Ending tobacco smoking in Britain. Radical strategies for prevention and harm reduction in nicotine addiction

Transcription

1 Ending tobacco smoking in Britain Radical strategies for prevention and arm reduction in nicotine addiction A report by te Tobacco Advisory Group of te Royal College of Pysicians, September 2008

2 Acknowledgements Te autors tank Joanna Reid, Hanna Tompson and Suzanne Fuzzey of te RCP Publications Department for editing and producing tis report. Te Royal College of Pysicians Te Royal College of Pysicians plays a leading role in te delivery of ig quality patient care by setting standards of medical practice and promoting clinical excellence. We provide pysicians in te United Kingdom and overseas wit education, training and support trougout teir careers. As an independent body representing over 20,000 Fellows and Members worldwide, we advise and work wit government, te public, patients and oter professions to improve ealt and ealtcare. Citation for tis document: Royal College of Pysicians. Ending tobacco smoking in Britain: radical strategies for prevention and arm reduction in nicotine addiction. A report by te Tobacco Advisory Group of te Royal College of Pysicians. London: RCP, Copyrigt All rigts reserved. No part of tis publication may be reproduced in any form (including potocopying or storing it in any medium by electronic means and weter or not transiently or incidentally to some oter use of tis publication) witout te written permission of te copyrigt owner. Applications for te copyrigt owner s written permission to reproduce any part of tis publication sould be addressed to te publiser. Copyrigt 2008 Royal College of Pysicians ISBN Royal College of Pysicians of London 11 St Andrews Place, London NW1 4LE Registered Carity No Designed and typeset by te Publications Department of te Royal College of Pysicians Printed in Great Britain by Te Lavenam Group Ltd, Suffolk Contents Members of te Tobacco Advisory Group of te Royal College of Pysicians ii Wy we need radical solutions to te smoking epidemic 1 Wat are conventional approaces to preventing smoking, and ow do tey work? 1 Wat is arm reduction, and ow would it work for smoking? 2 Wat is te safest way to provide nicotine witout smoke? 3 Wat are te alternatives to medicinal nicotine? 4 How sould arm reduction be incorporated into conventional tobacco control? 4 How are nicotine products regulated at present? 5 How sould nicotine regulation be reformed? 5 1 Smoked tobacco 6 2 Existing medicinal nicotine products 8 3 New medicinal nicotine products 10 4 Non-medicinal smoke-free nicotine products 11 Regulating, monitoring and managing nicotine product use: te need for a Nicotine Regulatory Autority 13 Oter roles of te Nicotine Regulatory Autority 14 Targets 14 References 16 Members of te Tobacco Advisory Group of te Royal College of Pysicians Jon Britton (Cair) Debora Arnott Tim Coleman Linda Cutbertson Anna Gilmore Cristine Godfrey Allan Hacksaw Martin Jarvis Jon Macfarlane Ann McNeill Jennifer Percival Mike Ward ii

3 Wy we need radical solutions to te smoking epidemic More tan one in five adults, or 10 million people, in te UK smoke tobacco. 1 Tobacco smoking kills more people and contributes more to social inequalities in ealt in te UK tan any oter avoidable factor. Preventing smoking will terefore improve UK public and individual ealt, and reduce ealt inequalities, more tan any oter intervention available to government. Conventional tobacco control policies as advocated by te World Healt Organization (WHO) and te World Bank reduce te prevalence of smoking by preventing uptake and encouraging cessation. 2,3 Most of tese measures ave now been implemented in te UK, 4 were smoking prevalence as been falling by about 0.4 percentage points per year over recent years. 5 Experience from oter countries indicates tat, at best, conventional tobacco control measures reduce smoking prevalence by between 0.5 and 1.0 percentage point per year. 6 9 At tese rates it will take between 11 and 22 years to reduce te prevalence of smoking in te UK by alf and, even ten, around 5 million UK citizens will still smoke. Half of tese lifelong smokers will die prematurely, typically losing 10 years of life, as a result of smoking. 10 Preventing tese deats would be a major benefit to te nation s ealt, but will require more extensive and radical approaces tan are currently in place. We ave argued previously tat in addition to conventional approaces, arm reduction strategies offer a major opportunity to reduce te prevalence and ealt impacts of tobacco smoking. 11,12 In tis document we propose an extensive range of conventional policy developments and arm reduction strategies tat we believe would substantially increase te rate of decline in smoking prevalence in te UK. We also call again for substantial reform of te current irrational regulatory systems tat apply to nicotine products in te UK as a fundamental requirement for more effective and compreensive tobacco control policy in te future. 12 Wat are conventional approaces to preventing smoking, and ow do tey work? Conventional tobacco control measures reduce te prevalence of tobacco smoking troug te combined effect of a range of policies, 2,3 including: increasing te cost of cigarettes and oter smoked tobacco products making public places and workplaces smoke-free preventing advertising, sponsorsip and oter forms of promotion Ending tobacco smoking in Britain Radical strategies for prevention and arm reduction in nicotine addiction 1

4 sustained and imaginative ealt promotion campaigns strong ealt warnings on packs providing treatment for smokers wo want to quit preventing supply of tobacco products to cildren and young people. To varying degrees, all of tese policies are now implemented in te UK. 4 Tey work by reducing incentives to young people to start smoking, increasing incentives to existing smokers to quit smoking, and supporting tose wo try to quit. Collectively tey elp to denormalise smoking in society. Denormalising smoking, and ence reducing exposure to smoking products and role models, appears to be te most effective way to prevent te uptake of smoking by young people. 13 It is terefore important to maximise te effectiveness of tese conventional measures. It is also important to arness te potential of oter approaces, particularly arm reduction. Wat is arm reduction, and ow would it work for smoking? Harm reduction strategies are measures intended to reduce te arm to self and oters arising from a beaviour. Harm reduction measures are widely used in medicine, consumer protection and oter policy areas, but ave not to date been applied to tobacco smoking. People smoke because tey are addicted to nicotine, but nicotine itself is not especially azardous; it is te oter constituents of tobacco smoke tat cause most of te arm. 12 Harm reduction is terefore feasible in tobacco smoking by providing smokers wit nicotine from a source tat does not involve inaling tobacco smoke. Use of smoke-free nicotine would benefit smokers directly by reducing te personal arm caused by nicotine addiction. Use of smoke-free nicotine by smokers would also reduce involuntary exposure of oters, particularly cildren, to tobacco smoke. Use of smoke-free nicotine would elp to denormalise smoking, decrease exposure of cildren and young people to smoking role models, and ence reduce uptake of smoking. 2 Ending tobacco smoking in Britain Radical strategies for prevention and arm reduction in nicotine addiction

5 Wat is te safest way to provide nicotine witout smoke? Te safest form of nicotine is medicinal or pure nicotine, suc as tat contained in nicotine replacement terapy (NRT) products including skin patces and cewing gum. Medicinal nicotine is by far te safest alternative to smoking, oter tan quitting nicotine use altogeter. However, altoug elpful, few smokers find NRT to be a satisfying alternative to smoking. Tis is partly because NRT products deliver lower doses of nicotine, and deliver tem more slowly, tan cigarettes. 14 NRT products are also uncompetitive wit cigarettes in oter important caracteristics, including price, packaging, promotion and availability. Current NRT products terefore need to be made more affordable and available, to increase teir use as quitting aids. Use of existing products as a temporary substitute for smoking (for example, in te ome), or as a long-term substitute for smoking by tose unable to quit, also needs to be encouraged. In addition, new, more effective, affordable and acceptable forms of medicinal nicotine are needed to elp smokers quit and to provide a satisfactory alternative to smoking for tose unable to do so. However, little progress as been made in developing suc alternatives, for several reasons: NRT products are strictly regulated, as are all medicinal drugs, making it very expensive to develop, evaluate and bring new products to market, and limiting promotion and advertising. NRT products wit te potential to be strongly competitive wit cigarettes would almost certainly be addictive, wic under current regulations would result in strict restrictions on promotion and use. Te major parmaceutical companies ave proved reluctant to engage in te production and marketing of nicotine products for use in arm reduction. Te regulatory obstacles make it difficult for new competitors to enter te medicinal nicotine market wit more innovative, effective or affordable products. Te regulations tat apply to NRT tus inibit rater tan promote te development of better medicinal nicotine products, and are terefore counterproductive to public ealt. Ending tobacco smoking in Britain Radical strategies for prevention and arm reduction in nicotine addiction 3

6 Wat are te alternatives to medicinal nicotine? Nicotine can also be obtained witout smoke from a range of tobacco products, usually referred to as smokeless tobacco. Tese include traditional products suc as nasal snuff and cewing tobacco, and also a range of compressed tobacco tablets for oral use. 15 Before te advent of cigarettes, smokeless products were widely used in te UK; tey still are in some parts of te world. All of tese products contain nicotine, and some deliver nicotine in ig doses. 14,16 Tey also contain oter tobacco constituents, including many tat are armful. 15,17 All smokeless tobacco products are terefore more azardous tan medicinal nicotine, and in some cases especially so, 15,17 but all are also substantially less azardous tan smoking. 15 It is possible tat some of te associated tobacco caracteristics of tese products, suc as taste and smell, elp to make tem acceptable to smokers as a substitute for tobacco smoking. In Sweden, te availability and use by men of an oral tobacco product called snus, one of te less azardous smokeless tobacco products, is widely recognised to ave contributed to te low prevalence of smoking in Swedis men and consequent low rates of lung cancer. 12,15,18,19 Sale of snus is proibited in oter countries of te European Union, but te product is available in Norway were uptake to date as been low and wit no appreciable influence on smoking prevalence. 15 However, te Swedis data provide proof of concept tat substitution of smokeless for smoked tobacco can be effective as a arm reduction strategy. How sould arm reduction be incorporated into conventional tobacco control? Te conventional tobacco control measures currently being implemented in te UK need to be developed, extended and refined to make tem as effective as possible. Harm reduction strategies using currently available medicinal nicotine products sould be implemented as a matter of ig priority, as an addition to tese conventional measures. Te use and development of more innovative and effective medicinal nicotine substitutes for smoking sould be encouraged. Safeguards to prevent abuse and minimise unwanted effects of arm reduction, and particularly te use of nicotine products by non-smokers, must be put in place. Te role of non-medicinal nicotine products, including smokeless tobacco, as a complement to medicinal nicotine could ten be given furter consideration and, if judged 4 Ending tobacco smoking in Britain Radical strategies for prevention and arm reduction in nicotine addiction

7 on clinical trial evidence of effectiveness and relative azard to ave te potential to contribute significant additional benefit, market tested under close supervision. Current nicotine product regulation must undergo radical reform to allow te above to appen as safely and as quickly as possible. How are nicotine products regulated at present? Nicotine products are currently subject to grossly inconsistent regulation. Smoked tobacco, wic is te most dangerous nicotine product, is freely available and te content and emissions of te product are virtually unregulated. It is now illegal to advertise smoking products in te UK, but cigarettes are available and easily accessible to smokers from a wide range of sources at all times of day and nigt. NRT products promoted wit any ealt claim come under te control of te Medicines and Healtcare products Regulatory Agency (MHRA), and are tigtly regulated. Non-tobacco nicotine products marketed wit no ealt claims are currently unregulated, so teir purity and safety are unknown. Smokeless tobacco tat is not intended to be sucked, including a number of products wit significant azard profiles, is unregulated and can be sold as freely as smoked tobacco. Supply of smokeless tobacco tat is intended to be sucked, including te relatively lowazard Swedis snus products, is proibited in te UK. 20 Tis regulatory imbalance perpetuates smoked tobacco as te most freely available, affordable, effective and widely used nicotine delivery product. Te current regulatory system terefore strongly favours te most dangerous tobacco products over tose tat are less azardous, wile imposing te strictest restrictions on medicinal nicotine. Tis regulatory approac needs to be reformed in te interests of public ealt. How sould nicotine regulation be reformed? We propose tat all nicotine products sould be brougt under te control of a single autority (ere referred to as a Nicotine Regulatory Autority) tasked to provide a single, consistent framework wic regulates products in direct relation to teir azard. Te Nicotine Regulatory Autority sould also be responsible for implementing te measures necessary to drive down te prevalence of tobacco smoking as quickly as possible, and for monitoring progress in acieving tis objective. Te measures used by te Autority sould include initiatives to maximise te effectiveness of conventional tobacco control, complemented by arm reduction approaces. Ending tobacco smoking in Britain Radical strategies for prevention and arm reduction in nicotine addiction 5

8 Tese measures, as follow, relate to four defined categories of nicotine products: smoked tobacco existing medicinal nicotine products new medicinal nicotine products non-medicinal smoke-free nicotine products. 1 Smoked tobacco Te primary objective of regulation of smoked tobacco sould be to make smoking and smoked tobacco products as unappealing, unattractive, unaffordable and unavailable as possible, as quickly as possible. A secondary objective is to require product modifications likely to reduce te azard of te product. All of te following measures ave te potential to make a significant contribution: Increase te retail price of smoked tobacco Use tax to increase te retail price of all cigarettes, cigars and oter smoked tobacco products by at least 10%, year on year. Add furter incremental increases to te cost of and-rolling tobacco to remove te current price differential between manufactured and and-rolled cigarettes. Underpin tis price strategy wit measures to reduce substantially te availability of smuggled and counterfeit tobacco products. Reduce te availability of smuggled and counterfeit tobacco Require all tobacco products manufactured, sold, supplied, or offered for sale or supply in te UK to be overtly and covertly marked so tey can be traced trougout te supply cain wit cecks tat all applicable taxes and duties ave been paid. Enable autorities to identify, trace, freeze, seize, confiscate, destroy or oterwise dispose of property used in, and proceeds derived from, illicit trade in tobacco. Reform te penalties applied to participants in illicit trade in tobacco products to acieve parity wit tose applied to Class A drugs. Hold individual tobacco company directors personally liable to prosecution if tey fail to exercise due care to ensure tat teir products do not enter te illicit market. Identify and implement measures to incentivise te police, trading standards, customs and excise and oter enforcement agencies to prioritise tobacco smuggling and counterfeiting for investigation. Set callenging targets for all relevant government departments to reduce te market sare of smuggled and counterfeit tobacco products. Establis accurate and timely systems to monitor te availability and use of smuggled and counterfeit smoking tobacco in te UK. 6 Ending tobacco smoking in Britain Radical strategies for prevention and arm reduction in nicotine addiction

9 Cooperate fully wit international initiatives to combat illicit trade in tobacco. 21 Reduce te retail availability of smoked tobacco License all existing retail tobacco outlets. Prosecute and revoke te retail licence of anyone wo sells tobacco illegally. Set and progressively increase a minimum annual retail licence fee sufficient to discourage small retailers from selling tobacco. Add a proportional levy on sales to discourage larger volume retailers. Progressively reduce, year on year, te number of licensed retailers. Set a ig start-up fee to discourage establisment of new retail tobacco outlets. Proibit internet purcase of smoked tobacco. Restrict te number of ours eac day during wic tobacco products can be sold. Proibit tobacco company incentives to retailers to increase promotion or sale. Proibit sale of smoked tobacco products from vending macines. Prevent promotion of smoking and tobacco brand imagery Continue to monitor and enforce te existing proibition of advertising and promotion, including internet sites. Proibit all display of smoked tobacco products and related point-of-sale displays. Proibit te advertising and promotion of tobacco accessories suc as cigarette papers. Discourage te promotion of smoking troug television and cinema by: ensuring tat all new films tat endorse, glamourise, encourage or oterwise condone smoking are age certified to te same extent as tose depicting violence, explicit sexual beaviour or illegal drug use ensuring tat TV programmes tat condone, glamourise, encourage or oterwise endorse smoking are not sown before te 9pm watersed. Require plain generic packaging for all smoked tobacco products. Require tobacco companies to provide detailed information on marketing spending. Protect cildren Proibit sale of smoked tobacco products in premises to wic cildren are admitted. Require proof of age for purcase from all wo appear to be under 25 years of age. Apply Class A drug penalties to individuals wo breac laws on underage sale. Promote strategies, including use of medicinal nicotine for temporary abstinence, to protect cildren from passive smoke exposure in te ome and in cars. Ending tobacco smoking in Britain Radical strategies for prevention and arm reduction in nicotine addiction 7

10 Inform te public Deliver a sustained and varied programme of media campaigns covering, for example: te benefits of quitting smoking te risks of passive smoke exposure in te ome te effects of smoking by role models on uptake in cildren ways of quitting smoking and effective use of cessation terapies arm reduction troug use of medicinal nicotine instead of smoking tobacco industry tactics, including messages aimed at recruiting cildren. Replace te listing of tar and nicotine contents of smoke on cigarette packs wit more accessible and effective communications on content of armful substances. Increase te size of pictorial ealt warnings on cigarette packs, put warnings on all sides of te pack, and continue to improve and vary te warning messages and images. Use te pack and all media campaigns to promote NHS stop smoking services. Work wit retailers to encourage promotion of arm reduction and cessation. Improve smoked tobacco emissions, reduce fire azard and control development Compel manufacturers to disclose full details of design, content and emissions of tobacco products. Establis and resource a data repository to make tis information available to government, independent experts and academics. Proibit new smoked tobacco brands, brand extensions or flavours unless supported by persuasive evidence of appreciably reduced arm in relation to existing products. Proibit use of additives or oter measures tat make smoke more palatable to new users, or increase nicotine content or delivery. Require existing metods of reducing te toxicity of te product, suc as measures to reduce nitrosamine content, to be implemented trougout te industry. Reduce fire risks by implementing reduced ignition propensity regulations. 2 Existing medicinal nicotine products Existing medicinal nicotine products comprise tose currently licensed as NRT. Te primary objective of regulating tis product group is to make tem as available and attractive to smokers as possible, and to encourage smokers to switc as completely as possible to use of medicinal nicotine in place of smoking. A secondary objective is ten to encourage as many medicinal nicotine users as possible to quit all nicotine use. 8 Ending tobacco smoking in Britain Radical strategies for prevention and arm reduction in nicotine addiction

11 Te following measures are likely to promote wider accessibility to, experimentation wit, and subsequent use of medicinal nicotine by smokers: Reduce te retail purcase cost of medicinal nicotine Permanently exempt all medicinal nicotine products from value added tax (VAT). Assess te current pricing structure and profit margins of existing medicinal nicotine products, and if possible act to reduce te cost to te consumer. Provide incentives to promote price competition in over-te-counter sales. Encourage retail sale of single day packs at significantly lower price tan smoked tobacco. Provide medicinal nicotine free for all smokers using NHS services. Increase availability and incentives to try NRT Revoke restrictions on sale of medicinal nicotine, making all products available for over-te-counter general sale in any retail outlet. Encourage innovative design, promotion and marketing of single day packs. Require medicinal nicotine to be displayed prominently for sale werever tobacco is on sale. Allow medicinal nicotine to be sold from vending macines. Replace te current extensive list of contraindications and cautions in medicinal nicotine packs wit simple consumer information outlining te potential risks of medicinal nicotine and comparing tese wit smoking. Inform te public on te safety and optimal use of medicinal nicotine Reform advertising and promotion rules to encourage commercial marketing of medicinal nicotine as cessation terapy or a temporary or sustained substitution for smoking, or bot. Encourage media campaigns communicating: tat medicinal nicotine offers te satisfying constituent of te cigarette witout te azard of smoke te absolute and relative risks of nicotine and smoking optimal use of nicotine products, including background and sort-acting combination terapy, and appropriate duration of use use of medicinal nicotine for temporary abstinence, particularly in te ome use of nicotine to support quit attempts. Ending tobacco smoking in Britain Radical strategies for prevention and arm reduction in nicotine addiction 9

12 3 New medicinal nicotine products Te objective of regulating new medicinal nicotine products is to encourage development and marketing of medicinal-grade formulations tat are more acceptable and satisfying alternatives to smoking tan current NRT products. Te following measures are intended to encourage innovation and development of products tat deliver nicotine to medicinal standards of purity tat sare te safety profile of existing medicinal nicotine products, and offer an improved experience to te smoker: Provide clear guidance on wat constitutes a medicinal product Define pragmatic minimum nicotine purity standards for medicinal products. Indicate acceptable limits for inclusion of oter constituents necessary to acieve favourable formulations and delivery profiles. Define medicinal products as tose tat meet te above criteria. Implement a permissive licensing system for new medicinal products Define acceptable limits for dose delivery equivalent to tose delivered by tobacco smoking. Establis fast-track licensing for new medicinal products tat deliver doses up to tese limits for marketing as substitutes for tobacco smoking. Permit market access for tese products as outlined for existing medicinal products. Revoke te current requirement to demonstrate efficacy as smoking cessation terapy as a prerequisite for licensing as a smoking substitute. Monitor use of new products to ensure tat arm reduction is being acieved, and act to prevent adverse use or effects. Promote te development of fast-acting medicinal nicotine products Provide strategic grant support to encourage development and marketing of new, more effective medicinal nicotine products. Require safety data in addition to tat already available for medicinal nicotine products only if indicated by use of different routes of delivery (eg inalation) or formulation, or if tey deliver total doses in excess of tose provided by smoking. Assess any risks or potential risks arising from te above in relation to te risk of smoking. In te absence of significant safety concerns arising from te above, permit market access as proposed above for oter medicinal nicotine products. Require direct evidence of efficacy in cessation or temporary abstinence for products provided free troug te NHS. Safeguard against irresponsible promotion troug market monitoring. 10 Ending tobacco smoking in Britain Radical strategies for prevention and arm reduction in nicotine addiction

13 Inform te public Communicate potential ealt risks and benefits in absolute terms and relative to smoking on or in packs, using accessible language and/or imagery. Allow oter marketing and promotion of new medicinal products in te above category as for existing medicinal products. 4 Non-medicinal smoke-free nicotine products Non-medicinal smoke-free nicotine products are tose tat deliver nicotine below te medicinal purity standard defined above for new medicinal products, or use a delivery system or formulation tat is a potential azard to te user. Smokeless tobacco products fall into tis category, as do oter existing or potential new products tat do not meet te above criteria for existing or new medicinal nicotine products. Tese products ave te potential to offer an alternative substitute for smoking, and a possible route to cessation, for some smokers wo would oterwise continue to smoke. However, te azard associated wit teir use is likely to be iger tan medicinal products, and in some cases especially so. Te objective of regulating tis group of products is to realise any real benefit tat tese products migt offer as an alternative to existing or new medicinal nicotine products, wile minimising te azard to te user. Any potential benefit arising from availability and use of suc products is likely to be realised by applying te following principles to teir use: Allow limited market access to low-azard arm reduction products of proven efficacy Allow restricted sale of nicotine products tat do not meet medicinal purity standards, or ave oter caracteristics likely to represent an appreciable azard to te user, on condition of: complete disclosure of design, content and, if relevant, product emissions evidence tat all reasonable attempts ave been made to minimise te likely azard of te product clinical trial evidence of efficacy as a smoking cessation aid, or effective smoking substitute for temporary abstinence, of at least te same efficacy and acceptability to smokers as existing medicinal nicotine products. Proibit te more azardous existing and new non-medicinal products Proibit te sale of all non-medicinal products, including existing conventional smokeless tobacco products, tat do not meet te above conditions. Ending tobacco smoking in Britain Radical strategies for prevention and arm reduction in nicotine addiction 11

14 Manage te availability and promotion of permitted non-medicinal products Restrict marketing of tese products to licensed tobacco retailers, as alternatives to smoking. Permit above counter display only in licensed tobacco retailers. Proibit sale to people under te age of 18. Allow promotion only as a smoking substitute and/or cessation aid for existing smokers. Monitor promotion outcomes to ensure tat, as far as is reasonably possible, brand awareness is limited to adult smokers. Require promotion and packaging to carry information on ealt risks in absolute terms, and relative to bot cigarette smoking and medicinal nicotine use. Apply strategic pricing policies Require all permitted products in tis category to be marketed at a significant price advantage relative to smoking tobacco. If necessary, use tax to acieve a retail price differential relative to medicinal nicotine and smoked tobacco tat is commensurate wit te likely azard of te product. Tus ensure tat tese products are typically more expensive and less available tan medicinal products, but less expensive tan smoked tobacco. Prevent use as veicles for smoked tobacco brand promotion Proibit sared branding or imagery wit smoked tobacco products. Assess and review marketing strategies and effects Commit to early and regular review of te introduction of te above canges. Monitor use and uptake of non-medicinal products and act to minimise counterproductive trends. Consider relaxation of market restrictions if initial experience is judged likely to be beneficial to overall arm reduction strategy. 12 Ending tobacco smoking in Britain Radical strategies for prevention and arm reduction in nicotine addiction

15 Regulating, monitoring and managing nicotine product use: te need for a Nicotine Regulatory Autority No single body is currently responsible for implementing rational regulation across te range of nicotine products. Altoug one or more existing regulatory agencies could be tasked wit nicotine regulation, we believe tat te nature of te task requires specific skills and focus tat are most likely to be delivered effectively by a new autority wit sole responsibility for nicotine product regulation and monitoring. 11 Tis new Nicotine Regulatory Autority must be entirely independent from te parmaceutical, tobacco or oter industries producing nicotine products. Te Autority sould be responsible for reforming nicotine product regulation and use along te lines argued in tis document. Te Autority sould also ave te power to act promptly and as necessary to capitalise on successful approaces, deal wit problems, close loopoles and counteract unforeseen adverse effects arising from tese canges. Te Autority sould terefore be carged wit full responsibility and te necessary powers to: regulate all nicotine products respond to new or unforeseen developments wit a remit to act in te best public ealt interest undertake product testing and cecking were appropriate monitor price and consumption trends and act to promote use of te least azardous products set tax levels to promote use of te least azardous products work wit external agencies to oversee and police retail sale of smoked tobacco, and reduce smuggling and oter illicit sale or supply work wit NHS services to optimise stop smoking service delivery carry out all oter activities outlined in tis document, or oters relevant to te remit. Te Autority will terefore need to establis frequent and timely monitoring of te nicotine product market to: track canges in prevalence of use of different nicotine products monitor promotion metods and advertising claims monitor te impact of new developments on te market identify and prevent abuses of marketing and promotion identify and reverse trends in use likely to be counterproductive to public ealt. Ending tobacco smoking in Britain Radical strategies for prevention and arm reduction in nicotine addiction 13

16 Te Autority sould also monitor and act as above in relation to specific minority or special needs groups, including etnic minorities, pregnant women, cildren and young people. Te Autority would need to be staffed and resourced to provide te multidisciplinary and multiagency skills, and te implementation processes, necessary to fulfil te remit. Delivering on te remit will ave significant cost implications. Te Autority sould be funded troug tax on te most azardous nicotine products. Establisment of suc an Autority will take time; proposals for smoked tobacco and medicinal nicotine outlined above tat can be implemented witin existing regulatory structures sould be implemented as soon as possible. Oter roles of te Nicotine Regulatory Autority Te Autority sould work closely wit oter government departments and agencies to maximise tobacco control effects from te actions of oters. Te Autority sould also act wit te medical royal colleges and oter relevant professional organisations to ensure tat stop smoking services continue to expand te coverage and range of services provided for smokers wo want to quit, and specifically ensuring tat: all smokers admitted to NHS ospitals are provided wit individual cessation and/or arm reduction counselling, a trial dose of medicinal nicotine, and a more sustained supply if acceptable GPs, secondary care specialists and oter ealt professionals intervene effectively to promote smoking cessation or arm reduction in all of teir patients wo smoke appropriate resources are put in place to support te above activity. Te Autority sould develop NHS stop smoking services to include arm reduction, relapse prevention and relapse management strategies. Te Autority sould encourage te development and use of existing and new cessation terapies and interventions. Targets For te immediate future te main objective will be to encourage discontinuation of smoking, by any available means. Te longer-term objective will ten be to encourage as many nicotine users as possible to discontinue all nicotine use. In te sorter term, tis approac provides an opportunity to save tousands of lives. 22 Acieving tese objectives will also substantially denormalise smoking in te UK, and tus radically reduce uptake of smoking by cildren and te young. 14 Ending tobacco smoking in Britain Radical strategies for prevention and arm reduction in nicotine addiction

17 Given tat conventional tobacco control metods can reduce prevalence by up to one percentage point per year, 6 9 and tat a arm reduction strategy (using an example based on a non-medicinal product) as been estimated to be likely to reduce smoking prevalence by a furter 0.4 of a percentage point a year, 23 te Nicotine Regulatory Autority sould be expected to acieve an average annual decline of at least 1.4 percentage points per year. Te target for te Autority sould terefore be to eradicate tobacco smoking from te UK by te year In te longer term tis intervention will prevent millions of premature deats, and improve te ealt and wellbeing of millions of adults and cildren in te UK. Ending tobacco smoking in Britain Radical strategies for prevention and arm reduction in nicotine addiction 15

18 References 1 Goddard E. Smoking and drinking among adults General Houseold Survey Newport: Office for National Statistics, WHO Framework Convention on Tobacco Control. Geneva: WHO, World Bank. Tobacco control at a glance, June (accessed 20 July 2008) 4 Joossens L, Raw M. Progress in tobacco control in 30 European countries, 2005 to Berne: Swiss Cancer League, Lader D. Smoking-related beaviour and attitudes, Newport: Office for National Statistics, Pierce JP, Gilpin EA, Emery SL et al. Has te California tobacco control program reduced smoking? JAMA 1998;280: Biener L, Harris JE, Hamilton W. Impact of te Massacusetts tobacco control programme: population based trend analysis. BMJ 2000;321: Centre for Epidemiology and Researc report on adult ealt from te New Sout Wales population ealt survey. Sydney: NSW Department of Healt, Healt Canada. Long-term trends in te prevalence of current smokers, (accessed 20 July 2008) 10 Doll R, Peto R, Boream J, Suterland I. Mortality in relation to smoking: 50 years observations on male Britis doctors. BMJ 2004;328: Tobacco Advisory Group of te Royal College of Pysicians. Protecting smokers, saving lives: te case for a tobacco and nicotine regulatory autority. London: RCP, Tobacco Advisory Group of te Royal College of Pysicians. Harm reduction in nicotine addiction: elping people wo can t quit. London: RCP, Pierce JP, Wite MM, Gilpin EA. Adolescent smoking decline during California s tobacco control programme. Tob Control 2005;14: Henningfield JE. Nicotine medications for smoking cessation. N Engl J Med 1995;333: Scientific Committee on Emerging and Newly Identified Healt Risks. Healt effects of smokeless tobacco products. European Commission, February ttp://ec.europa.eu/ealt/p_risk/committees/04_scenir/docs/scenir_o_013.pdf (accessed 20 July 2008) 16 Fant RV, Henningfield JE, Nelson RA, Pickwort WB. Parmacokinetics and parmacodynamics of moist snuff in umans. Tob Control 1999;8: WHO International Agency for Researc on Cancer. Volume 37: Tobacco abits oter tan smoking: betel quid and areca nut cewing and some related nitrosamines. IARC monograp on te evaluation of te carcinogenic risk of cemicals to umans. Lyon: IARC, Swedis National Board of Healt and Welfare. Folkalsorapport Stockolm: Socialstyrelsen, European Respiratory Society. Tobacco smoking: arm reduction strategies. ERS researc seminar. Brussels: ERSJ, Te Tobacco for Oral Use (Safety) Regulations (accessed 20 July 2008) 21 Framework Convention Alliance for Tobacco Control. Comments on te template for a protocol on illicit trade in tobacco products. Geneva: Framework Convention Alliance, Lewis S, Arnott D, Godfrey C, Britton J. Public ealt measures to reduce smoking prevalence in te UK: ow many lives could be saved? Tob Control 2005;14: Levy DT, Mumford EA, Cummings KM et al. Te potential impact of a low-nitrosamine smokeless tobacco product on cigarette smoking in te United States: estimates of a panel of experts. Addict Beav 2006;31: Ending tobacco smoking in Britain Radical strategies for prevention and arm reduction in nicotine addiction