E-<strong>cigarettes</strong>: <strong>an</strong> <strong>evidence</strong> <strong>update</strong>product. This does not include the costs of making m<strong>an</strong>ufacturing facilities <strong>an</strong>d productsMHRA compli<strong>an</strong>t – estimated at several million pounds.At the time of writing one non-EC nicotine inhaler product, Voke, developed <strong>by</strong> KindConsumer, <strong>an</strong>d to be marketed <strong>by</strong> British Americ<strong>an</strong> Tobacco (BAT), had received amedicinal licence, although it is not yet being marketed in Engl<strong>an</strong>d. A further BATproduct (<strong>an</strong> EC) is currently going through the application process. Other EC productsare currently in the pipeline with the MHRA but it is not clear at what stage theapplications are or what types of products, eg cigalikes or t<strong>an</strong>k models, are involved.The absence of a licensed product, five years after the MHRA’s consultation took place,suggests that this route to market is not commercially attractive. The fact that the onlyproduct at the application stage is a BAT product suggests that the process is veryresource intensive. As well as cost, other possible reasons include complexity, a lack ofdesire to engage with medicinal licensing or the MHRA, the entrepreneurial nature ofthe EC m<strong>an</strong>ufacturers <strong>an</strong>d a possible lack of perceived benefits to acquiring a licence.This could be problematic when the EU TPD is implemented, which is likely to constrainthe over-the-counter market. Additionally, having a diverse r<strong>an</strong>ge of EC on prescriptionis likely to be beneficial (similar to nicotine replacement tobacco (NRT) products – whennew products are introduced, <strong>evidence</strong> suggests that they do not c<strong>an</strong>nibalise theexisting NRT product market but instead exp<strong>an</strong>d the use of medications). This me<strong>an</strong>sthat small m<strong>an</strong>ufacturers, particularly non-tobacco industry m<strong>an</strong>ufacturers, who may beproducing a greater variety or more satisfying EC, will not compete with largercorporations such as the tobacco industry in the prescriptions market. There are severalconsequences of this which should be explored. These could include <strong>an</strong> inhibition ofinnovation <strong>an</strong>d damage public health. Alternatively, given the dem<strong>an</strong>d for prescribed ECproducts is as yet unknown, particularly in the population groups where smokingprevalence is elevated, the medicinal route may not impact public health. The appeal ofEC may rest in the fact that they are not medicines. A review of the MHRA licensingprocess for EC, <strong>an</strong>d its likely impact, is recommended.Summary of findingsThe revised TPD will introduce new regulations for EC or refill containers which are notlicensed <strong>by</strong> the MHRA. The cap on nicotine concentrations introduced <strong>by</strong> the TPD willtake high nicotine EC <strong>an</strong>d refill liquids off the market, potentially affecting heaviersmokers seeking higher nicotine delivery products.The fact that no licensed EC are yet on the market suggests that the licensing route tomarket is not commercially attractive. The absence of non-tobacco industry productsgoing through the MHRA licensing process suggests that the process is inadvertentlyfavouring larger m<strong>an</strong>ufacturers including the tobacco industry, which is likely to inhibitinnovation in the prescription market.24
E-<strong>cigarettes</strong>: <strong>an</strong> <strong>evidence</strong> <strong>update</strong>Policy implicationsoooFrom May 2016, following the introduction of the revised TPD, ECs will be morestrictly regulated. As detailed elsewhere in the <strong>report</strong>, the information we presentdoes not indicate widespread problems as a result of EC. Hence, the currentregulatory structure appears broadly to have worked well although protecting nonsmokingchildren <strong>an</strong>d ensuring the products on the market are as safe <strong>an</strong>d effectiveas possible are clearly import<strong>an</strong>t goals. New regulations currently pl<strong>an</strong>ned shouldbe implemented to maximise the benefits of EC whilst minimising these risks.An assessment of the impact of the TPD regulations on the UK EC market will beintegral to its implementation. This should include the degree to which theavailability of safe <strong>an</strong>d effective products might be restricted.Much of Engl<strong>an</strong>d’s strategy of tobacco harm reduction is predicated on theavailability of medicinally licensed products that smokers w<strong>an</strong>t to use. Licensed ECsare yet to appear. A review of the MHRA EC licensing process therefore seemsappropriate, including m<strong>an</strong>ufacturers’ costs, <strong>an</strong>d potential impact. This could includea requirement for MHRA to adapt the processes <strong>an</strong>d their costs to enable smallerm<strong>an</strong>ufacturers to apply, <strong>an</strong>d to speed up the licensing process. The review couldalso assess potential dem<strong>an</strong>d for the EC prescription market <strong>an</strong>d what types ofproducts would be most appropriate to meet that dem<strong>an</strong>d.Prevalence in Engl<strong>an</strong>d / GB25
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