A RIA-compliant approach to policy analysis of standardised packaging in Ireland Rupert Darwall February 2014 1 Rupert Darwall is an independent consultant focusing on the interface between governments and market. He previously worked in the City of London as an equities analyst and in corporate finance before becoming a Special Adviser to the British Chancellor of the Exchequer. He has advised British Airways during the Competition Commission market investigation into BAA and assisted Virgin Atlantic Airways on the drafting of two rounds of submissions in the Heathrow and Gatwick regulatory reviews. In addition, he was retained by BAA during its appeal to the Competition Appeal Tribunal and developed a framework for quantifying the detriment of forced divestitures. In 2012, he wrote a report on behalf of Virgin Rail Group analysing the defects in the Department for Transport’s decision in the award of the West Coast rail franchise based on its own policies and criteria. Together with Virgin’s legal team, he helped develop the grounds for a Judicial Review, which led the Department to rescind its decision. In 2013 he was asked by PMI to review the UK Department of Health’s impact assessment papers on standardised tobacco packaging. 2 Executive summary ............................................................................................... 4 Overview ....................................................................................................................................................................4 Policy context ..........................................................................................................................................................4 Six principles of better regulation .................................................................................................................4 International experience ...................................................................................................................................5 Benefits of RIA ........................................................................................................................................................5 Part I. Overview .................................................................................................... 6 1. Purpose of paper .......................................................................................................................................... 6 1.1 Background ......................................................................................................................................................6 1.2 Policy objective ...............................................................................................................................................6 1.3 Applicability of RIA framework ..............................................................................................................7 2. Regulating Better Objectives and Principles ..................................................................................... 7 2.1 Six Principles of Better Regulation ........................................................................................................8 2.2 National competitiveness ....................................................................................................................... 10 Part II. Policy context and objectives ....................................................................11 3. Policy context ..............................................................................................................................................11 3.1 Overall objective ......................................................................................................................................... 11 3.2 Tobacco control policy in Ireland ....................................................................................................... 11 3.3 International comparisons .................................................................................................................... 11 3.4 Smoking prevalence in Ireland ............................................................................................................ 13 3.6 Possible disbenefits of existing tobacco control policies .......................................................... 15 3.7 Policy considerations ................................................................................................................................ 16 Part III. Potential Issues for RIA ............................................................................18 4. Application of the Six Principles ..........................................................................................................18 4.1 Necessity ......................................................................................................................................................... 18 4.2 Effectiveness.................................................................................................................................................. 22 4.3 Proportionality ............................................................................................................................................ 29 4.4 Transparency ............................................................................................................................................... 29 4.5 Accountability .............................................................................................................................................. 30 4.6 Consistency .................................................................................................................................................... 30 4.7 Summary ........................................................................................................................................................ 32 Part IV. Conclusions .............................................................................................33 Annex 1: Regulatory Principles and the implications for RIA ................................35 Annex 2: Domestic and international experience ..................................................40 A2.1. Ireland ......................................................................................................................................................40 A2.1.1 Policy background ............................................................................................................................... 40 A2.1.2 Tobacco Free Ireland ......................................................................................................................... 41 A2.1.3 Considerations for RIA....................................................................................................................... 41 A2.2 Relevant international experience ................................................................................................42 A2.2.1 Australia................................................................................................................................................... 42 A2.2.2 Canada’s examination of standardised packaging .............................................................. 44 A2.2.3 RIA and standardised packaging – the UK’s experience.................................................... 45 A2.2.4 The US and youth smoking programmes .................................................................................. 46 A2.2.5 Germany: Effective practices to reduce youth smoking ..................................................... 47 References ...........................................................................................................48 This report was commissioned and funded by Philip Morris Limited (PML). All judgments and opinions expressed in it are those of the author. 3 Executive summary Overview Ireland is currently considering legislation to require standardised packaging of cigarettes and other tobacco products to remove all branding and logos from tobacco packaging. New legislation and regulations in Ireland are subject to Regulatory Impact Assessment (‘RIA’) to improve the quality of interventions and better achieve policy objectives at less cost and fewer unintended consequences. RIA also examines whether alternatives to regulation might be better. Standardised packaging falls outside the limited exemptions from the requirement to conduct a RIA. The Department of Health has announced a RIA for its standardised packaging legislation. The present paper outlines the key issues a RIA could be expected to address in order to give policymakers the relevant information and analysis to enable them to properly assess the proposal. Policy context The public health objective of tobacco control is to reduce smoking prevalence among the general population and smoking initiation by teens and young adults. In pursuit of this objective, Ireland has implemented measures that place it number two in a tobacco control scale ranking of 15 western EU members. At the same time, Ireland has one of the highest smoking prevalence, topped by only two countries. These tobacco control measures include the highest tobacco taxes in Europe. High tobacco taxation has made Ireland a lucrative market for illicit tobacco. Ireland has the highest market share taken by illicit supply of any EU member apart from the Baltic states (which, because of their geographical location, are a special case). Thus the principal challenge of tobacco control in Ireland is to reduce smoking prevalence and initiation whilst shrinking the share taken by illicit tobacco, which is currently estimated to cost the taxpayer approximately €500 million a year. Six principles of better regulation Ireland’s RIA framework is based on the Six Principles of the Regulating Better White Paper (2004). These are further developed in 2009 by the Department of the Taoiseach in its RIA Guidelines. The present paper applies these principles to standardised packaging: 1) evidence and analysis on the measure’s likely effectiveness, its cost and unintended consequences; 2) where this is insufficiently robust, to consult with stakeholders to verify the key assumptions being made; and 3) to evaluate a broad range of policy options to enable policymakers to assess the optimal approach to cutting smoking and saving lives. Necessity - What are the demonstrable benefits of standardised packaging? - What are the key assumptions on which the policy succeeds or fails? Effectiveness - Is the regulation properly targeted? - What would happen to trends in smoking if the policy were not enacted? 4 - What is the expected contribution of standardised packaging to meeting the Government’s target of reducing prevalence to 5% by 2025? - What are the monetized benefits and costs of standardised packaging? - What is the likely impact of the policy on the tobacco tax base and would it need more resources to crack down on trade in illicit tobacco? Proportionality - Is standardised packaging significant and important? The more significant a regulation, the more analysis is required. Transparency - Has a bona fide consultation of stakeholders been conducted? Accountability - Who is responsible for whether the policy is a success or a failure? Consistency - Does the regulation support the Government’s overall objective of restoring the economy? - What might Ireland’s exposure be to legal action within the World Trade Organization and under the Irish Constitution, the European Convention on Human Rights and the EU Charter of Fundamental Rights? International experience The EU decided against standardised packaging as part of the revised Tobacco Products Directive and Australia remains the only country to have implemented it. Like Ireland, Australia has a stringent tobacco control regime and high tobacco taxes. It has also seen a shift in the market towards illicit supply. The evidence so far shows no change in adult smoking prevalence since December 2012 and the introduction of standardised packaging, while illicit trade has grown. Other countries have pursued alternative policies and have observed strong reductions in youth smoking prevalence. In the US, youth anti-smoking programmes focus on mass media campaigns, increased tobacco prices and schoolbased campaigns. Like the US, Germany has had considerable success with youth campaigns and school programmes, despite comparatively liberal regulation of advertising and packaging. Benefits of RIA Consistent application of RIA principles to standardised packaging will provide policymakers with the analysis to enable them to fashion more effective tobacco control policies and reduce the risk of repeating the mistakes of the past, in particular the failure to anticipate the threat from illicit tobacco. 5 Part I. Overview 1. Purpose of paper 1. Part I of this paper is about the applicability of Regulatory Impact Assessment (‘RIA’) to legislation introducing standardised packaging of tobacco products.* Part II outlines the RIA principles and guidelines. Part III goes on to suggest what issues a RIA complying with the Government’s regulatory principles and RIA guidelines would analyse and the type of evidence it would bring to the attention of policymakers. Part IV provides some concluding observations. 1.1 Background 2. To improve the quality of policy making, Ireland has a rigorous system of regulatory impact assessment. This system follows a 2001 OECD report on regulatory reform. It recommended Ireland adopt systematic economic assessment of proposed new regulation to improve economic performance. The Government agreed. 3. The purpose of Ireland’s RIA framework is to test the validity of the claims made for regulatory interventions, assess whether the policy is likely to achieve its aim, identify possible unintended consequences before they occur and assess whether regulation is the most effective way of achieving policy objectives or if other approaches might be better. 4. On 19th November 2013, the Government announced its approval of the General Scheme of legislation on standardised packaging. If enacted, it would make Ireland the second country in the world and the first in the European Union to require standardised packaging for cigarettes and other tobacco products. 5. Standardised packaging is defined in the bill’s General Scheme as the removal of all forms of branding – trademarks, logos, colours and graphics. The identity of the product would be presented in a uniform typeface. All packs would be in a plain neutral colour except for the mandatory health warnings, the tax stamp and other legal requirements.1 6. The Department of Health has now announced a RIA on these important proposals. Given the importance of adopting tobacco control measures that actually work, a rigorously conducted RIA is critical. 1.2 Policy objective 7. When in May 2013 the Department of Health first announced its proposals for standardised packaging, it stated that there was strong evidence that the measure would increase the effectiveness of health warnings; reduce false beliefs about cigarettes and reduce brand appeal, particularly among young people. The Health Minister, Dr. James Reilly T.D., said that standardised Referred to as standardised packaging in this document, the measure is also called plain packaging in Australia and some of the published literature. * 6 packaging was one of a number of measures aimed at denormalising smoking in Ireland: ‘As such this initiative should not be looked at in isolation. Education and awareness, cessation services and extending the smoking ban to other areas are just some of the other measures which I am currently progressing.’2 1.3 Applicability of RIA framework 8. The Department of the Taoiseach’s revised RIA Guidelines of June 2009 (‘the Guidelines’) state that RIA applies to all new legislative and regulatory proposals. According to the Guidelines, ‘international best practice indicates that the “do nothing” or “no policy change” option should be included for consideration. Even where doing nothing is not a viable option in practice, it can serve as a useful benchmark against which other options can be compared.’3 If a proposal has little impact on business in general but has major implications for one particular sector, it should be subject to RIA.4 2. Regulating Better Objectives and Principles 9. RIA is designed to increase the efficiency and effectiveness of the public services, the Guidelines state. ‘It will improve the quality of policy advice given to Ministers through promoting increased use of evidence in policy-making and providing more information on the likely implications of regulatory proposals.’5 If properly implemented, RIA helps identify any ‘possible side effects or hidden costs’ associated with the regulation. It should involve the detailed examination of impacts and consideration of the use of alternatives to regulation. The greater the importance or significance of the proposal, the more analysis will be required.6 10. RIA should provide decision-makers with a solid factual evidence base about the costs benefits and other impacts of a range of feasible policy options.7 This requirement is similar to that specified by the European Commission in its Impact Assessment Guidelines published in January 2009. The logical steps that should be followed in preparing an impact assessment include comparing the main options in terms of effectiveness, efficiency and coherence in solving the problems.8 As far as possible, a clear baseline for the Impact Assessment should be established, i.e., what would happen under a ‘do nothing’ policy option, preferably expressed in quantitative terms.9 7 2.1 Six Principles of Better Regulation 11. The Guidelines state that RIA should contribute to achieving the six principles of the 2004 Regulating Better White Paper.10 Box 1: Six Principles of Better Regulation Necessity Is the regulation necessary? Effectiveness Is the regulation properly targeted? Proportionality Are we satisfied that the advantages outweigh the disadvantages of the regulation? What is the possible use of alternatives? Transparency Have we consulted with stakeholders prior to regulating? Accountability Who is responsible to whom and for what? Consistency Will the regulation give rise to anomalies and inconsistencies? Source: Department of the Taoiseach, Regulating Better (2004), p.6; Department of the Taoiseach, Revised RIA Guidelines: How to conduct a Regulatory Impact Analysis (2009), para 2.1 12. The essence of RIA is cost benefit analysis. Regulating Better describes RIA as ‘an evidence based approach that allows for the systematic consideration of the benefits and costs of a regulatory proposal to the economy and society.’11 The Guidelines state that RIA helps ‘identify any possible side effects or hidden costs associated with regulation.’12 13. On Necessity, Regulating Better pledges that the State should avoid the ‘regulatory impulse.’ In future, ‘we will require regulation to be more rigorously supported in terms of the information, analysis and assumptions that underpin them.’13 The Government will strengthen the ability of departments to produce ‘evidence-based policy options.’14 14. Before regulating, the Government must assess the evidence to determine if regulation is the right option. ‘The key test here is that there must be demonstrable benefits in terms of achieving public policy objectives flowing from the regulation that would not otherwise accrue.’15 15. ‘We need a results-orientated approach to regulation,’ Regulating Better states with respect to Effectiveness.16 This principle requires that ‘the objectives of regulation will be stated clearly in explanatory guides.’17 It is important to distinguish between the general or ultimate objectives and the immediate objectives. Both should be included in the RIA.18 16. Objectives should be SMART: Specific Measurable Accepted Realistic 8 Time-dependent19 The assumptions underlying the stated objective must be clear, which the White Paper defines as ‘the important events, conditions or decisions outside the regulation that must nevertheless prevail for the objective to be attained.’20 17. Cost of enforcement is a consideration. ‘If we had unlimited resources, we could probably achieve close to 100% compliance with all regulations, by putting in place large teams of inspectors, enforcement agents, monitoring mechanisms,’ the White Paper states. ‘In reality, we do not have such resources and we must regulate more effectively to ensure the greatest level of compliance without excessive enforcement procedures.’21 18. Under Proportionality, the Guidelines state that RIA should ‘provide decision-makers with a solid factual evidence base about the costs, benefits and other impacts of a range of feasible policy options relating specifically to the identified issue or problem.’22 The Guidelines set out the principle of proportionate analysis: ‘The greater the importance or significance of the proposal, the more analysis will be required.’23 19. The White Paper says that just as there may be alternatives to regulation, ‘there may also be alternative types of regulation, for use in cases where the full rigour of primary legislation is not required.’24 A problem with traditional ‘command and control’ regulation is that ‘it is often seen as a quick fix. However problems may not always have a regulatory solution or regulation may only be part of the solution, if used alongside information campaigns, or some other measures.’25 One of the fundamental goals of the RIA process is to explore the possible use of alternatives to regulation. This means that RIA should be conducted at an early stage and before a decision to regulate has been taken, the Guidelines state.26 20. As regards Transparency, the Guidelines speak of ‘structured consultation with stakeholders.’27 According to the White Paper, transparency is ‘critically important’ to the performance of the economy and acknowledges that ‘the State does not have a monopoly on wisdom and expertise in all areas of economic and social life.’28 In a Written Answer in June 2013, Dr. James Reilly T.D. confirmed that the Department of Health would be consulting as part of a RIA on standardised packaging, noting that ‘consultation is an integral part of the RIA process.’29 The Guidelines state that ‘ideally, RIA should be used as the basis for consultation.’30 21. The Guidelines state that RIA serves the important values of openness, public involvement and Accountability.31 Conducting a proper RIA increases the quality of governance by increasing the transparency and legitimacy of the regulatory process.32 9 22. Consistency is needed to assess whether the proposed intervention might undercut other regulatory safeguards or attainment of the Government’s overall economic objective of putting Ireland on the path of economic recovery (Box 2). Box 2: Excerpt from Foreword of ‘Programme for Government: Annual Report 2013’ ‘When we formed this Government in March 2011, our core promise to the Irish people was to fix our economic problems and to get Ireland working again. Since then, the Government has been working with the people to implement our agreed plan for economic recovery. That plan is working.’ ‘… Ireland is rebuilding its reputation, restoring confidence and laying the foundation for a better future ... It shows a Government hard at work, reforming, legislating and delivering on its commitments.’ Enda Kenny T.D. Taoiseach Eamon Gilmore T.D. Tánaiste Source: Department of the Taoiseach, ‘Programme for Government: Annual Report 2013’(March 2013), p.4 2.2 National competitiveness 23. The Guidelines state that national competitiveness is one of the impacts that must be considered as part of the RIA process.33 It quotes the comprehensive definition of competitiveness used by the National Competitiveness Council (‘NCC’): ‘the ability to achieve success in international markets leading to better standards of living for all. It stems from a number of factors, notably firm level strategies and a business environment that supports innovation and investment, which combined lead to strong productivity growth, real income gains and sustainable development.’ 34 10 Part II. Policy context and objectives 3. Policy context 24. According to the Guidelines, the RIA should begin by describing the policy context.35 3.1 Overall objective 25. Tobacco smoking is the single largest avoidable cause of morbidity and mortality in developed countries. Governments around the world have therefore adopted a range of measures to discourage smoking: Educating the public on the dangers of smoking Taxation to raise the price of tobacco, reduce affordability and discourage consumption Direct regulatory interventions Preventing youth access to tobacco products Cessation support to help smokers quit Whilst there is debate about the respective effectiveness of individual measures, taken as a whole, they have constituted the core of tobacco control policies in developed countries, where rates of smoking prevalence have shown long-term declines together with decreases in associated mortality and morbidity. 3.2 Tobacco control policy in Ireland 26. At the beginning of this century, Ireland decided to take a lead in tobacco control by adopting the recommendations in ‘Towards a Tobacco Free Society’ (‘TTFS’). Today, Ireland has one of the toughest tobacco control regimes in the world: The highest cigarette prices in the EU The first country in Europe to ban smoking in pubs and restaurants Ban on in-store advertising and display of tobacco products Requirement for all retailers of tobacco products to register with the Health Service (HSE) Overall Ireland is ranked No. 2 out of 31 European countries in the Tobacco Control Scale 2010 in Europe produced by the Association of the European Cancer Leagues.36 3.3 International comparisons 27. Table 1 provides a comparison of tobacco control regimes across the pre2004 EU-15 member states, i.e., before the accession of the former Eastern bloc countries.* Assessments of the effectiveness of tobacco control policies need to compare countries at similar stages of economic and social development, otherwise apparent * 11 Table 1. Tobacco Control Scale and smoking prevalence – EU-15 Tobacco Control Scale rank (2010) Smoking prevalence ranking – from low to high (2012) Smoking prevalence % (2012) UK 1 8= 27% Ireland 2 12 29% France 3 11 28% Finland 4 5 25% Sweden 5 1 13% Belgium 6 8= 27% Italy 7 3= 24% Spain 8= 13= 33% Denmark 8= 6= 26% Netherlands 8= 3= 24% Portugal 11 2 23% Germany 12 6= 26% Luxemburg 13 8= 27% Austria 14= 13= 33% Greece 14= 15 40% Sources: 1) Luk Joosens and Martin Raw, The Tobacco Control Scale 2010 in Europe, Table 4 2) Special Eurobarometer 385, Attitudes of Europeans towards Tobacco, p.7 28. It is difficult to discern any pattern between tobacco control scale rankings and smoking prevalence other than Greece, which scores lowest on the Tobacco Control Scale and has the highest smoking prevalence. However Portugal, at a similar stage of economic development as Greece, has the second lowest smoking prevalence but is ranked 11 out of 15 on the Tobacco Control Scale. 29. Sweden, the EU-15 member state with the lowest smoking prevalence, has a mediocre score on tobacco control. The UK, ranked highest on its tobacco control score, is ranked only eight out of 15 on smoking prevalence. France, Belgium and Luxemburg, with the same level of smoking prevalence as the UK, are ranked 3, 6 and 13 respectively on tobacco control. Ireland, with the second highest score on the tobacco control scale, has the highest smoking prevalence of the EU-15 except for Greece and Austria. correlations could simply indicate that more advanced states tend to have tighter tobacco control regimes and lower smoking prevalence, that is to say, a third factor, economic and social development, could account for both lower smoking prevalence and for tighter tobacco control policies. 12 3.4 Smoking prevalence in Ireland 30. A 2013 report by the Irish Cancer Society characterises Irish smoking prevalence as ‘stubbornly high.’37 A 2009 Slán analysis of smoking patterns in Ireland noted: ‘There is no evidence that Ireland has achieved a sustained downward trend in overall smoking rates.’38 Trends in smoking prevalence since Ireland adopted TTFS are shown in Table 2. Table 2. Smoking Prevalence – Ireland compared to the EU average (2001 – 2012) Year DOH/Slán DOH/ OTC ITMAC/ Landsdowne Eurobarometer IRL 2001 n/a n/a 29.04 n/a 2002 27 n/a 30.3 32 2003 n/a 28.7 (1) 31.3 n/a 2004 n/a 28.0 (1) 31.1 n/a 2005 n/a 27.1 32.2 29 2006 n/a 28.1 31.3 29 2007 29 27.3 29.6 n/a 2008 n/a 27.2 29.5 n/a 2009 n/a 24.6 29.5 31 2010 n/a 23.0 n/a n/a 2011 n/a 22.9 n/a n/a 2012 n/a 21.9 (2) n/a 29 Notes: (1) 12-month average to September (2) 12-month average to June 31. In 2000, TTFS cited DOH/Slán data that 31% of the adult population of Ireland were smokers.39 Data since then from four separate surveys suggest a mixed picture. For example, the Eurobarometer series implies, at best, trivial reductions in smoking prevalence. Up until 2008, the DOH/OTC series confirms this impression, then, between 2008 and June 2012, prevalence fell by 5.3 percentage points. Nearly half (49%) of the decline in prevalence according to the DOH/Slán series occurred in a single year – 2009, when according to the ITMAC/Landsdowne survey, prevalence was unchanged.* There was a change in DOH/OTC survey methodology in May 2008 when respondents were contacted via mobile phone as well as landline. According to the OTC website, this change in sampling method resulted in an increase in prevalence (of about 3%) from May 2008 on. ‘The pre-May 2008 data have therefore been recalibrated to allow for trend analysis, with the caveat that calibration may not restore strict comparability.’ http://www.ntco.ie/research.asp#method * 13 32. The falling trend in prevalence on the DOH/OTC series has opened up a growing divergence with the level of prevalence shown by Eurobarometer. In 2006, DOH/OTC was only 0.9 percentage points lower than Eurobarometer (28.1% compared to 29%). In 2012 prevalence as recorded by Eurobarometer was the same as 2006, but according to DOH/OTC, it had fallen to 21.5% - a gap of 7.1 percentage points. Implications for RIA on standardised packaging #1 A RIA of standardised packaging should examine trends in smoking prevalence since 2000 to determine the overall effectiveness of existing tobacco policies and attempt to explain the markedly differing trends in prevalence between different surveys. 3.4.1 Youth smoking 33. There is a strong policy rationale to dissuade teens and young people from smoking. For example, the European Commission’s Impact Assessment on revisions to the Tobacco Products Directive states that 70% of the smokers start before the age of 18 and 94% before the age of 25 years.40 34. The 36-country European School Survey Project on Alcohol and other Drugs (‘ESPAD’) shows smoking among Irish school children falling from 37% in 1999 to 21% compared to a fall from 35% to 29% among the EU-15 (Table 3.1).41 Table 3.1 ESPAD – Cigarette use during the last 30 days - % of all students 1999 2003 2007 2011 Change 1999 - 2011 Ireland 37 33 23 21 -16 pts Average 19 countries 35 34 28 29 - 6 pts Source: The 2011 ESPAD Report: Substance Use Among Students in 36 European Countries, Cigarette use during the last 30 days by gender. Percentages. 1995–2011, Table 43 . 35. Similarly, the WHO’s Health Behaviour in School-aged Children (‘HBSC’) surveys (which also include Canada, the USA and the Russian Federation) show the percentage of Irish 15-year olds smoking at least once a week falling more sharply (35% fall) than the HBSC average (down 24%) (Table 3.2). 14 Table 3.2 HBSC – % of 15 yr olds who smoke at least once a week (average of boys and girls) 2001/02 2005/06 2009/10 Change 2001/02 – 2009/10 Ireland 20 19.5 13 -7 pts HBSC average 23.6 19 18 -5.6 pts Source: WHO, Health Behaviour in School-aged Children, 2001/02 Survey (Fig. 3.5); 2005/06 Survey (p.121), 2009/10 Survey (Fig. 2.5) 36. According to the Department of Health’s 2013 policy document Tobacco Free Ireland, while these falls represent progress, ‘it does however indicate that smoking in childhood remains a public health challenge.’42 It goes on to note that Ireland is ranked 19 out of 40 in ESPAD (2011) – ‘a further indication of the challenge that lies ahead for Ireland.’43 37. Analysis of survey evidence suggests the nature of the challenge might be changing, with initiation being weighted towards females and starting slightly later. The Slán 2009 analysis of smoking patterns (which is based on 2007 survey data) discussed the divergence between male and female teen smoking trends: ‘while overall rates decreased in the 4-year period 2002-2006, this decrease was much smaller among girls than among boys aged 15-17.’44 38. The report also provides a possible explanation of the discrepancy between survey evidence suggesting a static trend in overall prevalence and schoolbased survey evidence. It noted a 19-percentage point increase in smoking prevalence (from 36% to 55%) between 2002 and 2007 among a cohort of females born between 1987 and 1989 drawn from Social Classes 5-6. ‘This finding suggests that there may be a high level of smoking initiation among young women especially in SC5-6, soon after leaving school,’ the report suggested.45 Implications for RIA on standardised packaging #2 Given the importance of reducing smoking initiation among teens and young people, further analysis is needed to understand better recent trends in initiation and their possible implications for policy. 3.6 Possible disbenefits of existing tobacco control policies 39. A 2011 paper by economists Frank Chaloupka and John Tauras points out that cigarette taxes and prices saw inflation-adjusted prices rise by more than 40% between 2002 and 2009.46 Another way of looking at Ireland’s teen smoking rates is that for a similar level of teen smoking prevalence as the UK, Ireland’s cigarette prices are €2 a pack or 31% higher than the UK (Table 4). 15 Table 4: Cigarette Price Index (EU Average = 100) and notional 2011 price Index 2011 price for pack of 20 Difference Index of EU-27 gross household disposable income per household (2011) 98.6 Notional pack price adjusted by index of disposable income €8.62 Ireland 217 €8.50 n/a UK 166 €6.50 €2.00 111.7 €5.82 EU-27 100 €3.92 €4.58 100.0 €3.92 Source: Padraic Reidy & Keith Walsh, ‘Economics of Tobacco: Modelling the Market for Cigarettes in Ireland’ (2011), Table 3. EU-27 household income data from Eurostat http://epp.eurostat.ec.europa.eu/tgm/table.do?tab=table&language=en&pcode=tec00113 40. When differences in household income are taken into account, the gap is even greater. In relation to disposable income, cigarette prices in Ireland are 48% higher than in the UK for similar levels of teen smoking rates. The €2 per pack price premium over the UK makes Ireland a more attractive market for smuggling. Ireland’s overall level of pricing has made it the premier destination for cigarette smuggling in Western Europe. 41. Chaloupka and Tauras cite a Euromonitor estimate that consumption of untaxed cigarettes in Ireland rose roughly five-fold from 2002 to 2010 and from 5.6% of Irish cigarette consumption to about 27.4% in 2009.47 According to a 2012 KPMG Star report, Ireland now has the highest level of counterfeit and contraband consumption of tobacco in Western Europe. Within the EU, only Latvia, Lithuania and Estonia have higher levels of illicit tobacco trade.*48 This has a direct impact on tax receipts, as acknowledged by Minister for Finance Michael Noonan, T.D. in a Written Answer last year (Box 3). Box 3: Written Answer by Michael Noonan T.D. on illicit trade in tobacco (14th March 2012) ‘The high price and tax levels make Ireland an attractive location for cigarette smugglers. I am informed by the Revenue Commissioners that surveys undertaken in 2009 and 2010 estimated that 20% of the cigarettes consumed in the State had not been taxed in this jurisdiction, and that this broke down between 14% illicit product and 6% legally imported by passengers arriving into the State. Based on the estimate of 14%, the loss of excise duty and VAT to the Exchequer from illicit cigarette consumption in 2011 would be in the region of €250 million.’ Source: Dáil Éireann Debate Vol. 759 No. 2, p.54 3.7 Policy considerations 42. The policy context for standardised packaging is the outcome of the TTFS tobacco control policies developed at the beginning of the last decade. As noted in Section 5 below, they were not subject to any RIA, as they pre-dated In terms of the illicit trade, the Baltic states are geographical outliers bordering the Russian Federation. When the Russian Ministry of Finance announced it was increasing tobacco taxes by 64% in June 2013, the average tax for 20 cigarettes was $0.34 retailing for around $2 a pack. http://rt.com/business/russia-excise-taxincrease-927/ * 16 Ireland’s adoption of its RIA framework. In particular, TTFS systematically underplayed the potential threat to its recommendations of a supply response via the illicit market (discussed further in Section 5.1 below). The experience illustrates the rationale for RIA contributing to better outcomes and helping reduce unintended consequences. 17 Part III. Potential Issues for RIA 4. Application of the Six Principles 43. This section describes how the Regulating Better White Paper’s six principles might be applied to standardised packaging and the issues which a proper RIA could address. Passages from the RIA framework outlined in Section 2.1 above are excerpted and their potential relevance in the context of a RIA of standardised packaging are then discussed. 4.1 Necessity 44. As regards necessity, the RIA framework lays down a clear standard which a regulation should meet. ‘The key test here is that there must be demonstrable benefits in terms of achieving public policy objectives flowing from the regulation that would not otherwise accrue.’ The ‘necessity’ of introducing standardized packaging to achieve demonstrable benefits that would not otherwise accrue should be assessed both against the recent ban on display of tobacco products (point of sale display ‘POSD’ ban) and the pack standardisation measures soon to be introduced under the EU’s new Tobacco Products Directive (‘TPD’). 45. On 1 July 2009 Ireland enacted a POSD ban making cigarettes and other tobacco products invisible at the point of sale. This renders nugatory one of the key arguments for standardised packaging, that seeing packs in shops triggers the impulse to buy. Announcing the measure, Minister Reilly commented that standardised packaging would remove the last way tobacco companies could promote their products. Insofar as branded packaging would act as a ‘mobile advertisement,’ its effect on tobacco purchases and consumption should be greatest at the point of sale.49 46. Evidence of the effect of the POSD ban on smoking prevalence is important for a RIA on standardised packaging. Both measures are predicated on branded packaging being causal factors in smoking initiation and prevalence. If analysis of the evidence suggests that the POSD ban has not been effective, it would weaken the case for standardised packaging. On the other hand, if it were shown to be an effective tobacco control measure, it raises the question as to whether one of the putative benefits of standardised packaging had been achieved by alternative means. Implications for RIA on standardised packaging #3 Examine evidence on the effectiveness of the POSD ban and assess the extent to which it either vitiates a key assumption underlying standardised packaging or makes redundant one component of the case for standardised packaging. 47. On 18 December 2013, the European Commission and the Lithuanian presidency announced agreement on the revised TPD. The Directive’s explicit focus is to reduce smoking prevalence among young people and, with that in mind, regulators deemed it appropriate to introduce strict pack 18 standardisation measures. These include much enlarged text and pictorial health warnings covering 65% of the front and back of cigarette packets and additional text warnings placed on the side of the packets.50 The Directive also prescribes the shape, size and opening of packs as well as the product presentation (including, for example, descriptors). 48. As further discussed in Section 4.2.1 below, RIA established a policy baseline against which the effects of the regulation are assessed. RIA on standardized packaging should incorporate the anticipated effects of implementing the new TPD. This implies that the costs and benefits to Ireland of standardised packaging can be summarized as the additional benefits of further standardizing the packs, over and above measures already being introduced by the new TPD, and of de-branding the remaining of tobacco packaging. Implications for RIA on standardised packaging #4 What might be the incremental benefits of removing the residual branding over and above those from recently introduced measures and the pack standardisation measures to be introduced by the new TPD? 49. The principle of ‘necessity’ also provides that there must be demonstrable benefits in terms of achieving public policy objectives flowing from the regulation. The intrinsic difficulty with standardised packaging in meeting this standard is that, so far, Australia is the only country to have implemented such measure and it only took effect in December 2012. A November 2013 study by London Economics commissioned by Philip Morris International found that survey data do not demonstrate a change in smoking prevalence since the introduction of standardised packaging in December 2012. These findings are corroborated by evidence from an October 2013 report by KPMG (commissioned by three tobacco companies) which also found total tobacco consumption unchanged.* This is discussed further in Annex 2. Implications for RIA on standardised packaging #5 What are the demonstrable benefits in terms of attaining public health goals from standardised packaging? Are they sufficient to meet the RIA ‘key test’? 50. Absent direct evidence, much of the case for standardised packaging is of, necessity, inferred from artificial situations (for example, using auctions to find out the differential values ascribed to branded and standardised packaging)51 and asking smokers what they would do when presented with choices of branded and standardised cigarette packs.52 The limitations of such approaches were noted by the expert panel appointed by the Canadian government to examine the case for standardised packaging in the mid-1990s. The panel cautioned that most studies evaluated differences between branded and standardised packaging but did not look at potential consumer behaviour in situations where the whole product class was in generic packaging. Comparison is with 12 months to 30 June 2013 and the 12 months to 31 December 2012. * 19 51. Furthermore a study by the UK Department of Health compared smokers’ stated intentions prior to the July 2007 implementation of smoke-free legislation to what smokers actually did after it had come into force. Its conclusion under-scores the questionable predictive capability of surveys based on asking people what they might do: ‘Although many participants felt the smokefree legislation would be likely to encourage them to cut back on the number of cigarettes they smoked, there was a disparity between intentions and actions.’53 Implications for RIA on standardised packaging #6 What weighting should policymakers ascribe to indirect evidence and/or conclusions based on inference? 52. The RIA framework requires that the policy rationale of a proposed regulation be supported by information and analysis. The assumptions underpinning the regulation should be made explicit. ‘We will require regulation to be more rigorously supported in terms of the information, analysis and assumptions that underpin them.’ The case for standardised packaging as a tobacco control measure rests on the assumption that branded tobacco packaging is a causal factor in smoking initiation, prevalence and a factor impeding cessation. 53. Analysis in a RIA would need to distinguish the causal role, if any, of branded packaging between two distinct phases: 1) smoking initiation and trialing; and 2) tobacco consumption by habituated smokers. 4.1.1 Potential impacts of branding on smoking initiation 54. On 1), evidence from a 2012 Eurobarometer survey found little to support advertising and brand causality in smoking uptake. According to the survey, the response most often given by smokers and ex-smokers to the question ‘what were the most significant elements in their starting to smoke?’ was ‘friends smoked’ (Table 5 below). For Ireland, the response rate was 89% (only Bulgaria was higher) – nearly four times higher than having parents who smoked (23%). Only 3% of smokers and ex-smokers mentioned cigarette packaging as an element.* 55. Whilst the survey was carried out after tobacco advertising had been banned throughout the EU, 88% of those surveyed were aged 25 or older and 51% were over 40, so a large majority is likely to have started smoking when cigarettes were advertised and/or tobacco brands were promoted.54 Yet Note that the survey allowed for multiple answers, which is why the totals in Table 5 sum to more than 100%. Hence among the three percent who gave packaging as one of their responses, it might have been the least significant of the factors mentioned by those three percent. * 20 there is little evidence from the Eurobarometer survey that cigarette advertising or awareness of cigarette brands were factors in people’s decisions to start smoking. Table 5: Why smokers and ex-smokers started smoking – ‘Among the following, what were the most significant elements that made you start smoking?’ Ireland EU-27 Your friends smoked 89% 79% Your parents smoked 23% 21% You liked the taste or smell of tobacco 21% 19% Cigarettes were affordable 15% 12% You liked the packaging of the cigarettes (or other tobacco products) 3% 3% You liked menthol cigarettes 1% 1% You liked cigarettes with a specific sweet, fruity or spicy flavor 1% 1% Other (spontaneous) 12% 8% None (spontaneous) 1% 3% Don’t know 2% 2% At least one element related to a specific tobacco taste 2% 5% Source: Special Eurobarometer 385, ‘Attitudes of Europeans towards Tobacco’ (2012), QD6, p.70 Implications for RIA on standardised packaging #7 What is the evidence that branded packaging is a causal factor in smoking initiation and what is the evidence of its weighting relative to other causal factors driving initiation? 4.1.2 Potential impacts of branding on habituated smokers 56. For smokers who have become addicted to nicotine, the case for removing branding and all brand identifiers (other than the name in a standard typeface) depends on the assumption that branding increases the propensity of smokers to smoke independently of nicotine addiction and/or branding acts as a barrier to attempts at cessation. Furthermore, this assumption must hold despite the presence of textual and pictorial health warnings covering half the cigarette packet. 57. Experts agree that nicotine is a highly addictive drug and that smokers smoke cigarettes to satisfy their nicotine addiction. The plausibility of branding as a factor raising the propensity to smoke should be set in the context of the 21 addictive properties of nicotine and its impacts on smokers’ behaviour. According to the EU’s Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR), ‘a drug like nicotine that produces rewarding effects will also promote behavioural responses to obtain the drug, i.e. positive reinforcing effects.’55 This suggests a possible role for harm-reduction products for nicotine addicts such as e-cigarettes. Implications for RIA on standardised packaging #8 What are the critical assumptions that underpin the public health case for standardised packaging and what is the evidence for them? 4.2 Effectiveness 58. Assessing the effectiveness of a regulatory intervention in accordance with the White Paper principle and the Guidelines implies a six-stage process: Establish the policy baseline to define what would happen without the intervention; Set the objectives of the regulation; Challenge the appropriateness of the proposed regulation as the optimal policy response and assess a range of credible policy options; Conduct a cost benefit analysis; Specify the external conditions which must hold for the regulation to be effective; and Identify potential unintended consequences. These steps constitute the core of a RIA. Each is commented in turn. 4.2.1 Policy baseline ‘International best practice indicates that the “do nothing” or “no policy change” option should be included for consideration. Even where doing nothing is not a viable option in practice, it can serve as a useful benchmark against which other options can be compared.’ 59. For EU legislation, the European Commission requires that the relevant impact assessment include a clear baseline scenario as the basis for comparing policy options: ‘The aim of the baseline scenario is to explain how the current situation would evolve without additional public intervention – it is the “no policy change” scenario.’56 60. This requirement is the starting point for conducting an economic analysis of the potential benefits and costs of a proposed regulation.57 It provides a reference point that enables policymakers to answer the question: What would happen on unchanged policies? 22 Implications for RIA on standardised packaging #9 Establish the policy baseline: What would be the trends in smoking prevalence and youth smoking initiation on a ‘no policy change’ basis? 4.2.2 Setting the objectives ‘We need a results-orientated approach to regulation,’ Regulating Better states with respect to Effectiveness. This principle requires that ‘the objectives of regulation will be stated clearly in explanatory guides.’ It is important to distinguish between the general or ultimate objectives and the immediate objectives. Both should be included in the RIA. 61. Defining the regulation’s objectives provides clarity to the goal of the regulation and enables policymakers and society as a whole to see whether, in practice, the regulation succeeds in achieving its objective. The Government has specified the policy objective for tobacco control as to ‘effectively denormalise smoking in our society.’58 The Guidelines state that objectives should be SMART: Specific; Measurable; Accepted; Realistic; and Timedependent. 62. In its 2013 policy document, Tobacco Free Ireland, the denormalisation objective is defined as smoking prevalence of less than 5% by 2025.59 However Table 2 above shows widening disparities between the principal measures of smoking prevalence. In 2009 for example, the difference between DOH/OTC and Eurobarometer on prevalence is more than five percentage points, widening to 7.1 points in 2012. This implies that to be fully SMART, a preferred measure of prevalence should be specified. Implications for RIA on standardised packaging #10 What should be the criteria for specifying a SMART indicator of smoking prevalence? 63. The Minister of Health’s announcement argued that standardised packaging should not be viewed in isolation as a tobacco control measure. This creates something of a tension with the RIA framework. In order to assess the effectiveness of a proposed measure, RIA requires the sponsoring Ministry to use its analytical capability to isolate and quantify the impact of the proposed measure. Implications for RIA on standardised packaging #11 What is the sponsoring Ministry’s quantified estimate of the contribution of standardised packaging to the denormalising of smoking in Ireland? 4.2.3. Appropriateness of regulation 64. A key question which RIA is designed to expose is whether standardised packaging is likely to achieve its objective and whether it is an appropriate policy response, given the multi-dimensional nature of the problem. 23 A problem with traditional ‘command and control’ regulation is that ‘it is often seen as a quick fix. However problems may not always have a regulatory solution or regulation may only be part of the solution, if used alongside information campaigns, or some other measures.’ 65. Smoking is associated with indicators of social and economic disadvantage. A 2013 report by the Irish Cancer Society, Women and Smoking: Time to Face the Crisis, highlighted that female smoking and lung cancer rates were disproportionately high among the socio-economically disadvantaged: ‘Twenty seven percent of women now smoke but the highest rate is seen among women aged 18 to 29 in the more deprived social class groups (SC) 5-6. More than half of women in these groups smoke. This is twice the rate among women in more affluent SC1-2.60 66. A study of a British cohort by Jefferis et al helps explain the link between smoking prevalence and socio-economic disadvantage. It found that not only do educational factors predict adolescent smoking, but also the future course of smoking: ‘The individual’s education level explained most of the association and had a strong graded effect on the odds of persistent smoking … Men and women who had no education qualifications were most likely to smoke.’61 67. Focus group research carried out on behalf of the Irish Cancer Society illustrates the challenge to conventional tobacco control messaging. ‘Women are now de-sensitised from hearing about all the ill-effects smoking can have,’ it found. ‘The invincibility of youth is very apparent as 18 to 24 year olds are least concerned about health risks.’62 68. This finding is similar to that in the 1994 report of the US Surgeon General on youth smoking, which corroborates the finding that low socio-economic status is associated with a high prevalence of smoking.63 The report went on to illustrate the deep-seated social problems associated with high smoking prevalence: ‘A growing body of evidence suggests that social and organizational characteristics of disadvantaged neighbourhoods may contribute independently to higher rates of smoking, above and beyond the aggregate demographic profile of the community’s residents.’64 69. The Surgeon General’s report also emphasises the causal relationship between peer group pressure, social influences and the initiation and maintenance of smoking behaviours during adolescence: ‘By definition, adolescence and young adulthood represent the social transition to adulthood, with accompanying risk-taking associated with trying and acquiring adult behaviours. Yet brain development is not complete, and there is immaturity in consequential thinking, impulsivity, and decision-making skills before adulthood. Notably peer group influences emerge as powerful motivators of behaviour change. These 24 changes create a unique window of vulnerability for tobacco use onset in adolescence and young adulthood.’65 A review of eleven studies found that ‘tolerance for deviance (an intrapersonal variable) appeared uniquely related to the onset of smoking in some of the prospective studies.’66 70. In terms of recommendations for policies to reduce prevalence and initiation, the 2012 Surgeon General’s report reiterated the conclusion of the 1994 report. Approaches based on social-cognitive theory that focused on the teaching of social and self-management skills held the greatest promise, it found. In addition, social and environmental factors were recognized as increasing risk or providing protection: ‘Thus, some research during the last 18 years has focused on involving families in educational efforts, and on changing family dynamics, to protect young people against smoking. Other ecologically driven efforts involve reducing youth access to tobacco products, increasing taxes on tobacco, enacting clean indoor air policies, and reducing images of smoking in movies.’67 Implications for RIA on standardised packaging #12 Given the salience of social-cognitive approaches to reducing smoking initiation, are there non-regulatory options that might be better calibrated to achieving the Government’s public health objectives? 71. A properly conducted RIA enables policymakers to cross-check the appropriateness of a regulation by comparing it with a range of options. For example, the European Commission’s 2009 Impact Assessment Guidelines state that a ‘wide but credible range of options’ should be considered.68 Presenting only the status quo, the ‘extreme’ option and the preferred option should be avoided, as should only presenting complementary actions. Following publication of the bill’s General Scheme, a RIA analysing a broad range of options (including non-regulatory ones) would enable legislators and the general public to be more informed in assessing the potential benefits, costs and possible unintended consequences of the legislation. Implications for RIA on standardised packaging #13 RIA should assess a number of feasible policy options relating specifically to the identified issue or problem. 4.2.4 Cost benefit analysis 72. The essence of RIA is a cost benefit analysis of each regulatory option. The Guidelines stress the importance of all impacts being analysed and, where possible, that the benefits and costs have monetary values placed on them.69 In the case of standardised packaging, the costs would include expenditure on additional compliance (Section 4.2.5 below); possible losses to the Exchequer from any growth of the illicit market and the consequential shift of economic activity to the black economy (Section 4.2.6 below); and the Exchequer’s 25 exposure to legal action by tobacco in respect of compensation for loss of intellectual property (Section 4.6.1 below). Implications for RIA on standardised packaging #14 RIA would need to answer the question: What are the monetized costs and benefits of standardised packaging? 4.2.5 External conditions and unintended consequences The assumptions underlying the stated objective must be clear, which the White Paper defines as ‘the important events, conditions or decisions outside the regulation that must nevertheless prevail for the objective to be attained.’ 73. The effectiveness of a regulation is undermined by non-compliance. The Guidelines require that compliance targets be set out within the RIA. ‘As a general rule of thumb, the higher the level of risk associated with a policy area, the higher the necessary level of compliance,’ the Guidelines state.70 74. With standardised packaging, the threat of non-compliance comes not from legitimate tobacco manufacturers and retailers, but from illicit sources. In 2011, the Irish Tobacco Manufacturers’ Advisory Committee reported that approximately 24% of cigarettes consumed in Ireland were illegal.71 The KPMG October report (referred to in para 52 above) found that although total tobacco consumption was unchanged, illicit consumption rose by 9.5%.* 75. In the context of a market characterized by well-developed illicit channels, evaluating the risk of non-compliance should take account of its dynamic characteristics. The more prevalent the illicit trade is and the higher its penetration, the more it can attract new consumers. Furthermore, the effect of standardised packaging in reducing visual and pricing differentiation between licit and illicit products could also increase the share of illegal products (further discussed in paras 86-87 below). 76. Already there are significant revenue losses and resource costs from the trade in illicit tobacco. The Irish Tobacco Manufacturers Association estimates that €569m was lost the Exchequer in 2012.72 Indirect losses to the Exchequer are harder to measure, but arise principally from economic activity being shifted from retailers and suppliers who pay income taxes to the black economy and to those who don’t. 77. In their 2012 Cross-Border Organised Crime Assessment, the two police services of Ireland note: ‘organised crime gangs on both sides of the border are known to work closely together in the trafficking of counterfeit/contraband cigarettes.’73 In turn, the increase in criminality diverts resources from rebuilding the economy to policing and the criminal justice system. Comparison is with 12 months to 30 June 2013 and the 12 months to 31 December 2012. * 26 ‘If we had unlimited resources, we could probably achieve close to 100% compliance with all regulations, by putting in place large teams of inspectors, enforcement agents, monitoring mechanisms,’ the White Paper states. ‘In reality, we do not have such resources and we must regulate more effectively to ensure the greatest level of compliance without excessive enforcement procedures.’ 78. It is hard to conceive ways in which standardised packaging might reduce the cost of curbing illicit tobacco trade and enforcing tobacco taxation. Removing branding would make it easier for counterfeiters and reduce differentiation between fully taxed and illicit cigarettes. Implications for RIA on standardised packaging #15 What impact is standardised packaging likely to have on the burden of protecting Ireland’s tobacco tax base? 79. The White Paper says that evidence-based policy, through use of RIA, will ensure that attaining the policy objective is not outweighed by the unintended consequences.74 A possible unintended consequence that RIA would need to consider is the impact of standardised packaging on the tobacco tax base. 80. A 2011 paper by Padraic Reidy and Keith Walsh, economists at the research and analytics division of the Revenue Commissioners, analysed the relationship between Ireland’s high tobacco taxes and untaxed consumption. Because of Ireland’s vulnerability to illicit supply, Reidy and Walsh found that higher tobacco taxes in Ireland no longer carried the combined benefits of better public health and higher revenues for the public finances. ‘At the very least, these benefits are severely weakened by the substitution of untaxed for taxed consumption,’ the paper concluded.75 81. The authors quote a finding from a study of the Canadian market: ‘Contraband cigarettes are perceived to be a near-perfect substitute for lawfully purchased cigarettes. As such, contraband tobacco use neutralizes the deterrent effect of higher taxes. Moreover, the tobacco tax revenues sought by politicians shrink when the contraband market enables smokers to evade taxation.’76 According to a report by Eriq Bloomquist, an investment analyst at Berenberg Bank, standardised packaging would reduce consumer differentiation between legal standardised packaged products and illicit products. Over time, this would cause the ‘unintended destruction of the tobacco tax base.’77 Implications for RIA on standardised packaging #16 What might be the implications of standardised packaging for tobacco tax revenues? 82. In addition to potential losses to the Exchequer, every illicit pack of cigarettes represents a transfer from retailers who pay income and business taxes, and provide valuable services to local communities, to the untaxed and often criminal shadow economy, shrinking overall tax revenues and GDP. 27 Implications for RIA on standardised packaging #17 Might there be wider unintended fiscal and economic consequences beyond the direct impact on tobacco tax revenues from the adoption of standardised packaging? 83. The core objective of standardised packaging is public health policy. An effective RIA process will test the policy’s underlying assumptions to assess whether the policy might have perverse outcomes which could undermine this core objective. In particular such a RIA would assess three areas which might cause the policy to be self-defeating: Effect of denormalising smoking on teen perceptions of rebellious behaviour. There might be a risk that policies designed to make cigarette smoking unattractive might perversely increase the attractiveness of smoking to young people. As the UK Department of Health noted in a 2008 consultation on the future of tobacco control, ‘children may be encouraged to take up smoking if plain packages were introduced, as it could be seen as rebellious.’*78 Effect of de-branding on cigarette pricing structure. RIA should examine the role of branding in enabling premium tobacco brands to charge premium pricing. Were standardised packaging to erode the pricing differentials, it could lead to lower prices and higher consumption. As the UK’s 2008 tobacco control consultation noted, ‘plain packaging may force tobacco companies to compete on price alone, resulting in cigarettes becoming cheaper.’79 Whilst the consultation suggested that the effect on price might be countered with additional tax increases, this in turn would increase the incentives for illicit supply. The impact of standardised packaging in reducing the differentiation between licit and illicit tobacco, thereby facilitating the illicit trade. 84. Following the change of government, in 2013, the UK Department of Health conducted a further RIA, this time focused solely on standardised packaging. As described in Annex 2, it did not analyse the effect of de-branding cigarettes on prices. Instead the Department of Health parked the impact on cigarette prices as a ‘risk’ of the policy. Similarly the Department of Health did not examine the potential impact on the consumption of illicit tobacco of homogenising packaging, thereby reducing barriers to illicit tobacco. This too was treated as a risk of the policy and not subjected to thorough analysis. The consultation document went on to say that the Department of Health was not aware of any research evidence that supported such concerns. However there is a large literature on teen consumption of illegal drugs. In 1995, the expert panel appointed by the Canadian government on standardised packaging cited research papers from 1982 and 1991 on ‘the notion of utilitarianism and enhancing one’s image among an adolescent’s peer group’ helping explain why adolescents take up smoking, drinking or drug abuse. Marvin Goldberg, John Liefeld et al, ‘When Packages Can’t Speak: Possible impacts of plain and generic packaging of tobacco products’ (1995), p.26 * 28 Implications for RIA on standardised packaging #18 What might be the perverse consequences for public health policy of standardised packaging, specifically from denormalising tobacco, in increasing status among teens’ peer groups, and from the effect of de-branding packaging on tobacco prices and in reducing differentiation between licit and illicit tobacco? 4.3 Proportionality 85. The Regulating Better principle of proportionality asks whether regulation is required in the first place, if it is appropriate and to what extent it is of good quality. Thus there is considerable overlap with the principle of effectiveness discussed above. This section considers a further dimension of proportionality. 80 ‘The greater the importance or significance of the proposal, the more analysis will be required.’ 86. Standardised packaging has potentially major implications for tobacco manufacturers and retailers. Manufacturers claim that banning the use of their brands constitutes a deprivation of their valuable Intellectual Property (‘IP’) rights and, in the event the legislation were enacted, are likely to seek substantial compensation from the Irish taxpayer. Retailers argue that standardised packaging would have serious economic impacts and lead to significant job losses. These are significant factors which would need due consideration in the regulatory assessment process. The Guidelines require that RIA should provide sufficient evidence to respond to concerns and objections that can be anticipated in the context of the decision-making process and in terms of public reaction.81 Implications for RIA on standardised packaging #19 Because of its significance, RIA on standardised packaging would need to provide decision-makers with a solid factual evidence base about the costs, benefits and other impacts of the feasible policy options referred to in #13. 4.4 Transparency 87. The White Paper pledges: ‘We will consult more widely before regulating.’82 The White Paper pithily states the rationale for consultation – the State does not have a monopoly of wisdom. International best practice recognises the importance of consultation. For example, the New Zealand Treasury – a pioneer of public sector management reform states that having a consultation process as part of RIA ‘provides an important safeguard against regulatory failure.’83 For EU policy initiatives, consultation is a Treaty obligation. In its impact assessment guidelines, the European Commission describes consultation as ‘an essential tool for producing high quality and credible policy proposals. Consultation helps to ensure that policies are effective and efficient, and it increases the legitimacy of EU action from the point of view of stakeholders and citizens.’84 29 88. The converse can be seen with the adoption of the measures recommended by TTFS. Then, there was no RIA or consultation. As result, the putative policy benefits were not adequately analysed and, as discussed further in Section 5 below, the potential threat from the illicit market dismissed. On consultations, the Guidelines states: ‘Don’t forget to analyse consultation responses. It’s not enough to look like you’re listening. You need to show that you are listening to stakeholders’ perspectives.’85 Fourth of Regulating Better principles is: ‘Have we consulted with stakeholders prior to regulating?’ Implications for RIA on standardised packaging #20 Conduct a bona fide consultation of stakeholders and the general public from which the evidence is carefully weighed to inform the optimal policy response. 4.5 Accountability 89. Ultimately, accountability – fifth of the Regulating Better principles – is about who receives the credit and the blame for policy successes and policy failures. Accountability is also relevant to the process of policy-making. If a proposed policy is not subjected to the rigour of RIA, it is more likely that any flaws and mistaken assumptions are not detected and remedied and that the policy fails to achieve its objectives. 4.6 Consistency 90. Successful tobacco control is about designing policies which have the greatest impact in reducing smoking prevalence and teen smoking initiation without damaging economic competitiveness. The Guidelines include a diagram of the NCC Competitiveness Pyramid.86 All proposed regulations, it states, should be examined to assess their impact on Ireland’s business and work environment.87 91. Standardised packaging has implications for tobacco companies’ use of Intellectual Property (‘IP’). Abrogation of rights to use IP might adversely impact perceptions of Ireland’s business environment. According to a report in the Irish Times in July 2013, some of America’s largest business organisations have urged the Taoiseach to rethink plans to introduce standardised packaging for tobacco products. Such a move would mandate the ‘destruction of legitimate and legally sanctioned trademark protection and branding,’ the heads of the organisations warned.88 Implications for RIA on standardised packaging #21 For an objective assessment of the likely impact of standardised packaging on Ireland’s business climate, as well as the retail sector, an option would be to consult the National Competitiveness Council and IP-intensive companies and their trade associations. 30 4.6.1 Impacts on rights 92. The Guidelines require RIA to assess whether the proposals under consideration impinge disproportionately on the rights of citizens: ‘There is often a balance to be achieved between protecting individual freedoms and promoting the welfare of society and judgments in relation to the appropriate balance in each case will be made by the relevant Minister based on the advice of officials, legal obligations and other factors.’89 Standardised packaging raises important legal issues with respect to the Irish Constitution, the country’s obligations under the World Trade Organization (WTO), as a party to European Convention on Human Rights (ECHR) and under the EU Charter of Fundamental Rights. 93. Five countries are challenging Australia’s action on standardised packaging under the WTO. The logic of international trademark and intellectual property agreements (notably the Trade Related Aspects of Intellectual Property Rights) is to prevent parties separating the IP from the underlying product. 94. Ireland’s move was discussed at the June 2013 meeting of the WTO and was criticised by Malawi, the Dominican Republic, Cuba, Guatemala, Honduras, Zimbabwe and Nigeria. (Australia, New Zealand and Norway supported the proposal.) Among the concerns raised were ‘the lack of scientific basis, uncertainty about the means of attaining the objective, the possible adverse effects, and the negative effect on the competitiveness of Least Developed Countries.’90 95. As a party to the ECHR, Ireland would be exposed to additional legal risk were it to implement standardised packaging. In an opinion submitted on behalf of the tobacco company PMI as part of the UK standardised packaging consultation, the distinguished jurist Lord Hoffmann asked whether the prohibition of branding required by standardised packaging would be contrary to Article I of the First Protocol to the European Convention on Human Rights. ‘Although this point is controversial,’ Lord Hoffmann wrote ‘Parliament may be entitled to take the view that there is a public interest justification in extinguishing the use of the marks on the ground that their use encourages people to smoke. But that is not enough to justify extinguishment of the marks without compensation’ (emphasis in the original).91 96. In response to the Irish government’s decision to introduce legislation to require standardised packaging, PMI commissioned a report from Michael Collins S.C. Without compensating tobacco companies, such moves would not ‘withstand legal scrutiny’ and warned that the legal implications were ‘predictable and stark.’92 Following a critical legal opinion on plain packaging by the European Parliament’s Legal Affairs Committee (JURI)* as well as JURI, Opinion on the proposal for a directive of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States * 31 rejection of the measure by all of the other four Opinion Giving Committees as well as the lead Committee, ENVI*, the EU Commission, Council and Parliament on December 18, 2013, decided against requiring EU-wide standardised packaging as part of the revised EU Tobacco Products Directive. Implications for RIA on standardised packaging #22 What is the Exchequer’s potential exposure to legal action by tobacco companies seeking compensation for the loss of Intellectual Property? 4.7 Summary 97. The aim of RIA is to improve the quality of policy making so the Government delivers better outcomes in terms of economic competitiveness and national welfare. The RIA framework is designed to avoid a repetition of the policy failures of the past, when policies were adopted without the evidence being tested against a rigorous set of objective criteria. The goal of tobacco control does not exempt it from such scrutiny. Ineffective, poorly designed tobacco control policies have a high human cost if they fail to cut tobacco consumption when alternative policy options might. concerning the manufacture, presentation and sale of tobacco and related products, 25 June 2013, A7-0276/2013 at http://www.europarl.europa.eu/sides/getDoc.do?pubRef=%2f%2fEP%2f%2fNONSGML%2bCOMPARL%2bPE510.591%2b02%2bDOC%2bPDF%2bV0%2f%2fEN * See at http://www.europarl.europa.eu/committees/en/juri/opinions.html?action=3#menuzone. 32 Part IV. Conclusions 98. Unlike government spending programmes, regulatory interventions have far lower direct costs to government budgets. Because regulation appears virtually free, there can be less concern about obtaining quality outcomes. However governments around the world found that over-regulation was failing to deliver desired policy objectives and harmed the performance of their economies. This led to structured scrutiny of proposed regulations to assess their likely costs and benefits – RIA. 99. The growth of illicit tobacco trade demonstrates that there are downsides to poorly designed tobacco control measures and that they are not without cost or risk. In the case of Ireland’s post-2000 tobacco control regime, whilst there is some evidence of progress, the outcomes can hardly be said to match the expectations of a tobacco-free Ireland with: one of the highest smoking prevalence of the western EU-15, topped only by two countries; and ranking number one in the EU-15 for the share of the tobacco market taken by illicit sources. 100. Unlike in 2000, when Ireland’s current tobacco framework was first adopted, application of RIA principles means that new interventions are subject to structured appraisal to assess whether, based on the evidence, they are likely to deliver their objectives; whether those objectives might be better delivered by nonregulatory alternatives; and to identify potential unintended consequences. In 2000, the threat to public health and to the Exchequer from illicit tobacco was dismissed rather than analysed. In 2014, it is, unfortunately, an established reality. 101. The ‘key test’ required by RIA sets the evidentiary standard required of a new regulation: demonstrable benefits in meeting a policy objective which would not otherwise occur. Only one country in the world has implemented standardised packaging of tobacco products. Before Australia did so, the case for standardised packaging was hypothetical, principally based on inferences drawn from studies exploring what smokers claimed they would do in a standardised packaging world. This lack of evidence is the reason why EU rejected standardised packaging as part of the revision of the TPD. Preliminary Australian data show no change in smoking prevalence together with an increase in illicit consumption. 102. Inevitably, the possible impact of standardised packaging on tobacco prices and illicit consumption will bulk large in a RIA. The effectiveness of taxation as a tobacco control measure is undermined by illicit consumption stimulated by high tobacco prices. In its 2013 tobacco control policy document, Tobacco Free Ireland, the Department of Health proposes higher taxation plus more resources dedicated to anti-smuggling efforts. This means a crucial aspect of a RIA on standardised packaging is its possible effects on price potentially undermining public health objectives as well as broader economic and social policy objectives: 33 what is the likely effect of de-branding packaging on the pricing of premium cigarette brands and on the pricing structure in the tobacco market? What is the likely effect of eroding visible differentiation between licit and illicit tobacco on facilitating consumption of illicit tobacco? 103. The potential interaction of standardised packaging, tobacco prices and illicit tobacco consumption highlights the benefit of RIA in requiring assessment of nonregulatory options. High smoking prevalence is associated with socio-economic disadvantage. There is evidence of the effectiveness of anti-smoking approaches based on the teaching of social and self-management skills. These do not incur the downside of stimulating or facilitating illicit supply. Rather the contrary, they work by reducing the demand for tobacco. 104. The importance of having effective tobacco control policies does not exempt them from RIA. Indeed, tobacco control will be more effective the more they are grounded in policies that demonstrably work. Structured application of the Regulating Better principles and the Guidelines to the standardised packaging legislation would improve the prospect of Ireland having greater success at reducing smoking and reducing the unintended consequences of tobacco control policies, notably the size of the illicit market. 34 Annex 1: Regulatory Principles and the implications for RIA Regulatory Principle / RIA implication Considerations Ref 0. Policy context #1 Examine trends in smoking prevalence since 2000 to determine the overall effectiveness of existing tobacco policies and attempt to explain the differing trends in prevalence between different surveys After the decision to adopt stringent tobacco control policies in 2000, smoking prevalence in Ireland remained ‘stubbornly high’ #2 Analyse recent trends in smoking initiation and their possible implications for policy Survey evidence suggests a shift in smoking initiation towards females and the later teen years Para 33-38 #3 Examine evidence on the effectiveness of POSD ban POSD ban and standardised packaging are overlapping measures Para 45-46 #4 The potential benefits of standardised packaging should be assessed as the incremental benefits over and above those from pack standardisation measures to be introduced by the new TPD In practice, the policy baseline is represented by implementation of revisions to the Tobacco Products Directive Para 30-32 Table 2 More recently, one measure of prevalence (DOH/OTC) shows declining prevalence whilst others do not 1. Necessity If POSD ban ineffective, has implications for likely effectiveness of standardised packaging The effects of these measures need to be considered and quantified as part of the policy baseline 35 Para 47-48 Regulatory Principle / RIA implication #5 Identify demonstrable benefits and ask if they are sufficient to meet the RIA ‘key test’ Considerations The RIA ‘key test’ is the demonstrable benefits in meeting a policy objective which would otherwise not occur Ref Para 49 Except for emerging evidence from Australia (which, so far, does not indicate any change in prevalence) there is a paucity of direct evidence on the effects on smoking rates #6 What weighting should be placed on indirect evidence and inference as distinct from direct evidence? Emerging direct evidence from Australia does not demonstrate any decrease in smoking prevalence since the implementation of standardised packaging Para 50-51 Annex II By default, the case for standardised packaging rests principally on indirect evidence and inference #7 Identify causal factors in smoking initiation and their weighting relative to other causal factors #8 Identify critical assumptions and underlying evidence for public health case for standardised packaging Analyse literature and survey data from smokers and ex-smokers on what they considered factors as to why they started smoking RIA should present evidence on the extent to which branded tobacco packaging might be a causal factor in smoking initiation Para 54-55 Table 5 Para 56-57 2. Effectiveness #9 Establish the policy baseline: trends in smoking prevalence and initiation without standardised packaging Best practice is to quantify ‘no policy change’ scenario Policymakers and legislators need the best estimate of what would happen without the proposed policy intervention 36 Para 59-60 Regulatory Principle / RIA implication #10 Identify the criteria for specifying a SMART indicator of smoking prevalence Considerations There is a growing inconsistency between different measures of adult smoking prevalence Ref Para 61-62 Table 2 Policymakers and the public need to know which is the most reliable indicator of progress towards meeting the Government’s goal of 5% prevalence #11 Estimate the contribution of standardised packaging to achieving 5% smoking prevalence by 2025 RIA aims to isolate the contribution of the policy option to attainment of the policy objective Para 63 Para 64-70 #12 Examine whether non-regulatory approaches might be better calibrated to achieve the policy objective High levels of smoking initiation and prevalence are associated with socio-economic disadvantage that might be less responsive to regulatory interventions than non-regulatory approaches #13 Outline a broad range of feasible policy options relating to the specific policy problem International best practice is for RIA to examine a number of distinct policy options Para 71 #14 Estimate the policy’s monetized costs and benefits The essence of RIA is cost /benefit analysis qualified by the risks and possible unintended consequences Para 72 Ireland has the highest share taken by illicit tobacco trade in western Europe Para 74-78 #15 Potential impact of the policy on protecting the tobacco tax base The trade in illicit tobacco is likely to be the principal channel undermining tobacco control policy RIA should examine the threat to the policy from non-compliance and the consequential enforcement costs 37 Regulatory Principle / RIA implication #16 Potential impact on tobacco tax revenues Considerations At present the trade in illicit tobacco is estimated to cost the Exchequer around €0.5bn annually Ref Para 79-81 To what extent might standardised packaging make enforcement of tobacco taxation harder? #17 Unintended policy consequences beyond any impact on the tobacco tax base In shifting economic activity from legitimate channels, the negative impacts of illicit trade of tobacco are wider than undermining tobacco control policy and reducing the yield from tobacco taxes #18 Potential unintended consequences on public health objectives of policy on illicit trade and tobacco prices High prices are known to be effective in reducing initiation and prevalence Para 82 Para 83-84 What might be impact on tobacco prices of de-branding tobacco packaging and the consequential impact on smoking propensities? Would standardised packaging be more likely to hinder or facilitate trade in illicit tobacco? 3. Proportionality #19 Solid, factual evidence about costs, benefits and other impacts of the policy options identified in #11 RIA in respect of a measure deemed important or significant requires more analysis Para 85-86 The rationale for consultation is that the State does not have a monopoly of wisdom Para 87-88 4. Transparency #20 Conduct bona fide consultation with stakeholders Bona fide consultation helps reduce risk of policy failure 5. Accountability A flawed or incomplete RIA is more likely to result in an ineffective policy with significant unintended consequences 38 Regulatory Principle / RIA implication Considerations Ref 6. Consistency #21 Consultees might include the retail sector, the National Competitiveness Council and IP-intensive multinationals #22 Exchequer’s potential exposure to compensate tobacco companies for the loss of IP The Government’s overall policy objective is restoring the economy to health Para 90-91 Possible impacts on business perceptions of Ireland as destination for Foreign-Direct Investment Under the Irish Constitution and as a member of the World Trade Organization and a signatory of the European Convention on Human Rights, Ireland could be exposed to legal action by tobacco companies in respect of the loss of IP 39 Para 95-96 Annex 2: Domestic and international experience A2.1. Ireland A2.1. The evolution of tobacco control policy domestically provides evidence which can be incorporated into a RIA on standardised packaging: Analysis of the effectiveness of precursor measures, such as display bans, in reducing prevalence; Examination of the quality of policy analysis in prior rounds of tobacco control policy to assess whether there is a linkage with the quality of policy outcomes; and Key issues revealed from analysis of the case for standardised packaging in other countries. A2.1.1 Policy background A2.2. The foundations of Ireland’s current tobacco control regime were laid before the RIA framework was put in place, following adoption of the recommendations set out in TTFS in 2000. It therefore provides evidence on types of outcomes from a more intuitive, less structured approach to policy making. With its ‘Healthy Ireland’ initiative, the current Government has expressed an intent to put in place a more structured approach to public health policy making. A2.3. TTFS stated that if tobacco were a new drug, its sale would, the Review Group’s report suggested, be prohibited. However a complete ban on tobacco would lead to the emergence of a substantial black market in smuggled tobacco with its associated criminality.93 It expressed confidence that its recommendations would go a long way towards achieving this objective. Past efforts had not been as successful as their initiators might have hoped. This lack of success, the report argued, was due, at least in part, to ‘the lack of a sustained effort of enforcement.’94 TTFS assumed that the public health benefits of higher tobacco prices would not be compromised by smuggling. ‘While high prices may increase inward smuggling the evidence suggests that tax buoyancy remains high and more smokers quit,’ TTFS stated.95 The high level of tobacco taxes advocated by TTFS helped drive a shift from consumption of tax cigarettes to untaxed cigarettes. Rather than the lack of progress in reducing smoking being ascribed to a lack of sustained enforcement – the explanation offered in TTFS – a case can be made that TTFS helped create an enforcement problem. A2.4. Healthy Ireland’ sets out the Government’s policy framework for public health through to 2025. It involves the specification of a comprehensive set of indicators and monitoring of progress towards meeting relevant outcomes. It is based on seven operating principles. ‘Better use of evidence’ is the fifth and ‘better measurement and evaluation,’ the sixth. In terms of tobacco control, these suggest interventions should target variables which are causal factors in smoking 40 initiation and reduce the overall demand for cigarettes and that the effectiveness of interventions should be monitored and assessed. A2.1.2 Tobacco Free Ireland A2.5. In October 2013, the Department of Health published Tobacco Free Ireland (‘TFI’), the first comprehensive statement on tobacco control policies since TTFS. It marks a continuation of TTFS rather than an assessment of what works and what did not in the earlier document. TFI’s starting point is the ‘high levels’ of smoking in Ireland.96 Significant progress has been made in implementing the actions recommended by TTFS which, it says, ‘have been instrumental in reducing tobacco consumption.’97 A2.6. Like TTFS, TFI views the policy challenge as principally one of compliance and enforcement, noting the poor level of compliance prior to TTFS: ‘The improvement in compliance levels has been achieved by widespread public support for the measures, delivering stakeholder education initiatives and developing and implementing a proactive national enforcement programme.’98 A2.7. In advocating more of the same, TFI sets out a policy of raising tobacco taxes ‘over a continuous five year period.’99 Unlike TTFS however, TFI recognises the threat from illicit tobacco trade: ‘The health gain from high-priced tobacco, however, can be adversely affected by the smuggling and sale of illicit tobacco products.’100 … ‘The Office of the Revenue Commissioners view the illicit trade in tobacco products as a very serious matter, because of the threats that it poses to tax revenues, to legitimate law-abiding businesses and to the Government’s policy of reducing smoking prevalence.’101 A2.8. The solution proposed by TFI is more rigorous and sustained action against the illicit market. This includes: a levy on the tobacco industry to fund tobacco control initiatives including those ‘to end the illicit trade’102 international cooperation under the Protocol to Eliminate the Illicit Trade in Tobacco Products adopted under the Framework Convention on Tobacco Control Its response to the threat posed by illicit tobacco is reminiscent of TTFS – more and better enforcement. Yet there is little recognition of the possibility that tobacco control policy might have contributed to its growth. A2.1.3 Considerations for RIA A2.9. Coming from a pre-RIA era, TTFS might be characterized as being stronger on rhetoric than on analysis. In particular, TTFS was dismissive of the threat posed by illicit tobacco which is now a major factor. The Government’s ‘Healthy Ireland’ public health policy framework uses more rigorous, quantitative methodologies 41 and better programme management than in the past. It is an approach that fits well with the RIA framework and addressing the issues discussed in Part III above. A2.2 Relevant international experience A2.10. The Regulating Better principle of Necessity requires regulations to be more rigorously supported in terms of the information, analysis and assumptions that underpin them. International experience is highly relevant to meeting this RIA objective. As the only country to have implemented the measure, Australia is the sole source of direct evidence as to its effectiveness and for meeting the RIA ‘key test’ that there must be demonstrable benefits in terms of achieving public policy objectives flowing from the regulation that would not otherwise accrue. Other countries’ approaches to tobacco control, notably the US and Germany, provide evidence on the effectiveness of non-regulatory measures – the second half of the RIA key test. A2.11. The way other countries have analysed the regulatory case for standardised packaging yields insights and lessons that might be applicable to the conduct of RIA in Ireland. Canada undertook and extensive exercise in the mid-1990s and in 2013, the UK concluded a RIA on standardised packaging. A2.2.1 Australia A2.12. Australia has one of the most stringent tobacco control regimes in the world. As a federation, precise regulations vary from state to state. For example, Victoria has criminalised the possession of contraband tobacco. However with the Tobacco Plain Packaging Act 2011, Australia became the first country to implement standardised packaging, which took full effect at the beginning of December 2012. In parallel, Australia is sharply raising tobacco taxes. In 2010, there was a one-off 25% increase. Duty is indexed to average earnings and in August 2013, the Government announced a duty escalator of 12.5% a year for four years on top of the earnings indexation. It means that in four years, tobacco taxes are planned to rise 60% above the increase in average earnings. A2.13. Already, Australia has the highest cigarette prices in the Asia Pacific region. According to an October 2013 report by KPMG (commissioned by the Australian subsidiaries of Imperial Tobacco, British American Tobacco and PMI), Australian cigarette prices are 50% higher than those of the nearest non-Australasian market.103 A2.14. Table A1 extracts provides data on recent trends in Australian tobacco consumption from the KPMG report. (Note that data for the six months to 31st December 2012 are included twice – first for 2012, then for the 12 months to 30th June 2013.) 42 Table A1: Tobacco consumption in Australia (million kgs, rounded) 2007 2009 2010 2011 Total consumption 2012 Year to 30/6/13 19.4 19.4 18.8 18.0 17.4 17.4 Licit 17.6 17.6 16.4 15.7 15.3 15.1 Illicit 1.8 1.8 2.4 2.2 2.1 2.3 8.3% 9.1% 12.8% 12.4% 11.8% 13.3% of which: Illicit proportion Source: Based on KPMG, Illicit Tobacco in Australia: 2013 Half Year Report (October 2013), p.28 A2.15. Some observations can already be made: The 25% tobacco tax increase in 2010 was accompanied by a 0.6 million kg fall (3.1%) in overall consumption. The components of the 0.6 million kg fall were a 1.2 million kg decline in licit consumption, partially offset by a 0.6 million kg increase in consumption of illicit tobacco Total consumption continued to decline over the next two years – down by 1.4 million kg (2012 on 2010), with falls in consumption of licit (down by 1.1 million kg) and illicit tobacco (down by 0.3 million kg) The year to 30th June 2013 (i.e., including the first seven months of standardised packaging) saw no change in overall consumption, but a reversal of the decline in illicit consumption, which rose by 0.2 million kg. Because half the data are identical between 2012 and the 12 months to 30th June 2013, this is likely to understate the underlying increase in the illicit market Since 2007, the volume of illicit tobacco in Australia has risen by 28% to record its highest share of total consumption (13.3%). Although the two most recent periods overlap, the share taken by illicit supply in the 12 months to 30 June 2013 (comprising 7 months of standardised packaging) was 13.3% compared to 11.8% for the 12 months to 31 December 2012 (with only one month of standardised packaging). The growth in the share of consumption taken by illicit tobacco does suggest that the possible responses from illicit sources should be a material consideration in formulating tobacco control policies. A2.16. A study by London Economics (commissioned by Philip Morris International) is one of the first comprehensive analyses examining smoking prevalence since the introduction of standardised packaging. London Economics’ interim assessment, 43 produced in November 2013, notes that in contrast to a number of other studies that are predictive in nature, its analysis concentrates on actual smoking behaviour.104 A2.17. Nearly 20,000 adults (18+) took part in an online survey. 9,226 adults were surveyed prior between July and October 2012 prior to the introduction of standardised packaging. Post-introduction, 5,114 were surveyed in March 2013 and a further 5,247 surveyed in July 2013. Based on analysis of the survey data, London Economics stated: ‘Over the timeframe of the analysis, the data does not demonstrate that there has been a change in smoking prevalence following the introduction of standardised packaging.’105 A2.2.1.1 Relevance of Australia to RIA A2.18. As the only market in the world producing direct evidence on the impact of standardised packaging, data from Australia should be central to any RIA on standardised packaging. Survey evidence analysed by London Economics and KPMG does not show a statistically significant change in adult smoking prevalence. (The survey did not examine smoking by teens under 18 years of age.) Furthermore, the proportion of the market taken by illicit tobacco rose in the 12 months to 30 June 2013, as did the absolute quantity of illicit tobacco. A2.2.2 Canada’s examination of standardised packaging A2.19. Five years before TTFS, the Canadian government explored the case for standardised packaging and appointed an expert panel to examine it. Although the expert panel recommended standardised packaging (which the Canadian government rejected), its 160-page report, ‘When Packages Can’t Speak: Possible impacts of standardised and generic packaging of tobacco products’ (‘WPCS’) involved a much more searching analysis than in TTFS. A2.20. As part of its analysis, the Canadian expert panel carried out a national survey of teens. Its findings, which excluded committed anti-smokers, support those of the Eurobarometer survey cited in Section 4.1.1 above. When non-smoking teens were asked, ‘What are some reasons that might encourage you to start smoking?’, virtually all respondents said: ‘to be cool’ or ‘to fit in with friends’ (99.7%).106 A2.21. The expert panel conducted a series of focus groups to provide its members with a ‘reality check.’107 It provides evidence on the sequencing of decisions and the factors associated with each step in smoking initiation from smoking the first cigarette to the first cigarette purchase: smoking initiation is dominated by peer and parental influence it occurs prior to a new smoker’s choice of brand brand and brand awareness come into play when an initiated smoker purchase tobacco and has to specify a cigarette brand A2.22. Like TTFS, WPCS focused on the possible responses by the tobacco industry to undermining the intent of standardised packaging. The potential response from illicit suppliers was treated almost as an afterthought. ‘It is speculated that illegal 44 US imports through smuggling may rise,’ the Canadian expert panel wrote in WPCS. However the threat from illicit imports was not analysed. ‘The impact of standardised and generic packaging on smuggling has yet to be determined,’ the expert panel wrote at the end of the sole paragraph devoted to the illicit market in WPCS.108 A2.2.2.1 Relevance of Canada for RIA A2.23. The caveats and qualifications made by the Canadian expert panel in 1995 on the lack of empirical data on standardised packaging highlight the importance of the evidence now emerging from Australia. The results from its qualitative research (derived from focus groups) on smoking initiation corroborate quantitative survey data from Eurobarometer (Table 5 above). It is an approach that remains relevant to a RIA on standardised packaging. A2.2.3 RIA and standardised packaging – the UK’s experience A2.24. In 2012, the UK Department of Health (‘DH’) consulted on the introduction of standardised packaging four years after the previous Labour government’s consultation on tobacco control had rejected it.109 The 2012 consultation and RIA contained a number of flaws: Failure to establish the benefits of existing tobacco control measures to provide a yardstick to assess the effectiveness of standardised packaging, contrary to domestic and EU impact assessment standards Little effort to validate the assumption that cigarette packaging is a factor causing people to smoke and one preventing them from stopping Reliance on survey evidence of what people say they would do (rather than what they actually would do), which the DH had previously acknowledged was a poor predictor of smokers’ behaviour Selectivity in choosing favourable findings and experts and ignoring others who might have questioned the preferred policy option Although the RIA admitted that the process was prone to bias, it did not attempt to remedy for its effects A2.25. The most critical deficiencies revolved around the DH’s treatment on the possible impacts of standardised packaging on tobacco prices and the illicit trade. Price is central to the success or failure of standardised packaging. Not only might it render the policy ineffective, it could lead to more smoking, as the price of cigarettes is known to be a major factor influencing smoking. The DH recognised that standardised packaging would reinforce the trend of downtrading to lower priced cigarette brands.110 Cheaper cigarettes ‘might threaten’ the effectiveness of the policy and the possibility that standardised packaging would lead to lower prices is described by the DH as a policy risk and not analysed any further. A2.26. The consultation’s treatment of the threat to the policy from illicit tobacco was limited solely to the potential duty lost to the Exchequer.111 It ignored the impact on price from any growth in the share of the market taken by illicit cigarettes. Here, the DH stated that the impact of standardised packaging on the sale of illicit cigarettes is ‘hard to predict.’112 As with the potential impact on price, the DH 45 described this as a risk of the policy, without examining what the consequences might be, i.e., not doing precisely what RIA should. A2.27. The UK’s recent approach illustrates the pitfalls when standardised packaging is treated as a totemic issue rather than analysing tobacco control measures for their effectiveness in achieving public health objectives. As a result, the DH consultation ducked the critical issues of the potential impact of standardised packaging on tobacco prices and on the illicit trade. A2.2.4 The US and youth smoking programmes A2.28. The context for the 2012 report of the Surgeon General on tobacco use by youth and young adults was the disappointing trend in youth smoking in the US. From 1997 into the start of the 21st century, youth smoking rates fell sharply. Since then, the declines slowed and have been more sporadic. If high school smoking levels had continued to decline at the 1997-2003 rate, prevalence in 2009 would have been 8% rather than 19.5%.113 Since 2005, initiation rates have been rising among 18-25 years olds.114 A2.29. The report reviews research to identify effective strategies to reduce smoking initiation, prevalence and promote cessation. In the conclusion to its chapter on prevention and reduction efforts, the report states that the evidence is sufficient to conclude that: mass media campaigns; increased tobacco taxation; and school-based campaigns reduce smoking initiation and prevalence among youth.115 A2.2.4.1 Mass media campaigns A2.30. According to the report, ‘evidence indicates that mass media campaigns can be one of the most effective strategies in changing social norms and preventing youth smoking.’116 Furthermore, used in combination with increases in tobacco taxation, such activity reduced cigarette consumption by more than would be expected from price increases alone.117 Research from controlled exposure studies provides evidence that advertising that evokes strong negative emotions, including those on the health effects of smoking, have greater recall.118 A2.2.4.2 Tobacco taxes A2.31. Estimates from studies on the effect of tobacco taxes suggest adolescents are considerably more responsive to price changes than adults.119 However the report noted that using average prices within a state does not account for an individual’s ability to avoid taxes: ‘Some individuals living near American Indian reservations or close to the border of a state with lower taxes on cigarettes will be able to pay less than the average price for cigarettes in their own states … Future studies on demand that account for a person’s opportunities for tax avoidance are warranted.’120 46 A2.2.4.3 School-based programmes A2.32. A systematic review of studies on the effectiveness of school-based identified the following as important components of effective smoking prevention programmes: Use of interactive delivery methods Programme designs based on social influences model Inclusion of components on norms and commitments not to use tobacco Inclusion of community elements Involvement of peer leaders rather than relying totally on adults Training and practice in the use of refusal and other life skills121 Furthermore, school-based initiatives were found to produce larger and more sustained effects when implemented in combination with supplementary or complementary family, mass media or community-based programmes.122 A2.2.4.4 Relevance of the US to RIA A2.33. In the US, there is less emphasis on what appears on tobacco packaging than in other jurisdictions. Nonetheless, America’s federal system encourages a wide range of tobacco control policy experimentation. Thus the policy successes reported by the Surgeon General represent a proven basis for adopting policies to reduce smoking initiation and prevalence among teens and young adults. A2.2.5 Germany: Effective practices to reduce youth smoking A2.34. Germany shows that very substantial progress in reducing youth smoking can be made in current regulatory environments.123 The primary difference between the German and Irish tobacco control strategies is Germany’s targeted prevention and education campaigns, many of which are school-based. Through the use of credible messengers, including parents and teachers, these programmes focus on at-risk young people in order to empower them to make informed decisions about tobacco, alcohol, and other drugs. A2.35. The Federal Centre for Health Education (BzgA) reported that the ‘percentage of smokers among young people aged between 12 and 17 years has dropped to a new all-time low: 11.7 per cent in 2011 from 27.5 per cent in 2001.’124 The Federal Drug Commissioner explained this success as follows: ‘Alongside regulatory measures such as the Youth Protection Bill’s smoking restriction for under-age persons, tobacco tax increases and regulations aimed to provide protection from passive smoking in Germany, the Federal Office for Health Education’s (BZGA) “Smoke Free” youth campaign has contributed significantly to the success of tobacco policies in the target group of under-aged and young adults.’125 A2.2.5.1 Relevance of Germany to RIA A2.36. The success of Germany’s school-based anti-smoking programmes reinforces the lessons from the US on the effectiveness of such programmes. Unlike many other tobacco control policies, including standardised packaging, these are not exposed 47 to the risk of unintended consequences in the form of the growth of illicit tobacco consumption. References Department of Health, General Scheme of the Public Health (Standardised) Packaging of Tobacco) Bill 2013, p.8 2 Department of Health press notice, ‘Ireland set to become second country in the world to introduce plain pack cigarettes,’ 28 May 2013 http://www.dohc.ie/press/releases/2013/20130528.html 3 Department of the Taoiseach, Revised RIA Guidelines: How to conduct a Regulatory Impact Analysis (2009), para 4.11 4 Department of the Taoiseach, Revised RIA Guidelines: How to conduct a Regulatory Impact Analysis (2009), para 3.3 5 Department of the Taoiseach, Revised RIA Guidelines: How to conduct a Regulatory Impact Analysis (2009), para 1.11 6 Department of the Taoiseach, Revised RIA Guidelines: How to conduct a Regulatory Impact Analysis (2009), para 3.1 7 Department of the Taoiseach, Revised RIA Guidelines: How to conduct a Regulatory Impact Analysis (2009), para 3.5 8 European Commission, Impact Assessment Guidelines (15 January 2009), p.4 9 European Commission, Impact Assessment Guidelines (15 January 2009), p.24 10 Department of the Taoiseach, Revised RIA Guidelines: How to conduct a Regulatory Impact Analysis (2009), para 1.12 11 Department of the Taoiseach, Regulating Better (2004), p.2 12 Department of the Taoiseach, Revised RIA Guidelines: How to conduct a Regulatory Impact Analysis (2009), para 1.5 13 Department of the Taoiseach, Regulating Better (2004), p.11 14 Department of the Taoiseach, Regulating Better (2004), p.11 15 Department of the Taoiseach, Regulating Better (2004), p.12 16 Department of the Taoiseach, Regulating Better (2004), p.16 17 Department of the Taoiseach, Regulating Better (2004), p.10 18 Department of the Taoiseach, Revised RIA Guidelines: How to conduct a Regulatory Impact Analysis (2009), para 4.8 19 Department of the Taoiseach, Revised RIA Guidelines: How to conduct a Regulatory Impact Analysis (2009), para 4.9 20 Department of the Taoiseach, Regulating Better (2004), p.16 21 Department of the Taoiseach, Regulating Better (2004), p.17 22 Department of the Taoiseach, Revised RIA Guidelines: How to conduct a Regulatory Impact Analysis (2009), para 3.5 23 Department of the Taoiseach, Revised RIA Guidelines: How to conduct a Regulatory Impact Analysis (2009), para 3.1 24 Department of the Taoiseach, Regulating Better (2004), p.20 25 Department of the Taoiseach, Regulating Better (2004), p.21 26 Department of the Taoiseach, Revised RIA Guidelines: How to conduct a Regulatory Impact Analysis (2009), para 2.1 27 Department of the Taoiseach, Revised RIA Guidelines: How to conduct a Regulatory Impact Analysis (2009), para 1.6 1 48 Department of the Taoiseach, Regulating Better (2004), p.26 Dáil Éireann Debate (unrevised), 13 June 2013, WA 189 30 Department of the Taoiseach, Revised RIA Guidelines: How to conduct a Regulatory Impact Analysis (2009), para 2.1 31 Department of the Taoiseach, Revised RIA Guidelines: How to conduct a Regulatory Impact Analysis (2009), para 1.7 32 Department of the Taoiseach, Revised RIA Guidelines: How to conduct a Regulatory Impact Analysis (2009), para 1.10 33 Department of the Taoiseach, Revised RIA Guidelines: How to conduct a Regulatory Impact Analysis (2009), para 4.38 34 Department of the Taoiseach, Revised RIA Guidelines: How to conduct a Regulatory Impact Analysis (2009), para 4.39 35 Department of the Taoiseach, Revised RIA Guidelines: How to conduct a Regulatory Impact Analysis (2009), para 4.6 36 Luk Joosens and Martin Raw, The Tobacco Control Scale 2010 in Europe, Table 4 37 Irish Cancer Society, Women and Smoking: Time to Face the Crisis (2013), p.2 38 Brugha, R., Tully, N., Dicker, P., Shelley, E., Ward, M. and McGee, H. (2009) SLÁN 2007: Survey of Lifestyle, Attitudes and Nutrition in Ireland. Smoking Patterns in Ireland: Implications for policy and services, Department of Health and Children, p.9 39 Tobacco Free Policy Group, Towards A Tobacco Free Society (2000), p.27 40 European Commission, IMPACT ASSESSMENT Accompanying The Document Proposal For a Directive of The European Parliament and of The Council (19 December 2012), p.2 28 29 41 Hibell, B., Guttormsson, U., Ahlström, S., Balakireva, O., Bjarnason, T., Kokkevi, A., Kraus, L. (2011) The 2011 ESPAD Report. Substance Use Among Students in 36 European Countries Department of Health, Tobacco Free Ireland: Report of the Tobacco Policy Review Group (October 2013), p.24 43 Department of Health, Tobacco Free Ireland: Report of the Tobacco Policy Review Group (October 2013), p.25 44 Brugha, R., Tully, N., Dicker, P., Shelley, E., Ward, M. and McGee, H. (2009) SLÁN 2007: Survey of Lifestyle, Attitudes and Nutrition in Ireland. Smoking Patterns in Ireland: Implications for policy and services, Department of Health and Children, p.6 45 Brugha, R., Tully, N., Dicker, P., Shelley, E., Ward, M. and McGee, H. (2009) SLÁN 2007: Survey of Lifestyle, Attitudes and Nutrition in Ireland. Smoking Patterns in Ireland: Implications for policy and services, Department of Health and Children, p.7 46 Frank Chaloupka & John Tauras, ‘The Demand for Cigarettes in Ireland’ (2011), p.7 47 Frank Chaloupka & John Tauras, ‘The Demand for Cigarettes in Ireland’ (2011), p.19 & p.8 48 Grant Thornton, ‘Illicit Trade in Ireland’ (2013), Figure 5.1 49 Department of Health press notice, ‘Ireland set to become second country in the world to introduce plain pack cigarettes,’ 28 May 2013 http://www.dohc.ie/press/releases/2013/20130528.html 50 European Commission, ‘Commissioner Borg welcomes agreement on the revision of the Tobacco Products Directive,’ 18 December 2013 http://europa.eu/rapid/press-release_MEMO-13-1177_en.htm 51 See for example JF Thrasher, MC Rousu, D Hammond, A Navarro & JR Corrigan, Estimating the impact of pictorial health warnings and "plain" cigarette packaging: evidence from experimental auctions among adult smokers in the United States (2011) 42 49 See for example J Hoek, C Wong, P Gendall, J Louviere & K Cong, Effects of dissuasive packaging on young adult smokers (2010) 53 DH, Statistics on Smoking: England, 2012, p.19 54 Special Eurobarometer 385, ‘Attitudes of Europeans towards Tobacco’ (2012), Table QD1, p.8 55 SCENHIR, ‘Addictiveness and Attractiveness of Tobacco Additives’ (November 2010), p.32 56 European Commission, Impact Assessment Guidelines (15 January 2009), p.24 57 This is the formulation used by the EPA in the United States http://yosemite.epa.gov/ee/epa/eerm.nsf/vwAN/EE-0568-05.pdf/$file/EE-056805.pdf 58 Department of Health press notice, ‘Ireland set to become second country in the world to introduce plain pack cigarettes,’ 28 May 2013 http://www.dohc.ie/press/releases/2013/20130528.html 59 Department of Health, Tobacco Free Ireland: Report of the Tobacco Policy Review Group (October 2013), p.4 60 Bracketed reference omitted, Irish Cancer Society, Women and Smoking: Time to Face the Crisis (2013), p.2 61 Jefferis et al. ‘Changing social gradients in cigarette smoking and cessation over two decades of adult follow-up in a British birth cohort,’ Journal of Public Health (2004) 26(1):13-18. 62 Irish Cancer Society, Women and Smoking: Time to Face the Crisis (2013), p.5 63 US Department of Health and Human Services, Preventing Tobacco Use Among Youth and Young Adults: A Report of the Surgeon General (2012), p.433 64 US Department of Health and Human Services, Preventing Tobacco Use Among Youth and Young Adults: A Report of the Surgeon General (2012), p.434 65 US Department of Health and Human Services, Preventing Tobacco Use Among Youth and Young Adults: A Report of the Surgeon General (2012), p.427 66 US Department of Health and Human Services, Preventing Tobacco Use Among Youth and Young Adults: A Report of the Surgeon General (2012), p.429 67 US Department of Health and Human Services, Preventing Tobacco Use Among Youth and Young Adults: A Report of the Surgeon General (2012), p.631 68 European Commission, Impact Assessment Guidelines (15 January 2009), p.29 69 Department of the Taoiseach, Revised RIA Guidelines: How to conduct a Regulatory Impact Analysis (2009), para 4.13 70 Department of the Taoiseach, Revised RIA Guidelines: How to conduct a Regulatory Impact Analysis (2009), para 4.66 71 Police Service of Northern Ireland & An Garda Síochána, ‘Cross-Border Organised Crime Assessment 2012,’ p.22 72 Grant Thornton, Illicit Trade in Ireland: Uncovering the Cost to the Irish Economy (2013), Table 5.6 73 Police Service of Northern Ireland & An Garda Síochána, ‘Cross-Border Organised Crime Assessment 2012,’ p.22 74 Department of the Taoiseach, Regulating Better (2004), p.11 75 Padraic Reidy and Keith Walsh, ‘Economics of Tobacco: Modelling the Market for Cigarettes in Ireland’ (2011), p.iv 76 Padraic Reidy and Keith Walsh, ‘Economics of Tobacco: Modelling the Market for Cigarettes in Ireland’ (2011), p.9 52 50 Erik Bloomquist, The Plain Risk to Global Tobacco (March 2011), Berenberg Bank, p.17 78 DH, Consultation on the future of tobacco control (May 2008), para 3.77 79 DH, Consultation on the future of tobacco control (May 2008), para 3.76 80 Department of the Taoiseach, Revised RIA Guidelines: How to conduct a Regulatory Impact Analysis (2009), para 3.3 81 Department of the Taoiseach, Revised RIA Guidelines: How to conduct a Regulatory Impact Analysis (2009), para 3.3 82 Department of the Taoiseach, Regulating Better (2004), p.26 83 New Zealand Treasury, Regulatory Impact Analysis Handbook (August 2013), Part 3 Effective Consultation, 3.1 84 European Commission, Impact Assessment Guidelines (15 January 2009), p.19 85 Department of the Taoiseach, Revised RIA Guidelines: How to conduct a Regulatory Impact Analysis (2009), p.51 86 Department of the Taoiseach, Revised RIA Guidelines: How to conduct a Regulatory Impact Analysis (2009), Fig. 5 87 Department of the Taoiseach, Revised RIA Guidelines: How to conduct a Regulatory Impact Analysis (2009), para 4.42 88 Ronan 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Department of Health and Human Services, Preventing Tobacco Use Among Youth and Young Adults: A Report of the Surgeon General (2012), p.850 115 US Department of Health and Human Services, Preventing Tobacco Use Among Youth and Young Adults: A Report of the Surgeon General (2012), p.812 116 US Department of Health and Human Services, Preventing Tobacco Use Among Youth and Young Adults: A Report of the Surgeon General (2012), p.809 117 US Department of Health and Human Services, Preventing Tobacco Use Among Youth and Young Adults: A Report of the Surgeon General (2012), p.694 118 US Department of Health and Human Services, Preventing Tobacco Use Among Youth and Young Adults: A Report of the Surgeon General (2012), p.692 119 US Department of Health and Human Services, Preventing Tobacco Use Among Youth and Young Adults: A Report of the Surgeon General (2012), p.692 120 US Department of Health and Human Services, Preventing Tobacco Use Among Youth and Young Adults: A Report of the Surgeon 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