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

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o

lit-

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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