July 5th, 2013

Call to arms on e-cigarettes in the European Parliament (updated)

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Take action: join the Brussels Vape In 10 July at the European Parliament !!  

I did a recent full update on where we are with the tobacco products directive – this posting is a further update to that.  We are now in a crucial period before the ENVI committee vote on 10/11 July and it’s time to get busy… ask MEPs on the  committee to reject medicines regulation as excessive and inappropriate, and to support regulation for e-cigarettes that provides enough confidence in safety and quality but most importantly does not impose so much red tape, costs and restrictions that it kills off the appeal of the products to smokers.

Situation. The various players are haggling over the text that should apply to e-cigarettes – trying to get some sort of compromise hammered out before the crucial votes next week (10/11 July).  The approaches are broadly dividing as follows… Socialist and Green groups seem unable to resist the urge to regulate e-cigarettes as medicines, smothering  a very clever innovation with red tape, costs and restrictions that will make them appeal less to smokers. Liberal Democrats (ALDE group) and UK Conservatives (ECR group) are the good guys so far, and have proposed a much more proportionate approach based on consumer protection legislation – recognising that this gives e-cigs the best chance to compete with cigarettes. The key political grouping is the large conservative European People’s Party (EPP) group .  EPP is split – but how they go will probably be decisive.

Updated 5 July Options in play. There are broadly three options in play, with a default to the Commission’s proposal if none are agreed by a majority of the ENVI committee.

Bad option 1. Regulate everything that isn’t a tobacco product but contains nicotine as a medicine – see 10 reasons why this is a bad idea

Bad option 2. A ‘simplified procedure’ – the rapporteur’s effort to find a compromise, but is basically badly drafted and incomplete medicines regulation in disguise (see my critique)

Good option. The Liberal (ALDE) group and Conservative (ECR) group have come to a common position (see below) – update: great news – the ban on flavours in the earlier version has gone!. The warnings requirement remains excessive  – these are basically safe products and don’t need big warnings to put people off. The table below is a copy of the ALDE-ECR amendment… they will be haggling right to the end so this will probably continue to change. It something that we can live with and much much better than having regulators micro-managing everything. The advantage of this is that it has already built up support – if EPP members will support it, then it could come out ahead.  Any remaining problems could be ironed out before the plenary. The Legal Affairs committee led by Klaus Heiner Lehne (a senior German EPP member) proposed a very good amendment on e-cigarettes in its formal ‘opinion‘ .  This is now replaced by this ALDE-ECR-EFD consolidated amendment.

Amendment 58 ALDE-ECR – EFD Consolidated amendment replacing Amendments 1146 to 1248, JURI 65, IMCO 59, INTA 55, AGRI 69, ITRE 65

Proposal for a directive

1. Nicotine-containing products may only be placed on the market in accordance with the provisions for tobacco products as laid out in articles 5, 17, 20, 21, 22, 23, 24, 25 and 26 of this Directive. Member States shall ensure that nicotine containing products comply with all relevant EU legislation.

2. Nicotine-containing products that are presented as having properties for treating or preventing disease may only be placed on the market if they were authorised pursuant to Directive 2001/83/EC.

3. For all nicotine-containing products notified in accordance with the procedure set out in article 18 (1), Member States shall ensure that:

(a) the product is clearly labelled with the nicotine content, instructions for use, instructions for reporting adverse reactions, and details of the manufacturer;

(b) each unit packet and any outside packaging shall carry the following health warning: “This product is intended for use by existing smokers above the legal smoking age as an alternative to tobacco products. It contains nicotine which is a highly addictive substance. Consult your doctor if you are pregnant, breast feeding, allergic to nicotine or propylene glycol, or have high blood pressure.”

(c) the sale of the product shall be restricted in line with the legal age for sale of tobacco products in the relevant Member State;

(d) the products shall be available to be sold outside pharmacies; (e) advertising and promotion shall be appropriately regulated;

4. The health warning referred to in paragraph 3 shall comply with the requirements specified in Article 10. In addition, it shall:

(a) be printed on the two largest surfaces of the unit packet and any outside packaging;

(b) cover 30 % of the external area of the corresponding surface of the unit packet and any outside packaging. That proportion shall be increased to 32 % for Member States with two official languages and 35 % for Member States with more than two official languages.

5. Member States shall monitor the development of the nicotine-containing products market, including any progress made in harm reduction, as well as any evidence of gateway use amongst young people. Based on the evidence, the Commission shall report back to the European Parliament and the Council 5 years after the transposition date of this Directive. The report shall assess whether amendments to this Directive are necessary;

6. The Commission shall request an opinion from the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) within 24 months of the entry into force of the Directive in order to obtain reliable scientific and toxicological data to determine the health effects of the main ingredients of electronic cigarettes as well as suggestions for potential measures to regulate this tobacco related product.

What to do? If you want to influence the decision then this week is critical.  E-mail, tweet including MEPs name, meet the MEPs, stir up the local papers, and make sure these remote legislators know what you want – they should be listening, there’s an election in May 2014.  Join the Brussels Vape In 10 July.

My talking points would be:

  • Medicines regulation is grossly excessive, and in any case these products are not medicines, either legally or as a matter of common sense
  • Why make it harder to sell e-cigarettes than cigarettes? Why impose more red tape, costs and restrictions on the products that can free people from smoking?
  • Why use a form of regulation that will destroy the very things that has made e-cigarettes a success – innovation, diversity, niche products and consumer enthusiasm?
  • Please do not support any approach that is or looks like medicines regulation
  • Please do support any approach that provides a sensible level of protection but leaves it to consumers market to decide which products
  • Banning flavour is totally counterproductive – e-cigs are basically flavoured nicotine products, and it is good you can get them in flavours other than tobacco
  • There are virtually no risks to children or any other downsides associated with e-cigarettes – they are always better and far less risky than cigarettes
  • Ask where they stand and why, tell them how much it matters to you

… but you should always use your own ideas and words, and add you own experience and concerns. You can also draw on my own letter to MEPs: 10 things to think about before you vote sent 4 July.

Who to contact: You can write to your own MEP (use writetothem.com).  MEPs on the ENVI committee are particularly important at this time, and you can write to them as they are making the decisions. MEPs on the ENVI committee and part of the EPP group are the most critical of all – there are no UK MEPs in this group, but if you are reading from other members states, especially Germany, please act now!!

Feed the fire – leave comments and feedback here and spread the news to other forums.

18 comments to Call to arms on e-cigarettes in the European Parliament (updated)

  • Mick, you’re making a fundamental error: that common sense and logic will rule the day! Actually it is arguments like those that you have articulated very well here that have been winning the day in court and why almost no-one other than the health lobby and civil servants thinks this makes any sense. If you are interested in seeing how these arguments are winning in court have a look at my briefing Are e-cigarettes medicines?.

  • There is a reason why e-liquid cannot be a medicine… its not a medicine wheter its touted as one or not becasue it does not have any medicinal properties. There is no pharmacology or ingrediants in e-liquid that would result in an alleviation of addition to nicotine. The only active ingrediant with any relationship to nicotine addiction is nicotine…and thats hardly an ingrediant that is medicinal in causing cessation for nicotine addicts.

    Now I say this as a nicotine addict myself. More nicotine is not in any way a cure for my addiction. I’d go further and point out that the same applies to gum and patches…they have no medicine in them but are regulated as such. Those licences need to be removed.

    This entire regulation as a medicine is the sole result of people considering the ‘behavior’ of nictonie addicts as the disease. The behavior is called smoking… its not the disease its induced by the disease. Smoking is not a disease and hence cannot have a medicine that will control it. Rather it is nicotine addiction that is the deisease. Why is this so hard to understand? Has nobody advised any of these EU members of their clear mistake in not understanding the basics of pathology of disease?

    Since e-liquid and electronic cigarettes cannot in fact impact on this disease except by the addict themselves using them cleverly to reduce their nicotine intake slowly. Or by a doctor perhaps producing a program based on research to do the same, then any talk of these inventions being medicinal is in danger of opening a can of worms that will not close.

    Heres what will happen. electronic cigarettes will be labeled a medicine becasue they are cited as being sold as a cure for smoking (which is not a disease). Added to this I and others will then point out other products that claim precisely the same and will need to be classified as ‘medicines’ too. Those would be Homeopathy, Hypnosis, Accupunture, Praying, etc. etc.

    Now if this can of worms is to open fair engouh but I really do feel that the religions of Europe might have something to say about prayer only legally being allowed to be practiced or sold by priests, imams or rabbis with a licence from the EU as the activity being suggested is medicinal. Same with hypnosis etc.

    All ready to open the can are we?…Just becasue the difference between a behavior induced by a disease and the disease itself are delibrately conflated? Is that the way it really needs to go?

    Added to this of course since it’ll be applied so stricktly its imortant to note that tobacco products themselves are included here. They need to get a license…as a medicine. And show their efficacy in preventing this disease and of course their safety.

    Anyone think cigarettes can demonstrate their safety?

  • Thankyou again for all this information, set out in such a clear, concise way. Without it I would not be able to keep up with this at all. Much much appreciating your work.

    I have used this information to enable me to write to my MEPS on the subject. Lets hope that all this hard work bears some fruit. I feel a little confident that it will. Especially after seeing the presentation that was made at the press conference in Brussels on vapertrails.tv last night.

    Great job!

  • […] For further information regards this situation, please visit Clive bates very clear and informative page here […]

  • […] especially EPP members if you are outside the UK. No pressure is too great – but remember always keep it personalised, polite and on the point. Every politician has grown weary of mass form letter mailings, foaming ranters and conspiracy […]

  • […] EPP members if you are outside the UK. No pressure is too great – but remember always keep it personalised, polite and on the point. Every politician has grown weary of mass form letter mailings, foaming ranters and conspiracy […]

  • Just used the writetothem site to blast all the Yorkshire & the HUmber MEPs with the AIDUCE pdf.
    Plus a plead for them to remeber in these austere times in their region any legislation regarding e-cigarettes is more likely to increase the cost at a time when their constituents can least afford it.

    • Dodderer

      I hope you didn’t blast all of them – Rebecca Taylor and Godfrey Bloom are on our side!Ms McA is still searching for the way,the truth and the light!

      On a more serious note,given the small, uncertain benefits of the ‘tobacco’ bits,there would be a significant public health gain from dropping the whole proposed revision – Yes Commissioner?

  • Jonathan Bagley

    I congratulate AIDUCE on its excellent report. Yesterday I emailed my (Yorkshire and Humberside) MEPS. I have received a very supportive reply from Rebecca Taylor. Anyone thinking of contacting their MEPs in the few days remaining before the July 10/11 vote might consider providing a link to the AIDUCE report, which covers, safety, strength, flavours, comparisons with NRT and all other aspects of ecig use with great clarity.

    • Clive Bates

      I totally agree – it’s a great report. Also, something very good happened in the Council – France raised an objection to medicines regulation.

  • Humph

    In France we’re also doing our bit! Here’s a letter the French electronic cigarette users’ association sent to ENVI MEPs a few days ago. It seeks to present the experience and testimony of tens of thousands of vapers and comment upon the nature of the debate on electronic cigarettes.

    http://www.aiduce.fr/AIDUCE_ENVI_EN.pdf

  • I’ve translated your text into german and published it on my blog.

    http://blog.rursus.de/?p=799

    furthermore, posted the links in several forums!

    Feed the fire – spread the word!

  • Anonymous

    I tried my best to come up with caption, but your talking points are exactly what I think people need to communicate to MEPs. Would you mind if people spread this picture? i.imgur.com/i8aPt1b.jpg [updated]

  • Zillatron

    In Germany you may use the abgeordnetenwatch.de platform to publicly ask your MEPs. Link to the page for ENVI

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