Submission to the Chantler Review into the public health impacts of standardised packaging for tobacco products

10 January 2014

Japan Tobacco International (JTI) is part of the Japan Tobacco group of companies, a leading international tobacco product manufacturer. JTI’s UK headquarters is in Weybridge, Surrey, and its manufacturing facility is in Lisnafillan, Northern Ireland, where it has a long-standing and significant presence. JTI’s cigarette brand portfolio includes Benson & Hedges, Silk Cut, Winston, Camel, Mayfair, Sterling, Sovereign and more, as well as a number of other tobacco products including cigars (such as Hamlet), roll-your-own tobacco (such as Amber Leaf) and pipe tobacco (such as Condor). In the UK alone, JTI employs over 1,800 people. Gallaher Limited is the registered trading company of JTI in the UK. More information about JTI is set out at paragraphs 1.5 to 1.7 of the Consultation Response.

EXECUTIVE SUMMARY

No evidence of positive health impacts

There was no evidence in 2008, no evidence in 2013, and there is no evidence now that plain packaging is likely to have actual positive public health impacts (despite repeated and sustained attempts to create this evidence).

No evidence has emerged from Australia, where plain packaging has been in place for over a year, showing that plain packaging has changed the rate of decline in smoking or has had any positive behavioural impact at all.

As a result, even the fiercest proponents of the measure now argue that it could be many years before the impact they said plain packaging would have is felt. Some have also conceded that plain packaging will have no positive impact on existing smokers who wish to quit.

This is unsurprising as it is wrong to assume packaging influences smoking behaviour, particularly of minors. This view is not consistent with a credible and scientifically rigorous understanding of smoking behaviour and ignores what HM Government and others have previously said about why people smoke.

A leading expert in the area of adolescent judgment, decision-making, and risk- taking has concluded that “The introduction of standardized packaging would be unlikely to affect underage smoking, either in terms of initiation or progression from experimentation to regular use.”

Even DH-funded research recognises that “Current approaches to combat smoking which highlight its health risks may be ineffective for [young people], as health messages are known to have little salience for children and young people... Approaches that inhibit young people’s ability to obtain tobacco may therefore be more appropriate for preventing smoking in this age group.”

The ‘evidence’ supporters of plain packaging rely upon, written largely by a small group of tobacco control advocates whose independence is at best questionable, is unreliable and unconvincing. The individual consumer surveys underlying the ‘systematic’ reviews test what people (principally adults) say they will do rather than what they actually do. Grouping them together does not make them any more reliable.

Reflecting this fact, a leading expert in the conduct and evaluation of consumer research studies is of the opinion that the “current evidence base is insufficient to justify the conclusion that plain packaging is likely to have any impact on actual smoking behaviour.”

Negative public health impacts

The DH seeks to protect minors and those from the most disadvantaged backgrounds from smoking, but plain packaging will make the problem of illicit trade worse (impacting negatively on public health) by making tobacco more accessible to those two groups in particular.

Page 2 In the case of illicit trade, this has the public health impact that smokers would also be buying from an illegal and unregulated source.

If, as expert analysis demonstrates, plain packaging leads to average prices of tobacco products (and cigarettes in particular) falling, this might further negatively impact on public health.

The risk, previously recognised by the DH, that: “Children may be encouraged to take up smoking if plain packages were introduced, as it could be seen as rebellious” also needs to be assessed carefully.

The standard to be met by the Chantler Review

Plain packaging is an issue of critical importance to JTI. It deprives us of our most valuable assets and unjustifiably infringes our fundamental legal rights. This means it is not enough for plain packaging only to be likely to have an effect on public health. That said, the current evidence base fails even this (inappropriately low) threshold test.

The independent reviewer has to be satisfied, having carefully and thoroughly considered all relevant evidence (irrespective of whether it has been submitted by proponents or opponents of plain packaging), that a robust and compelling case can be made that plain packaging is likely to have actual positive public health impacts before he could advise there was sufficient evidence to take it forward.

The independent reviewer can also only reach this view if he is satisfied that such likely positive impacts are attributable specifically to plain packaging. The impacts in question must go beyond those attributable to other recent/planned initiatives (including both the display ban and revised Tobacco Products Directive) and beyond pre-existing trends.

If further expert advice is commissioned, that must occur in a transparent way and in accordance with best practice.

Alternative means of achieving public health impacts

JTI draws to the attention of the Chantler Review alternative regulatory solutions to achieve actual positive public health impacts (as they address the key methods by which minors access tobacco products).

Page 3 1. INTRODUCTION

1.1 Tobacco products carry risks to health. We believe that appropriate and proportionate regulation is both necessary and right. Minors should not smoke and should not be able to obtain tobacco products. Everyone should be appropriately informed about the health risks of smoking. These core principles are central to our Code of Conduct, Global Marketing Standard, operational policies and the way JTI does business.

1.2 Therefore, JTI supports legislative and regulatory measures on tobacco control which meet internationally and nationally accepted principles of Better Regulation.1 However, JTI will question, and where necessary challenge, regulation that is flawed, unreasonable, disproportionate or without evidential foundation.

1.3 Plain packaging is an issue of critical importance to JTI. It deprives us of our most valuable assets and unjustifiably infringes our fundamental legal rights. This means it is not enough for plain packaging only to be likely to have an effect on public health. That said, the current evidence base fails even this (inappropriately low) threshold test.

1.4 The reasons why JTI is categorically opposed to the plain packaging of tobacco products were set out in detail in its Consultation Response.2 One of the most important reasons (and central to the Chantler Review)3 is that there was no evidence in 2008, there was no evidence in 2013, and there is no evidence now that plain packaging is likely to have actual positive public health impacts (despite repeated and sustained attempts by tobacco control groups to create this evidence).

1.5 Accordingly, we welcome the Chantler Review as an opportunity for an independent assessment that, in our view, could only reasonably conclude that the evidence base does not show plain packaging is likely to achieve public health goals by changing actual smoking behaviour (even if that conclusion is disappointing/unpalatable to tobacco control groups).

2. NO EVIDENCE PLAIN PACKAGING IS LIKELY TO ACHIEVE POSITIVE PUBLIC HEALTH IMPACTS

2.1 There is no reliable evidence that plain packaging has achieved/is likely to achieve positive public health impacts. Expert research and analysis makes clear that:

(a) the assumption that packaging changes smoking behaviour, particularly of minors, is wrong and is not supported by the research; and

(b) the survey evidence relied upon by the proponents of plain packaging to suggest that “plain packaging works” (including that in the Systematic Reviews)4 is incapable of constituting reliable research evidence of the likely impact of plain packaging on actual smoking behaviour.

2.2 JTI’s view in this regard is, in particular, based upon the following expert research/analysis which has been updated for, and provided to, the Chantler Review:

(a) Professor Devinney’s 2014 Report5 (prepared at the request of external legal counsel to JTI) specifically addresses the evidence base which the Chantler

Page 4 Review has identified in its Method Statement,6 including the Systematic Review Update. Professor Devinney has concluded that the current evidence base is insufficient to justify the conclusion that plain packaging is likely to have any impact on actual smoking behaviour. He bases this conclusion on the fact that, when considered collectively, the studies examined suffer from serious limitations as a body of scientific research.

(b) Professor Steinberg’s 2010 Report (prepared at the request of external legal counsel to JTI and which is reinforced by Professor Steinberg’s 7 January 2014 letter to Sir Cyril Chantler) is based upon his considerable expertise in the area of adolescent judgment, decision-making, and risk-taking.7 In respect of the question whether plain packaging is likely to have any actual positive public health impacts, Professor Steinberg explains that: “Measures to prevent or reduce youth smoking are only likely to be effective if they are informed by scientific research on risk-taking and decision-making in this age group. I know of no scientific evidence that suggests, nor would my understanding of the current research on adolescent decision-making suggest, that cigarette packaging is relevant to adolescents’ decisions to experiment with or continue smoking”.

2.3 To ensure that the Chantler Review consists of a thorough and comprehensive analysis of materials of potential relevance to the question posed by the Terms of Reference,8 it must also take into account the following experts’ reports9 (notwithstanding the fact that they have previously been submitted as part of the Consultation):10

(a) Professor Cave’s Report,11 which concludes that the evidence base needed to justify introducing plain packaging should be the best available, reliable and needs to include a careful assessment of whether equally effective and more targeted measures should be applied first.

(b) Professors Dhar and Nowlis’ Report, which concludes that plain packaging is unlikely to be effective as a means to reduce smoking and encourage quitting by adults.12

(c) Dr Keegan’s Reports (between the two of them, Professor Devinney and Dr Keegan have independently as experts reviewed the publicly available consumer survey studies relevant to plain packaging and found that they do not constitute reliable evidence that plain packaging will change actual smoking behaviour, either by preventing minors from smoking or by increasing smoking cessation among minors or adults).13

(d) Dr Lilico’s 2012 Report, which (in respect of the question whether plain packaging is likely to have any negative public health impacts), anticipates (in addition to other impacts which the independent reviewer has identified as falling outside the scope of the Chantler Review) that a market reaction to plain packaging would be large scale downtrading into lower price products.14

(e) Professors Zimmerman and Chaudhry’s Report, which concludes that plain packaging will have negative public health impacts as it will worsen the illicit trade in tobacco products by opening up a number of new opportunities for illicit traders while making it more difficult for consumers, retailers and law

Page 5 enforcement agencies to differentiate between genuine and fake packs.15 In this context, the Schedule to this submission provides an overview of the illicit trade position in Australia after the introduction of plain packaging.

PACKAGING IS NOT A PREDICTOR OF SMOKING BEHAVIOUR

2.4 As JTI made clear in the Consultation Response, plain packaging is based on a fundamental mischaracterisation of the role of packaging. The assumption that packaging changes smoking behaviour, particularly of minors, is wrong. It is not supported by the evidence and is inconsistent with a credible and scientifically rigorous understanding of smoking behaviour.

2.5 Two key points flow from the pre-existing independent research/analysis of leading experts (notably Professors Steinberg, Dhar and Nowlis) as to how the smoking behaviour of adults and minors should best be understood on the basis of contemporary scientific thinking.

2.6 First, measures to reduce smoking among minors will only be effective if they control minors’ ability to obtain tobacco products and remove cigarettes from the social networks of teenagers. Access-based solutions take due account of the fact that minors are naturally more prone to risk-taking behaviour than adults. As Professor Steinberg explains, decision-making during adolescence is characterised by a heightened emphasis on rewards over risks; a tendency to focus on the immediate, rather than longer term, consequences of a decision; a susceptibility to peer influence; and weak self-regulation. Minors are well aware of the health risks of smoking, but may choose to experiment anyway. Taken together, these factors explain why a psychological profile characterised by sensation-seeking, peer and family influence (i.e., peers and family members who smoke) and the availability of cigarettes are the main risk factors for smoking. Accordingly, measures focused on packaging are unlikely to be effective.

2.7 Secondly, measures directed at adult smoking behaviour need to target adults’ decision-making at the point of consumption in order to be effective, taking due account of the analysis that adults employ when making decisions about risk. They would also need to be more individualised and positively framed, in the light of the triggers to smoking behaviour. Professors Dhar and Nowlis therefore dismiss the likely effectiveness of interventions that reflect the so-called ‘traditional model’ of consumer decision-making, which is based on the notion that rational consumers will shift their smoking behaviour based on their evaluation of information on the health risks of smoking.

2.8 JTI notes that Professor Steinberg has recently reaffirmed his view that plain packaging is not likely to be an effective means of reducing smoking initiation among minors in the UK.16 His further analysis is set out in Professor Steinberg’s 7 January 2014 letter to Sir Cyril Chantler. In short:

(a) He is aware of “no scientific evidence that suggests, nor would [his] understanding of the current research on adolescent decision-making suggest, that cigarette packaging is relevant to adolescents’ decisions to experiment with or continue smoking”.

Page 6 (b) Minors in England and Wales who smoke are more likely to ask someone else to buy cigarettes for them rather than try to buy them in shops, or to obtain them from friends or family. Professor Steinberg considers that “the ways in which adolescents, who may be experimenters or irregular users, and adults, who are likely to be regular smokers, obtain cigarettes are very different, which diminishes the reach and force of policies aimed at regulating how cigarettes are packaged”.

(c) It is “abundantly clear” that adolescents in the UK are aware of and understand the risks of smoking and know that it has harmful long-term health consequences. Therefore, even if plain packaging was shown to increase the prominence of health warnings, Professor Steinberg’s view is that this would “have no influence on adolescent experimentation with, or use of, tobacco products”.

(d) Finally, measures like plain packaging are unlikely to be effective if they are easily undermined by those they seek to protect: “Those adolescents who may find standardized packaging less appealing are most likely to take measures to personalize their packages similar to the way many adolescents do for their smartphones. There has been a sharp rise in sales of such personalized cases or labels since the introduction of graphic health warnings or standardized packaging (in Australia).”17

2.9 Such analysis accords with DH-funded research which notes that: “Current approaches to combat smoking which highlight its health risks may be ineffective for [young people], as health messages are known to have little salience for children and young people... Approaches that inhibit young people’s ability to obtain tobacco may therefore be more appropriate for preventing smoking in this age group”.18

2.10 Smokers take smoking-related health messages from a variety of different sources and media, including on-pack health warnings, and are well aware of the health risks of smoking. In 2011, JTI created a website, www.nosafecigarette.com, with information to reinforce the message that no cigarette is safe, and to clarify any misconceptions that consumers may have.

2.11 Finally, HM Government has ignored its own evidence on the predictors of smoking: this evidence does not include packaging.19 The DH’s own previous analysis therefore corroborates the expert research on which JTI relies.20

NO EVIDENCE OF ACTUAL SMOKING BEHAVIOUR

Introduction

2.12 A significant number of consumer surveys have been conducted which seek to demonstrate what the reactions of people to plain packaging might be. These surveys are often relied upon by the proponents of plain packaging to suggest that “plain packaging works”. In the case of the Systematic Reviews (discussed below), the studies are batched in an attempt to try and compensate for their individual failings. These surveys (individually or collectively) are incapable of constituting reliable research evidence of the likely impact of plain packaging on actual smoking behaviour. That is made clear by expert analysis of what those surveys in fact show and of their methodological reliability.

Page 7 2.13 As explained previously in the Consultation Response (see Section 3 and Schedule 2) and affirmed here (taking into account new material made available), expert research makes clear that there is no reliable evidence (whether in the Consultation, the IA,21 the Systematic Reviews or elsewhere) to suggest that banning branded packaging is likely to lead to a change in actual smoking behaviour, either by way of a reduction in smoking uptake by minors or increased smoking cessation among minors or adults.

2.14 In this context, in August 2012, a senior US Federal Court of Appeal, when evaluating the evidence in support of the introduction of pictorial health warnings on packs in the US, noted that “it is mere speculation to suggest that respondents who report increased thoughts about quitting smoking will actually follow through on their intentions” (emphasis in original).22 The US Government did not appeal the ruling against the health warnings and instead restarted the legislative process. Similarly, the DH should not proceed with – and the Chantler Review should not support – plans for plain packaging unless such a measure is supported by robust and compelling evidence of what people actually do, rather than merely what they say they will do.

The Systematic Reviews

2.15 In 2012, the Systematic Review reported on “37 studies assessing the potential impacts of plain packaging in relation to appeal, perceptions of harm, and salience and effectiveness of health warnings” and “examined what the available literature had found about smoking-related attitudes, beliefs, intentions and behaviour in respect to plain packaging, and facilitators and barriers to plain packaging”.23

2.16 The Updated Systematic Review was made available in late 2013 (the precise publication date is unclear, but appears to be at a point later than the “September 2013” reference on the front cover would suggest).24 This document states: “…in the period since the systematic review was published, there have been a number of new plain packaging studies. This briefing paper provides an update on the evidence published since the systematic review” and “[w]e located 17 studies that have been published between August 2011, the cut-off date for study inclusion in the original systematic review, and mid-September 2013”.25

2.17 Accordingly, the Systematic Reviews together report on 54 consumer survey studies. Each of the 54 studies has been reviewed by Professor Devinney or Dr Keegan. In addition, in their reports, Professor Devinney and Dr Keegan have reviewed further plain packaging-related consumer survey studies which are not included in the Systematic Reviews.

Actual smoking behaviour

2.18 No evidence has been put forward that addresses the likely impact on actual smoking behaviour. The Systematic Review made this clear as: (a) it reviews evidence on plain packaging in order to “inform responses to this Consultation and any subsequent policy making”;26 and (b) its primary aim is “to assess the impact of plain tobacco packaging on the:(i) appeal of the packaging or product; (ii) salience and effectiveness of health warnings; and (iii) perceptions of product strength and harm”.27

Page 8 2.19 Further, the authors of the Updated Systematic Review have acknowledged that “research from the UK is unable to gauge the impact of plain packaging on youth uptake and adult smoking behaviour as it has not been introduced”.28 This is consistent with the finding by the authors of the Systematic Review that the evidence is inconclusive in terms of what – if any – behavioural changes may occur as a result of plain packaging.29

2.20 In fact, not a single study can be pointed to in the Systematic Reviews which demonstrates that plain packaging is likely to achieve actual public health benefits.

2.21 The authors of the Updated Systematic Review seek to mitigate the absence of any such evidence by stating that “since the [Systematic Review] the evidence base has continued to grow at a considerable pace”.30 However, it is Professor Devinney’s expert opinion that “while there are now a number of studies purporting to determine the potential impact of plain packaging in achieving these goals, a close examination of them reveals that: (i) the body of research has not examined any specific aspect of market related behaviour directly, instead relying exclusively on attitudes, opinions and self reports of possible behaviours; (ii) the body of research has continued to apply the same flawed methodological approaches over and over again; and (iii) the body of research has failed to take into account important related research that could improve and inform both the scientific and policy debate”.31

2.22 Two points follow regarding the quality of the evidence relied upon.

2.23 First, the Systematic Reviews rely only on attitudinal consumer research; but it is well established that people are not particularly reliable at self-assessment. Dr Keegan states that “recall reliability is an important methodological consideration” when reviewing the evidence,32 and that “observing what people do is a better predictor of behavior than recording how people respond to questions about what they think they will do” and, moreover, that “it is well established that consumer recall of past behaviors can be inaccurate, as the time elapsed between the event and the time of reporting can distort respondents’ perceptions”.33 Professor Steinberg notes that “One must be very cautious in attempting to extrapolate the results of studies involving adults to adolescents, given the differences in adults’ and adolescents’ decision-making” and that “Demonstrating that, when presented with a particular pack design by a researcher, a person will say that he or she would be more likely to quit smoking, or never to take it up, is not the same as demonstrating that the packaging actually leads to a change in behavior. There is a long tradition of research showing that it is far easier to change what people say they will do than to change their actual behavior”.34 This issue was acknowledged in the Systematic Review.35

2.24 Secondly, good research will seek to try to mitigate the problem of a gap between attitudinal and behavioural data. Professor Devinney speaks to the issue of “attitude-behaviour gap or the difference between ‘stated’ intentions and ‘revealed’ or actual purchases” in Section 2 of his reports.

2.25 Professor Devinney and Dr Keegan’s research has evaluated the studies forming part of the Systematic Reviews (and others) against international standards and best practice for consumer survey analysis. These criteria include:

Page 9 (a) examining “the extent to which a study provides valid and generalisable conclusions that align with what an individual would do across a range of contexts”,36 against which Professor Devinney found that “all of the studies fail to meet reasonable incentive compatibility requirements. There is no indication that the studied individuals’ attitudes and intentions, as measured, align with their actual or future intentions”;37

(b) attempting to “determine what an individual’s decision is via the choices they make”,38 against which Professor Devinney found that “one would take an unjustified “leap of faith” about the importance of various measures used in the studies to relate them to actual behaviours”;39 and

(c) seeking to “understand the degree to which stated intentions align better with actual behaviour”,40 on which Professor Devinney states that “it is my conclusion that, as in my 2010 and 2012 Reports, none of the studies met enough of the criteria whereby one could argue that they would provide potentially valid predictions of actual purchasing behaviour”.41

2.26 Professor Devinney finds that: (a) in the case of all the studies, there are significant limitations in the structuring of questions, which in many cases assumed knowledge or led the respondent; (b) the sampling frame in the studies varies, implying that none can be used to make predictions about either the general population or the population of minors (both smokers and non-smokers); and (c) the analysis in the studies suffers from significant statistical validity issues.42 To summarise these points, Professor Devinney provides an overview of each of the studies examined in his 2014 report and a summary of their limitations against the above criteria.43

2.27 Following Professor Devinney’s review of the publicly available consumer survey studies on plain packaging, he concludes that:

(a) “there is no indication that the studied individuals’ attitudes and intentions, as measured, align with their actual or future behaviour” and further that “the studies also fail to provide experimental or situational contexts in which the individual would be applying the decision model that they used when making purchasing decisions”;44 and

(b) “it is my expert opinion based on the publicly available consumer surveys and experiments that I have evaluated in this report that they do not provide reliable evidence that plain packaging would be effective in achieving the public policy goals of changing actual smoking behaviour”.45

2.28 Others have expressed similar concerns. In reviewing a request from prominent tobacco control advocates for a grant relevant to studies considering “the effects of current and plain cigarette package design on smokers’ cigarette evaluation”,46 one of the independent assessors of the study design commented that “the public health benefit of this type of research into differences in packaging strategies must ultimately be predicated on whether there is change in consumption of cigarettes (and of a level which is likely to be clinically significant). The problem I have with the study as it stands is that the link between the ‘sensory experience’ and behaviour change is not well established. In other words, it may well be the case that

Page 10 one form of packaging may be associated with a more enjoyable experience than another but why will this necessarily lead to differences in smoking levels[?]”.

2.29 The Systematic Review, however, states that: “there is strong evidence […] relating to the role of plain packaging in helping reduce smoking rates”.47 The reasons why this statement is deeply flawed include:

(a) The authors of the IA reached a different conclusion. The IA only says that there are “plausible scenarios” under which plain packaging “could be effective” and that there is only a “possible impact” on consumption.48 This massively departs from the notion that there is “strong evidence”.

(b) Professor Devinney and Dr Keegan show that there is no reliable evidence, as described above.

(c) On a closer inspection, the Systematic Review itself suggests that the evidence base reviewed is far from “strong”. Indeed, its authors acknowledge that “there are a number of limitations with the plain packaging studies found”.49 For example, amongst other concerns, the Systematic Review concedes that:

(i) “individual studies are limited by elements of study design”;50

(ii) “…the evidence in the review is largely drawn from correlational studies, which makes it difficult to draw conclusions about expected outcomes. Many of the studies use hypothetical scenarios, and therefore are not truly able to test how individuals would react or behave if plain packaging was introduced”;51 and

(iii) “…some of the surveys use samples representative of the general population but most do not, and instead use convenience or probability sampling” and “…when comparing new packs (in this case plain packs) with those already in the marketplace, the new packs typically attract a great deal of both favourable and unfavourable attention”.52

2.30 Indeed, of the 54 studies reviewed in the Systematic Reviews, over 30 adopt the methodology of asking respondents to provide their opinions and perceptions on a comparison between a branded pack and a plain pack. Professor Devinney has questioned studies which utilise this experimental design, stating that “…none actually test only plain packaging alternatives – which is the purchasing reality consumers would face – nor do they consider features and contexts which influence cigarette purchasing, such as price or availability. Hence, in my view, they are making conclusions based on false comparisons”.53

Serious methodological flaws in the Systematic Reviews

2.31 The Systematic Reviews are themselves subject to serious methodological limitations which make reliance on them by the Chantler Review inappropriate.

2.32 First, the Systematic Reviews are forced, in view of the “limitations” of all of the individual studies, to rely upon the consistency demonstrated by the studies. So, while the Systematic Review states that “there was a consistency in study findings regarding the potential impacts of plain packaging…this consistency can provide

Page 11 confidence about the observed potential effects of plain packaging”,54 this defies logic and cannot be correct:

(a) The study designs are systematically and consistently flawed. The Systematic Reviews ignore the fact that the findings are consistent because, in Professor Devinney’s words, they “apply what are effectively the same, or very fundamentally similar, flawed approaches to the structure of their experiments”55 and “given the fact that many of these studies mimic the same empirical (and incorrect) approach, the consistency of the findings may be revealing very little”.56

(b) The Systematic Review wrongly presupposes that “consistency” can be used as a proxy for ‘correct’. The authors assume that because the study findings appear consistent when taken as a whole, the evidence base must be methodologically sound and reliable (despite the recognition of the limitations of the individual studies).

(c) Adding together multiple flawed studies does not make an unreliable study reliable. Nor does it make the studies collectively reliable. By way of analogy, students who fail one exam do not have their position improved if they fail multiple exams. The sum cannot, in this case, be more than its constituent parts.

2.33 Secondly, and despite claims to the contrary, the Systematic Reviews are inherently biased and self-interested, and do not account for either author or journal partiality. For example:

(a) The lead author of the Systematic Reviews (Dr Crawford Moodie) is reviewing (i) his own work (he authored or co-authored 8 of the 54 studies reviewed) and (ii) the work of a network of scholars with whom he interacts directly and has co-authored many works. Moreover, the Systematic Review extends gratitude to “Dave Hammond for his contribution to the development of the protocol” who also authored or co-authored 8 of the 54 studies reviewed.57

(b) 6 authors are responsible for nearly two-thirds of all of the studies included in the Systematic Reviews, and the studies are repetitive in their (incorrect) methodological approach.

(c) Many of the journals examined are unlikely to publish studies that have findings which are contrary to the overall objective of the journal. For example, the studies are published in a very small number of publication outlets, with Tobacco Control, the BMJ Open, Addiction and Nicotine and Tobacco Research, being the dominant outlets for approximately one third of the studies. Tobacco Control has the stated aim of “provid[ing] a forum for research, analysis, commentary, and debate on policies, programmes, and strategies that are likely to further the objectives of a comprehensive tobacco control policy”,58 and the BMJ and its affiliates, including the BMJ Open, has recently taken the decision not to publish science which is funded, wholly or in part, by tobacco product manufacturers.59

Page 12 (d) The Systematic Reviews do not appear to have considered the findings set out in the expert reports of Professor Devinney or Dr Keegan,60 both of which are relevant to the issue of plain packaging and are in the public domain on www.jti.com. While JTI would not expect these reports to be considered as primary research, their exclusion from the broader search appears to further suggest that the approach adopted in the Systematic Review is at best flawed, and at worst, skewed.

(e) In short, Professor Devinney has concluded that “a systematic review of fundamentally invalidly conducted research will amount to little more than “garbage in, garbage out””.61

These issues are discussed in more detail in Schedule 2 to the Consultation Response.

2.34 In summary, the evidence base for plain packaging is as weak or non-existent as it was in 2008. There has been no meaningful development of the evidence base since 2008, despite a number of new studies having been published.

3. PLAIN PACKAGING’S NEGATIVE PUBLIC HEALTH IMPACTS

PLAIN PACKAGING EXACERBATING ILLICIT TRADE

3.1 Plain packaging will worsen the trade in illicit tobacco products in the UK. In doing so it will have a negative public health impact.

3.2 JTI’s views on this point are based on (a) JTI’s own industry expertise; (b) the expert opinions contained in Professors Zimmerman and Chaudhry’s Report (which concludes that plain packaging “will worsen the illicit trade in tobacco products”);62 and (c) the analysis of the illicit trade position in Australia after the introduction of plain packaging, as set out in the Schedule to this submission.

3.3 The Consultation and the IA have previously recognised the risk that the illicit trade problem will be made worse by the introduction of plain packaging, stating that although “it is hard to predict the potential impact on the complex and dynamic nature of the illicit trade in contraband and counterfeit tobacco”,63 “there is a risk that plain tobacco packaging may lead to some reversal of [the existing downward trend in the illicit trade in tobacco products]”.64 The IA also notes that “it may be argued that plain tobacco packaging would be easier and cheaper to copy, so increasing the supply of illicit tobacco”.65

3.4 To the extent that plain packaging facilitates the trade in counterfeit and/or contraband cigarettes, Professors Zimmerman and Chaudhry note that it is “highly likely to aggravate the existing negative impacts of the already serious and socially damaging trade in illicit tobacco”66 and [t]he loss of tax revenues as more smokers shift from licit to illicit product has a multiplier effect since governments have less funding for healthcare, education, and other public services”.67

3.5 Of particular relevance to the Chantler Review, plain packaging will therefore undermine the UK’s stated public health aim of using pricing as a means of tobacco control regulation. Those criminal gangs conducting illicit trade in tobacco products are unlikely to be concerned about who they sell their products to.

Page 13 3.6 As black market tobacco products are often more accessible to those underage, and those from low income groups, plain packaging also risks undermining the key objective of reducing smoking by minors and those groups. As stated by one tobacco control group: “Poorer people are more likely to be tempted by cheaper prices, and access to smuggled tobacco therefore undermines efforts to quit smoking, exacerbating health inequalities. […] one in four of the poorest smokers buy smuggled tobacco compared to one in eight of the most affluent”.68 As Professors Zimmerman and Chaudhry note, one study conducted in the UK has found that: “Cigarette and tobacco smuggling is therefore viewed positively by low-income smokers as a way of dealing with the increasing cost of cigarettes”.69

3.7 Regulators and public health officials in the UK (and in Australia)70 have repeatedly expressed the concern that smokers could be exposed to greater health risks by consuming an illicit product.71 By way of example, the DH has previously stated that “a significant amount of tobacco worldwide is sold illegally, avoiding tax. The result is a continuing supply of very cheap cigarettes, which undermines the benefits of high taxation in reducing tobacco use and ultimately presents a significant threat to public health in many countries, including the UK”.72

3.8 Further, due to an absence of product-related information being provided to them, regulators are left unable to determine certain issues of product safety for illicitly traded products and consumers cannot rely on the existence of regulatory oversight that occurs for legitimate products. This is particularly the case where counterfeiters make no effort to comply with applicable regulation/industry best practice for tobacco products. One December 2013 media piece (using the headline “Counterfeit fags are ‘even more dangerous’”) observes: “Smokers are being warned about the increased dangers of fire as well as health risks from cheap illicit cigarettes. Derbyshire County Council found that all the illicit tobacco products seized in recent raids were missing vital safety features which help to prevent house fires… An accredited laboratory carried out tests on 18 samples collected from nine Derbyshire shops using a council trial…”.73

PLAIN PACKAGING LEADING TO CHEAPER LAWFUL TOBACCO

3.9 JTI believes plain packaging will lead to further downtrading in consumer purchasing. JTI’s approach to this issue is informed by the work undertaken by Dr Lilico regarding the impact of plain packaging on competition and the tobacco market.74 Dr Lilico anticipates, amongst other things, large-scale downtrading into lower quality products, including a reduction in market share for the premium segment and an increase in the value for money segment. Further, average prices for tobacco products as a whole fall in a plain packaging scenario. Dr Lilico states, “our judgement… is that one should expect enough brand degradation, from a plain packs requirement, to produce scenarios of these sorts”.75 Dr Lilico’s model demonstrates that average prices for tobacco products as a whole fall when plain packaging results in even modest degrees of brand degradation.76

3.10 Of particular relevance to the Chantler Review, any price drops caused by plain packaging are at odds with the DH’s aim of reducing smoking initiation by minors, as it has stated that lower prices generally mean increased availability and greater access for minors to tobacco products.77 The Regulatory Policy Committee expressed the same concern prior to the Consultation.78

Page 14 3.11 The DH has previously indicated that if a decrease in price were to follow the introduction of plain packaging, increases in tax on tobacco could counter the effect.79 High tobacco taxation rates and/or tax rates largely in excess of those practiced in neighbouring countries have already resulted in UK consumers increasingly purchasing lower-priced tobacco products rather than premium brands, and have encouraged the illicit trade in tobacco products. As noted at paragraph 5.31 of Dr Lilico’s 2012 Report, the risk of counterfeit and contraband increasing might well limit the scope for tax rises to offset these price falls.

PLAIN PACKAGING MAY ENCOURAGE YOUTH SMOKING

3.12 The risk, previously recognised by the DH, that: “Children may be encouraged to take up smoking if plain packages were introduced, as it could be seen as rebellious”80 also needs to be assessed carefully.

3.13 In this context, JTI notes the following analysis by other commentators:

(a) DH-funded research has recognised that “[i]ncreased regulation may serve to inadvertently heighten the kudos of smoking as an act of rebellion against adult regulation”.81

(b) In an article entitled “Smoke signals: Will plain packaging cause cigarette sales to fall or will minimalist designs have a cachet in their own right?”, one commentator (in The Independent newspaper) has recently stated: “Though all attempts to make cigarettes less appealing should be celebrated, I worry that dressing fags up like forbidden fruit will have the reverse effect to the one intended. If implemented, I envisage plain packaging acquiring a kind of cachet; a kind of outlawed cool that would make it oh-so-appealing to youngsters. After all, it’s not that kids are attracted to the brands themselves; it’s that they’re fixated by the way they’re perceived by their peers when wearing, drinking, or eating the branded items. That’s why my friend chose to keep her tobacco in an unbranded box. It was cooler”.82

(c) The journal Pediatrics has published an article, albeit in a different context, that highlights the potential risks of steps taken “to protect youth from objectionable content”: “These unintended effects of labels are in line with the forbidden-fruit hypothesis, which is deduced from reactance theory” and “The more restrictive the age label, the more attractive the video games were judged to be”.83 This accords with the following comment made in 1999 by the Social Issues Research Centre in “The side effects of health warnings”: “Rebellious teenagers seem particularly susceptible to the forbidden-fruit effect: extensive anti-smoking campaigns in recent years, for example, coincide with reported significant increases in teenage smoking. Heavy- handed warnings about the dangers of drugs and alcohol have been equally ineffective”.84

4. THE STANDARD TO BE MET BY THE CHANTLER REVIEW

BETTER REGULATION

4.1 As set out above, there is no evidence that plain packaging is likely to be effective; rather, plain packaging is likely to have negative impacts which would in

Page 15 fact undermine public health. In this context, Better Regulation principles require the independent reviewer to be satisfied, having carefully and thoroughly considered all relevant evidence irrespective of whether that has been submitted by proponents or opponents of plain packaging, that a “robust and compelling”85 case can be made that plain packaging will have actual, quantifiable positive public health impacts before the independent reviewer could advise the Secretary of State for Health there was sufficient evidence to take forward such a proposal.

4.2 Reflecting these core principles, Professor Martin Cave OBE86 has identified the following core Better Regulation requirement which would need to be met for regulatory interventions like plain packaging to be recommended:

Evidence-based assessment – the evidence base for the policy must be both the best available and reliable; there must be evidence to support the proposal over alternative options; impact assessments must be conducted and must be as accurate and complete as is reasonably practicable.87

4.3 The level of scrutiny required of the evidence base is especially important here as the only country which has actual experience of plain packaging (Australia) has not been able to show that public health benefits (in terms of actual changes in smoking behaviour) have been achieved in the first year of the measure. Further, an assessment of the measure will not be commissioned until the end of 2014.88

4.4 Indeed, even the fiercest proponents of the measure now argue that it could be many years before the impact they said plain packaging would have is felt and some have also conceded that plain packaging will have no positive impact on existing smokers who wish to quit.89 Most recently (on 8 January 2014), this has been acknowledged (in surprisingly frank terms) by the Head of the British Lung Foundation Scotland: “It won’t make smokers quit. We know that. Nobody has claimed it will”.90

“LIKELY TO HAVE AN EFFECT”

4.5 The Chantler Review also raises the important question of the standard of proof applicable to such an assessment of the evidence base (a question made more complex by competing legal definitions as to what “likely” means in these circumstances). In simple terms, to what extent must the independent reviewer be satisfied that plain packaging will actually have public health benefits if introduced in the UK?

4.6 The Terms of Reference require the independent reviewer to “…give advice to the Secretary of State for Health, taking into account existing and any fresh evidence, as to whether or not the introduction of standardised packaging is likely to have an effect on public health (and what any effect might be), in particular in relation to the health of children”.

4.7 Despite the fact that JTI remains firmly of the view that plain packaging is unlikely to have an effect on public health, it wants to make clear that:

(a) it is not enough for plain packaging only to be likely to have an effect on public health given such a measure would deprive us of our most valuable assets and unjustifiably infringe our fundamental legal rights;91 and

Page 16 (b) the only appropriate interpretation of the wording “likely to have an effect on public health” in this (inappropriately low) threshold test is for the Chantler Review to assess whether plain packaging, if introduced in the UK, would be likely to have an actual, quantifiable positive public health effect here.92

4.8 The likely effect would need to be a public health benefit as a result of changes in actual smoking behaviour. This test would not be satisfied by “reducing the appeal of tobacco products”93 or increasing the prominence of health warnings94 if that did not result in people not taking up smoking, smoking less or quitting.95 This has been recognised by the Method Statement when it refers to establishing “whether the introduction of standardised packaging is likely to lead to a decrease in the consumption of tobacco” (emphasis added).96

4.9 If it is concluded (wrongly in JTI’s view) that plain packaging is “likely to” have such an effect in the UK, such a determination would not be sufficient to justify action by the DH given the obligations placed on it before making policy. This is a result of the narrow focus of the Chantler Review.

4.10 The Method Statement makes clear that the Chantler Review is not assessing the potential consequences of plain packaging as regards “competition, trade-marking and freedom of choice”, “the merits of alternative means of tobacco control”, nor “issues such as the overall impact of standardised packaging”. But the DH cannot limit itself to considering the public health impacts (potential or otherwise) of plain packaging.97 This reinforces the need for further, detailed consultation following a separate and additional independent review by experts in each of these fields (and those other areas in respect of which the Consultation Response identified evidence of the negative consequences plain packaging would have in the UK), before the DH could reach any view as to the status of the broader evidence base relating to plain packaging. The Chantler Review could not excuse the DH from this obligation – indeed, it leads to the very clear conclusion that it could only form part of the review that would be necessary.

4.11 Given the severity and the significance of a measure like plain packaging, and its disproportionate impact on specific groups (in particular, tobacco manufacturers), it is particularly important that (if the independent reviewer concludes plain packaging would be likely to have an actual, positive public health effect in the UK) the DH undertakes a thorough analysis of all relevant factors, based on reliable evidence. The relevant factors in this context have previously been identified separately by JTI98 and Professor Cave.99

PRIOR CONCLUSIONS AS TO THE STATE OF THE EVIDENCE

4.12 The threshold to be met before the independent reviewer could advise that, on the basis of the current evidence, plain packaging is likely to have a positive public health effect is increased significantly by the fact that prior reviews in the UK of this evidence-base have concluded that it was inadequate to justify moving forwards at that point in time.

4.13 In June 2009, after an extensive public consultation on the issue in the context of the FTC Document,100 the DH said that there was no evidence that plain packaging reduced smoking uptake amongst minors or helped people to quit. On 25 June 2009, the then Minister of State for Public Health stated: “No studies have been undertaken

Page 17 to show that plain packaging of tobacco would cut smoking uptake among young people or enable 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 benefits 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”.101 (Emphasis added.) This is after the then Secretary of State for Health (Rt Hon Alan Johnson MP, Labour) told Parliament in 2008 that “there is no evidence base that [plain packaging] actually reduces the number of young children smoking”.102 (Emphasis added.)

4.14 In May 2011, a DH official noted in correspondence with a counterpart at the Australian Department of Health and Ageing that “… there isn’t any hard evidence to show that [plain packaging] works”.103

4.15 In July 2013, after a second consultation which received over 668,000 responses, almost two thirds of which were opposed to the measure, HM Government announced that it had decided “to wait until the emerging impact of the decision in Australia can be measured before making a final decision on this policy”.104

ANALYSIS OF ALL RELEVANT PUBLIC HEALTH EVIDENCE

A comprehensive approach

4.16 For the reasons set out in this submission, JTI considers it critical that the Chantler Review consists of a thorough and comprehensive analysis of all materials of potential relevance to the question posed by the Terms of Reference. It would be highly inappropriate for the Chantler Review to exclude analysis of such materials which were provided in the context of the Consultation.

4.17 It is also important, so as to ensure transparency, that the Chantler Review makes clear:

(a) what materials have been taken into account; and

(b) what materials have not been taken into account and why.105

All materials which have been taken into account should then be made publicly available (subject to necessary redactions for confidentiality as indicated in the Method Statement).

4.18 The need for a thorough and comprehensive analysis of all materials of potential relevance to the question posed by the Terms of Reference also requires the independent reviewer to ensure he is not adopting an overly narrow approach to the nature of the evidence he will consider:

(a) The Method Statement indicates that parties can submit “research-based evidence”. This should not be used to preclude submissions which are in the nature of secondary, rather than primary, research. It has been made clear from the Method Statement that the Chantler Review will consider some literature reviews (namely the Systematic Review and the Systematic Review Update). Therefore, it would be wrong to preclude (for example) the

Page 18 Devinney 2014 Report from the independent review on the basis that it critiques primary research sources.

(b) The Method Statement indicates that submissions to the Chantler Review should “indicate the status of the evidence adduced (e.g. peer reviewed)…”. In this context, JTI wishes to make clear that it would be inappropriate to make assumptions about the relevance and weight attributable to materials submitted to the Chantler Review on the basis of whether they have been peer reviewed or not. The main reasons why this is the case are:

(i) Whilst peer review can help to improve the quality of any given study, peer review is a non-standardised process. Particularly in the field of social sciences, it is a subjective process, open to every sort of bias (the independent reviewer should, in particular, question the benefit of peer review in the context of tobacco control studies being reviewed by other tobacco control advocates). The level of scrutiny given to a manuscript differs from journal to journal, conference to conference, reviewer to reviewer. It makes an assumption of honesty and independence, and so, while it can assist in establishing validity, it cannot guarantee it.

(ii) There is a significant body of literature which is critical of the peer review process. Peer review is no guarantee that a particular manuscript or study is reliable or independent. Nor is it a stamp of quality.

(iii) Methodological limitations that would prevent a study, or survey, being reliable evidence would not necessarily prevent publication in peer-reviewed tobacco control journals. Experts (for instance, Dr Keegan and Professor Devinney) have set out in detail the methodological tests which lead to reliable analyses, irrespective of whether a particular report has been peer-reviewed.

(iv) For the same reasons, the absence of peer review does not mean that an author’s text is any less reliable. A peer reviewed text can remain less reliable than a more detailed and robust analysis by a leading expert which has not been subjected to peer review. Moreover, certain types of evidence which are central to the question the independent reviewer has been asked to address may not be suitable for peer review or may be automatically excluded from certain peer reviewed journals (as noted above, the BMJ and its affiliates, will not publish science which is funded, wholly or in part, by tobacco product manufacturers).106

(c) To ensure independence and credibility in the conclusions of the Chantler Review, it must be ‘commissioning source blind’ when assessing the evidence submitted to it. The Method Statement refers to this being a “polarised debate” and it is right that there are competing views as to what the evidence base should consist of and what it shows. The only appropriate way to address this is to weigh the evidence irrespective of whether it has been commissioned by one side of the debate or the other.

Page 19 The Systematic Review Update should not be disregarded simply because it has been authored by a team of academics “core funded” by one of the tobacco control groups who are most vocal in their support of plain packaging (Cancer Research UK).107 Equally, expert reports commissioned on behalf of tobacco product manufacturers should be assessed by reference to the academic credentials of the reports’ authors, the quality of the analysis and what they add to the debate. Doing so is consistent with the statement made by the Parliamentary Under-Secretary of State for Health that the independent reviewer: “…is free to draw evidence from whatever sources he considers necessary and appropriate”.108

(d) It is necessary to consider also the evidence of plain packaging’s negative public health impacts (as discussed above).

NEED FOR EVIDENCE OF ADDITIONAL POSITIVE PUBLIC HEALTH IMPACTS

Impacts beyond that deemed attributable to existing initiatives

4.19 Better Regulation means that the independent reviewer could only advise that the evidence justifies plain packaging proposals being taken forward if he determined there was robust and compelling evidence that the introduction109 of plain packaging is likely to have actual positive public health impacts beyond and in addition to such impacts (if any) arising from the recent tobacco control initiatives listed in paragraph 2.27 of the Consultation Response. Certain of these measures have not been fully implemented and it remains unclear what public health impacts (if any) can be attributed to them (by way of example, as far as JTI is aware, the DH has not assessed either the effectiveness in the UK of the increase in the minimum purchase age from 16 to 18 or the introduction of large pictoral health warnings).110

4.20 Notably, the tobacco display ban, which prohibits the permanent display by retailers of tobacco products for retail sale and which has been introduced as a means of achieving, the DH claims, essentially the same public health goals as plain packaging, took effect only for large shops in England on 6 April 2012, in Scotland on 29 April 2013 in Northern Ireland on 31 October 2012 and in Wales on 3 December 2012. Small shops and other outlets to which the display ban applies (the vast majority of retail outlets selling tobacco products) will not need to comply in England, Scotland, Northern Ireland and Wales until 6 April 2015.

4.21 In this context, JTI notes that an agreement between the European Commission, Parliament and Council has been recently announced on the proposal for a second Tobacco Products Directive (generally known as TPD2), which is expected to (among other things) require much larger warnings with pictures positioned at the top of the pack and the use of standardised pack shapes and sizes.111 As a result, the TPD2 is in the final stages leading to its adoption by the European Parliament and the Council. Against this backdrop, the Chantler Review will need to determine whether the existing state of the law in the UK alone or together with the soon to be adopted TPD2 (which must be implemented into UK law) constitutes the appropriate baseline beyond which any alleged public health impacts of plain packaging must be examined. This assessment will go to the heart of the baseline scenario.

Page 20 Impacts beyond public health pre-existing trends

4.22 In a similar vein, Better Regulation requires of the independent reviewer that he could only advise that the evidence justifies plain packaging proposals being taken forward if he determined there was robust and compelling evidence it is likely to have actual positive public health impacts separate and in addition to pre-existing trends in the decline in smoking consumption and prevalence (for those over and under 18) in the UK over time. Put simply, the independent reviewer would need to satisfy himself as to whether there is robust and compelling evidence that plain packaging is likely to accelerate the pre-existing and projected downward trend in the UK (taking into account any anticipated changes resulting from the recent legislative developments noted above).

4.23 HM Government’s own statistics indicate that smoking by minors is falling. For example, the 2012 annual government survey of smoking among minors under the age of 16 shows that smoking prevalence has continued to decline.112 Prevalence of ‘regular’ smoking (defined as usually smoking at least one cigarette per week) fell to 4% in 2012, the lowest rate recorded since the survey began.113 The authors of the report note: “this is in line with the overall decline in regular smoking since the mid- 1990s”.114

FURTHER EVIDENCE GATHERING

Evidence gathering meetings

4.24 The Method Statement refers to the intention to “hold two main meetings – one on each side of this polarised debate – to address specific questions relevant to the effect of standardised packaging on public health”. JTI supports the intention to open up the debate to such meetings, but would welcome greater clarity on how the independent reviewer will decide who to invite and how these meetings will be structured to ensure that competing views can be meaningfully and fairly heard (taking into account, for example, the potential unfairness of holding, first, a meeting of those “for” plain packaging and, subsequently, one for those “against” it (or vice versa)).

Commissioning of further expert advice

4.25 The Method Statement suggests an intention to commission further expert advice to assist in qualitative analysis of the key evidence. JTI submits that, in doing so, the independent reviewer must obviously act in a transparent manner (using a public process in which experts from beyond the DH’s pre-existing pool of known tobacco control contacts could volunteer to participate), and in accordance with UK best practice guidelines on the choice and selection of experts. Such guidelines require the drawing upon of a “range of appropriate expert sources” that “should be sufficiently wide to reflect the diversity of opinion among experts in the appropriate field(s) in a balanced way”.115

4.26 JTI is strongly of the view that the independent reviewer should follow such guidelines to avoid some of the deficiencies of previous efforts by the DH to commission further expert advice in this area. For example, in 2012, the DH ignored academic best practice to justify commissioning experts solely in the area of “tobacco control”.116 The IA stated that “the latter two requirements suggested by Hora and

Page 21 Winterfeldt (impartiality and lack of an economic or personal stake in potential findings) are considered impractical in this area”.117 It was indefensible that the DH did not seek objectivity in its ‘evidence’ gathering, particularly when it intended to rely on such evidence to support its proposal for plain packaging. Simply stating that controlling for bias and self-interest is “impractical” cannot mean fundamental protections may be ignored.

4.27 If the independent reviewer does commission further expert advice to assist him in qualitative analysis of the key evidence, he would be well-advised to consider Hora and Winterfeldt’s statement (which the DH chose not to mention in 2012) that when considering the use of an expert panel: “a formal nomination process should also be considered. This is particularly important when there is controversy or alternative viewpoints concerning the subject matter to be treated. Inviting public interest groups as well as professional organizations to submit nominations may ward off later criticism that the experts were chosen from a select pool that shares only one of several possible viewpoints…. In addition, when there are multiple viewpoints, it is important that balance exists among the experts. Without such balance, the true state of uncertainty in a given situation may be significantly understated”.118

4.28 Ensuring experts are drawn from a much larger pool than that previously considered by the DH is likely to mean that the contemporary scientific thinking on smoking behaviour is captured, thereby avoiding the incorrect assumption that packaging changes smoking behaviour.

4.29 This is a view consistent with that of Professor Devinney, who has reviewed the study commissioned by the DH at paragraphs 4.3 to 4.17 of his 2014 Report. In his opinion, the use of expert judgment “can be a valid and useful method of analysis when there is a clear base model on which to anchor the judgments. However, the approach applied in this study is seriously flawed and its conclusions cannot be considered to have much, if any, validity”.119

4.30 In this context, Professor Devinney also found that “unlike the case of volcanic eruptions, where there is a clear science, or clinical judgments, where causes are understood, the elicitation being asked in this study is little more than pure guesswork as none of the existing studies on plain packaging actually measured the relevant variables” and ultimately that “focusing on “tobacco experts” biases the approach. The experts are themselves likely to want to promote specific outcomes. But there is no real way of determining this without creating an alternative panel of non-experts or those who are experts in other areas (e.g., marketing modellers, industrial organisation economists, psychologists, and so on who would be considered to be experts in packaging, marketing, pricing, and regulatory responses)”.120

Evidence gathering in Australia

4.31 Finally, the Method Statement refers to the intention to visit Australia to “take account of the experience of standardised packaging in that country”. Again, JTI welcomes the independent reviewer’s steps in this regard but would encourage that the visit is structured so as to ensure that the Chantler Review benefits from a broad spectrum of views to assess the Australian experience from various perspectives, rather than just the anecdotal insights of tobacco control advocates. Consistent with the transparency points made above, JTI notes that all those with whom the

Page 22 independent reviewer has had contact in Australia (or indeed elsewhere) in the context of the Chantler Review should be listed in the final report published.

5. ALTERNATIVE MEANS OF ACHIEVING PUBLIC HEALTH IMPACTS

5.1 Minors should not smoke and should not have access to tobacco products. Adult smokers should be reminded about the health risks of smoking. Accordingly, JTI supports efforts to achieve these goals through appropriate and proportionate regulatory interventions. We set out alternative regulatory solutions to achieve these goals in the Consultation Response, including:

(a) ensuring better enforcement of the current regulatory regime (including the under-utilised provision of the 1933 Act on the confiscation of cigarettes from minors) and tackling the illicit trade in tobacco products;

(b) reinforcing retail access prevention measures, such as ‘No ID, No Sale’; and

(c) following the Scottish example by penalising proxy purchasing by adults and penalising the purchase or attempted purchase of tobacco products by minors.

5.2 These solutions are likely to be effective when evaluated against Better Regulation principles. JTI draws this to the attention of the Chantler Review121 as:

(a) these solutions address the key methods by which minors access tobacco products, and studies exist to support their efficacy;122 and

(b) the independent reviewer has stated that he is concerned with evidence directed to the specific question whether plain packaging is likely to lead to a decrease in the consumption of tobacco, including “in particular a decrease in the risk of children becoming addicted”.123 Whatever one’s view on this issue (and JTI’s position on the issue of addiction generally is explained at http://www.jti.com/how-we-do-business/smoking-and-health/addiction/), such a risk does not materialise if youth smoking initiation is avoided/access by children to tobacco is prevented in the first place. This requires the Chantler Review to analyse measures proposed to prevent minors’ access to tobacco products.

JTI 10 January 2014

Page 23 SCHEDULE

OVERVIEW OF THE ILLICIT TRADE POSITION IN AUSTRALIA AFTER THE INTRODUCTION OF PLAIN PACKAGING

1. As explained in the Consultation Response and Professors Zimmerman and Chaudhry’s Report, smokers could be exposed to greater health risks by consuming unregulated illicit tobacco products, and regulators/public health officials have repeatedly warned of this additional risk.124

2. For instance, and in addition to the public health impact of illicit tobacco being more easily accessed by Australian children than lawful products, the Australian Customs and Border Protection Service (ACBPS) notes that tobacco smuggling “poses public health risks”.125 The Australian Department of Health & Ageing has made clear that:

“Counterfeit cigarettes are not produced under regulated conditions and as such there are no government imposed controls over hygiene, ingredient composition or the level of toxic materials. An increase in the availability of counterfeit tobacco products in Australia would be likely to increase health risks to consumers arising from unregulated products.”126

3. JTI understands that the Australian Federal Government and the ACBPS have not conducted any official review to assess whether plain packaging has had an impact on the Australian illicit tobacco trade since its introduction in December 2012. However, a number of recent developments in Australia reinforce JTI’s serious concern that plain packaging will fuel the illicit trade. A report published by KPMG in October 2013, “Illicit tobacco in Australia”,127 suggests an increase in consumption of contraband cigarettes has taken place between June 2012 and June 2013.

4. Further, this report suggests that the presence of illicit whites128 (which was almost non-existent in pre-plain packaging Australia) has grown since plain packaging came into force.129 Manchester is said to be the most popular illicit whites brand in Australia. The images below illustrate that this brand is offered in a number of variants which resemble the Marlboro Red brand of cigarettes.130

Manchester varieties seized in Australia

5. In particular, the packaging of the Manchester variant shown below closely resembles Marlboro Red. The font, the crest, and the layout of the white triangle

Page 24 against the red background (in the inverse), and the white text box on the top portion of the pack looks very similar to those of Marlboro Red.131

6. In a plain packaging environment, branded and familiar looking illicit whites may have an appeal over plain packs to some smokers who are seeking products that look similar to (albeit not exactly the same as) branded packs that they used to purchase before the introduction of plain packaging.

Manchester vs. Marlboro Red

7. The Australian experience has also clearly demonstrated that illicit traders will take advantage of new ‘market opportunities’ created by plain packaging. The image below shows a brand of illicit cigarettes (as far as JTI is aware, not available legally anywhere in the world and only emerging after the introduction of plain packaging) called Spoonbill in plain packaging.

Images of Spoonbill in plain packs

8. Some smokers may be purchasing packs of illicit whites, such as Manchester or Spoonbill, under the assumption that they are lawful products outside Australia or are just cheap cigarettes. If these consumers see these brands in plain packs, they may assume that these products are simply complying with the law. Under these circumstances, illicit whites in plain packs may further their legitimacy in the eyes of the consumer over time.

9. Other perceived public health protection measures also risk being undermined by plain packaging. For example, measures that facilitate the sale of illicit products

Page 25 undermine efforts to reduce the number of domestic and bush fires, which regularly cause significant damage in Australia.132

10. As is the case in the UK, genuine cigarettes sold in Australia are manufactured to safety standards under which cigarettes are considered by regulators to be more likely to self-extinguish when they are not being smoked.133 However, as stated by the UK All-Party Parliamentary Group on Smoking and Health, counterfeit tobacco products and illicit whites are unlikely to conform to the fire safety standards imposed on legitimate manufacturers.134 As noted above, one December 2013 media piece (using the headline “Counterfeit fags are ‘even more dangerous’”) observes: “Derbyshire County Council found that all the illicit tobacco products seized in recent raids were missing vital safety features which help to prevent house fires…”.135

Page 26 ENDNOTES

1 As defined and explained in Section 2 of the Consultation Response. 2 In this submission, Consultation Response means JTI’s Response to the Department of Health’s Consultation on the Standardised Packaging of Tobacco Products, dated 3 July 2012 and which is available at http://www.jti.com/how-we-do-business/key-regulatory-submissions/. 3 In this submission, Chantler Review means Sir Cyril Chantler’s review into the public health impact of standardised packaging of tobacco (more generally known as plain packaging). 4 In this submission, (a) Systematic Review means Moodie C, Stead M, Bauld L, McNeill A, Angus K, Hinds K, Kwan I, Thomas J, Hastings G and O’Mara-Eves A (2012). Plain tobacco packaging: A systematic review. Report prepared for the Department of Health. Stirling: Centre for Tobacco Control Research, University of Stirling. http://phrc.lshtm.ac.uk/papers/PHRC_006_Final_Report.pdf; (b) Updated Systematic Review means Moodie C, Angus K, Stead M and Bauld L (2013). Plain Tobacco Packaging Research: An Update. Stirling, Scotland: Centre for Tobacco Control Research, Institute for Social Marketing, University of Stirling. http://www.stir.ac.uk/management/about/social-marketing/; and (c) Systematic Reviews means the Systematic Review and the Updated Systematic Review. 5 Timothy M. Devinney is the Leeds University Business School’s Leadership Chair in International Business and Co-joint Professor in the Faculty of Medicine at the University of New South Wales, Australia. He is an expert in consumer survey research, experimental methods and associated statistical analysis. In respect of the question whether plain packaging is likely to have any actual positive public health impacts, Professor Devinney has prepared three relevant reports: (a) Professor Devinney’s January 2014 report entitled “Analysis of Consumer Research Evidence on the Impact of Plain Packaging for Tobacco Products (Updated to 2014)” (which has been submitted to the Chantler Review and addresses specifically the evidence base which the Chantler Review has identified in its Method Statement, including the Systematic Review Update); (b) Professor Devinney’s June 2012 report entitled “Analysis of Consumer Research Evidence on the Impact of Plain Packaging for Tobacco Products (Updated to 2012)”, which was annexed to the Consultation Response; and (c) Professor Devinney’s November 2010 report entitled “Analysis of Consumer Research Evidence on the Impact of Plain Packaging for Tobacco Products”, which was also annexed to the Consultation Response. 6 In this submission, Method Statement means the method by which the Chantler Review will be conducted, as set out in the independent reviewer’s method statement dated 16 December 2013. 7 Laurence Steinberg is the Distinguished University Professor and Laura H. Carnell Professor of Psychology at Temple University, Philadelphia, United States of America. He is a leading authority on adolescent judgement, decision making and risk-taking. In this submission, Professor Steinberg’s 2010 Report means his November 2010 report, entitled “Adolescent Decision Making and the Prevention of Underage Smoking”, which was annexed to the Consultation Response. 8 In this submission, Terms of Reference means the terms of reference for the Chantler Review, as set out in a letter to Sir Cyril Chantler dated 27 November 2013, from the Parliamentary Under Secretary of State for Health, Jane Ellison MP. 9 All of which are available from http://www.jti.com/how-we-do-business/key-regulatory-submissions/. 10 In this submission, Consultation means the DH’s 16 April 2012 consultation on standardised packaging of tobacco products. Despite indications to the contrary in paragraph 2(i) of the Method Statement, it would be wrong for the Chantler Review to exclude analysis of such materials which were provided in the context of the Consultation. As regards JTI, this necessitates that the Chantler Review analyses the Consultation Submission together with the following expert research/analysis accompanying it: (a) Professor Cave’s Report; (b) Professors Dhar and Nowlis’ Report; (c) Dr Keegan’s Reports; (d) Dr Lilico’s 2012 Report; and (e) Professors Zimmerman and Chaudhry’s Report. 11 Professor Cave’s November 2010 report entitled “Better Regulation and Certain Tobacco Control Measures”, was annexed to the Consultation Response. 12 Ravi Dhar is George Rogers Clark Professor of Management and Marketing and Director of the Centre for Customer Insights at the Yale School of Management, New Haven, United States of America. Stephen Nowlis is August A. Busch, Jr. Distinguished Professor of Marketing in the Olin School of Business at Washington University in St. Louis, United States of America. Both are award-winning marketing professors at leading universities in the United States, who have published extensively on the subject of consumer behaviour and decision making. 13 Warren J. Keegan is the Distinguished Professor of Marketing and International Business at the Lubin School of Business, Pace University, New York, United States of America, and a Visiting Professor at ESSEC, Cergy-Pontoise, France. He is Head of Keegan & Company LLC, Rye, New York, United States of America. Professor Devinney concurs with the relevance of Dr Keegan’s evaluation criteria outlined in Dr Keegan’s Report. Professor Devinney’s 2010 Report and his 2012 report therefore build on Dr Keegan’s criteria. See Professor Devinney’s 2010 Report, paragraphs 1.3 to 1.5 and 2.1; and Professor Devinney’s 2012 Report, paragraphs 2.1 and 2.12. 14 Andrew Lilico is Director and Principal of Europe Economics, London. He is an expert in microeconomic analysis and regulatory impact assessment. 15 Alan Zimmerman is Professor of International Business and leads the International Business Programme at City University of New York, College of Staten Island, New York, United States of America. Peggy

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Chaudhry is an Associate Professor of International Business at the Villanova School of Business, Villanova, Pennsylvania, United States of America. They are the co-authors of “The Economics of Counterfeit Trade”, “Protecting Your Intellectual Property Rights: Understanding the Role of Management, Governments, Consumers and Pirates (Protecting Your Intellectual Property Rights)”, published in 2013, and have been involved in an extensive set of research projects examining various aspects of the global trade in illicit products. Professors Zimmerman and Chaudhry’s June 2012 report entitled “The Impact of Plain Packaging on the Illicit Trade in Tobacco Products” was annexed to the Consultation Response. 16 On the specific question being considered by the Chantler Review, Professor Steinberg concluded in 2010 that: “… there is no evidence that changes in cigarette packaging affect adolescents’ experimentation with or use of cigarettes… [T]he impact of changes in cigarette packaging on adolescent smoking is, at best, likely to be very small” (paragraph 75 of Professor Steinberg’s 2010 Report). Professor Steinberg’s 7 January 2014 letter to Sir Cyril Chantler explains that his view remains unchanged today, despite the further studies published since 2010 (which he has reviewed) and the introduction of plain packaging in Australia. 17 See, for example, in this context: (a) “Label printer turns plain cigarette packaging into sticker success”, 9 January 2013, Steven Kiernan, http://www.proprint.com.au/News/328190,label-printer-turns-plain-cigarette- packaging-into-sticker-success.aspx; (b) “Stickers to cover plain cigarettes packaging go on sale”, 12 December 2012, Shannon Willoughby, http://www.theaustralian.com.au/news/stickers-for-sale-to-cover- plain-packaging-for-cigarette-packets/story-e6frg6n6-1226535061929; and (c) “ROXON WRAPPERS DEFIED”, 4 January 2013, Tim Blair, http://blogs.news.com.au/dailytelegraph/timblair/index.php/dailytelegr aph/comments/roxon_wrappers_defied/. 18 Sutcliffe K, Brunton G, Twamley K , Hinds K, O’Mara-Eves AJ, Thomas J (2011) “Young people’s access to tobacco: a mixed-method systematic review”, page 4. London: EPPI-Centre, Social Science Research Unit, Institute of Education, University of London, which is available at: http://eppi.ioe.ac.uk/cms/LinkClick.aspx?f ileticket=1PIIjjvuy3Y%3D&tabid=3301. 19 FTC Document, paragraph 3.8. 20 In this submission, DH means the UK Department of Health. 21 In this submission, IA means the Impact Assessment accompanying the Consultation. 22 R J Reynolds Tobacco Company v Food and Drug Administration, US Court of Appeals, District of Columbia Circuit, 24 August 2012 at p.25 and p.26, available at http://www.cadc.uscourts.gov/internet/opinions.nsf/4C0311C78EB11C5785257A64004EBFB5/$file/11- 5332-1391191.pdf. 23 Updated Systematic Review, page 1. 24 The front cover of the document states “September 2013”, but it appears to be the case that the document was at least modified subsequent to this (the document properties of the PDF version of the document indicate it was modified at 11.29.41 on 24 October 2013). No publication date is identified on http://www.stir.ac.uk/management/about/social-marketing/, the site from which the document can be accessed. 25 Updated Systematic Review, pages 1 and 2. 26 Consultation, paragraph 6.1. 27 Systematic Review, page 5. 28 Updated Systematic Review, page 50. 29 Systematic Review, page 89. 30 Updated Systematic Review, page 14. 31 Professor Devinney’s 2014 Report, paragraph 1.7. 32 Dr Keegan’s Report, page 9. 33 Dr Keegan’s Report, page 9. 34 See Professor Steinberg’s 7 January 2014 letter to Sir Cyril Chantler. 35 Systematic Review, page 87: “Some caution is required in interpreting these findings, as expressed smoking- related intentions are not always predictive of future smoking behaviour (Ajzen & Madden 1986, Sheeran 2002) and perceptions of the impact of a future policy measure on the behaviour of others are of course subjective”. 36 Professor Devinney’s 2010 Report, paragraph 5.2, Professor Devinney’s 2012 Report, paragraph 5.3 and Professor Devinney’s 2014 Report, paragraph 5.4. 37 Professor Devinney’s 2010 Report, paragraph 5.2 (a), Professor Devinney’s 2012 Report, paragraph 5.3(c) and Professor Devinney’s 2014 Report, paragraph 5.4. 38 Professor Devinney’s 2012 Report, paragraph 2.9. 39 Professor Devinney’s 2014 Report, paragraph 5.5. 40 Professor Devinney’s 2014 Report, paragraph 5.9. 41 Professor Devinney’s 2012 Report, paragraph 5.8. 42 Professor Devinney’s 2014 Report, paragraph 5.9. 43 Professor Devinney’s 2014 Report, Table 3. Table 3 of Professor Devinney’s 2012 Report summarises the studies reviewed in that report. 44 Professor Devinney’s 2014 Report, paragraph 5.4 and 5.5. 45 Professor Devinney’s 2010 Report, paragraph 5.6; Professor Devinney’s 2012 Report, paragraph 5.11 and Professor Devinney’s 2014 Report, paragraph 5.17.

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46 Grant application in 2009 by Professors Melanie Wakefield, David Hammond, Marvin Goldberg, Simon Chapman and Dr Sarah Durkin. Materials made available by way of a Freedom of Information request to the Australian National Health and Medical Research Council (NHMRC). NHMRC FOI reference number 2012- 009. 47 Systematic Review, page v. 48 IA, paragraph 95. 49 Systematic Review, page 88. 50 Systematic Review, page v. 51 Systematic Review, page 89. 52 Systematic Review, page 89. 53 Professor Devinney’s 2010 Report, paragraph 5.5(c). 54 Systematic Review, page v. 55 Professor Devinney’s 2010 Report, page 43. 56 Professor Devinney’s 2014 Report, paragraph 4.10(e). 57 Systematic Review, Acknowledgements. 58 See http://tobaccocontrol.bmj.com/site/about/guidelines.xhtml. 59 See “Journal Policy on Research Funded by the Tobacco Industry”, BMJ 2013;347:f5193 doi: 10.1136/bmj.f5193. Interestingly, and as noted in the article itself, this new policy overturns the BMJ’s previously stated position that such a ban would be “antiscience”. 60 Professor Devinney’s 2010 Report was mentioned in a protocol to the 2012 Systematic Review, but was not subsequently included in the list of references in either of the Systematic Reviews. See: http://phrc.lshtm.ac.uk/papers/PHRC_006_Protocol.pdf. 61 Professor Devinney’s 2014 Report, paragraph 4.10(a). 62 Professors Zimmerman and Chaudhry’s Report, paragraph 429. 63 IA, paragraph 75. 64 IA, paragraph 76. 65 IA, paragraph 78. 66 Professors Zimmerman and Chaudhry’s Report, paragraph 432. 67 Professors Zimmerman and Chaudhry’s Report, page 2. 68 “Tobacco Smuggling”, ASH (April 2011), page 3, http://ash.org.uk/files/documents/ASH_122.pdf. 69 S. Wiltshire et al., “They’re doing people a service – qualitative study of smoking, smuggling and social deprivation”, British Medical Journal, 323, 2001, pp. 203- 207, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC35272/pdf/203.pdf. 70 See the Schedule to this submission. 71 Professors Zimmerman and Chaudhry’s Report, paragraphs 293 to 299. 72 FTC Document, p.21, http://webarchive.nationalarchives.gov.uk/20130107105354/http://www.dh.gov.uk/pro d_consum_dh/groups/dh_digitalassets/documents/digitalasset/dh_085651.pdf. 73 Page 5 of the Derby Evening Telegraph, 19 December 2013. Similar reporting available at http://www.derbytelegraph.co.uk/Counterfeit-cigs-pose-health-risks-Derbyshire/story-20338050- detail/story.html. 74 See Dr Lilico’s 2008 Report and Dr Lilico’s 2012 Report, as defined in the Consultation Response. 75 Dr Lilico’s 2012 Report, paragraph 7.4. These points are demonstrated through the results of a simulation model, where his conclusion is borne out robustly and reproduced in all cross-checks. The simulation model, based on UK data for RYO and RMC products, calibrates so as to reflect well the recent UK tobacco market (although brands are anonymised as the model does not purport to make predictions about individual brands) and produces results that are qualitatively robust to multiple cross-checks. The model necessarily adopts various assumptions: see notably paragraph 6.46 and Annex 1 to Dr Lilico’s 2012 Report. 76 The effect of plain packaging on prices of individual brands is more complex. Dr Lilico concludes that, on the basis of his model, “for modest degrees of brand degradation, effects on prices of individual brands vary – prices for some products rise (as market power increases) whilst those of others decrease (as consumer uncertainty reduces the willingness to pay for quality)”. Dr Lilico’s 2012 Report, Summary, point 10. 77 FTC Document, paragraph 3.76. 78 “The IA acknowledges that as a result of this proposal, there is the possibility that tobacco companies will decide to compete on other grounds, if they can no longer compete on branding” and proposed that “[t]he IA should discuss clearly the risks of how tobacco manufacturers are likely to respond to the [plain packaging] proposal in terms of achieving the policy objectives of reducing smoking”. From the RPC Opinion made available as a response to a Freedom of Information Act request and shared on the following website: http://www.handsoffourpacks.com/blog/angela-harbutt-department-of-health-not-fit-for-purpose/. 79 FTC Document, paragraph 3.76. 80 FTC Document, paragraph 3.77. 81 Sutcliffe K, Brunton G, Twamley K , Hinds K, O’Mara-Eves AJ, Thomas J (2011) “Young people’s access to tobacco: a mixed-method systematic review”, page 46. London: EPPI-Centre, Social Science Research Unit, Institute of Education, University of London, which is available at: http://eppi.ioe.ac.uk/cms/LinkClick.aspx?f ileticket=1PIIjjvuy3Y%3D&tabid=3301. 82 “Smoke signals: Will plain packaging cause cigarette sales to fall or will minimalist designs have a cachet in their own right?”, 28 November 2013, Chloё Hamilton (the editorial assistant on The Independent news

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desk), http://www.independent.co.uk/life-style/health-and-families/features/smoke-signals-will-plain- packaging-cause-cigarette-sales-to-fall-or-will-minimalist-designs-have-a-cachet-in-their-own-right- 8971024.html. 83 “Age and Violent-Content Labels Make Video Games Forbidden Fruits for Youth”, Marije Nije Bijvank, Elly A. Konijn, Brad J. Bushman and Peter H. M. P. Roelofsma, Pediatrics2009;123:870–876, doi:10.1542/peds.2008-0601, www.pediatrics.org/cgi/doi/10.1542/peds.2008-0601. 84 “The side effects of health warnings”, Social Issues Research Centre, 1999, available at http://www.sirc.org/news/sideeffects.html. 85 See, in this context, the first of the UK Government’s Better Regulation operating principles, which provides that regulation should not be taken forward unless a “robust and compelling” case has been made. See also, in the EU context, the European Commission’s Impact Assessment Guidelines, available at http://ec.europa.eu/governance/impact/commission_guidelines/docs/iag_2009_en.pdf, which emphasise, at paragraph 4.1, that “Good quality data – facts as well as figures – are an essential part of an IA.… Particular attention needs to be paid to quality and credibility of data”. 86 Martin Cave OBE is a regulatory economist specialising in competition law and in the network industries, including airports, broadcasting, energy, posts, railways, telecommunications and water. He has published extensively in these fields, and has held professorial positions at Warwick Business School, University of Warwick, UK, and the Department of Economics, Brunel University, UK. In 2010/11, Martin held the BP Centennial Chair at the London School of Economics, based in the Department of Law. He is now Visiting Professor at Imperial College Business School. He is a Deputy Chair of the Competition Commission from January 2012. 87 Professor Cave’s Report, paragraph 3.16. 88 Hearing of the Senate Community Affairs Legislation Committee, 20 November 2013, http://parlinfo.aph.gov.au/parlInfo/search/display/display.w3p;db=COMMITTEES;id=committees%2Festimat e%2Ffdbc4df4-3e21-4c80-a905- 44b3e703b991%2F0001;query=Id%3A%22committees%2Festimate%2Ffdbc4df4-3e21-4c80-a905- 44b3e703b991%2F0000%22. Senator MOORE: Is there any kind of evaluation or monitoring role for the department on how that is going? Mr Smyth: Yes, there will be. There will be a post-implementation review that will be commissioned by the department before the end of next year. Senator MOORE: The end of 2014, the calendar year? Mr Smyth: That is correct. There is a two-year window post implementation within which we need to do a review of the measure. 89 Professor Simon Chapman has commented on the introduction of plain packaging in Australia and stated that: “we’re not expecting plain packaging to have much impact on existing smokers. It's a policy about the next generation of kids who are coming through, so we would expect to slowly starve the industry of new customers by de-normalising and de-glamorising their products.” http://www.theguardian.com/society/2012/jan/24/simon-chapman-plain-cigarette-packaging-activist, and “but the point I would like to emphasise is that any expectation that plain packaging would somehow cause hundreds of thousands of smokers to somehow stub out cigarettes and run out of their beds as non-smokers overnight is really, really unrealistic. Nothing in tobacco control works like that, and if you look back over the last 30 years the average annual fall that we’ve had in Australia is about a third of a percentage point a year. So, plain packaging if its going to increase, that is going to be a fraction of that, amplifying that trend, and that is of course going to be a very, very finely tuned thing to measure.” BBC News Channel interview, 28 November 2013, 9:08am, 1 minute and 6 seconds into the interview. This is despite Professor Chapman having previously stated that plain packaging is a “weapons-grade public health policy” that would “turbocharge” the decline in youth smoking rates (http://www.huffingtonpost.co.uk/simon-chapman/plain- tobacco-packs_b_1499203.html) and noting before the introduction of plain packaging in Australia that “the eyes of the world are now on Australia over plain packaging and we’re very confident that we’ll see domino effects in the months and years to come” (http://what-matters.sydney.edu.au/topic/introducing-plain- packaging-for-cigarettes). Cancer Research UK has previously said: “isn’t about telling people to quit, it’s about stopping the next generation from starting in the first place”. The website where this was stated is no- longer accessible (http://www.cancer-campaigns.org.uk/ourcampaigns/theanswerisplain/moreinformation), but the content is archived at http://web.archive.org/web/20130329102747/http://www.cancercampaigns.org.uk/ourca mpaigns/theanswerisplain/moreinformation/. 90 “Plain packs offer a smoke-free future”, Dr James Cant, 8 January 2014, The Scotsman, http://www.scotsman.com/news/plain-packs-offer-a-smoke-free-future-1-3259434. 91 It is unclear why the Chantler Review is being asked to consider whether plain packaging would be “likely to” have a positive effect on public health rather than simply whether it “would” have such an effect. It may be that this is intended to be a lower threshold, but as is made clear above, the evidence base does not come close to passing this threshold. 92 Therefore: (a) it is not relevant what effect (if any) plain packaging would be likely to have elsewhere (for example, Australia); (b) the effect on public health would need to be a positive one (improving public health rather than damaging it); and (c) whether there is likely to be a positive public health effect needs to be looked at in the round having taken into account the potential negative public health effects plain packaging will have (see Section 3).

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93 Reducing the “appeal” of tobacco products to consumers per se is not, and cannot be, a self-standing justification for tobacco regulation. It is an amorphous and vague concept. It fails to establish ‘issue definition’ criteria: it is lacking in any evidential foundation and is inherently uncertain and arbitrary. 94 See Question 3 to the Consultation. 95 For example, and as stated in the Consultation Response (paragraph 3.51), increasing the prominence or salience of health warnings on tobacco packaging is not, of itself, a legitimate public policy goal capable of justifying a plain packs measure. ‘Noticing’ something, particularly something one knows already – such as a health warning on a tobacco product – does not necessarily translate into a change in actual smoking behaviour. While there is already a very high level of awareness of the health risks of smoking in the UK (indeed the Public Health Minister stated in 2012 that the UK has passed “a great deal of legislation and run a lot of public health campaigns [to inform the public of the harms of smoking] and no one is in doubt” to the extent that she believed that “96% of the population agree that smoking harms your health”; see “Written evidence from the Department of Health: Government’s Alcohol Strategy”, Health Committee, Uncorrected Transcript of Oral Evidence, Parliament, 12 June 2012, available at http://www.publications.parliament.uk/pa/ cm201213/cmselect/cmhealth/132/132.pdf), JTI supports the continued provision of information to consumers about the health risks of smoking in order to ensure that smokers continue to be reminded of those risks. 96 Third paragraph of page 1 of the Method Statement. 97 Plain packaging would infringe fundamental legal rights, including trade mark rights, other property rights, freedom of expression and freedom of trade, that are protected under UK, EU and international law. Indeed, five World Trade Organisation (WTO) members have directly taken steps towards commencing a dispute settlement procedure at the WTO against plain packaging legislation that was implemented in Australia in 2012. The legal implications is one of the areas that the DH would need to have full regard of in relation to any plain packaging measure, as set out in more detail in the Consultation Response. 98 See, for example, Sections 2, 5, 6 and 7 of and Schedule 1 to the Consultation Response. 99 Professor Cave’s Report, paragraph 4.13. 100 In this submission, FTC Document means the DH’s 2008 Future of Tobacco Control Consultation. 101 Parliamentary Debate (26 June 2009), available at http://www.publications.parliament.uk/pa/cm200809/cmpublic/health/090625/pm/90625s09.htm. 102 Statement by Alan Johnson, UK Secretary of State for Health, during a Parliamentary Question Session. See Hansard – Commons Debates (16 December 2008), Volume 485, Colum 945. 103 In an email dated 10 May 2011, DH has stated that “there isn’t any hard evidence to show that [plain packaging] works”. This email was part of the material disclosed on 19 August 2011 pursuant to a Freedom of Information Act request by Philip Morris International (Ref TO00000633879). 104 https://www.gov.uk/government/news/consultation-on-standardised-packaging-of-tobacco-products. 105 The need for a comprehensive statement of the evidence relied upon is increased bearing in mind that some materials (for good reasons) may be previously unpublished or not available in a publicly-available peer reviewed journal. 106 See “Journal Policy on Research Funded by the Tobacco Industry”, BMJ 2013;347:f5193 doi: 10.1136/bmj.f5193. 107 The Centre for Tobacco Control Research was established by The Cancer Research Campaign (now Cancer Research UK) in 1999. See further: http://www.cancerresearchuk.org/science/research/who-and-what-we- fund/browse-by-location/stirling/university-of-stirling/grants/gerard-hastings-15192-cancer-research-uk- centre-for. 108 HC Deb, 28 November 2013, c407; http://www.theyworkforyou.com/debates/?id=2013-11-28b.407.0. 109 The Terms of Reference create a further challenge for the Chantler Review in that the independent reviewer is required to assess the effect on public health of “the introduction of standardised packaging” without knowing when that “introduction” would take place or in what context. So assumptions have to be made as to whether (a) the display ban has come into effect fully; (b) TPD2 has been implemented; and (c) pre-existing trends are continuing. 110 The minimum purchase age for tobacco products was raised from 16 to 18 years of age in England and Wales (via the Children and Young Persons (Sale of Tobacco etc.) Order 2007) and Scotland (via the Smoking, Health and Social Care (Scotland) Act 2005 (Variation of Age Limit for Sale of Tobacco Purchase and Consequential Modifications) Order 2007) on 1 October 2007, and in Northern Ireland (via the Children and Young Persons (Sale of Tobacco etc.) Regulations (Northern Ireland) 2008) on 1 September 2008. The use of large pictoral health warnings on tobacco packaging took effect in the UK on 1 October 2008 by way of the Tobacco Products (Manufacture, Presentation and Sale) (Safety Amendment) Regulations 2007. 111 JTI does not accept (indeed, it strongly rejects) the view that TPD2 will in fact have any positive public health effects and also reserves its rights as to the issue of the legal validity of TPD2. JTI also considers that many of the measures proposed are disproportionate and a threat to the internal market from an innovation, competition, consumer choice and cross-border trade standpoint. See further: http://www.jti.com/media/news- releases/jti-hasty-decisions-revised-eu-tobacco-products-directive-will-only-lead-ineffective-legislation/. 112 See Tables 2.1a to 2.3b of “Smoking, drinking and drug use among young people in England in 2012”, edited by Elizabeth Fuller (a survey carried out for the Health and Social Care Information Centre by the National Centre for Social Research and the National Foundation for Educational Research): https://catalogue.ic.nhs.uk/publications/public-health/surveys/smok-drin-drug-youn-peop-eng-2012/smok- drin-drug-youn-peop-eng-2012-repo.pdf.

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113 Table 2.3b of ibid. 114 Paragraph 2.2.1 of ibid. 115 “The Government Chief Scientific Adviser’s Guidelines on the Use of Scientific and Engineering Advice in Policy Making”, available at http://www.bis.gov.uk/assets/bispartners/goscience/docs/g/10-669-gcsa- guidelines-scientific-engineering-advice-policy-making.pdf, which provide that: “Departments should draw on a range of appropriate expert sources, both within and outside government. The selection of advisers should match the nature of the issue and should be sufficiently wide to reflect the adversity of opinion amongst experts in the appropriate field(s) in a balanced way… Gathering evidence from a range of experts or from an expert committee ensures a more independent view as, for example, lobbying will become apparent”. 116 As JTI said at the time, experts in this area are those who are likely already to have entrenched views on plain packaging as a regulatory measure. Many will have written, published or carried out research in this area, potentially including the flawed studies relied upon by the DH. 117 IA, page 28. The reference to Hora and Winterfeldt relates to the relevant factors when considering the use of an expert panel as discussed in Hora, Stephen C., and von Winterfeldt, D., (1997), “Nuclear waste and future societies: A look into the deep future”, in Technological Forecasting and Social Change, Vol. 56, Issue 2, pages 155 to 170 (Hora and Winterfeldt). 118 See Hora and Winterfeldt. 119 Professor Devinney’s 2014 Report, paragraph 4.4. 120 Professor Devinney’s 2014 Report, paragraph 4.12. 121 Notwithstanding the fact that Sir Cyril Chantler has stated he is not “assessing the merits of alternative means of tobacco control”, see final paragraph of page 1 of the Method Statement. 122 Various studies have been completed to assess the efficacy of the suggested solutions, using a range of methodologies. JTI makes no comment on, nor does it endorse the methodology of (or any assertions, statements or conclusions made in) any of the studies referred to in this section of the Response. 123 Third paragraph of page 1 of the Method Statement. 124 See paragraph 4.30(d) of the Consultation Response and paragraphs 293 to 200 of Professors Zimmerman and Chaudhry’s Report. 125 ACBPS Annual Report 2010 to 11, ACBPS, p.55: http://www.customs.gov.au/webdata/resources/files/879316 AUSCUSwebpdf.pdf. 126 Department of Health & Ageing’s assessment of risks posed by counterfeit cigarettes: http://www.yourhealth.gov.au/internet/yourhealth/publishing.nsf/Content/amcor-limited~chapter4~greater- health-risk-to-consumers. 127 “Illicit tobacco in Australia”, KPMG, October 2013: http://www.pmi.com/eng/media_center/documents/kpm g%20report%20on%20illicit%20trade%20australia.pdf (the KPMG Report). The report was commissioned by British American Tobacco Australia, Imperial Tobacco Australia Limited and Philip Morris Limited. 128 The KPMG Report defines ‘illicit whites’ as “brands of manufactured cigarettes that are not legally available in the local market. Whilst possibly legal at the point of manufacture, these brands are typically not sold legally anywhere, and are often made exclusively for smuggling.” However, the meaning of the term of ‘illicit whites’ varies, and determining when this product becomes illicit in its supply chain is controversial. See further Professors Zimmerman and Chaudhry’s Report, paragraphs 153 to 159. 129 The KPMG Report, p.38. 130 “Trident Taskforce shuts down multi-million dollar tobacco importation syndicate” (24 October 2013), Australian Federal Police: http://www.afp.gov.au/media-centre/news/afp/2013/october/media-release-trident- taskforce-shuts-down-multi-million-dollar-tobacco-importation-syndicate.aspx. 131 The image on the left was obtained from http://ipkitten.blogspot.co.uk/2013/11/tobacco-troubles-whats-bad- for-brands.html and the image on the right was obtained from http://www.happyspeedy.com/content/marlboro-red. 132 Historically, it has been noted that 7% of Australian bushfires are caused by discarded cigarettes, causing AUD$108 million worth of fire-related damage in 2008. Cigarettes (reduced fire risk), Australian Competition & Consumer Protection: http://www.productsafety.gov.au/content/index.phtml/itemId/974709. 133 Trade Practices (Consumer Product Safety Standard)(Reduced Fire Risk Cigarettes) Regulations 2008: http://www.comlaw.gov.au/Details/F2009C00252. 134 The APPG explains that it has been estimated that the cigarettes with reduced fire risks could prevent 1,800 fires, 67 fire deaths and 600 casualties each year in the UK. The introduction of such cigarettes in Finland led to a 43% reduction in the number of victims of cigarette-ignited fires. “Inquiry into the illicit trade in tobacco products”, the APPG (March 2013). See paragraphs 165 to 267. 135 Page 5 of the Derby Evening Telegraph, 19 December 2013. Similar reporting available at http://www.derbytelegraph.co.uk/Counterfeit-cigs-pose-health-risks-Derbyshire/story-20338050- detail/story.html.

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