July 22nd, 2013

A dog’s breakfast

dogI was trying to pen some wonkish words about the state of play on the tobacco products directive now the European Parliament scrutiny debate, Council General Approach and Commission proposals are all done. But then I thought: no, why dignify all this?   In a crowded field, it’s possibly the worst legislative mess I have ever seen – a gargantuan dog’s breakfast, a gluttonous feast of uncooked ideas unfit for human consumption.  It’s hard to express just how incoherent the main measures in the proposed tobacco products directive really are. But here we go….

The least dangerous, most promising, fastest growing nicotine products (e-cigarettes) with the greatest public health potential are to be barred from the market unless authorised as medicines (Article 18), which they aren’t and never will be. They will be subject to an onerous regulatory regime increasing cost, limiting choice and appeal, holding back innovation and generally making the products less competitive relative to high-risk cigarettes. The views of the users and supposed beneficiaries of e-cigarette regulation are to be ignored and the opposite of what they want will be done.

If someone wants to bring a low risk nicotine product to market, they should make sure it contains tobacco – all they have to do for a novel tobacco product (eg that heats rather than burns tobacco) is to let the authorities have some information about it (Article 17). Nothing wrong with that, except the contrast with the extreme regulatory burdens of Article 18 on e-cigarettes.

That is unless the tobacco product in question is snus, the least dangerous tobacco product in earthly existence, in which case it is banned completely everywhere but Sweden (Article 15), where it has delivered a spectacular public health success. Apparently the EU is determined to prevent replication of this success anywhere else and for any individual who might wish to try it on their own initiative and at their own expense. This product is banned because it is put in the mouth and sucked rather than chewed (Article 2.32), even though it is less toxic than many forms of chewing tobacco and much less toxic than smoking.

Cigarettes can be put on the market pretty well at will, as long as they meet some easy and irrelevant tests for smoking machine measured ‘yields’ (Article 3 & 4), the results of which are no longer to be printed on packs because they are misleading (Article 12) because, unsurprisingly, humans and machines use nicotine in a different way (the former controlling the dose). That difference was known when the last directive, 2001/37/EC, was written, but it still required these totally misleading numbers to be printed on packs.

Cigarettes are to be generally allowed,  except the five percent of cigarettes that are flavoured, mostly with menthol (Article 6). They will be banned – apparently because of the fake folk wisdom that ‘tobacco should taste like tobacco‘ (Commissioner Borg is fond of this justification). We have no reason to believe they are more or less toxic than other cigarettes and they can’t be inherently more attractive or more people would use them. It’s just that different people like them and these different people are to be protected by being required to switch to unflavoured cigarettes. In this way, the EU will choose a small group of consumers to annoy, because it can.

Something will be done with additives (Article 6), but no-one really knows what or what effects, good or bad, whatever is done will have on smoking behaviour. No-one designing this legislation has a Scooby-Do about nicotine psychopharmacology but they are changing product formulation with hapless abandon. Less addictive nicotine sounds clever until you realise smokers are looking for a satisfying shot – so ‘less addictive’ might mean more is needed, more exposure to smoke and more ill-health. Who knows? I don’t. They certainly don’t.

The labelling of products will carefully avoid providing the most useful consumer information about e-cigs and smokeless tobacco (Article 8-11) – namely that they are 90-99% less risky than smoking, and will instead reinforce an undifferentiated message that all these products are harmful and addictive. In fact, the directive goes further and makes it illegal to suggest that a particular tobacco product is less harmful than others (Article 12) – even though this is actually true – there is an approximate 100-fold range in risk. Consumer are basically mislead by the evasions and lack of insight into relative risk.

Much political wheel spin will go into whether warnings cover 50% or 75% of the pack (Article 9), though there is nothing to suggest the difference is a matter of life or death or has any effect at all.

There will be a passionate row about whether the phrase “Cigarettes with a diameter of less than 7.5 mm shall be deemed to be misleading” is as insane as it sounds (article 12) – as if a covert fatty was passing itself off as an athlete. Perhaps the theory is that ‘slim‘ cigarettes signify that smoking makes you thin and this somehow makes girls smoke? Only the most tenuous evidence for that… But wait… what if smoking does cause weight loss? Would it be misleading to pretend that it does? It does. Oh dear.

Teenagers will be infantilised, girls will be patronised, and the experimental experiences of adolescence will be misunderstood – but children will repeatedly evoked as a ‘force majeur‘ argument to override the deficit of evidence, ethics, legality and common sense. We will be endlessly reminded that 90% of smokers start before age 25 – as if discovering that adolescence precedes adulthood is an insightful revelation on which to base tobacco policies.

You couldn’t make it up…

Please focus on what matters and try not to get that quite so wrong.   The Commission estimates (Impact Assessment Annex 5) that the package will reduce consumption by just two percent – the same as a fall in EU smoking prevalence from 28 to 27.4 percent – ie. in the statistical noise. Yet analysts now forecast that e-cigs could overtake cigarettes within 10 years. If that happened it would create one of the biggest public health wins of all time and without coercive policies or loss of liberty through banning things. Legislators just need to get the regulatory framework right, properly proportionate, non-discriminatory and risk-based. They need to recognise the importance of the commercial freedoms of e-cigarettes makers in taking on the entrenched cigarette oligopoly and their market share is closely aligned with public health results.  So that would be about the opposite of the dog’s breakfast they have heaved up all over irritated, despairing, and ever more hostile European citizens.

My serious point is that this utter mess is more or less the outcome of months of highly remunerated work of the civil service elite of the European Commission, regular intensive meetings of dozens of officials from the member states and several months of scrutiny by a European Parliament Committee.  As a former  civil servant myself, I look at the quality of this work and think all involved should be professionally ashamed.  If anyone can come up with a worse piece of European legislation, I’d like to hear about it. Let’s hope it is fixed or patched up before it becomes law, or else sent back to the drawing board to start again from scratch after the 2014 Euro elections – not by any means the worst outcome.

Doesn’t the public really deserve better?

27 comments to A dog’s breakfast

  • […] for MEPs to study the text and opinions and to design and win support for amendments to address the numerous flaws in the […]

  • Paul the happy vaper

    I really don’t think they have thought about the knock on effect of there proposed legislation. Would bring about the same effects as Prohibition in the 30’s. it would create a massive black market, making criminals rich and then heaven knows what would be in the liquids then! I am all for some form of regulation on e liquids so we know they are safe and not made in people’s garden sheds, but going to the extent of trying to make them medical is totally ludicrous.

  • […] for MEPs to study the text and opinions and to design and win support for amendments to address the numerous flaws in the […]

  • […] to her officials – but she had no reason to. They have managed to create one almighty dog’s breakfast of a tobacco directive and to drop her in it procedurally. It looks like civil servants have been […]

  • Zillatron

    And now for something completely different: “Always look an the bright side of life …”

    Even if the texts are in german, our hope hit the bullseye with her pictures: http://www.e-rauchen-forum.de/thread-67084.html

  • Zillatron

    Do the ENDS justify Mean?
    WHO cares?

    I don’t think so …

  • Robert L.

    They should be proud to trying to save lives when others, like you, want people to continue smoking and dying.

  • […] given a view on what an incoherent piece of regulation is emerging from the European institutions – a gargantuan dog’s breakfast, and McAvan bears some of the responsibility for that. There’s a lot in this and he does a […]

  • Andy Morrison

    The problem in fighting this is that the case against the regulators is far too disjointed. I’ve lost count of how many petitions and letters i’ve been asked to sign up to since all this started kicking off. What this needs is for someone to lead from the front and gather everything in. Is there anyone out there who can do this?

    • Clive Bates

      Andy… Don’t despair – all that activity is paying off. Three political groups in the European Parliament are listening and a fourth large bloc is more sceptical. The diffuse campaigning is more effective than you might think because it is authentic and quite ompelling in a way that slick orchestrated campaigns are not. That doesn’t mean there aren’t people taking on ‘soft leadership’ – I think Dave Dorn of VTV is doing a good job for example, and he’s not the only one. The tone of overage in the media is changing – and vapers are on to every ridiculous story in seconds. The companies are getting more professional and better aligned. The public health community is backing off.

      None of this to say success will be easy or likely… and the issue may eventually be settled in court. But opinions are definitely shifting, understanding is increasing, and we are making progress.

  • “If someone wants to bring a low risk nicotine product to market, they should make sure it contains tobacco”

    This suggests an approach like the JTI Ploom, or the Discreet tobacco e-cig, or a re-vamped Accord.

  • Many thanks for that! It’s great to sense your extreme irritation in that piece, especially when the opposite view is so clinical, emotionless… and so damaging to public health through its blinkered and limited intent.

    “Doesn’t the public really deserve better?”

    Damned right it does.

    • Clive Bates

      For me it’s painful as much through professional ethos- the people doing this should simply do much better. It’s not even a hard issue like Syria, the planning system or world trade agreements.

  • For me its a matter of my “Human Rights” to have the choice how I best look after my health. Not some uninformed morons who have no idea what they’re talking about.

  • Another nail in the coffin for the EU. I used to think it was great but in the last decade it has been turning into a bureaucratic shambles run by and for pressure groups. Can we just leave now please?

  • ENVI position, yes… But other hands are well and truly dipped in the blood: Dalli, Borg, the college of Commissioners, the Commission civil servants, the Council working group, the Irish presidency, member state health ministers have all contributed to this total mess.

  • godek

    Good summary of the faults of the ENVI proposal.

    Anything apart from keeping Snus banned and banning e-cigs is designed so that it’ll have minimal real world impact on smoking prevalence while making the politicians look like they really do fight against tobacco.

    I agree with the statement that ENVI should start over in 2014.

    Still it could at least be entertaining what remains of the proposal when it is published after jurisdictional scrutinizing as announced by MEP Groote.

  • Margaret Hermon

    Not only is it a dog’s breakfast, it’s been served up in a very dirty dish right from its inception. The whole business stinks to high heaven. Their own JURI committee have said that medicalisation will not stand in a court of law but the stakes must be so high they have chosen to ignore this. Not that I would suggest that any form of corruption is involved even though I heard on radio today that a certain firm’s representatives are being closely questioned by the Chinese regarding bribery of hospitals to endorse and purchase their products – a large pharmaceutical company I believe. I firmly believe that plain packaging of tobacco cigarettes was of secondary importance in the TPD – everyone is aware that e-cigs are the greatest threat to both big tobacco and big pharma. Unfortunately it seems that recourse to law has to wait for a final outcome – until then we work even harder to bring some sanity into this. It can, and must, be stopped.

  • Clive, someone leaked an EU research brief in March supposedly for completion in April. With time I can track it down. The brief was for a major study of electronic cigarette use, for completion within weeks.

    As a researcher for more than two decades, the brief was instantly absurd. Nothing like the research needed could have been done in a month.

    Many vapers have never looked this closely at public health legislation. All I can say is we are horrified. Really, genuinely, stomach churningly horrified by what we are watching unfold in front of us.

    • FlamingKaty

      I think you may be referring to this letter to Dr Mounier-Jack at the London School of Tropical Medicine? Posted on UKVapers.org on 7/3/13:

      Dear Dr Mounier-Jack,

      I am contacting you from Milieu Ltd as we have just received a urgent request from the European Parliament to conduct a study on electronic cigarettes. Although they still have not sent us the official terms of reference for the study, I already wanted to check with you whether this is something that you would be interested/available to work on – or if you know someone that would be.

      In essence, the Parliament is looking for a briefing, which should cover the following aspects:
      – Who is the standard user of this type of cigarettes
      – What is the influence of electronic cigarettes on smokers’ decisions to quit smoking, switch to electronic cigarettes, or start smoking (electronic cigarettes)
      – How does the market for this type of products look like
      – What is the legislative context (e.g. in some countries they are banned, in others it seems that they could soon be sold as a life-saving medicine)
      – Possible indicators to assess the health impacts of electronic cigarettes

      As this is a relatively new phenomenon, I suspect that not much literature exist and a lot of the work will consist in gathering and analysing data. Please see this recent article from NewScientist that provides a bit of background: http://www.newscientist.com/article/mg21…oking.html

      The Parliament would want this analysis to be conducted quite quickly. Most probably the deadline for the draft report would be around mid-April.

      We do not have much more information at this stage, but I would appreciate your feedback at your earliest convenience on whether this is something of your interest.

      Thank you in advance for your attention.

      Kind regards,

      Monica Guarinoni
      Senior Policy Advisor
      Milieu Ltd – Law & Policy Consulting
      15 rue Blanche | Brussels 1050 | Belgium
      T. + 32 2 506 1000 | F. + 32 2 514 3603 | Skype: milieu_mg
      Visit our website at http://www.milieu.be
      http://www.linkedin.com/company/milieu-ltd

  • slim

    Aha – but they are fine, whilst obviously any flavoured e-cig would be far too tempting for children to resist :-

    “For fruit flavoured nicotine gums, it is shown that they are not a gateway to
    smoking in adolescent non-smokers. Cleary, there is need for more research.”

    – Prof. Jean-Francois Etter, Faculty of Medicine,University of Geneva, (CH) as presented to the EU Electronic Workshop on 7th May 2013.

  • Hi Clive,

    your going to love this, the nicotine chewing gum comes in a bunch of flavours!! https://catalogue.ic.nhs.uk/publications/prescribing/primary/pres-cost-anal-eng-2012/pres-cost-anal-eng-2012-rep.pdf Page 93

    liquorice, “fruit fusion”, mint, fresh mint, icy white

    So is NCP’s a gateway to vaping and ergo a gateway to smoking for children?

  • Craig Bootz

    Spot on. Nothing more to say; just spot on.

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