Public Health Minister Anna Soubry’s 17 July performance in front of the European Scrutiny Committee [link to full length video] was widely regarded as a shocker. There have been several write-ups: Minister denied MPs opportunity to scrutinise Tobacco Product Directive; Why are Labour not outraged by this; Anna Soubry must go; Anna Soubry: one woman walking disaster; The disingenuous Anna Soubry MP and, looking ahead, Why David Cameron needs his iPad on holiday. You get the picture, and I don’t wish to add to the commentary on this…. However, I do think the session was also revealing in a useful way. It is worth writing to her if you are interested in the regulation of e-cigarettes and the Tobacco Products Directive.
Aside from the obvious protocol violation, I think there were three things worth focussing on in her grilling.
- She claimed that the provisions on e-cigarettes ‘in the end fell out of the directive‘ – this is untrue of course (see p. 51 of the General Approach) and she had to be corrected later in the hearing. But this suggests that she is not focussing on this aspect of the policy – that is something that could change given some encouragement.
- She did acknowledge there was a ‘genuine debate‘ about medicines regulation for e-cigarettes – this is good. We now need to have the genuine debate. The minister should take a more sceptical view of the advice she has received so far, listen to wider range of views and take stock.
- She paid tribute to her officials – but she had no reason to. They have managed to create one almighty dog’s breakfast of a tobacco directive and to drop her in it procedurally. From outside, it looks like civil servants have been running the ‘e-cigarettes’ part of the tobacco brief and are basically continuing with the policy formed before 2010. She should reassert a policy approach based on more liberal values, respect for individual choice, the power of markets, regulation where strictly necessary etc – exactly as Conservatives and Liberal Democrat MEPs are doing in Brussels.
I actually find Anna Soubry quite likeable as a politician (see this Total Politics interview), and I suspect she would instinctively support a more consumer-based approach to regulating e-cigarettes had she focussed on it and been given better advice by her officials. I also think many in the government have been sold medicines regulation on a false premise – that it will somehow be ‘light touch’. However, it is not and can never be light touch. The UK government prides itself on its deregulation agenda and not suffocating innovative new businesses with red tape (see the government’s Red Tape Challenge: Disruptive business models / challenger businesses) but the new guidance on applying for marketing authorisation suggests very significant regulatory impacts.
Write to the Minister for Public Health
- Write to your MP and ask them to take the issue up with the Minister [use this: www.writetothem.com to write to your MP]. If your MP will forward on your concerns or write him or herself, this is the best way to have impact.
- Use her Department of Health position email address: [email protected]
- Write using old-school mail: see address below
- Writing to the Department of Health [contact form] addressing it for the attention of the Minister for Public Health
- Use of twitter @Anna_SoubryMP – though she mainly uses this for constituency business
- If you are a Broxtowe constituent, you can raise this with her as your MP (rather than as a minister) here
Anna Soubry MP
Parliamentary Under Secretary of State for Public Health
Department of Health,
79 Whitehall, London,
London SW1A 2NS
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.
- 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.
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.