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Competent or careless?
Directions in European policy on low-risk nicotine products
Clive Bates
Counterfactual Consulting
20 April 2021
Five messages
1. The threat
2
Europe’s beating cancer plan – February 2021
• Commission will continue to prioritise protecting young people from the harmful effects of tobacco
and related products
• Decisive action will be taken by reviewing the Tobacco Products Directive, the Tobacco Taxation
Directive and
• The legal framework on cross-border purchases of tobacco by private individuals.
• This includes working in full transparency towards plain packaging and a full ban on flavours, using
existing EU agencies to improve the assessment of ingredients,
• Tackling tobacco advertising, promotion and sponsorship on the internet and social media.
• Update Council Recommendation on SmokeFree Environments both extending its coverage to
emerging products, such as e-cigarettes and heated tobacco products, and expanding smoke-free
environments, including outdoor spaces.
• In addition, the EU track and trace system will be extended to all tobacco products by 2024.
3
European legislative developments
4
Tobacco Excise Directive
2011/64/EU
Tobacco Advertising Directive
2003/33/EC
• Inclusion of more products
• Minimum excise levels
• Choice of tax base
• Maximums and differentials?
• No change in sight
Tobacco Products Directive
2014/40/EC
• Flavours and Ingredients
• Nicotine
• Medicalisation
• No relaxation of bad regulation
4Q 2021 or 1Q 2022
Mid-2022
Not applicable
Tax posture – 5 elements
5
1. No tax justified
2. Zero minimum rate
3. Maximum
4. Tax base: mg nicotine?
5. Cigarette equivalence factor
Tobacco Products
Directive
2014/40/EU
Article 20 (1)
Medical
Medicines
Directive
2001/83/EC
Medical Devices
Directive
93/42/EEC
Consumer
Tobacco Products
Directive
Article 20 ( 2-13)
Pathways for ENDS in the Tobacco Products Directive
6
Five messages
1. The threat
2. The public health model
7
The public health mechanism
8
Smoking cessation vs consumer alternative
9
The public health mechanism is not “smoking cessation medication”
Harm reduction = Reduced risk x Number who switch
Product toxicity &
other risks
Proportion who succeed
Who tries and how
many
Harm reduction equation (simplified)
Appeal and
user choice
10
The public health mechanism: consumer “value propositions” – the 7 Ps
Value
Price
Promotion
Place
Product
Positioning
People
Packaging
11
Adapted from: Bitner MJ, Booms BH (1981). Marketing Strategies and Organization Structure for Service Firms.
Conference Proceedings: American Marketing Association, Chicago, IL,.
The public health mechanism: rival “value propositions”
Tobacco control
Smoking
Price
Promotion
Place
Product
Positioning
People
Packaging
Degrade the value
Tobacco harm reduction
Enhance the value to smokers
12
2. The public health mechanism: rival “value propositions”
Tobacco control
Smoking
Price
Promotion
Place
Product
Positioning
People
Packaging
Degrade the value
Tobacco control
Degrade the value to everyone
13
Evidence for beneficial population effect ‘triangulates’
• Also, user testimony
• And… it is what you would expect!!
14
Professor Robert West, UCL. Presentation at SRNT-Europe 2019
Five messages
1. The threat
2. The public health model
3. The unintended consequences
15
…if a risk-averse, precautionary approach
makes e-cigarettes:
• less easily accessible
• less palatable or acceptable
• more expensive
• less consumer friendly
• pharmacologically less effective
• inhibits innovation …
…then it causes harm by perpetuating
smoking.
Royal College of Physicians – unintended consequences
16
Royal College of Physicians. Nicotine without smoke: tobacco harm reduction London: RCP; 2016.
Taxing economic substitutes
17
… implementing differential
taxes on nicotine-yielding
products on the basis of degree
of risk could substantially
expedite the move away from
cigarette smoking
Chaloupka FJ, Sweanor D, Warner KE. Differential Taxes for Differential Risks — Toward Reduced Harm from Nicotine-Yielding Products.
N Engl J Med 2015;373(7):594–597.
18
High e-cigarette tax
More smokers
Pesko MF, Courtemanche CJ, Maclean JC. The effects of traditional cigarette and e-cigarette tax rates on adult tobacco product use. J Risk Uncertain 2020
19
20
Highlights
• E-cigarette advertising on TV causes
adult smokers to quit.
• A ban on these ads would have
reduced the number of smokers who
quit by 3%.
• A more relaxed regulatory
environment might have increased
the quit rate by 10%.
Dave D, Dench D, Grossman M, Kenkel DS, Saffer H. Does e-cigarette advertising encourage
adult smokers to quit? J Health Econ ];68:102227.
21
 Don’t be socially irresponsible
 Don’t target or feature children
 Don’t confuse e-cigarettes with tobacco products
 Don’t make health or safety claims
 Don’t make smoking cessation claims
 Don’t mislead about product ingredients
 Don’t mislead about where products may be use
Set standards avoid bans
Banning e-liquid flavours
22
Perverse consequences: flavour bans
Tobacco
Fruit
Dessert
or pastry
Choc,
sweets
Russell et al. vaping
flavour preferences
Russell C, et al. Changing patterns of first e-cigarette flavor used and current flavors used by
20,836 adult frequent e-cigarette users in the USA. Harm Reduct J. BioMed Central; 2018 23
CDC, Tobacco Product Use and Associated Factors Among Middle and
High School Students — United States, 2019, Table 6 (simplified)
Reasons for e-cigarette use among middle and high
school students who reported using e-cigarettes and
other tobacco products during the past 30 days
Reason given for vaping
Use e-cigarettes
only
Use e-
cigarettes and
other tobacco
products
I was curious about them 56.1% 38.4 %
Friend or family member used them 23.9% 22.2%
They are available in flavors, such as
mint, candy, fruit, or chocolate
22.3% 26.6 %
I can use them to do tricks 22.0% 29.0%
They are less harmful than other
forms of tobacco, such as cigarettes
17.2% 19.1%
Adolescents are curious
24
Possible consequences – a flavour ban
• The intended outcome - abstinence from nicotine and not adopting any other risk behaviour
• Using tobacco flavoured vape products instead of other flavoured products
• Accessing flavoured vapes via an illicit supply chain (a black market)
• Relapsing back from vaping to smoking – both teenagers and adults
• Not switching from smoking to vaping and continuing to smoke
• Continuing to smoke or to start smoking as an adolescent because parents or adult role models smoke instead of vaping
• Using other tobacco or nicotine products – hand-rolling tobacco, smokeless tobacco, heated tobacco, or new nicotine pouches
• Buying from foreign suppliers in person or via the internet and importing for personal use
• Buying from foreign suppliers to resell to others through informal networks
• Making and mixing their own flavours at home or buying or selling home-mixed flavours
• Using vapes that are made to look tobacco flavoured but have other flavours
• Using flavour agents for food, drink or aromatherapy for adding to unflavoured nicotine liquids
• Using flavours made for vaping but ostensibly marketed for another purpose
• Switching to cannabinoid (THC or CBD) vapes
• Initiating smoking instead of initiating vaping
• Adopting another risk behaviour that may be worse
25
Five messages
1. The threat
2. The public health model
3. The unintended consequences
4. Concern about teenage vaping
26
UK experience
27
Low levels of
regular youth
vaping
ASH / YouGov surveys 2013-2020
UK experience
28
Vaping concentrated in
young smokers (black
bars)
ASH / YouGov survey 2020
Youth smoking has fallen rapidly
29
Rate of decline
post-2010 is 4 times
greater than 1975-
2010
3 times
Youth risk behaviors in context – United States 2017
0.0
5.0
10.0
15.0
20.0
25.0
30.0
35.0
E-cigarette Smoking any
combusible
tobacco
Marijuana Alcohol Binge
drinking
Drink driver
riding as
passenger
Carried a
weapon
Texting while
driving
Percentage
of
high
school
students
Past 30 day prevalence – high school students NYTS and YRBS
2019
2018
2017
2020
Kann L, McManus T, Harris WA, et al. Youth Risk Behavior Surveillance — United States, 2017. MMWR Surveill Summ 2018;67(No. SS-8):1–114.
* Refers to driver or passengers riding in vehicles where the driver had been drinking.
Competent or careless?  Directions in European policy on low-risk nicotine products
Five messages
1. The threat
2. The public health model
3. The unintended consequences
4. Concern about teenage vaping
5. Risk proportionate regulation
32
Risk-Proportionate Regulation
Measure Cigarettes, hand-rolling tobacco and other
combustibles
Vaping, heated tobacco smokeless and oral
nicotine
Taxation Relatively high taxes Low or zero tax (sales tax only)
Illicit trade Track and trace (FCTC protocol) Complaint-driven
Advertising Prohibit other than within trade Control themes and placement
Warnings Graphic warnings depicting disease Messages encouraging switching
Public places Legally mandated controls Up to the discretion of the owner
Plain packaging Yes No
Ingredients Control reward-enhancing additives Blacklist material health hazards
Flavours Prohibit Allow, subject to health hazards
Flavour descriptors Not applicable if flavours banned Control appeal to youth/trademarks
Age restrictions No sales to under-21s No sales to under-18s
Internet sales Banned Permitted with age controls
Product standards Control risks and reduce appeal Control risks
33
Five messages
1. The threat
2. The public health model
3. The unintended consequences
4. Concern about teenage vaping
5. Risk proportionate regulation
34
35
Thank you
Clive Bates
Counterfactual Consulting
@clive_bates
clivedbates@gmail.com
20 April 2021

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Competent or careless? Directions in European policy on low-risk nicotine products

  • 1. 1 Competent or careless? Directions in European policy on low-risk nicotine products Clive Bates Counterfactual Consulting 20 April 2021
  • 3. Europe’s beating cancer plan – February 2021 • Commission will continue to prioritise protecting young people from the harmful effects of tobacco and related products • Decisive action will be taken by reviewing the Tobacco Products Directive, the Tobacco Taxation Directive and • The legal framework on cross-border purchases of tobacco by private individuals. • This includes working in full transparency towards plain packaging and a full ban on flavours, using existing EU agencies to improve the assessment of ingredients, • Tackling tobacco advertising, promotion and sponsorship on the internet and social media. • Update Council Recommendation on SmokeFree Environments both extending its coverage to emerging products, such as e-cigarettes and heated tobacco products, and expanding smoke-free environments, including outdoor spaces. • In addition, the EU track and trace system will be extended to all tobacco products by 2024. 3
  • 4. European legislative developments 4 Tobacco Excise Directive 2011/64/EU Tobacco Advertising Directive 2003/33/EC • Inclusion of more products • Minimum excise levels • Choice of tax base • Maximums and differentials? • No change in sight Tobacco Products Directive 2014/40/EC • Flavours and Ingredients • Nicotine • Medicalisation • No relaxation of bad regulation 4Q 2021 or 1Q 2022 Mid-2022 Not applicable
  • 5. Tax posture – 5 elements 5 1. No tax justified 2. Zero minimum rate 3. Maximum 4. Tax base: mg nicotine? 5. Cigarette equivalence factor
  • 6. Tobacco Products Directive 2014/40/EU Article 20 (1) Medical Medicines Directive 2001/83/EC Medical Devices Directive 93/42/EEC Consumer Tobacco Products Directive Article 20 ( 2-13) Pathways for ENDS in the Tobacco Products Directive 6
  • 7. Five messages 1. The threat 2. The public health model 7
  • 8. The public health mechanism 8
  • 9. Smoking cessation vs consumer alternative 9
  • 10. The public health mechanism is not “smoking cessation medication” Harm reduction = Reduced risk x Number who switch Product toxicity & other risks Proportion who succeed Who tries and how many Harm reduction equation (simplified) Appeal and user choice 10
  • 11. The public health mechanism: consumer “value propositions” – the 7 Ps Value Price Promotion Place Product Positioning People Packaging 11 Adapted from: Bitner MJ, Booms BH (1981). Marketing Strategies and Organization Structure for Service Firms. Conference Proceedings: American Marketing Association, Chicago, IL,.
  • 12. The public health mechanism: rival “value propositions” Tobacco control Smoking Price Promotion Place Product Positioning People Packaging Degrade the value Tobacco harm reduction Enhance the value to smokers 12
  • 13. 2. The public health mechanism: rival “value propositions” Tobacco control Smoking Price Promotion Place Product Positioning People Packaging Degrade the value Tobacco control Degrade the value to everyone 13
  • 14. Evidence for beneficial population effect ‘triangulates’ • Also, user testimony • And… it is what you would expect!! 14 Professor Robert West, UCL. Presentation at SRNT-Europe 2019
  • 15. Five messages 1. The threat 2. The public health model 3. The unintended consequences 15
  • 16. …if a risk-averse, precautionary approach makes e-cigarettes: • less easily accessible • less palatable or acceptable • more expensive • less consumer friendly • pharmacologically less effective • inhibits innovation … …then it causes harm by perpetuating smoking. Royal College of Physicians – unintended consequences 16 Royal College of Physicians. Nicotine without smoke: tobacco harm reduction London: RCP; 2016.
  • 17. Taxing economic substitutes 17 … implementing differential taxes on nicotine-yielding products on the basis of degree of risk could substantially expedite the move away from cigarette smoking Chaloupka FJ, Sweanor D, Warner KE. Differential Taxes for Differential Risks — Toward Reduced Harm from Nicotine-Yielding Products. N Engl J Med 2015;373(7):594–597.
  • 18. 18 High e-cigarette tax More smokers Pesko MF, Courtemanche CJ, Maclean JC. The effects of traditional cigarette and e-cigarette tax rates on adult tobacco product use. J Risk Uncertain 2020
  • 19. 19
  • 20. 20 Highlights • E-cigarette advertising on TV causes adult smokers to quit. • A ban on these ads would have reduced the number of smokers who quit by 3%. • A more relaxed regulatory environment might have increased the quit rate by 10%. Dave D, Dench D, Grossman M, Kenkel DS, Saffer H. Does e-cigarette advertising encourage adult smokers to quit? J Health Econ ];68:102227.
  • 21. 21  Don’t be socially irresponsible  Don’t target or feature children  Don’t confuse e-cigarettes with tobacco products  Don’t make health or safety claims  Don’t make smoking cessation claims  Don’t mislead about product ingredients  Don’t mislead about where products may be use Set standards avoid bans
  • 23. Perverse consequences: flavour bans Tobacco Fruit Dessert or pastry Choc, sweets Russell et al. vaping flavour preferences Russell C, et al. Changing patterns of first e-cigarette flavor used and current flavors used by 20,836 adult frequent e-cigarette users in the USA. Harm Reduct J. BioMed Central; 2018 23
  • 24. CDC, Tobacco Product Use and Associated Factors Among Middle and High School Students — United States, 2019, Table 6 (simplified) Reasons for e-cigarette use among middle and high school students who reported using e-cigarettes and other tobacco products during the past 30 days Reason given for vaping Use e-cigarettes only Use e- cigarettes and other tobacco products I was curious about them 56.1% 38.4 % Friend or family member used them 23.9% 22.2% They are available in flavors, such as mint, candy, fruit, or chocolate 22.3% 26.6 % I can use them to do tricks 22.0% 29.0% They are less harmful than other forms of tobacco, such as cigarettes 17.2% 19.1% Adolescents are curious 24
  • 25. Possible consequences – a flavour ban • The intended outcome - abstinence from nicotine and not adopting any other risk behaviour • Using tobacco flavoured vape products instead of other flavoured products • Accessing flavoured vapes via an illicit supply chain (a black market) • Relapsing back from vaping to smoking – both teenagers and adults • Not switching from smoking to vaping and continuing to smoke • Continuing to smoke or to start smoking as an adolescent because parents or adult role models smoke instead of vaping • Using other tobacco or nicotine products – hand-rolling tobacco, smokeless tobacco, heated tobacco, or new nicotine pouches • Buying from foreign suppliers in person or via the internet and importing for personal use • Buying from foreign suppliers to resell to others through informal networks • Making and mixing their own flavours at home or buying or selling home-mixed flavours • Using vapes that are made to look tobacco flavoured but have other flavours • Using flavour agents for food, drink or aromatherapy for adding to unflavoured nicotine liquids • Using flavours made for vaping but ostensibly marketed for another purpose • Switching to cannabinoid (THC or CBD) vapes • Initiating smoking instead of initiating vaping • Adopting another risk behaviour that may be worse 25
  • 26. Five messages 1. The threat 2. The public health model 3. The unintended consequences 4. Concern about teenage vaping 26
  • 27. UK experience 27 Low levels of regular youth vaping ASH / YouGov surveys 2013-2020
  • 28. UK experience 28 Vaping concentrated in young smokers (black bars) ASH / YouGov survey 2020
  • 29. Youth smoking has fallen rapidly 29 Rate of decline post-2010 is 4 times greater than 1975- 2010 3 times
  • 30. Youth risk behaviors in context – United States 2017 0.0 5.0 10.0 15.0 20.0 25.0 30.0 35.0 E-cigarette Smoking any combusible tobacco Marijuana Alcohol Binge drinking Drink driver riding as passenger Carried a weapon Texting while driving Percentage of high school students Past 30 day prevalence – high school students NYTS and YRBS 2019 2018 2017 2020 Kann L, McManus T, Harris WA, et al. Youth Risk Behavior Surveillance — United States, 2017. MMWR Surveill Summ 2018;67(No. SS-8):1–114. * Refers to driver or passengers riding in vehicles where the driver had been drinking.
  • 32. Five messages 1. The threat 2. The public health model 3. The unintended consequences 4. Concern about teenage vaping 5. Risk proportionate regulation 32
  • 33. Risk-Proportionate Regulation Measure Cigarettes, hand-rolling tobacco and other combustibles Vaping, heated tobacco smokeless and oral nicotine Taxation Relatively high taxes Low or zero tax (sales tax only) Illicit trade Track and trace (FCTC protocol) Complaint-driven Advertising Prohibit other than within trade Control themes and placement Warnings Graphic warnings depicting disease Messages encouraging switching Public places Legally mandated controls Up to the discretion of the owner Plain packaging Yes No Ingredients Control reward-enhancing additives Blacklist material health hazards Flavours Prohibit Allow, subject to health hazards Flavour descriptors Not applicable if flavours banned Control appeal to youth/trademarks Age restrictions No sales to under-21s No sales to under-18s Internet sales Banned Permitted with age controls Product standards Control risks and reduce appeal Control risks 33
  • 34. Five messages 1. The threat 2. The public health model 3. The unintended consequences 4. Concern about teenage vaping 5. Risk proportionate regulation 34
  • 35. 35 Thank you Clive Bates Counterfactual Consulting @clive_bates [email protected] 20 April 2021

Editor's Notes

  • #11: Don’t worry if you aren’t mathematical… this is just codifying common sense…. The simple idea is that a the impact of reduced risk alternative to cigarettes is the risk reduction per user multiplied by the number of users who switch. Both terms are important. The first term is really determined by toxic exposure arising from continued nicotine use – a product characteristic. For e-cigs and snus this is 95-99% - at least 20-fold improvement… The second term is why we don’t want to be too prescriptive and end up dissuading people from take the 95-99% reduction and carrying on with the greatest danger. That’s why alarm bells should ring when there are plans to restrict reduced risk only to the ‘cleanest and safest’ - or there are plans to ban things that might make these products attractive – like flavourings – or to have regulators control ingredients – or attempt to remove all residual toxins (some of which might be important for flavour) The consumer and mechanisms of market competition should be the primary driver of what makes these products attractive – not regulators who may insist they are safe at the expense of making them less attractive [The equation could be elaborated to have a second term… those that use the reduced risk products who would otherwise have stopped completely. Not shown here because the residual risk is so low – the reduced risk products are not that much difference to quitting completely].