NEWS
By Dr. Christopher Proctor,
Chief Scientific Officer,
British American Tobacco
process for establishing reduced exposure and risk for a
potential modified risk tobacco product. But the US is not
the only jurisdiction to recognise the potential of tobacco
harm reduction. In the UK, for example, while there is no
equivalent to the FDA Center for Tobacco Products, there
is general support for tobacco harm reduction and the
policy decision to promote harm reduction is seen as an
important part of regulatory efforts to reduce the health
burden of tobacco use.
In 2013, the UK National Institute for Clinical Excellence
(NICE) issued guidance on tobacco harm reduct ion. NICE
is the agency that provides guidance for the UK National
Health Service. At the time, Professor Mike Kelly, Director
of the NICE Centre for Public Health, said: “This is the
first time anywhere in the world that national guidance will
endorse cutting down on smoking with the help of licensed
nicotine products.”
As far as regulation goes, in the UK, electronic cigarettes
are currently subject to consumer product regulation
only. But there is the option to voluntarily apply to the UK
Medicines and Healthcare Products Regulatory Agency
(MHRA) for a medicines licence. In 2014, the UK company
Kind Consumer working with Nicovations Limited, part of
the British American Tobacco group of companies, was
granted a medicines licence for the Voke nicotine inhaler.
Voke is not an electronic cigarette. The MHRA licence for
Voke was transferred from Kind Consumer to Nicovations
‘In a situation where
the new products are
competing with a dangerous
established incumbent,
cigarettes, too much
regulation of the wrong
type can amount to a
regulatory protection of
the product that all agree
to be the most harmful’.
in April 2015. Nicovations has an exclusive licence in
respect of this technology. To date, the licence granted by
the MHRA in the UK for Voke is the only one granted for a
nicotine inhaler the size and shape of a cigarette.
From mid-2016, electronic cigarettes containing up to
20mg/ml of nicotine will be regulated in the European
Union under national implementations of the revised
EU Tobacco Products Directive. Above that level, or if
manufacturers or importers decide to opt into medicines
regulation, such products will require a medical licence in
the same way as over-the-counter nicotine replacement
therapy (NRT). Reduced risk tobacco and nicotine
products could transform the public health impact
of conventional cigarettes by offering adult smokers
substantially less risky tobacco and nicotine products.
Tobacco harm reduction is a major potential opportunity for
public health and business interests alike, but can only be
delivered by products that smokers want, that work, and
that are at an acceptable price, underpinned by research
characterising their reduced risk potential, and supported
by regulators willing to set policies to encourage the uptake
of reduced risk products. As Clive Bates said: ‘In a situation
where the new products are competing with a dangerous
established incumbent, cigarettes, too much regulation
of the wrong type can amount to a regulatory protection
of the product that all agree to be the most harmful. It is
imperative to avoid that error3’.
VAPOUROUND MAGAZINE WINTER EDITION 27