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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
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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 

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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.

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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].

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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).

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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.

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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>.

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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.

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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.

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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.