10.2. SR 09-08-2015 - Laserfiche WebLink

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E-cigarettes: an evidence update 24 product. This does not include the costs of making manufacturing facilities and products MHRA compliant – estimated at several million pounds. At the time of writing one non-EC nicotine inhaler product, Voke, developed by Kind Consumer, and to be marketed by British American Tobacco (BAT), had receive d a medicinal licence, although it is not yet being marketed in England. A further BAT product (an EC) is currently going through the application process. Other EC products are currently in the pipeline with the MHRA but it is not clear at what stage the applications 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 only product at the application stage is a BAT product suggests that the process is very resource intensive. As well as cost, other possible reasons include complexity, a lack of desire to engage with medicinal licensing or the MHRA, the entrepreneurial nature of the 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 constrain the over-the-counter market. Additionally, having a diverse range of EC on prescription is likely to be beneficial (similar to nicotine replacement tobacco (NRT) products – when new products are introduced, evidence suggests that they do not cannibalise the existing NRT product market but instead expand the use of medications). This means that small manufacturers, particularly non-tobacco industry manufacturers, who may be producing a greater variety or more satisfying EC, will not compete with larger corporations such as the tobacco industry in the prescriptions market. There are several consequences of this which should be explored. These could include an inhibition of innovation and damage public health. Alternatively, give n the demand for prescribed EC products is as yet unknown, particularly in the population groups where smoking prevalence is elevated, the medicinal route may not impact public health. The appeal of EC may rest in the fact that they are not medicines. A review of the MHRA licensing process for EC, and its likely impact, is recommended. Summary of findings The revised TPD will introduce new regulations for EC or refill containers which are not licensed by the MHRA. The cap on nicotine concentrations introduced by the TPD will take high nicotine EC and refill liquids off the market, potentially affecting heavier smokers seeking higher nicotine delivery products. The fact that no licensed EC are yet on the market suggests t hat the licensing route to market is not commercially attractive. The absence of non-tobacco industry products going through the MHRA licensing process suggests that the process is inadvertently favouring larger manufacturers including the tobacco industry, which is likely to inhibit innovation in the prescription market.