The impending need for e-cigarettes and other non-tobacco nicotine products, either currently on the market or in development, to comply with one of the above regulatory options has significant implications for suppliers of these devices, and for wider public health. Both approaches have significant advantages and disadvantages, which suppliers will have to balance in their decision on which route or routes to pursue. These are as follows.
10.4.1 Medicines licensing
Key advantages to manufacturers who pursue medicines licensing include: > higher consumer confidence in product quality and safety
> relief from TPD limits on nicotine solution concentration and volume > freedom to advertise on TV, radio and in printed media, in line with MHRA
rules12
> freedom to make justified health claims in relation to quitting and harm reduction
> no obligation to carry health warnings informing consumers that nicotine is addictive
> eligibility for use in, and for subsidised prescription through, the NHS > potentially subject to 5% rather than 20% VAT in the UK.
The main disadvantage of medicines licensing is the cost in time and money of the application process itself, and of the much higher manufacturing standards required of medicines. It is understood that the MHRA estimates first application costs at between £252,000 and £390,000, and annual recurring costs at between £65,000 and £249,000 for each product.22In practice, however, it is likely that application costs incurred by companies inexperienced in negotiating this regulatory system may be significantly higher, whereas the additional cost of manufacturing to the medicines standard is estimated at several million pounds.22These financial and related opportunity costs inevitably represent a significant barrier to innovation and market entry for new licensed nicotine products, and favour larger, better resourced entities such as pharmaceutical and transnational tobacco companies. Licensing and presentation of products as medicines may also undermine the perception of e-cigarettes as a consumer rather than a medical product, and hence inhibit experimentation and use. That only one licence has been awarded to an e-cigarette product in the 5 years since the MHRA announced its ‘light touch’ licensing option, despite the rapid growth and hence evident value of the e-cigarette market and verbal reports from
the MHRA that ‘several’ e-cigarette companies had enquired about licensing, indicates that mandatory medicines regulation, had it been imposed as originally intended by the MHRA, would indeed have resulted in a period of several years in which no e-cigarettes were available for sale in the UK. Mandatory medicines licensing, as originally proposed, would therefore have been counterproductive to public health. Given the high product quality and safety standards that medicines licensing guarantees, as well as the option of providing products on prescription to those on low incomes, it is clearly desirable that the range of e-cigarette products available to consumers and health professionals includes some that are licensed as medicines. As recommended elsewhere,22a review of the MHRA licensing process for e-cigarettes, to minimise the extent to which licensing procedures and demands unnecessarily obstruct the progress of new medicinal products to market, is clearly needed.
10.4.2 TPD regulation
At the time of writing, the exact detail of how the proposed TPD regulation will operate has not been published. It appears likely, however, that regulation under the TPD will offer e-cigarettes and other non-tobacco nicotine products a route to market that is less onerous, and hence quicker and less expensive, than medicines regulation.
The principal benefits of TPD regulation to consumers are that they will ensure that products that claim to deliver nicotine actually do so, and therefore that consumers are likely to find them effective, and provide reassurance that toxins and other by-products in vapour are at known and pragmatically low levels, thus protecting consumers from easily avoidable harm. Although it is inevitable that these reporting and performance requirements will impose costs on
manufacturers and importers, these TPD measures appear to be congruent with the basic regulatory objective of ensuring that products are fit for purpose, and reasonably safe.
Other measures imposed by the TPD on e-cigarettes are less overtly constructive, however. The cap on nicotine concentrations may limit the effectiveness of e-cigarettes as a smoking substitute, particularly for heavier smokers. The derogation to member states of limits on the use of flavours, which may be a significant source of oxidant activity in e-cigarette vapour23(see Chapter 5), may result in marked differences in relative potential harm of e-cigarettes available in different member states. Restrictions may also result in non-compliance. The restrictions on e-cigarette marketing, in effect limiting these to the point of sale, billboards, bus stops and other advertising that does not cross borders, limits opportunities for inappropriate promotion of e-cigarettes to non-smokers, including children, but also inevitably inhibits promotion to smokers. However,
as most smokers are aware of e-cigarettes, and word of mouth and social media appear to have been the main drivers of use to date, it remains to be seen whether these advertising restrictions will reduce uptake by smokers. The Scottish Parliament is currently considering going further than the TPD to prohibit all advertising of e-cigarettes in Scotland other than at the point of sale.24
The requirement for nicotine products covered by the TPD to carry a health warning emphasising the risks of nicotine, when licensed nicotine products do not, appears illogical, as does the restriction on statements comparing the relative risks of e-cigarettes and tobacco cigarettes. The health warning required under the TPD provisions may also reinforce misperceptions about nicotine (see Section 10.7 below).
A further concern about TPD regulation is that, although a facility to recall products from the market is written into the legislation, there are no powers to relax regulations if usage and innovation are unnecessarily or inappropriately constrained by them. Despite requiring a review 3.5 years after implementation and at 2-yearly intervals thereafter, the previous EU TPD was not revised for 13 years, which is of great concern because much quicker mechanisms of feedback and revision will be required to maximise the benefits as well as minimise the risks of e-cigarettes. For these reasons, it is clearly important that TPD implementation be closely monitored to assess the extent of unintended, as well as intended, effects on the availability and use of non-tobacco nicotine products and, in particular, the consequences of these effects on tobacco smoking rates; it should also ensure that prompt action be taken if TPD regulation proves to work against, rather than for, the benefit of public health. We therefore recommend annual review in the UK.