The Art of the Possible

1
The Art of the Possible
Evidence -informed Provisions for Tobacco Control
Legislation
Rose Nathan, JD, MPH Global Public Health Law
Services, LLC (GPHLS)
2
Strong and comprehensive TC regulation is possible
G P H L S

• Despite political constraints, many countries
  have legislative that is
• Stringent
• Comprehensive
• Forward thinking

3
Countries TC successes (examples)
G P H L S

• Strong, graphic and very large health
  message/labeling requirements

Canada
Brazil
4
Countries successes, contd

• Virtual bans on smoking in
• public places/workplaces
• S. Africa, Ireland, Norway, Italy, New Zealand,
  others
• Advertising, sponsorship, and promotion bans
• S. Africa, Thailand
• Meaningful reporting requirements
• Canada, State of Mass (US)
• Comprehensive TC laws covering multiple topics
• Brazil, Canada, Poland, S. Africa, Thailand

5
Priority Interventions for Tobacco Control
G P H L S

• 1. Excise taxes-all tobacco products
• 2. Protection from exposure to tobacco smoke
  bans in public places
• 3. Comprehensive bans on all forms of
  advertising, sponsorships and other forms of
  promotion
• 4. Packaging and labeling
• 5. Anti-smuggling provisions
• 6. Sales/distribution/displays
• 7. Product regulation and industry reporting
• 8. Licensing
• 9. Cessation support
• 10. Inspections and enforcement

6
Excise taxes the evidence

• Raising taxes on tobacco products is the
• single most important intervention
• 10 increase in price worldwide could save 10
  million lives
• Higher Price ?Lower Consumption, Fewer Youth
  Starting
• Price elasticities are higher in low and middle
  income countries
• Higher Excise Tax more government revenue
• Higher taxes ? more smuggling
• Source Jha P, Chalupka F. Curbing the epidemic
  governments and the economics of tobacco control.
  Washington, DC World Bank 1999)

7
Real cigarette tax rate and real cigarette tax
revenue in South Africa 1960-1997
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Taxation best practices

• Tax rate should be between 2/3 and 4/5 of retail
  price
• Automatic increases to exceed the rate of
  inflation
• Tax on all tobacco products
• Tax tied to a stable currency
• Earmarking tax revenues for tobacco
  control/health promotion
• (Source Jha P, Chalupka F. Curbing the
  epidemic governments and the economics of
  tobacco control. Washington, DC World Bank
  1999)

9
Smoke-free environments
10
The evidence secondhand smoke causes
disease/death

• Preventable mortality and morbidity from
• Cancers
• Heart Disease and Stroke
• Chronic Lung Ailments
• Asthma
• Respiratory Infections
• Low Birth Weight
• SIDS

11
Second-hand smoke, contd

• Tobacco smoke contains gt4000 chemicals more than
  60 known or suspected carcinogens
• 30 increased risk of cancer
• and heart disease
• 50 increased risk for restaurant/bar workers
• (Sources National Cancer Institute. Risks
  associated with smoking
• cigarettes with low machine-measured yields of
  tar and nicotine. NIH Pub.
• No. 02-5074, October 2001 International Agency
  for Research on Cancer.
• Monograph on tobacco smoke and involuntary
  smoking. Vol. 83 (In press)
• Whincup, PH et al, Passive smoking and risk of
  coronary heart disease and
• stroke prospective study with cotinine
  measurement, British Medical Journal,
• BMJ, doi10.1136/bmj.38146.427188.55, June 30,
  2004)

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Best Practice smoking bans in public/workplaces

• Smoking bans in public/work places protect the
  public/workers and result in less smoking and
  higher quit rates
• 29 reduction in consumption (3.8 drop in
  prevalence, and 3.1 fewer cigarettes per employee
  per day)
• (Sources Philip Morris POL data base, Impact
  of Workplace Restrictions on Consumption and
  Incidence U.S. Department of Health and Human
  Services (HHS), Reducing Tobacco Use A Report of
  the Surgeon General, 2000, National Cancer
  Institute, Population Based Smoking Cessation
  Proceedings of a Conference on What Works to
  Influence Cessation in the General Population,
  Smoking and Tobacco Control Monograph No. 12, NIH
  Pub. No. 00-4892, November 2000)

13
Smoking bans in public places in the industrys
own words

• Total prohibition of smoking in the workplace
  strongly affects industry volume. Smokers facing
  these restrictions consume 11-15 less than
  average and a quit rate that is 84 higher than
  average
• (Phillip Morris internal document, Bates No.
  2025833451-5 January 21, 1992)

14
Industry responses (1) courtesy of
choice/separate ventilation

• But, the evidence shows
• Separate smoking areas do not provide protection,
  whether ventilated or not
• Even separately ventilated smoking rooms provide
  questionable protection due to imperfect
  conditions (swinging doors, maintenance of the
  ventilation system, etc.)
• Concerns about workers entering the smoking rooms
  during and after smoking
• (Department of Labor, Occupational Safety and
  Health Administration, Federal Register notice of
  proposed rulemaking, Indoor Air Quality, FR
  5915968-16039, April 5, 1994 ASHRAE 62-1999
  Ventilation for Acceptable Indoor Air Quality,
  see Addendum 62e. ASHRAE 62-1999 Ventilation
  for Acceptable Indoor Air Quality, see Addendum
  62e ASHRAE 62-1999 Ventilation for Acceptable
  Indoor Air Quality, see Addendum 62e.)

15
Industry response (2) lost revenues

• But the evidence shows
• Scientifically rigorous studies show smoking bans
  in hospitality venues do not cause loss in
  revenues
• (Source Scollo M, Lal A. Summary of studies
  assessing the economic impact of smoke-free
  policies in the hospitality industry. VicHealth
  Center for Tobacco Control, Melbourne, Australia
  Aug. 2003)
• More and more countries, provinces and cities are
  going smoke free, including in bars and
  restaurants

16
Tobacco Advertising
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The evidence advertisings relationship to
consumption

• Advertising increases tobacco consumption
• youth are especially vulnerable
• Youth who own promotional items are more likely
  to become smokers
• Comprehensive advertising, sponsorship, and
  promotion bans decrease consumption (approx. 6
  percent)
• Restrictions/partial bans are ineffectiveadvertis
  ing /promotion will increase in permitted forms
• (Sources Saffer (2000) Chaloupka and Warner
  (2000) Saffer and Chaloupka (2000) Tobacco
  Advertising Economic Theory and International
  Evidence Wakefield, et al. (2000) Changes at
  the Point-of-Sale for Tobacco Following the 1999
  Tobacco Billboard Ban Pierce, et al. 1998
  Biener Siegel 2000 Sargent et al 2000
  Phillip Morris. Marketing new products in a
  restrictive environment. June 1990. Bates No.
  2044762173-2364) )

18
Comprehensive advertising/promotion bans reduce
cigarette consumption
Consumption trend in countries w/bans v. w/out
bans
(Source Saffer, Tobacco control in developing
countries 2000)
19
Advertising/promotion best practices

• Ban all forms of direct and indirect advertising,
  sponsorships, and other forms of promotion
• Define terms very carefully

20
Packaging and labeling
Smokers are unaware of the true risks and
under- estimate their own risk (Source Ayanian
J, Cleary P. Perceived risks of heart disease and
cancer among cigarette smokers. Journal of the
American Medical Asssociation, 1999
281(11)1019-21.
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Labeling the evidence

• Studies show that large, picture based warnings
• increase the motivation to quit
• increase concern about health effects of smoking
• increase awareness of the health effects for a
  significant proportion of smokers
• Source Environics Research Group, Ltd.,
  Evaluation of New warning on Cigarette
  Packages, Prepare for the Cancer Society, 2001)

22
The evidence, contd size matters

• Picture-based
• warnings are more
• effective than text-
• only warnings, and
• the effectiveness
• increases with
• size
• (Source Environics Research Group Ltd., 2001)

23
Warning/message size, contd
FCTC requires a minimum size of 30 of package
main display panels
Brazilian warning/message
24
Labeling best practices

• 50 is better
• Rotating messages keep the information from
  getting stale
• (SourcesJha and Chaloupka, 1999
  EnvironicsResearch Group Ltd., 2001)

25
Misleading descriptors the evidence

• Smokers compensate
• with low tar products, inhaling more deeply
• Results in equal or greater harm than from
  regular tar cigarettes
• For that reason, tar, nicotine, and CO levels are
  not measured accurately and disclosed levels are
  misleading
• (Source National Cancer Institute, Risks
  Associated with Smoking Cigarettes with Low
  Machine-measured Yields of Tar and Nicotine,
  2001)

26
Misleading descriptors best practices

• Ban misleading descriptors, colors, graphics,
  etc., as well as packaging design that implies
  light or mild products
• Ban display of tar, nicotine, and CO levels on
  packages since they inherently are misleading
  under current testing methods
• (Source WHO/SACTOB

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Anti-smuggling provisions
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The evidence smuggling

• Defrauds governments and taxpayers
• Increases level of crime and corruption
• Puts cheaper cigarettes on the street
• Undermines a powerful tobacco control policy
  use of higher taxes to reduce tobacco use
• (Source Joossens L. How to combat tobacco
  smuggling through the WHO Framework Convention on
  Tobacco Control. Presentation at the Second World
  Conference on Modern Criminal Investigation,
  Organized Crime and Human Rights, Durban. Dec 7,
  2001)

29
Industry arguments higher taxes increase
smuggling

• But the evidence shows
• Higher taxes alone do not increase smuggling
• High prices taxes, low smuggling (lt5)
• Sweden, Denmark, Norway, France, Finland (UK
  in previous years), Ireland
• Low prices taxes, high smuggling (gt10)
• Spain, Italy, Pakistan, Nigeria, Yugoslavia,
  Ukraine, Moldova, Colombia, Iran, Austria,
  Cambodia

30
As Cigarette Tax Rises, Revenue Increases, even
with smuggling
Source Statistics Finland
31
Best practices to prevent smuggling

• High penalties
• Tax paid markings/stamps, end duty-free sales
• Require unique identifying code on packages and
  chain of custody information, so smuggled
  cigarettes can be traced
• Make exporters responsible (strictly liable) for
  final legal destination of cigarettes
• Resources for detecting and prosecuting smuggling
• Collaboration/communication among customs
  officials around the globe
• License all cigarette exporters, manufacturers
  and distributors, require detailed records
• (Source Joosens, 2001)

32
Licensing

• In addition to its importance as an
  anti-smuggling measure, licensing
• helps governments track tobacco businesses
• can be a powerful enforcement mechanism
• Best practices
• License manufacturers, importers, and
  wholesalers also license retailers, if feasible
• (Source Joosens, 2001)
• Recover government-incurred health and TC costs
  through manufacturer and importer/exporter
  licensure fees

33
Product regulation the evidence

• Manufactured tobacco products are highly
  engineered nicotine delivery devices
• They contain thousands of carcinogenic and toxic
  chemicals
• To enhance flavor
• To enhance nicotine uptake
• To stay lighted (causing fires)
• Cigarettes in different markets have been found
  to contain different levels of tar, nicotine,
  tobacco-specific nitrosamines (TSNAs), etc.
• TSNAs and Polyaromatic hydrocarbons levels can be
  eliminated
• (Sources Hoffmann D, Hoffmann I, and
  El-Bayoumy K. The less harmful cigarette a
  controversial issue. Chemical Research in
  Toxicology, July 2001 14(7)767-90 National
  Campaign for Tobacco-Free Kids. Tobacco fact
  sheet cigarette content and design. National
  Campaign for Tobacco-Free Kids Washington, DC,
  1999)

34
Product regulation and reporting best practices

• Presently, there are no best practices for
• product regulation--WHO SACTOB and
• FCTC COP are charged with providing guidance
• Most governments that regulate tobacco products
  set limits for tar, nicotine and CO BUT
• Current testing methods are flawed and provide
  inaccurate measures for tar, nicotine and CO
• compensatory smoking behavior
• tobacco industrys manipulation of the tests

35
Product regulation best practices, contd

• Result tar, nicotine, and CO levels are
  misleading to consumers
• (Source WHO, SACTOB Recommendation on Tobacco
  Product Ingredients and Emissions, 2002)

36
Product regulation and reporting recommendations

• In the meantime
• Provide broad Ministerial/agency authority to
  regulate tobacco products and to prescribe
  testing methods
• Require reporting by the tobacco
  manufacturers/importers of the constituents and
  additives (existence, levels, functions) in its
  tobacco products, by brand, may help regulators
  and inform the public
• also, reporting of business practices

37
Inspections and enforcement

• For effective inspection and enforcement
• broad inspection and subpoena power
• premises, records, employees, processes, products
• range of penalties
• licensure sanction, fines, jail, forfeiture of
  ill gotten gains and non-compliant products
• clear divisions of authority for inspecting and
  enforcing entities
• private rights of action for citizens and
  citizens groups (if legally and socially
  feasible)

38
Inter-related provisions for tobacco control

• Certain TC topics are inter-related--addressing
  one without addressing the related topic(s)
  creates a loophole the industry readily will
  exploit
• Inter-related topics include
• Advertising, sponsorships, and other forms of
  promotion Package Displays
• Labeling - Packaging
• Tax/Price - Promotion - Packaging Smuggling -
  Labeling Licensing- Packaging (size)
• Inspections- Enforcement-Litigation Enabling
  Provisions (including private rights of action)

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Promotion - Packaging - Sales Displays

• If goal is to eliminate all forms of tobacco
• promotion, we must address
• advertising, sponsorships and all other forms of
  promotion
• why OECD study, industry documents, many
  countries experiences substitution in permitted
  forms
• how comprehensive direct and indirect promotion
  ban
• packaging, lest the packaging itself and
  commercial displays take on the role of
  advertising
• why Industry memos, Uganda example (ad removed
  from billboards put on cigarette packs), S.
  Africa example (5 package displays)
• how commercial package display bans, generic
  packaging

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Example advertising or news?

• Is it advertising or
• news coverage of
• sports?
• Brand stretching
• News as advertising

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Tobacco promotions
This is what happens when advertising is
banned but other forms of promotion are not
Contest Prize Trip to L.A. for fun and adventure
42
Labeling Packaging

• If goal is to eliminate misleading labeling
  (e.g., light and mild), we must also address
• packaging
• why package color schemes replacing light and
  mild descriptors (e.g., Brazil) product and
  package shapes (e.g., long and thin) suggesting
  light
• how generic packaging regulation of package
  design along with labeling

43
Misleading descriptors from labeling to
packaging
Before the ban on misleading descriptors
After the ban
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Tax/Price-Smuggling-Labeling-Licensing

• If goal is to increase the price/tax, we
• must address
• anti-smuggling provisions
• why industry involvement in organized smuggling
• how labeling export bonding and reporting
  requirements
• labeling
• why counterfeiting, falsified documents (e.g.,
  country of destination)
• how country of origin and destination, mfgr
  info, serial/ license numbers, etc. on
  packages/cartons/boxes)

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Tax/Price-Smuggling-Labeling-Licensing, contd

• packaging
• why single stick sales make products more
  affordable
• how minimum pack size
• licensing
• why allows tracking of companies, sanctioning
• how licensing of manufacturers, wholesalers,
  importers, exporters, and retailers, if feasible