IBVTA welcomes new MHRA guidelines
The MHRA have today updated their guidance on how to licence electronic cigarettes as medicines in the UK. The key changes made relate to guidance on the quality standards for dose uniformity, non-clinical toxicological data requirements, and the design of the clinical pharmacokinetic studies. The updates also reflect changes to the regulatory environment post-Brexit. The IBVTA hopes that these changes might significantly lower the barrier to independent vape businesses considering applying for medicinal licensing, as this was previously set too high to be realistically achievable.
E-cigarettes and vaping products regulated as consumer products are currently the UK’s most popular, cost effective, and effective tools used by smokers to quit. Recent trials have found that vaping can be more than twice as effective as NRT in helping smokers to quit.
The majority of this success comes from smokers having a wide variety of products, flavours and nicotine strengths to choose from. The route for a medicinally licenced product has previously been hindered by costs and the timescales involved, added to the risk that reduced customer choice of products would make it less attractive, and thus less effective for as many smokers to make the switch.
While the new guidance could mean that England becomes the first country in the world to make e-cigarettes available on prescription, any licenced product would require approval from the National Institute for Health and Care Excellence (NICE). Doctors could then make a choice whether to prescribe it to someone who is looking to stop smoking.
Speaking on the announcement, Health Secretary Sajid Javid said: “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.”
Prof Peter Hajek, Director of the tobacco dependence research unit at Queen Mary University of London, said: “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.”
Prof Robert West, Professor of Health Psychology, Department of Behavioural Science and Health, UCL, said: “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.”
Gillian Golden, IBVTA Chief Executive said: “The IBVTA welcomes the Health Secretary’s recognition that vaping plays a vital role in reducing smoking rates. The independent vape industry is a UK success story, enabling us to have become the global leader in vaping and harm reduction. Our members are already providing a choice of vaping products to a number of stop smoking services, NHS trusts and smoking cessation projects which call for quality, affordable products, supplied by businesses that are not affiliated with the tobacco industry.
The IBVTA looks forward to working with the MHRA to ensure that reputable independent businesses can effectively participate in this important new initiative.”