The WTO dispute settlement understanding: An unlikely weapon in the fight against AIDS

American Journal of Law and Medicine

Volumn 27, Issue 4, 2001, Pages 469-485

  Curti, Andrea M ^a,b,c  

^a BOSTON UNIVERSITY   (United States)

^b TUFTS UNIVERSITY   (United States)

^c GEORGETOWN UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTI HUMAN IMMUNODEFICIENCY VIRUS AGENT; DRUG;

ACQUIRED IMMUNE DEFICIENCY SYNDROME; ARTICLE; CANADA; COMMERCIAL PHENOMENA; DEVELOPING COUNTRY; DRUG INDUSTRY; DRUG LEGISLATION; ECONOMICS; HUMAN; INDIA; INTERNATIONAL COOPERATION; LEGAL ASPECT; LICENSING; PATENT; PUBLIC HEALTH SERVICE; SOUTH AFRICA; THAILAND;

ACQUIRED IMMUNODEFICIENCY SYNDROME; ANTI-HIV AGENTS; CANADA; COMMERCE; DEVELOPING COUNTRIES; DRUG INDUSTRY; HUMANS; INDIA; INTELLECTUAL PROPERTY; INTERNATIONAL AGENCIES; LEGISLATION, DRUG; LICENSURE; PATENTS; PHARMACEUTICAL PREPARATIONS; PUBLIC HEALTH ADMINISTRATION; SOUTH AFRICA; THAILAND;

EID: 0035754915     PISSN: 00988588     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (182)

1. See generally Final Act Embodying the Results of the Uruguay Round of Multilateral Trade Negotiations, Apr. 15, 1994, LEGAL INSTRUMENTS - RESULTS OF THE URUGUAY ROUND vol. 1 (1994), 33 I.L.M. 1125 (1994) [hereinafter WTO Agreement]. This issue came to the fore in October 2001, when the United States negotiated with Bayer to lower prices for the patented drug Cipro, which is used to treat anthrax. Canada suspended Cipro's patent altogether. See Keith Bradsher, Bayer Agrees to Charge Government Lower Price for Anthrax Medicine, N.Y. TIMES, Oct. 24, 2001, at A1. The United States' policy on drug patents also shifted noticeably at the November 2001 trade talks in Doha, Qatar, when U.S. Trade Representative Robert Zoellick softened the United States' stance on drug patents. This helped countries reach an understanding that will help increase access to generic forms of drugs. See Joseph Kahn, Nations Back Freer Trade, Hoping to Aid Global Growth, N.Y. TIMES, Nov. 15, 2001, at A12.
2. See generally Final Act Embodying the Results of the Uruguay Round of Multilateral Trade Negotiations, Apr. 15, 1994, LEGAL INSTRUMENTS - RESULTS OF THE URUGUAY ROUND vol. 1 (1994), 33 I.L.M. 1125 (1994) [hereinafter WTO Agreement]. This issue came to the fore in October 2001, when the United States negotiated with Bayer to lower prices for the patented drug Cipro, which is used to treat anthrax. Canada suspended Cipro's patent altogether. See Keith Bradsher, Bayer Agrees to Charge Government Lower Price for Anthrax Medicine, N.Y. TIMES, Oct. 24, 2001, at A1. The United States' policy on drug patents also shifted noticeably at the November 2001 trade talks in Doha, Qatar, when U.S. Trade Representative Robert Zoellick softened the United States' stance on drug patents. This helped countries reach an understanding that will help increase access to generic forms of drugs. See Joseph Kahn, Nations Back Freer Trade, Hoping to Aid Global Growth, N.Y. TIMES, Nov. 15, 2001, at A12.
3. See generally Final Act Embodying the Results of the Uruguay Round of Multilateral Trade Negotiations, Apr. 15, 1994, LEGAL INSTRUMENTS - RESULTS OF THE URUGUAY ROUND vol. 1 (1994), 33 I.L.M. 1125 (1994) [hereinafter WTO Agreement]. This issue came to the fore in October 2001, when the United States negotiated with Bayer to lower prices for the patented drug Cipro, which is used to treat anthrax. Canada suspended Cipro's patent altogether. See Keith Bradsher, Bayer Agrees to Charge Government Lower Price for Anthrax Medicine, N.Y. TIMES, Oct. 24, 2001, at A1. The United States' policy on drug patents also shifted noticeably at the November 2001 trade talks in Doha, Qatar, when U.S. Trade Representative Robert Zoellick softened the United States' stance on drug patents. This helped countries reach an understanding that will help increase access to generic forms of drugs. See Joseph Kahn, Nations Back Freer Trade, Hoping to Aid Global Growth, N.Y. TIMES, Nov. 15, 2001, at A12.
4. See, e.g., OXFAM, PATENT INJUSTICE: HOW WORLD TRADE RULES THREATEN THE HEALTH OF POOR PEOPLE (2001), available at http://www.oxfam.org.uk/cutthecost/indepth.html.
5. See, e.g., Shanker A. Singham, Competition Policy and the Stimulation of Innovation: TRIPS and the Interface Between Competition and Patent Protection in the Pharmaceutical Industry, 26 BROOK. J. INT'L L. 363, 363-64 (2000).
6. Agreement on Trade-Related Aspects of Intellectual Property Rights, Apr. 15, 1994, WTO Agreement, Annex 1C, LEGAL INSTRUMENTS - RESULTS OF THE URUGUAY ROUND vol. 31; 33 I.L.M. 81 (1994) [hereinafter TRIPS Agreement].
7. World Trade Organization Secretariat, Canada - Patent Protection of Pharmaceutical Products, WT/DS114/R (Mar. 17, 2000) [hereinafter Panel Report on Canada].
8. See id.
9. See Understanding on Rules and Procedures Governing the Settlement of Disputes, Apr. 15, 1994, WTO Agreement, Annex 2, LEGAL INSTRUMENTS - RESULTS OF THE URUGUAY ROUND vol. 31; 33 I.L.M. 112 (1994) [hereinafter Dispute Settlement Understanding].
10. See Assoc. Press, Discarded AIDS medication a priceless gift in Haiti, BOSTON GLOBE, Nov. 24, 2000, at B13 (citing a World Health Organization estimate that ninety-five percent of the more than thirty-three million people infected with HIV and AIDS are in developing nations).
11. Nadine Gordimer, Refusing to 'Live with AIDS', N.Y. TIMES, Dec. 1, 2000, at A31.
12. See generally Agreement on the Application of Sanitary and Phytosanitary Measures, General Agreement on Tariffs and Trade, Oct. 30, 1947, 61 Stat. A-11, T.I.A.S. 1700, 55 U.N.T.S. 194 [hereinafter SPS Agreement].
13. See id.
14. Id. art. 2.
15. See Marney L. Cheek, The Limits of Informal Regulatory Cooperation in International Affairs: A Review of the Global Intellectual Property Regime, 33 GEO. WASH. INT'L L. REV. 277, 287 (2001).
16. See General Agreement on Tariffs and Trade 1947, Apr. 15, 1994, WTO Agreement, Annex IA, art. XX(d), LEGAL INSTRUMENTS - RESULTS OF THE URUGUAY ROUND vol. 31; 33 I.L.M. 81 (1994) (allowing contracting parties to restrict trade in order to protect intellectual property rights) [hereinafter GATT].
17. See generally Lynne Saylor & John Beton, Why the TRIPS Agreement? in INTELLECTUAL PROPERTY & INTERNATIONAL TRADE: A GUIDE TO THE URUGUAY ROUND TRIPS AGREEMENT 12, 12-13 (1996) (discussing the evolution of the TRIPS Agreement). See also MARCO C. E. J. BRONCKERS, A CROSS SECTION OF WTO LAW 186 (2000).
18. See generally Lynne Saylor & John Beton, Why the TRIPS Agreement? in INTELLECTUAL PROPERTY & INTERNATIONAL TRADE: A GUIDE TO THE URUGUAY ROUND TRIPS AGREEMENT 12, 12-13 (1996) (discussing the evolution of the TRIPS Agreement). See also MARCO C. E. J. BRONCKERS, A CROSS SECTION OF WTO LAW 186 (2000).
19. See generally TRIPS Agreement.
20. See 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, 17 U. PA. J. INT'L ECON. L. 1069, 1069 (1996) (discussing the irony that the TRIPS restrictions exist within a multilateral treaty that aims to reduce trade barriers).
21. See TRIPS Agreement art. 1.1.
22. See GATT, annex 1A.
23. See Saylor & Beton, supra note 15, at 12 (discussing the United States' need for IP protection).
24. See id.
25. See id. at 13.
26. See id.
27. See discussion infra Part III.A.
28. See BRONCKERS, supra note 15, at 190-202 (outlining WTO accession rules).
29. Id. at 191. WTO members categorize themselves as a developed or developing country, although placement in the least developed category must be made by GATT and may be influenced by the U.N. list and other considerations. See id. at 194-99. For a discussion of the implications of self-categorization, see id. at 199-201 (suggesting that the WTO would benefit from legal certainty in its categorization process, and suggesting that the WTO generate a list of which countries may take advantage of the transitional arrangement). For a list of least developed countries according to U.N. classification, see id. at 193.
30. See BRONCKERS, supra note 15, at 191.
31. See TRIPS Agreement art. 66.1. Developed countries must comply within one year. Id. art. 65.1.
32. Id. art. 65.2.
33. See id. art. 65.5.
34. See BRONCKERS, supra note 15, at 191.
35. See TRIPS Agreement art. 66.1. The MFN principle states that WTO members must grant the same terms of trade to all other WTO members. See GATT art. III. The national treatment principle stipulates that WTO members cannot discriminate between domestic goods and like domestic imports. See id.
36. See BRONCKERS, supra note 15, at 192.
37. See Id.
38. Id.
39. See id.
40. Id.
41. TRIPS Agreement art. 70.9. See also BRONCKERS, supra note 15, at 192.
42. See BRONCKERS, supra note 15, at 196.
43. See TRIPS Agreement art. 65.2. Developed countries have only a one-year transitional period. Id. art. 65.1.
44. See BRONCKERS, supra note 15, at 196.
45. See TRIPS Agreement art. 65.5.
46. See id. art. 65.1, 65.2.
47. See generally Dispute Settlement Understanding.
48. See id. art. 3.7.
49. Daphne Yong-d'Hervé, Implementation and Administration of TRIPS and Dispute Settlement, in INTELLECTUAL PROPERTY & INTERNATIONAL TRADE: A GUIDE TO THE URUGUAY ROUND TRIPS AGREEMENT 72, 77 (1996).
50. See Dispute Settlement Understanding art. 2.1.
51. Id. art. 4.2.
52. See id. art. 4.11.
53. See id. art. 4.7.
54. Id. art. 8.
55. Id. art. 10.
56. Id. art. 17.
57. Id.
58. See id.
59. See Yong-d'Hervé, supra note 46, at 77.
60. Dispute Settlement Understanding art. 21.
61. Id. art. 21.3.
62. See id. art. 21.3(c).
63. Id. art. 22.1.
64. Id. art. 22.2.
65. Id. art. 25.
66. Id. art. 25.2.
67. Id. art. 25.3.
68. Id. art. 25.4.
69. See BRONCKERS, supra note 15, at 211 (noting that the United States uses Section 301 of the 1974 Trade Act, and the European Union uses Regulation 2641/84, 1984 O.J. (L252) 1 as a tool of foreign policy to these ends).
70. See Dispute Settlement Understanding art. 23.
71. See discussion supra Part II.D.
72. See BRONCKERS, supra note 15 (citing specifically Dispute Settlement Understanding arts. 12.11, 4.10, 8.10 & 12.10).
73. All decisions are published on the WTO website; see http://www.wto.org/english/tratop_e/ dispu_e/distab_e.htm (last visited Oct. 3, 2001).
74. Assoc. Press, supra note 8, at B13.
75. See Rachel L. Swarns, AIDS Drug Battle Deepens in Africa, N.Y. TIMES, Mar. 8, 2001, at A1.
76. See Assoc. Press, supra note 8, at B13.
77. See Melody Petersen & Donald G. McNeil, Jr., Maker Yielding Patent in Africa for AIDS Drug. N.Y. TIMES, Mar. 15, 2001, at A1.
78. See generally Rosemary Sweeney, The U.S. Push for Worldwide Patent Protection for Drugs Meets the AIDS Crisis in Thailand: A Devastating Collision, 9 PAC. RIM L. & POL'Y J. 445, 446 (2000) (describing how trade policy has exacerbated the AIDS crisis in Thailand).
79. See id.
80. See id. at 446-47.
81. See id. at 451.
82. See id. at 458.
83. See id.
84. See Trade Act of 1974, Pub. L. No. 93-618, §§ 301-302, 88 Stat. 1978, 2041 (1975). See also Sweeney, supra note 75, at 459-60; BRONCKERS, supra note 15, at 211.
85. See Sweeney, supra note 75, at 458.
86. See Sheryl Gay Stolberg, Africa's AIDS War, N.Y. TIMES, Mar. 20, 2001, at A4.
87. See Swarns, supra note 72.
88. Donald G. McNeil, Jr., Selling Cheap 'Generic' Drugs, India 's Copycats Irk Industry, N.Y. TIMES, Dec. 1, 2000, at A1.
89. See id.
90. See id.
91. See id.
92. See Tina Rosenberg, Look at Brazil, N.Y. TIMES MAG., Jan. 28, 2001, at 58.
93. See Swarns, supra note 72, at A1.
94. See Sara M. Ford, Compulsory Licensing Provisions under the TRIPS Agreement: Balancing Pills and Patients, 15 AM. U. INT'L L. REV. 941, 952 (2000) (suggesting that South Africa institute a compulsory licensing scheme to deal with its AIDS epidemic).
95. See Rosenberg, supra note 89, at 52.
96. See Rachel L. Swarns, Drug Makers Drop South 'Africa Suit Over AIDS Medicine, N.Y. TIMES, Apr. 20, 2001, at A1.
97. See id.
98. See Swarns, supra note 72.
99. See Sheryl Gay Stolberg, Africa's AIDS War: Pressure for Affordable Medicine: 'If' Becomes 'When' for Patients. N.Y. TIMES, Mar. 10, 2001, at A1.
100. See Petersen & McNeil, supra note 74, at A1.
101. See Swarns, supra note 93.
102. See Petersen & McNeil, supra note 74, at A1.
103. See McNeil, supra note 85, at A1.
104. See id.
105. Id.
106. See id.
107. See discussion supra Part II.C for a description of the concessions made to developing countries that join the WTO.
108. See McNeil, supra note 85.
109. See id.
110. See id.
111. See Appellate Body Report, India - Patent Protection for Pharmaceutical and Agricultural Chemical Products, WT/DS50/AB/R (Dec. 19, 1997) [hereinafter Appellate Body Report on India]; Report of the Panel, India - Patent Protection for Pharmaceutical and Agricultural Chemical Products, WT/DS79/R (Aug. 24, 1998) [hereinafter Panel Report on India (E.C.)]. In brief, Article 70.8 requires India to (a) provide a means by which patent applications can be filed; (b) apply the criteria of patentability to the applications; and (c) provide patent protection to applications that meet the criteria in part (b). Article 70.9 requires India to grant exclusive marketing rights to products that are the subject of another WTO member's patent application. See TRIPS Agreement art. 70.
112. See Appellate Body Report, India - Patent Protection for Pharmaceutical and Agricultural Chemical Products, WT/DS50/AB/R (Dec. 19, 1997) [hereinafter Appellate Body Report on India]; Report of the Panel, India - Patent Protection for Pharmaceutical and Agricultural Chemical Products, WT/DS79/R (Aug. 24, 1998) [hereinafter Panel Report on India (E.C.)]. In brief, Article 70.8 requires India to (a) provide a means by which patent applications can be filed; (b) apply the criteria of patentability to the applications; and (c) provide patent protection to applications that meet the criteria in part (b). Article 70.9 requires India to grant exclusive marketing rights to products that are the subject of another WTO member's patent application. See TRIPS Agreement art. 70.
113. See Appellate Body Report, India - Patent Protection for Pharmaceutical and Agricultural Chemical Products, WT/DS50/AB/R (Dec. 19, 1997) [hereinafter Appellate Body Report on India]; Report of the Panel, India - Patent Protection for Pharmaceutical and Agricultural Chemical Products, WT/DS79/R (Aug. 24, 1998) [hereinafter Panel Report on India (E.C.)]. In brief, Article 70.8 requires India to (a) provide a means by which patent applications can be filed; (b) apply the criteria of patentability to the applications; and (c) provide patent protection to applications that meet the criteria in part (b). Article 70.9 requires India to grant exclusive marketing rights to products that are the subject of another WTO member's patent application. See TRIPS Agreement art. 70.
114. See Appellate Body Report on India, at 33-34.
115. See Panel Report on India (E.C), at 73.
116. Id. ("[T]he Panel's findings do not in any way foreshorten the transition period of until, at the latest, 1 January 2005 that India has for meeting its obligations under [the TRIPS Agreement].").
117. See Weissman, supra note 17, at 1112 (discussing four provisions in the TRIPS Agreement that would allow for public health licenses).
118. See Panel Report on Canada. Canada successfully argued that a provision in its Patent Law qualified under the TRIPS Agreement Article 30 exception to patent protection. See discussion infra Part IV.A.
119. TRIPS Agreement art. 30.
120. See Panel Report on Canada.
121. See Panel Report on India (E.C.), at 60-61. The Panel stated: It can thus be concluded that panels are not bound by previous decisions of panels or the Appellate Body even if the subject-matter is the same. . . . However, in the course of [settlement procedures], we will take into account the conclusions and reasoning in the Panel and Appellate Body reports. . . . Moreover . . . we should give significant weight to . . . the DSU, which stresses the role of the WTO dispute settlement system in providing security and predictability to the multilateral trading system, and to the need to avoid inconsistent rulings . . . . Id.
122. See Panel Report on Canada, at 169.
123. See id. at 16.
124. Id. at 2.
125. See id. at 16-25.
126. Id.
127. Id. at 146. According to the Panel's findings, the regulatory review process can take from one to two-and-a-half years to complete. Id. at 4.
128. Id. at 171, 174.
129. TRIPS Agreement art. 27.1.
130. Id. art. 28.1.
131. Panel Report on Canada, at 151.
132. Panel Report on Canada, at 152.
133. TRIPS Agreement art. 30.
134. Panel Report on Canada, at 158.
135. Id. (emphasis added).
136. See id. at 174.
137. id. at 2.
138. Id. at 9.
139. Id. at 16.
140. See id. at 174.
141. Id. at 156.
142. See id.
143. See id.
144. See id. at 156.
145. TRIPS Agreement art. 30.
146. See Panel Report on Canada, at 161.
147. See id.
148. Id. at 131.
149. See id.
150. See McNeil, supra note 85.
151. See Ford, supra note 91, at 945.
152. See Panel Report on Canada, at 13.
153. See Weissman, supra note 17, at 1111.
154. See id.
155. TRIPS Agreement art. 30.
156. See Panel Report on Canada, at 24.
157. See Panel Report on Canada, at 153.
158. TRIPS Agreement art. 7 (emphasis added).
159. See Panel Report on Canada, at 153.
160. TRIPS Agreement art. 8.
161. See Panel Report on Canada, at 153.
162. See id. at 154.
163. Panel Report on Canada, at 24-25.
164. TRIPS Agreement art. 30.
165. Id. at 164.
166. Id. at 9, 16.
167. Id. at 165.
168. TRIPS Agreement art. 8, as discussed supra Part IV.A.2.
169. Id.
170. Id.
171. TRIPS Agreement, preamble.
172. Id. at 156.
173. Id. at 161.
174. Id.
175. See Swarns, supra note 72, at A6.
176. See Barbara Crossette, Poor African Countries Lack Ways to Monitor Use of New AIDS Drugs. Experts Warn, N.Y. TIMES, Apr. 1, 2001, at A8.
177. Id.
178. See id.
179. Stolberg, supra note 96, at A4. Uwe Reinhardt, a healthcare economist at Princeton University, noted that "Africa is not known for benign, democratic leaders, let's be honest," and said that companies do not want "some potentate grabbing these drugs and reselling them within Africa for S25 a dose." Id.
180. See McNeil, supra note 85.
181. See Ford, supra note 91, at 968.
182. See id.