E-cigarettes an evidence update A report commissioned by Public Health England

E-cigarettes: an evidence updateproduct. This does not include the costs of making manufacturing facilities and productsMHRA compliant – estimated at several million pounds.At the time of writing one non-EC nicotine inhaler product, Voke, developed by KindConsumer, and to be marketed by British American Tobacco (BAT), had received amedicinal licence, although it is not yet being marketed in England. A further BATproduct (an 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 tank 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 manufacturers and 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 range of EC on prescriptionis likely to be beneficial (similar to nicotine replacement tobacco (NRT) products – whennew products are introduced, evidence suggests that they do not cannibalise theexisting NRT product market but instead expand the use of medications). This meansthat small manufacturers, particularly non-tobacco industry manufacturers, 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 an inhibition ofinnovation and damage public health. Alternatively, given the demand 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, and its likely impact, is recommended.Summary of findingsThe revised TPD will introduce new regulations for EC or refill containers which are notlicensed by the MHRA. The cap on nicotine concentrations introduced by the TPD willtake high nicotine EC and 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 manufacturers including the tobacco industry, which is likely to inhibitinnovation in the prescription market.24