A number of newspapers have reported on Friday’s announcement by the Secretary of State for Health, Sajid Javid, that medicinal licensing of e-cigarettes may be more of a possibility after guidance was changed by the Medicines and Healthcare products Regulatory Agency (MHRA). The story appeared on the front page of no fewer than four national dailies.
While this is a ground-breaking policy proposal, and rightly described as world-leading by Mr Javid, there is much more to it than the media headlines suggest. Social media has been abuzz with a diverse range of opinions on what this entails so here is an explainer.
Firstly, this is not a change in current policy, nor is it an instant guarantee that doctors will begin to prescribe vaping products. Instead, it is billed as a streamlining of the process by which the MHRA would accept a vaping product to be licensed for medicinal purposes. You can read the new guidelines on the MHRA site here.
It is important to note here that if you smoke and want to stop, there is no need to wait for a vape on prescription, not least because the Under-Secretary of State estimated in parliament yesterday that the process from application to approval would take 18 to 24 months. Go into your local vape shop now and ask for help to choose a product that’s right for you. They’ll be happy to help
There have been regular calls in recent years by public health bodies for the MHRA to make it easier for manufacturers to register a product for this purpose. Regulations are incredibly strict which has severely deterred companies from pursuing this route. The only products gaining approval up to now were those submitted by a tobacco company which never made it to market, presumably to test the system. The new guidance seeks to address this by lowering those barriers.
There is some uncertainty if this will be the outcome as the MHRA has placed a number of conditions on measuring nicotine delivery which are unrealistic, but presumably those matters will be ironed out at some point, or the proposal will fail at the first hurdle.
Consumers will rightly be concerned as to how this will play out. Considering the long-term stated ambition of some public health groups to see e-cigarettes medicinally regulated, there will understandably be a level of suspicion at this new development. Consumers who fought the EU Tobacco Products Directive nearly a decade ago will remember that medical licensing was the primary aim for many health groups in this and other member states and resisting it was a focus for early adopters of reduced risk products in the UK who subsequently set up the NNA to speak for the rights of consumers here.
The issue of value for money must also be addressed. The National Institute for Health and Care Excellence (NICE) assesses whether the taxpayer is best served by interventions supplied by prescription on the NHS, and it is not yet known what their view may be on this announcement.
There is then the selling of the idea to GPs and health practitioners who may be resistant. This is no easy task considering a survey commissioned by Cancer Research UK two years ago revealed significant reluctance to endorse vaping due to perceived doubt about long-term effects.
Consumers, in general, would agree that a prescribed product will most likely be bland and uninspiring due to precautionary barriers imposed by authorities; that smokers are quite able to cover the cost of a starter kit considering the high price of cigarettes (a reaction widely held on social media); and that smokers do not consider themselves ill so why the need for a medicine?
On the other hand, for many less well-off smokers – of which there are many due to prevalence being overwhelmingly amongst lower socioeconomic groups – the risk of spending even the modest outlay for a starter kit will prove prohibitive if they are unsure if it will work for them. While the NNA has written regularly of the need to abandon the upper nicotine limit of 20mg/ml for e-liquid now we have left the EU, there has not been any movement by government so far to change that and we know that heavier smokers require the higher kick than 20mg can provide. Medical licensing may afford an option for strengths higher than those available as consumer products.
It could also provide assurance to sceptical GPs and other medical staff that vaping is nothing to be afraid of for smokers looking to quit. This is important as where doctors lead on health issues, history tells us that the public tends to follow.
As consumers, we should be very wary of this proposal being employed by public health organisations to insist that it is the only way of bringing vape products to market. Vaping products and accessories should continue to be sold as consumer products under a twin-track approach, as recommended by PHE since 2014. It is also important that the sale of other safer nicotine options such as nicotine pouches and heated tobacco are not restricted or encumbered by the new policy.
And snus, as we have consistently advocated, should be legalised at the first opportunity to correct the indefensible mistake made by the UK and the EU to ban its sale in the 1980s and 1990s.
On a political level, Mr Javid’s announcement and support for vaping is very good news. It re-emphasises that government and NHS support e-cigarettes as a harm reduction strategy. The message coming directly from the Secretary of State for Health is also a timely reminder that the UK delegation to the WHO FCTC’s Conference of the Parties (COP9) meeting in early November should resist any efforts by anti-vaping activists to impose binding bans or restrictions on vaping products. We trust they will take heed and do so.
While the media headlines were overly simplistic, this proposal is a positive one, albeit one which poses more questions than it provides answers. It is a development to be welcomed but progress towards it should be watched with care.