February 5th, 2014

Tobacco directive – surgery needed to remove harmful e-cigarette text

schulz

European Parliament President Martin Schulz MEP – he has work to do

Procedural position. The difficult situation with the Tobacco Products Directive is summarised very well by Martin Callanan MEP – here.  The only way to reverse some of the absurd, impractical and excessive regulation of e-cigarettes now built into the Tobacco Products Directive is to have the MEPs vote for/against individual parts of the directive, in what are called ‘split and separate votes’ in which Article 18  or some part of it can be voted down so it can be done again, properly.  It seems that even at ‘first reading’, it is not possible to amend this text because it has been blessed by the ENVI committee. We know with reasonable confidence that the various weird restrictions, prohibitions and burdens will diminish the appeal of e-cigarettes and protect cigarettes, while doing almost nothing for health. If it is not possible to treat the harmful text with sensible amendments, then surgery is required to remove it.  And the time to press for that is now…

Write a letter… soon!   This won’t be easy, not least because the decision on whether to allow split or separate votes rests with one man, the President of the European Parliament, Martin Schulz MEP. But if you feel strongly about this, then you should be relentless in pressing for the right measures to the very end – this is what tells politicians you are serious.  So I have written to Mr Schulz and the political group leaders, and I hope you will too… soon!  My letter is below, but as always: you are free to draw on this, but please use you own words and experience; keep it polite and constructive – I want good regulation not no regulation; avoid expounding conspiracy theories; and assume the people you are writing to will read it in good faith and are willing to be persuaded.   I’ve written to Martin Schulz and the leaders of the main political groups: click this link to send an e-mail to the President, CC: Political Group Leaders and also to my MEPs via via writetothem.com (UK only).  And don’t forget Twitter: @MartinSchulz

Timing update. Latest rumours are that they are running towards first reading (= last reading) in Strasbourg 24-27 February (not yet definite, previous assumption was 10-13 March). This means key decisions will be taken in the group week before, and possibly the decision on split vote taken before that – ie. very soon.

_________________ TEXT OF LETTER __________________

To: President of the European Parliament:Martin Schulz MEP (S&D) [contact form for President]
CC: Political Group Leaders: Joseph Daul MEP (EPP); Hannes Swoboda MEP (S&D); Guy Verhofstadt MEP (ALDE); Rebecca Harms MEP & Daniel Cohn Bendit MEP (Greens-EFA); Gabrielle Zimmer MEP (GUE-NGL); Nigel Farrage MEP & Francesco Enrico Speroni MEP (EFA)

CC: My own MEPs 

Re: Tobacco Products Directive and e-cigarettes – 

Dear Mr Schulz

I am writing to ask you to use your authority and experience to address a serious problem regarding the regulation of e-cigarettes through the tobacco products directive.  As it stands, Article 18 of the directive contains a number of measures that will cause more harm than they prevent.  Many MEPs have come to understand these products well over the last year and recognise their great potential to reduce smoking related disease and death.  This potential will be squandered, and lives lost as a result, if badly designed regulation is agreed by the European Union.  I would like to urge you therefore to allow split and/or separate votes on Article 18 at the European Parliament’s first reading.  I also hope you will lead by example, by voting against Article 18 so that better regulation for e-cigarettes can be developed while the rest of the tobacco products directive can proceed to a conclusion.  In support of this, I would like to invite  you to consider the following concerns:

1. No consultation. E-cigarettes and related products are used by 8-10 millions Europeans, now involve thousands businesses and are the subject of intense research efforts in the expert community. It simply is not credible to produce 4,500 words of new regulation in a closed and insular process between October and December 2013 with no consultation with these stakeholders. Not only has that led to poorly designed regulation, but it violates obligations set out in the EU treaties, which require consultation on legislative proposals (see Article 11 TFEU, Article 2 Protocol 2). On what basis can the Parliament simply ignore these obligations and proceed with poor regulation regardless?

2. Flawed science, inadequate analysis. For EU legislation to be good for public health, and therefore to have a firm legal base, it needs to be based on sound science and analysis.  To the extent that science has been used to justify the proposals, it has drawn stinging criticism from the scientists whose work has been cited. See: Scientific errors in the Tobacco Products Directive – a letter sent by scientists to the European Union and follow-up The supporting analysis for this part of the directive is completely inadequate: there is no impact assessment or credible justification for the measures.  The little there is (a one page fact sheet) has been dismissed by experts as a set of scientifically illiterate baseless assertions. Again, the treaties require proper justification and comprehensive impact assessment and none has been done (Article 5, Protocol 2).

3. Measures that will cause harm.  There is no logic or scientific basis for imposing a limit to nicotine strength of 20mg/ml – about 25% of users use liquids stronger than this, and there is no basis for preventing the trade in these products.  The stronger liquids are important to heavier smokers and to people as they make their first switch into e-cigarettes.  The result of this limit will be less switching and more relapse to smoking. The result: more disease and premature death.  Further harms are likely to arise from a black market forming in stronger liquids – this will of course be uncontrolled and potentially cause further harm.  Measures that restrict the free movement of goods are justifiable under the legal base if they protect health, but not if they increase harm.

4. Measures that invite ridicule. The wide range of flavours is integral to the e-cigarette market and it is good news that flavours will be allowed under the directive.  However, convoluted drafting has created a legal fiasco. Vendors can sell flavoured products but cannot say what the flavour actually is on the packaging.  This is the sort of ‘straight banana’ regulation that makes the European legislature a laughing  stock and feeds anti-politics movements. 

5. Measures that protect the cigarette market. The directive bans most forms of advertising,  treating e-cigarettes in the same way as tobacco. This will have the highly undesirable effect of protecting the cigarette market from competition from much safer products.  It will impede free movement of goods, inhibit innovation and limit the appeal relative to smoking.   The justification for banning tobacco advertising rests on the reality that smoking kills over half a million Europeans annually (see recital 3 in 2003/33/EC).  No such justification exists for e-cigarettes, which are actually reducing death and disease by reducing smoking.  The advertising provisions blatantly fail the ‘proportionality’ test of the EU treaties. A regime more like that used for alcohol advertising would be proportionate, but not outright bans – and the e-cigarette industry has many constructive proposals for regulation of marketing. Similar concerns apply to excessively large and bold warnings and packaging leaflets.

6. Measures that introduce arbitrary clashes with other EU legislation. The directive creates a new approach to handling potentially dangerous substances – by limiting container size, apparently to with the aim of keeping the volume of contents below an (incorrectly) estimated lethal dose. In doing so, it is more likely to have created an increased choking hazard than protected anyone at all.   The European Union has a well established approach to handling hazardous substances through the 1272/2008 Classification, Labelling and Packaging (CLP) Regulation, and that is all that is needed for nicotine liquids. Imagine if we controlled the risks from household bleach or drain cleaner by reducing the container size to a few millilitres?

7. Measures that should be included but are missing. It would have been useful to have some standards, or at least a standard-setting regime, for the purity of e-liquids and operational parameters of e-cigarettes. These would build confidence in the products and bring about efficient standardisation.

Insist on a new proposal. This letter is not intended as a full critique of Article 18 – sadly, there is more to say about excessive technical requirements, information demands that have no purpose, and discriminatory burdens placed on e-cigarette makers that are not placed on cigarettes.  But I hope this is sufficient to explain why many well-informed MEPs should wish to pause and see the regulation of e-cigarettes done properly.  Now is the time to insist on a new Commission proposal that is properly researched and assessed, and, above all, formulated with the benefit of consultation.

Timing. There is no ‘crisis’ that demands immediate action and no manifestation of theoretical problems raised by some opponents of e-cigarettes are visible.  The European Parliament was correct to reject an excessively burdensome and ill-fitting medicines regulation regime for e-cigarettes. However,  at that point further work was needed to develop an evidence based, pro-health, legally robust alternative.

Given these doubts and controversies, and the public interest in the issue, I can see no justification in denying MEPs the option to vote separately on this part of the directive. If MEPs are concerned – and they have good reason to be – then they should be given to option to make the right decisions at first reading.  In October, the European Parliament plenary showed its independence and its willingness to listen to voters and those affected. There is a good case for that to happen again. I hope you will show leadership and allow split and/or separate votes and lend your support to removal of Article 18 so that it can be done properly. 

Yours sincerely

Clive Bates
Counterfactual

Covering note to copy to my MEPs.

Dear London MEPs
As London constituency MEPs, I thought you would welcome sight of my communication with the president and political group leaders on the subject of e-cigarettes and what an utter mess the tobacco products directive has created. I hope you find this briefing letter useful as you consider how to vote.  I would be grateful if you could make a representation to the President to request a split or separate vote on the provisions relating to e-cigarettes, or let me know if you think this is inappropriate.
It is distressing to see such poor legislation and egregious violation of the treaties. I hope you are willing to take a principled stand and do something about it.
Clive Bates
[my address]

15 comments to Tobacco directive – surgery needed to remove harmful e-cigarette text

  • Wow, that’s what I was looking for, what a material! present here at this webpage, thanks admin of this website.

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  • mike adkins

    copied sent with slight mods and my additions , i found the link does not ork for me so sent it via email to

    [email protected]

    Dear Mr Schulz

    I am writing to urge you to favorably think about and consider the ECR group’s request to open up the Tobacco Products Directive revision to a split and separate vote.

    I am very concerned about the illiberal, anti-competitive, disproportionate, and even legally questionable (in terms of inviting costly legal challenge) measures contained in the TPD amendment with respect to electronic cigarettes and thier components

    As a user of of e-cigarettes, who has successfully given up smoking thanks to them after a 35-year habit, I am not prepared to see this revolutionary harm-reduction technology restricted or made ineffective on ideological grounds /personal agendas

    As has been documented by many observers, including foremost Clive Bates, the ex-director of Action on Smoking and Health UK, the procedure followed in formulating the current TPD amendment is deeply questionable. Scientific opinion has not merely been ignored but wilfully misrepresented (as the scientists concerned have made clear in public statements); there has been a complete lack of transparency about the rationale for the new measures, and a complete absence of consultation or impact assessment.

    This kind of lawmaking brings the EU (of which I am still a reluctant supporter, in principle) into disrepute. I urge you to use your powers as President, as well as your political influence, to rectify this situation and allow the European political bodies the opportunity to revisit the question of e-cigarettes soberly and reflectively, to continue as is will create a black market/underground witht he real associated issues therein

    There is a good case for sensible regulation that could both protect public health and promote a stable, diverse, truly competitive market in these revolutionary products. The current measures in the TPD amendment are as far from this kind of sensible regulation as can be imagined. E-cigarettes and their components should be removed from the current TPD amendment, allowing the amendment to be examined on its other merits or demerits, and made the subject of a new legislative process, following the due process we expect from a democratic institution. end of the day the claims that tobacco is dangerous pales when you have such total disregard for something that is far far less dangerous, is proven to have a better result than nrt for those that wish to use them for such, the whole senario im afraid in my and and many other peoples thoughts is this tpd is based around corruption within the eec, or at least selective vision , you have the chance to grossly improve world health, or do you and your fellow meps wish to be remembered as `angels of death` who forced those that vape back to cigarettes, please dont have the assumption it wont happen, it will and in droves

    regards mike adkins

  • Martin Cartwright

    I wish to add that I and many of my friends & family have also given up smoking tobacco after years of also failed attemtps, Ive even a friend who’s grandma gave up at the age of 68 years old after smoking tobacco for 50 years and after 2 months using an Ecig her cough that was terrible is fading away, she also feels so much better in health as im sure we would all agree that we do since turning to the wonderful Ecig, this is only from my experiences and I know there are so many that vaping has helped it would absoloutly disastous for us all

  • davederby

    vaping has helped me give up smoking after many failed attempts with tablets nicotein gum stuff like that and I love using my ecig and don’t want to loose it and can say that article 18 will be disastrous for me and many other vapers

  • Thbb

    Thanks for this informative letter, as always. Following you’re suggestion, I’ve written to Schulz and his representatives. Considering this letter has more chances of being read here than in Strasbourg or Brussels, I feel compelled to paste here, as some of its elements coud be reused. The stuff on the EFVI notably, which may have the power to make them think.


    Dear Mr Schulz, dear representatives,

    On February 26th, you will be called to vote again on the Tobacco products directive. Like the in the former directive on the subject proposed in the last fall, the article 18, which legislates on e-cigarettes, is ill-informed, ill-designed and not ready for approval.

    You may have taken note of the letter by recognized tobacco experts, stating that their own research had been misinterpreted and deformed in justifying the current dispositions you are to vote on.

    You may also be aware of the European Citizen Initiative for Free Vaping, which aims at proposing a properly designed directive on this topic to your very legislative body, and is starting to catch serious steam.

    This initiative will be designed by e-cig users and for them and their blooming industry which promises to finally succeed at curbing the nuisances of tobacco. It will be grounded in science and the will of the European people foremost, as legislation is supposed to. It will leverage the unique and innovative tool that EU Citizen initiatives, as defined by the Lisbon treaty, promised to enable. It will showcase this device and its ability to improve our democratic process in general.

    Should this follow-up directive pass and be voted by the next legislature, a vote that would let the current Article 18 pass as-is would not shine in the legacy record of your legislature.

    This is why I urge you, together with many other European citizens supporting this initiative, to

    – allow split and/or separate votes on Article 18 at the European Parliament’s first reading.

    – lead by example, by voting against Article 18 so that better regulation for e-cigarettes can be developed while the rest of the tobacco products directive can proceed to a conclusion

  • sebt

    Thank you to Clive Bates for keeping up with the dizzying complexities of this.

    My email to President Schulz:

    Dear Mr Schulz

    I am writing to urge you to favourably consider the ECR group’s request to open up the Tobacco Products Directive revision to a split and separate vote.

    I am very concerned about the illiberal, anti-competitive, disproportionate, and even legally questionable (in terms of inviting costly legal challenge) measures contained in the TPD amendment with respect to electronic cigarettes.

    As a user of of e-cigarettes, who has successfully given up smoking thanks to them after a 23-year habit, I am not prepared to see this revolutionary harm-reduction technology restricted or made ineffective on ideological grounds (e.g. through scientifically baseless nicotine-concentration restrictions, or restrictions on the type of equipment allowed, based on some concocted exaggeration of the risk of skin contact with relatively low concentrations of nicotine).

    As has been documented by many observers, including foremost Clive Bates, the ex-director of Action on Smoking and Health UK, the procedure followed in formulating the current TPD amendment is deeply questionable. Scientific opinion has not merely been ignored but wilfully misrepresented (as the scientists concerned have made clear in public statements); there has been a complete lack of transparency about the rationale for the new measures, and a complete absence of consultation or impact assessment.

    This kind of lawmaking brings the EU (of which I am still a reluctant supporter, in principle) into disrepute. I urge you to use your powers as President, as well as your political influence, to rectify this situation and allow the European political bodies the opportunity to revisit the question of e-cigarettes soberly and reflectively.

    There is a good case for sensible regulation that could both protect public health and promote a stable, diverse, truly competitive market in these revolutionary products. The current measures in the TPD amendment are as far from this kind of sensible regulation as can be imagined. E-cigarettes should be removed from the current TPD amendment, allowing the amendment to be examined on its other merits or demerits, and made the subject of a new legislative process, following the due process we expect from a democratic institution.

  • Thanks for sharing it. I’m sending a copy of this letter straight away.
    Cheers,
    Emil

  • Chris D

    The content of my email if it is of any interest…

    Dear President Shulz

    Re: Tobacco Products Directive, Article 18 – without prejudice

    I make this request in writing, by email communication, ahead of any decisions taken on the Tobacco Products Directive.
    Article 18 of the Directive includes a number of components that are counter-intuitive to the aims of the Directive itself, in my opinion. I am hereby requesting that you make necessary the provision to allow MEPs to vote on split and/or separate elements of Article 18 in order that the proposition for tobacco products can go ahead without the infringements being afforded to ecigarette products.

    From my personal research garnered over the previous 18 months, I contend that it is the right and proper course of action to allow more time for further research into the benefits of switching from tobacco smoking to inhaling partial nicotine vapour. From early indications, it would appear that the pre-sustained research consensus would suggest that prohibiting easy access to these ecigarette products would lessen the likelihood of transfer from tobacco products and consequently strengthen the ongoing use of tobacco. In addition by prohibiting the use of the more successful types and ranges of devices that are developing, it is again almost certain that the Directive will drive people away from switching. The result of which would surely be outside the aims of the Directive.

    As I have not been involved in a consultation on this subject, I have not had time to prepare any compelling single arguments without acceptable risk or clear substantiation though it would seem clear that the proposition being codified is somewhat counter-productive.

    As a result of such inadequacy of time or consultation, I ask that you make the above mentioned provision to allow MEPs to vote in the manner mentioned and prevent what appears to be a certainty to be otherwise a hard-driven and uninformed Directive.

    I sincerely hope and trust that you, on reflection, will help to support better informed and researched regulation by considering and enacting my request.

    Yours faithfully

    Chris Dyson

  • Chris D

    Many thanks Clive for your efforts and also for bringing them and the deadline/s to our attention. I wished there was some cohesive way of co-ordinating the efforts of so many people who vape to establish a congruent series of messages that could be used to communicate our position in addition to the letters we write. I have written to my local Member of Parliament and received no reply whatsoever. I will put together an email to President Shulz in the hope that it reaches him and is taken into consideration. Do you have any other way/s of strengthening the Vaper’s Voice? Through social media or the like to try and draw more attention to the subject than the mainstream media have so far given it? I’d be happy to join forces if we could generate something creative that could be shared throughout the vaping community. I know these things take time and perhaps there is little of that but it feels that something more public needs to be done to generate sufficient momentum to turn political heads. Your thoughts appreciated. Chris.

  • I hope everyone will write. One letter is easy to ignore. 1000 letters not so easy… Even the sullen unresponsive one need to hear from the people who vote them in. I just don’t think they are that used to it… locked away in their bubble in Brussels surrounded by 6000 registered lobbyists…

  • Cliff

    Brilliant letter Clive as usual ,let’s hope he reads it and understands the importance .

  • mav

    Do we play Operation with this TPD, or do we try to rip the entire thing out and start again?

    If we can rip it out and do it properly, of course that would be best, but which option is actually more realistic in terms of getting those 76 votes come March Plenary.

  • Irish Lass

    Great stuff, Clive. Sadly, I have written to my MEP – Martina Anderson – but got no reply, despite several attempts. I have also written to my Alliance Party MP, Naomi Long, hoping that she might at least lobby in the UK Parliament (since Alliance have no MEPs); but she takes the view that she is “not willing to take the risk” that e-cigarettes may perhaps prove – 20 or 30 years down the road – to be harmful to health. Nothing I could say to her – including that the real risk was to the lives of those wishing to exchange smoking for vaping – would change her mind on this. I won’t give up altogether, but will now limit my attempts to writing to Mr Schultz and the political group leaders. Fingers crossed, but no breath being held. My faith in politicians is at an all time low.

  • […] Procedural position. The difficult situation with the Tobacco Products Directive is summarised very well by Martin Callanan MEP – here. The only way to reverse some of the absurd, impractical and excessive regulation of e-cigarettes now built into the Tobacco Products Directive is to have the MEPs vote for/against individual parts of the directive, in what are called ‘split and separate votes’ in which Article 18 or some part of it can be voted down so it can be done again, properly. It seems that even at ‘first reading’, it is not possible to amend this text because it has been blessed by the ENVI committee. We know with reasonable confidence that the various weird restrictions, prohibitions and burdens will diminish the appeal of e-cigarettes and protect cigarettes, while doing almost nothing for health. If it is not possible to treat the harmful text with sensible amendments, then surgery is required to remove it. And the time to press for that is now…  […]

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