On 16th November 2015 a new milestone in the e-cigarette world was reached: the first electronic cigarette was licensed as a medical product. But it never made it to market. We wrote about the product back in 2015 – and now, with the recent announcement by Public Health England, we take a refresh look at the product and the potential of medicinal e-cigs.
E-Voke, manufactured by British American Tobacco-owned Nicovations, was granted a Marketing Authorisation by the UK medicines regulatory authority, the MHRA. The authorisation – or licence – would have allowed the product to be prescribed by doctors and available on the NHS.
e-Voke was similar to the ‘ciga-like’ device. It comprised a battery unit, vaporiser and cartridge. The cartridge held the nicotine, glycerol and water solution within a polyurethane foam matrix. There were no flavourings.
e-Voke was similar to the ‘ciga-like’ type pictured
e-Voke was categorised by the MHRA in the group of medicines called Nicotine Replacement Therapy (the same as Nicorette Inhaler). Specifically, the device had been approved to:
e-Voke was also approved for use by pregnant and lactating women to help them quit smoking.
Difficult to say but to achieve medical product status, Nicovations, must have been able to show – through clinical trials – that the product could help users to quit smoking. Given there were no flavourings it probably didn’t taste great – especially in comparison with full favour TPD compliant products.
No. The company did not take the product through the final regulatory processes to make the product available on the NHS and it looks like now they never will.
No, the product never made it to the consumer market but it was probably always only intended for the medicinal category. Due to the strict design requirements of medicine regulation, the simple ‘ciga-like’ design would have the best chance of approval.
Obtaining medical status for any product is quite an achievement – it can take years and can cost millions – and more so for this type of product, given the novelty factor.
Nicovations is the medical product arm of British American Tobacco (BAT). The company is not new to the regulatory process for medicines. In September 2014 they received approval for Voke, a non-electronic cigarette that functions in a similar way to the Nicorette Inhalator.
Public Health England (PHE) recently published their findings on a review of e-cigs. As part of their review, they looked at the use of e-cigs among the youth, public perceptions of vaping, e-cigs efficacy in helping smokers quit and the health risks. An extract of some of the findings are below:
The PHE also believes: “there is compelling evidence that e-cigarettes be made available to NHS patients.”
This is difficult to predict but some factors that may play a part are explored below:
If a medicinal e-cig was available, a smoker looking to try e-cigarettes would have the option to choose a product, which has met quality, safety and efficacy standards equal to medicines. On this basis alone, it could have lead to an improved confidence in e-cigs in general and boosted sales of non-medicinal e-cigs.
Despite the medical status, the shear number of regulations that apply to medical products would adversely affect the design of the medicinal e-cig (flavours, voltage and other customisations) and palatability. It is unclear if the limited design features of a medicinal e-cig would meet needs of the majority of smokers/vapers.
One key benefit, a medicinal e-cig has over a regular e-cig, is advertising. There are fewer advertising restrictions for medicinal products: unlike standard TPD e-cigs, T.V and radio advertising is allowed for non-presciption (‘over the counter’ or OTC) medicines. It is unclear if medicinal e-cigs could achieve this status but considering other nicotine replacement therapies are OTC it has a good chance.
It is unclear if a medicinal e-cig, with its medical status and the associated advertising benefits, could take a significant share of the e-cig market. However, with pressure from health bodies, such as the recent announcement from Public Health England, and developments in government policy, the MHRA could change the way they regulate medicinal e-cigs. They could make allowances for medicinal e-cigs and relax some of the strict requirements. It could pave the way for a more palatable medicinal e-cig: this would be a real game changer.