A Deal On E-cigarettes – What next?

Guest post by Rebecca Taylor, Lib Dem MEP.   Rebecca Taylor

 

The final trialogue negotiations on e-cigarettes are now several weeks behind us.

Although the deal reached was far from perfect, we must recognise that remarkable progress has been made.

Just a few months ago it looked like e-cigarettes were well and truly doomed. The original Commission proposal would have effectively imposed pharmaceutical regulation across the whole of the EU on all but the least effective devices, and enjoyed majority support of Parliament’s public health committee (ENVI) and unanimous backing from all 28 national governments.

But a decisive victory was won for e-cig users in October when MEPs in Parliament adopted the Liberal-drafted amendment, which steered e-cigs away from over-burdensome medicinal licensing towards a more appropriate consumer product regulatory framework.

Several national governments then began to privately doubt whether the pharmaceutical regime was the best route for e-cigs, although none said so publicly. This did however lay the groundwork for the deal agreed in December, which whatever you think of it, represents a significant climb down from a position unanimously held by 28 national governments.

The package must now be signed off for a final time by a vote of the European Parliament, which is likely to take place in March.

There have been calls to table an amendment to article 18 ahead of the Parliament’s final vote. This is an infrequently used procedure which, if an amendment were to be adopted, would effectively break the deal reached by the Parliament and national governments on the entire Directive. If the amendment adopted by parliament was not accepted by national governments, the entire Tobacco Directive would then go into second reading.

I fear this could jeopardise the important work that has been done on the rest of the Directive upon which parliament and national governments were able to agree without too many problems. Although this would allow article 18 to be re-visited, it would also give tobacco companies another opportunity to chip away at the tobacco control measures.

In addition, it would provide those who have opposed sensible regulation of e-cigarettes with another opportunity to lump e-cigarette advocates together with the tobacco lobby, which in the worst case scenario could see an even more inappropriate article 18 emerge.

It would be untrue to say that I am happy with Article 18 as agreed in trialogues, but for the reasons stated above, I would not advocate that the Parliament reject the TPD in its entirety.

I do believe there is still a battle left to fight, and so I am currently looking carefully in to a number of options and discussing them with colleagues.

There are essentially three options open:

1)    Tabling an amendment which removes article 18 from the Tobacco Products Directive altogether and requires the Commission to come up with a new proposal

This should allow the development of a regulatory framework specifically designed for e-cigs, which could then go through the appropriate consultation procedures. However, if adopted, such an amendment would break the trialogue deal, but it doesn’t have to if national governments can accept moving forward with the rest of the TPD intact.

Potential advantages: the chance to develop a customised regulatory framework for e-cigs that would be workable for manufacturers and vapers and help encourage more switching. With more public health organisations and leading experts moving away from the medicines route, we can be reasonably optimistic that a better outcome can be achieved. This would also not touch the tobacco control measures as long as national governments could agree to move forward with the rest of the TPD.

Potential risks: e-cig opponents get better organised (they thought medicines regulation was in the bag until shortly before the October plenary vote and the hysteria of some anti e-cig messages helped secure amendment 170), and re-opening article 18 results in a worse outcome than the current trialogue deal. This is also linked to uncertainty about the shape of the post June 2014 Commission (Commissioners are appointed by national governments) and Parliament (more Eurosceptics who do not engage with legislation meaningfully?). This is a worst case scenario, which I think is rather unlikely, but not impossible.

2)    Tabling amendment which alters the text of article 18 as agreed in trialogues

Potential advantages: we get the right framework for e-cigs sooner rather than later.

Potential risks: As well as being very difficult to convince fellow MEPs to back this option, I am almost certain it would not be accepted by national governments, so it would break the trialogue deal and push the TPD into second reading. This could easily result in e-cigs advocates being held responsible for giving tobacco companies another crack at the whip.

Also worth noting: One of the arguments for removing article 18 and re-doing it, is on procedural grounds, namely that article 18 was inserted into the draft directive at the last minute and not subject to the same consultation as the rest of the proposal and that the final text that emerged in trialogue negotiations has had no input from stakeholders. This is in some ways a stronger argument than simply opposing the content of the trialogue deal on article 18, as the same could be argued about many other proposals, and it could be seen as merely sour grapes. If we were to push a new text that would, due to the nature of the procedures involved, be put forward without any proper consultation or significant time for MEPs to examine it, then we would be doing what we criticised others for doing.

3)    We accept the trialogue deal and focus our energies on ensuring the regulatory framework agreed is implemented in the most flexible and workable way possible.

Whatever happens, this needs to be done as with most legislation “the devil is in the details”, so getting things implemented in a workable way is vital.

In the UK, I continue to try and win over more Lib Dem colleagues at Westminster to ensure greater pressure is placed on the UK government not to push regulation towards the MHRA route, as has been advocated by Conservative Health Secretary Jeremy Hunt and Health Minister Jane Ellison. Already, Liberal Democrat MPs such as Norman Lamb (social care minister), Dan Rogerson, John Pugh and Lorely Burt have been fighting the corner for e-cig users.

Potential advantages: we know what we are getting and our engagement cannot make it worse.

Potential risks: losing the opportunity to get something better.

I would repeat my previous call for concerned individuals to contact their local MP to raise this issue (regardless of which way things go), so that a greater number of MPs including Labour and Conservatives, can also be won over.

Until then, as always, I welcome comments from e-cig users, who can rest assured that I and my Liberal Democrat colleagues are still very much on their side.

 

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31 thoughts on “A Deal On E-cigarettes – What next?

  1. “Potential advantages: we know what we are getting”

    Yes – a de facto ban on every device that’s currently on the market! How is this even remotely acceptable to vapers? Just to make it worse (if that were possible) it’s now been confirmed that the restrictions on liquid strength and tank capacity were arrived at by deliberately misrepresenting the work of Professors Dawkins and Farsalinos. So not only is it a stupid law; it’s fraudulent as well.

    • Well this directive is unfortunate, especially for existing legitimate vaping businesses and possibly noob vapers. But I don’t think there’s anything the EU or national governments can do to stop (or even tax or regulate) existing users. They can only drive them underground.

      All the necessary hardware is so absurdly simple that users could easily make it themselves. Tanks could be 3D printed. Even the more complex regulated “mods” are really very simple things that any competent electronics engineer could design and publish the resulting design on the interwebs. Mechanical mods are simpler still. You could even make your own NIC juice if needed. Nicotiana rustica grows rather well in european climate and I can hardly see them banning propylene glycol and/or vegetable glycerine.

      Of course having to actually do all this would be somewhat tiresome, so let’s hope it doesn’t become necessary.

  2. I pray for option two.
    I hope for option one.
    I expect option three (which I believe is an appeasement to the symbiotic Pharmaceutical and Tobacco industries to compensate for revenue lost through the otherwise admirable European TPD. I expect to break the law and I look forward to the court case.

  3. Dear Rebecca – that’s a very good assessment and I think you have laid out the three options very clearly. My own view is that there is no crisis that requires a rushed response or anything that justifies waiving the obligations to consult and to ensure the policy is evidence based and legally robust. Two scientists, Farsalinos and Dawkins, have already disputed the Commission’s use of their work to support the proposals and I’m pretty sure more will follow. As a consequence of the strategic change introduced by the Parliament on 8 October, the procedure followed has sidestepped several important treaty obligations, and may be unlawful. The decisions that the EU makes on e-cigarettes will set the direction for the next decade or more in Europe and will probably set norms internationally. The measures for e-cigarettes have been formed through deal-making in a secretive process with no consultation, drawing on misrepresented science and without the the normal efforts to justify the proposals or assess their impacts. That is hardly going to lead to good law, and these weaknesses are all too visible in the revised article 18. There are millions of consumers, thousands of businesses and hundreds of experts and public health advocates with views and experience to contribute. To invent an entirely new regulatory framework for one of the most significantly disruptive and rapidly growing technologies likely this century without consulting these stakeholders borders is really quite contemptuous. I don’t think the EU will ever win more trust and respect if it is prepared to legislate on matters that affect so many people with such insouciance.

    Finally, thanks for all you have done and continue to do. You have championed the real public health imperatives on this issue.

  4. It is clear that the ‘new’ Article 18 was cobbled together at the last minute with every anti-ecig objector’s input included.As Chris Davies pointed out,the Commission have little idea how this new article will work in practice – and neither had the Council nor parliament’s representatives.Saying it will be sorted out AFTER the directive is adopted is surely ridiculous for a measure that could adversely affect over 100m citizens of Europe.2 scientists have now accused the Commission of misrepresenting their work – how clear does the writing on the wall need to be before someone in Brussels grabs the wheel of the steamroller?

    The other articles in the TPD are virtually irrelevant – 2% fall in consumption(equivalent to a 0.6% fall in prevalence) over 5 years is probably optimistic and unmeasurable with sampling techniques.Plain packaging will hurt the tobacco industry – but only by transferring some of their sales to the black market.

    Ecigs sales have been growing rapidly over the last 5 years – the urgency is political not related to public health.The best interests of public health would be served by proper consumer regulation which encouraged use whilst ensuring a minimum level of quality.Millions in the EU have switched away from lit tobacco – no-one has found evidence of any problem.There is no problem to solve,only an opportunity to be squandered by the European Union.This is a battle between democracy and bureaucracy and we have seen who influences bureaucracy.If the European Parliament is ever to gain influence,it has to make a stand on obvious mistakes,otherwise we only need one person with a rubber-stamp.

  5. Thanks for your hard work, Rebecca.

    In my view, getting ecigs out of the TPD and requiring bespoke legislation would be the most appropriate option. This should mean that consultation and risk assessment would be carried out. There would be a chance that new regulations would be harsher than current proposals but that would have to be justified and proportionate. Current regulation as general sales products has been adequate so far and I see no reason to rush away from that.

    This option allows the rest of the TPD to go ahead. I don’t see why it’s important to be honest, it merely fiddles around the edges of tobacco regulation and continues to keep the best proven tobacco harm reduction product known (snus) from consumers.

  6. Thank you, Rebecca.

    As far as the community is concerned, the only acceptable solution is removal of Article 18. This is because it can be interpreted in many different ways, and you can be absolutely assured that the UK Dept of Health will ensure its transposition be accomplished with the worst possible outcomes for EV (electronic vapouriser) users. If a regulation can be interpreted in two ways (which certainly applies to many clauses in A18), then be assured that the UK will implement the least favourable interpretation for us. A18 can be construed to prohibit many normal and effective ecig products, and that is both the purpose of A18 and the way it will be interpreted and implemented in the UK.

    It seems that the best way to remove A18 would be a procedural issue such as lack of consultation.

    Please be advised the ecig community should not be held responsible in any way for any improvement in prospects for the cigarette trade; the guilt for this falls squarely on those responsible for attempting to ban ecigs. Complaints about that part of the result are in any case the utmost hypocrisy: all the industries involved in funding the lobbying for a ban on ecigs, and governments (due to the enormous tax revenues) actively protect cigarette sales at every opportunity. Such pressure is well camouflaged from the public but it should be increasingly obvious to you that public health is not best served by banning something that will probably reduce smoking prevalence by more than 50%, and that the funds for such pressure are commercial in origin, and such initiatives are backed by government approval and in particular by specific government agencies that control the topic area and are very close to the industries funding anti-ecig pressure.

  7. Please also note that the scientists whose work was misused to supply evidence in support of the TPD ecig provisions, Farsalinos and Dawkins, have both issued statements that prohibit the EU from misusing their work; they state that their evidence is misused, misinterpreted, wrongly applied and cannot be used for the purpose the EU have employed it.

  8. It is great that there are politicians supporting sensible e-cig regulation!

    Just a comment on the concern that a delay would strengthen opposition to e-cigarettes. The opposite is more likely. Evidence is now appearing confirming that e-cigs are safe and effective and opinions are becoming more rather than less favorable.

    • In what way is it sensible? Refillables banned and strength limited to 20mg. Cost increased from £5 a week to £60 a week. Perhaps you are being sarcastic?

      • My understanding of Article 18 was that refillables are going to be allowed but the e-liquid must be in a “dedicated” (whatever that might mean) container not exceeding 10 ml.

        More worrying is the IMO highly ambiguous wording and what the compliance costs are actually likely to be for any aspiring e-liquid vendors. The obvious danger is that the costs are so high that big tobacco and big pharma effectively have the market to themselves (this is the intention of course). So as you say, we’ll end up paying the same kind of absurd prices as users of nicorette spray or the BAT vype.

  9. I thank you for writing this guest post and for your openness. But I can’t believe you are seriously discussing options 2 and 3. Ecigs have nothing to do with tobacco! It’s that simple.
    How on earth did they get *in* the TPD in the first place? If I had to guess I’d say that already was Big Tobacco at work.
    The only sane option is to remove Art 18 and all other references to ecigs from the TPD.

  10. You say,
    “Although this would allow article 18 to be re-visited, it would also give tobacco companies another opportunity to chip away at the tobacco control measures.”

    So now we know your real agenda. You appear now to be more a hindrance than a help. We want ecigs out of the TPD.

    I for one don’t care about your Tobacco Control measures and I’m sure that goes for a great many vapers, many of whom originally took it up to get around the smoking ban and accidentally found it was a satisfactory substitute for smoking. I despise the Anti Tobacco Industry and the Public Health Industry in general. I despise their frauduIent statistics and abuse of science, violently disagree with the smoking ban and, although I have switched to vaping, would have the occasional cigarette in a pub if I could. If you want to fight the tobacco industry, do it without our help and don’t consider yourself an ally of vapers if you consider it more important than our pastime not being interfered with.

    • I was wondering what she meant by that too. She talks about the ” tobacco control measures” as if they were a good thing. They’re not in my opinion and I say that as someone who no longer smokes anyway. Why exactly is snus banned across the EU, except in Sweden I gather? Where’s the common sense?

  11. I’ll keep it simple – the only reasonable thing to do were is to get the obviously corrupt article 18 out of the TPD altogether and let the rest of it pass.

    We vapers all know what will happen if this “fudge” of a farce is allowed in any form other than the removal of article 18. This is a ban, there is no other word to describe it and it cannot be dressed up in any other way. It will be used and abused throughout Europe and the rest of the world will follow.

    This looks like the MEPs final chance to get it right. Article 18 out and then do a proper job.

    Millions of lives are at stake. Do you want to be on the wrong side of this decision?

    As others have said – Thank you Rebecca for all you have done for us so far. Please do not reverse all of this good work at what could be the final hurdle by not seeing to it that article 18 is completely removed from the TPD. We are depending on you to ensure our survival,

  12. Here is a start at rewriting
    1. Nicotine strengths must be based on current laws for nicotine 70 mg/ ml in uk
    2. Eliquids containers must meet current laws for toxic liquids e.g bleach
    3. Eliquid diluents must comply with european pharmacopeia
    4. Flavourings in diluents (liquid and condensed vapour) must pass international standard cytoxicity tests at maximum recommended concentration. Initially and at end of shelf life in specified containers.
    5. LD50 for nicotine solution to be determined by scientists, and toxic dose determined.
    6. Ecig users can apply to be monitered by physicians at yearly intervals, and data reported to eu

  13. I have to support the removal of all instances of e-cigs from the TPD and a new directive being established to bring about proportionate and bespoke regulation. Clive Bates has it right. This is a complete mess that will do nothing to help those who have already switched and will drastically reduce the numbers of future switchers. It is probably the most important thing the whole of the EU legislative establishment will consider in a decade, and it must be got right.

  14. “uncertainty about the shape of the post June 2014… Parliament (more Eurosceptics who do not engage with legislation meaningfully?).”

    If the European Parliament is worried – probably rightly – that the people of Europe are intending to send you a huge influx of Eurosceptic MEPs this May, has it occurred to you as a body that you and the rest of the EU may be doing something wrong? Further, has it occurred to you that constantly passing arbitrary, poorly thought out and unnecessary laws may be a large part of what you are collectively doing wrong?

    I know you have fought our corner, but you now seem to be leaning towards accepting this vile compromise that will effectively impose a total ban across the EU on all but the most ineffective devices. If you do that then all your efforts up to now will have been a waste of time. This is not a law that vapers can accept. It’s unnecessary, unjust and based on lies. If the best the EU can do is move us from a perfectly adequate status quo to an end state that’s not QUITE as bad as it could have been, should it even exist? Can anyone deny that vapers are going to suffer from the TPD as it stands, just to save a collection of nit-picking measures planned to achieve a five-year reduction in tobacco consumption that’s a quarter of what e-cigs have managed in ONE?

    The TPD is appalling and the conduct of EU institutions in developing it has been worse. What’s worst of all is the way we’re now being portrayed as ungrateful to our unelected rulers, who have magnanimously decided not to shaft us quite as hard as they might have done. If the EU doesn’t want us to send it another few dozen UKIP MEPs in May it might want to stop treating us with such utter contempt.

  15. Rebecca, you and other right-thinking MEPs have done so much, and we are not ungrateful or unmindful of the efforts which defeated the medicalisation of the e-cig proposal. However, the only people who have had no say in all this, the end-users, are uniting throughout the EU, and we are becoming a formidable force. We are the victims of the stupid nicotine level proposal which the EU falsely claims is “validated” by scientists – and they are being called out by those scientists; we are the people who will have to use the wasteful and ecologically disastrous 10ml bottles – quite unnecessarily – it is tantamount to purchasing household bleach in an eye-dropper bottle – or, more infamously, olive oil! Removal of a non-tobacco product from a Tobacco Products Directive is the only sane and logical course open to us. It is bad law, it has been engineered from day one by those with a very questionable agenda and it has now treated elected MEPs and their decision-making with total contempt.
    Whatever the outcome we will press for option 1 and if it results in delay so be it.

  16. The only rational, evidence based option is to remove article 18 entirely. It is incorrect from the foundation up and is quite simply bad law that can and will cost lives.
    When the authors of a law do not understand the product, have decidedly biased input from NGOs on ideological grounds as the social engineering basis for it, are given distorted and blatantly fabricated science that even the scientific community who did the research dispute vociferously, has not followed correct legal procedure in its creation and still leave it open to be arbitrarily changed by any individual government or group of three, there is serious cause for concern.

    When it is pushed through in order to get another law through that till recently had zero connection to it, it is a travesty.

    Clive Bates has it right. Electronic cigarettes are important enough to deserve their own regulations separate from the TPD. There is no rush.

    If it is worth doing, it is worth doing properly.

  17. Rebecca, you cannot seriously consider this anything close to an acceptable compromise? Ecigs have nothing to do with tobacco or the “Tobacco Products Directive” they need to be removed entirely and discussed separately and lawfully using real scientific fact not biased part fact part fiction. Nothing less than this is acceptable or lawful

  18. If you really see the revised article 18 as a victory for vapers, I can only despair at the lack of critical thinking by politicians.

    To accept article 18 is to accept, and in the future promote, legislation founded on wilfully misinterpreted information, weighted by the interests of multi-national businesses as more important than citizens’ health (no surprise there) and totally ignoring the concerns and interests of engaged voters.

    As has already been highlighted, complaints have already been made by two researchers about the cynical misinterpretation of their research by the Commission. I find it hard to recognise any ‘facts’ in the so called fact-sheet that are based on factual information, just innuendo, ‘fears’, and suspicions.

    It is clear that the pharmaceutical lobby have significant influence on national governments (see Baroness Hayter’s comments on the Lobbying Bill) and quite probably on the Commission. Several of the revised sections in article 18 are so unwieldy that they seem designed to favour large manufacturing/marketing operations, and are unreasonably punitive towards an innovative and fast growing industry that has been built by SMEs. Just imagine demanding in legislation that every new ‘app’ for smartphones had to be presented for assessment 6 months before release to the public.

    At no point, neither while the original proposal was being formulated or in the drafting of the revised article, have the most important ‘stakeholders’ (we users) interests been consulted or listened to. This has led to thousands of voters becoming engaged in the political process, both at EU and national level, only to be palmed off as ‘astroturf’ and largely ignored. We have educated ourselves about the political process within the EU, tried to engage our representatives and democratically influence this legislation, only to see that the whole thing is ‘traded’ behind closed doors.

    Accepting article 18 is to make a mockery of the democratic process, to undermine the relevance, necessity and justness of legislation and, in all honesty, in one go do more damage to the credibility of the EU than the Daily Mail and UKIP could ever hope for.

  19. I don’t really understand any of this politiking or have any strong opinion about what’s best to do. Honestly, I don’t want any regulatory framework for tobacco products or e-cigs. I want individual liberty, individual responsibility, free consumer choice and free market competition. I wish politicians at both the EU and national level could just butt out of our lives and stop trying to “protect” us with regulation. Nanny state tyranny (“protection” as some see it) scares me a lot more than big tobacco, big pharma or unregulated e-cig suppliers. Thankyou for your attention.

  20. Echoing most of the comments ,firstly many thanks for your continued efforts Rebecca . I would personally rather run the risk of having product specific regulation advanced as the desired outcome, with a new consultation and impact assessment process so Option 1 in your list . The other options fudge and muddy the issue which will be a bureaucrats delight BUT will not be in the best interests of present or future consumers whatsoever .

  21. Dear all,

    I am very grateful for your feedback and appreciate your words of thanks!

    I take on board your comments, and am looking into how best option 1 could be implemented. Obviously this does not all depend on me, and so I don’t want to raise any false hopes by committing myself to tabling a plenary amendment which removes article 18. However I am consulting with colleagues and hope to be able to provide you with an update soon!

    Rebecca

  22. I have been intrigued by the technical intricacies l of the requirements of the first proposal from the EU Commission for the renewed TPD and its developments over time, including limits on nicotine. Who could for example assign a maximum nicotine level in the blood not to exceed 2 ng / ml, a normal dose after eating ratatouille? There has been an invisible touch from “experts” from the very start of negotiations.

    “The devil is in the details” : option 3 is utmost risky. The details of the regulation implementation will be set up by groups of “experts”. Where do these “experts” come from? Industry? Do you think they will not have conflicts of interest? I don’t trust them a priori. You should ask for a high level of transparency during that phase, after the political decisions.

  23. Thank you for continuing to listen to us and our rants Rebecca. Whilst I do not agree the current proposition is even close to a victory I do appreciate that you are doing your best.

    Most people; and I include politicians in this; fail to understand how passionate many of us are. This is literally a life and death decision for us. Effectively I believe if the Article goes through in its current form it will mean some of us will die earlier and probably quite horrible deaths.

  24. Vapers hold ‘the high moral ground’ – they have done everything that they have been ordered to do. There is no reason whatsoever that they should be subjected to force.
    The only correct step for the Parliament to take is to to reject the whole ‘tobacco directive’.
    The reason that it is ‘the only correct step’ is that the whole proposition, from start to finish, has been concocted by a single issue group, who, at present, are in control. For example, why does the directive not include a proposition that ‘private bars and clubs’ should be free to offer smoking facilities? Why does it not include a proposition for the widespread advertising and use of snus? Why does it not encourage the use of ‘heating’ rather than ‘burning’ of tobacco?
    In short, why are MEPs allowing themselves to be used by The Tobacco Control Industry?

    REJECT THE WHOLE THING! REJECT THE WHOLE ‘ARYAN’ PHILOSOPHY! REJECT THE WHOLE TYRANNY!
    That is your duty.

  25. Hi Rebecca

    Firstly I just want to say thank you to you for everything you’ve done so far and also for being one of only a handful of politicians who are actively engaging with consumers on this issue. It makes a refreshing change and I’m gutted that you won’t be standing in May.

    I have honestly tried to sit back and look at this problem within the political framework we are stuck with, and whilst I appreciate the fact that consideration must (if you are politically minded) be given to what is possible (i.e. which solution could you gain sufficient support for) sometimes the solution that is possible, despite being better than it could have been, is still entirely the wrong solution. It is so in the case of ecigs.

    I think it has become clear in the last few days particularly, that the limits and restrictions proposed by the draft which emerged from trilogue have no justification in either science or real world experience. Indeed where research has been cited as the basis for the decision the scientists involved have stated publicly that their research has been misunderstood or distorted. Ecigs have the potential to be a game (not to mention life) changer in the world of tobacco related public health and are far too important to be sidelined by the poor legislation which is emerging from this overly rushed process.

    So, despite the fact that I appreciate your concerns regarding support from either EP Or national governments I would urge you find a way to implement option 1. I am confident that with proper consultation with consumers, the industry and experts in the field, an appropriate framework can be found. If we do end up losing the gains we have made so far this will mean that those of us who like me, already use juice at strengths under 18mg/ml and quite often tanks under 2ml, will simply find ourselves in the same boat as the 1/3 of vapers who are already excluded by these proposals. Frankly I can’t think of better company.

  26. Pingback: Flawed science, irregular procedure, unlawful measures « The counterfactual

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