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England Could Be First to Allow e-Cigarettes on Prescription

Vaping is already promoted as being a safer alternative to tobacco cigarettes, but the Medicines and Healthcare products Regulatory Agency (MHRA) is now considering licensing the devices for use in smoking cessation.

That could mean England becomes the first country in the world to prescribe e-cigs to help reduce smoking rates, if devices are supported for NHS funding by the National Institute for Health and Care Excellence (NICE).

The Department for Health and Social Care acknowledges that vapes can still contain nicotine but says US and UK evidence suggests that regulated electronic cigarettes cause less harm than smoking tobacco.

Vapes or e-cigarettes have already become the most popular method among people wanting to quit smoking, used by 27.2% compared with 18.2% using patches, gum, and other nicotine replacement therapy products.

To obtain medical approval, devices would have to undergo tougher assessments than the current general sale approval.

England's Health and Social Care Secretary, Sajid Javid, said in a statement: "Opening the door to a licensed e-cigarette prescribed on the NHS has the potential to tackle the stark disparities in smoking rates across the country, helping people stop smoking wherever they live and whatever their background."

'Major Development'

"Having a medically licensed e-cigarette available for prescription would be a major development, so any move by the MHRA to make that more likely is welcome," said John Britton, emeritus professor of epidemiology, University of Nottingham.

He is among experts commenting via the Science Media Centre. He continued: "However, e-cigarette manufacturers have had the option to apply to the MHRA for a medicine license for years, but the costs of compliance with medicines regulations have been prohibitive and none has yet come to market. That's why a bespoke regulatory system for all nicotine products, that allows market access and endorsement by health professionals in inverse proportion to health hazard, is urgently needed. Otherwise, tobacco will remain the default choice of the more than six million smokers in the UK."

Professor Linda Bauld, Bruce and John Usher chair in public health, University of Edinburgh, said: "This is excellent news. While there is good evidence that e-cigarettes available as consumer products can help smokers to quit, we also know that up to 1 in 3 smokers in the UK has not tried these devices. Smokers have concerns about safety and misperceptions about the relative risks of e-cigarettes compared with tobacco. For some, cost is also perceived as a barrier. The option of having approved devices that could be prescribed would reassure smokers about relative risks and also assist in reaching those least able to afford e-cigarettes."

Tobacco Industry Involvement?

Professor Peter Hajek, director of the Tobacco Dependence Research Unit, Queen Mary University of London, said: "I have an ambivalent take on this. On the one hand, the initiative provides a positive message that e-cigarettes are much less risky than smoking and help smokers quit. On the other hand, I am not sure that medicinal licensing of e-cigarettes is a good idea as it is likely that only the tobacco industry will be able to face the costs that medicinal licensing entails, and they may only want products that will not endanger their core business. Smokers are more likely to benefit from e-cigarettes if they can select flavours, strengths, and products that they like, rather than being limited to whatever becomes licensed. It also does not seem necessary for the NHS to pay for something that smokers are happy to buy themselves.

"Overall, it would seem easier to just recommend existing products which are well regulated by consumer protection regulations. There is sufficient evidence available now that these products are effective and dramatically reduce the risks of smoking."

Robert West, professor of health psychology, Department of Behavioural Science and Health, UCL, said that "the regulatory hurdles to be overcome for a product to be licensed are still huge and I am not confident that any e-cigarette manufacturer that is independent of the tobacco industry will have the resources to overcome these hurdles. This could very easily lead to a situation where tobacco company e-cigarettes with limited effectiveness can be prescribed while much better ones cannot. In my view, no healthcare provider should prescribe an e-cigarette produced by a tobacco company."