Plain packaging of tobacco products is a new tobacco control tool which has been considered in recent times by several governments throughout the world. By standardizing the appearance of all cigarette boxes, plain packaging aims to make all packs look unattractive and render health warnings more prominent. Australia is set to become the first country in the world to introduce legislation requiring “plain packaging” for cigarettes. Plain packaging raises both health-related and legal tricky issues. Indeed, it is being persistently challenged not only by the tobacco industry as to its legality, but also in its genuine effectiveness.After summing up the state of the art of the debate triggered by this innovative tobacco control tool, this report predicts that plain packaging is a thorny issue which is likely to keep busy IPRs and WTO specialists as well as academics in the years to come

Alemanno, A.

Bonadio, E.

City Research Online

Bonadio, E. & Alemanno, A. (2010). The Case of Plain Packaging for Cigarettes - an Overview. European Journal of Risk Regulation, 1(3), pp. 268-270. City Research OnlineOriginal citation: Bonadio, E. & Alemanno, A. (2010). The Case of Plain Packaging for Cigarettes - an Overview. European Journal of Risk Regulation, 1(3), pp. 268-270. Permanent City Research Online URL: http://openaccess.city.ac.uk/3659/ Copyright & reuseCity University London has developed City Research Online so that its users may access the research outputs of City University London's staff. Copyright © and Moral Rights for this paper are retained by the individual author(s) and/ or other copyright holders.  All material in City Research Online is checked for eligibility for copyright before being made available in the live archive. URLs from City Research Online may be freely distributed and linked to from other web pages. Versions of researchThe version in City Research Online may differ from the final published version. Users are advised to check the Permanent City Research Online URL above for the status of the paper.EnquiriesIf you have any enquiries about any aspect of City Research Online, or if you wish to make contact with the author(s) of this paper, please email the team at publications@city.ac.uk.EJRR 3|2010Reports268Intellectual PropertyThis section is devoted to giving readers an inside view of the crossing point between intellectual prop-erty (IP) law and risk regulation. In addition to up-dating readers on the latest developments in IP law and policies in technological ields (including chemi-cals, pharmaceuticals, biotechnology, agriculture and foodstuffs), the section aims at verifying whether such laws and policies really stimulate scientiic and tech-nical progress and are capable of minimising the risks posed by on-going industrial developments to indi-viduals’ health and safety, inter alia.The Case of Plain Packaging of CigarettesAlberto Alemanno* and Enrico Bonadio**In a bid to reduce smoking rates, Australia is set to become the irst country in the world to introduce legislation requiring “plain packaging” for cigarettes. “Plain packaging” (also known as “generic packag-ing”) means that all forms of tobacco branding are required to be labelled exclusively with simple una-dorned text. This means that trademarks, graphics and logos are removed from cigarette packs with the exception of the brand name which is displayed in a standard font. By standardising the appearance of all cigarette boxes, plain packaging aims to make all packs look unattractive and render health warnings more prominent.This legislative move by Australia inds its origin in the National Health Taskforce discussion paper issued in 20081, which put forth recommendations on how to address a number of health issues over the next decade. The stated goal of the plain packag-ing, as recently enshrined by the Australian Federal Government, is (a) to curb the initiation of tobacco use, reduce tobacco consumption and incidences of relapse in those who quit smoking; (b) to enhance the effectiveness of package warnings; and (c) to remove the power of the packaging to mislead and deceive consumers.Australia is not alone. The United Kingdom, Can-ada and New Zealand are also considering laws for making this marketing restriction mandatory.However, plain packaging raises both health-relat-ed and legal tricky issues. Indeed, it is being persist-ently challenged not only by the tobacco industry as to its legality, but also its genuine effectiveness for public health in reducing tobacco consumption levels.On the one hand, supporters of generic packaging argue that this innovative way of marketing cigarette packs would make them look not only less attractive but also contribute to make health warnings (“Smok-ing can kill you”) more visible. Warnings on plain white packages may be more effective at grabbing attention and enhancing recall than warnings on regular packages.On the other hand, tobacco companies argue that generic packaging would not be very effective in serving the stated purpose of reducing smoking and protecting human health. To support this claim, they often refer to the lack of evidence proving that generic packaging (i) makes cigarette boxes less attractive to consumers and health warnings and renders the infor-mation more visible and (ii) as a result induces smoking cessation2. Plain packaging could even increase smok-ing uptake – it is argued – because companies would be prompted to compete on the basis of cigarette prices only. This would make tobacco cheaper and more af-* Associate Professor, HEC Paris, France.** Lecturer, University of Abertay Dundee, United Kingdom.1 The report is available on the Internet at <http://www.preventative-health.org.au/internet/preventativehealth/publishing.nsf/Content/discussion-technical-1> (last accessed on 7 July 2010).2 In a 1995 report entitled “The Tobacco Industry and the Costs of Tobacco-Related Illness” (released by the Australian Senate Com-munity Affairs References Committee) the following conclusion was reached: “The Committee received a range of often conlict-ing evidence on the eficacy of generic packaging. While some evidence suggested that generic packaging would reduce the at-tractiveness of cigarettes for children, other evidence raised some doubts concerning the effectiveness of this approach. The Com-mittee believes that more research needs to be undertaken into the role generic packaging could play in an integrated strategy address-ing the problem of adolescent smoking. The Committee considers that, on the basis of the evidence received, there is not suficient evidence to recommend that tobacco products be sold in generic packaging.” (para. 3.54). The report is available on the Internet at <http://www.plain-packaging.com/Australia> (last accessed on 7 July 2010). Moreover, in the UK Parliamentary session of 25 June 2009 the Minister of State for Public Health, Ms Gillian Merron, was reported to have said: “There is some evidence that branding on cigarette packs may increase brand awareness among young people but it is not conclusive. […] While there is also evidence to suggest that branding on packs may mislead customers about the relative safety of different tobacco products, that too is very limited. No studies have been undertaken to show that plain packaging of tobacco would cut smoking uptake among young people or en-able those who want to quit to do so. Given the impact that plain packaging would have on intellectual property rights, we would undoubtedly need strong and convincing evidence of the beneits to health, as well as its workability, before this could be promoted and accepted at an international level – especially as no country in the world has introduced plain packaging”. This excerpt is avail-able on the Internet at <http://www.publications.parliament.uk/pa/cm200809/cmpublic/health/090625/pm/90625s09.htm> (last accessed on 7 July 2010).EJRR 3-2010.indd   268 02.09.2010   16:39:02EJRR 3|2010 Reports 269fordable for consumers, particularly amongst young people. As alternative, it is believed that other less in-vasive instruments than generic packaging would be far more effective in the struggle against smoking, for example, educational campaigns, health information and warnings on cigarette boxes, etc.Moreover, according to Big Tobacco, plain pack-aging represents an encroachment on the rights of trademark owners and their ability to use their trademarks properly and lawfully. Indeed, the most threatening argument used against plain packaging consists in its alleged incompatibility with WTO law. In particular, such a marketing restriction might turn out to contravene TRIPs provisions on trademarks, thus triggering a dispute before the WTO dispute set-tlement adjudication bodies. Critics argues that plain packaging would violate several TRIPs trademark-re-lated provisions, i.e. Articles 17, 20 and 15(4) TRIPs and Article 6-quinquies (B) Paris Convention, which is incorporated by reference into TRIPs pursuant to its Article 2(1)3.One of the most relevant questions concerning the alleged TRIPs-incompatibility of generic packaging relates to Article 8(1) TRIPs.This provision states that “Members may, in formu-lating or amending their laws and regulations, adopt measures necessary to protect public health and nutri-tion, and to promote the public interest in sectors of vital importance to their socio-economic and techno-logical development, provided that such measures are consistent with the provisions of this Agreement.”It should be noted that any WTO Member State seeking to adopt a measure (e.g. a public health meas-ure) pursuant to Article 8(1) should prove inter alia that this is (i) necessary for the promotion of the public interest in sectors of vital importance (e.g. to protect human health) and (ii) consistent with the TRIPs Agreement4.The irst requirement, i.e. a necessity test, is two-fold. A causal link needs to be established between the measure and the protection of the speciic public interest, and then the measure should be the least restrictive on intellectual property rights (IPRs). The scope of this provision is further limited by the sec-ond abovementioned requirement, i.e. that the meas-ure be compatible with the TRIPs Agreement.First, plain packaging could fail to satisfy the abovementioned causal link requirement. Because of the uncertainty surrounding its inherent ability and effectiveness to reduce the incidence of smoking, it might be dificult for states seeking to adopt generic packaging to prove the existence of a causal relation-ship between such a measure and the protection of public health. In addition, plain packaging would appear to be unlikely to satisfy the necessity test for a further reason. As shown above, there might in-deed be other means of attaining the same public health objective that would be more effective and less restrictive of IPRs, such as educational campaigns, health information and warnings as well as advertis-ing restrictions.Finally, it is not an easy matter to meet the sec-ond condition of Article 8(1) – i.e. consistency of the measure in question with TRIPs. Thus a Panel’s deci-sion inding generic packaging is contrary to TRIPs cannot be ruled out.Nevertheless, states willing to adopt plain packag-ing may overcome the abovementioned dificulties if they succeed in proving (a) the existence of the caus-al link between this marketing restriction and the protection of public health (e.g. by relying on studies conirming that this measure would make cigarette boxes less attractive to consumers and health warn-ings and information more visible and accordingly increase the incidence of smoking cessation); and (b) that there exists no less trade-restrictive means of achieving the chosen policy goal. In addition, states should also prove that plain packaging is compli-ant with TRIPs. In this respect, particular weight should be attached to both Article 8.1 TRIPs and paragraph 4 of the 2001 Doha Declaration on the TRIPS Agreement and Public Health. In particular the latter reproduces the spirit of the former by stress-ing that “the TRIPs Agreement does not and should not prevent members from taking measures to protect public health”5.Plain packaging is a thorny issue that is likely to keep busy IPRs and WTO specialists as well as aca-demics in the years to come.3 For a irst analysis of the compatibility of plain packaging with the trademark-related provisions of the TRIPs Agreement see Benn Mc-Grady, “TRIPs and Trademarks: The Case of Tobacco”, 3(1) World Trade Review (2004), pp. 53–82.4 See Nuno Pires de Carvalho, The TRIPs Regime of Patent Rights (The Hague: Kluwer 2005), pp. 119 et sqq.5 The Doha Declaration on the TRIPS Agreement and Public health was adopted on 14 November 2001 by the WTO Ministerial Con-ference. States seeking to adopt plain packaging should also stress that each country has the right to decide the level of health pro-tection that it considers appropriate in a given situation, as it was stated by the WTO Panel in EC – Asbestos, see European Com-munities – Measures Affecting Asbestos and Asbestos-Containing Products, Report of the Appellate Body, WTO Doc. WT/DS135/AB/R, 5 April 2001, at para. 168.EJRR 3-2010.indd   269 02.09.2010   16:39:02EJRR 3|2010Reports270As shown above, the tobacco industry is partic-ularly keen to emphasize both the futility of plain packaging for reducing smoking rates and its in-compatibility with TRIPs provisions on trademarks. Clearly, major tobacco companies fear to lose a pow-erful means of communication between themselves and their consumers and are afraid that what they see as a serious curtailment of their trademark and goodwill-related rights could hit their lourishing businesses hard and decrease cigarette sales. Indeed, it is a fact that sales of tobacco products continue to rise worldwide. For example, some igures revealed that tobacco sales in UK rose to £11.3 billion in 2009, an increase of 3.3 % on the previous year6. Moreo-ver, the World Health Organization found that the developing world tobacco consumption is rising by 3.4 % per year7.On the other hand, those who support plain packaging stress its enormous potential in the ight against tobacco-related diseases and defend its legal-ity and conformity with WTO law and particularly with international provisions protecting trademarks. In their eyes, plain packaging is both useful and law-ful.Given the high economic stakes related to the in-troduction of plain packaging and the impact that such measure could have on tobacco consumption, it is not unlikely that any state that adopts such a marketing restriction will expose themselves to a WTO dispute settlement proceedings. Needless to say, such actions might be triggered by countries particularly keen in protecting their tobacco majors. Yet, the outcome of such a dispute would be uncer-tain and – as is often the case – technical expertise is likely to make the difference. What is the impact of plain packaging on consumer’s choice and tobacco consumption? There does not seem to be any deini-tive answer yet.NanotechnologyThis section is meant to give readers an insight into the emerging ield of nanotechnologies and risk regu-lation. It informs and updates readers on the latest European and international developments in nanote-chnologies and risk regulation across different sectors (e.g., chemicals, food, cosmetics, pharmaceuticals) and policy areas (e.g., environmental protection, oc-cupational health and consumer product, food and drug safety). The section analyzes how existing regula-tory systems deal with new kinds of risks and reviews recent regulatory developments with a focus on how best to combine scientiic freedom and technological progress with a responsible development and com-mercialization of nanotechnologies.Nanomaterial Safety: The Regulators’ DilemmaNico Jaspers*I. IntroductionNanotechnologies have been hyped as bringing about another industrial revolution. But they have also caused concern about their potential adverse effects on human health and the environment, mis-use for military purposes, and excessive corporate control of intellectual property. Policy-makers ind themselves in the dificult position of promoting the development of nanotechnologies while at the same time securing public trust in their safe com-mercial application. Having invested enormous inancial resources into nanotechnology research and development,1 policy-makers often struggle to convince an increasingly informed – and some-times sceptical – public that existing regulatory frameworks are suficiently able to address po-tential risks related to nanotechnologies. In most cases, this is not for lack of want or interest, but due to the challenge of framing “nano” for regulatory purposes. Regulators face a dilemma: they have to ensure the safety of nano technology applications without being able to state exactly what nanotech-nology is.6 See News.Scotsman.com of 21st February 2010.7 See the relevant smoking statistics available on the Inter-net at <http://www.wpro.who.int/media_centre/fact_sheets/fs_20020528.htm> (last accessed on 7 July 2010).* London School of Economics, United Kingdom. Please send in-quiries to n.jaspers@lse.ac.uk.1 Cientiica, “Nanotechnology Takes a Deep Breath … and Prepares to Save the World!”, Cientiica Report (2009).EJRR 3-2010.indd   270 02.09.2010   16:39:02

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