The High Price of “Free” Trade: U.S. Trade Agreements and Access to Medicines

World Trade Organization, Agreement on Trade-Related Aspects of Intellectual Property Rights, April 15, 1994, available at <http://www.wto.org/english/tratop_e/TRIPS_e/t_agm0_e.htm> (last visited February 19, 2013).

Yamane H. , Interpreting TRIPS: Globalisation of Intellectual Property Rights and Access to Medicines (Oxford: Hart Publishing, 2011): at 480; Drahos P. , “Four Lessons for Developing Countries from the Trade Negotiations over Access to Medicines,” Liverpool Law Review 28, no. 1 (2007): 11–39, at 20.

Sell S. K. , “TRIPS-Plus Free Trade Agreements and Access to Medicines,” Liverpool Law Review 28, no. 1 (2007): 41–75, at 51; Drahos P. , “Intellectual Property and Pharmaceutical Markets: A Nodal Governance Approach,” Temple Law Review 77, no. 2 (2004): 401–424, at 406 et seq.

See, for example, Flood C. M. and Epps T. D. , “Have We Traded Away the Opportunity for Innovative Health Care Reform? The Implications of the NAFTA for Medicare,” McGill Law Journal 47, no. 4 (2002): 747–790; Howard M. J. , “Canada's healthcare protectionism violates NAFTA, Trade Agreement,” 2009, available at <http://www.jdsupra.com/post/document-Viewer.aspx?fid=36e4af3a-fc55-44e5-88bc-90ea9aa5453d> (last visited February 19, 2013).

Smith R. D. Correa C. , and Oh C. , “Trade, TRIPS, and Pharmaceuticals,” The Lancet 373, no. 9664 (2009): 684–91, at 684.

It is also argued that extending intellectual property rights actually creates barriers to trade. See Mitchell A. D. and Voon T. , “TRIPS,” in: Bethlehem D. Van Damme I. Neufeld R. , and McRae D. , eds., The Oxford Handbook on International Trade Law (Oxford: Oxford University Press, 2009): 186–208, at 187 et seq; and Lindstrom B. , “Scaling Back TRIPS-Plus: An Analysis of Intellectual Property Provisions in Trade Agreements and Implications for Asia and the Pacific,” NYU Journal of International Law and Politics 42, no. 3 (2010): 917–980, at 921.

See Mitchell and Voon , supra note 6, at 188.

See WTO, supra note 1.

See Drahos , supra note 2, at 16.

Smith Reid S. , “Introduction to Intellectual Property, Trade and Access to Medicines,” in “Our Health, Our Right: The Roles and Experiences of PLHIV Networks in Securing Access to Generic ARV Medicines in Asia,” Asia Pacific Network of People Living with HIV/AIDS, 2010, APN+, 9–22, at 12 et seq.

This provision is frequently misrepresented by the pharmaceutical industry as representing the only circumstances in which TRIPS permits compulsory licensing as opposed to the circumstances in which the requirement to seek a voluntary license may be waived.

See Smith , supra note 5, at 686.

Subsequent to the November 2001 Declaration on the TRIPS Agreement and Public Health, WTO Members adopted instruments on TRIPS and public health in 2002 – extending until 2016 the deadline for LDCs to provide patent protection for pharmaceuticals; in 2003 – introducing a “waiver” removing limitations on exports under compulsory license to countries without domestic manufacturing capacity; in 2005 – the related Protocol Amendment giving effect to the waiver and replacing the August 2003 decision; and in 2007, 2009 and 2011, extending the deadline for the adoption of the amendment.

See Drahos , supra note 2, at 33; Sell S. K. , “TRIPS Was Never Enough: Vertical Forum Shifting, FTAs, ACTA and TPP,” Journal of Intellectual Property Law 18 (2011): 447–478.

See Drahos , supra note 2, at 33.

Chorev N. , “Political and Institutional Manoeuvres in International Trade Negotiations: The United States and the Doha Development Round,” in Blaas W. and Becker J. , eds., Strategic Arena Switching in International Trade Negotiations (Aldershot: Ashgate Publishing, 2007): At 56.

Oxfam International, All Costs, No Benefits: How TRIPS-Plus Intellectual Property Rules in the US-Jordan FTA affect Access to Medicines, Oxfam Briefing Paper, 2007, at 2; see Drahos , supra note 2, at 33.

See Sell , supra note 14, at 448.

't Hoen E. , The Global Politics of Pharmaceutical Monopoly Power: Drug Patents, Access, Innovation and the Application of the WTO Doha Declaration on TRIPS and Public Health (The Netherlands: AMB Publishers, 2009): at 70 et seq; see Smith Reid , supra note 10, at 16 et seq; Krikorian G. P. and Szymkowiak D. M. , “Intellectual Property Rights in the Making: The Evolution of Intellectual Property Provisions in US Free Trade Agreements and Access to Medicine,” Journal of World Intellectual Property 10, no. 5 (2007): 388–418, at 393.

Evergreening refers to the variety of strategies employed by patent holders to prolong monopolies by securing additional patent protection for minor and arguably trivial product variations, thereby delaying generic competition, and facilitating maintenance of monopoly pricing.

Despite referring specifically to delay in the “marketing approval process,” this is generally interpreted as the delay between the granting of the patent and the entry to market, rather than within the regulatory evaluation process per se. Delays in generic market entry are usually taken to refer to the period of time between the discovery and patenting of the molecular entity and its entry to market, which because of the long lead times required for clinical trials can be 10–15 years. However, in reality the marketing approval process only begins with the submission of an application dossier to the regulatory agency.

See Sell , supra note 3, at 61.

See Sell , supra note 3, at 62. Patent linkage mechanism fundamentally alter the role and remit of the regulatory agency, forcing them to take into account factors not relevant to the safety, efficacy or quality of the product for which marketing approval is being sought, and requiring them to adjudicate the existence and/or relevance of patents on reference products.

Abbott F. M. , “The Doha Declaration on the TRIPS Agreement and Public Health and the Contradictory Trend in Bilateral and Regional Free Trade Agreements. Occasional Paper 14,” (Geneva: Quaker United Nations Office, 2004), at 8, available at <http://www.quno.org/geneva/pdf/economic/Occassional/TRIPS-Public-Health-FTAs.pdf> (last visited February 19, 2013).

The Drug Price Competition and Patent Term Restoration Act 1984, Public Law 98–417 a.k.a. the Hatch-Waxman Act.

See Article 126 of Directive (EC) No 2001/83, and Article 81(2) of Regulation (EC) No. 726/2004. See also Kumar A. , “Patent or Patient, Link Them Properly: ‘Patent Linkage and Competition’ (A Comparative Study),” ExpressO, 2012, available at <http://works.bepress.com/ashutosh_kumar/1> (last visited February 19, 2013). Where individual EU member states have introduced forms of patent linkage, they have been instructed to desist.

See Sell , supra note 3, at 60.

In some jurisdictions, it is possible for a generic manufacturer to submit a literature-based application, relying on efficacy and safety data already in the public domain rather than on the dossier submitted by the originator. A literature-based submission is not possible unless protection is limited to undisclosed data. This distinguishes a data “protection” from a data “exclusivity” regime.

See Sell , supra note 3, at 61; World Health Organization. Intellectual Property Rights and Access to Medicines: A South-East Asia Perspective on Global Issues (New Delhi: WHO Regional Office for South-East Asia, 2008): at 28.

Outterson K. , “Disease-Based Limitations on Compulsory Licenses Under Articles 31 and 31bis,” Boston University School of Law Working Paper No. 09-26, 2009, at 1.

See Sell , supra note 3, at 62.

For further empirical studies, see Shaffer E. R. and Brenner J. E. , “A Trade Agreement's Impact on Access to Generic Drugs,” Health Affairs 28, no. 5 (2009): W957-w968. For modelled analyses, see Kessomboon N. Limpanonont J. Kulsomboon V. Maleewong U. Eksaengsri A. , and Paothong P. , “Impact on Access to Medicines from TRIPS-Plus: A Case Study of Thai-US FTA,” Southeast Asian Journal of Tropical Medicine and Public Health 41, no. 3 (2010): 667–677. See also Impact of the EU-Andean Trade Agreement on Access to Medicines in Colombia, Fundacion IFARMA, 2009, Fundacion Mision Salud, Minas Gerais, at 34 and Impacto de 10 Años de Proteccio de Datos en Medicamentos en Colombia, Fundacion IFARMA, 2012.

See Oxfam International, supra note 17, at 5.

See 't Hoen , supra note 19, at 72.

The provision requires notification of generic application to patent holder only.

See Oxfam International, supra note 17, at 7.

Id., at 2.

Id., at 15 et seq.

See 't Hoen , supra note 19, at 72.

Office of the U.S. Trade Representative, Final Bipartisan Agreement on Trade Policy: Intellectual Property Provisions, Fact Sheet, May 11, 2007, available at <http://www.ustr.gov/sites/default/files/uploads/factsheets/2007/asset_upload_file945_11283.pdf> (last visited February 19, 2013).

See Smith , supra note 5, at 688.

See Office of the U.S. Trade Representative, supra note 40.

See, for example, Sell , supra note 3, at 57–64, and Krikorian and Szymkowiak , supra note 19.

Australia US Free Trade Agreement, Chapter 17 – Intellectual Property Rights, available at <http://www.dfat.gov.au/fta/ausfta/final-text/chapter_17.html> (last visited February 19, 2013).

Drahos P. Lokuge B. Faunce T. Goddard M. , and Henry D. , “Pharmaceuticals, Intellectual Property and Free Trade: The Case of the US-Australia Free Trade Agreement,” Prometheus 22, no. 3 (2004): 243–257, at 249 et seq.

For example, AUSFTA required “at least” five years of test data protection, but undisclosed test data were already protected for five years under s25 of the Therapeutic Goods Act 1989. Parallel importation was already prohibited by the Australian Patents Act, and up to five years of patent term extension had been in place since 1998.

Outterson K. , “Agony in the Antipodes: The Generic Drug Provisions of the Australia–USA Free Trade Agreement,” Journal of Generic Medicines 2, no. 4 (2005): 316–326, at 321.

This is a particularly interesting example of the template approach. The text of article 17.10.2 of the agreement specifies – consistent with the template – that the parties will provide an additional three years of data protection for new uses and new indications of a known product. However, a sometimes overlooked footnote permits non-adherence to this provision by Australia, thus limiting the data protection obligation to five years – as already provided for by s25 of the Therapeutic Goods Act 1989.

Therapeutic Goods Act 1989, s26b, available at <http://www.comlaw.gov.au/Details/C2012C00355> (last visited February 19, 2013).

Harvey K. J. Faunce T. A. Lokuge B. , and Drahos P. , “Will the Australia-United States Free Trade Agreement Undermine the Pharmaceutical Benefits Scheme?” Medical Journal of Australia 181, no. 5 (2004): 256–259, at 257–258.

Faunce T. A. Bai J. , and Nguyen D. , “Impact of the Australia-US Free Trade Agreement on Australian Medicines Regulation and Prices,” Journal of Generic Medicines 7, no. 1 (2010): 18–29, at 20.

Public Citizen, Health Gap, I-MAK and Third World Network, Analysis of the Leaked U.S. Paper on Eliminating Pre-grant Opposition, Public Citizen Briefing Memo, 2011, available at <http://www.citizen.org/documents/analysis-of-leaked-US-paper-on-eliminating-pregrant-opposition.pdf> (last visited February 19, 2013).

While literature-based applications are uncommon, they can be a potential workaround where data exclusivity provisions would otherwise preclude the approval of a generic produced under compulsory license.

Annex 2C to the Goods Chapter of the Australia United States Free Trade Agreement, available at <https://www.dfat.gov.au/fta/ausfta/final-text/chapter_2.html> (last visited February 19, 2013).

Trade Promotion Authority Act, Public Law No. 107-210 (2002); Lopert R. and Rosenbaum S. , “What Is Fair? Choice, Fairness and Transparency in Access to Prescription Medicines in the United States and Australia,” Journal of Law, Medicine & Ethics 35, no. 4 (2007): 643–656, at 650.

Pharmaceutical Research and Manufacturers of America, PhRMA Special 301 Submission, 2003, available at <http://www.cptech.org/ip/health/phrma/301-03/2003-PhRMA-301.pdf> (last visited February 19, 2013), at 107 et seq.

The use of comparative cost effectiveness evaluation to inform drug reimbursement and coverage decisions is sometimes referred to as a “fourth hurdle,” reflecting the additional obstacle to be overcome by a drug company (over and above the requirement to demonstrate safety, efficacy, and quality for marketing approval) before funding of a new product within a public program.

Office of the U.S. Trade Representative, “National Trade Estimate Report on Foreign Trade Barriers,” at 11, available at <<http://www.ustr.gov/archive/Document_Library/Reports_Publications/2004/2004_National_Trade_Estimate/2004_NTE_Report/Section_Index.html> (last visited February 5, 2013).

See PhRMA, supra note 56, at 107, et seq.

Kyl J. , Pharmaceutical Price Controls Abroad: An Unfair Trade Policy, United States Senate Republican Policy Committee: Washington, November 2003; International Trade Administration, Pharmaceutical Price Controls in OECD Countries: Implications for U.S. Consumers, Pricing, Research and Development, and Innovation, U.S. Department of Commerce 2004, available at <http://www.ita.doc.gov/td/health/Drug-PricingStudy.pdf> (last visited February 5, 2013).

Sainsbury P. , “Australia-United States Free Trade Agreement and the Australian Pharmaceutical Benefits Scheme,” Yale Journal of Health Policy, Law & Ethics IV, no. 2 (2004): 387–400, at 392.

Id., at 395.

See Harvey , supra note 50.

Outterson K. , “The U.S.-Australia Free Trade Agreement's Unfortunate Attack on Good Healthcare Policy,” Comments to the House Ways and Means Committee, June 22, 2004, available at <http://ita.doc.gov/td/health/phRMA/Outterson%20Response1.pdf> (last visited February 19, 2013); see Drahos , supra note 46, at 251.

See Harvey , supra note 63, at 257.

See Lopert and Rosenbaum , supra note 55, at 651; Aldonas G. D. , “Testimony of Under Secretary of Commerce for International Trade Grant D Aldonas before a Joint Session of the Senate Finance Committee, Subcommittees on Health and Trade,” April 27, 2004, available at <http://www.finance.senate.gov/imo/media/doc/042704gatest.pdf> (last visited February 5, 2013). Prices of many PBS medicines have in fact decreased since the AUSFTA, albeit neither as a result of, nor despite, the provisions of the Agreement. The text of the AUSFTA contains no provision that could credibly mandate changes to the pricing of PBS medicines. Subsequently, there have been claims that changes introduced in 2007 under a program of “PBS Reforms” (including the splitting of the formulary into two separate categories of drugs) were driven by US industry interests through the Medicines Working Group. However, changes to generics pricing as a result of PBS reform have no influence on pricing at the point of formulary listing. The PBS Reforms were the culmination of a well-publicized longitudinal domestic policy debate driven by concerns that Australian generic medicines prices were much higher than in comparable jurisdictions. This resulted in modifications to the application of reference pricing to facilitate more rapid and larger price reductions on generic medicines, but no changes to pricing at the time of formulary listing – and thus no capacity to increase prices of new medicines.

See Lopert and Rosenbaum , supra note 55, at 650. To date only two PBS Independent Reviews have been completed. On both occasions the independent external reviewer supported the PBAC's view and the PBAC found no reason to revise its original recommendation.

See Australian Government, Department of Health and Ageing, available at <http://www.health.gov.au/internet/main/publishing.nsf/Content/health-ausfta-sops> (last visited February 19, 2013).

In Australia DTCA is prohibited under s42 of the Therapeutic Goods Act 1989.

See Lopert and Rosenbaum , supra note 55.

Yang B. Bae E. , and Kim J. , “Economic Evaluation and Pharmaceutical Reimbursement Reform in South Korea's National Health Insurance,” Health Affairs 27, no. 1 (2008): 179–187, at 180; Bae E. Y. and Lee E. K. , “Pharmacoeconomic Guidelines and Their Implementation in the Positive List System in South Korea,” Value in Health 12, Supp. 3 (2009): S36–S41, at S40.

See Yang , supra note 71, at 180 et seq.

Id., at 181.

See Yang , id., at 183; Bae and Lee , supra note 71, at S36.

Yang , id., at 184; Bae and Lee , supra note 71, at S36.

See Yang , id., at 182; Ha D. Choi Y. Kim D. U. Chung K. H. , and Lee E.-K. , “A Comparative Analysis of the Impact of a Positive List System on New Chemical Entity Drugs and Incrementally Modified Drugs in South Korea,” Clinical Therapeutics 33, no. 7 (2011): 926–932, at 926. The A-7 agreement required South Korea to use external reference pricing for new medicines, based on the average ex-factory prices in the U.S., U.K., Germany, France, Italy, Switzerland, and Japan – despite South Korea having a far lower per capita GDP than any of these countries. The effect of the 1999 agreement was to substantially increase prices of medicines, with most patented products reported to become more expensive than in the A-7 countries as a share of average income, and some even in absolute terms. See Flynn S. M. , Access to Medicines Issues in the U.S.-Korea Free Trade Negotiations, Program on Information Justice and Intellectual Property, Washington College of Law, 2007.

Kim C.-Y. , “Health Technology Assessment in South Korea,” International Journal of Technology Assessment in Health Care 25, Supp. 1 (2009): 219–223, at 222.

See Flynn , supra note 76.

See Yang , supra note 71, at 186.

See Ha , supra note 76, at 927.

Id., at 927.

Id., at 931.

Flynn S. and Palmedo M. , “Initial Response to the Korus FTA Pharmaceuticals and IP Chapters,” Program on Information Justice and Intellectual Property, American University Washington College of Law, 2007, at 1.

Id.

Of 91 submissions made to HIRA by the end of 2008, 28 (31%) were appealed by manufacturers and the appeals resulted in changes to the outcomes for 12 of these. See Park E. S. Lim S. H. Choi H. W. , and Lee S. M. , “Evaluation on the First 2 Years of the Positive List System in South Korea,” Health Policy 104, no. 1 (2012): 32–39, at 34.

A committee comprising trade officials whose role is oversight of the entire agreement and its implementation.

Gilbody S. Wilson P. , and Watt I. , “Benefits and Harms of Direct to Consumer Advertising: A Systematic Review,” Quality & Safety in Health Care 14 (2005): 246–250, at 246; Frosch D. L. Grande D. Derjung M. , and Kratitz R. L. , “A Decade of Controversy: Balancing Policy with Evidence in the Regulation of Prescription Drug Advertising,” Health Policy and Ethics 100 (2010): 24–32; Toop L. Richards D. Dowell T. Tilyard M. Fraser T. , and Arroll B. , Direct To Consumer Advertising of Prescription Drugs in New Zealand: For Health or for Profit? Report to the Minister of Health Supporting the Case for a Ban on DTCA (Christchurch: University of Otago, 2003), available at <http://www.haiweb.org/campaign/DTCA/DTCAinNZcaseforaban2003.pdf> (last visited February 4, 2013).

Flood C. M. . “The Evidentiary Burden for Overturning Government's Choice of Regulatory Instrument: The Case of Direct-to-Consumer Advertising of Prescription Drugs,” University of Toronto Law Journal 60, no. 2 (2010): 397–424.

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See Park , supra note 85, at 33.

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Gleeson D. H. Tienhaara K. S. , and Faunce T. A. , “Challenges to Australia's National Health Policy from Trade and Investment Agreements,” Medical Journal of Australia 196, no. 5 (2012): 354–356, at 354.

See Kelsey , supra note 92.

Trans Pacific Partnership, “Intellectual Property Rights Chapter: Draft – February 10, 2011,” available at <http://keionline.org/sites/default/files/tpp-10feb2011-us-text-ipr-chapter.pdf> (last visited February 19, 2013); Trans Pacific Partnership, Intellectual Property Rights Chapter –Selected Provisions, September 2011, available at <http://www.citizenstrade.org/ctc/wp-content/uploads/2011/10/TransPacificIP1.pdf> (last visited February 19, 2013).

Pharmaceutical Research and Manufacturers of America (PhRMA), PhRMA Urges President Obama to Secure an Ambitious Trans-Pacific Partnership Agreement, Media Release, May 8, 2012, available at <http://www.phrma.org/media/releases/phrma-urges-president-obama-secure-ambitious-trans-pacific-partnership-agreement> (last visited February 19, 2013).

Flynn S. Kaminski M. Baker B. , and Koo J. , “Public Interest Analysis of the US TPP Proposal for an IP Chapter, Draft Version 1.3, December 6, 2011,” Program on Information Justice and Intellectual Property, American University Washington College of Law, at 3.

See Krikorian and Szymkowiak , supra note 19, at 399.

See Trans-Pacific Partnership, supra note 97.

See Flynn , supra note 99, at 20.

Kiliç B. and Maybarduk P. , “Comparative Analysis of the United States' TPPA Intellectual Property Proposal and Australian Law,” Public Citizen, August 2011 (updated March 2012), at 3.

Id., at 4.

See Flynn , supra note 99, at 26.

See Trans Pacific Partnership, supra note 97.

Biologics Price Competition and Innovation Act of 2009, Sec. 7002, Approval Pathway for Biosimilar Biological Products, available at <http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/UCM216146.pdf> (last visited February 19, 2013).

Zuhn D. , “President's Latest Budget Proposal Seeks Decrease of Data Exclusivity Period and Elimination of Pay-for-Delay Agreements,” Patent Docs Biotech and Pharma Patent Law and News Blog, February 21, 2012, available at <http://www.patentdocs.org/2012/02/presidents-latest-budget-proposal-seeks-decrease-of-data-exclusivity-period-and-elimination-of-pay-f.html> (last visited February 4, 2013).

USTR Signals Support for Longer Data Protection for Biologics in TPP, Inside U.S. Trade, 27 May, 2011, available at <http://tinyurl.com/as54vqv> (last visited February 4, 2013; registered users only). Twelve years of data exclusivity for biologics would actually result in substantially longer protection than the 4 years of data exclusivity and 12 years of market exclusivity currently in place in the U.S.

See Kiliç and Maybarduk , supra note 103, at 10; Flynn , supra note 99, at 33.

See, for example, the 2009 UN Human Rights Council Report recommended that “developed countries should not encourage developing countries and LDCs to enter into TRIPS-Plus FTAs and should be mindful of actions which may infringe upon the right to health.” Human Rights Council, Promotion and Protection of All Human Rights, Civil, Political, Economic, Social and Cultural Rights, Including the Right to Development, Report of the Special Rapporteur on the Right of Everyone to the Enjoyment of the Highest Attainable Standard of Physical and Mental Health, U.N. General Assembly A/HRC/11/1231, March 2009, available at <http://daccess-dds-ny.un.org/doc/UNDOC/GEN/G09/127/11/PDF/G0912711.pdf?OpenElement> (last visited February 19, 2013).

Médecins Sans Frontières, TPP Issue Brief: How the Trans-Pacific Partnership Agreement Threatens Access to Medicines, September 2011, available at <http://www.doctorswithout-borders.org/press/2011/MSF-TPP-Issue-Brief.pdf> (last visited February 19, 2013).

Oxfam International, “Oxfam Analysis of US Proposals for IP and Pharmaceutical Pricing Provisions in Trans-Pacific Partnership Agreement Negotiations,” available at <http://infojustice.org/download/tpp/tpp-civil-society/Oxfam-Paper-on-the-TPPA-leaked-IP-chapter.pdf> (last visited February 19, 2013).

See, for example, Australian Federation of AIDS Organisations, “NGOs Call on Government to Prioritise Access to Medicines over Trade Interests,” available at <http://www.afao.org.au/news/archive/ngos-call-on-government-to-prioritise-access-to-medicines-over-trade-interests> (last visited February 5, 2013); Vietnam Network of People Living with HIV/AIDS (VNP+), VNP+ Declaration on the Trans-Pacific Free Trade Agreement & Access to Medicines in Vietnam, February 29, 2012, available at <http://www.citizen.org/Vietnam-Trans-Pacific-FTA#!prettyPhoto[iframe]/0/> (last visited February 19, 2013); Australian Fair Trade and Investment Network and Public Health Association of Australia, United States Undermines Access to Medicines in Australia and Pacific, Media Release, October 25, 2011, available at <http://infojustice.org/wp-content/uploads/2011/09/AFTINET-and-PHA-Statement-10252011.pdf> (last visited February 19, 2013); Center for Policy Analysis on Trade and Health, Medicine and Public Health Groups Oppose U.S. Trans-Pacific Partnership: Threats to Tobacco Control, Affordable Medicines. AMA, AAP, ACPM, AMSA, CPATH Call for New Direction in Trade Talks, September 15, 2011, available at <http://www.reducedrugprices.org/read.asp?news=6253> (last visited March 6, 2013).

Kiliç B. and Maybarduk P. , “Comparative Analysis of the United States' TPFTA Intellectual Property Proposal and Vietnamese Law,” Public Citizen, 2011, available at <http://www.citizen.org/documents/Comparative-Analysis-of-the-US-TPFTA-IP-Proposal-and-Vietnamese-Law.pdf> (last visited February 19, 2013); Kiliç B. and Maybarduk P. , “Comparative Analysis of the United States' TPFTA Intellectual Property Proposal and Malaysian Law,” Public Citizen, September 2011 (Updated December 2011), available at <http://www.citizen.org/documents/Malaysia-Chart.pdf> (last visited February 19, 2013); Public Citizen, “Comparative Analysis of the U.S. Intellectual Property Proposal and Peruvian Law, 2011,” available at <http://www.citizen.org/documents/Comparative-Analysis-of-the-US-Intellectual-Property-Proposal-and-Peruvian-Law.pdf> (last visited February 19, 2013); Kiliç B. and Maybarduk P. , “Comparative Analysis of the United States' TPPA Intellectual Property Proposal and Chilean Law,” Public Citizen, April 2012, available at <http://www.citizen.org/documents/Chart-TPPA-and-Chilean-Law1.pdf> (last visited February 19, 2013).

Id. ( Kiliç and Maybarduk , “Comparative Analysis of the United States' TPFTA Intellectual Property Proposal and Vietnamese Law”).

Nguyen A. T. Knight R. Mant A. Cao Q. M. , and Auton M. , “Medicine Prices, Availability and Affordability in Vietnam,” Southern Med Review 2, no. 2 (2009): 2–9.

United Nations Development Program, Human Development Report, 2009, UNDP, New York, at 177, available at <http://hdr.undp.org/en/media/HDR_2009_EN_Complete.pdf> (last visited February 20, 2013).

UNAIDS, “Vietnam Overview Country Situation Analysis,” available at <http://www.unaids.org/en/regionscountries/countries/vietnam/> (last visited February 20, 2013).

UNAIDS, “Report on the Global AIDS Epidemic, 2010,” at 98, available at <http://www.unaids.org/globalreport/global_report.htm> (last visited February 20, 2013).

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See Flynn , supra note 99, at 7; Oxfam International, supra note 113, at 1; Médecins Sans Frontières, supra note 112, at 2.

See Krikorian and Szymkowiak , supra note 19, at 389.

Trans Pacific Partnership. Transparency Chapter – Annex on Transparency and Procedural Fairness for Healthcare Technologies, June 22, 2011, available at <http://www.citizenstrade.org/ctc/wp-content/uploads/2011/10/TransPacificTransparency.pdf> (last visited February 20, 2013).

See Flynn , supra note 99, at 5.

See Trans Pacific Partnership, supra note 124.

See Flynn , supra note 99, at 52.

See Gleeson , supra note 95.

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Trans Pacific Partnership, “U.S. Textual Proposal for the TBT Chapter: Annex on Pharmaceutical Products,” March 4, 2010, available at <http://www.citizenstrade.org/ctc/wp-content/uploads/2011/10/TransPacificTBTwMedicalAnnexes.pdf> (last visited February 20, 2013); and “U.S. Textual Proposal for the TBT Chapter: Annex on Medical Devices,” March 4, 2010, available at <http://www.citizenstrade.org/ctc/wp-content/uploads/2011/10/TransPacificTBTwMedicalAnnexes.pdf> (last visited March 5, 2013).

Trans Pacific Partnership, Draft Investment Chapter, June 2012, available at <http://www.citizenstrade.org/ctc/wp-content/uploads/2012/06/tppinvestment.pdf> (last visited February 20, 2013).

See Gleeson , supra note 95; Porterfield M. C. and Byrnes C. R. , “Philip Morris v. Uruguay: Will Investor-State Arbitration Send Restrictions on Tobacco Marketing Up in Smoke?” Investment Treaty News 4, no. 1 (2011): 3–5.

Gleeson , supra note 95, at 355; Tienhaara K. , Investor State Dispute Settlement in the Trans-Pacific Partnership Agreement: Submission to the Department of Foreign Affairs and Trade, 19 May 2010, available at <http://www.dfat.gov.au/fta/tpp/subs/tpp_sub_tienhaara_100519.pdf> (last visited Apr. 29, 2012).

Id. (Tienhaara), at 21.

A current example is a $300 million action by French pharmaceutical company Servier against the Polish government – while details of the case are scant, it appears to relate to the review of medicines by regulatory bodies in the process of Poland's accession to the EU. See Peterson L. E. , “France's Second Largest Pharmaceutical Company Quietly Pursues Arbitration against Republic of Poland,” Investment Arbitration Reporter, August 19, 2011, available at <http://www.iareporter.com/articles/20110819_9> (last visited April 30, 2012; subscribers only). Other health-related ISDS cases have involved pharmaceutical regulation and drug patents (e.g., Signa v. Canada, Apotex v. USA), health care services (e.g., Centurion Health v Canada) and a range of environmental health issues such as potable water, food contamination, pesticides, and other environmental health contaminants. See International Investment Arbitration and Public Policy website, available at <http://www.iiapp.org/> (last visited February 20, 2013). Eli Lilly has also indicated its intention to commence investor-state action against the Canadian Government for invalidating a drug patent – see Public Citizen, Fact Sheet: U.S. Pharmaceutical Corporation Uses NAFTA Foreign Investor Privileges Regime to Attack Canada's Medicine Patent Policy, Demand $100 Million for Denial of a Patent (Washington, D.C.: Public Citizen, 2013).

The South Korean Supreme Court apparently recommended renegotiation of the KORUS ISDS provision as early as June 2006, citing concerns over the capacity for such a mechanism to infringe national and judicial sovereignty and the potential distortion of state public policy that could result from administrative bodies assessing and reviewing government policies. The South Korean government recently announced that it would be seeking to renegotiate the investment-related provisions in the KORUS FTA with the US within 90 days of its effective date of March 15, 2012. See “Supreme Court recommends renegotiation of ISD clause,” The Hanyoreh, April 26, 2012, available at <http://www.bilaterals.org/spip.php?article21397> (last visited February 20, 2013).

See Krikorian and Szymkowiak , supra note 19, at 405.

For a list of ITAC Committees and members, see <http://www.keionline.org/node/1362> (last visited February 20, 2013).

See <http://www.mfat.govt.nz/Trade-and-Economic-Relations/2-Trade-Relationships-and-Agreements/Trans-Pacific/1-TPP-Talk/0-TPP-talk-29-Nov-2011.php> (last visited February 20, 2013).

See Flynn , supra note 99, at 6; Cox K. , Inconsistencies between the U.S. Proposal for the IP Chapter of the TPPA and U.S. Law, Knowledge Ecology International, August 31, 2011, available at <http://keionline.org/sites/default/files/TPPA_USplus_30Aug2011.pdf> (last visited February 20, 2013).

See Flynn , id.

Inside US Trade – 12/03/2012. Groser: NZ seeking reasonable compromises on PHARMAC, GIs. Posted 3 December 2012.

See Hoen , supra note 19, at 79.

Id.

Correa C. M. , “Intellectual Property Rights and Inequalities in Health Outcomes,” in Labonté R. Schrecker T. Packer C. , and Runnels V. , eds., Globalization and Health: Pathways, Evidence and Policy (New York: Routledge, 2009): At 263–288, at 267. A 2006 report by the U.S. Government Accountability Office found that between 1993 and 2004, pharmaceutical research and development expenditure increased by 147%, while marketing applications for “new molecular entities” (NME) rose by only 7% during the same period. See Government Accountability Office, New Drug Development: Science, Business, Regulatory, and Intellectual Property Issues Cited as Hampering Drug Development Efforts, GAO-07-49, November 2006, available at <http://www.gao.gov/new.items/d0749.pdf> (last visited February 20, 2013).

See 't Hoen , supra note 19, at 81.

Kyle M. K. and McGahan A. M. , “Investments in Pharmaceuticals Before and After TRIPS. Review of Economics and Statistics,” NBER Working Paper No. 15468, October 2009, available at <http://www.nber.org/papers/w15468.pdf> (last visited February 20, 2013).

Key recommendations of the CEWG included a proposal for a binding global convention requiring both developed and developing countries to spend 0.01% of GDP on R&D directed at drugs needed by developing countries. See World Health Organization, Report of the Consultative Expert Working Group on Research and Development: Financing and Coordination. April 2012, available at <http://www.who.int/phi/cewg_report/en/index.html> (last visited March 5, 2013). Despite opposition from the U.S., the 65th World Health Assembly adopted a resolution in May 2012 to begin a process of developing concrete proposals and actions to implement the CEWG report. See 65th World Health Assembly, Agenda Item 13.4, Consultative Expert Working Group on Research and Development: Financing and Coordination: Draft Resolution, May 25, 2012, available at <http://keionline.org/sites/default/files/Item13.14_AdvanceDraftResolution.pdf> (last visited February 20, 2013).

Young R. A. and DeVoe J. E. , “Who Will Have Health Insurance in the Future? An Updated Projection,” Annals of Family Medicine 10, no. 2 (2012): 156–162; Himmelstein D. U. Thorne D. Warren E. , and Woolhandler S. , “Medical Bankruptcy in the United States, 2007: Results of a National Study,” American Journal of Medicine 122, no. 8 (2009): 741–746.

OECD Health Data 2011, available at <http://www.oecd.org/document/16/0,3746,en_2649_37407_2085200_1_1_1_37407,00.html> (last visited February 20, 2013).

Serafini M. W. , “Drug Prices: A New Tack,” National Journal 36, no. 16 (2004): 1176–1182.

See Kyl , supra note 60. Those countries failing to meet US expectations for standards of IP protection are “named and shamed” each year in the USTR's Special 301 Reports. Described as “an annual review of the global state of intellectual property rights (IPR) protection an enforcement, conducted by the Office of the United States Trade Representative…(the report) reflects the Administration's resolve to encourage and maintain effective IPR protection and enforcement worldwide,” available at <http://www.ustr.gov/sites/default/files/2012%20Special%20301%20Report_0.pdf> (last visited February 20, 2013). The reports also devote special attention to countries whose pharmaceutical reimbursement programs do not meet industry approval. See also <http://keionline.org/ustr/special301> (last visited February 20, 2013).

Kyl J. , Senator Kyl's Senior Bulletin, June 2004, at 2, available at <http://kyl.senate.gov/constit_center/newsletter/0604_newsletter.pdf> (last visited February 20, 2013); United States Department of Commerce, Pharmaceutical Price Controls in OECD Countries: Implications for U.S. Consumers, Pricing, Research and Development, and Innovation, December 2004, available at <http://www.ita.doc.gov/drug-pricingstudy> (last visited February 20, 2013).

See Lopert and Rosenbaum , supra note 55.

Blouin C. , “Trade Policy and Health: From Conflicting Interests to Policy Coherence,” Bulletin of the World Health Organization 85, no. 3 (2007): 169–173.

See WHO and Government of South Australia, Adelaide Statement on Health in All Policies, Report from the International Meeting on Health in All Policies, Adelaide 2010, available at <http://www.who.int/social_determinants/hiap_statement_who_sa_final.pdf> (last visited February 20, 2013).