10.2. SR 09-08-2015 - Laserfiche WebLink

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E-cigarettes: an evidence update 8 Summary of Chapter 3: UK policy framework 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 that 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. Policy implications o From May 2016, following the introduction of the revised TPD, ECs will be more strictly regulated. As detailed elsewhere in the report, the information we present does not indicate widespread problems as a result of EC. Hence, the current regulatory structure appears broadly to have worked well although protecting non- smoking children and ensuring the products on the market are as safe and effective as possible are clearly important goals. New regulations currently planned should be implemented to maximise the benefits of EC whilst minimising these risks. o An assessment of the impact of the TPD regulations on the UK EC market will be integral to its implementation. This should include the degree to which the availability of safe and effective products might be restricted. o Much of England’s strategy of tobacco harm reduction is predicated on the availability of medicinally licensed products that smokers want to use. Licensed ECs are yet to appear. A review of the MHRA EC licensing process therefore seems appropriate, including manufacturers’ costs, and potential impact. This could include a requirement for MHRA to adapt the processes and their costs to enable smaller manufacturers to apply, and to speed up the licensing process. The review could also assess potential demand for the EC prescription market and what types of products would be most appropriate to meet that demand. Summary of Chapter 4: Prevalence of e-cigarette use in England/Great Britain Adults: Around one in 20 adults in England (and Great Britain) use EC. Current EC users are almost exclusively smokers (~60%) or ex-smokers (~40%), that is smokers who now use EC and have stopped smoking altogether. EC use among long-term ex- smokers is considerably lower than among recent ex-smokers. Current EC use among