Hostname: page-component-8448b6f56d-qsmjn Total loading time: 0 Render date: 2024-04-18T10:15:58.480Z Has data issue: false hasContentIssue false
  • English
  • Français

Public Health and the Trans-Pacific Partnership Agreement

Published online by Cambridge University Press:  22 August 2014

Andrew D. MITCHELL Open the ORCID record for Andrew D. MITCHELL [Opens in a new window] ,
Tania VOON Open the ORCID record for Tania VOON [Opens in a new window]  and
Devon WHITTLE
Andrew D. MITCHELL
Affiliation:
University of Melbourne, Australiaa.mitchell@unimelb.edu.au
Tania VOON
Affiliation:
University of Melbourne, Australiatania.voon@unimelb.edu.au
Devon WHITTLE
Affiliation:
University of Melbourne, Australiadevonwhittle@gmail.com
Get access Rights & Permissions [Opens in a new window]

Abstract

The Trans-Pacific Partnership Agreement (TPP) has an ambitious agenda and could radically reshape trade in the Asia-Pacific. At the same time, TPP obligations have the potential to significantly restrict the ability of governments to regulate in the interests of public health. This paper examines the impact the TPP could have on two areas of public health regulation—tobacco control and access to medicines. It concludes that a number of legitimate concerns arise from the known content of the TPP, that the inclusion of a general health exception would be the preferable means of safeguarding the regulatory space of governments in relation to public health, and that the United States’ proposals for stronger intellectual property protections be resisted. With negotiations shrouded in secrecy, TPP parties’ desires to promote international trade and investment must not overshadow the need of governments to be able to implement sensible and effective public health policy.

Type
Articles
Information
Asian Journal of International Law , Volume 5 , Issue 2 , July 2015 , pp. 279 - 309
Copyright
Copyright © Asian Journal of International Law 2014 

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.)

Footnotes

†

Professor, Melbourne Law School, The University of Melbourne. Andrew is a member of the Australian Government's Expert Advisory Group on Plain Packaging of Tobacco Products (an unpaid position). We gratefully acknowledge the generous financial support provided for this independent research by the Australian National Preventive Health Agency (Grant ID 203MIT2011) and the Australian Research Council (Linkage Project LP120200028). Thank you also to James Munro and Elizabeth Sheargold for valuable research assistance and to Jessica Casben for editorial assistance at the proof stage. The opinions expressed here are our personal views as academics and are not necessarily shared by any government, employer, or other entity. Any errors or omissions are ours. This paper was largely finalized in November 2013.

‡

Professor and Associate Dean (Research), Melbourne Law School, The University of Melbourne; Former Legal Officer, Appellate Body Secretariat, World Trade Organization.

♯

Researcher, Melbourne Law School, The University of Melbourne; Legal Officer, Australian Attorney-General's Department.

References

1. FERGUSSON, Ianet al., “The Trans-Pacific Partnership Negotiations and Issues for Congress”, Report for Congress No R42694, Congressional Research Service, 17 June 2013Google Scholar, online: <http://www.fas.org/sgp/crs/row/R42694.pdf> at 2.

2. NOTTAGE, Luke, “Throwing the Baby Out with the Bathwater: Australia's New Policy on Treaty-Based Investor-State Arbitration and Its Impact in Asia” (2013) 37 Asian Studies Review 253 at 258Google Scholar.

3. See “Trans-Pacific Partnership Leaders Statement” (8 October 2013), online: <http://www.dfat.gov.au/fta/tpp/131008-tpp-leadership-statement.html>.

4. Office of the United States Trade Representative, “Joint Statement of TPP Ministers: Trans-Pacific Partnership Ministers Chart Path Forward on Key Issues and Confirm Next Steps on Japan's Entry (Press Release)” (20 April 2013), online: USTR <http://www.ustr.gov/about-us/press-office/press-releases/2013/april/joint-statement-tpp-ministers>.

5. Office of the United States Trade Representative, “Outlines of the Trans-Pacific Partnership Agreement (Fact Sheet)” (12 November 2011), online: USTR <http://www.ustr.gov/about-us/press-office/fact-sheets/2011/november/outlines-trans-pacific-partnership-agreement>.

6. See e.g. KELSEY, Jane, “How the Trans-Pacific Partnership Agreement Could Heighten Financial Instability and Foreclose Governments’ Regulatory Space” (2010) 8 New Zealand Yearbook of International Law 3Google Scholar.

7. FLYNN, Sean, “Law Professors Call for Trans-Pacific Partnership (TPP) Transparency” InfoJustice (9 May 2012)Google Scholar, online: InfoJustice <http://infojustice.org/archives/21137>.

8. Trans-Pacific Strategic Economic Partnership Agreement, 18 July 2005 (provisionally entered into force 1 May 2006; officially entered into force 28 May 2006).

9. Ibid.

10. Trans-Pacific Strategic Economic Partnership Agreement, 2 August 2005 (entered into force 12 July 2006).

11. Trans-Pacific Strategic Economic Partnership Agreement, 18 July 2005 (entered into force 8 November 2006).

12. Department of Foreign Affairs and Trade (Cth), “Update on the First Round of Trans-Pacific Partnership (TPP) Negotiations—A Strong Start” (10 December 2012), online: DFAT <http://www.dfat.gov.au/fta/tpp/100326-tpp-stakeholder-update-1.html>.

13. Office of the United States Trade Representative, “Round 17: Lima, Peru”, online: USTR <http://www.ustr.gov/trade-agreements/free-trade-agreements/trans-pacific-partnership/round-17-peru>.

14. See WILLIAMS, Brock, “Trans-Pacific Partnership (TPP) Countries: Comparative Trade and Economic Analysis”, Report for Congress No R42344, Congressional Research Service, 10 June 2013Google Scholar, online: FAS <http://www.fas.org/sgp/crs/row/R42344.pdf>: see Table A-1 for a full list of agreements between the TPP negotiating countries.

15. Outlines of the Trans-Pacific Partnership Agreement (Fact Sheet), supra note 5.

16. Ibid.

17. Kelsey, , supra note 6Google Scholar.

18. FAUNCE, Thomas and TOWNSEND, Ruth, “The Trans-Pacific Partnership Agreement: Challenges for Australian Health and Medicine Policies” (2011) 194 Medical Journal of Australia 83 at 83Google ScholarPubMed.

19. SALACUSE, Jeswald and SULLIVAN, Nicholas, “Do BITs Really Work? An Evaluation of Bilateral Investment Treaties and Their Grand Bargain” (2005) 46 Harvard International Law Journal 67 at 75Google Scholar.

20. ROJID, Farazet al., “No Coverage for Tobacco Industries with Regard to Tobacco-Control Measures—the Future of International Investment Agreements?” (2012) 9 Transnational Dispute Management 120 at 129Google Scholar.

21. See e.g. KURTZ, Jürgen, “Australia's Rejection of Investor-State Arbitration: Causation, Omission and Implication” (2012) 27 ICSID Review: Foreign Investment Law Journal 65 at 76−77CrossRefGoogle Scholar.

22. “Seoul not to Scrap Investor-State Dispute Mechanism in Korea-US FTA” Korea Times (22 February 2012), online: Korea Times <http://www.koreatimes.co.kr>.

23. Signed 17 December 1992, 32 ILM 289 and 605 (entered into force 1 January 1994).

24. KURTZ, Jürgen, “Review Essay: The Shifting Landscape of International Investment Law and Its Commentary” (2012) 106 American Journal of International Law 686 at 686CrossRefGoogle Scholar.

25. UNCTAD, World Investment Report 2013—Global Value Chains: Investment and Trade for Development (2013) 103−115Google Scholar.

26. Investor-State Dispute Settlement—Public Consultation: 16 May–9 July 2012 (2012) [1].

27. See <https://nafta-sec-alena.org/Default.aspx?tabid=95&language=en-US>.

28. See e.g. Apotex Holdings v. USA, Request for Arbitration, ICSID Case No ARB(AF)/12/1 (29 February 2012); Apotex v. USA (Award on Jurisdiction and Admissibility) (14 June 2013); Les Laboratoires Servier v. Poland (Final Award), Permanent Court of Arbitration (14 February 2012).

29. Melvin Howard v. Canada (Order for the Termination of the Proceedings and Award on Costs) (UNCITRAL Arbitration Rules, PCA Case No 2009-21, 2 August 2010).

30. Luke Eric PETERSEN, “US Businessmen are Latest to Bring Poland to International Arbitration” (28 September 2010) 3 Investment Arbitration Reporter (online).

31. Achmea (formerly Eureko) v. Slovak Republic (Award on Jurisdiction) (UNCITRAL Arbitration Rules, PCA Case No 2008-13, 26 October 2010); HICEE v. Slovak Republic (Partial Award) (UNCITRAL Arbitration Rules, PCA Case No 2009-11, 23 May 2011); HICEE v. Slovak Republic (Supplementary and Final Award) (UNCITRAL Arbitration Rules, PCA Case No 2009-11, 17 October 2011); Luke Eric PETERSEN, “UNCITRAL Tribunal Chaired by Christopher Greenwood Declines to Let Claimant Use MFN Clause to Detour Around Highly-Restrictive Arbitration Clause” (22 January 2013) 6 Investment Arbitration Reporter (online).

32. Chemtura Corporation v. Canada (Award) (UNCITRAL Arbitration Rules, Ad Hoc Tribunal, 2 August 2010); Dow Agrosciences LLC v. Canada, Notice of Arbitration under the UNCITRAL Arbitration Rules and NAFTA (31 March 2009); Dow Agrosciences LLC v. Canada, Settlement Agreement (25 May 2011).

33. Ethyl v. Canada (Award on Jurisdiction) (UNCITRAL Arbitration Rules, Ad Hoc Tribunal, 24 June 1998); Department of Foreign Affairs, Trade and Development, Ethyl Corporation v. the Government of Canada, online: <http://www.international.gc.ca/trade-agreements-accords-commerciaux/topics-domaines/disp-diff/ethyl.aspx?lang=eng>.

34. Gallo v. Canada (Award) (UNCITRAL Arbitration Rules, Ad Hoc Tribunal, 15 September 2011).

35. Citizens Trade Campaign, “Section B (‘Investment Chapter’)” (June 2012)Google Scholar, online: <http://www.citizenstrade.org/ctc/wp-content/uploads/2012/06/tppinvestment.pdf>.

36. Ibid., art. 12.17(1).

37. Ibid., art. 12.18.

38. See e.g. HARTEN, Gus VANet al. “Public Statement on the International Investment Regime” Osgood Hall Law School (31 August 2010)Google Scholar, online: Osgood Hall Law School <http://www.osgoode.yorku.ca/public-statement/documents/Public%20Statement%20%28June%202011%29.pdf>.

39. See e.g. GLEESON, Deborahet al., “Challenges to Australia's National Health Policy from Trade and Investment Agreements” (2012) 196 Medical Journal of Australia 354 at 355Google ScholarPubMed. See also SY, Deborah, “Warning: Investment Agreements are Dangerous to Your Health” (2011) 43 George Washington International Law Review 625Google Scholar; RIMMER, Matthew, “Plain Packaging for the Pacific Rim—Tobacco Control and the Trans-Pacific Partnership” in Tania VOON, ed., Trade Liberalization and International Co-operation: A Legal Analysis of the Trans-Pacific Partnership Agreement (Cheltenham: Edward Elgar, 2013), 75 at 89–95Google Scholar.

40. RIMMER, Matthew, “A Dangerous Investment: Australia, New Zealand and the Trans-Pacific Partnership” The Conversation (2 July 2012)Google Scholar, online: The Conversation <https://theconversation.com/a-dangerous-investment-australia-new-zealand-and-the-trans-pacific-partnership-7440>.

41. See e.g. Gleeson, , supra note 39 at 354–355Google Scholar; KELSEY, Jane, “The Trans-Pacific Partnership Agreement: A Gold-Plated Gift to the Global Tobacco Industry?” (2013) 39 American Journal of Law & Medicine 237 at 251Google ScholarPubMed.

42. Kelsey, , supra note 6 at 5Google Scholar; STUMBERG, Robert, “Safeguards for Tobacco Control: Options for the TPPA” (2013) 39 American Journal of Law & Medicine 382 at 396Google ScholarPubMed.

43. See e.g. Sharon TREAT et al., “An Open Letter from US State Legislators to Negotiators of the Trans-Pacific Partnership Urging the Rejection of Investor-State Dispute Settlement” Public Citizen (5 July 2012)Google Scholar, online: Public Citizen <http://www.citizen.org/documents/State-Legislators-Letter-on-Investor-State-and-TPP.pdf>; Van Harten et al., supra note 38.

44. Tobacco Plain Packaging Act 2011 (Cth).

45. Department of Health (Ireland), “Ireland Set to Become Second Country in the World to Introduce Plain Pack Cigarettes” (28 May 2013)Google Scholar, online: DOHC <http://www.dohc.ie/press/releases/2013/20130528.html>. See also Department of Health, “Tobacco Free Ireland: Report of the Tobacco Policy Review Group” (October 2013).

46. TURIA, Tariana, “Biennial Oceania Tobacco Control 2013” Beehive (23 October 2013)Google Scholar, online: Beehive <http://www.beehive.govt.nz/speech/biennial-oceania-tobacco-control-2013>: “our Government is committed to introducing plain packaging as part of our drive to Smokefree 2025”.

47. United Kingdom, Parliamentary Debates, House of Commons, 28 November 2013, col 25WS (Jane Ellison); United Kingdom Department of Health, “Independent Review of Standardised Packaging for Tobacco” (28 November 2013), online: DH <https://www.gov.uk/government/news/independent-review-of-standardised-packaging-for-tobacco>; The Scottish Government, “Tobacco Plain Packaging: Scottish Government to Press Ahead with Plans” (7 September 2013), online: SG <http://news.scotland.gov.uk/News/Tobacco-plain-packaging-3ce.aspx>.

48. Philip Morris Asia Ltd v. Australia (Permanent Court of Arbitration Case No 2012-12, UNCITRAL Arbitration Rules, ongoing).

49. Agreement Between the Government of Hong Kong and the Government of Australia for the Promotion and Protection of Investments, 15 September 1993, 1748 U.N.T.S. 385 (entered into force 15 October 1993).

50. Request for Arbitration: FTA Holdings SA (Switzerland) v. Uruguay (19 February 2010); Philip Morris Brands Sarl v. Uruguay, ICSID Case No ARB/10/7, Decision on Jurisdiction (2 July 2013). See also MCGRADY, Benn, “Implications of Ongoing Trade and Investment Disputes Concerning Tobacco: Philip Morris v. Uruguay” in Tania VOON et al., eds., Public Health and Plain Packaging of Cigarettes: Legal Issues (Cheltenham: Edward Elgar, 2012)Google Scholar, 173.

51. Agreement Between the Swiss Confederation and the Oriental Republic of Uruguay on the Reciprocal Promotion and Protection of Investments, 7 October 1988, 1976 U.N.T.S. 389 (entered into force 22 April 1991).

52. See e.g. GLEESON, Deborah and FRIEL, Sharon, “Emerging Threats to Public Health from Regional Trade Agreements” (2013) 381 The Lancet 1507 at 1508Google ScholarPubMed; RANALD, Patricia, “The Trans-Pacific Partnership Agreement: Contradictions in Australia and in the Asia Pacific Region” (2011) 22 The Economic and Labour Relations Review 81 at 92Google Scholar.

53. Productivity Commission, “Bilateral and Regional Trade Agreements: Productivity Commission Research Report” (2010) 271–4, online: <http://www.pc.gov.au/__data/assets/pdf_file/0010/104203/trade-agreements-report.pdf>.

54. Department of Foreign Affairs and Trade, “Gillard Government Trade Policy Statement: Trading Our Way to More Jobs and Prosperity” (April 2011), online: DFAT <http://www.acci.asn.au/getattachment/b9d3cfae-fc0c-4c2a-a3df-3f58228daf6d/Gillard-Government-Trade-Policy-Statement.aspx> at 14.

55. See e.g. MARTIN, Peter, “Marles Vows Not to Cave to US Pressure” Sydney Morning Herald (15 July 2013)Google Scholar, online: SMH <http://www.smh.com.au>.

56. Investment Chapter, supra note 35, Section B (ISDS), note 20 (in square brackets): “Section B does not apply to Australia or an investor of Australia. Notwithstanding any provision of this Agreement, Australia does not consent to the submission of a claim to arbitration under this Section.”

57. See e.g. BISHOP, Julie, “Free Trade Focus” On Line Opinion (28 March 2013)Google Scholar, online: OO <http://www.onlineopinion.com.au/view.asp?article=14855>. See also “Australia May be More Open to ISDS in TPP with Government Change” (15 March 2013) 31 Inside US Trade (online).

58. MARTIN, Peter, “Robb Stands Firm on Foreign Lawsuits” Sydney Morning Herald (23 September 2013)Google Scholar, online: SMH <http://www.smh.com.au/business/robb-stands-firm-on-foreign-lawsuits-20130922-2u7tv.html>.

59. See e.g. “New Australian Government Says No Position Yet on ISDS in TPP” (27 September 2013) 31 Inside US Trade (online). See also Rimmer, supra note 39 at 90–1.

60. Nottage, , supra note 2 at 258–261Google Scholar.

61. CHAISSE, Julien, “TPP Agreement: Towards Innovations in Investment Rule-Making” in Chin Leng LIM et al., eds., The Trans-Pacific Partnership (Cambridge: Cambridge University Press, 2012), 147 at 154Google Scholar.

62. Ibid.

63. Nottage, , supra note 2 at 269Google Scholar.

64. TRAKMAN, Leon, “Investor State Arbitration or Local Courts: Will Australia Set a New Trend?” (2012) 1 Journal of World Trade 83 at 91Google Scholar. See also Kurtz, , supra note 21 at 73Google Scholar.

65. Rojid, , supra note 20 at 129Google Scholar; Nottage, , supra note 2 at 263–264Google Scholar.

66. Investment Chapter, supra note 35, art. 12.2.

67. FOOKS, Gary and GILMORE, Anna, “International Trade Law, Plain Packaging and Tobacco Industry Political Activity: the Trans-Pacific Partnership” Tobacco Control (20 June 2013)Google Scholar, online: Tobacco Control <http://tobaccocontrol.bmj.com/content/early/2013/06/19/tobaccocontrol-2012-050869.full> at 4.

68. Cf. Maffezini v. Kingdom of Spain (Decision on Jurisdiction) (ICSID Arbitral Tribunal, Case No. ARB/97/7, 25 January 2000) [64]. See also Vannessa Ventures Ltd v. Venezuela (Award) (ICSID Arbitral Tribunal, Case No ARB(AF)/04/6, 16 January 2013) [133], where the Tribunal rejected an argument that attempted to apply a BIT's MFN provisions to the definition of “investment” to expand its coverage.

69. Investment Chapter, supra note 35, art. 12.5.2.

70. Cf. Australia-United States Free Trade Agreement, signed 18 May 2004, [2005] A.T.S. 1 (entered into force 1 January 2005), art. 11.5.2 [AUSFTA].

71. Investment Chapter, supra note 35, art. 12.6.2.

72. AUSFTA, supra note 70, annex 11-B.

73. Investment Chapter, supra note 35, annex 12-C, art. 4(b). See also alternative wording in the Investment Chapter's annex 12-D, art. 5: “Except in rare circumstances to which paragraph 4 applies, such measures taken in the exercise of a state's regulatory powers as may be reasonably justified in the protection of public welfare, including public health … shall not constitute and [sic] indirect expropriation … Non-discriminatory regulatory actions by a Party that are designed and applied to achieve legitimate public welfare objectives, such as the protection of public health … do not constitute indirect expropriation.”

74. Investment Chapter, supra note 35, art. 12.12.5.

75. Marrakesh Agreement Establishing the World Trade Organization, opened for signature 15 April 1994, 1867 U.N.T.S. 3 (entered into force 1 January 1995), annex 1C. See also MITCHELL, Andrew and VOON, Tania, “Patents and Public Health in the WTO, FTAs and Beyond: Tension and Conflict in International Law” (2009) 43 Journal of World Trade 571Google Scholar; World Trade Organization, “Intellectual Property Meeting Mulls Irish Tobacco Plan, Drug Tariffs, Sport, Non-violation” WTO News (10−11 October 2013)Google Scholar, online: WTO News <http://www.wto.org/english/news_e/news13_e/trip_10oct13_e.htm>.

76. Cameroon-Turkey Bilateral Investment Treaty (2012), art. 10(4).

77. See e.g. Canada-Jordan Foreign Investment Promotion and Protection Agreement (2009), arts. 17, 47; China-Japan-Republic of Korea Investment Agreement (2012) arts. 15, 20.

78. See e.g. Canada-Peru Bilateral Investment Treaty (2006), art. 16; Canada-Latvia Bilateral Investment Treaty (2009) arts. XII−XIII; Peru-China Free Trade Agreement (2009), art. 142.

79. India-Malaysia Comprehensive Economic Cooperation Agreement (2011), art. 12.2.5, annex 12-2.

80. GATT Doc LT/UR/A-1/A/1/GATT/2, signed 30 October 1947, as incorporated in the Marrakesh Agreement Establishing the World Trade Organization, opened for signature 15 April 1994, 1867 U.N.T.S. 3 (entered into force 1 January 1995), annex 1A.

81. Marrakesh Agreement Establishing the World Trade Organization, opened for signature 15 April 1994, 1867 U.N.T.S. 3 (entered into force 1 January 1995), annex 1B.

82. Canadian Model Agreement for the Promotion and Protection of Investments (2004), art. 10. See also e.g. Singapore-Jordan Bilateral Investment Treaty (2004), art. 18(b); Canada-Armenia Bilateral Investment Treaty (1997), art. XVII: 3(b).

83. Czech Republic-Singapore Bilateral Investment Treaty (1995), art. 11; India-Mauritius Bilateral Investment Treaty (1998), art. 11(3). See also Romania-Mauritius Bilateral Investment Treaty (2000) art. 2(1); New Zealand-Hong Kong Bilateral Investment Treaty (1995), art. 8(3) (emphasis added).

84. See generally CHAISSE, Julien, “Exploring the Confines of International Investment and Domestic Health Protections—Is a General Exceptions Clause a Forced Perspective?” (2013) 39 American Journal of Law & Medicine 332CrossRefGoogle Scholar.

85. Investment Chapter, supra note 35, art. 12.15.

86. USTR, “Fact Sheet: New US Proposal on Tobacco Regulation in the Trans-Pacific Partnership” (21 August 2013): “The TPP agreement will, like other trade agreements, contain a general exception for matters necessary to protect human life or health.”

87. See e.g. CHALOUPKA, Franket al., “Effectiveness of Tax and Price Policies in Tobacco Control” (2011) 20 Tobacco Control 235CrossRefGoogle ScholarPubMed; RIORDAN, Meg, “Tobacco Warning Labels: Evidence of Effectiveness” Campaign for Tobacco-Free Kids (19 March 2013)Google Scholar, online: <http://www.tobaccofreekids.org/research/factsheets/pdf/0325.pdf>; Melanie WAKEFIELD et al., “Introduction Effects of the Australian Plain Packaging Policy on Adult Smokers: A Cross-sectional Stud”’ (2013) BMJ Open 3:e003175.

88. USTR, “Fact Sheet: TPP Tobacco Proposal” (18 May 2012).

89. USTR, “Fact Sheet: New US Proposal on Tobacco Regulation in the Trans-Pacific Partnership” (21 August 2013).

90. See “Malaysia Poised to Table Complete Carveout from TPP for Tobacco Measures” (25 August 2013) Inside US Trade (online) [Malaysia's Carveout Proposal].

91. At this time it is unclear whether tobacco products would still be subject to tariff reduction obligations under the Malaysian proposal.

92. See e.g. PALMER, Doug, “US Tobacco Trade Proposal Draws Fire From Both Sides” Reuters (22 August 2013)Google Scholar, online: Reuters <http://www.reuters.com/article/2013/08/22/us-usa-tobacco-trade-idUSBRE97L0ZD20130822>. BOLLYKY, Thomas, “The Tobacco Problem in US Trade” Council on Foreign Relations (5 September 2013)Google Scholar, online: CFR <http://www.cfr.org/trade/tobacco-problem-us-trade/p31346>.

93. USTR, supra note 88.

94. Stumberg, , supra note 42 at 427–428Google Scholar, 430–2,

95. See Appellate Body Report, United States—Measures Affecting the Production and Sale of Clove Cigarettes, WTO Doc WT/DS406/AB/R (circulated 4 April 2012, adopted 24 April 2012). See also VOON, Tania, “International Decision: United States—Measures Affecting the Production and Sale of Clove Cigarettes” (2012) 106 American Journal of International Law 824Google Scholar; VOON, Tania and MITCHELL, Andrew, “Implications of International Investment Law for Tobacco Flavouring Regulation” (2011) 12 Journal of World Investment & Trade 65CrossRefGoogle Scholar.

96. USTR, supra note 89.

97. Ibid.

98. See e.g. BLOOMBERG, Michael, “Why is Obama Caving on Tobacco?” New York Times (22 August 2013)Google Scholar, online: NYT <http://www.nytimes.com/2013/08/23/opinion/why-is-obama-caving-on-tobacco.html>; “Anti-Tobacco Group Urges US To Support Malaysian TPP Tobacco Proposal” (26 August 2013) Inside US Trade (online). Cf. “A Bad Smoke: The US Tries to Exempt Tobacco Regulation from Pacific Trade Talks” Wall Street Journal (8 September 2013), online: WSJ <http://online.wsj.com/news/articles/SB10001424127887324463604579040833940586254>.

99. Malaysia's Carveout Proposal, supra note 90; Carey BIRON, “US, Malaysia Skirmish over Free-Trade Tobacco” Inter Press Service (7 September 2013), online: IPS <http://www.ipsnews.net/2013/09/u-s-malaysia-skirmish-over-free-trade-tobacco/>.

100. See Rimmer, , supra note 39 at 104–105Google Scholar.

101. See “US Businesses Quick to Reject New USTR Tobacco Proposal in TPP” (2013) 31 Inside US Trade (online); Malaysia's Carveout Proposal, supra note 90.

102. For a similar view, see LESTER, Simon, “Free Trade and Tobacco: Thank You for Not Smoking (Foreign) Cigarettes” (15 August 2012)Google Scholar 49 Free Trade Bulletin 1 at 4.

103. See e.g. WHO, WHO Report on the Global Tobacco Epidemic, 2013: Enforcing Bans on Tobacco Advertising, Promotion and Sponsorship (2013) at 22.

104. Lester, , supra note 102 at 4Google Scholar.

105. Appellate Body Report, European Communities—Measures Affecting Asbestos and Asbestos-Containing Products, WTO Doc WT/DS135/AB/R (circulated 12 March 2001, adopted 5 April 2001) [114], [118], [162], [172].

106. See e.g. Transcript of Proceedings, JT International v. Commonwealth [2012] HCA Trans 091 (17 April 2012) 700, 2500, 3315, 3675, 3750, 3880–935; Transcript of Proceedings, JT International v. Commonwealth [2012] HCA Trans 092 (18 April 2012) 3950, 5075–85; Transcript of Proceedings, JT International v. Commonwealth [2012] HCA Trans 031 (19 April 2012) 7290–305.

107. See e.g. WTO Committee on Technical Barriers to Trade, Minutes of the Meeting of 23–24 June 2010: Note by the Secretariat, G/TBT/M/51 (1 October 2010), [237]–[251].

108. See e.g. WHO, Interventions on Diet and Physical Activity: What Works—Summary Report (WHO, 2009).

109. Lester, , supra note 102 at 4Google Scholar.

110. See supra note 48 and corresponding text.

111. JT International SA v. Commonwealth of Australia [2012] HCA 43. See also LIBERMAN, Jonathan, “Plainly Constitutional: The Upholding of Plain Tobacco Packaging by the High Court of Australia” (2013) 39 American Journal of Law & Medicine 361CrossRefGoogle Scholar; VOON, Tania, “Acquisition of Intellectual Property Rights: Australia's Plain Tobacco Packaging Dispute” (2013) 2 European Intellectual Property Review 113Google Scholar.

112. See Australia—Certain Measures Concerning Trademarks and Other Plain Packaging Requirements Applicable to Tobacco Products and Packaging: Request for the Establishment of a Panel by Ukraine, WTO Doc WT/DS434/11 (17 August 2012); Australia—Certain Measures Concerning Trademarks, Geographical Indications and Other Plain Packaging Requirements Applicable to Tobacco Products and Packaging: Request for the Establishment of a Panel by Honduras, WTO Doc WT/ DS435/16 (17 October 2012); Australia—Certain Measures Concerning Trademarks, Geographical Indications and Other Plain Packaging Requirements Applicable to Tobacco Products and Packaging: Request for the Establishment of a Panel by the Dominican Republic, WTO Doc WT/DS441/15 (14 November 2012); Australia—Certain Measures Concerning Trademarks, Geographical Indications and Other Plain Packaging Requirements Applicable to Tobacco Products and Packaging: Request for Consultations by Cuba, WTO Doc WT/DS458/1 (7 May 2013); Australia—Certain Measures Concerning Trademarks, Geographical Indications and Other Plain Packaging Requirements Applicable to Tobacco Products and Packaging: Request for Consultations by Indonesia, WTO Doc WT/DS467/1 (25 September 2013).

113. See Philip Morris Asia Limited, Notice of Arbitration (21 November 2011) [1.3]; FTR Holding SA (Switzerland) v. Uruguay (Request for Arbitration) (ICSID Arbitral Tribunal, 19 February 2010) [6], [43], [81], [83]; JT International SA v. Commonwealth [2012] HCA 43, [149] (Gummow J).

114. See e.g. VADI, Valentina, “Tobacco Wars: Tobacco Control-related Investment Disputes in a Comparative Public Law Perspective” (2012) 9 Transnational Dispute Management 86 at 89Google Scholar; DAVISON, Mark, “Plain Packaging of Tobacco and the ‘Right’ to Use a Trade Mark” (2012) 8 European Intellectual Property Review 498Google Scholar; FRANKEL, Susy and GERVAIS, Daniel, “Plain Packaging and the Interpretation of the TRIPS Agreement” (2013) 46 Vanderbilt Journal of Transnational Law 1149Google Scholar.

115. JT International SA v. Commonwealth of Australia [2012] HCA 43, [36], [43] (French CJ), [248] (Crennan J), [348] (Kiefel J), cf. [107] (Gummow J).

116. Investment Chapter, supra note 35, art. 12.2 (Definitions).

117. WikiLeaks, “Secret Trans-Pacific Partnership (TPP)” (13 November 2013), online: Wikileaks <http://www.wikileaks.org/tpp> [IP Chapter].

118. Emphasis added, citations removed.

119. Emphasis added.

120. Panel Report, EC—Trademarks and Geographical Indications (Australia), [7.610]-[7.611].

121. Fergusson et al., supra note 1 at 43; Kelsey, supra note 41 at 246. See also “USTR Highlights Four TPP Areas Where Negotiations Mostly Wrapped Up” (2013) 31 Inside US Trade (online).

122. Citizens Trade Campaign, “Regulatory Coherence Proposal” (4 March 2010)Google Scholar, online: <http://www.citizenstrade.org/ctc/wp-content/uploads/2011/10/TransPacificRegulatoryCoherence.pdf>.

123. But see infra note 181 and corresponding text.

124. Kelsey, , supra note 41 at 249Google Scholar.

125. Ibid.; KELSEY, Jane, Preliminary Analysis of the Draft TPP Chapter on Domestic Coherence (2011)Google Scholar Citizens Trade Campaign, online: <http://www.citizenstrade.org/ctc/wp-content/uploads/2011/10/TransPacific_RegCoherenceMemo.pdf>. See also Stumberg, supra note 42 at 38, noting that “[t]hese elements are modelled after administrative procedures that tobacco companies are using to challenge tobacco-control measures in the domestic courts of New Zealand”.

126. See e.g. Kelsey, , supra note 125Google Scholar, Preliminary Analysis of the Draft TPP Chapter on Domestic Coherence 2; Stumberg, supra note 42 at 392.

127. WHO Framework Convention on Tobacco Control, opened for signature 16 June 2003, 2302 U.N.T.S. 166 (entered into force 27 February 2005) [FCTC]. See also WHO, Confronting the Tobacco Epidemic: In a New Era of Trade and Investment Liberalization (WHO, 2012).

128. Parties to the WHO Framework Convention on Tobacco Control, WHO FCTC, online: <http://www.who.int/fctc/signatories_parties/en/>. See also generally, WHO, Confronting the Tobacco Epidemic: In a New Era of Trade and Investment Liberalization (WHO, 2012).

129. WHO Framework Convention on Tobacco Control Conference of the Parties, Guidelines for Implementation of Article 5.3 of the WHO Framework Convention on Tobacco Control, FCTC/COP3(7) (22 November 2008).

130. Regulatory Coherence Proposal, supra note 122, art. X.3(7) (emphasis added).

131. Ibid., art. X.2(1).

132. And only where harm is demonstrated to have been caused by non-compliance.

133. Kelsey, , supra note 41 at 249Google Scholar.

134. Regulatory Coherence Proposal, supra note 122, art. X.3(1).

135. Ibid., art. X.3(1)(b)(4).

136. Kelsey, , supra note 41 at 249Google Scholar.

137. See e.g. AGUINAGA, Stella and GLANTZ, Stanton, “The Use of Public Records Acts to Interfere with Tobacco Control” (1995) 4 Tobacco Control 222CrossRefGoogle Scholar; Department of Health and Ageing, “List of Tobacco FOI Requests on Hand in the Department of Health and Ageing” (Document Tabled Before Senate Community Affairs Legislation Committee, Parliament of Australia, Canberra, 20 October 2010); Kevin DUNION, Scottish Information Commissioner, Decision 129/2011 Philip Morris International and the University of Stirling (30 June 2011), online: <http://www.itspublicknowledge.info/applicationsanddecisions/Decisions/2011/201100481.aspx>.

138. Stumberg, , supra note 42 at 394Google Scholar.

139. “US Backs Malaysian TPP Proposal Aiming to Protect Product Formulas” (2013) 31 Inside US Trade (online).

140. Ibid., see comments by the Grocery Manufacturers of America: “there is no reason that manufacturers should be required to disclose the precise weight or percentage of each ingredient.”

141. BRACKEN, Len, “TPP Chief Negotiators, Key Experts Gather in Salt Lake City to Advance Negotiations” Bloomberg International Trade Daily (18 November 2013)Google Scholar.

142. Citizens Trade Campaign, “TPP IP Rights Chapter (Selected Provisions)” (September 2011)Google Scholar, online: <http://www.citizenstrade.org/ctc/wp-content/uploads/2011/10/TransPacificIP1.pdf>.

143. IP Chapter, supra note 117.

144. See e.g. Médicins Sans Frontières, “Countries Must Fix Critical Access to Medicines Flaws in Trans-Pacific Trade Pact” (14 May 2013), online: MSF <http://www.msfaccess.org/about-us/media-room/press-releases/countries-must-fix-critical-access-medicines-flaws-trans-pacific>.

145. See e.g. Médicins Sans Frontières, “Briefing Note: Trading Away Health” (2013), online: MSF <http://www.msfaccess.org/sites/default/files/MSF_assets/Access/Docs/Access_Briefing_TPP_ENG_2013.pdf>; Gleeson, supra note 39.

146. FRANKEL, Susy, “Intellectual Property in New Zealand and the TPPA” in Jane KELSEY, ed., No Ordinary Deal: Unmasking the Trans-Pacific Partnership Free Trade Agreement (Wellington: Bridget Williams Books, 2011)Google Scholar, 163, 165–6.

147. See e.g. Médicins Sans Frontières, “Issue Brief: Trading Away Health” (August 2012), online: MSF <http://aids2012.msf.org/wp-content/uploads/2012/07/TPP-Issue-Brief-IAC-July2012.pdf> at 11.

148. FLYNN, Seanet al., “The US Proposal for an Intellectual Property Chapter in the Trans-Pacific Partnership Agreement” (2012) 28 American University International Law Review 105 at 169Google Scholar, note 206.

149. Frankel, , supra note 146 at 173Google Scholar.

150. Gleeson, , supra note 39Google Scholar.

151. IP Chapter, supra note 117, art. QQ.E.16(1)(a).

152. Ibid., art. QQ.E.16(1)(c).

153. Ibid., at 36.

154. United States-Singapore Free Trade Agreement, signed 6 May 2003 (entered into force 1 January 2004) art. 16.8 [US-Singapore FTA].

155. United States-Chile Free Trade Agreement, signed 6 June 2003 (entered into force 1 January 2004) art. 17.10(1) [US-Chile FTA].

156. United States-Korea Free Trade Agreement, signed 30 June 2006 (entered into force 15 March 2012) art. 18.9.1(b) [US-Korea FTA].

157. AUSFTA, supra note 70, art. 17.10(1)(a).

158. IP Chapter, supra note 117, art. QQ.E.16(2).

159. See Mitchell, and Voon, , supra note 75Google Scholar; WTO News, supra note 75.

160. IP Chapter, supra note 117, art. QQ.A.5.

161. Ibid., art. QQ.A.5(a) (emphasis added) (citations removed) (square bracketed text in original).

162. LOVE, James, “KEI Analysis of Wikileaks Leak of TPP IPR Text, from August 30, 2013” Knowledge Ecology International (13 November 2013)Google Scholar, online: KEI <http://keionline.org/node/1825>.

163. See MCGRADY, Benn, “Narrowing of the Doha Declaration in the Draft TPPIP Chapter” O'Neill Institute, Trade, Investment & Health (15 November 2013)Google Scholar, online: <http://www.oneillinstitutetradeblog.org/narrowing-doha-declaration-draft-tpp-ip-chapter/>.

164. US-Chile FTA, supra note 155, art. 17.10(1).

165. IP Chapter, supra note 117, art. QQ.E.1(1).

166. AUSFTA, supra note 70, art. 17.9(1).

167. Public Citizen, “What's New in the WikiLeaks TPP Text?” (13 November 2013), online: <http://www.citizen.org/documents/Whats%20New%20in%20the%20WikiLeaks%20TPP%20Text-11.pdf> at 2−3.

168. See Knowledge Ecology International, online: <http://keionline.org/sites/default/files/tpp-10feb2011-us-text-ipr-chapter.pdf>, art. 8.1: “In addition, the Parties confirm that: patents shall be available for any new forms, uses, or methods of using a known product; and a new form, use, or method of using a known product may satisfy the criteria for patentability, even if such invention does not result in the enhancement of the known efficacy of that product.”

169. Frankel, supra note 146, 166; Flynn et al., supra note 148, 155–6.

170. See also e.g. TRIPS, art. 27.

171. IP Chapter, supra note 117, art. QQ.E.1(1) (citations omitted).

172. WEATHERALL, Kimberlee, “The TPP as a Case Study of Changing Dynamics for International Intellectual Property Negotiations” in Tania VOON, ed., Trade Liberalisation and International Co-operation: A Legal Analysis of the Trans-Pacific Partnership Agreement (Cheltenham: Edward Elgar, 2013)Google Scholar, 50 at 73.

173. Ibid., at 74.

174. Frankel, , supra note 146 at 168Google Scholar.

175. IP Chapter, supra note 117, art. QQ.E.XX.

176. Frankel, , supra note 146 at 168Google Scholar. See also Flynn et al., supra note 148 at 161.

177. IP Chapter, supra note 117, art. QQ.E.XX (emphasis added).

178. IP Chapter, supra note 117, art. QQ.E.14(c) (emphasis added).

179. Gleeson, and Friel, , supra note 52 at 1508Google Scholar; Gleeson, supra note 39 at 2Google Scholar.

180. Gleeson, , supra note 39 at 2Google Scholar. See also FLYNN, Seanet al., “Public Interest Analysis of the US TPP Proposal for an IP Chapter” PIJIP Research Paper 21 (12 June 2011)Google Scholar, online: <http://digitalcommons.wcl.american.edu/research/21> at 50−4.

181. Citizens Trade Campaign, “Transparency Annex” (22 June 2011), online: <http://www.citizenstrade.org/ctc/wp-content/uploads/2011/10/TransPacificTransparency.pdf>. At the same time, the US proposed text dated 19 March 2010 was leaked containing Annexes to the Technical Barriers to Trade chapter for medical devices, pharmaceutical products, and cosmetic devices: online: <http://www.citizenstrade.org/ctc/wp-content/uploads/2011/10/TransPacificTBTwMedicalAnnexes.pdf>.

182. Transparency Annex, supra note 181, para. X.1.

183. Ibid., at 3, note 1.

184. Ibid., para. X.3.

185. Fergusson, , supra note 1 at 38Google Scholar.

186. Ibid.

187. DUCKETT, Stephen, “Drug Policy Down Under: Australia's Pharmaceutical Benefits Scheme” (2004) Health Care Financing Review 55 at 56Google Scholar.

188. SWEENY, Kim, “Trends in the Use of and Cost of Pharmaceuticals Under the Pharmaceutical Benefits Scheme”, Centre for Strategic Economic Studies, Working Paper No 5, June 2002Google Scholar, online: <http://vuir.vu.edu.au/15922/1/15922.pdf> at 5, discussing Australia's PBS.

189. MITCHELL, Andrew and VOON, Tania, “Australia-United States Free Trade Agreement” in Simon LESTER and Bryan MERCURIO, eds., Bilateral and Regional Trade Agreements (Cambridge: Cambridge University Press, 2009), 6 at 17Google Scholar.

190. Ibid.; National Health Act 1953 (Cth), s 101(3A); Department of Health (Cth), PBS Frequently Asked Questions, online: <http://www.pbs.gov.au/info/general/faq#WhatisthePharmaceuticalBenefitsSchemePBS>.

191. Sweeny, , supra note 188 at 6Google Scholar.

192. Ibid., at 7.

193. Ibid.

194. See Department of Health (Cth), About the PBS, online: <http://www.pbs.gov.au/info/about-the-pbs>.

195. HAMILTON, Cliveet al., “Barrier to Trade or Barrier to Profit? Why Australia's Pharmaceutical Benefits Scheme Worries U.S. Drug Companies” (2004) 4 Yale Journal of Health Policy, Law & Ethics 373 at 382Google ScholarPubMed.

196. See e.g. statements by Australia: Letter from the Australian Permanent Mission to the UN Geneva to the United Nations Special Rapporteur on the Right to Health (23 November 2011), online: <https://spdb.ohchr.org/hrdb/19th/Australia_23.11.11_(4.2011).pdf> at 2; Michael JANDA, “Leaked Document Shows Big Rifts in Proposed Pacific Trade Deal” Australian Broadcasting Corporation (14 November 2013), online: ABC <http://www.abc.net.au/pm/content/2013/s3891114.htm>: “the Government will not permit any outcome in its trade negotiations which undermines the PBS or Australia's health system more generally”; Ministry of International Trade and Industry (Malaysia), “Brief on the Trans-Pacific Partnership (TPP)”, online: MITI <http://www.miti.gov.my/cms/storage/documents/1ed/com.tms.cms.document.Document_c5ada311-c0a8156f-72160910-3ecfcd41/1/TPP%20-%20Briefing%20Notes%20-%20Website%20%28FINALrev1%29.pdf> at 5.

197. See FAUNCE, Thomas and TOWNSEND, Ruth, “Public Health and Medicine Policies” in Jane KELSEY, ed., No Ordinary Deal: Unmasking the Trans-Pacific Partnership Free Trade Agreement (Wellington: Bridget Williams Books, 2011), 149 at 154Google Scholar.

198. Ibid., para. X.1(c). See also AUSFTA, supra note 70, annex 2-C (Pharmaceuticals), art. 1(d).

199. Flynn, et al., supra note 180 at 52Google Scholar.

200. Ibid.

201. See also ibid.

202. Transparency Annex, supra note 181, para. X.4.

203. See e.g. GILBODY, S.et al., “Benefits and Harms of Direct to Consumer Advertising: A Systematic Review” (2005) 14 BMJ Quality & Safety 246CrossRefGoogle ScholarPubMed.

204. TOOP, Les and RICHARDS, Dee, “New Zealand Deserves Better. Direct-to-Consumer Advertising (DTCA) of Prescription Medicines in New Zealand: For Health or for Profit?” (22 August 2003)Google Scholar 116 The New Zealand Medical Journal, online: <http://journal.nzma.org.nz/journal/116-1180/556/>. See also MINTZES, Barbara, “Direct to Consumer Advertising is Medicalising Normal Human Experience” (2002) 13 British Medical Journal 324Google Scholar. See also LOPERT, Ruth and GLEESON, Deborah, “The High Price of ‘Free’ Trade: US Trade Agreements and Access to Medicines” (2013) The Journal of Law, Medicine & Ethics 199 at 206Google Scholar.

205. Deborah GLEESON, “Submission to the Department of Foreign Affairs and Trade” Department of Foreign Affairs and Trade (Australia) (7 September 2012), online: DFAT <https://www.dfat.gov.au/fta/tpp/subs/tpp_sub_gleeson_120911.pdf> 3 at 5−6.

206. AUSFTA, supra note 70, annex 2-C.

207. Gleeson, , supra note 205 at 4Google Scholar.

208. Flynn, et al., supra note 180 at 51Google Scholar.

209. Transparency Annex, supra note 181, para. X.3(i). See also Gleeson, , supra note 205 at 5Google Scholar.

210. See Kelsey, , supra note 41 at 247Google Scholar, regarding “resistance” from some TPP parties “who believe that best practice should be sensitive to each state's individual system of governance, constitutional structure, national priorities, and constitutional and international obligations”.

211. Nottage, , supra note 2 at 258Google Scholar.

212. Letter from the Australian Permanent Mission to the UN Geneva to the United Nations Special Rapporteur on the Right to Health, supra note 196 at 2.

213. Ibid., at 1.

214. Gleeson, and Friel, , supra note 52 at 1508Google Scholar. See “US Mulls Strategy on TPP Medicines Proposal in Light of Stiff Resistance” (2012) 30 Inside US Trade (online); “USTR Highlights Four TPP Areas Where Negotiations Mostly Wrapped Up” (2013) 31 Inside US Trade (online). See also “TPP Countries Slowly Restart Formal Talks on Pharmaceutical IP Protections” (2013) 31 Inside US Trade (online).

215. Letter from the Australian Permanent Mission to the UN Geneva to the United Nations Special Rapporteur on the Right to Health, supra note 196.

216. Brief on the Trans-Pacific Partnership (TPP), supra note 196.

217. “Ministro Silva: no se negociará más sobre la propiedad intelectual en el TLC con EE.UU” La Republica (12 June 2013), online: <http://www.larepublica.pe/12-06-2013/ministro-silva-no-se-negociara-mas-alla-de-lo-establecido-en-el-tlc-con-eeuu>.

218. For example, art. QQ.E.1(a) (the US's proposed expansion of the scope of patentable inventions, or “evergreening” provision) is supported only by Australia but opposed by Brunei, Canada, Chile, Mexico, New Zealand, Peru, Singapore, and Vietnam; art. QQ.E.XX (the US's proposed requirement that patent terms be adjusted to account for unreasonable delays in the patent approval process) is opposed by Canada, Japan, and New Zealand; art. QQ.E.14 (the US's proposal for patent term adjustments for delays in marketing approval) is opposed by Australia, Brunei, Canada, Chile, Malaysia, Mexico, New Zealand, Peru, Singapore, and Vietnam; and art. QQ.E.16(1) (the US's data exclusivity proposal) is opposed by Australia, Brunei, Chile, Malaysia, New Zealand, Peru, Vietnam, and Singapore.