- Medical regulator to work with manufacturers to assess safety and effectiveness of products
- Move supports government ambition for England to be smoke-free by 2030 and to reduce stark health disparities in smoking rates
The Medicines and Healthcare products Regulatory Agency (MHRA) is publishing updated guidance that paves the way for medicinally licensed e-cigarette products to be prescribed for tobacco smokers who wish to quit smoking.
Manufacturers can approach the MHRA to submit their products to go through the same regulatory approvals process as other medicines available on the health service.
This could mean England becomes the first country in the world to prescribe e-cigarettes licensed as a medical product.
If a product receives MHRA approval, clinicians could 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. It remains the case that non-smokers and children are strongly advised against using e-cigarettes.
A medicinally licensed e-cigarette would have to pass even more rigorous safety checks than regular products.
The Government notes that smoking remains the leading preventable cause of premature death and while rates are at record low levels in the UK, there are still around 6.1 million smokers in England – plus, there are stark differences in rates across the country, with smoking rates in Blackpool (23.4%) and Kingston upon Hull (22.2%) poles apart from rates in wealthier areas such as Richmond upon Thames (8%).
E-cigarettes were the most popular aid used by smokers trying to quit in England in 2020.
The Departments say: “E-cigarettes have been shown to be highly effective in supporting those trying to quit, with 27.2% of smokers using them compared with 18.2% using nicotine replacement therapy products such as patches and gum.”
Health and Social Care Secretary Sajid Javid said: “This country continues to be a global leader on healthcare, whether it’s our COVID-19 vaccine roll-out saving lives or our innovative public health measures reducing people’s risk of serious illness.
“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.
“Almost 64,000 people died from smoking in England in 2019 and the Office for Health Improvement and Disparities (OHID) is supporting efforts to level up public health and ensure communities across the country have equal health outcomes.
“Reducing health disparities – including in smoking rates – and keeping people in better health for longer is good for the individual, families, society, the economy and NHS. To achieve this overall ambition, OHID will work collaboratively at national, regional and local levels as well as with the NHS, academia, the third sector, scientists, researchers and industry.
“The government will soon publish a new Tobacco Control Plan which will set out the roadmap for achieving a smoke-free England by 2030.”
- MHRA Guidance for licensing electronic cigarettes and other inhaled nicotine-containing products as medicines - https://www.gov.uk/guidance/licensing-procedure-for-electronic-cigarettes-as-medicines