This is my letter….

Anna Soubry MP

Parliamentary Under Secretary of State for Public Health

Department of Health,

Richmond House,

79 Whitehall, London,

London SW1A 2NS

Dear Minister

Re: excessive regulation of e-cigarettes

Further to your appearance before the European Scrutiny Committee on 17 July and following the release last week of new guidance from MHRA, I would like make some suggestions regarding the government’s approach to regulation of e-cigarettes. With no exaggeration, the replacement of cigarette smoking by ‘vaping’ (use of e-cigarettes) is likely to be one of the most important developments in public health this century. The main risk is that excessive or inappropriate regulation with throttle this development – smothering the suppliers with red tape instead of supporting the commercial freedoms needed to make the products compete effectively against the dominant nicotine product, cigarettes. with that risk in mind, I am writing to express concern that the government is about to make a serious error in the regulatory approach it is taking to e-cigarettes. I would be grateful if you could consider the following.

1. Of all the measures in the Tobacco Products Directive, low risk alternative to smoking (e-cigarettes, smokeless tobacco) have by far the greatest potential for public health. The numerous measures in the directive to do with packaging, ingredients, warnings etc are not the most important from a health point of view, even if they are the focus of health campaigners. The European Commission thinks these measures, as defined in the directive, will reduce cigarette consumption by only two percent (see European Commission Impact Assessment Annex 5). That would be equivalent of a fall in EU smoking prevalence from 28% to 27.4%, which is in the statistical noise. On the other hand, e-cigarettes and other low risk forms on nicotine products have potential public health benefits that dwarf these other measures. Investment analysts see e-cigarettes as a major disruptive technology, with the possibility that e-cigarette use could surpass cigarettes within a decade (Bonnie Herzog, Wells Fargo Securities). I cannot stress this enough: that is huge in public health terms, given these products create a tiny faction of the risk of smoking (about 99% less would be a fair estimate) and no risks from secondhand smoke. The value of low risk alternatives is already established through the experience of snus in Sweden, where nicotine use is quite high, but smoking has fallen to 13% – the lowest in the EU by far, and also with the one of the fastest rates of decline in recent years. The result is that Sweden has much lower rates of smoking-related disease (about half the lung cancer rate of its near neighbour Denmark). Absurdly, the UK supports a ban on snus in the EU and UK, though there is no scientific, ethical or legal basis to justify it. I respectfully suggest that these issues deserve your attention more than any other aspect of the Tobacco Products Directive and probably much else in the public health agenda.

2. Strong ideological alignment with liberal values, but threatened by excessive regulation. The rapid growth of e-cigarette use would not only disrupt the established business model of the cigarette industry and create huge health gains, it would do this through the choices made by consumers spending their own money at their own initiative, matched by the innovation of dozens of suppliers, all interacting in a market where better products emerge through consumer choice and competition – not the decisions of regulators. No coercion, prohibition or public spending is required to secure very substantial health benefits. The products are already very popular and growth has been dramatic, with no major problems evident. A public health development with these characteristics this should be warmly embraced and carefully nurtured by the Coalition. However, the greatest risk to these developments turns out to be the Coalition itself. The government’s policy of regulating these products as though they are medicines, even though they obviously are not medicines, would be highly counterproductive. It would impose excessive costs, burdens and restrictions, limit the diversity of products and obstruct innovation. Analysts have already suggested that medicines regulation would ‘seriously inhibit e-cigarette growth’.

3. Political disconnection. The medicines approach originated in the previous government and has been aggressively promoted since by officials, in spite of mass opposition from the users. It is supported primarily by health campaigners that are instinctively hostile to e-cigarettes (most of the supporters of medicines regulation wanted all e-cigarettes available in the UK removed from the market by 2011 or sooner). The idea has been championed by the Socialist and Green political groupings in the European Parliament, for whom excessive regulation is rarely a concern. In contrast, Brussels-based Conservative and Liberal Democrat MEPs have assiduously opposed the policy of regulating e-cigarettes as medicines. There is a clear political disconnect between London and Brussels, but it is the Brussels-based MEPs who have properly gauged the politics, understood health the potential, recognised the alignment with liberal values and grasped the risks of excessive regulation. These MEPs support robust application and rigorous enforcement of the existing 17 EU safety and consumer protection directives that already apply to e-cigarettes. They rightly contend that this form of regulation is sufficient, proportionate and non-discriminatory. With your leadership, the London-based government of the same parties could now do the same. There are now 1.3 million ‘vapers’ in the UK, well networked and increasingly effective at mobilisation through social media. It is hard to find any informed users who agree with approach the government is taking, supposedly for their benefit. By the time of the 2015 election, it would be reasonable to expect double or triple that number, with a growing base of SMEs on the supply side. Medicines regulation would start to apply from 2016, and its consequences would be evident before.

4. Medicines regulation for e-cigarettes is anything but ‘light touch’. The Coalition is in danger of severely inhibiting the growth of e-cigarettes, and hence the health benefits, through application of inappropriate and burdensome medicines regulation. This runs counter to the government’s otherwise admirable instinct for lifting the burdens of regulation, especially on disruptive or ‘challenger’ businesses (see below). The MHRA has published initial guidance on Licensing Procedure for Electronic Cigarettes and Other Nicotine Containing Products (NCPs) as Medicines. This shows the processes to be exceedingly burdensome for the existing vendors and products. I will offer three examples:

The entire supply chain would need to be upgraded to pharmaceutical manufacturing and distribution standards with a heavy duty quality control system staff by biomedical graduates (see the Good Manufacturing Practice requirements). In practice, such upgrades are unlikely to be possible within much of the existing supply chain, which is based on manufacturing in China. This requirement would mean abandoning the existing suppliers, rebuilding the industry from scratch and destroying many established businesses. This is wholly unnecessary and excessive, given that most nicotine is currently consumed through inhalation of toxic smoke. However, the costs and disruption associated with this have not even been properly exposed in the government’s Impact Assessment (see para 53-56).

Separate authorisations are required for each flavour and strength of e-liquid. So a company marketing 100 flavours in four strengths (hardly unusual) would require 400 marketing authorisations . Medicines, of course, do not come in a great variety of flavours, but for e-cigarettes diverse flavours are an integral part of the product and experience. This is another reason why medicines regulation is a poor fit. The European Commision said it expected: [Nicotine Containing Products] with characterising flavours are unlikely to be authorised under the medicinal products’ legislation” (Commission Impact assessment p81) – apparently oblivious to the damage this would do to the category and the competitiveness of e-cigarettes relative to cigarettes.

. Medicines, of course, do not come in a great variety of flavours, but for e-cigarettes diverse flavours are an integral part of the product and experience. This is another reason why medicines regulation is a poor fit. The European Commision said it expected: [Nicotine Containing Products] with characterising flavours are unlikely to be authorised under the medicinal products’ legislation” (Commission Impact assessment p81) – apparently oblivious to the damage this would do to the category and the competitiveness of e-cigarettes relative to cigarettes. E-cigarette businesses would be required to conduct market surveillance and risk management to assess pattern of use by smokers, ex-smokers, non-smokers, under-18s and when and how the products is used. This would be a reasonable academic study, but these requirements not placed on tobacco or alcohol companies despite much higher risks. What justifies the inconsistency?

5. This regulatory policy should be subjected to a Red Tape Challenge. The government’s Red Tape Challenge has a specific theme on disruptive or ‘challenger’ businesses (see Red Tape Challenge: disruptive and challenger businesses). Its mission is as follows:

We understand that new business models – particularly those that involve doing things differently – may fall foul of regulations that were intended for another age, or for another purpose entirely. We want to ensure that our regulatory system is fit for purpose, and is not holding back disruptive new companies

E-cigarettes and inappropriate medicines regulation fit this purpose very well. I hope you will support a rapid Red Tape Challenge examination of this policy before the government makes any further commitment to it in the EU Council and in time for proper scrutiny by the European Scrutiny Committee . I have written separately to the Red Tape Challenge to suggest they take this on as a priority (see letter).

6. Challenge the illiberal approach to snus. The government’s position on snus is indefensible and many experts favour lifting the ban (see 2011 letter to Commissioner Dalli). Even if there were only a few people in the UK who wished to use snus to reduce their risk (95-99% reduction compared to smoking) why would the Coalition government think it appropriate to use the force of law to stop them doing this on their own initiative and at their own expense? Especially given what we know of the experience of Sweden.

As Minister for Public Health, I hope you will take these concerns seriously and initiate a rapid review of the impact medicines regulation in the light of the new e-cigarette guidance issued by the MHRA last week. It has only now become clear just how burdensome and disruptive the proposed approach would be. It would be entirely appropriate for you to seek further advice and external challenge to your officials at this point. If possible I would appreciate a meeting with you to discuss a better way forward, better aligned with the liberal values of the Coalition.

Yours sincerely

Clive Bates

Disclosure: I am a former Director of Action on Smoking and Health (1997-2003) and a former public servant (2003-2012). I now run my own consulting and advocacy practice – Counterfactual Consulting. I have no competing interests. These views are my own and not necessarily those of former employers.