October 7th, 2013

The case for regulating e-cigarettes as medicines – a line by line examination

envelope2I was forwarded a letter circulated to MEPs by the rapporteur for the Tobacco Products directive, Linda McAvan MEP.  I decided to respond by commenting on her arguments for medicines regulation line by line and adding 10 points not addressed.
Here is the critique I sent to MEPs in advance of the vote on 8th October.  I am pleased to say that we won that vote. I doubt it was much to do with this letter, but the persuasive weight of thousands of vapers contact their MEPs – backed up by the fact they are  right.

4 October

Dear colleagues,

Next week you will be asked to vote on electronic cigarettes as part of the Tobacco Directive.

We all agree that e-cigarettes have the potential to help smokers quit smoking, and save lives. The question is how should they be regulated? There are two options on the table: a light-touch medicines framework (amendment 71), and a tobacco framework (amendment 170).
Comment: Amendment 71 does not provide for a ‘light touch’ framework. It provides for medicines regulation and authorisation under the medicines directive 2001/83/EC. The TPD cannot modify that directive or change the way it is applied. No clinical trials for drug efficacy are necessary given that nicotine is a widely used drug, but that is true under any other regime and it certainly does not make medicines licensing ‘light touch’.  The burdens associated with regulating these products as medicines are formidable.  They do not simply provide a quality mark for the producers and products on the market today. They will create a ham-fisted and damaging restructuring of this market. Medicines regulation will create costs and burdens that will put most producers out of business, take most products off the market, slow innovation and weaken the competitiveness of these products relative to cigarettes.  Professor Gerry Stimson and I examined the issues in our report: Costs and Burdens of Medicines Regulation for E-cigarettes, which I attach.  I hope you will at least read the summary of this and come to your own view of how ‘light touch’ medicines regulation would be in reality.
Why we support medicines regulation 
·     National governments want to regulate e-cigarettes as medicines – in the same way as nicotine gums and patches.
 Comment: The appropriate comparator is not nicotine gum and patches.  These NRT products are classed as medicines and used for treating nicotine withdrawal while a person quits smoking and nicotine use.  It should be obvious that e-cigarettes are highly competitive alternatives to cigarettes, and used as low risk-way of taking recreational nicotine. The huge health benefit that arises from the switch from cigarettes to e-cigarettes is the great public health prize – but it comes from persuading smokers that e-cigarettes are a better way to take nicotine than smoking, not that e-cigarettes are are better way of quitting than using NRT.   Given that the vast majority of nicotine consumed in Europe is delivered in tobacco smoke,  a toxic aerosol of smouldering tar particles and hot gases, it is absurd to require hugely expensive exacting standards for their most effective competitors that go far beyond what is necessary to safeguard a smoker choosing these alternatives. The European Parliament is a distinct part of the legislature directly representing voters – member state governments are represented in the Council.
·      Medicines regulation is not “over-regulation”. We are talking about “light touch” medicines regulation – as nicotine is a well-known substance like paracetamol and aspirin. This means no expensive clinical trials. Manufacturers just have to prove quality and safety. 
Comment:  the main costs are not in clinical trials for this type of drug – this is a distraction.  The main costs are in: wholesale replacement of the manufacturing supply chain (not possible for most companies);  the unnecessary design changes required to make an e-cigarette a medical drug delivery system; the enforced requirement for suppliers to adopt a pharmaceutical company business model for IT, process controls, and qualified personnel;  the costs of licensing hundreds of flavour and strength combination; unnecessary pharmacokinetic and pharmacodynamic testing as a proxy for customer satisfaction (which should be a matter for consumer preferences); and a risk management and surveillance system, which is unnecessary and not applied to much riskier products.  None of these costs fall on tobacco companies marketing cigarettes.
·     We want to encourage good products which are safe and effective. There are many poor quality products on the market, which do not help people quit smoking. Also, just because smoking is so much more harmful doesn’t mean we shouldn’t set safety standards for e-cigarettes to ensure they don’t contain carcinogenic and other toxic substances.
Comment:  it is possible to set standards for e-cigarettes to cover residual contaminants (which are in practice extremely low). There are perfectly good legislative routes available if standards are necessary – and these offer a better approach to internal market harmonisation than medicines regulation.  In fact, when the Commission consulted on revising the TPD in 2010, it proposed to do exactly that.  It asked for views on the following proposal: an extension of the scope of the Directive could be envisaged to include novel forms of oral tobacco, herbal cigarettes, and electronic nicotine delivery systems, insofar as they are not already covered by other EU legislation (food, pharmaceutical). Specific safety and quality requirements would be developed for ENDS. (emphasis added).  It would be better for the Parliament to be pressing for this framework to be reinstated.  As an aside, it is worth noting the the Commission has never consulted on the proposal to force e-cigarettes into a medicines regulatory framework.
·     Long-term safety would be monitored – little is known about long-term effects.
Comment: surveillance is worthwhile but better conducted at the level of the whole market and as an independent scientific exercise, outside the licensing process.  ‘Surveillance’ for medicines safety is focussed on detecting adverse reactions emerging in large populations following prolonged use, for example the emerging signs of neuropsychiatric events (such as suicidal impulses) in the licensed smoking cessation drug Varenicline.  No such issues arise with nicotine use.  Of course ‘little is known about long-term effects’ now, but just by looking at what is in these products we can have some confidence they will not be serious, even if not zero or even negligible.
·     It is up to Member States where e-cigarettes could be sold. 18 countries already allow some medicines to be sold outside pharmacies – e.g. in corner shops, supermarkets and petrol stations. The other countries have the opportunity to amend their national law when they transpose the Tobacco Directive.
Comment: This refers to a significant issue with medicines licensing – that in many countries (in fact, those with the largest populations other than the UK) medicines are only available in pharmacies.  Among the 18 referred to here not all have ‘general sales’.  So the application of the TPD will significantly reduce the places and times at which most people in Europe would be able to access e-cigarettes compared to cigarettes.  It is simply wishful thinking that member states will adjust their medicines legislation to accommodate a single new products.
·     Flavourings would be allowed. There are already nicotine gums and inhalers on the market in different flavours. But flavourings which are clearly aimed at kids, like bubble-gum and ice-cream would probably not be approved by regulators…
Comment: This is highly misleading.  Flavours would be allowed if approved, but the approval process would be immensely costly and burdensome, and it would not be economic or possible for most flavours provided by most companies.  It amounts to a de facto ban on most flavours.  In fact, there are only a very small number of flavours that are approved for use in inhaled products (eg. asthma inhalers) in the European Pharmacopeia, yet there are hundreds of flavours on the e-cigarette market and these are intrinsic to the appeal to smokers.  Of course the concept of a medicine coming in 200 flavour varieties is absurd and medicines regulation is not set up to cope with that. But this is a good illustration of why e-cigarettes are not medicines.
·     Advertising would be allowed. But regulators would be able to control advertising to make sure it is only aimed at smokers.  
Comment: This can be addressed without medicines regulations – for example using the approach taken for alcohol advertising. We should also recall that e-cigarettes cause very little harm and the case for curtailing advertising beyond protecting children is weak. In the UK, medicines regulation would mean advertisements for e-cigarettes would have to be approved by a pharmaceutical industry interest group, with obvious conflicts of interest.
·     Companies would not be able to market e-cigarettes as a fun, recreational product. This is important as tobacco companies are already moving into the e-cigarettes market.
Comment: This illustrates perfectly the misunderstandings behind the proposal to regulate these products as medicines.  The health benefit of the these products arises from their appeal to smokers as an enjoyable alternative to smoking.  Perfectly safe, bland products with insipid branding and dull marketing are unlikely to appeal to many smokers. in this situation, risk averse regulation simply favours the much more dangerous product.
·     The e-cigarette market has the potential to grow so much more. We need a regulatory framework that protects public health first and foremost and makes sure only products which are safe and effective reach the market.
Comment: The proposal to regulate as medicines will smother an emerging disruptive industry in red tape and retard its development as an alternative to cigarettes, while most likely concentrating ownership into the hands of the tobacco companies. Many of those supporting medicines regulation see it as a way of suppressing rather than growing this important new market. The mostly like effect is to protect cigarettes and to gift control of the e-cigarette market to pharmaceutical affiliates of tobacco companies.
Problems with the ECR, EPP and ALDE amendments on e-cigs (tobacco framework)
Comment: Amendment 170 is not regulating e-cigarettes as tobacco, though it draws on aspects of tobacco regulation.
·     This is weaker regulation which puts the burden on authorities to identify sub-standard products and remove them – rather than on companies to prove their products work before they put them on the market.
Comment: There is nothing wrong with this – it is the way regulation works for almost everything.  In fact the Commission and Council positions allow low-risk nicotine products to be placed on the market through a notification process, if they contain tobacco (Article 17).  For cigarettes there is even less to stop a new product: merely some easy and long established but misleading yield standards to be met (Article 3 & 4).
·     There would be a total ban on advertising. It does not make sense to ban the advertising of products that have the potential to improve public health.
Comment: This is an excessively restrictive and I believe the intention is to signal some limits on advertising, most of which should properly be the responsibility of member states.  Suitable wording that meets the concern expressed here could easily be agreed in the negotiations with the Council and Commission that would follow agreement to amendment 170.  Amendment 170 also keeps open the option of having products regulated as medicines – it simply requires the vendor to make a claim.
·     Governments may be tempted to tax e-cigarettes like cigarettes. France and Italy are already considering this. This could add up to 80% to the price. On the other hand, some countries have a special low VAT rate for medicines.
 Comment: Member state governments determine their tax base and VAT regime within some limits set by EU law.  If they wish to tax these products to recover lost tobacco tax revenue that is a matter for them and their taxpayers and their views of the how valuable e-cigarettes are as a public health strategy, it not something the Parliament can or should try to prevent.

Issues not discussed in this letter

1. Legality.  That the medicines approach is highly vulnerable to legal challenge. The JURI committee’s opinion found it to be unlawful. The medicines classification has been struck down in five courts in members states based on EU law and jurisprudence. Counsel’s opinion for a trade body demonstrated a sound legal rationale for challenging the measure as disproportionate. It helps no-one for the European legislature to proceed undaunted by legal advice.

2. User views. The voices of thousands of users who strongly oppose these proposals have been ignored and even dismissed, even though the users are supposed to be beneficiaries or regulation. This conflicts with all good practice in public health.

3. Innovation.  No insights at all into what medicines regulation would do to the pace and quality of innovation. Pharmaceutical innovation follows a long cycle of drug discovery, approval and then 10-15 years patent-protected monopoly. Generics do not, by definition, involve much innovation. E-cigarettes in contrast are more like ‘tech’ gadgets – with products refreshed every 8-12 months and a frenetic pace of innovation driven by consumer pressures.

4. Consultation. There has been no formal or meaningful consultation on medicines regulation with those affected. It was not proposed in the Commission’s 2010 consultation on the revision of the directive (see above) and the Commission has not found time to consult in the intervening two years.

5. Alternative approaches. The absence of any consideration of alternative forms of regulation that could be developed post-2014. The regulation of this category should be purpose-built and fit for purpose – not tobacco or medicines, but and appropriate light touch ‘enabling’ framework for nicotine containing products.

6. Small business impact. No meaningful assessment of the impact on thousands of small businesses now operating in this new industry throughout the EU

7. Problem definition. No coherent definition of the problem that highly expensive and burdensome regulation is supposed to address. In fact, the market is functioning very well, growing rapidly and appears to winning over thousands of smokers and decreasing cigarettes consumption.

8. Unintended support for smoking. The extent to which these proposals protect the cigarette market from competition and so support the tobacco oligopoly. The perverse consequences arising from these proposals will be exactly what MEPs on all sides wish to avoid – more smoking than there would otherwise be.

9. Black market. There is no recognition that users will not be passive takers of bad policy harmful to their health. Black market trade, home mixing and brewing – with increased danger to health and rising criminality- are the likely result of medicines regulation.

10. Oral tobacco. The letter ought to cover harm reduction more broadly – not least by explaining why oral tobacco (snus) should be banned when it is largely responsible for the greatest tobacco and health success in Europe: the low rate of smoking in Sweden (13%) compared to the EU (28%).

In reality snus should be treated as any other smokeless tobacco, but the rapporteur has refused to consider anything but continuing the ban, regardless of the huge weight of contrary evidence showing it is protective to health and functions as an alternative to smoking and aid to quitting. As a very minimum please support amendments 131 and 134 (very similar) that would allow oral tobacco to be authorised where it has been used traditionally.

I hope you find these views useful as you prepare for the debate and vote.

Yours sincerely

Clive Bates
Counterfactual Consulting and Advocacy
Former Director Action on Smoking and Health (UK)
Twitter: Clive_Bates
Disclosure: no competing interests.

35 comments to The case for regulating e-cigarettes as medicines – a line by line examination

  • Roger Hall

    Clive, an awesome piece of work, which I hope (and pray) obtains the deserved attention and response from MEPs that it truly deserves.

    My sincerest thanks for all your hard work and efforts.

    Kind regards

  • Roger Hall

    Good luck and safe journey. BTW do we really care if Linda McAvan is happy?

  • Andy Morrison

    Thanks yet again Clive – where would we be without you?

  • Dodderer

    Yes Amt 71 is full med reg – light touch/right touch is just a selling gimmick concocted by the DoH/MHRA.The MHRA have confirmed that,even under light/right touch regs,no current ecig would be approved – perhaps we could call it ‘goodnight’ touch

    Following the links on the MHRA’s Q&A re proposed ecigs regulation gives 7,243 pages of rules,regulations and requirements and the up to £2m cost of this per product excludes Good Manufacturing Practice, details of which are available in their handy 440 page booklet.

    OK 7,243 is a guess – but no-one in their right mind would ever check it – using tobacco control tactics,if we all repeat it often enough it automatically becomes true

  • Fantastic stuff Clive, you are the voice of reason.

  • Alan Depauw

    Thank you, Mr Bates, for this good read on our way to Strasbourg.

  • Linda

    Many Thanks Clive.

  • This looks like a very thoughtful and considered response to the general state of electronic cigarette regulation in the UK and Europe. Regulation for e-cigarette products should be proportional to their risk in comparison to other comparable tobacco, NRT or ENDS products, and not just an emotional response to something that might be seen to be ‘just another tobacco alternative’.
    I’m trying to provide a balanced answer the question of ‘are electronic cigarettes bad for you?‘ elsewhere, and this response will certainly feed into my research and reporting.

  • Nigel

    Excellent stuff as usual Clive. But I think there is a typo regarding the date in your mail (Wednesday 8th October; I presume this should be Tuesday ?)

  • AnjaM

    Great work!
    By the way, here is an article from a Czech newspaper about Ms. McAvan’s contacts with Big Pharma. Run it through the Google Translator.. very interesting indeed: http://nazory.euro.e15.cz/komentare/cas-rozhodnuti-na-regulaci-tabaku-vydela-farma-1026440

  • Cliff clark

    Awesome nothing more to say

  • Clive, many thanks for writing this letter. It sets out exactly how things are and does so in clear and concise language much better than I would be able to.

    Lets hope it has the desired effect.

    • Clive Bates

      Thanks Mark…

      If only arguments worked!

      Everyone: don’t hold off now… write/tweet to MEPs today and tomorrow (Tues 8th) morning. They need to hear from their constituents.

      Clive

  • Jonathan Bagley

    Clive, I came across a report of a conversation an ecig business owner had with a Trading Standards Officer, who suggested that the MHRA might bring forward an ecig ban to earlier than 2016, depending on the result of the vote. This would make sense to them as by 2016, ecigs will be a normal part of everyday life for millions. Is this possible or likely? I need to consider getting in supplies if there is a risk of an early ban.

  • Clive Bates

    That sounds like petulance to me… sort of thing low grade civil servants sometimes say (I paraphrase): “if you stop me doing what I want to do, you’ll only make it worse for yourself because we will react in a way you don’t like”. Cooler heads will want to understand why it happened and use it to have a rethink…

  • Sebt

    Thanks!

    Great to know what’s going on over there in the EP.

    Just re-written to all my MEPs with a new message taking into account many of the points you’ve raised here.

    Good luck in Strasbourg!

  • Martin Musther

    I keep asking myself the same question:

    how can it be right to make an alternative product that is without doubt many many times safer less freely available than cigarettes?

    The choice is therefore:
    MEDICINAL REGULATION amendment 71 – Hand a monopoly to Big pharma & Tobacco corporations – and suffer a vast increase in illness & deaths.
    SENSIBLE REGULATION amendment 170 – allow ecigs to become *normal” reducing cigarette sales and most importantly providing an alternative and save lives.

    it really is a no brainer

  • Margaret Hermon

    Am all written out. Just want to join in thanking you for all the help and all the effort. We’ll win because we must.

  • mike adkins

    http://nazory.euro.e15.cz/komentare/cas-rozhodnuti-na-regulaci-tabaku-vydela-farma-1026440

    bombshell or what ???

    clive many thanks for everything you have done mate, hopefully all not in vane

  • Dean Jackson

    Clive,

    Thank you for going to such effort in explaining what e-cigarettes are all about, There are many people that are using these products to keep them away from harmful cigarettes and it is extremely successful, I myself used e-cigarettes to quit smoking and continue to use them to satisfy my nicotine habit, I see no problem with this and have noticed a dramatic rise in my health, also suffering with asthma I have found no need for my inhalers which compared to a couple of years ago was something I needed to take 2-3 times every day.

    I think the whole idea that people are fighting so hard to get these classed as medicines is laughable when I could go to the shop right now and buy as many cigarettes as id like which have been proven to cause so many illnesses and are killing people every day due to the effect of smoking TOBACCO.

    I cant help think that the push on these products to be limited is somehow linked with the amount of money lost due to the high taxes on cigarettes and it came at no surprise that the government has already planned an 80% tax hike on e-cigarettes, Personally I think these products should be pushed as hard and as fast as possible to make everyone aware of the BENEFITS they have, and if money (as in most cases) is the issue, wouldn’t it make sense that the more people that came off cigarettes and onto e-cigarettes the healthier people will be long term and the less the NHS will have to treat with Tobacco related illnesses.

    Yes there are other means of quitting out there but being someone that has tried a good number of them with no success I believe that this extremely successful way of quitting should be praised as it is certainly working for more people than other alternatives.

    In my opinion to call something a medicine is to say it is a treatment for something…..for what?..cigarettes?
    so why cant the people aiming all of there time and energy on trying to get e-cigarettes classed as medicines not simply trying to ban smoking all together?
    I can only think that cigarettes bring in too much money to warrant this and that the increasing popularity in e-cigarettes is going to damage the amount of money made on cigarette tax, I can think of no other reason why anyone would be against these products being freely sold and widely available when they continue to help so many people stop smoking, get healthier and improve there lives.

    Please vote 170,

    Thank you, Dean

  • Dawn Randall

    Thanks for all your hard work Clive – I hope it doesn’t fall on deaf ears.

  • Hi Clive,

    I’d just to take this opportunity so say a HUGE thank you for your efforts. The level of awareness you raised on this issue has clearly had a profound effect on the mindset those who voted in Brussels today.

    A huge victory for vapers across Europe and hopefully this should have a knock on effect in North America. I don’t suspect we would have had the same result if we didn’t have people like you fighting by our side.

    You’re a modern day hero! Kudos to you.

  • [email protected]

    I am astonished at the ostensible outflanking of big tobacco w amendment 170 — seems to me big tobacco will be shut out of vapor if this language is enacted.

  • Hi Clive, I’m totally baffled by the voting by MEPs on this issue. Paul Nuttall, for example, who has a vid up on You Tube berating the EU for their craziness in trying to regulate e-cigs, voted for both amendment 170 and 71, and many voted like him. Are they just stupid and lazy or am I missing something here?

    • Clive Bates

      Neal… I think it is because it requires formidable organisation within each political group to produce a ‘voting list’ to guide the MEPs on the party line. The voting happens very rapidly, so if you don’t have a script to work to it can be very confusing. It may be that their group is not that well organised. You could always ask him… It’s a good job it didn’t go right down to the wire.

  • I have asked but thus far no reply.

  • This is appreciable idea that use e cigarette at medicine. But It required many changes and restriction. It is like dead lock situation. E Cigarette rules are depend on long term effect of e cigarette. As it required long time to find effect then we have to wait for long term.

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  • […] to persuade the European Parliament to reject mandatory medicines regulation – see arguments here and here – why has it crept back in by stealth?  The language was intended to recognise a […]

  • […] science from WHO (here and here) and negligence on the part of the European Parliament rapporteur (here), evidence free ideas of the European Commission (here) and the unrivalled pomposity and […]

  • […] science from WHO (hereand here) and negligence on the part of the European Parliament rapporteur (here), evidence free ideas of the European Commission (here) and the unrivalled pomposity and negligence […]

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