Transcript What’s on the Global Regulatory Horizon?

US/World Regulatory
Overview
Adrian N Payne PhD
Tobacco Horizons
TMA Conference, Williamsburg May 2009
Basics of Tobacco Regulation
Preventing Onset
Promoting Cessation
Protecting Third Parties
Reduction of
Death,
Injuries and
Disease
Harm Reduction
(adapted from Sweanor, 2008)
Tobacco Control Scale 2007*
Rank
Country
Price P. Place P. info
Bans
spend
(Europe) (30)
(22)
(15)
Adv.
Bans
(13)
Health
TreatWarnings ment
(10)
(10)
Total
(100)
1
UK
30
21
15
11
6
10
92
2=
Ireland
23
21
3
12
6
9
74
2=
Iceland
22
17
14
13
6
2
74
4
Norway
22
17
4
13
6
4
66
5
Malta
22
17
3
12
7
1
62
6
Sweden
19
15
1
13
6
7
61
7
France
21
12
3
11
6
6
59
8=
Finland
17
12
2
13
7
7
58
8=
Belgium
16
13
3
12
9
5
58
10
Italy
17
17
1
10
6
6
57
30
Austria
13
4
0
9
6
3
*Joossens, L & Raw, M, 2007
35
UK - a comprehensive approach
£5.78
£5.85
UNDER
18 yrs
(£51m)
(£51m)
Smoking Prevalence (Adults) %
But likely diminishing payback
‘Outlook hazy for smoking rates in the USA’
(Lancet, April 25th 2009)
Year
Note: Value for UK 1999 is estimated
Harm reduction - so far unexploited
Risk relative to
lit-end cigarettes
100
50
Non lit-end
cigarettes?
E-cigarettes???
Smokeless
Medicinal
tobacco
nicotine
10
0
Continuum of risk
FCTC - Global Policy Framework
• Entered into force in
February 2005
• Setting agenda for
national tobacco
regulatory priorities
• 168 signatories (inc. USA)
• 164 parties (but not USA)
• 2010-2011 budget of
US$12.88 million
Timelines 1995-2009
FCTC
Development
Feasibility
Public
Hearings
Drafting
Adoption
INB
Meetings
COP1
Into Force
COP3
COP2
95 96 97 98 99 00 01 02 03 04 05 06 07 08 09
FDA
Claims
Authority
MSA
McCain
S. 1415
FDA/HHS
FDA
Authority
Invalidated
107th-109th
Congress:
Various Acts
Introduced
Waxman
H.R. 1108
Waxman
H.R. 1256
FCTC vs. FDA/HHS Legislation
SUPPLY
DEMAND
FCTC Topic Area
FDA/HHS?
Price and Tax Measures
NO
Second Hand Smoke Exposure
Regulation of contents
Regulation of disclosures
NO
YES
YES
Packaging/labelling
Education and training
Advertising, promotion, sponsorship
Cessation
Illicit trade
Sales to/by minors
Alternative activities to growing tobacco
YES
YES
YES
YES
YES
YES
NO
Tax hikes and ‘user fees’
(used under licence from Caglecartoons.com)
FDA/HHS Expert Committee
•
•
•
•
•
•
Tobacco Products Scientific Advisory Committee
12 members
7 from Public Health
1 Government employee
1 representative of the general public
2 representatives of the interests of the
tobacco manufacturing industry*
• 1 representative of the interests of tobacco
growers*
* consultants, nonvoting; H.R. 1256
FCTC - no role for Tobacco Industry
‘Parties should not allow any
person employed by the
tobacco industry or any
entity working to further its
interests to be a member of
any government body,
committee or advisory group
that sets or implements
tobacco control or public
health policy’
(Article 5.3 Guidelines)
Product advertising a touchstone
(used under licence from Cagle cartoons.com)
FDA/HHS : Restrictions FCTC: Elimination
FCTC definition of advertising
• Communications through audio, visual or
audiovisual means
• Brand marking, stretching, sharing
• Display at point of sale, vending machines
• Internet sales
• Retailer incentives
• Supply of free-samples
• Corporate Social Responsibility Activities
• Etc, etc…… (FCTC Art.13 Guidelines appendix + Article 16)
Harm Reduction Elements
WHO FCTC
FDA/HHS (H.R.1256)
Product Regulation
Product Regulation
(Articles 9 &10)
?
Product Innovation
?
Communication
Impact on FCTC Working Groups?
Working
Groups
Articles
9 &10
Article
12
Article
14
Articles
17&18
Subject
Area
Product
Education; DependContents & Comms;
ence &
Disclosure Training;
Cessation
Awareness
Alternative
activities;
Protection
of ENVRMT
Key
facilitators
Canada
EU
Norway
Germany
Palau
Sweden
Turkey
Iran
Uruguay
Brazil
Greece
India
Mexico
Partners
21 others
26 others
36 others
14 others
COP4
(Q4/10)
Draft
1st Set of
Guidelines
Draft
Guidelines
Progress
Report
Progress
Report
WHO Study Group on Tobacco
Regulation (TobReg)
•
•
•
•
•
•
•
Ashley
Burns
Costa e Silva
Djordevic
Gray
Hammond
Henningfield
•
•
•
•
•
•
Jarvis
Opperhuizen
Reddy
Robertson
Ayo Yusuf
Zaatari (Ch)
(membership as at 21/04/2009)
The sixty-four-thousand-dollar
question
What might happen
if/when the US ratifies*
the FCTC?
*Would require floor action in the Senate
Framework Convention Alliance
Mission
…..to perform the
watchdog function for the
WHO FCTC; to develop
tobacco control capacity particularly in developing
countries; to support the
development, ratification,
accession, implementation
and monitoring of the
FCTC; …
US Members
•
•
•
•
American Cancer Soc.
American Heart Assoc.
American Lung Assoc.
American Medical
Assoc.
• ASH
• CTFK
• + 21 others including
the RWJF & SRNT
NUMBER OF MEMBER STATES
The future – WHO Targets
Source: WHO Medium-Term Strategic Plan 2008-2013 (Amended Draft )
Bans - from smoking to smokers?
‘SMOKE FREE’
‘SMOKE SAFE’
NO SMOKERS
‘Third-hand’ smoke
NO SMOKING
‘SMOKER FREE’
‘SMOKER SAFE’
Denormalisation - Desocialisation
FCTC on Advertising - No Logo?
‘Parties should consider
adopting measures to
restrict or prohibit the use of
logos, colours, brand
images or promotional
information on packaging
other than brand names and
product names displayed in
a standard colour and font
style (plain packaging)’
[Art.11 Guidelines, Art.13]
20 Cigarettes
To recap
• Evidence that impact of orthodox tobacco
regulation on smoking prevalence is waning
• ‘Harm reduction’ so far largely unexploited
• FDA/HHS* proposed legislation largely
overlays FCTC, but is not fully compliant
• FDA/HHS* factors in harm reduction, but
barriers to innovation and communication
• Global acceleration and widening of scope of
bans on smoking and advertising/sponsorship
• Potential commoditisation will likely become a
major challenge for the tobacco industry
*H.R.1256
Thank you
www.tobaccohorizons.com
Disclosure of interest: ANP receives a pension from, and holds shares in, British American Tobacco (a
manufacturer of tobacco products) and GlaxoSmithKline (a manufacturer of stop smoking medicines).
Copyright: Material copyrighted by others has been used in this presentation either with permission or
under a claim of ‘fair use’. All other material © Tobacco Horizons 2009.