MHRA enhanced guidance on medical licensing for e-cigs welcomed by health leaders, clinicians and tobacco experts



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The updated guidance for e-cigarette firms seeking a medicinal licence for their products published today by the Medicines and Healthcare Products Regulatory Agency (MHRA) [1] has been welcomed by health leaders, clinicians and tobacco experts.

Rt Hon Sir Norman Lamb, former health minister and Chair of the Science and Technology Select Committee said,

“As an MP I chaired a select committee inquiry into e-cigarettes which concluded that there would be significant benefit to having medicinally licensed e-cigarettes which could be prescribed. Our committee was particularly concerned about the need for more effective help to quit for those with mental health problems, who have much higher than average smoking rates. I look forward to seeing the first licenced e-cigarette on sale, I am convinced this will be a game changer.”

Professor Alan Boobis, OBE, Chair of the Committee on Toxicity said,

“I believe that in any discussion on public health it is important to include an objective assessment of potential harm. In the debate on the use of e-cigarettes, the Committee on Toxicity has assessed the relative risk from vaping.[2] I think it’s fair to say that using an e-cigarette that meets current consumer standards will be a lot less harmful than smoking cigarettes. Smokers trying to quit can try vaping, without waiting for a medicinally licensed product to go on sale before doing so. However, licensed vaping products will have to meet a defined standard set by the medicines regulator, the MHRA, and in return they will be available to clinicians to prescribe to their patients, which will be an important step forward.

Consumer e-cigarettes bought over the counter are already proven to be an effective quitting aid. In 2017 they are estimated to have helped over 50,000 smokers in England to stop smoking with a vaping product who would otherwise have carried on smoking.[3]  In a stop smoking service setting, where smokers also get behavioural support from clinicians, those randomised to e-cigarettes were found to nearly double their chances of successful quitting compared to those assigned nicotine replacement therapy.[4] However, until there are products with a medicinal licence which can be made available on prescription their potential will not be fully realised.

Deborah Arnott, Chief Executive of ASH said:

“The MHRA guidance opens the door to a day when smokers can be prescribed e-cigarettes to improve their chances of successfully quitting. Just as the MHRA led the world in licensing vaccines for COVID-19, today it is leading the world by backing medicinal licensing of e-cigarettes. This is entirely justified, as the CMO Chris Whitty has pointed out, smoking is likely to have caused more premature deaths in the UK last year than the covid pandemic.[5]  Thanks to vaccines, COVID-19 is being brought under control, but smoking will kill as many people this year as last. With nearly 7 million smokers in the UK [6]  smoking will continue to kill people for many years to come until we make smoking obsolete.[6]

Smokers find it hard to quit, taking on average 30 attempts to succeed [4] which is why we need new tools in the toolbox, such as medicinally licensed e-cigarettes. Consumer e-cigarettes bought over the counter are proven to be the most successful quitting aid, but nearly a third of smokers have never tried them, and a similar proportion believe, wrongly, that e-cigarettes are as, or more harmful, than smoking.[7] These are the smokers who are more likely to try vaping if they had the reassurance provided by a medicines licence and products which are available on prescription.”

Dr Paul Aveyard, GP and Professor of Behavioural Medicine at Oxford, said,

“The evidence is there that e-cigarettes are helping more smokers quit successfully than traditional nicotine replacement therapies such as patches or gum. However, until there is a licensed e-cigarette on the market doctors can’t recommend them as a smoking cessation tool or prescribe them to their patients. Having a prescribable e-cigarette will enable doctors to encourage their patients to use them and increase smokers’ chances of successfully quitting.  This new guidance demonstrates that the MHRA recognises the value of licensed e-cigarettes as a quitting aid, and I hope it will encourage e-cigarette companies to apply to the MHRA for licences for their products.”

Professor Nick Hopkinson consultant physician at the Royal Brompton and medical director at Asthma UK and the British Lung Foundation, said:

“Most of the people that I see in clinic have lung disease which is caused and worsened by smoking. Despite this many still smoke, trapped by an addiction which for almost all of them began in childhood. There is already good evidence that commercially available e-cigarettes enable people to switch away from smoking to a much safer alternative.  However, the development of medicinally licensed e-cigarettes would be a really important step forward, providing patients and healthcare professionals with an additional tool to break dependence on smoking, backed up by the reassurance that comes from a rigorous authorisation process.”

ENDS

Notes to the Editor

Action on Smoking and Health is a health charity working to eliminate the harm caused by tobacco use. For more information see: www.ash.org.uk/about-ash

ASH receives funding for its programme of work from Cancer Research UK and the British Heart Foundation.

Deborah Arnott, Chief Executive of ASH, Professor Alan Boobis and Professor Paul Aveyard were all members of the Commission on Human Medicines e-cigarette expert working group which was responsible for updating the MHRA guidance for licensing electronic cigarettes and other inhaled nicotine-containing products as medicines.

ASH staff are available for interview. For more information send an email to press@ash.org.uk or ring Deborah Arnott (Chief Executive, ASH) on 07976 935 987.

References

[1] MHRA. Guidance for licensing electronic cigarettes and other inhaled nicotine-containing products as medicines. October 2021.

[2] https://cot.food.gov.uk/sites/default/files/2020-09/COT%20E%28N%29NDS%20statement%202020-04.pdf

[3] Hajek, P., A. Phillips-Waller, D. Przulj, F. Pesola, K.M. Smith, N. Bisal, J. Li, S. Parrott, P. Sasieni, L. Dawkins, L. Ross, M. Goniewicz, Q. Wu, and H. McRobbie. A randomized trial of E-cigarettes versus nicotine-replacement therapy. New England Journal of Medicine, 2019. 380(7): p. 629-637

[4]  Hayward E. Professor Chris Whitty attacks ‘kill for profit’ tobacco companies and warns smoking killed 90,000 Brits last year – more than Covid. Daily Mail. 19 May 2021.

[5]  Office for National Statistics (ONS). Adult smoking habits in the UK 2019. July 2020.

[6] Chaiton M, Diemert L, Cohen JE, et al. Estimating the number of quit attempts it takes to quit smoking successfully in a longitudinal cohort of smokers. BMJ Open 2016;6:e011045. doi: 10.1136/bmjopen-2016-011045

[7] ASH. Use of e-cigarettes (vapes) among adults in Great Britain. June 2021.On online survey for ASH carried out In February and March 2021 found that 30.1% of adult smokers aged 18+ had never tried e-cigarettes and 32% of smokers incorrectly believed that e-cigarettes were more than or equally harmful as smoking.