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![Analysts
We remain very bullish on the vast potential of e-cigs given the
rapid pace of innovation. [We believe] that the benefits of ecigs are becoming increasingly apparent to consumers, helping
to drive trial and repeat purchases aided by stepped-up
advertising and a lot of internet “buzz”
Wells Fargo](https://image.slidesharecdn.com/electroniccigaretteregulationecigarettesummit-131124004858-phpapp01/85/Electronic-Cigarette-Regulations-When-Less-is-More-23-320.jpg)
![Analysts
We remain very bullish on the vast potential of e-cigs given the
rapid pace of innovation. [We believe] that the benefits of ecigs are becoming increasingly apparent to consumers, helping
to drive trial and repeat purchases aided by stepped-up
advertising and a lot of internet “buzz”
Wells Fargo](https://image.slidesharecdn.com/electroniccigaretteregulationecigarettesummit-131124004858-phpapp01/75/Electronic-Cigarette-Regulations-When-Less-is-More-23-2048.jpg)
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Similar to Electronic Cigarette Regulations: When Less is More
Electronic Cigarette Regulations: When Less is More
- 1. Regulation: when lessis more Counterfactual www.clivebates.com @clive_bates
- 2. WHO – 1billion deaths
- 4. I smoked for45 years and tried every NRT product available, none of them worked. I continued to smoke even though my health was getting worse, resulting in COPD and using oxygen daily. September 2011 I discovered e-cigarettes and they worked. It was like someone handed me a miracle. In less than a week I stopped using regular cigarettes. I haven’t had a tobacco cigarette since. Unsolicited comment left on www.clivebates.com
- 5. From WHO TobaccoAtlas 2006 edition
- 6. The Endgame? Billion adults> 15 years Projected global adult population growth 9.0 Adult population 8.0 7.0 6.0 5.0 4.0 3.0 2.0 1.0 0.0 2010 2015 2020 2025 2030 2035 Smokers: WHO Tobacco Atlas 2006. Population: UN 2040 2045 2050
- 7. The Endgame? Billion adults> 15 years Projected global adult population growth 9.0 Adult population 8.0 7.0 6.0 5.0 4.0 3.0 Smoker population at constant prevalence 2.0 1.0 0.0 2010 2015 2020 2025 2030 2035 Smokers: WHO Tobacco Atlas 2006. Population: UN 2040 2045 2050
- 8. The endgame? Billion adults> 15 years Scenarios for future smoker population 2.5 Constant prevalence (28%) 2.0 1.5 1.0 0.5 0.0 2010 2015 2020 2025 2030 Scenario – 15% global prevalence by 2050 2035 2040 2045 2050
- 9. The endgame? Billion adults> 15 years Scenarios for future smoker population 2.5 Constant prevalence (28%) 2.0 1.5 Global smoking prevalence declines to 15% 1.0 0.5 0.0 2010 2015 2020 2025 2030 Scenario – 15% global prevalence by 2050 2035 2040 2045 2050
- 10. If all goeswell Billion adults > 15 years Scenarios for future smoker population 2.5 Constant prevalence (28%) 2.0 Contested by tobacco control 1.5 Global smoking prevalence declines to 15% 1.0 HARM 0.5 0.0 2010 2015 2020 2025 2030 2035 2040 2045 2050
- 11. The endgame –a nicotine product contest? Billion adults > 15 years Scenarios for future nicotine markets 2.5 Constant prevalence (28%) 2.0 Contested by tobacco control 1.5 Global nicotine prevalence declines to 15% 1.0 Contested by nicotine products 0.5 0.0 2010 2015 2020 2025 2030 2035 2040 2045 2050
- 12. How far couldlow-risk nicotine products go? Billion adults > 15 years Scenarios for future nicotine markets 2.5 Constant prevalence (28%) 2.0 Contested by tobacco control 1.5 Global nicotine prevalence declines to 15% Contested by low risk nicotine products 1.0 Global smoking prevalence declines to 5% 0.5 Cigarettes and other combustible tobacco 0.0 2010 2015 2020 2025 2030 2035 2040 2045 2050
- 13. How far couldlow-risk nicotine products go? Billion adults > 15 years Scenarios for future nicotine markets 2.5 2.0 1.5 1.0 This boundary matters most for public health 0.5 0.0 2010 2015 2020 2025 2030 2035 2040 2045 2050
- 14. The endgame: analystview Consumption of e-cigs may overtake traditional cigarettes in the next decade … and they’ll only evolve and improve as time goes forward. Bonnie Herzog, Wells Fargo Securities, 2013
- 15. The endgame: analystview Consumption of e-cigs may overtake traditional cigarettes in the next decade … and they’ll only evolve and improve as time goes forward. Bonnie Herzog, Wells Fargo Securities, 2013
- 16. 50:50 by 2030 Billionadults > 15 years ”Modified Herzog scenario" for future nicotine markets 2.5 Constant prevalence (28%) 2.0 1.5 Global nicotine prevalence declines to 15% 1.0 "E-cigarettes overtake cigarettes by 2030" 0.5 0.0 2010 Global smoking prevalence declines to 5% 2015 2020 2025 2030 2035 2040 2045 2050
- 17. Who is this? MitchZeller (now) Director of the Center for Tobacco Products FDA
- 18. Harm reduction equation Harmreduction = Reduced risk x Number who switch Product toxicity & other risks Product attractiveness Consumer preference
- 19. Harm reduction equation Harmreduction = Reduced risk x Number who switch Product toxicity & other risks Product attractiveness Consumer preference
- 20. Harm reduction categories– risk estimates Crude estimate of risk – Cigs = 100 120 100 80 60 40 20 0 Cigarettes Heat not burn Smokeless E-cigs NRT
- 21. Focus on theright relative risk More regulation Lower risk regulated e-cig 0 “unregulated” e-cig 10 10 0 0 e-cigarettes 100 cigarette
- 22. Harm reduction equation Harmreduction = Reduced risk x Number who switch Product toxicity & other risks Product attractiveness Consumer preference
- 23. Analysts We remain verybullish on the vast potential of e-cigs given the rapid pace of innovation. [We believe] that the benefits of ecigs are becoming increasingly apparent to consumers, helping to drive trial and repeat purchases aided by stepped-up advertising and a lot of internet “buzz” Wells Fargo
- 24. Regulation comes ata price Less Fewer, duller innovations personalisation branding & marketing Slower innovation pace Trusted brands & firms destroyed Greatly reduced variety & niche products Increased cost Boring Oligopoly & reduced competition Reduced appeal Black market, DIY
- 25. Harm reduction equation Harmreduction = Reduced risk x Number who switch Trade offs Conclusion 1. The perfectly risk free product that no-one wants scores badly in the harm reduction equation Conclusion 2. A diverse range of products with substantially reduced risk lets each smoker decide which product is best
- 27. Triple negative Tough onharm reduction
- 28. Specialised medicines language Consistentdrug dosing Quality Treats or prevents disease Adverse drug reactions Efficacy Safety
- 29. Getting tough onharm reduction? Counter-productive Harm reducing Safety Safest possible Safe enough Quality Control processes (eg. GMP) Proportionate standards Efficacy Regulator decides Consumer decides Labelling Warns of danger Encourages switching Marketing Like medicines Like consumer products Bans on use Fear of ‘renormalisation’ Normalise harm reduction Retail Pharmacies / as tobacco General sales Age restrictions Adults Makes little real difference Taxation Like tobacco Fiscal incentive to switch
- 30. What do analyststhink…? We believe many current suppliers would struggle to meet medical standards, and for the UK they may have to by 2016. Big players with deeper pockets would survive and prices could rise – a hugely preferable outcome for Tobacco. BNP Paribas Tougher regulation, as well as providing a relative advantage to their e-cigarette divisions, would result in higher prices for e-cigarettes – which could also benefit tobacco companies by limiting their attraction for smokers and slowing the decline in tobacco sales. Fitch
- 31. What do analyststhink…? We believe many current suppliers would struggle to meet medical standards, and for the UK they may have to by 2016. Big players with deeper pockets would survive and prices could rise – a hugely preferable outcome for Tobacco. BNP Paribas Tougher regulation, as well as providing a relative advantage to their e-cigarette divisions, would result in higher prices for e-cigarettes – which could also benefit tobacco companies by limiting their attraction for smokers and slowing the decline in tobacco sales. Fitch
- 32. European Parliament –amendment 170 • • • • • • • • • • • • • • • Requires medicines regulation if claim made Requires Article 17 notification regime otherwise Emphasises general safety requirement Applies Article 16 – cross border distance sales Applies advertising directive 2003/33/EC and audiovisual services 2010/13/EU Information leaflet Warning “this product is intended for use by existing smokers. It contains nicotine which is a highly addictive substance” Warning size - 30% or 40% (Council =30%) and specification from Article 10 30mg/ml threshold – “are not placed on the market” (?medicine) Age restriction (no less than 18) Restriction on additives – application of Article 6.4 (vitamins etc) No tobacco branding Allows flavourings Requires sales allowed ‘outside pharmacies’ Review
- 35. Purpose built regulationfor e-cigs / NCPs 1. Accountabilities – responsible person 2. Disclosure and notification regime 3. Labeling and consumer information 4. Safety assessment and product file 5. Contaminants / purity 6. Prohibited ingredients 7. Specific standards for vaping devices CEN/ISO 8. Updating: review & technical committee 9. Marketing (like alcohol?) – mostly member state 10. Retail sales age restriction – member states 11. … public vaping?
- 36. Harm reduction equationwith population effects Harm reduction = Reduced risk x Number who switch - Extra smokers + Extra quitters Gateway to smoking Dual use Reduced quitting Normalising smoking Gateway exits Complete cessation Extra quitting Normalising non-smoking
- 37. Conclusion • Be positiveabout the (vast) potential • Put the (minor) risks in perspective • Regulate as though the 1 billion matter most
- 38.
- 39. Summary of theECigarette Summit For more information about the E-Cigarette Summit, a full review of the event, and more presentations, read this article. Visit the E-Cigarette Summit's website here: http://e-cigarette-summit.com/