August 4th, 2013

Write to Anna Soubry about e-cigarettes


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 DirectiveWhy are Labour not outraged by thisAnna Soubry must goAnna 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

If you think the minister may be not fully appreciating the benefits of e-cigarettes or the risks from inappropriate regulation, you can contact Anna Soubry with your views on this.  As always, I stress the value of being polite and constructive, drawing on your own experience and views. If you start from the assumption that the minister is trying to do the best she can, and is open-minded and open to persuasion, you are more likely to have impact than haranguing or sneering – however tempting that might be.  To get in touch with her y
ou may have to use your imagination a bit, as the Department of Health is set up to fend off thousands of letters a month from people generally annoyed with them. Options include:
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.
  • 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.

 

20 comments to Write to Anna Soubry about e-cigarettes

  • Thank you for writing this Clive, as a user and vendor of electronic cigarettes watching the regulatory wheels spin ever faster is like watching a slow motion car crash.

    I will be picking up some of the points you make in my reply to a recent letter signed by Anna Soubry via my MP.

    Will you be uploading your response onto the ECCA website? This will allow us to see responses from the full list of MP/MEPs and ministers that have replied on the subject of electronic cigarettes?

    Just finalizing a letter to Vince Cable asking his department for to look at the impact of proposed medicinal regulation on the UK’s highly innovative and fast moving electronic cigarette industry.

    Vince Cable’s press secretary told me over the phone the issue was now in the hands of the department of health and the BIS has no jurisdiction, so I asked to speak to his boss! He gave me Vince Cable’s email which I guess is fair enough.

    I will surely follow this up by submitting a red tape challenge. It looks like the red tape challenge is a no 10 initiative?

    My view is this needs to be taken higher than Soubry. She may well have been badly informed and capable of taking new information into account. But given the history, I think it may take someone else to sort this out. I will continue my own dialogue with her by letter. But this is becoming more pressing. Maybe the time has come for someone with an inter-ministerial view to get involved?

  • godek

    The MHRA initial guidance slipped by me until now.

    That is one scary prospect for our future. It would really in effect ban anything that is not cartridge based and limit flavor and nicotine strength combination severely.

    Good luck with Ms. Soubry.

    best regards from Germany
    godek

  • Adam

    http://www.ecigarette-politics.com/ash-uk-e-cigarette-regulation-pdf.html
    Hi Clive, The above is also interesting. It would appear that ASH is displaying a mixed view. I believe you now think slightly differently to them, so your interpretation / reply would be interesting…….Thoughts?
    Cheers
    Adam.
    PS thank you for everything that you are doing.

    • Clive Bates

      It’s a nice piece of work, mostly, but I think some of it is a bit unfair to ASH. I think you can divide the supporters of medicines regulation into two camps: (1) those who think it will benefit the category in the longer term by creating higher quality devices, more reliable performance and better nicotine delivery; (2) those who think regulators will obstruct something they instinctively dislike because they are closet prohibitionists, anti-corporate or whatever.

      I think the latter are despicable and the former are well-intentioned but wrong in practice (and they can’t both be right). I think ASH and RCP are in the former category (Professor John Britton supports e-cigarettes AND medicines regulation for example) and ASH’s public statements generally embrace a harm reduction philosophy, but based on regulated licensed products. I don’t think it is right to see these groups as doing the dirty work of Big Pharma, even if that’s the de facto result… more likely they have judged that to make any headway on harm reduction or the appearance of promoting recreational nicotine use, they’d need to have strong regulatory safeguards to satisfy nervous politicians, health charities etc. That’s not how I’d approach it, but there’s a tactical argument for it.

      Clive

  • Adam

    As ever, a balanced reply. Many thanks, personally I would like to see ASH being a little more vociferous but I suppose it’s a fine line to tread.
    (Slowly slowly catch the monkey)
    Adam.

  • ASH have been admirably vociferous in response to St Helen’s Council’s recent ignorant and ludicrous pronouncement on vaping in taxis. :)

    Great letter Clive, and thanks for the link.

    • Jonathan Bagley

      Yes, very keen to tell us ecigs are not tobacco products. Not surprising as they want them regulating as medicines, and they are not going to advocate a ban in taxis becuse that will then apply to all similar futue products sold under medicines regulation. I agree with Dave Dorn below. Don’t trust ASH UK one inch. It was only a few months ago that Arnott was filmed trying to persuade us that ecigs exploded in people’s faces because they are manufactured in China.

  • Let’s be be right. It’s not ASH, but Deborah Arnott who espouses the medicines approach. She pays lip service to harm reduction, but doesn’t actually believe in it, much preferring the complete and utter destruction of nicotine use worldwide. Sorry for butting in – back to the sun sea and sangria…

  • Marc

    Will you guys ever learn it?
    Big money from industries and business makes decisions, politicians are nothing more than puppets put before the cameras to announce the decisions.
    In a case like this, where it is beyond any doubt obvious Anna Soubry didn´t have the slightest clue what she was talking about, how much more proof do you need to figure out, theres no point in talking to her, she has no clue, because she doesn´t have the power to make any decisions.
    If you want to make a difference, you first have to find the bribers and lock them up.

    • Clive Bates

      Whilst I understand the sentiment, I think that’s a recipe for helplessness… it genuinely is difficult to turn around political and policy positions that have been in place for so long. But I doubt the government would adopt this policy if (1) it hadn’t already been in place; (2) they had recognised the importance of this relative to the issues that fill the tobacco control / public health agenda. It may well totally fail…. but if you want to try, it is better to proceed on the basis that ministers like Anna Soubry are not stupid, corrupt or prohibitionist – she isn’t any of those. Most ministers are persuadable if a cogent argument is made, if it is aligned with their values and enough people are making it to generate a compelling political case.

      • Jonathan Bagley

        Cive, many of us have arrived at the conclusion that these people are at least one of stupid, corrupt or prohibitionist by a process of elimination. We genuinely cannot understand why a sane, reasonable person would wish to extend current ecig regulation. I have read no recent reports of the devices harming anybody, there has been an enormous amount of past research into the properties of all the ingredients, the vapour has been analysed and its components found to be at safe levels. Non smoking teenagers are not interested and even if they were, its not going to lead to them taking up a ten times more expensive habit, banned almost everywhere. Probably a couple of hundred thousand smokers have now cut down on tobacco drastically or given up. Please explain. I am genuinely puzzled.

      • Jonathan Bagley

        Clive, many of us have arrived at the conclusion that these people are at least one of stupid, corrupt or prohibitionist by a process of elimination. We genuinely cannot understand why a sane, reasonable person would wish to extend current ecig regulation. I have read no recent reports of the devices harming anybody, there has been an enormous amount of past research into the properties of all the ingredients, the vapour has been analysed and its components found to be at safe levels. Non smoking teenagers are not interested and even if they were, its not going to lead to them taking up a ten times more expensive habit, banned almost everywhere. Probably a couple of hundred thousand smokers have now cut down on tobacco drastically or given up. Please explain. I am genuinely puzzled.

      • Jonathan – of course I agree with your assessment of the facts about e-cigs, but that doesn’t make the minister stupid, corrupt or prohibitionist. But the point is about how ministers change policy and what their motivation is. Unless they come into office with a clear agenda or strong personal concern, a manifesto commitment, or mandate from the PM or Secretary of State to do something, they will find themselves facing the officials who have invested time and commitment into the policy as it already stands – in this case, that of the last government and the MHRA. In advice to her officials will have defended this policy, and reassured her that it will all work just fine, be ‘light touch’ and keep everything under control. She will take credit for dealing responsibly with rogue traders an unregulated e-cig Wild West etc. MHRA will have looked technocratic and reassuring, so as a minister, you’d trust them. At the same time she will have heard from ASH, RCP, CR-UK, BMA etc that this is the right way to go. In DH these are the important stakeholders, even though they have little experience in what regulation means for the businesses and products involved. She’s also probably more engaged by the plain packaging idea, which has been constructed by these groups and others as the big issue in tobacco policy, and because is upsets Big Tobacco, is good publicity. Now consider how the alternative case been made to the minister? The most significant thing about the hearing, was that it showed it wasn’t really on her radar.

        Ministers aren’t all powerful or all-knowing, they respond to the information and incentives they encounter, with their approach mediated by their values and instincts – they are human. Advocates or lobbyists try to influence the information and incentives, and will also shape propositions that take account of the values and instincts of the decision makers. That’s why I included the Total Politics interview with her. I think it suggests she is not instinctively in the more regulation, prohibitionist, nannying camp.

        As a more practical matter, there is the question of how best to approach someone if you want them to change course and agree with you. I’ve never regretted treating people positively and with the benefit of the doubt, but have sometimes regretted taking a more hostile approach. But if others want to go hostile and say she is stupid, corrupt or prohibitionist, that’s their call – I would only do that if I could look her in the eye and make those accusations to her face, confident that they are true. As set out above, I think there is a different explanation based on the ‘ecology’ of being a minister.

  • Adam

    Hi Mark.
    I think most of us are of the same opinion, the problem is proving it.
    There’s so much of it going on that sooner or later they will slip up and with so many of us now ‘on watch’ they’ll come croppers.
    I’ve notice that the media appears to be fare more vigilant lately, so, maybe soon eh?

  • Jonathan Bagley

    I’ve just taken a look at the MHRA impact assessment. It’s an absolute disgrace from start to finish, a pack of lies and to cap it all, its’s clear the MHRA anticipates future ecig use being about as expensive as smoking and that this is entirely reasonable. Actually, ecig use costs around £5 a week if you know what you are doing. People who can’t afford to have for years been spending £50 a week on cigarettes, and now they don’t have to. They can spend it on food, or their families, but the Government doesn’t want that. Words fail me.

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