1. Global Tobacco Control: what to do about e-cigarettes? Deborah Arnott Chief Executive Action on Smoking & Health Copenhagen June 2014

2. What is ASH? ASH is a British NGO dedicated to reducing the harm caused by tobacco Set up by the Royal College of Physicians in 1971 Our role is advocacy, networking and information provision - anti-smoking not anti-smoker ASH (UK) receives core funding from British Heart Foundation and Cancer Research UK ASH (UK) receives no commercial funding

3. What to do about e- cigarettes? Maximise benefit Encourage switching Support quitting Discourage relapse Minimise risk Discourage uptake in youth Discourage uptake in never smokers

4. Current issues facing policy makers E-cigs ‘disruptive technology’ which could end the tobacco epidemic BUT How should they be regulated Can they helping smokers quit Will they undermine denormalisation of smoking Is there a gateway effect into smoking

5. Tale of Two letters expert onslaught on WHO PRO ‘If WHO gets its way and extinguishes e-cigs it will …. Have passed up …one of the biggest public health innovations of the last three decades which could potentially save millions of lives’ ANTI ‘We support WHO’s evidence-based approach to determine the best way to respond to Electronic Nicotine Delivery Systems (ENDS)’

6. Summary of the evidence: a view from Britain Use tripled in last 2 years from 700K to over 2 million 2/3 smokers and 1/3 ex-smokers For every 3 who try only 1 carries on using Almost no never smokers use e-cigarettes Growing experimentation amongst youth but almost entirely amongst smokers

7. Explosion in use since 2010 E-cigarette use among British smokers, 2010-14

8. Sustained use among adults is confined to smokers & ex-smokers E-cigarette use in Britain, 2014 (All adults)

9. Most users motivated by quitting or preventing relapse

10. Children who have never smoked rarely use e-cigarettes E-cigarette use among children in Britain, 2013 (Children who have heard of e-cigarettes, by smoking status) N=1042N=177N=64N=65N=22N=53

11. E-cigarette use in Britain, 2013 (Children who have heard of e-cigarettes, by age) Weekly use is confined to older children

12. US data from CDC shows similar pattern to Britain US CDC data from National Youth Tobacco Survey 2011 and 2012 analysis Clive Bates and Brad Rodu

13. Advertising and promotion has taken off First at point of sale - booths in railway stations, shops Newspaper ads TV ads Promotional videos Sports sponsorship

14. Are e-cigarettes a gateway into smoking? Renormalise Mimics smoking behaviour Socially attractive, pleasurable, cool Celebrity endorsement, sport sponsorship Social media, price promotions Denormalise Promotes vaping not smoking Promotes switching to safer alternative Promotes idea smoking not cool 14

15. Adult and youth smoking in England % E-cig marketing starts taking off

16. Cigarette smoking prevalence 16 Graph shows prevalence estimate and upper and lower 95% confidence intervals Base: All adults in England

17. E-cigs not a magic bullet Massive increase in electronic cigarette use No evidence of regular use by never smokers or children so far BUT : Around 1 in 3 of those who try them carry on using Around 1 in 3 users have quit smoking completely 2 out of 3 carry on smoking too PLUS: Rapid growth of marketing causing concern Just because not yet a gateway doesn’t mean it won’t be SO: Not a magic bullet Concerns about potential youth uptake 17

18. Why don’t more smokers use them? Embarassment factor down –1 in 3 in 2010 –1 in 6 in 2014 Concerns about affordability down –Over half in 2010 –Just over 1 in 3 in 2014 18

19. Why don’t more smokers use them? Embarassment factor down –1 in 3 in 2010 –1 in 6 in 2014 Concerns about affordability down –Over half in 2010 –Just over 1 in 3 in 2014 Concerns about effectiveness remain –39% in 2010 –37% in 2014 AND concerns about safety growing –1 in 5 in 2010 –1 in 3 in 2014 19

20. Global policy responses No level playing field US will regulate as tobacco product Europe twin track approach – from 2016 either consumer product or medicine Canada personal consumption legal – sales banned South Korea legal but heavily taxed LMICs: banned – Brazil, HK, Malaysia, Turkey, UAE… legal – China, India…. WHO examining regulatory options

21. Future regulatory framework in Europe – twin track Tobacco Products Directive regulation of electronic cigarettes MHRA licenced Nicotine Containing Products (NCPs) including e-cigs Products not available on prescriptionProducts available on prescription 20% VAT5% VAT Cross border advertising banned by 2016; up to Member States to decide on domestic advertising (billboards, Point of Sale, buses etc.) Advertising allowed – under OTC rules so no celebrity or health professional endorsement; or free samples; and must be targeted at adult smokers etc. Products widely availableProducts available on general sale (GSL) Can’t make health claimsCan make health claims Upper limits for nicotine content will be set and likely to be in force by 2017. MHRA regulation is flexible; there are no upper limits. 30% health warning on packs about nicotine on front and back of packs No health warnings on packs Member States retain powers e.g. on flavours, domestic advertising. Flavours require a marketing authorisation Children and Families Bill allows for age of sale of 18 for nicotine products. Age of sale 12 but can be varied by product so could be higher for electronic cigarettes.

22. Future regulatory framework in Europe – twin track Tobacco Products Directive regulation of electronic cigarettes MHRA licenced Nicotine Containing Products (NCPs) including e-cigs Products not available on prescriptionProducts available on prescription 20% VAT5% VAT Cross border advertising banned by 2016; up to Member States to decide on domestic advertising (billboards, Point of Sale, buses etc.) Advertising allowed – under OTC rules so no celebrity or health professional endorsement; or free samples; and must be targeted at adult smokers etc. Products widely availableProducts available on general sale (GSL) Can’t make health claimsCan make health claims Upper limits for nicotine content will be set and likely to be in force by 2017. MHRA regulation is flexible; there are no upper limits. 30% health warning on packs about nicotine on front and back of packs No health warnings on packs Member States retain powers e.g. on flavours, domestic advertising. Flavours require a marketing authorisation Children and Families Bill allows for age of sale of 18 for nicotine products. Age of sale 12 but can be varied by product so could be higher for electronic cigarettes.

23. Will medicines regulation be beneficial or not? FOR regulation triggers innovation making production more efficient. Cost savings overcompensate for compliance/ innovation costs of regulation Reassurance of quality and safety to smokers AGAINST Users will be put off if medicines Costs disproportionate slows down innovation Will reduce diversity Will destroy supply chain

24. EUROPEAN STATE OF PLAY Twin track approach gives producers and consumers choice about which market they’re in UK has made commitment to make medicines regulation work UK licences expected soon Opt in model so proof will be whether manufacturers opt in or not And whether licenced products popular or not

25. ASH (UK) position Policy should be evidence-based Regulatory framework should be consistent; and: –Ensure easy access for smokers –Restrict marketing to adult smokers only –Facilitate communication of accurate information on relative risks –Encourage improvements in quality, safety and efficacy –Support innovation –Monitor the market The UK can set the standard for effective regulation, in Europe and worldwide

26. Medicines regulation can: Maximise benefit Encourage switching Support quitting Discourage relapse Minimise risk Discourage uptake in youth Discourage uptake in never smokers

27. Background information from the UK Public Health England –Evidence papers. Policy position in favour of regulation of electronic cigarettes as medicines. http://tinyurl.com/qfgtcww http://tinyurl.com/qfgtcww NICE guidance on tobacco harm reduction –Prioritises quitting but supports harm reduction approaches for smokers currently unable or unwilling to quit. http://www.nice.org.uk/PH45 http://www.nice.org.uk/PH45 NCSCT briefing –Summarises evidence with helpful advice for stop smoking advisers http://tinyurl.com/ovwcnny http://tinyurl.com/ovwcnny MHRA regulatory approach http://tinyurl.com/l4h8xom http://tinyurl.com/l4h8xom ASH briefings and research www.ash.org.uk www.ash.org.uk Smoking in England toolkit data http://www.smokinginengland.info/latest-statistics/ http://www.smokinginengland.info/latest-statistics/