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Debate over e-cigarettes heats up as European Parliament tightens rules

Our professional body says e-cigarettes should not be sold in pharmacies and the World Health Organization agrees. The makers do not. Elizabeth Sukkar investigates

The UK e-cigarette market is estimated to be worth about £200m a year, with about half of sales taking place online. This sales distribution is expected to shift to a more traditional retail channel, predicts the analyst group Panmure Gordon & Co.

You cannot get more traditional than the local pharmacy, where these products are now increasingly sold. Multiples such as Boots and Lloydspharmacy have recently started selling e-cigarettes (PJ 2014;292:154), but the Royal Pharmaceutical Society is uneasy about their sale from any pharmacy.

The professional body for pharmacists has taken a stand against e-cigarettes, believing they should not be sold or advertised from pharmacies until there are licensed products available.

We are asking for consensus and support for the original June 2013 intention of the Medicines and Healthcare products Regulatory Agency to regulate e-cigarettes as medicinal products as an aid to smoking cessation only.

Royal Pharmaceutical Society

It is also seeking a consensus on how the profession and pharmacy owners approach the promotion and supply of e-cigarettes. “We are asking for consensus and support for the original June 2013 intention of the Medicines and Healthcare products Regulatory Agency to regulate e-cigarettes as medicinal products as an aid to smoking cessation only.” To this end it has published an updated position statement on e-cigarettes and is actively seeking support for its policy from other health organisations.

The RPS’s stand comes as the European Parliament makes its own position on e-cigarettes known. This week, it voted for a dual supply route for e-cigarettes: they could be regulated, either as medicinal products, if they are marketed as a quitting aid, or alternatively as tobacco products. In the latter case, their nicotine concentration should not exceed 20 mg/ml. Electronic cigarettes should be childproof and should carry health warnings and they would be subject to the same advertising restrictions as tobacco products. But the EU Tobacco Directive still has to be signed off by the Council of Ministers on 14 March and member states will not have to implement it until 2016.

The e-cigarette industry says the proposal could seriously undermine the potential of e-cigarettes as a harm reduction product and many of the proposed limits are disproportionate to the risks. The Electronic Cigarette Industry Trade Association (ECITA) told The Journal that it is considering a legal challenge “when and if” the directive is adopted into national law.

In the meantime, the Society will continue to seek support for its position. Consensus building is hard work, but it appears that government and public health bodies are expressing similar concerns about the safety and quality of e-cigarettes.

A spokeswoman for the Department of Health told The Journal that it “does not endorse the use of e-cigarettes”. She added: “E-cigarettes are new products and, as they contain nicotine, are addictive. It is clear that these products need to be effectively regulated. This issue is still being considered as part of the new European Tobacco Products Directive that is in the final stages of negotiation.”

The Scottish minister for public health, Michael Matheson, backed the RPS. He said: “I share the view that selling or promoting [e-cigarettes] — often owned by tobacco manufacturers — from pharmacies is highly undesirable.” He added that the use of these devices risks normalising smoking behaviours.  

A Welsh Government spokesman told The Journal: “What we don’t want is for e-cigarettes to become a gateway to real cigarettes. The Welsh Government recognises that some smokers have given up tobacco by using e-cigarettes. However, there is, as yet, little published data to substantiate the quality, safety and efficacy of e-cigarettes.”

He added that the Welsh Government advises users to be cautious and urges people to speak to their pharmacist or GP, or contact Stop Smoking Wales, for help to stop smoking rather than rely on e-cigarettes.

WHO: RPS’s stance “very reasonable”

The World Health Organization has also backed the RPS, describing its position statement as “very reasonable”. Armando Peruga, the Tobacco Free Initiative Programme Manager at the WHO, echoed the view that e-cigarettes should not be sold in pharmacies unless they are regulated as pharmaceuticals or medical devices.

He said: “In short, in each country e-cigarettes need to be regulated by an appropriate national regulatory agency to make [them] as safe and as effective smoking quitting system as possible. When these conditions are met, e-cigarettes should not be used in enclosed spaces where smoking is not permitted and their advertising should not be allowed.”

He added that the WHO is concerned that e-cigarettes could be used as a bridge for children and young people to start smoking tobacco or as an additional form of maintaining nicotine addiction among smokers.

Kevin Fenton, director of health and wellbeing at Public Health England, said: “At present there are no licensed e-cigarettes, so Public Health England cannot support the use of these products as an aid to smoking cessation.”

He added that current evidence suggests that e-cigarettes are no more effective than other supported smoking cessation methods, for which there are already substantial safety data.

NICE’s public health guidance also recommends the use of licensed nicotine replacement therapy (NRT) to reduce the harms of smoking to smokers and those around them.

Licensing of e-cigarettes no simple task

A licensed product looks to be months away, according to industry sources, but the MHRA is not divulging timelines. Katherine Devlin, the president of the ECITA, says the delay, despite one company seeking a license in 2010, is “probably in part because [the MHRA has] little idea of how to fit e-cigs into the existing framework — it is a far from simple process.” However, ECITA would welcome a product gaining a licence.

She added: “Despite the fact that such a product would inevitably be crippled by the process, it would at least allow doctors to prescribe e-cigarettes to their patients, who are very likely to then go on and discover the more varied and enjoyable products that will exist outside of the medicines framework.”

It is, however, unfortunate that the first e-cigarette to gain a licence is likely to come from a tobacco company, she states, since only they have the level of funding needed to achieve this. The “independent” electronic cigarette industry is clear in its approach that these are not medicinal products (unless presented as such), as supported by no fewer than seven EU Court cases confirming just that, Ms Devlin says.

ECITA has also rejected the RPS position and is “astonished” that Boots and Lloydspharmacy are selling e-cigarettes made by the tobacco industry (see Panel).

The industry’s view: Pharmacies should sell them 

The Electronic Cigarette Industry Trade Association (ECITA) has rejected theRoyal Pharmaceutical Society’s call for pharmacies not to stock e-cigarettes until they are regulated. Katherine Devlin, its president, said that the RPS position is unfortunate, claiming that it ignores all currently available evidence.

“Sadly, [the RPS] does not appear to be able to recognise that while, in an ideal world, the regulation ofall electronic cigarettes as medicines would make them marginally saferthan they are now, this is simply not practical [because] electronic cigarettes do not fit well within the medicines framework, particularly [with regard] to dose control.”

Because electronic cigarettes areintended to allow users to self-titrate their dosage, they do not have well defined doses, anymore than tobacco cigarettes do, she said. “It isthe customisable aspect that gives electronic cigarettes their broad appeal, and it is this appeal which gives them the opportunity to do what no medicinal product can — appeal to smokers as a safer choice thatthey want to make. Making an electronic cigarette 1 per cent safer, but90 per cent less appealing will not yield significant health gains [because] the danger to smokers is from the smoke; continuing their nicotine use is of trivial risk by comparison.”

ECITA thinks pharmacists should inform themselves as to the potential risks and benefits around the products so they can decide whether or not to sell them. “We are aware of many independent pharmacies who have enhanced theservice they are offering to their customers by carrying electronic cigarette products, alongside the medicinal nicotine replacement therapyproducts, and see no reason why they should not be able to continue to do so.”

She argues that pharmacies are not restricted to selling exclusively licensed medicinal products, and frequently carry a range ofconsumer products. “Indeed, there are good profit margins for them in selling electronic cigarettes as part of their ranges, and we are aware of several independent pharmacies who would not wish to lose this revenue stream.”

As for Boots and Lloydspharmacy selling Fontem’s Puritane and Nicoventure’s Vype e-cigarettes, respectively, she says ECITA is “astonished that two companies with such reputations would seek to associate with the tobacco industry in this way”.

 OTC industry: stick to licensed products

The Proprietary Association of Great Britain pointed out that the recent EU Tobacco Products Directive limits the level of nicotine and the claims that can be made if products are not licensed as medicines. “This means that unlicensed products will not be able to claim they can help people stop smoking. In addition, unlicensed products will be subject to restrictions on advertising and limitations on sales to under 18s and be required to comply with a range of new product related and information requirements,” a spokeswoman for the PAGB said.

The PAGB would like to see the Directive implemented in the UK ahead of the transposition date of 2016 in order to make the benefits of using a licensed nicotine product clear to the public.

Asked if it backed the RPS, the spokeswoman said the PAGB “will discuss the consensus statement in due course”.  

Fontem Ventures, owned by Imperial Tobacco, which makes Boots’s e-cigarette Puritane, has, unsurprisingly, rejected the RPS call for e-cigarettes not to be sold from pharmacies. Its director of communications and corporate affairs, Marc Michelsen, said that the Puritane product uses only “pharmaceutical grade nicotine” produced in the EU and is filled and packed in a UK pharmaceutical facility registered with the MHRA. He would not disclose the manufacturer of the product.

A Boots spokeswoman said that the company already plays a major role in helping people who smoke to cut down or quit smoking tobacco cigarettes, and will continue to do so. “From listening to our customers, we know many people are looking for access to an alternative to smoking tobacco cigarettes, such as e-cigarettes.”

The issue is not confined to the UK. John Chave, secretary general of the Pharmaceutical Group of the European Union, which represents European community pharmacists, says: “Most pharmacists in the EU accept that, where e-cigarettes are classified as medicinal products, they should be available in pharmacies. Under the new EU rules about to be adopted not all e-cigarettes will fall into that category. There is some concern that, although e-cigarettes probably do help quitters, their long-term effects are still not fully understood. This will make some pharmacists reluctant to stock them, especially those which are not regulated as medicines.”

The challenge facing the pharmacy profession, governments and regulators is how to deal with these products until they are regulated. For now, their safety and efficacy has not been demonstrated, so it is no bad thing to be cautious. This would seem to be a reasonable approach given that the WHO says it is “not aware of any decrease of smoking as a consequence of the use of e-cigarettes”.

But there remains the ethical dilemma facing pharmacists who have to deal with requests for these products from patients, some of whom have tried and failed to quit smoking through more conventional means.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2014.11135126

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