for the High Court of Justice, Queen s Bench Division, Administrative Court

Transcription

1 Expert Report Report of for the High Court of Justice, Queen s Bench Division, Administrative Court Case Name Claim number The Queen on the application of Swedish Match AB -v- The Secretary of State for Health CO/3471/2016 Dated 30 January 2017 On the instructions of Subject matter Name Address New Nicotine Alliance (Intervener) New Nicotine Alliance Critical evaluation of the scientific evidence on the impact on public health and consumer responses to snus New Nicotine Alliance Telephone number Page 1 of 44

2 Introduction: 1. I Chair the New Nicotine Alliance. I am Emeritus Professor at Imperial College London, and Honorary Professor at the London School of Hygiene and Tropical Medicine. My research field is public health social science, particularly in the field of the addictions. I have published over 210 scientific publications and 9 books as sole or joint author. Between 1990 and 2004 I directed the largest UK social science research centre on the addictions at Imperial College London. I was instrumental in the development of the harm reduction approach to reducing drug related harms, starting with the prevention of HIV/AIDS among vulnerable populations including injecting drug users, from the late 1980s. I helped provide the evidence base, and to develop and evaluate harm reduction interventions for drug users. 2. From , I was Executive Director of the International Harm Reduction Association, an international NGO that aimed to promote drugs harm reduction to multi-lateral organisations. In my research and advocacy career I have worked with and advised the World Health Organization, the United Nations Office on Drugs and Crime, the Global Fund to Fight AIDS Tuberculosis and Malaria, UNICEF, World Bank, and government agencies in the UK and globally. Since 2010 I have advocated for tobacco harm reduction. A company of which I am Director runs the Global Forum on Nicotine which is an annual conference on the science, policy and regulation of safer nicotine products. 3. Full details of my professional qualifications and publications are given in the appended curriculum vitae. 4. I have written this submission on behalf of the New Nicotine Alliance. The aim of this statement is to give a consumer perspective on the potential individual and public health benefits of using snus for those who wish to avoid smoking. 5. This statement is made in support of the New Nicotine Alliance s request to intervene in the proceedings being brought by Swedish Match in the High Court of England and Wales to apply for a judicial review of the Tobacco and Related Products Regulation It refers also to the statements of Dr Karl Page 2 of 44

3 Lund (Lund), Louise Ross (Ross), Judy Gibson on behalf of the International Network of Nicotine Consumer Organisations (Gibson), the Expert Report of Professor Martin Jarvis for Swedish Match (Jarvis) and the Witness Statement of Patrick Hildingsson for Swedish Match (Hildingsson). 6. In this statement references to snus are to a type of low-nitrosamine smokeless tobacco (see illustration) that is sold in Sweden and Norway. The Reality: Quitting smoking is difficult: 7. Over the recent decades the prevalence of adult smoking has declined in the UK. Smoking rates have more than halved since 1974 when 51% of men and 41% of women smoked: in % of adults were smoking daily, some 9.6 million adult smokers 1. This decline has come about as a result of a wide range of anti-smoking measures and substantial changes in the public perception of smoking. 8. According to the Royal College of Physicians, over the past 10 years the prevalence of smoking has fallen by about 0.7 percentage points each year. Whilst promising, progress is slow and even if this rate of decline continues, it would take more than two decades before the prevalence of smoking even approaches zero. Meanwhile large numbers of people the 9.6 million smokers in the UK are exposed to harms from smoking 2. 1 Action on Smoking and Health. (2016). Smoking statistics. 2 Royal College of Physicians, Tobacco Advisory Group (2016). Nicotine without smoke: Tobacco harm reduction. Page 3 of 44

4 9. Despite social pressures to stop, measures to prevent smoking, and the availability of stop smoking medications and services, many smokers find it hard to stop smoking on their own or with the help of Stop Smoking Services: (Ross paras 7-9). 10. Most smokers say they want to stop smoking, most have tried to give up smoking, but some 60% state that they would find it difficult to go a day without smoking. In England in 2008, the latest year for which national data are available, two thirds (67%) of current smokers reported that they wanted to quit smoking and around a quarter to a third of all smokers make at least one attempt to stop in any given year 3. Common reasons for wanting to quit are for health, finance, because of harms to children, or because of family pressure. Those who tried to give up but who relapsed said that they started smoking again because it was too stressful or not the right time, that they liked smoking, their friends smoked, they missed the habit or could not cope with the cravings. Many people make multiple attempts: (Ross paras 9, 10, 12). 11. Most smokers know that quitting is difficult and the failure rate one year following a quit attempt is between 92% and 97%. The success rate is higher for those who use professional help, but is still only around 8% at one year Given the large numbers of people who continue to smoke, provision needs to be made to help those smokers who cannot or do not want to stop using nicotine. The alternative is to accept that many of them will suffer smokingrelated illness and premature death sometimes referred to as a quit or die policy. This is unacceptable. It is not good public health policy. Tobacco related harms are related to how nicotine is consumed: 3 Health and Social Care Information Centre Statistics on Smoking, England Bauld, L, Hiscock R, Dobbie F, Aveyard P, Coleman T, Leonardi-Bee J, McRobbie H and McEwen A English Stop-Smoking Services: One-Year Outcomes. Int J Environ Res Public Health 13, Page 4 of 44

5 13. Smoking tobacco is the most harmful way to consume nicotine. Combustion of the vegetable matters releases tars and toxins. The smoke from tobacco contains in excess of 4000 chemicals many of which are harmful to health. 14. There are many nicotine products that are substantially less risky to health than cigarettes. Products used as alternatives to smoking tobacco include e- cigarettes (electronic cigarettes) and smokeless tobacco products such as snus, or those which heat but do not combust tobacco (for details of the types of novel tobacco products see Hildingsson paras 19-24). The key feature of lower risk products is that they do not involve the combustion of tobacco; hence they are less risky than smoking. Providing for the safer delivery of nicotine enables people to continue using it, but helps them to avoid the health risks of smoking. 15. There is an increasing range of safer nicotine products on the market. Snus is exceptional in that smokers are denied this product whilst other safer products are allowed on the market (as indeed are tobacco cigarettes and harmful types of oral and chewing tobacco). 16. The key comparison of the risk of these products is with smoking tobacco, as for both the smoker and for public health policy it is a matter of relative rather than absolute risk of such products. 17. A recent Public Health England evidence review estimates that e-cigarettes are 95% less risky than smoking regular cigarettes 5. It is estimated that snus is at least 90 to 95% less risky, though some evidence reviews put the figure higher than this (see below). Tobacco Harm reduction: 18. The provision of safer nicotine products as alternatives to smoking is known as tobacco harm reduction. There is a long history of the idea and approach in the United Kingdom. Contemporary tobacco harm reduction proponents point 5 McNeill A, Brose LS, Calder R, Hitchman SC Hajek P, McRobbie H (2015) Public Health England. E-Cigarettes: An Evidence Update A Report Commissioned by Public Health About Public Health England. Page 5 of 44

6 to Prof Michael Russell as a pioneer of the idea, for he observed that people smoke for nicotine, but they die from the tar they inhale, and pointed to the health gains that might be achieved if the tar in cigarettes could be reduced whilst maintaining nicotine levels A similar assessment forms the basis for the National Institute for Health Care Excellence guidance on tobacco harm reduction: Nicotine inhaled from smoking tobacco is highly addictive. But it is primarily the toxins and carcinogens in tobacco smoke not the nicotine that cause illness and death The potential for tobacco harm reduction was elaborated by the UK Royal College of Physicians in the 2007 report Harm Reduction in Nicotine Addiction 8 which argued that: Harm reduction in smoking can be achieved by providing smokers with safer sources of nicotine that are acceptable and effective cigarette substitutes and further suggested the potential for rebalancing the market in favour of the safest nicotine products. At the time this report was written there was in much of Europe (excepting the case of snus in Sweden) no widely available, attractive and viable source of safer nicotine for smokers to switch to. The safer nicotine option for most smokers was Nicotine Replacement Therapy, mainly in the form of patches, gums, sprays and tablets. 21. Nicotine is not an especially hazardous substance, a point made by the Royal College of Physicians in 2016: Nicotine is not, however, in itself, a highly hazardous drug... It increases heart rate and blood pressure, and has a range of local irritant effects, but is 6 Russell, M. A Low-Tar Medium-Nicotine Cigarettes: A New Approach to Safer Smoking. British medical journal 1(6023): National Institute of Health and Care Excellence (2013) Smoking Harm Reduction 8 Royal College of Physicians, Harm Reduction in Nicotine Addiction Helping People Who Can t Quit. Page 6 of 44

7 not a carcinogen. Of the three main causes of mortality from smoking, lung cancer arises primarily from direct exposure of the lungs to carcinogens in tobacco smoke, COPD from the irritant and pro inflammatory effects of smoke, and cardiovascular disease from the effects of smoke on vascular coagulation and blood vessel walls. None is caused primarily by nicotine Although the nature and extent of any long-term health hazard from inhaling nicotine remain uncertain, because there is no experience of such use other than from cigarettes, it is inherently unlikely that nicotine inhalation itself contributes significantly to the mortality or morbidity caused by smoking. The main culprit is smoke and, if nicotine could be delivered effectively and acceptably to smokers without smoke, most if not all of the harm of smoking could probably be avoided Noting that the rate of decline in smoking is slow, which means that millions of smokers are exposed to the immediate and long term hazards of smoking, the RCP concludes that: Harm reduction aims to reduce or prevent harm in those smokers who do not respond to conventional tobacco control approaches by quitting smoking. also that Harm reduction works by providing smokers with the nicotine to which they are addicted without the tobacco smoke that is responsible for almost all of the harm caused by smoking and that Provision of the nicotine that smokers are addicted to without the harmful components of tobacco smoke can prevent most of the harm from smoking. 23. Writing both in 2007 and again in 2016 the Royal College of Physicians acknowledged that the use of snus in Sweden provided proof that smokers want to and are able to switch from smoking to lower risk products. The Right to Health includes the right to conduct oneself in a manner that avoids dangers to health: 24. Tobacco harm reduction is consistent with international obligations in the international treaty on tobacco control. All European Union states are signatories to the Framework Convention on Tobacco Control ( FCTC ), the 9 Royal College of Physicians, Tobacco Advisory Group (2016). Nicotine without smoke: Tobacco harm reduction. Page 7 of 44

8 international health treaty that aims to reduce the use of tobacco. The preamble to the FCTC notes obligations (as above) under the Article 12 of the International Covenant on Economic, Social and Cultural Rights. Article 1d of the FCTC specifically refers to harm reduction as one of the defining strategies of tobacco control, which is: a range of supply, demand and harm reduction strategies that aim to improve the health of a population by eliminating or reducing their consumption of tobacco products and exposure to tobacco smoke Tobacco harm reduction is consistent with the basic principle of public health, which is one of creating the conditions in which people can chose and act to lead healthier lives. One of the principles of the World Health Organisation is that: Informed opinion and active co-operation on the part of the public are of the utmost importance in the improvement of the health of the people. 11 Empowering individuals and communities to take control of their health is a fundamental aspect of promoting the health of the public, and as set out in the World Health Organization Ottawa Charter on Health Promotion: Health promotion is the process of enabling people to increase control over, and to improve, their health. 12. Rise of e-cigarette use in the UK demonstrates that smokers are interested in lower-risk products: 26. Smokers in the UK have until recently had a restricted choice of lower risk products. Turning tobacco harm reduction from an idea into a practical alternative to smoking was made possible by the arrival of e-cigarettes, which came onto the UK market around There is now a wide range of products, with considerable and rapid product innovation and improvement. 10 Framework Convention on Tobacco Control 11 Constitution of the World Health Organisation 12 Ottawa Charter on Health Promotion. World Health Organization Page 8 of 44

9 27. The rise of e-cigarette use is a grassroots phenomenon driven by consumers: until recently there has been little advertising in the UK (certainly in comparison with other fast moving consumer products). Awareness of e- cigarettes has come about mainly by word of mouth, supplemented by social media forums, and information and advice offered at vape-shops (shops selling e-cigarettes and nicotine liquids and flavours). 28. E-cigarettes have proved to be popular. The Office for National Statistics report that 8.7m people in the UK - almost entirely smokers or ex-smokers - have tried an e-cigarette 13. This comprises 2.2m people who are currently using them, which is 4% of the adult population, and compares with the 19% of the UK adult population who smoke cigarettes. There is a further 3.9 million former users of e-cigarettes and 2.6 million people who said they had tried an e-cigarette but never went on to use them. 29. ONS data indicate that 836,000 e-cigarette users are no longer smoking and there is a further 720,000 people who are both former smokers and former e- cigarette users. E-cigarettes are now the most common device used by smokers in the UK to help them quit smoking 14. Accompanying this rise in the use of e- cigarettes has been a decline in the use of NHS Stop Smoking Services and a decline in the use of NRT. Some Stop Smoking Services have adapted to this by endorsing e-cigarettes for quitting and by incorporating them into their service (Ross paras 15-21). 30. Accompanying the rise in e-cigarette use there has been continued, and possibly enhanced, reduction in the prevalence of smoking in the UK, and significantly, no increase in youth use of e-cigarettes and no rise in smoking by youth (as had been predicted by some). 31. It is unlikely that any formal Public Health stop-smoking campaign or treatment initiative could claim so much impact in such a short time, in terms 13 Office for National Statistics, UK (2016). Statistical Bulletin Adult smoking habits in Great Britain, West R. (2016) Impact of e-cigarettes on smoking cessation in England. Smoking in England, STS Page 9 of 44

10 of reach - the 8.7 million who have tried e-cigarettes, in terms of successful converts the 2.2 million current users of e-cigarettes, or with such success - the 800,000 plus e-cigarette users who no longer smoke cigarettes (plus a further 700,000 ex-smokers/ex-e-cigarette users). 32. An important reason for the popularity of e-cigarettes is that for the first time stopping smoking is a pleasurable and shared experience, evidenced by the enthusiasm for different flavours and new devices, and the sharing of information on social media sites, something that is not seen with medical interventions such as NRT, nor indeed with tobacco cigarettes. One UK e- cigarette forum website has 10,000 visits a day 15. For some, becoming a vaper is an important transformation in personal identity. Smoking cessation has been repositioned from a medical treatment with its associated displeasure - to one of guilt-free enjoyment of nicotine The uptake of e-cigarettes (and the decline in smoking) has been at no cost to the taxpayer, for no NHS money has been spent on this initiative, a point well recognised by Nicola Blackwood, Public Health Minister:..it is notable that one of the most significant disruptions to smoking in recent years has had nothing to do with Government intervention. We have seen considerable take-up of e-cigarettes in the UK, and we know that almost half of the 2.8 million current users are no longer smoking tobacco. We need to continue to embrace developments that have the potential to reduce the burden of disease caused by tobacco use (The 2.8m users in her statement refers to a survey from Action on Smoking and Health). 34. The rise of e-cigarettes indicates an appetite amongst smokers for reducing tobacco-related harms and indicates huge potential to reduce smoking if the right products are available from which consumers can choose (see also evidence from the International Network of Nicotine Consumer Organisations, Gibson paras 14-15). However, e-cigarettes are not suitable for all smokers who wish to switch from smoking, evidenced in part by the difference between the total 8.7 million tryers and the 2.2m current users. 15 McLaren (2016) Personal communication. Visits to E-Cigarette-Forum.com. Website visits United Kingdom, Sarah Jakes The Pleasure principle House of Commons, 13 th October a Page 10 of 44

11 35. A Stop Smoking Service which is e-cigarette friendly has noticed that this increases the number of clients and their success in quitting smoking (Ross para 19). Snus and tobacco harm reduction using snus is much lower risk than smoking tobacco: 36. From the point of view of a smoker and the health of the public snus fulfils the criteria for a tobacco harm reduction product. It is a low risk way of using nicotine and delivers acceptable doses of nicotine. It is popular in those countries in which is allowed, and in those countries it has contributed to declines in smoking and in smoking related disease (for further details of the impact of snus on smoking prevalence in Sweden and Norway see Lund). 37. Snus poses no respiratory risk. Respiratory diseases, predominantly lung cancer, chronic obstructive pulmonary disease (COPD) and pneumonia account for 46% of deaths due to smoking (Scientific Committee on Emerging and Newly Identified Health Risks, quoted in Jarvis para 44). With snus there is no excess morbidity or mortality from COPD, or other respiratory diseases and in little in the way of other adverse effects (Jarvis paras 72-87). 38. Snus poses no risk to others, such as work colleagues and family members as there is no combustion and consequently no second hand smoke. 39. In 2004 an expert panel concluded, based on the literature to 2003, that the relative risk of cardiovascular disease in snus users was 90% less than that in smokers, lung cancer 97 to 98% less, and upper aerodigestive, pancreatic, bladder and renal cancer 70 to 85% less 18. Overall the panel concluded that in comparison with smoking snus exhibits between a 90 and 95% reduction in risk. 40. Because several single studies can have contradictory findings evidence must be sought from overviews of key studies and pooled results. A more 18 Levy, D. T., Mumford, E. A., Cummings, K. M., Gilpin, E. A., Giovino, G., Hyland, A., Warner, K. E. (2004). The Relative Risks of a Low-Nitrosamine Smokeless Tobacco Product Compared with Smoking Cigarettes: Estimates of a Panel of Experts. Cancer Epidemiol Biomarkers Prev, 13(12), Page 11 of 44

12 recent systematic review and meta-analysis has examined the evidence relating to snus and health across six major Swedish, Norwegian, Danish and Finnish studies up to 2010 and concludes that the evidence provides scant support for any major adverse health effects of snus: snus is not associated with cancers of the oropharynx, oesophagus, pancreas, or heart disease or strokes 19. The author concludes that compared with smoking snus poses about 1% of the risk of cancer or cardiovascular disease. 41. Snus is not completely free from adverse health effects (Jarvis paras 85-86) but these are miniscule compared with the risks of smoking. 42. Given the lower risk profile for snus it has been calculated in one study that the life expectancy of smokers who switch from smoking to snus is little different to the life expectancy of those who quit smoking altogether 20. The authors of this study conclude that: Individual smokers who switched to snus instead of continuing to smoke and new tobacco users who only used snus rather than smoking would achieve large health gains compared with smokers. This finding is confirmed by a recent analysis of six major studies which found that switching from smoking to snus is associated with major reductions in morbidity and that switching to snus appears to have much the same reduced health risk as quitting smoking 21. Snus is not only lower risk but is also protective against smoking: 43. Consumers in both Sweden and Norway are choosing to use snus rather than to smoke, as described in the Witness Statement of Lund. There has been a major increase in the use of snus and a concomitant decline in the smoking of tobacco. 19 Lee, P. N. (2011). Summary of the epidemiological evidence relating snus to health. Regulatory Toxicology and Pharmacology, 59(2), Gartner, Coral E. et al Assessment of Swedish Snus for Tobacco Harm Reduction: An Epidemiological Modelling Study. Lancet 369(9578): Lee, Peter N The Effect on Health of Switching from Cigarettes to Snus - a Review. Regulatory toxicology and pharmacology : RTP 66(1):1 5. Page 12 of 44

13 44. The prevalence of smoking in Sweden is 11% and Sweden now has the lowest male smoking prevalence in Europe, and Norway the second lowest at 13% (Lund paras 11-12). 45. In Sweden snus overtook cigarettes in 1996; In Norway the rise of snus and the decline in smoking resulted in male use of snus overtaking cigarettes by 2006 (Lund para 15). Snus use in Sweden and Norway developed in a context where active promotion of the product was banned and health authorities warned smokers against snus use (Lund paras 8, 28). 46. Snus is used to avoid the uptake of smoking, to quit smoking, and to reduce smoking (Lund paras 14-25, and 22 ). It can therefore be considered protective against smoking. The decline in smoking has come about both by smokers using snus to avoid smoking, and by the fact that younger nicotine users are choosing to use snus rather than to smoke, and that the uptake of snus does not lead to tobacco smoking. 47. Snus is now the most popular product that smokers use when they wish to quit smoking and the quit success rate is higher when using snus than when using NRT products (Lund paras 18-20). 48. Overall in Sweden and Norway the total level of tobacco use has remained stable or slightly declined what is important is that there has been a major shift away from smoking. 49. The rise in the use of snus has resulted in Sweden having the lowest lung cancer mortality and tobacco-related mortality in Europe (Jarvis 49.2). It is estimated that if the Swedish smoking prevalence were extrapolated to the rest of the EU there would be a 54% reduction of male mortality from lung cancer The Royal College of Physicians, in its review in 2016 and referring also to its assessment of the evidence in its 2007 report states that: 22 Ramstrom L, Borland R and Wikman T (2016) Patterns of smoking and snus use in Sweden: implications for public health. Int J Environ Res Public Health, 13, Rodu, Brad and Philip Cole Lung Cancer Mortality: Comparing Sweden with Other Countries in the European Union. Scandinavian journal of public health 37(5): Page 13 of 44

14 The availability and use of an oral tobacco product known as snus in Sweden, documented in more detail in our 2007 report (and revisited in Chapter 7), demonstrates proof of the concept that a substantial proportion of smokers will, given the availability of a socially acceptable and affordable consumer alternative offering a lower hazard to health, switch from smoked tobacco to the alternative product. Particularly among men, the availability of snus as a substitute for smoking has helped to reduce the prevalence of smoking in Sweden, which is now by far the lowest in Europe. The magnitude of the contribution made by the availability of snus over and above conventional tobacco control measures is difficult to quantify, but a recent study of the effect of withdrawal of snus from the market in Finland in 1995, when both Finland and Sweden joined the EU, but only Sweden was allowed to continue its use, estimates that over the following 10 years the availability of snus reduced smoking prevalence in Sweden by an additional 3.7 percentage points. Trends in snus use in Norway are similar to, and perhaps stronger than, those in Sweden, and there the use of snus is strongly associated with quitting smoking. 51. The evidence from Sweden suggests that the use of snus could add a further 0.4 percentage points per year to the rate of decline in smoking prevalence 24. Snus has the potential to enhance THR measures in the UK: 52. Considerable progress has been made with tobacco harm reduction (THR) in the UK and smoking continues to decline, yet 9.6 million still smoke and for whom there is a limited number of options to continue using nicotine but without the smoke from cigarettes. But it is clear also that e-cigarettes do not work for all. 53. The popularity of e-cigarettes indicates high interest among smokers for alternative products and is proof of concept that tobacco harm reduction works in the UK. But e-cigarettes are not acceptable to all, or suitable in all circumstances. The experience of a Stop Smoking Service indicates that e- cigarettes do not work for all people who want to stop smoking, hence other products are needed (Ross para 20 ). 54. Snus has a number of advantages as a harm reduction product as indicated in the table. 24 Jennifer Maki (2105)The incentives created by a harm reduction approach to smoking cessation: Snus and smoking in Sweden and Finland. International Journal of Drug Policy, Volume 26, Issue 6, June 2015, Pages Page 14 of 44

15 Snus as a harm reduction product Smoked e- snus tobacco cigarettes Risk profile High Low Low Acceptable alternative to smoking - Yes Yes from point of view of users Effective alternative to smoking from - Yes Yes point of view of users Simulates smoking - Yes No Easy to use and carry Yes Less so Yes Titration of dose Yes Yes Yes Inhalation Yes Yes No Fire risk Yes Minimal No battery fault Risk to bystanders and household Yes No No members from second hand toxins Visible to bystanders Yes Partial No Annoyance to bystanders from smells Yes Yes No Covered by legal bans on smoking in public enclosed spaces Yes No No Can be used where smoking or - - Yes vaping are banned or inappropriate Burnt tobacco smell on clothes, in Yes No No rooms etc. 55. There is already interest in snus in the UK. Although it is illegal to sell snus in the UK, it is available online from Europe and within the UK: in the case of the latter by home delivery, or by post. An online test purchase resulted in postal delivery, from within the UK, within two days. A study of online test purchases within 10 EU member states identified 80 websites selling snus; test purchases were made from 18 sites, and of 43 orders placed only 2 failed. Most orders were despatched from Sweden The question arises as to whether snus, if legally available, would become a popular tobacco harm reduction product. In my opinion the potential for the uptake of snus in the UK is supported by evidence from the recent history of 25 Peeters S and Gilmore A (2013) How online sales and promotion of snus contravenes current European Union legislation. Tobacco Control, 22, Page 15 of 44

16 the rise in the use of snus in Sweden and Norway (Lund paras 14-15; Gibson paras 10-11), and from the rise in the use of e-cigarettes in the UK 57. Historical evidence of the use of tobacco in the UK that shows that there can be rapid transitions in routes of administration of tobacco. For example, the machine rolled cigarette with which we are familiar only emerged in 1880 with the invention of the cigarette rolling machine: there was a subsequent rapid rise in cigarette use and consequent decline in the use of pipe tobacco, snuff, and hand rolled tobacco. The dominance of cigarettes can now be reversed. Ethical implications of restricting access to a lower risk tobacco harm reduction product: 58. Given the evidence that snus is substantially safer than smoking cigarettes and that it protects against smoking, it is in my opinion, unethical to deny smokers access to this product. This view prevails amongst consumer groups in the European Union (Gibson 20, 33-34). Tobacco harm reduction is in line with the obligations of states to help people avoid illness and premature death and is consistent with the principles of public health. States have an obligation to allow smokers access to lower risk products in order to protect themselves from the adverse effects of smoking. It is contrary to human rights obligations to deny healthier alternatives to those who cannot give up the use of nicotine. 59. In compiling this statement, we are aware of evidence from ex-smokers in the UK who have managed to remain free from smoking using snus or a combination of lower risk products: for example, Mr. Mark Oates, a Parliamentary Researcher says I stopped smoking last year and now use a mixture of snus and e-cigarette and Mr. Oliver Kershaw, who is an entrepreneur and founder of E-Cigarette Forum says; I maintain my abstinence through a mixture of using Snus, nicotine lozenges and vaping. The NNA could quote many more individuals, but we refer to these two individuals as evidence that there is Right to Health for the individual to order their lives so as to Page 16 of 44

17 reduce harm; and by implication, access products that reduce the risk of harm The question then arises as to how states can help protect people from the adverse effects of smoking. The obligation to facilitate a high level of health protection underpins the EU Tobacco Products Directive. In my opinion when drafting and justifying the TPD the European Commission misconstrued the meaning of health protection. This obligation is met only in part by the implementation of measures to prevent smoking or to encourage smokers to stop smoking. Given the partial success of such measures there is a responsibility towards the residual population of smokers who have not been dissuaded from smoking and who are at risk of ill-health and premature death. 61. Unless provision is made to provide options for current smokers, the policy is in effect offering the options sometimes summarised as quit or die. In my opinion facilitating a high level of health protection also means making available products that can help people protect themselves from the harms of smoking by allowing them access to safer nicotine products. Summary and conclusions: 62. Smokers and ex-smokers in the UK and the EU are interested in lower risk nicotine products as a way to quit smoking and remain free from smoking. 63. Snus is a lower risk tobacco product that helps people to switch from smoking tobacco or avoid starting to smoke. 26 Article 12 of the International Covenant on Economic, Social and Cultural Rights recognizes: the right of everyone to the enjoyment of the highest attainable standard of physical and mental health and that States Parties must take steps regarding the prevention, treatment and control of epidemic, endemic, occupational and other diseases. This has been interpreted by the UN Special Rapporteur on the Right to Health to include access to harm reduction resources. Open Letter by the Special Rapporteur on the right of everyone to the highest attainable standard of mental and physical health, Dainius Pūras, in the context of the preparations for the UN General Assembly Special Session on the Drug Problem (UNGASS), which will take place in New York in April Page 17 of 44

18 64. The weight of evidence from Sweden and Norway obviates the injunction of the precautionary principle against the introduction of snus. 65. Snus fulfils the criteria for a tobacco harm reduction product in terms of its risk profile in comparison with smoked tobacco, and in terms of satisfactory nicotine delivery. Where it is available its popularity as an alternative to tobacco and the impact of its use on reducing the prevalence of smoking is evident. 66. The use of snus, as is the case with other tobacco harm reduction products, helps prevent smoking at no cost to the state. 67. There is inconsistency in the availability of different nicotine products. Snus is banned from sale whilst lower risk products such as e-cigarettes are available, and novel tobacco products can come onto the market without hindrance. Harmful oral tobacco products such as gutka and pan are not restricted 68. The ban on the sale of snus is inconsistent with the support for tobacco harm reduction from government, the NHS and professional organisations, including the Royal College of Physicians. 69. Given the evidence that snus is substantially safer than smoking cigarettes, and that it protects against smoking, it is unethical to deny smokers in the UK and the EU access to this product. 70. It is my opinion that the ban on the sale of snus within the EU (outside of Sweden) works against the interests of individual and public health as it deprives smokers of an alternative and safer nicotine delivery system: the ban is harmful to health rather than protective of health. 71. It is my opinion that Regulation 17 of the Tobacco and Related Products Regulations (which gives effect to Article 1c and Article 17 of the EU Tobacco Products Directive 2014 discriminates against products and consumers, works Page 18 of 44

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20 Appendix: Curriculum Vitae GERRY V. STIMSON Emeritus Professor, Imperial College London Honorary Professor, London School of Hygiene and Tropical Medicine I am a public health social scientist committed to: working to reduce harms from drug, alcohol and tobacco use improving public health and social policy addressing health issues in resource-poor countries. I have 45 years of experience of research on drug and alcohol problems. I was one of the founders of harm reduction and instrumental in the development and evaluation of harm reduction in the UK as a response to HIV/AIDS. I have played a major role in the international development, evaluation and promotion of harm reduction as a response to drug use. I have advised the UK government and UN organizations on drugs, HIV/AIDS and blood borne infections. I played an important role in developing the UK response to HIV/AIDS. The work I and others did contributed to a reduction in the spread of HIV infection. I now work in mainly in the fields of tobacco harm reduction, and urban health. I believe that people affected by policies should have a say in those policies Date of birth: 10 April 1945 Nationality: British Degrees: 1966 BSc Economics, London School of Economics 1967 MSc Social Psychology, London School of Economics 1971 PhD Sociology, Institute of Psychiatry Employment history and appointments, from most recent: 2010 Director Knowledge-Action-Change Honorary Professor, London School of Hygiene and Tropical Medicine (Department of Public Health and Policy, Centre for Research on Drugs and Health Behaviour) Emeritus Professor Imperial College London Executive Director, International Harm Reduction Association Imperial College London (formerly Charing Cross and Westminster Medical School - in 1997 Charing Cross & Westminster Medical School was incorporated into Imperial College) 2004 Emeritus Professor of Sociology of Health Behaviour Head of the Department of Social Science and Medicine Vice Head of the Division of Primary Care and Population Health Sciences 1991 Professor of Sociology of Health Behaviour Page 20 of 44

21 Director, Centre for Research on Drugs and Health Behaviour Senior Lecturer in Sociology Goldsmiths' College, University of London Senior Lecturer in Sociology Head of Sociology Department Director, Monitoring Research Group, Sociology Department Institute of Psychiatry Lecturer, then Senior Lecturer, Addiction Research Unit University College of Swansea Research Fellow, Medical Sociology Research Centre Institute of Psychiatry Research Worker, Addiction Research Unit MAIN ACTIVITIES Between 1990 and 2004 I was in senior academic management, responsible for a large social science research unit and an academic department of social science and medicine, with a combined staff or around 50 and annual budgets of between 1 and 2.5 million p.a. My research interests included: rapid assessment methods; community based interventions; diffusion of drug use; prevention of harms related to drug and alcohol use; evaluation of prevention and treatment interventions; research in resource poor settings; the risk environment; and historical and contemporary analysis of drug policy I built up the International Harm Reduction Association. Since 2010 I mainly advocate for tobacco harm reduction. Knowledge-Action-Change Director of K A C a public health events and consultancy company. Organises City Health International network and conference, the Global Forum on Nicotine (conference) and other events. I help run a website, a news service on nicotine. Advocacy for tobacco harm reduction, mainly using lessons learned from drugs harm reduction including the importance of community engagement and the ethos of nothing about us without us ; mobilising community voices on social media and in more joined up actions; networking across sectors that might be antipathetic (tobacco control, consumers, parliamentarians and regulators, industry). International Harm Reduction Association Executive Director of the International Harm Reduction Association (IHRA). IHRA (now Harm Reduction International) exists to reduce the negative social, health, economic and criminal impacts of drug and alcohol use for individuals, communities and society. Members and beneficiaries are policy makers, practitioners, communities and drug users throughout the world. IHRA s key activities are: advocacy, knowledge exchange, providing a supportive environment for harm reduction, technical advice on harm reduction, international research projects. I provided leadership for IHRA; developed the organisation as a leading international advocate of harm reduction policy and practice; and ensured that Page 21 of 44

22 IHRA commanded public and professional respect. I built the organisation from 1.5 staff to around 10, with a combined annual budget for the core activities and the annual conference of c 2m pa. Main activities: Annual conference the International Conference on the reduction of Drug Related Harm c participants from 90 countries. Campaigns and advocacy for a public health and human rights approach to drugs harm reduction Promoting harm reduction for all psychoactive drugs Providing information on harm reduction Technical advice to international organisations, national governments and NGOs Developing and supporting harm reduction networks Centre for Research on Drugs and Health Behaviour I established (in 1990) and directed (until 2004) The Centre for Research on Drugs and Health Behaviour. I developed this multi-disciplinary academic research unit at Imperial College London into the largest social science drug research centre within the UK. Staffing ranged between 22 and 35 over the period. Its objectives were: to undertake original research on the use of drugs and alcohol; to undertake research on the impact of services for drug users, and the role of various treatments and other interventions aimed at helping drug and alcohol users to modify their behaviour; and to inform practitioners, managers, policy makers and others, about state of the art developments in the field through information dissemination, teaching and training. Substantive research interests during my period as director included epidemiological, behavioural and social aspects of drug and alcohol use, and of associated infectious diseases (especially HIV infection) and evaluation of treatment and other interventions for helping people change their drug use and related health behaviours. Research was undertaken with major drug and alcohol clinical and preventive services. CRDHB led multi-national studies with WHO and UNAIDS, including studies of the prevalence of HIV-1 infection, and the diffusion of drug injecting in developing countries, and had collaborative links with major substance misuse research and intervention groups worldwide. Pioneered community engaged research Pioneered multi-methods and rapid assessment research Research grants and other contracts came from MRC, Department of Health, Home Office, medical charities, health regions, health authorities, local authorities, World Health Organization, UNAIDS, the United Nations International Drug Control Programme. From 1990 total income from external sources for research, teaching and training contracts, and technical advice contracts has ranged between 650K and 1300K per annum. Department of Social Science and Medicine In 1997 I established the Department of Social Science and Medicine at Imperial College within the new Division of Primary Care and Population Health Sciences. The Department was a leading centre for social interventions for improving public Page 22 of 44

23 health. The programme of work included research and teaching on theoretical concepts and models for understanding the social basis of health and social interventions, methods for empirical and theoretical research in these fields; developing approaches to influencing and informing policy makers, public health professionals and social and health agencies. The work encompassed five related themes: social aspects of risk and health behaviour, methods for health surveillance and investigation, theories, methods and strategies for social intervention, social and health policy, and evaluation. DSSM had grants from the health service for sexual health surveillance and development programmes. There is special interest and expertise in the treatment and prevention of sexually transmitted infections including STI prevention and control in developing and transitional countries, funded by the Department for International Development DSSM developed and ran the University of London Diploma and the ICSM Certificate in Drug and Alcohol Studies; the MSc Programme by Distance Learning in Drugs and Alcohol; and the MSc in Social Interventions for Health. The Department provided social science teaching in the undergraduate Social Medicine degree to medical undergraduate students at the Imperial College School of Medicine. ACTIVITIES FOR THE PUBLIC GOOD Postgraduate scholarship award 2006 The Foundation for Sociology of Health and Illness: sponsor of the Gerry Stimson Award 2006, for postgraduate study in the UK Membership of working groups 2015 to date Member CEN (European) Standards on e-cigarettes British Standards Institute working group on standards for electronic cigarettes PAS554115:2015 Vaping products, including electronic cigarettes, e-liquids, e-shisha and directly-related products Manufacture, importation, testing an labelling Guide National Institute for Health and Care Excellence Guidelines Development Group on Tobacco Harm Reduction Member, UN Reference Group on Injecting Drug Use and HIV/AIDS 2009 Member, Academic Advisory Group, WHO programme on Access to Opioid medications (ATOME) 2007 Member, project Management Group, Middle East and North Africa Harm Reduction Association 2006, 2007 Member, UK government delegation to UN Commission on Narcotic Drugs Independent Working Group on Drug Consumption Rooms. Joseph Rowntree Foundation. The Report of the Independent Working Group on Drug Consumption Rooms Joseph Rowntree Foundation. Page 23 of 44

24 Brain Science, Addiction and Drugs. Office of Science and Technology Foresight Programme. Drugs Futures Department of Trade and Industry Member of Department of Health Hepatitis C Steering Group. Hepatitis C Strategy for England Department of Health Greater London Authority Expert Working Group on a drug and alcohol strategy for London. Alcohol and drugs in London. The Mayor s policy and action plan to reduce the harm resulting from alcohol and drug use in the capital Greater London Authority Member of Royal College of Psychiatrists and Royal College of Physicians Joint Working Party on Drug Misuse. Drugs: Dilemmas and Choice Royal College of Psychiatrists. London: Gaskell 1995 Member of Public Health Laboratory Service Workshop on AIDS and HIV Forecasts: 1995 Update Member, Advisory Council on the Misuse of Drugs Working Group on AIDS and Drug Misuse. AIDS and Drug Misuse: Update A Report of the Advisory Council on the Misuse of Drugs. London: HMSO Member of Public Health Laboratory Service Workshop on AIDS and HIV Forecasts: 1992 Update Member Advisory Council on the Misuse of Drugs, Working Group on AIDS and Drug Misuse. AIDS and Drug Misuse: Part 1. A Report of the Advisory Council on the Misuse of Drugs. London: HMSO. AIDS and Drug Misuse: Part 2. A Report of the Advisory Council on the Misuse of Drugs. London: HMSO Member EEC working group on drug research Appointments, committees 2015 Founder, International Network of Nicotine Consumer Organisations 2014 Chair and founder Trustee, New Nicotine Alliance 2001 Chair and founder, UK Harm Reduction Alliance 2000 President, Action on Hepatitis C Trustee, AIDS Educational and Research Trust (AVERT) Re-appointed, Advisory Council on the Misuse of Drugs Re-appointed, Advisory Council on the Misuse of Drugs Chair, NW Thames Regional Substance Misuse Advisory Committee Chair, Statistics Information and Research Group, Advisory Council on the Misuse of Drugs Member, North West Thames Regional Health Authority Regional Drug Advisory Committee Re-appointed, Advisory Council on the Misuse of Drugs Re-appointed, Advisory Council on the Misuse of Drugs; member, Working Group on AIDS and Drug Misuse Vice-chair, Council of the Institute for the Study of Drug Dependence Member Governing Council of the Institute for the Study of Drug Dependence 1984 Appointed, Advisory Council on the Misuse of Drugs; Page 24 of 44

25 Academic memberships, offices, scholarships Honorary Member of Faculty of Public Health Medicine Member of Standing Panel of Experts in Sociology, University of London Board of Advisors Member of Academic Board, Charing Cross and Westminster Medical School Member, Special Advisory Committee in Health Studies, University of London Member, Special Advisory Committee in Sociology as Applied to Medicine, University of London 1983 Fulbright Scholar - Visiting Scholar, New York University Sociology Department. Editorial Boards Advisor to the Editorial Board, International Journal of Drug Policy Editor in Chief, International Journal of Drug Policy Chair of the International Editorial Board, Drugs, Education, Prevention & Policy 1994 Member of the Advisory Board, European Addiction Research Member of International Advisory Board, Addiction Abstracts Member of Editorial Board of Addiction Research Member of the Editorial Board of AIDS Member of International Editorial Board of Drug and Alcohol Review 1982 Member, Editorial Board, then Assistant Editor British Journal of Addiction, now Addiction Founder, Sociology of Health and Illness International research committees Executive Committee, WHO Study on Drug Injecting and risk of HIV Infection Member, EC concerted action on evaluation of drug services Member Executive Committee, WHO study on Drug injecting and risk of HIV infection Member, EC concerted action on HIV seroprevalence in drug users Consultancies 2000 Consultant, World Bank TB, AIDS and STI loan to Russia 2001 Short term consultant, WHO Tobacco Free Initiative 1995 Short-term Consultant, UNDCP, Myanmar 1993 Short-term Consultant, UNDCP, Myanmar 1991 Short term consultant, WHO, Geneva Switzerland and Madras India Consultant to WHO Programme on Substance Abuse Consultant to WHO Global Programme on AIDS Consultant, Department of Environmental Health, Municipal Health Service, Amsterdam 1986 Consultant, Drug Addiction Research Initiative (ESRC) Page 25 of 44