Vapouround magazine Issue 02 | Page 31

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