http://www.lexology.com/library/detail.aspx?g=2fd418f1-e1d9-4d19-ac31-e9228c3c2b91
E-cigarettes have become ever more popular since they first appeared on the market in 2007, and regulators have struggled to keep up. There has been much debate about the advantages and risks of using them. Community pharmacy is playing a significant role in the way the debate plays out, because many sell e-cigarettes, yet others regard such sales as unethical.
Increasingly, e-cigarettes are being seen as a positive tool in the ongoing battle to reduce smoking and last year research published by NHS England concluded that e-cigarettes were 95% safer than conventional cigarettes. The Royal College of Physicians published its own report at the end of April 2016 entitled “Nicotine without Smoke – Tobacco Harm Reduction”. The report explains that due to the negative impact on health of smoking tobacco, combined with other undesirable effects such as a reduction in economic productivity, smoking is responsible “for more loss of quality and quantity of life in the UK than any other avoidable cause” and concludes that the use of non-tobacco nicotine products, particularly e-cigarettes, has “huge potential to prevent death and disability from tobacco use.”
The number of people who smoke tobacco has already reduced considerably over recent decades. In 1972 51% of men and 41% of women smoked. By 2014, those figures had reduced to 21% of men and 16% of women. However, even these reduced percentages mean that there are still 8.7 million current smokers in the UK. According to the Royal College, the resulting direct cost to the NHS from smoking related illness is currently exceeds £2 billion each year. Taking into account other associated costs, such as social care and a decrease in economic productivity, the overall annual cost to the tax-payer is estimated to be approximately £14 billion. The Royal College has been involved in reviewing the effect of smoking for many years although, at first there was little enthusiasm at Government level for any real control over tobacco. The College published a report in 1962 identifying tobacco smoking as the main cause in the significant increase of cases of lung cancer, but, it was not until 1998 that a comprehensive tobacco control policy in the UK was published.
Because approaches to reducing the number of smokers have not been wholly successful, together with the fact that nicotine, in itself, is not a highly dangerous drug (although the smoke which is inhaled when smoking tobacco is), has led the Royal College to conclude that the use of e-cigarettes is, on balance, beneficial. This approach is consistent with Public Health England’s research that “While vaping may not be 100% safe, most of the chemicals causing smoking-related disease are absent and the chemicals present pose limited danger.
The views of Public Health England and the Royal College of Physicians will not mean that sales of e-cigarettes will be unregulated. Ministers in Wales attempted, unsuccessfully, to ban e-cigarettes from public spaces this year, and in the UK, the MHRA recently licensed e-Voke as the first e-cigarette to have a licence as a medicinal product, opening up the possibility of vaping on prescription. However, given the costs of obtaining the necessary licence – which the Royal College of Physicians puts at between £252,000 and £390,000 plus annual costs of up to £249,000, this is unlikely to be a particularly popular option, despite the credibility having a licence gives the product.
For those e-cigarettes that do not have a licence, the EU Tobacco Directive will came into force on 20 May. This regulates the content of e-cigarettes and imposes labelling and leaflet requirements. E-cigarettes must not contain more than 20 mg nicotine per ml; there are restrictions on additives; child resistant packaging is mandatory; and information leaflets must include possible adverse effects, addictiveness and toxicity. E-cigarettes must also continue to comply with advertising codes enforced by the Advertising Standards Authority.
Tobacco companies tried to prevent the Tobacco Directive coming into force. In May, the European Court of Justice rejected this challenge, holding that human health requires a high level of protection that descriptions such as ‘low-tar’, ‘light’, ‘ultra-light’, ‘natural’, ‘organic’, ‘without additives’, ‘without flavours’ or ‘slim’, could mislead consumers, by suggesting that the products concerned are less harmful or that they have beneficial effects. An argument by the tobacco companies that their descriptions were helpful to consumers was dismissed by the court, which said the descriptions were “intended more to exploit the vulnerability of consumers of tobacco products who, because of their nicotine dependence, are particularly receptive to any element suggesting there may be some kind of benefit linked to tobacco consumption, in order to vindicate or reduce the risks associated with their habits.”
Despite any residual disquiet about the long term effects of e-cigarettes, it looks as though they are here to stay, and this is reflected in the increasing number of pharmacies which are now selling them.
Charles Russell Speechlys LLP – Rachel Warren