2.2.

79 See discussion in Section 4.2 in particular.

80 Art. 7, TRIPS Agreement. Emphasis added.

81 Arts. 8(1) and 8(2), TRIPS Agreement.

82 For TRIPS’ exceptions to intellectual property rights and the nature of compulsory licensing, see discussion in Section 3.2.

83 Guan, W., ‘The Poverty of Intellectual Property Philosophy’, (2008) 38 Hong Kong Law Journal 359Google Scholar, at 393–6.

84 China – Intellectual Property Rights, Panel Report, para. 7.135.

85 Para. 5(a), the 2001 Doha Declaration.

86 Art. 30, the TRIPS Agreement.

87 Art. 31, the TRIPS Agreement.

88 Canada – Pharmaceutical Patents, Panel Report, para. 7.91. However, it should be made clear that Art. 30 and Art. 31 are distinct from one another. Although the three conditions set forth by Art. 30 define the kind and scope of the permissible exceptions, Art. 30 itself does not list the specific acts that might be exempted. Art. 31 then deals with ‘other use’ – i.e., use other than that allowed under Art. 30 – that requires no authorization from the right holders. This formulation indicates the drafters’ intension of distinguishing the ‘limited exceptions’ that are authorized under Art. 30 from compulsory licensing authorized under Art. 31.

89 Ibid., at para. 7.71.

90 Art. 9(2), Berne Convention.

91 The Panel in Canada – Pharmaceutical Patents (Original footnote 420 to para. 7.71) states:

The text of Berne Article 9(2) also served as the model for three other exceptions clauses in the TRIPS Agreement - Articles 13, 17 and 26.2, providing respectively for similar exceptions from obligations on copyright, trademarks and industrial designs. Article 13 is a nearly identical copy of Berne Article 9(2). Like Article 30, both Articles 17 and 26.2 made small changes to the text of Berne Article 9(2).

92 Canada – Pharmaceutical Patents, Panel Report, para. 7.71.

93 Art. 30, the TRIPS Agreement.

94 Arts. 17 and 26(2), the TRIPS Agreement.

95 Davison, M. and Emerton, P., ‘Rights, Privileges, Legitimate Interests, and Justifiability: Article 20 of TRIPS and Plain Packaging of Tobacco’, (2014) 29 (3)American University International Law Review, 505Google Scholar, at 528. According to the authors (at 530), ‘[t]he legitimate interests of the third parties are a basis for considering whether there exists a right to exclude others from using copyrighted or patented subject-matter, designs, and trademarks.’

96 Art. 17, the TRIPS Agreement.

97 Art. 13 of the TRIPS Agreement reads as follows:

Members shall confine limitations or exceptions to exclusive rights to certain special cases which do not conflict with a normal exploitation of the work and do not unreasonably prejudice the legitimate interests of the right holder.

98 United States – Standards for Reformulated and Conventional Gasoline (US – Gasoline), Appellate Body report (WT/DS2/AB/R, 29 April 1996), at 23.

99 Canada – Pharmaceutical Patents, Panel Report, para. 7.68.

100 Ibid., at para. 7.69.

101 Ibid., at para. 7.71.

102 EC - Trademarks and Geographical Indications (Australia), Panel report, para. 7.675.

103 Ibid., at para. 7.679, the Panel states:

The European Communities submits that “third parties” for the purposes of Article 17 include persons using a GI in accordance with a GI registration. The Panel agrees. Article 17 permits an exception to the rights conferred by a trademark which include, according to Article 16.1, a right to prevent “all third parties” from using certain signs. The basis of the complainant's claim is that those third parties include GI users. It is logical that, if GI users are included in the third parties subject to the trademark owner's right, they are also included in the third parties taken into account in assessing the availability of an exception to that right.

104 Canada – Pharmaceutical Patents, Panel Report, para. 7.26.

105 R. Ricupero and R. Melendez Ortiz, ‘Preface’, in UNCTAD and ICTSD eds., Resource Book on TRIPS and Development (2005) vii.

106 Ibid.

107 Yu, supra note 6, at 982.

108 UNCTAD-ICTSD, supra note 18, at 3.

109 Ibid., 3–4. The other ‘new area’ negotiation in the Uruguay Round concerned trade in services which resulted in the General Agreement on Trade in Services (GATS); See also, Yu, supra note 6, at 983–4.

110 Gervais, D.J., ‘Intellectual Property, Trade & Development: The State of Play’, (2005) 74 Fordham Law Review 505Google Scholar, at 507–8.

111 US submission, ‘Suggestion by the United States for Achieving the Negotiating Objective (Revision)’ (MTN.GNG/NG11/W/14/Rev.1, 17 October 1988), Communication from the US to, Negotiating Group on Trade-Related Aspects of Intellectual Property Rights, including Trade in Counterfeit Goods, 3.

112 Ibid., 18.

113 Indian submission, ‘Standards and Principles concerning the Availability, Scope and Use of Trade-Related Intellectual Property Rights’ (MTN.GNG/NG11/W/37, 10 July 1989), Communication from India to Negotiating Group on Trade-Related Aspects of Intellectual Property Rights, including Trade in Counterfeit Goods.

114 Ibid., 2.

115 Ibid.

116 Ibid., 19–20.

117 UNCTAD-ICTSD, supra note 18, at 4.

118 Gervais, supra note 110, at 508.

119 UNCTAD-ICTSD, supra note 18, at 462.

120 Art. 5.A(2), Paris Convention.

121 UNCTAD-ICTSD, supra note 18, at 463.

122 Indian submission, ‘Standards and Principles concerning the Availability, Scope and Use of Trade-Related Intellectual Property Rights’.

123 Arts. 5.A(2) and (4), the Paris Convention.

124 The issue of licensing on grounds of non-working was addressed indirectly by Arts. 27.1 and 70.6 of the Agreement. See UNCTAD-ICTSD, supra note 18, at 467.

125 For the EC's submission, see ‘Guidelines Proposed by the European Community for the Negotiations on Trade-Related Aspects of Intellectual Property Rights,’ (MTN.GNG/NG11/W/16, 20 November 1987), Communication from the EC to Negotiating Group on Trade-Related Aspects of Intellectual Property Rights, including Trade in Counterfeit Goods; for US's submission, see ‘Draft Agreement on the Trade-Related Aspects of Intellectual Property Rights: Communication from the United States’ (MTN.GNG/NG11/W70, 11 May 1990), Communication from the US to Negotiating Group on Trade-Related Aspects of Intellectual Property Rights, including Trade in Counterfeit Goods.

126 UNCTAD-ICTSD, supra note 18, at 578–9.

127 For the Indian delegation's submission, see ‘Enforcement of Trade-Related Intellectual Property Rights: Communication from India’ (MTN.GNG/NG11/W/40, 5 September 1989), Communication from India to Negotiating Group on Trade-Related Aspects of Intellectual Property Rights, including Trade in Counterfeit Goods.

128 UNCTAD-ICTSD, supra note 18, at 579, 585.

129 For more discussion on TRIPS’ ‘birth defect’, see W. Guan, Intellectual Property Theory and Practice: A Critical Examination of China's TRIPS Compliance and Beyond (2014), 5–7.

130 United Nations Industrial Development Organization (UNIDO), Public Goods for Economic Development (2008), 80.

131 See for example, the coalition of developing countries known as the Like Minded Group (LMG)’s attempt to challenge the launch of the Doha Round negotiation. A. Narlikar, World Trade Organization: A Very Short Introduction (2005) 54–5; see also, Dinwoodie and Dreyfuss, supra note 6, 1188–9.

132 As to TRIPS’ consideration of the legitimate interests of third parties in intellectual property exceptions, see discussion in Section 3.2.

133 US – Gasoline, Appellate Body report, 17.

134 See discussion in Section 2.2.

135 See discussion in Sections 3.1 and 3.2, in particular Section 3.1.

136 Jackson, supra note 9, at 247; see main text associated with supra note 33.

137 J.H. Jackson, The World Trading System: Law and Policy of International Economic Relations (1997), at 10, 29.

138 See P. Sutherland et al., The Future of the WTO: Addressing Institutional Challenges in the New Millennium (2004), para. 39. According to the Report (para. 39), both GATT and the WTO have been ‘intended to provide a structured and functionally effective way to harness the value of open trade to principle and fairness’; and their rules ‘provide checks and balances including mechanisms that reflect political realism as well as free trade doctrine.’

139 WTO Secretariat, World Trade Report 2009: Trade Policy Commitments and Contingency Measures (2009), xiii. The Report (at xiii) states:

Trade agreements define rules for the conduct of trade policy. These rules must strike a balance between commitments and flexibility. Too much flexibility may undermine the value of commitments, but too little flexibility may render the rules unsustainable.

140 For compulsory licensing as exceptions to patent rights, see discussion in Section 3.2.

141 For TRIPS’ principles in Art. 8.1 as the ‘general exceptions’ mechanism, see discussion in Section 2.1.

142 See discussion in Section 2.2.

143 UNCTAD-ICTSD, supra note 18, at 465.

144 Para. 1, 2003 TRIPS Waiver.

145 Paras. 2–3, 2003 TRIPS Waiver.

146 Paras. 4–5, 2003 TRIPS Waiver.

147 Abbott, supra note 7 (2005), at 335. According to Abbott (at 318.) the US considered the TRIPS Waiver as ‘a problematic compromise’, and ‘has since sought to limit its scope of application’ through bilateral or limited multilateral frameworks.

148 Art. 1.1, the TRIPS Agreement.

149 Art. 41.5 of the TRIPS Agreement states:

It is understood that this Part [Part III – Enforcement of Intellectual Property Rights] does not create any obligation to put in place a judicial system for the enforcement of intellectual property rights distinct from that for the enforcement of law in general, nor does it affect the capacity of Members to enforce their law in general. Nothing in this Part creates any obligation with respect to the distribution of resources as between enforcement of intellectual property rights and the enforcement of law in general.

150 R. Jennings and A. Watts, Oppenheim's International Law (1992), at 82 § 1.

151 M. Hilf and E. Petersmann, National Constitutions and International Economic Law (1993).

152 UNCTAD-ICTSD, supra note 18, at 23.

153 Ibid., at 31–5.

154 Section 102(c)(1)(A) and (B), Uruguay Round Agreements Act, Pub. L. 103-465, 108 Stat. 4818 (1994).

155 See, 94/800/EC: Council Decision (of 22 December 1994) concerning the conclusion on behalf of the European Community, as regards matters within its competence, of the agreements reached in the Uruguay Round multilateral negotiations (1986–1994).

156 UNCTAD-ICTSD, supra note 18, at 26.

157 Jennings and Watts, supra note 150, at 82–3.

158 Carvalho, supra note 27, at 223.

159 While positive rights entitle a person ‘to have another do some act for the benefit of the person entitled’, negative rights ‘entitl[e] a person to have another refrain from doing an act that might harm the person entitled’. See B.A. Garner, Black's Law Dictionary (2009).

160 EC - Trademarks and Geographical Indications (Australia), Panel report, para. 7.210. For detailed discussion of the negative rights jurisprudence, see Section 3.1.

161 United States – Sections 301-310 of the Trade Act 1974 (US – Section 301 Trade Act), Panel report (WT/DS152/R, 22 December 1999), para. 7.72.

162 Of course, the Panel also emphasized that the statement was made as a matter of fact, and that (Ibid., para. 7.72, footnote 661):

The fact that WTO institutions have not to date construed any obligations as producing direct effect does not necessarily preclude that in the legal system of any given Member, following internal constitutional principles, some obligations will be found to give rights to individuals. Our statement of fact does not prejudge any decisions by national courts on this issue.

163 Of course, international law protects human rights and individuals are ultimately the beneficiaries of international human rights protection. Recent developments in international criminal law, as Crawford points out, have made it ‘no longer possible to deny that individuals may have rights and duties in international law’: J. Crawford, Brownlie's Principles of Public International Law (2012), 17. However, this does not directly make individuals ‘subjects’ of international law who can directly bear rights and liabilities under international law. As Crawford suggested, ‘to classify the individuals as a ‘subject’ of international law is unhelpful,’ as individuals do not have the same capacities as other types of subjects of international law, and international human rights norms ‘are not yet regarded as applying horizontally between individuals, in parallel to or substitution for the applicable national law,’ and neither are there any means for their enforcement in international law. Therefore, Crawford points out that human rights and other obligations assumed for the benefit of individuals ‘arise against the state, which so far has a virtual monopoly of responsibility’: Ibid., 121.

164 I. Brownlie, The Rule of Law in International Affairs: International Law at the Fiftieth Anniversary of the United Nations (1998), 48.

165 L. Henkin, International Law: Politics and Values (1995), 7–8.

166 Jennings and Watts, supra note 150, at 846.

167 Ibid., 847.

168 Brownlie, supra note 164, at 48. Brownlie argues that ‘the principal connection between the individual and the system of international law is still via the status of nationality’. See also Jennings and Watts, supra note 150, at 857. Jennings and Watts state that ‘nationality is the principal link between individuals and international law.’

169 Jennings and Watts, supra note 150, at 859.

170 I. Brownlie, Principles of Public International Law (2008), 383.

171 PCIJ, Ser. B, no. 4 (1923), 24, as cited ibid.

172 Jennings and Watts, supra note 150, at 849.

173 Brand, R.A., ‘Sovereignty: The State, the Individual, and the International Legal System in the Twenty First Century’, (2002) 25 Hastings International and Comparative Law Review 279Google Scholar, at 286–7.

174 See Hudec, R.E., ‘Comment on “The Club Model of Multilateral Cooperation and Problems of Democratic Legitimacy”’, in Porter, R.B.et al. (eds), Efficiency, Equity, and Legitimacy: the Multilateral Trading System at the Millennium (2001) 297–8Google Scholar.

175 See E.U. Petersmann, The GATT/WTO Dispute Settlement System: International Law, International Organizations and Dispute Settlement (1997), 54. In his discussion on consensus decision-making, Petersmann suggests that it is the general principle underlying WTO decision-making that ‘the WTO does not have the power to impose new trade policy obligations.’

176 Henkin, supra note 165, at 27.

177 Art. 2.7, Charter of the United Nations (UN Charter).

178 For intellectual property rights as private and negative rights, in particular the barring effect thereof, see discussion in Section 3.1.

179 Art. 5A, Paris Convention.

180 For the right to adequate remuneration, see Art. 31(h) of the TRIPS Agreement.

181 EC - Trademarks and Geographical Indications (Australia), Panel report, para. 7.210. For detailed discussion of the negative right jurisprudence, see discussion in Section 3.1. Of course, it would not be unusual if the TRIPS Agreement concerned the use of right rather than the right itself. The TRIPS Waiver, however, directly touches and reallocates the right to remuneration.

182 Para. 3, the TRIPS Waiver.

183 Thapa, supra note 66, 472–3.

184 Abbott, F.M. and Reichman, J.H., ‘The Doha Round's Public Health Legacy: Strategies for the Production and Diffusion of Patented Medicines under the Amended TRIPS Provisions’, (2007) 10 Journal of International Economic Law 921CrossRefGoogle Scholar, at 932.

185 Ibid., 921, at 932.

186 Bhagwati, supra note 12, at 185.

187 Art. 5A, Paris Convention.

188 Art. 31(h), the TRIPS Agreement.