Special 301 of the Trade Act of 1974 and global access to medicines

Journal of Generic Medicines

Volumn 7, Issue 4, 2010, Pages 309-333

  Flynn, Sean M ^a  

^a AMERICAN UNIVERSITY   (United States)

Author keywords

access to medicine; Special 301; TRIPS; United States trade representative; World Trade Organization

Indexed keywords

GENERIC DRUG;

DEVELOPING COUNTRY; DRUG INDUSTRY; DRUG MANUFACTURE; ECONOMIC ASPECT; GOVERNMENT REGULATION; HEALTH CARE ACCESS; HEALTH CARE NEED; HEALTH CARE POLICY; HUMAN RIGHTS; INTERNATIONAL RELATIONS; LAW ENFORCEMENT; PATENT; PUBLIC HEALTH; REIMBURSEMENT; REVIEW; UNITED STATES;

EID: 78649234639     PISSN: 17411343     EISSN: 17417090     Source Type: Journal    
DOI: 10.1057/jgm.2010.24     Document Type: Review

References (145)

1. That is, policies that go beyond the minimum standards required by the World Trade Organization agreement on Trade-Related Aspects of Intellectual Property Rights.
2. Drahos, P. and Braithwaite, J. (2002) Information Feudalism: Who Owns the Knowledge Economy? London, UK: Earthscan, p. 85.
3. See generally Bhagwati, J. and Patrick, H.T. (eds.) (1993) Aggressive Unilateralism, pp. 18-26
4. Drahos and Braithwaite, supra; Lowenfeld, A.F. (2002) International Economic Law, 1st edn., p. 46 (discussing weak GATT enforcement rules)
5. Sell, S. (2003) Private Power, Public Law: The Globalization of Intellectual Property Rights (discussing the general history of the creation of the WTO).
6. USC 2411(a)-(c) (describing authorized sanctions as including suspension of trade agreements, the imposition of tariffs or restrictions on imported goods, and the withdrawal of Generalized System of Preferences (' GSP ') benefi ts for developing countries).
7. See (2008) Guide to United States Customs and Trade Laws after the Customs Modernization Act, 3rd edn. p. 150.19 U.S.C. § 2411(d)(3)(B)(i)(II) .19 U.S.C. § 2242(a) (listing identifi cation criteria);
8. see also, § 2242(e) (requiring Trade Representative to publish a list in the Federal Register).
9. U.S.C. § 2242(b)(1)(C) (specifying that ' In identifying priority foreign countries under subsection (a)(2) of this section, the Trade Representative shall only identify those foreign countries that are not entering into good faith negotiations, or making signifi cant progress in bilateral or multilateral negotiations '. (emphasis added)).9. 19 USC 2242(b)(1)(A). 19 USC 2242(b)(1)(B). 19 USC 2242(b)(3).
10. Glick L A. (2008) Guide to United States Customs and Trade Laws ajter the Customs Modernization Act, 3rd edn. pp. 150-151, (explaining the ' great deal of discretion ' USTR has to defi ne infringements).
11. Youssef H. (1999) Special and Differential Treatment for Developing Countries in the WTO. South Centre Trade-related Agenda, Development and Equity (T.RA.D.E.). Working Papers No. 2, http://www.southcentre.org/index. php?option=com-content & view=article & id=283% 3Aspecial-and- differential-treatment-for-developing-countries-in-the-wto & Itemid=1 & lang=en.
12. Bayard, T. and Elliot, K. (1994) Reciprocity and Retaliation in US Trade Policy. Washington DC: Published by Institute for International Economics, p. 189.
13. Correa, C. (2007) Guidelines for the Examination of Pharmaceutical Patents, Developing a Public Health Perspective. WHO, ICTSD, UNCTAD Working Paper (January 2007) (noting that at least 50 countries lacked pharmaceutical patents before the initiation of the Uruguay round of trade negotiations in 1986).
14. Balasubramaniam, K. (1987) Pharmaceutical patents in developing countries: Policy options. Economics & Political Weekly 22: 103-120 (explaining lack of international obligations on scope of patents at the time).
15. Bayard and Elliott, supra, at pp. 187-193
16. (noting that US-imposed duties on imported Brazilian goods cost Brazil approximately $ 39 million); see also § 19 USC 2411(a)(3) (stating that penalties under Section 301 are supposed to ' be devised so as to affect goods or services of the foreign country in an amount that is equivalent in value to the burden or restriction being imposed by that country on United States commerce. ').
17. See id.; New York Times. (1989) Brazil-US dispute set for GATT 22 February, http://www.nytimes.com/1989/02/22/business/brazil-us-dispute-set-for- gatt.html.
18. Drahos and Braithwaite, supra, at p. 103.
19. Harris, D. (2008) The honeymoon is over: The US-China WTO intellectual property complaint. Fordham International Law Journal 32: 96, 101 (hereinafter Harris I)
20. Harris, D. (2006) Carrying a good joke too far: TRIPS and treaties of adhesion. University of Pennsylvania Journal of International Economic Law 27:681, 735 (hereinafter Harris II) (explaining that in 1992, the US suspended India's GSP benefi ts (valued at $ 60 million). India's resolve was weakened in opposing the TRIPS, in light of a pragmatic issue of retaining good trade relations with the United States).
21. Harris II, supra, at p. 735.
22. Bayard and Elliot, at p. 207
23. Marrakesh agreement establishing the World Trade Organization, 15 April 1994, Annex 1C, Art. 8, Legal Instruments-Results of the Uruguay Round, Vol. 31, 33 I.L.M. 81 (1994) (hereinafter TRIPS).
24. Understanding on rules and procedures governing the settlement of disputes, 15 April 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 2, Legal Instruments-Results of the Uruguay Round, 33 I.L.M. 1125 (1994) (hereinafter DSU)
25. DSU Article 23(2) 23.2(a), Annex 2, Legal instruments-Results of the Uruguay Round, 33 I.L.M. 1125 (1994) (hereinafter DSU). Trade Act of 1974, 19 U.S.C. § 2242(d)(4). Research by Mike Palmedo, American University Washington College of Law Program on Information Justice and Intellectual Property (2010).
26. Argentina (WTO member since 1995) was identifi ed as PFC in 1994 (before WTO establishment), but US sanctions against Argentina became effective in 1996 (50 per cent GSP reduction). Drahos and Braithwaite, supra, at p. 100. Panel Report, United States-Sections 301-310 of the Trade Act of 1974, ¶ 7.89, WT/DS152/R (22 December 1999) (hereinafter Section 301 Panel Report).
27. DSU, supra. See Administrative Procedures Act 5 U.S.C. § 551(7) (defi ning ' adjudication ' as any ' agency process for the formulation of an order ' determining rights and responsibilities based on past conduct). The adjudication is ' informal ' because the governing statute does not require that the process be ' on the record after opportunity for an agency hearing ', which would trigger heightened procedural protections. Id. at § 554(a). 19 U.S.C. § 2242(d)(3). Section 301 Panel Report, supra.
28. Flynn, S., Hollis, A. and Palmedo, M. (2009) An economic justifi cation for open access to essential medicine patents in developing countries. The Journal of Law, Medicine & Ethics 37: 184
29. See, for example, Report of the Commission on Intellectual Property Rights, Integrating Intellectual Property Rights and Development Policy, p. 155 (2002)
30. Report of the Commission on Intellectual Property Rights Intellectual Property and Development, Lessons from Recent Economic Research, p. 215 (C. Fink and K.E. Maskus (eds.) 2005)
31. Stiglitz, J., Intellectual-Property Rights and Wrongs, http://www.project-syndicate.org/commentary/stiglitz61/English.
32. See TRIPS, supra, Art. 8 (expressing the overriding principles that countries remain free to ' adopt measures necessary to protect public health ' and to take measures ' to prevent the abuse of intellectual property rights '). See Section 301 Panel Report, supra.
33. t'Hoen, E.F.M. (2009) The global politics of pharmaceutical monopoly power drug patents, access, innovation and the application of the WTO Doha Declaration on TRIPS and Public Health
34. Sell, S. (2002) TRIPS and the access to medicines campaign. Wisconsin International Law Journal 20:481
35. Weissman, R. (1996) 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 17:1069. (Pubitemid 126406046)
36. Exec. Order No. 13,155, 65 Fed. Reg. 30,521 (10 May 2000).
37. Press Release, Office of the United States Trade Representative, USTR Releases Super 301, Special 301 and Title VII Reports (1 May 2000), http://hongkong.usconsulate.gov/uploads/images/YXuL-DZ9fkSv3SDt1zgbMg/ usinfo-301-00-30.pdf
38. t'Hoen, supra, see also Sell, supra, Weissman, A long strange TRIPS, supra.
39. World Trade Organization, Ministerial Declaration of 14 November 2001, WT/MIN(01)/DEC/1, 41 I.L.M. 755, ¶ 4 (2002) (hereinafter Doha Declaration) (emphasis added)
40. see Correa, C. (2002) Implications of the Doha Declaration on the Trips Agreement and Public Health, Health Economics and Drugs Series, No. 012, WHO, http://apps.who.int/medicinedocs/en/d/Js2301e/(discussing the legal implications of the Doha Declaration).
41. See United States House of Representatives, Committee on Government Reform-Minority Staff Special Investigations Division, Trade Agreements and Access to Medications under the Bush Administration, prepared for Rep. Henry A. Waxman (hereinafter Waxman Report) (June 2005)
42. Weissman, R., TRIPS-Plus Provisions in Trade Agreements: Consequences for Public Health (Essential Action, Working Paper), http://www.essentialaction. org/access/uploads/tripsplusprovisions.doc.
43. US Government Accountability Office (2007) Report to Congressional Requesters: U.S. Trade Policy Guidance on WTO Declaration on Access to Medicines May Need Clarifi cation, Publication No. GAO-07-1198 at p. 28 (hereinafter GAO Access Report) (quoting administration offi cials).
44. WHO. (2001) Globalization, TRIPS and access to pharmaceuticals. WHO/EDM/2001.2 at pp. 4-5 (March 2001) (stating ' Poorer populations in developing countries should not be expected to pay the same price as do the wealthy for newer essential drugs. TRIPS-compliant mechanisms can be used to lower drug prices. ').
45. WHO. (2006) Report of the Commission on Intellectual Property Rights, Innovation and Public Health. April, p. 145 (hereinafter 2006 CIPIH Report).
46. WHO. (2008) Global strategy and plan of action on public health, innovation and intellectual property of the sixty-fi rst World Health Assembly. WHA61.21, element 5.2.c, 24 May (hereinafter Global Strategy and Plan of Action) http://www.who.int/gb/ebwha/pdf-fi les/A61/A61-R21-en.pdf
47. CESCR General Comment No. 14: The Right to the Highest Attainable Standard of Health, ¶ 2, E/C.12/2000/4 (11 August 2000)
48. See The Right to Life, U.N. GAOR Human Rights Comm., 37th Sess., Supp. No. 40, at Gen. Comment No. 6, ¶ 5, U.N. Doc. A/37/40 (1982); Concluding Observations of the Human Rights Committee: Peru, ¶ ¶ 13, 15, U.N. Doc. CCPR/C/79/Add.72 (1996).
49. Universal Declaration of Human Rights, G.A. Res. 217, U.N. GAOR, 3d Sess., U.N. Doc. A/810 (1948) (hereinafter Universal Declaration of Human Rights) (noting that Art. 22 protects ' the economic, social and cultural rights indispensable for his dignity and the free development of his personality '; Art. 25 protects ' the right to a standard of living adequate for the health of himself and of his family, including medical care and necessary social services. ').
50. See U.N. Human Rights Council (UNHRC), Report of the Special Rapporteur on the Right of Everyone to the Enjoyment of the Highest Attainable Standard of Physical and Mental Health, ¶ 27, U.N. Doc. A/HRC/11/12 (31 March 2009) (prepared by Anand Grover)
51. UNHRC, Report of the Special Rapporteur on the Right of Everyone to the Enjoyment of the Highest Attainable Standard of Physical and Mental Health, ¶ 63, U.N. Doc. A/63/263 (11 August 2008)
52. U.N. Econ. & Soc. Council (ECOSOC), Human Rights and Intellectual Property: Substantive Issues Arising in the Implementation of the International Covenant on Economic, Social and Cultural Rights, 27th Sess., ¶ 12, U.N Doc. E/C. 12/2001/15 (14 December 2001);
53. ECOSOC, Sub-Comm. on the Promotion and Protection of Human Rights, Report of the High Commissioner: The Impact of the Agreement on Trade-Related Aspects of Intellectual Property Rights on Human Rights, ¶ ¶ 27-28, E/CN.4/Sub.2/2001/13 (27 June 2001). Cf. UNHCR, Commission on Human Rights Resolution: Access to medication in the context of pandemics such as HIV/AIDS, Tuberculosis and Malaria, E/CN. 4/2003/29 (22 April 2003).
54. See UNHCR, Comm. on the Rights of the Child, Concluding Observations: Thailand, ¶ 58(f), CRC/C/THA/CO/2 (17 March 2006) (admonishing Thailand to ' [e]nsure that regional and other free trade agreements do not have a negative impact on the enjoyment of the right to health ')
55. UNHCR, Comm. on the Rights of the Child, Concluding Observations: Peru, ¶ ¶ 48-49, CRC/C/PER/CO/3 (14 March 2006)
56. UNHCR, Comm. on the Rights of the Child, Concluding Observations: Ecuador, Concluding Observations, ¶ 21, CRC/C/15/Add.262 (13 September 2005)
57. UNHCR, Comm. on the Rights of the Child, Concluding Observations: Nicaragua, ¶ 16, CRC/C/15/Add.265 (21 September 2005)
58. UNHCR, Comm. on the Rights of the Child, Concluding Observations: Philippines, ¶ 59, CRC/C/15/Add.259 (3 June 2005) (recommending that the State uses ' all the fl exibilities reaffi rmed by the Doha Declaration to ensure access to affordable medicines ')
59. UNHCR, Comm. on the Rights of the Child, Concluding Observations: Chile, ¶ 59, E/C.12/1/Add.105 (26 November 2004) (encouraging Chile ' to provide greater access to generic medicine making use of the fl exibility clauses permitted in [TRIPS] ')
60. UNHCR, Comm. on the Rights of the Child, Concluding Observations: Ecuador, ¶ 55, E/C.12/1/Add.100 (7 June 2004) (' strongly urges the State party to make extensive use of the fl exibility clauses permitted in [TRIPS] in order to ensure access to generic medicine ')
61. UNHCR, Comm. on the Rights of the Child, Concluding Observations: Botswana, ¶ 20, CRC/C/15/Add.242 (3 November 2004)
62. UNHCR, Comm. on the Rights of the Child, Concluding Observations: El Salvador, ¶ ¶ 47-48, CRC/C/15/Add.232 (30 June 2004)
63. UNHCR, Comm. on the Rights of the Child, Concluding Observations: Uganda, CCPR/CO/80/UGA (4 May 2004).
64. See Denmark, Summary Record, E/C.12/2004/SR.37, ¶ 7 (16 November 2004).
65. Hunt, P. (2006) Report to the General Assembly, ¶ 63, A/61/338 (13 September).
66. See Consumer Project on Technology, Trade Promotion Authority and HIV/AIDS, http://www.cptech.org/ip/health/trade/kennedy.html.
67. Waxman Report, supra, at p. ii.
68. Letter from Rep. Henry Waxman, United States House of Representatives, et al to The Honorable Susan Schwab, United States Trade Representative (20 June 2007), http://waxman.house.gov/News/DocumentSingle.aspx?DocumentID=153595.
69. http://waysandmeans.house.gov/Media/eNewsLetter/5-11-07/ 07%2005%2010%20New%20Trade%20Policy%20Outline.pdf http://www.ustr.gov/sites/ default/files/uploads/factsheets/2007/asset-upload-file127-11319.pdf
70. S. Res. 241, 110th Cong. (2007)
71. H.Res. 525, 110th Cong. (2007).
72. See also Letter from Rep. Henry Waxman, United States House of Representatives, et al to The Honorable Susan Schwab, United States Trade Representative (9 April 2008), http://waxman.house.gov/UploadedFiles/letter- special-301 04-09-08.pdf (urging that in Special 301 ' countries should not be cited for the use of compulsory licenses or other fl exibilities in accordance with international trade rules ').
73. See Press Release, The White House, Presidential Statement on the Global Health Initiative (5 May 2009), http://www.whitehouse.gov/the-press- offi ce/Statement-by-the-President-on-Global-Health-Initiative/, accessed 1 July 2010 (describing the President's global AIDS program as guided by the principle that ' [t]he world is interconnected, and that demands an integrated approach to global health ' that supports ' the health and dignity of people everywhere '
74. Office of the US Global AIDS Coordinator, US Department of State. (2008) The Power of Partnerships: Fourth Annual Report to Congress on PEPFAR. February http://www.pepfar.gov/press/fourth-annual-report/, accessed 1 July 2010.
75. See Press Release, President's Emergency Plan for AIDS Relief Increasing the Availability of Safe, Effective, Low-cost Generic Medications (January 2009), http://www.pepfar.gov/press/108120.htm, accessed 1 July 2010 (claiming PEPFAR ' supports the increased availability of safe, effective, low-cost, and generic antiretroviral drugs (ARVs) in the developing world ').
76. Press Release, The Offi ce of the President-Elect, The Obama-Biden Plan to Combat Global HIV/AIDS, http://change.gov/pages/the-obama-biden- plan-to-combat-global-hiv-aids, accessed 1 July 2010.
77. Office of the United States Trade Representative, Executive Offi ce of the President. (2010) 2010 Special 301 Report. 30 April, p. 3 (hereinafter 2010 Special 301 Report).
78. Trade Act of 1974, 19 U.S.C. § 2242(b)(1)(A). 19 U.S.C. § 2242(b)(1)(B). 19 U.S.C. § 2242(b)(3). USTR Office of Intellectual Property and Innovation has a total of eight staff as verifi ed over a phone inquiry on 9 October 2009.
79. Drahos and Braithwaite, supra, at p. 94 (describing USTR's ' symbiotic ' reliance on industry submissions). 19 U.S.C. § 2242(b)(2)(B).
80. See Submissions Concerning Special 301, http://www.regulation.gov (choose ' Read Comments ' then enter ' USTR 2010-0003 ' in ' Keyword or ID ').
81. Essential Action, U.S. Civil Society Platform on Trade-related Intellectual Property and Access to Medicines Issues (2009) http://www. essentialaction.org/access/uploads/IP-MedsPlatformMay2009.pdf accessed 1 July 2010.
82. Office of the United States Trade Representative, Executive Offi ce of the President. (2002) 2002 Special 301 Report, p. 5 (hereinafter 2002 Special 301 Report).
83. Office of the United States Trade Representative, Executive Offi ce of the President. (2009) 2009 Special 301 Report, p. 6 (hereinafter 2009 Special 301 Report).
84. -2010 Special 301 Report, supra, at pp. 12-13.
85. -2009 Special 301 Report, supra, at p. 17 (noting that each of the 10 countries on the Priority Watch List is targeted for such a complaint as are 10 of the Watch List countries and Paraguay, identifi ed as a Section 306 monitoring case. In all but one of the entries (Israel), this vague language complaining of unidentifi ed ' lack of protection ' is used nearly verbatim with no explanation of what specifi cally is inadequate in the country's laws. For the Israel submission, the report specifi cally states that USTR considers 5 years of data exclusivity to be required, rather than the ' effective period ' of 3-4 years provided in Israel's law).
86. See World Medical Association. (1964) Declaration of Helsinki-Ethical principles for medical research involving human subjects. 18th WMA General Assemb. Art. 20, June (stating ' [p]hysicians may not participate in a research study involving human subjects unless they are confi dent that the risks involved have been adequately assessed and can be satisfactorily managed. Physicians must immediately stop a study when the risks are found to outweigh the potential benefi ts or when there is conclusive proof of positive and benefi cial results '. Repetition of clinical trials on human subjects would therefore violate international ethical standards for clinical trials, which forbid doctors to continue experiments on humans ' when there is conclusive proof of positive and benefi cial results '.)
87. see also Global Strategy and Plan of Action (committing to ' [p]romote ethical principles for clinical trials involving human beings as a requirement of registration of medicines and health-related technologies, with reference to the Declaration of Helsinki, and other appropriate texts, on ethical principles for medical research involving human subjects, including good clinical practice guidelines '.).
88. TRIPS Art. 39.3 specifi cally states: Members, when requiring as a condition of approving the marketing of pharmaceutical or of agricultural chemical products that utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use
89. Test data must be protected only if (1) national authorities require its submission; (2) it is undisclosed, that is, not already public (as many clinical trial results in the United States are by virtue of state and local clinical trial registry laws); and (3) it concerns a new chemical entity, that is, the undisclosed data are ' the result of signifi cant investment ', proof which could be required.
90. See Correa, supra, at pp. 41-47.
91. See Correa, supra at p. x.
92. Correa, supra at p. 5
93. Correa, supra at p. 5.
94. See also Musungu, S.F. and Oh, C. (2005) The use of TRIPS by developing countries: Can they promote access to medicine? Commission on Intellectual Property Rights, Innovation and Public Health, Study 4C, August, pp. 65-67
95. Rius-Sanjuan, J., Love, J. and Weissman, R. (2006) Protection of pharmaceutical test data: A policy proposal, Consumer Project on Technology, November, http://www.cptech.org/ip/health/data/CPTech-Test-Data.pdf
96. In the United States, the data originator obtains 5 years of data exclusivity for a new chemical entity and an additional 3 years for marketing approvals of new uses, new formulations or new dosages that require the submission of new clinical trial data. In Europe, the data originator obtains 10 years of data exclusivity and can obtain an additional, one-time-only 1-year extension for registering a signifi cant improvement.
97. See, for example, Baker, B. (2008) Ending drug registration apartheid-Taming data exclusivity and patent/registration linkage. American Journal of Law and Medicine 34: 303-344.
98. European Commission Directorate General for Enterprise and Industry. (2006) Letter from Martin Teberger, Head of Unit for Consumer Goods to the European Generic Pharmaceuticals Association, 20 February http://wcl.american. edu/pijip/go/eu02202006 (stating ' [t]he European pharmaceutical legislation does not foresee any exception in case of emergency situation or in case a compulsory patent license has been granted by an EU Member State ').
99. See Musungu and Oh, supra at pp. 65-67 (surveying countries).
100. Cf. Correa, supra, at p. xi (' This approach emphasizes that the registration of products should not erect barriers to otherwise legitimate competition. It holds, instead, that the registration system should promote price competition and access to more affordable medicines'.).
101. See Correa, supra at p. 53.
102. Correa, C. and Yusuf A. (1998) Intellectual property and international trade, the TRIPs agreement
103. Gervais, D. (1998) TRIPS agreement-Drafting history and analysis, pp. 182-183.
104. See Pharmaceutical Research and Manufacturers of America (PhRMA) Special 301 Submission 2009 (hereinafter 2009 PhRMA Submission), http://www.ipophil.gov. ph/ipenforcement/phrma- submission.pdf (stating that TRIPS requires ' a data exclusivity regime which prevents regulatory authorities from prematurely allowing generic producers to rely on or otherwise use the originator's proprietary data to gain approval of copies of the originator's drug ', and cannot be met through)
105. USTR 2003 Special 301 Report at pp. 4-5 (' the TRIPS Agreement recognizes that the original applicant should be entitled to a period of exclusivity during which second-comers may not rely on the data that the innovative company has created to obtain approval for their copies of the product '). Elsewhere, USTR has proclaimed that ' any other ' interpretation of Article 39.3 ' would be inconsistent with logic and the negotiating history of the provision '. Offi ce of the General Counsel, USTR, the protection of undisclosed test data in accordance with TRIPS Article 39.3 (May 1995), http://apps.who.int/medicinedocs/ en/d/Jh3009ae/11.html).
106. Waxman Report, supra, at p. 7
107. Letter from members of the house ways and means committee, United States House of Representatives, to Robert Zoellick, President of the World Bank (26 January 2005), http://www.cpath.org/sitebuildercontent/sitebuilderfi les/congressguatemalatest-data-secrecy-letter1-05.pdf.
108. World Health Organization Commission on Intellectual Property Rights, Innovation and Public Health. (2006) Public health, innovation and intellectual property rights. p. 126.
109. Federal Trade Commission (2002) Generic drug entry prior to patent expiration: An FTC study.
110. See also Weissman, R. (2002) The evergreen patent system: Pharmaceutical company tactics to extend patent protections. Multinational Monitor June 2002
111. Kaufman, M. (2006) Drug fi rms ' deals allowing exclusivity-Makers of generics being paid to drop patent challenges, FTC review fi nds. The Washington Post 25 April
112. Federal Trade Commission (2006) Agreements fi led with the Federal Trade Commission under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003: Summary of Agreements Filed in FY 2005-A Report by the Bureau of Competition, http://www.ftc.gov/os/2006/04/fy2005drugsettlementsrpt.pdf.
113. Waxman Report, supra, at p. 9.
114. -2009 Special 301 Report, supra, at p. 17.
115. -2010 Special 301 Report, supra, at p. 30.
116. Letter from US Ambassador Ralph L. Boyce to His Excellency, General Surayud Chulanont, Prime Minister of the Kingdom of Thailand, 20 July 2007, http://lists.essential.org/pipermail/ip-health/2007-August/011610.html.
117. -2009 Special 30w1 Report, supra, at p. 21.
118. -2010 Special 301 Report, supra, at p. 28.
119. -2010 Special 301 Report, supra, at 21-22
120. -2010 Special 301 Report, supra, at p. 31.
121. See Waxman Report, supra, at p. 8 (criticizing patent extensions that ' can work to delay access to low-cost generic drugs in developing nations '
122. New Trade Policy for America, p. 2, http://waysandmeans.house.gov/Media/ eNewsLetter/5-11-07/07%2005%2010%20New%20Trade%20 Policy%20Outline.pdf.
123. -2009 Special 301 Report, supra (requesting Israel ' amend its laws to increase the effective patent term extension given to pharmaceutical products to compensate for delays in the regulatory approval process '.)
124. TRIPS, supra, Art. 27(1)
125. See 2010 Report, supra, at p. 26 (India), p. 29 (Brazil), p. 36 (Philippines)
126. TRIPS, supra, Art. 51, n.14. ' For the purposes of this Agreement: (a) " counterfeit trademark goods " shall mean any goods, including packaging, bearing without authorization a trademark which is identical to the trademark validly registered in respect of such goods, or which cannot be distinguished in its essential aspects from such a trademark, and which thereby infringes the rights of the owner of the trademark in question under the law of the country of importation '
127. See 2010 Special 301 Report, supra, at p. 24 (Algeria cited for ' weak ' patents); p. 26 (India cited for needing ' stronger ' protection)
128. See 2009 Report at p. 31 (citing ' shortcomings in Paraguay's patent regime ').
129. Panel Report, Canada-Patent Protection of Pharmaceutical Products, WT/DS114 (17 March 2000)
130. Since late 2008, customs offi cials in the Netherlands, Germany and France have seized at least 20 shipments of legitimate generic medicines. Of the shipments, 19 were legally manufactured and exported from India and intended for developing countries where they could be legally imported. Patents did not exist on the medicines in either the country of origin or destination. These shipments were seized as a result of national implementation of an EU regulation that empowers border offi cials to classify and seize medicines as counterfeits if the customs offi cial determines (often at the direction of pharmaceutical companies) that the medicines violate territorial patents of the relevant EU country. The IP standards of the EU countries have been applied to medicines in-transit even though these medicines are not intended for domestic consumption in the EU. Medicines that were seized included a cardiovascular disease medicine (Losartan) intended for Brazil and a key antiretroviral medicine (Abacavir) purchased by the Clinton Foundation and intended for Nigeria. Without modifying or eliminating the EU regulation (or worse, expanding the regulation through new trade agreements), medicines supplied through US foreign assistance programs-such as PEPFAR-could be similarly affected
131. In the case of AIDS and other illnesses, an interruption in supply of medicines can lead to drug resistance-which harms not only the patient but the greater society effort to combat the disease
132. -2010 Special 301 Report, supra, at p. 14
133. -2009 Special 301 Report, supra, at pp. 7-8.
134. See Vermont State Senate Resolution 2006 J.R.S. 50 (urging USTR to ' pursue an exchange of Interpretive notes ' with Australia to formally ensure state Medicaid programs would not be covered by Annex 2(c)
135. Letter from Liz Figueroa and Sheila Kuehl, California State Senators, to USTR (16 February 2005)
136. Letter from National Legislative Association on Prescription Drugs, to USTR (26 May 2005) (warning about the dangers of the free trade agreement and asked for a binding interpretation that it did not cover US state programs); Letter from Washington Governor Christine Gregoire (13 March 2006) (expressing concerns over the FTA)
137. Letter from four Washington State Legislators to the Washington State Congressional Delegation (2 March 2006)
138. Letter from Meg Burton Cahill, Arizona State Senator, and Kevin Ryan, Connecticut State Representative, to Members of the House Ways and Means Committee Subcommittee on Trade (18 March 2007) (stating that legislators are ' extremely troubled by, and strongly oppose, USTR's efforts to alter public reimbursement formularies in the Korea FTA ')
139. National Legislative Association on Prescription Drug Prices (2007) Testimony before the Subcommittee on Trade of the House Committee on Ways and Means (20 March) (warning that the language applied to Medicaid programs would ' give pharmaceutical companies rights to block and delay implementation of the most important and proven medicine cost-control tools available '.)
140. Letter from Ginny Lyons, Vermont State Senator, and Kathleen Keenan, Vermont State Representative, to Senators Patrick Leahy and Bernard Sanders, and Representative Peter Welsh (18 April 2007) (asserting that ' Vermont uses a similar " positive list " approach [as Korea] ').
141. Testimony of Sean Fiil-Flynn on behalf of the Forum on Democracy and Trade, before the interagency hearing for the 2010 Special 301 Review (3 March 2010), http://www.wcl.american.edu/pijip/go/forum03032010
142. See Testimony of Jeff Kindler, Pfi zer CEO, before the Senate Finance Committee (15 July2008), http://media.pfi zer.com/fi les/news/kindler- testimony-sfc-071508.pdf accessed 17 February 2010).
143. A discussion with Prof John Barton, sponsored by PIJIP (19 February 2009), http://wcl.american.edu/pijip/go/barton, accessed 17 February 2010) (stating that the Pfi zer proposal includes as ' a trade goal the achievement of a sector-specifi c trade agreement ' that would ensure that high prices in wealthy countries subsidize lower prices for some populations in poor countries
144. -2010 Special 301 Submission of Groups Representing State Governments, http://www.wcl.american.edu/pijip/go/blog-post/pijip-represents-public-health- and-states-in-submissions-to-the-united-states-trade-representative.
145. Letter from Governor Baldacci to Secretary Sebelius and Ambassador Kirk (26 April 2010), http://www.wcl.american.edu/pijip/go/blog-post/governor- baldacci-writes-sebelius-on-special-301 (calling on the administration to ' reverse the previous administration's support for using trade policy to restrict governmental powers to control medicine prices ').