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E-cigarettes have been with us for some time but their use has become prolific in the last couple of years. The debate as to whether they are safe to use, and if they can be a useful tool in helping people to stop smoking, rages on, producing frequent mentions in media reports. The result of this is that it can be difficult to keep track of the current thinking on the safety and benefits, or otherwise, of e-cigarettes and this is an important consideration for the many pharmacy businesses which sell them.
E-cigarettes are currently unregulated. However, this will change in 2016 when the majority of the provisions of the 2014 European Commission’s revised Tobacco Product Directive come into force in the UK. This change to the legislation will require manufacturers and importers of e-cigarettes to provide certain information. This will include a list of ingredients and emissions; information about the nicotine dose and toxicological data. The UK will also be required to ensure that packets of e-cigarettes, together with refill containers, include an information leaflet which provides instructions for use and storage and information about contraindications. The changes will also require all outer packaging to display a health warning. Until the new rules come into force, where appropriate, the MHRA is trying to encourage manufacturers to apply for a marketing authorisation under the legislation which governs medicinal products and medical devices. Doing this will bring manufacturers within the existing regulatory framework in the UK.
Although e-cigarettes are not yet licensed, they can be advertised, and in November 2014 changes were made to the rules governing their advertising. As a consequence, adverts on television can now show e-cigarettes, although there are restrictions on when the adverts can be shown, the age of the actors, and who they can be aimed at. Indeed at the end of December 2014 there were news reports about three adverts having been banned by the Advertising Standards Authority on the grounds that two of them glamorised the use of e-cigarettes in a way that indirectly promoted the use of tobacco, and that the third could encourage non-smokers to use e-cigarettes. The new rules will be reviewed in 12 months and, in addition, the revised Tobacco Product Directive contains restrictions on the advertising of e-cigarettes which will come into force in due course.
There have been many reports in the media about the possible benefits and risks of e-cigarettes. For example, the World Health Organisation issued a report in August 2014 in which it concluded that there was insufficient evidence to confirm whether the use of e-cigarettes helped people to stop smoking, or not, and that until further studies had been carried out steps should be taken to address health concerns such as banning their use indoors. A Cochrane Review published in December 2014 concluded that evidence from previous studies suggested that the use of e-cigarettes may help smokers to stop smoking in the long term. However, the authors pointed out that the results needed to be treated with caution in view of the limited number of studies which had been carried out, and the limited number of participants.
Many pharmacies sell e-cigarettes, as doing so is not prohibited. However, due to the possible dangers of un-regulated products being sold in the UK, pharmacy representative bodies have urged pharmacists to take a cautious approach when deciding whether or not to sell them. For example, the Royal Pharmaceutical Society has said that once e-cigarettes are regulated, pharmacists can supply them confident in the knowledge that they will be safe, and that they will meet the necessary standards. This advice has been echoed by the Royal Pharmaceutical Society of Northern Ireland which has published an open letter to pharmacists in which they are reminded to make the “safety and welfare of patients your prime concern” when deciding whether to sell e-cigarettes. The GPhC has said that whether or not to sell e-cigarettes is a matter for a pharmacist’s professional judgment. However, the regulator has also indicated that when making this decision, it will expect pharmacists to have consulted available guidance, such as that issued by the RPS and MHRA.
So, until the Tobacco Product Directive comes into force in the UK, it will be up to pharmacists to make their own decision about whether or not to sell e-cigarettes. However, in light of the views expressed by the GPhC those who decide to do so should be prepared to be able to justify their decision, if necessary, and should keep a careful eye on any updates to relevant guidance published by the GPhC, RPS and MHRA, in case the position regarding the safety or efficacy of e-cigarettes should change.
The above is a general overview and we recommend that independent legal advice is sought for your specific concerns. Please contact Rachel Warren at firstname.lastname@example.org if you have any queries. Rachel Warren is a Solicitor and Senior Associate in the Healthcare Team at Charles Russell Speechlys