1 The EJRR provides ample coverage of the regulation of lifestyle risks; see the regular reports on Lifestyle risk.

2 See the WHO Global Status Report on NonCommunicable Diseases 2010, available at <http://www.who.int/chp/ncd_global_status_report/en/index.html>.

3 The documents can consulted at the following webpage: <http://www.who.int/nmh/events/un_ncd_summit2011/en/>.

4 Cfr. Chile – Proposed amendment to the Food Health Regulations, Supreme Decree No. 977/96 (G/TBT/N/CHL/219, G/TBT/N/CHL/219/Add.1); one of the most contested issues is that, according to a proposed amendment, warnings relating to the alleged unhealthiness of certain food would have to be placed in the middle of an octagonal icon (a STOP sign), occupying no less than 20% of the main face of the packaging.

5 Korea – Proposed SAR Values or EMF exposure in cell phones, (G/TBT/N/KOR/393).

6 Concerns over the Irish proposal were raised at the October 10–11, 2013 meeting of the TRIPS Council: see <http://www.wto.org/english/news_e/news13_e/trip_10oct13_e.htm#plainpackaging>.

7 Cfr. Tobacco Plain Packaging Act 2011, Act No. 148 of 2011, “An Act to discourage the use of tobacco products, and for related purposes” and subsequent amendments, available at <http://www.wipo.int/wipolex/en/details.jsp?id=11956>

8 Cfr. Artt. 19 and 20, Tobacco Plain Packaging Act 2011.

9 The European Union had also notified a proposal on the revision of the Tobacco Directive, with rules on plain packaging; see: European Union – Tobacco products, nicotine containing products and herbal products for smoking. Packaging for retail sale of any of the aforementioned products (G/TBT/N/EU/88). However, the original proposal was softened and, eventually, on October 8, 2013, a Parliament vote has further watered down some of the proposed rules on packaging, according to some, under the heavy lobbying of Philip Morris. Cfr. Reuters, European Parliament votes to weaken EU's anti-smoking plans, Brussels, 8 October 2013, available at: <http://uk.reuters.com/article/2013/10/08/uk-eu-tobacco-idUKBRE9970FG20131008>.

10 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, WT/DS434/11 (17 August 2012) (‘Ukraine Panel Request’)

11 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, WT/ DS435/16 (17 October 2012).

12 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 Dominican Republic, WT/DS441/15 (9 November 2012).

13 Australia — Certain Measures Concerning Trademarks, Geographical Indications and Other Plain Packaging Requirements Applicable to Tobacco Products and Packaging; Request for Consultations by Cuba, WT/DS458/1 (7 May 2013).

14 Australia — Certain Measures Concerning Trademarks, Geographical Indications and Other Plain Packaging Requirements Applicable to Tobacco Products and Packaging: Request for consultations, Indonesia, WT/DS467/1 (25 September 2013).

15 WTO law does not exhaust the international legal battlefield for the regulation of tobacco products. Philip Morris has also challenged the Australian Plain Packaging Act in the context of Hong Kong–Australia BIT. Cfr. Agreement between the Government of Hong Kong and the Government of Australia for the Promotion and Protection of Investments , signed 15 September 1993, 1748 UNTS 385 (entered into force 15 October 1993) (‘Hong Kong–Australia BIT’); Notice of Arbitration, Philip Morris Asia Ltd. v. Australia, UNCITRAL, PCA Case No. 2012-12 (Nov. 21, 2011), <http://www.italaw.com/sites/default/files/case-documents/ita0665.pdf>.

16 In particular the claims have indicated that the following Articles may be violated: Art. 2.1, 3.1, 15.4, 16.1,16.3, 20, 22.2(b) and 24.3, TRIPS Agreement.

17 The text of the Agreements is available at <http://www.wto.org>.

18 For an exhaustive analysis of the compatibility of the Australian measures with the TRIPS Agreement, the TBT Agreement and GATT 1994, the reader may read the study by Andrew Mitchell and Tania Voon, who in short argue that the Tobacco Plain Packaging Act is very well defensible, see Voon, T. S. and A.D. Mitchell, (2011), Implications of WTO Law for Plain Packaging of Tobacco Products (June 30, 2011). Public Health and Plain Packaging Of Cigarettes: Legal Issues, Mitchell, A.D., Voon T. and J. Liberman, eds., Edward Elgar, UK, 2012; U of Melbourne Legal Studies Research Paper No. 554. Available at SSRN: <http://ssrn.com/abstract=1874593> .

19 Alemanno, A and Bonadio, E (2010), The Case of Plain Packagingof Cigarettes, European Journal of Risk Regulation, 268–270 CrossRefGoogle Scholar; Frankel, S and D. J. Gervais (2013), Plain Packaging and the Interpretation of the TRIPS Agreement. Vanderbilt Journal of Transnational Law, Forthcoming; Victoria University of Wellington Legal Research Paper. Available at SSRN: http://ssrn.com/abstract=2234580

20 Davison, M (2012), The Legitimacy of Plain Packaging Under International Intellectual Property Law: Why There is No Right to Use a Trademark Under Either the Paris Convention or the Trips Agreement (February 21, 2012). Public Health And Plain Packaging Of Cigarettes: Legal Issues, A. Mitchell, T. Voon and J. Liberman, eds., Edward Elgar, 2012. Available at SSRN: <http://ssrn.com/abstract=2009115>; Davison, M (2012), Plain Packaging of Tobacco and the ‘Right’ to Use a Trade Mark (July 27, 2012). European Intellectual Property Review, No. 8, pp. 498–501, 2012; Monash University Faculty of Law Legal Studies Research Paper No. 2013/10. Available at SSRN: http://ssrn.com/abstract=2137455.

21 Higgins, A and Mitchell, A.D. and Munro, J., (2013), Australia’s Plain Packaging of Tobacco Products: Science and Health Measures in International Economic Law (June 16, 2013). In Mercurio, B. and Ni, Kuei-Jung (eds), Science and Technology in International Economic Law: Balancing Competing Interests, Routledge, 2013 Google Scholar; U of Melbourne Legal Studies Research Paper No. 653; Oxford Legal Studies Research Paper No. 79/2013. Available at SSRN: <http://ssrn.com/abstract=2280071>.

22 For an in-depth and lucid analysis of this issue, see: Gruszczynski, L. (2012a), The WHO Framework Convention on Tobacco Control as an International Standard Under the TBT Agreement? Transnational Dispute Management, 9(5)Google Scholar. Available at SSRN: <http://ssrn.com/abstract=2171630>; see also Gruszczynski L. (2012b), who discusses the potential role of international standards in the Clove-Cigarettes case, Gruszczynski L (2012), The TBT Agreement and Tobacco Control Regulations (July 9, 2012). Society of International Economic Law (SIEL), 3rd Biennial Global Conference. Available at SSRN: <http://ssrn.com/abstract=2102719>.

23 WHO Framework Convention on Tobacco Control, 2302 UNTS 166, entered into force on 27 February 2005; the text of the Convention can be downloaded at: <http://www.who.int/fctc/text_download/en/index.html>.

24 Cfr. Guidelines for implementation of Article 11 of the WHO Framework Convention on Tobacco Control (Packaging and labelling of tobacco products), available at: <http://www.who.int/fctc/guidelines/article_11.pdf> and Guidelines for implementation of Article 13 of the WHO Framework Convention on Tobacco Control (Tobacco advertising, promotion and sponsorship), available at: <http://www.who.int/fctc/guidelines/article_13.pdf>.

25 Paragraph 46 of the Guideline for the implementation of Article 11, cited above (emphasis added).

26 Paragraph 16 of the Guideline for the implementation of Article 13, cited above (emphasis added).

27 This part of the Report draws on the analysis of international standards previously articulated in Arcuri, Alessandra, “The TBT Agreement and Private Regulation”, in Trebilcock, Michael and Epps, Tracey (eds.), Research Handbook on the TBT Agreement (Cheltenham: Edward Elgar Publishing, 2013), pp. 485–524 Google Scholar.

28 International Organization for Standardization (ISO) / International Electrotechnical Commission (IEC) Guide 2, General Terms and Their Definitions Concerning Standardization and Related Activities, sixth edition (1991).

29 Decision of the Committee on Principles for the Development of International Standards, Guides and Recommendations with relation to Articles 2, 5 and Annex 3 of the Agreement, in WTO document G/TBT/1/Rev.10, Decisions and Recommendations adopted by the WTO Committee on Technical Barriers to Trade since 1 January 1995, 9 June 2011, at 46–48.

30 Appellate Body Report, United States – Measures Concerning the Importation, Marketing and Sale of Tuna and Tuna Products, adopted 16 May 2012, WT/DS381/AB/R (US –Tuna II), para. 353.

31 While the ‘ISO/IEC Guide 2’ uses the term ‘organization’, the TBT Agreement uses the term international standardization ‘bodies’. The AB argued that ‘[t]his suggests that, for the purposes of the TBT Agreement, “international” standards are adopted by “bodies”, which may, but need not necessarily, be “organizations”.’ Para 356. For the more extended legal reasoning on this issue, see the AB Report, para. 356.

32 Cfr. Annex 1(4) TBT Agreement.

33 The legal status of the Decision has been considered to be one of subsequent agreement within the meaning of Article 31(3)(a) Vienna Convention on the Law of Treaties. The relative passage by the Appellate Body in US-Tuna II reads: ‘We … consider that the TBT Committee Decision can be considered as a “subsequent agreement” within the meaning of Article 31(3)(a) of the Vienna Convention. The extent to which this Decision will inform the interpretation and application of a term or provision of the TBT Agreement in a specific case, however, will depend on the degree to which it “bears specifically” on the interpretation and application of the respective term or provision’. US-Tuna II, (AB Report), para. 372.

34 Another issue that was discussed in US-Tuna II relates to the question of whether an international body can qualify as open if accession takes place upon invitation. The AB concluded that theoretically it could, provided that the invitation was a mere formality and that it would be issued ‘automatically once a Member or its relevant body had expressed interest in joining such a standardization body; such issues therefore could be decided on a case-bycase basis’. Cfr. US-Tuna II, (AB Report) supra note 45, para. 386.

35 Gruszczynski correctly notes that one problem in relation to the openness criterion is that WHO membership is open only to states, whereas non-state territorial entities, such as custom territories can be members of the WTO. In fact, Taiwan, a WTO Member, applied for WHO membership without obtaining it. However, the author contends that while formally this may be a problem, in practice this may be a non-issue as Taiwan has implemented regulations in line with the WHO FCTC. More generally, if we would apply such an overly strict criterion, few international standardization bodies would qualify as such under the TBT Agreement. See Gruszczynski (2012a).

36 Committee Decision, p. 47.

37 Appellate Body Report, European Communities – Trade Description of Sardines , WT/DS231/AB/R, adopted 23 October 2002, (EC-Sardines), paras. 222–227.

38 Pauwelyn, J. Wessels, R. and Wouters, J. (Eds.), Informal International Lawmaking (Oxford University Press, 2012)CrossRefGoogle Scholar.

39 Rule 50 of the Rules of Procedure of the FCTC Conference of the Parties (2006), available at: <http://www.who.int/fctc/cop/rules_procedure/en/index.html>.

40 US-Tuna II, (Appellate Body Report), para. 357.

41 Ibidem, para. 357.

42 Id. , para. 394; see also para. 360 for the underlying reasoning relating to the composite term ‘activities in standardization’.

43 See Appellate Body Report, Brazil – Measures Affecting Imports of Retreaded Tyres, WT/DS332/AB/R, adopted 17 December 2007.

44 Data available at <http://www.who.int/mediacentre/fact-sheets/fs339/en/index.html>.

45 World Health Organization, Fifty-seventh World Health Assembly, Geneva, 17–22 May 2004, Resolutions and Decisions, Annexes (WHA57/2004/REC/1), resolution 57.17, annex.

46 World Health Organization, Sixty-third World Health Assembly, Geneva, 17–21 May 2010, Resolutions and Decisions, Annexes (WHA63/2010/REC/1), annex 3