The Medicines and Healthcare products Regulatory Agency (MHRA) has published updated guidance that could allow e-cigarette products to be prescribed to people who want to stop smoking.
This would mean England becoming the first country in the world to prescribe e-cigarettes as a licensed medical product.
Manufacturers can submit their products to MHRA to go through the same regulatory approval process as other medicines available on the NHS. To be granted a licence, products need to meet the ‘standards of quality, safety, and efficacy expected of medicinal products’, says MHRA. If a product is approved, clinicians can then decide on a case-by-case basis whether it would be ‘appropriate to prescribe an e-cigarette to NHS patients to help them quit smoking’, says the Department of Health and Social Care (DHSC). The NHS would still only be able to prescribe e-cigarettes when NICE recommends them for use, DHSC adds, and children and non-smokers are still ‘strongly advised’ not to use the products.
Although smoking rates in the UK are now at record low levels, there are still more than 6m smokers, with smoking rates approaching a quarter of the population in areas such as Blackpool or Kingston upon Hull, compared to less than 10 per cent in Richmond upon Thames. Just under 64,000 people died from smoking in England in 2019.
While e-cigarettes – which are used by an estimated 3.6m people and are far more popular than nicotine patches or gum – are ‘not risk free’, says DHSC, ‘expert reviews from the UK and US have been clear that the regulated e-cigarettes are less harmful than smoking’. Medicinally licensed e-cigarettes would have to pass ‘even more rigorous safety checks’, it adds. There is no consensus among healthcare agencies on the products, however, with WHO’s position continuing to be that e-cigarettes are harmful to health.
‘The updated guidance on licensing requirements we have published today is a strong first step towards availability of safe and effective licensed e-cigarette products,’ said MHRA chief executive Dr June Raine. ‘The MHRA will continue to support companies in the development of safe and effective e-cigarette products, to encourage the licensing of e-cigarette products as medicines in order to support patient-centred care and access. The evidence is clear that e-cigarettes are less harmful to health than smoking tobacco and that nicotine-containing e-cigarettes can help people quit smoking for good.’
‘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’, added health and social care secretary, Sajid Javid.
Guidance for licensing electronic cigarettes and other inhaled nicotine-containing products as medicines here.