Tobacco Harm Reduction:
Need for a more holistic regulatory framework
Adrian N Payne PhD
Tobacco Horizons
United Kingdom
IHRA Meeting; Liverpool, April 2010
Basics of Tobacco Regulation
Preventing Onset
Promoting Cessation
Protecting Third Parties
Harm Reduction
Reduction of
Death,
Injuries and
Disease
(adapted from Sweanor, 2008)
FCTC - Global Policy Framework
• Entered into force Feb 2005
• Setting agenda for national
tobacco regulatory priorities.
• 168 parties (86.4%).
• 2010-2011 budget US$12.88
million.
• Seeks increased access to
pharmaceutical nicotine, but a
comprehensive “Harm
Reduction” element is absent.
A missed opportunity
100
0
Ris
k r
ela
tiv
e t
o
lit-
en
d c
iga
rett
es
Non lit-end
cigarettes?
Smoke-
free* Pharmaceutical
nicotine
10
Continuum of risk *tobacco products
Gap in the
market
Why are “Smoke-Free” products
so much less harmful? • “Smoke-free” products do not expose the user to
tobacco smoke, which is the main cause for
pathological concern rather than nicotine.
• Every reason to believe and, in the case of snus,
incontrovertible epidemiological evidence to prove,
that they are vastly less harmful than cigarettes.
• Yet in the EU, apart from in Sweden, the sale of
snus is banned and regulatory barriers either exist,
or are being erected, to block the current sale of
“smoke-free” products other than pharmaceutical
nicotine.
Innovative “Smoke-free”
tobacco products
Being test-marketed in the USA
E-cigarettes & cigars
In cross-section
E-pipe
E-cigarette
E-cigar Pictures courtesy of Ruyan
Liquid Cigarette
Picture, data, courtesy “Smoke-Break®”
EU Regulation:
Nicotine-providing products
• A tobacco product?
• A medicinal product?
• A medical device?
• None of the above?
• Directive 2001/37/EC
(FCTC)
• Directive 2001/83/EC
(More time and cost!)
• Directive 93/42/EEC
(Time and cost!)
• Directive 2001/95/EC
?
Net Result?: Consumers may be denied access to vastly
safer nicotine-providing products than cigarettes that also
may be more consumer-friendly than pharmaceutical nicotine
A violation of Human Rights?
Article 27. (1) Everyone has the right freely to
participate in the cultural life of the
community, to enjoy the arts and to share
in scientific advancement and its benefits.
UDHR, 1948
UK: Royal College of Physicians
proposal for regulation • “All nicotine products should be brought under
the control of a single authority tasked to provide
a single, consistent framework which regulates
products in direct relation to their hazard” – Smoked tobacco
– Existing medicinal nicotine products
– New medicinal nicotine products
– Non-medicinal smoke-free nicotine products
• At the very least, a basis for engagement on a
more holistic regulatory framework.
Ending tobacco smoking in Britain: RCP 2008
UK: 2010 Tobacco Control
Strategy “ Although always encouraging smokers to
break their nicotine dependence entirely, we will support smokers to: cut down their levels of smoking before completely quitting; manage their nicotine addiction, using a safer alternative product, when they are unable to smoke; dramatically reduce their health harms, and the harms to those around them, by using a safer alternative to smoking”
A Smokefree Future: A comprehensive
tobacco control strategy for England, 2010
A welcome change from
stigmatisation – doesn’t work!
“...we suggest that stigmatizing smoking will not ultimately help to reduce smoking prevalence amongst disadvantaged smokers – who now represent the majority of tobacco users. Rather, it is likely to exacerbate health-related inequalities by limiting smokers’ access to healthcare and inhibiting smoking cessation efforts in primary care settings”
Bell et al, UBC 2010
Need for Global Consistency
Can TELL Can’t SELL Can SELL Can’t TELL
In summary
• Current approaches to regulation of tobacco and non-tobacco nicotine-providing products are disjointed and counterintuitive to harm reduction.
• “Smoke-free” nicotine-providing products deserve to be evaluated on their harm reduction potential relative to cigarettes rather than just on their absolute safety profile.
• An holistic global regulatory framework covering all nicotine-providing products that recognises a continuum of risk is urgently needed.
• Accurate information on reduced-harm products should be provided to smokers to give them options other than simply “quit or die”.
• But who will take the lead on this??
Thank you www.tobaccohorizons.com