December 22nd, 2015

Escaping the EU directive on e-cigarettes

Trash

I’ve written  and presented many times on the utter mess the EU Tobacco Products Directive (TPD 2014/40/EU) has made of regulating low-risk alternatives to smoking: notably Article 20 that regulates e-cigarettes and Article 17 that bans snus.

EU legislation is especially ill-suited to regulating new disruptive and controversial technologies that regulators don’t understand – see my discussion of regulating disruptive technology. Directives are produced by a kind of committee pinball game that reflect prejudices, esoteric beliefs and haggling of people with little knowledge of what they are dealing with and no accountability for the outcome or damage done.  But once agreed, they are really hard to reverse or amend, and they are a good reason to do only what is necessary at European level.

Here’re the escape routes I can think of.

  1. Legal action
  2. EU institutions recognise their errors and amend the directive
  3. The normal process of updating the directive
  4. Brexit – the UK leaving the EU and related reform negotiations
  5. UK Parliament defies Brussels
  6. Subversion, workarounds and civil disobedience
  7. What to do?

1. Legal action

On 23rd December 2015, we will have the first sign of whether some or all of Totally Wicked legal action at the Court of Justice of the European Union (CJEU) will be successful. This is the release of the opinion of the Advocate General assigned to the case.  Think of this as an expert legal opinion offered to the judges in the case. It is likely to be influential but it is not binding and the judges actually hearing the case can take a different view – and this does happen.  The CJEU judgement is about whether the parts of the directive that have been challenged comply with the requirements of the EU treaties and conventions – measures must be proportionate, non-discriminatory, have an adequate legal base and respect the right to property.

I think the key issue in the decision will be the scientific and technical literacy of the Advocate General and the judges: the legal position is intimately connected to the scientific evidence because it is the estimation of risks and benefits that will justify or invalidate the ‘proportionality’ of measures in Article 20.  If the court erroneously concludes the risks are serious, then it will be easier to justify burdensome and/or pointless regulations. On the other hand, if it recognises the great benefits to smokers and accepts the risks to others are minimal, then the regulation will be thrown out as disproportionate and discriminatory.

Update 23 December 2015: somewhat predictable. Bad science makes bad law:

… and the briefest possible critique (more to follow)

 

Future legal action. There is no appeal route after the CJEU decision.  But even if unsuccessful, the Totally Wicked case may not be the end of the matter. New cases can be brought using different legal argumentation or evidence.  However, the TW case will establish precedents and case law that will inform future cases.  It is also possible that specific national implementations will be challenged – for example, use of mandatory medicines classification.

Legal action to overturn the snus ban. Swedish Match should challenge this arbitrary ban in court. It tried this in 2003-4 and the case failed on the back of some absurd reasoning by the court. However, much has changed since then in the understanding of harm reduction and in evidence for and recognition of the public health benefits.  The fact that the directive contains a section for ‘novel tobacco products’ at Article 19 blasts away the court’s original reasoning.

Any promise? Yes, objectively the cases are very strong. The trouble is that they require the court to act as a non-political arbitrator of the law and to grasp the underlying science of risk and benefits. It is impossible to call the result and it is out of our hands.

2. EU institutions recognise their errors and amend the directive

The EU legislative institutions (Commission, Parliament, Council) could admit they’ve cocked it up completely and rethink –  in what would be an unprecedented act of humility. It is possible to amend a directive at any time, but the process for doing this is the same as writing the directive in the first place (Ordinary Legislative Procedure), and there is quite a barrier to getting it started. The Commission generally has the power to initiate this procedure, but I can’t see it doing that and inviting more work for itself and a tacit admission that the current legislation is a failure.

A majority of the European Parliament can ask the European Commission to bring forward proposals. If the Commission refuses, it merely has to give an explanation.

The Council (acting by a simple majority) may request the Commission to undertake any studies ministers consider desirable for the attainment of common objectives, and to submit to it any appropriate proposals.

Any promise? Frankly, I don’t think is a promising route unless there is a real will in the European Parliament.  So many of those with their hands dipped in the blood are still at the scene of the crime and I doubt they’d want the scrutiny this would create.  The Council power to request studies could be useful if its members were suddenly converted to high-quality policy-making. Studies might include: (1) the impact assessment for the e-cigarette measures that was never done – this would allow that expectation may one day be compared to reality; (2) regular review of real-world experience of costs, benefits and unintended consequences as they emerge; (3) inconsistencies in member state implementation legislation that create barriers to free movement of goods.

3.  The normal process of updating the directive

The TPD has built into it ‘a report’, which is described at Article 28, and this is part of the process of updating the directive to take account of new developments.  It requires the Commission to provide an assessment of how well the directive is contributing to the smooth running of the single market and to point out where it might require amendment in the light of scientific and technical developments. Point g. of the terms of reference deal specifically with e-cigarettes:

… the Commission shall pay special attention to:

(g) market developments concerning electronic cigarettes and refill containers considering, amongst others, information collected in accordance with Article 20, including on the initiation of consumption such products by young people and non-smokers and the impact of such products on cessation efforts as well as measures taken by Member States regarding flavours;

I guess you can see from this that the legislators were working on the basis that it’s all threat and no opportunity. The most important catch is that this report must be done no later than 20 May 2021.  Then the process of drawing up a new directive might begin.  The last update was to the 2001 Tobacco Products Directive, which was updated by the 2014 TPD – 13 years in the making.

Any promise? This is the most ponderous route to reform and by then so much damage is likely to have been done it would be irreversible. There may be some points of pressure: pushing for that report to be done in installments, with the e-cigarette assessment being done in 2018.  There is  a trade-off between how quickly this report can be done and how much experience there would be available to review. This call would become more persuasive if there was widespread evidence of unintended consequences, subversion, civil disobedience and non-compliance.

4. Brexit – the UK leaving the EU and related reform negotiations

The UK Conservative government elected on 7 May 2015 has committed to holding a referendum on exit from the EU no later than 2017 – this ‘British exit’ is sometimes known as Brexit. In doing this, the Prime Minister is hoping to negotiate for “a new settlement for the United Kingdom in a reformed European Union” in return for our continuing membership.   Does this have any potential for reform at all?

Does leaving the EU help? No. I think UK leaving the EU will not fix this problem at all.  If there is a Brexit, UK is likely to have to comply with this directive anyway [I think the Norway model would apply – but that’s a longer discussion] and we would lose one of the more progressive voices from the process of reforming it.

Is the politics of Brexit relevant? Yes.  There are now about 3 million vapers in the UK, and many will find this directive to be the crystallisation of all they despise about the European Union – petty, meddling, arrogant, aloof, indifferent, incompetent, anti-scientific, bureaucratic, and wholly unaccountable for the consequences.  Given the polls in the UK are now very close and moving towards ‘out’ and given the main ‘out groups’ (Leave.EU and Vote Leave) are well endowed and ramping up their campaigns, we can expect this dire piece of legislation to become more politically charged as the campaign evolves.

Can something be done in the renegotiation?  First question: is there a will to act? Unlikely that there is yet, but…  there is probably a political will not to have thousands of disgruntled vapers voting for an exit. And the Prime Minister has just shown he understands the value of e-cigarettes. In answer to a parliamentary question on 17 December:

Q7.[902729]
Mark Pawsey (Rugby) (Con): By the time the House next meets for questions, many people will have started their new year’s resolutions. For many, one resolution will be to give up smoking. Given that Public Health England recently stated that e-cigarettes are 95% safer than tobacco and half the population is unaware of that fact, will the Prime Minister join me in highlighting the role that e-cigarettes can play in helping people give up tobacco for good?

The Prime Minister: Certainly, speaking as someone who has been through this battle a number of times, eventually relatively successfully, lots of people find different ways of doing it, and clearly for some people e-cigarettes are successful. We need to be guided by the experts, and we should look at the report from Public Health England, but it is promising that over 1 million people are estimated to have used e-cigarettes to help them quit or have replaced smoking with e-cigarettes completely. We should be making it clear that this a very legitimate path for many people to improve their health and therefore the health of the nation

What could happen? I doubt that there would be a direct deal related to this particular directive on the table – it isn’t anywhere big enough at the level these negotiations are working at.  But you never know, and that should not stop anyone writing to the Prime Minister, MPs, MEPs and demanding that something is done to sort out this mess. How the politicians then do something is another matter.  But that doesn’t mean it could not be tackled indirectly… Mr Cameron has set out his negotiating agenda in a letter to Donald Tusk, President of the European Council. There are two relevant strands in Mr Cameron’s letter. Firstly under ‘competitiveness’:

In particular, for all we have achieved in stemming the flow of new regulations, the burden from existing regulation is still too high. So the United Kingdom would like to see a target to cut the total burden on business. (emphasis added)

Secondly under ‘sovereignty’:

I want to see the EU’ s commitments to subsidiarity fully implemented, with clear proposals to achieve that. As the Dutch have said, the ambition should be “Europe where necessary, national where possible”.

The UK focus on the burden from existing regulation is a valuable ‘hook’ – something in the official negotiation that is relevant for this cause. The focus on sovereignty suggests that what might replace EU regulation is national regulation until such time as the EU can produce decent regulation, and show that it is necessary to have EU level regulation at all – and it has failed on both counts so far.

Any promise? Yes, maybe.  Can this directive and its approach to citizens be made the exemplar of how bad the European Union legislative process is? Undoubtedly: it is a poster child for all that is wrong with EU law-making. Then the question is what will be agreed to meet the UK’s demands about the burden of existing regulation? Some new mechanism? A challenge process initiated by the member states? A review of impact assessments, legality and scientific advice?  Perhaps a critical mass of national parliaments will be able to ‘call in’ bad regulation and review it? Who knows…  but whatever is done to meet that requirement will be the most promising way to address this directive through the Brexit negotiations and EU reform.  All of this would be a major struggle with only a limited chance of success – and, given the progress of negotiations, may already be too late.

5. UK parliament defies Brussels

I’ve included this because I’ve heard it mentioned a few times. It is not possible to do this lawfully – directives are binding in UK law and the democratic assent for them is provided by the European Parliament and European Council, rather than Westminster. The Commission would bring legal action against UK government in what is known as ‘infraction’ proceedings.  It might be possible for parliament to limit the penalties and enforcement spending – and/or require civil servants to demonstrate value for the public money spent on this – though value-for-money tends to go out of the window when the government decides it is going to waste money on compliance with bad legislation.  Almost all spending on ‘the war on drugs’ is in that category.

Any promise? There’s very little prospect of a Westminster showdown with directly Brussels in my view – it just doesn’t work that way.  But UK parliamentarians can be very influential in pressing the government to sort out the mess by more legally workable means.  I think vapers should strongly and consistently press politicians in capitals and in Brussels to sort out this mess and explain what it means for them – let them work out how.  The most useful thing UK parliament could do right now is to hold a select committee inquiry into the policy and science behind this directive and the (truly terrible) process by which it was made.

6. Subversion, workarounds and civil disobedience

One mistake legislators often make is to assume that everyone will comply with their laws and act in the way they expect. This is unlikely, and I expect to see the considerable ingenuity applied to subverting this directive and showing how worthless it is. I am not saying this is good, just that it is inevitable when regulation this poor is introduced.  Some possible failures:

  • A trend to cottage industries making low-cost e-liquids from concentrated nicotine liquid and flavours and selling locally and informal markets in whatever containers they want
  • Hoarding and freezing of liquids
  • A trade in illicit high concentration nicotine solutions to support cottage industries and DIY
  • A trend to buying devices and liquids outside the EU over the internet, in person or by courier for personal use. Expect duty-free shops on the periphery of the EU to load up with gear and liquids and expect the Chinese internet sales to rocket (see these for example on Alibaba)
  • Isle of man will become the UK vapers’ paradise and the destination for UK vape-fests – matching its success in online gambling and plans to be a Bitcoin centre [update: some doubts expressed about whether IoM can do this – I will investigate]
  • Trade in ‘spare parts’ for existing units bought overseas and non-compliant plug-and-play upgrades to devices
  • A trend to ‘binary’ products where the active ingredients are sold separately and mixed by the user – with flavors sold for food purposes
  • Space fillers installed in tank systems to allow larger tanks when removed
  • Mislabelling stronger liquids
  • A meltdown in the registration / notification system which will fail and leave the competent authorities and Commission at fault
  • Advertising by word of mouth, social media and on the internet on servers outside Europe
  • Non-commercial UK-based portals to non-EU suppliers
  • Trading Standards Officers unable to cope and giving low priority to harmful regulation

Please help me develop this list… I would be grateful for advice from others more expert than me on what sort of workarounds we are likely to see…

Any promise? Yes. I don’t think politicians and regulators will see this is as a desirable state of affairs compared to a market that has reasonable pro-consumer regulation and quality control – and they would be right, it isn’t. The question is whether they will detect these developments and act to reverse them decisively enough to stop these activities becoming entrenched while legitimate businesses fail or struggle to comply.  This needs to be linked with the way governments monitor the impacts of the directive and used as a basis for early revision of its most egregious failings.

What to do?

It’s basic politics – in the run up to 20 May 2016, politicians who represent vapers and vapour businesses in their constituencies – MPs, MEPs, ministers – needs to know how poor this legislation is and why that matters for health, wellbeing, and welfare. Specific asks might include:

  • A proper monitoring regime to capture damage to health and small business, and other unintended consequences… (and benefits, if any).
  • An early review and report on Article 20 in the light of changing scientific knowledge and experience
  • A ‘red tape’ challenge to this especially poor piece of burdensome regulation under the Prime Minister’s plans for more competition
  • An inquiry by the Health Select Committee, European Scrutiny Committee or Lords Science and Technology Committee, Lords EU Committee into the policy and policy-making process that led to this directive
  • Suggestions welcome…

42 comments to Escaping the EU directive on e-cigarettes

  • Roger Hall

    An excellent and informative post as usual. With all politicians I often ask myself what motivates them? Sadly, I’ve come to the conclusion that the political arena is now almost bereft of individuals, but plagued by career politicians who toe the party line and are more concerned with their thespian illusion of acting as if they care and want to help as opposed to having any real desire to “rock the boat” in order change policies brought about by legitimate concerns. Politicians only really act when the media gets involved. After all even Ebola existed for decades before the media scare stories (no doubt Pharma led) started appearing and then all of a sudden politicians and Govts were falling over themselves to be seen and acting by pledging our money to fight Ebola. The real problem I believe is that even the UK Govt is happy with Article 20 and what it actually accomplishes. My latest blog here: https://www.misteliquid.co.uk/blog/a-billion-lives-the-e-cig-dilemma/ explains my reasoning. Public Health/Single market reasons are all decoys and therein lies the biggest issue. How do you change a policy/EU Directive when the predetermined objectives of that policy/Directive have been accomplished by the people wanting them? After all Article 20 has never been evidence led from a public health perspective. When you have a group of people affected by Article 20 that represent at most just 20% of the population politicians know that they have impunity. Somehow the 80% that aren’t affected have to be motivated to also support change to Article 20. International ebola funding only occurred because the public that weren’t affected by it became scared via the media that it may become more widespread and dangerous to them. The EU referendum is the only current achilles heel that the Govt has. The people that instigated Article 20 are the same people that want the UK to remain in the EU. For this to make a difference it requires the full media and political knowledge that vapers in their millions will vote to leave the EU because of the daft and irresponsible EU lawmaking that is represented by and Article 20 demonstrates. It also has to be a widespread mainstream media led campaign that reinforces this clear message – “why remain in the EU when poor legislation such as this happens and UK citizens and Govt are powerless to change it” The EU referendum certainly can be used as leverage, but unless it’s a full blown media led message which gains all vapers support and not just the few thousand that actually understand Article 20 then this also will fall on deaf ears. Focus on the media message would be my advice as then politicians will follow the audience in the manner that all thespians have become accustomed to.

  • Neil Robinson

    There are several ways to subvert the law through interpretation of the definitions.

    For example, an e-cigarette is defined as “a product that can be used for consumption of nicotine-containing vapour via a mouth piece.” Any device that has no mouthpiece therefore does not meet the definition, which could be achieved simply by plugging the 510 drip tip hole in the atomiser.

    Also, nowhere in the directive does it define nicotine as anything other than a liquid. Gels, waxes and powders are solids, so would not be covered by the definitions and restrictions on strength, and could conceivably be reconstituted into juice.

    I’m sure enterprising minds will find others too.

  • Sue Wilson

    I, and I’m sure many others, are of the opinion that life will continue via subversion. We will be forced to buy our tanks, and maybe even liquid if the ridiculous draft for refilling tanks is implemented, from non-EU sources. My concern is that I trust reputable UK-based companies to use safe materials when constructing tanks and to be responsible when formulating liquids. It’s not just about trust, it’s also having Trading Standards to keep an eye on things for me. I would not feel as secure about products manufactured in some other countries. Harm to health could result from this legislation, if we are forced to either return to combustibles or rely on under-the-counter sources.

    • Philip

      Hi Sue,
      I just want to put your mind at rest here on a matter here.
      The UK are not the only country safely producing atomisers! Joyetech, Kangertech and many others are Chinese manufacturing companies that design, produce and sell (wholesale and directly to consumers) atomisers, box mods, tube mods and starter kits. These companies use high grade materials and have their own manufacturing standards.
      I am unsure of a single atomiser that has been solely designed and manufactured in the UK. I have a vast collection of atomisers, many of which I have purchased from fasttech.com, a giant Chinese internet retailer, and they too have their own trading standards, which are held in high regard. If the say something is authentic, it is authentic! If they say an atomiser is made from 316l stainless steel, then it is!

      I would advise everyone who reads this, if UK and EU companies are forced to comply with article 20, look elsewhere for your liquids and atomisers. There are thousands of companies outside the EU that sell high quality products (and infact far cheaper, which is why the last time I ordered from a UK site was in 2012). The fact that they would be illegal in the UK would not make any difference to their quality. I buy most of my liquid from the US because there are companies selling 120ml for less than the price of 30ml here. That would continue, and continue to be made exactly the same.

      For smokers who want to get into vaping, it will be up to us vapers from the past, who understand what a truly good set-up can be like, to lend, give away, guide and educate the smokers to find a product that helps them get off analogs!

  • William

    It doesn’t matter in what form the nicotine may be. The phrase you quoted makes no mention of that. To be useful, the nicotine must ultimately be in vapour form to be usable in an PVD.

  • Tony

    Subversion of the law may be tolerated if its a few hundred thousand individuals. Lots of horror stories about the dangers of illegal products should keep it in control. If the main players can maintain the current tobacco market and control the millions in the new market they will be happy enough.
    I suspect the best way the subversion could spread is cost differance. If people find they are paying a £1 a mil for liquid the could buy before regulation for 20p a mil that may change attitudes. If prices do rise substatialy when the law comes in getting that information to a population with a sentiment that is already sceptical of EU regualtion could move many more to subversive behaviour.
    Then ever who puts the information out could be considered to be promoting vaping.

  • Dodderer

    One thing that might hasten a re-think by EU institutions is prevalence rising.This may happen anyway but could always be helped along by a little civil disobedience if vapers claimed to be smokers.Lying,of course, is an accepted Tobacco Control tactic!

    Difficult to organise on any meaningful level but I guess they would sacrifice Art 20 with enough media agitation before the rest of the TPD and PP/SP if prevalence increased by,say,2% between now and the end of 2017.

  • Very excellent post, Clive. I am about to send it to my MP who is a political party leader. I haven’t noticed he’s done anything earth shattering yet – but he’s written me a few nice letters and at least, he’s the top of the political chain. I sent him links to your site before as well, and I could see by the replies to my e mails, he’s read your stuff. So thank you for all this thoughtful, packed information.

    As you have realised, the problem is actually Tobacco Control’s attitude, which has been intrusive, dishonest and abusive for years, so it just continues. To be expected really.

    However, the EU “tertiary legislations on technical standards for the refill mechanism of electronic cigarettes ” need dealing with too. They are off the wall insane. Consultation by The Tobacco Control Team – Department of Health on the draft proposal is on now. The fact that they have to consult with interested parties regarding the draft proposals, and don’t see how completely ridiculous they are themselves gives me absolutely no confidence for next year at all! How vaping is going to be screwed by just these tiny details, is very scary. Even I wonder if I should just give up and go back to smoking. It’s the first time I’ve had that thought in over four years.

    Sadly.

    • Clive Bates

      Agreed – the refill thing is so nuts it’s out there in the ‘straight banana’ league as an icon of EU stupidity and pettiness. Will turn to this shortly…

      CB

  • Tony

    There are many things that annoy me about TPD article 20 and this is a big one. It looks like when they formulated this crazy stipulation they based it on people getting 100% nicotine on their skin (for example.)

    The worst thing is that most vaper’s would be around the 1-2mg/ml area, which is 1-2% by volume. And those same vaper’s will also no doubt at some stage spilt some on their skin or accidentally swallowed some e-liquid with no adverse affects. This whole thing is a sham and I’m hoping that people start to come to their senses and see what an utter public health disaster this is going to be.

    The worse thing above everything else is that by-and-large the whole market is doing fine without too much interference.

  • Anonymous

    VUSE Port: Liquid tank system that uses a Dock & Lock system to refill the device. The closed system prevents users from opening the top or the tank. To refill, the port and bottle must be locked together. – See more at: http://www.csnews.com/industry-news-and-trends/suppliers-wholesalers/rai-reveals-next-gen-vuse-products?nopaging=1#sthash.0V3JNeLC.dpuf

  • António Trindade

    I do not know about the UK’s, but Portugal’s constitution “permits” civil disobedience if it clashes with one’s liberties and civil rights and repel by force any aggression, when recourto to public authority is impossible. This is more or less a free translation of Article 21 of the Constitution of the Portuguese Republic.

  • JooboyI

    There is a perfect argument regarding civil disobedience, as you mentioned it will not only divert millions of pounds of revenue from the EU but will raise a massive BLACK MARKET ( or grey cottage industry depending on wether you want to SHOCK OR REASSURE)
    The problem still remains, WHO makes this argument and HOW does one ensure it is listened to?

    Another point to add to your list is that when one deals with the black market it not only throws safety out the window but also broadens access to OTHER illegal goods ie. knock off cigarettes, illegal booze, pirate DVDs recently legal highs…

    Surely this is the last thing a government wants to be seen to be encouraging?

  • Luc Van Daele

    The TPD is not about health it is about taxation. E-cigs need to be taxed now but everyone can mix DIY in the privacy of his own kitchen from taxfree ingredients, most of them you find in any corner shop. So how to enforce this? All the hardware that can be used for tax-evasion needs to be banned, meaning all hardware that can be refilled with the liquid of your choice. Remember the leaked proposal of the EU-commission in the trilogue. Have a guess which one off the CEN proposals (the normal refill bottle with a nozzle smaler then the refill hole, or the Big-T propriety and tamper free docking station) will be withhold and which one will be rejected by the EU-commission in delegated act. CEN is very influential, but withholding only one out two is also complying to CEN.

    Remember the words of Fédérique Ries when she came out the trilogue: refillable tanks will somehow be allowed for now, but only for two years (= may 2016).

    And there is a real possibility for us to act. Once the delegated act about the refill mechanism is a fact (to be expected just after may 2016), Rebecca Taylor told me it CAN be rejected by EU-parlement by some exceptional procedure. We should prepare ourselves to flood our MEP’s with mails and letters again in order to urge them to do so. The argument being by not withholding the normal refill bottle the EU-commission is handing over the entire market in a monopoly to Big-T and sending us back to the murderous industry (and the accompanying taxation, which is the silent but key issue here) we just escaped. How nice that will look in the newspapers “EU-commission forces millions of ex-smokers back to Big-T”; in the UK e.g. that would be quit an argument for BREXIT. The chances to convince EU-parliament are pretty high, convincing MEP’s will be a lot easier then the first time we did it.

    But if this does not lead to succes, another workaround on the limitations of hardware will be hacking the propriety threating and docking stations of the Big-T’s models. I would like to see such a model-T with a refill mechanism that is really “tamper free” in the hands of good modder, and if needed within a week YouTube will be flooded with instructional how-to-video’s and within one month our Chinese friends will be selling hacking-tools (designed of course by EU-modders) that make such hacks within the reach of a 6 year old. At the moment why bother? There is still plenty of gear available without the burden of having to hack badly performing model-T’s into good ones.

    History repeats itself, back to 2007, when the Chinese tried to sell us there closed architecture propriety models and we hacked them faster they could come up with it. In the end they had to cave in and produce models with open architecture. Glorious times for cottage industrie modders that work under the radar are afoot, with the only difference we are prepared now, we have experience and do not need to reinvent the vaping-weel. So modders will react like lightning. Only when the commission realized art.20 is not fit for their taxation purpose we can ask a revision in order to be relieved from the burdens of it. The EU-commission is prepared to kill for money, but if the tax income is way below expectations, chances are fair they will not be prepared to kill and risk bad publicity for little or no money.

    Remember our slogan “no medicine (= ban), no tobacco product (= monster tax)”. The first one we won against all odds; 2016 will be the battle for that second one. But this time we do have a really big allie in this, bigger than Big-T, bigger than Big-Gov bigger than Big-Health, even bigger than the three put together: namely the basic laws of economics about taxing are in our favor. The EU-commission is powerful, but even they are not capable of changing them. It will get worse before it gets better, but this EU-project “Tobacco Monster Tax – the sequel” will IMO fail miserably so at the end we will be victorious. And thus ended my prediction for 2016.

  • In reply to

    6. Subversion, work-arounds and civil disobedience

    For the hardware I believe with 3D printers getting cheaper, in a few years users will print out their devices in private and there’s nothing officials can do against that.

    For base ingredients of liquids, there has never been a problem, nor will there be one.
    PG and VG are available on every farm that has cattle, they come in containers of 1000 liters and they cost (in Germany) 0.15€ per liter, delivery included.
    If you have enough room in your back yard, you can get 10 lifetime supplies for 150€ and they have the very same pharma certificate our current vape base has.
    If you don’t have that much space, chemical companies like 1000liter.de sell it in 5 liter canisters, for 3-5€ per liter and they aren’t effected by any regulation either.

    Flavourings aren’t that cheap, but still no problem.
    Companies like Flavourart in Italy don’t sell vape flavours, they sell “kitchen magic” which means flavours ment to be used in the kitchen and they won’t be effected by any kind of tobacco regulation.
    It may take some research to figure out which of them are good for vaping, but that will be figured out in no time.

    The only problem remaining is the nicotine and on that part I’m quite sure the black market for it will quickly exceed the black market for cannabis.

  • Jonathan Bagley

    I haven’t yet read the comments, so others may have covered this, but yesterday came across the simplest “work around”. An online retailer told me, seemingly with absolute certainty, that he would be selling 72mg nic base after next May. He maintained its sale couldn’t be banned as it had too many other uses. I was actually going to buy two 500ml bottles (2.5 years supply). I probably still will, as I don’t completely share his confidence.

    • Clive Bates

      Interesting question about what happens in the wholesale and industrial nicotine liquids market. I guess it is covered by the European Union CLP regulation or pharma regulation if marketed to consumers.

  • Dumb question: why can’t the UK set up a 1-penny penalty for disobeying the TPD? Does the TPD explicitly spell out penalties?

    • Clive Bates

      Not a dumb question at all… First you would need the political will – and it’s far from clear that the UK government and/or Devolved Administration have the ‘policy intent’ to escape the regulatory mess of Article 20.

      Even so, it would not be possible to do what you suggest lawfully. Article 23(3) of the TPD sets out a general principle for penalties:

      3. Member States shall lay down rules on penalties applicable to infringements of the national provisions adopted pursuant to this Directive and shall take all measures that are necessary to ensure that these penalties are enforced. The penalties provided for shall be effective, proportionate and dissuasive. Any financial administrative penalty that may be imposed as a result of an intentional infringement may be such as to offset the economic advantage sought through the infringement.

      This has the effect of preventing the use of nugatory fines, which would have the aim and effect of making non-compliance economically viable. There would be complaints to or from the Commission and the UK would be challenged for improper transposition of the directive.

  • David Bugler

    I think we current vapers face a future of quiet non-compliance … where there’s a will there’s a way. I’d like to think something more organised could happen in challenging various aspects but campaigns so far have shown that vapers are broadly apathetic … the responses to some simple petition sign ups have been unbelievably poor.

    The vaping community is lying down and taking it, they don’t deserve the advocacy of the few.

  • David Bugler

    Don’t wish to be too negative but the suggested challenges to potential literal or semantic loopholes have little chance of success. The EU judges will go by the intent of the law not its literal interpretation.

  • Martin Smith

    Yeah good article Clive and totally agree with Luc and David, I would just like to add that I don’t think the EU are that bothered about a few of us finding a way to carry on vaping, I think they just want to stop any more people taking it up, the whole point is to hand the market back to big T, so my real concern is not people that vape now, but the many millions of smokers who are going to find it much harder to get into vaping in the future to save there lives, and as its obvious that very few governments are interested in saving lives, and as our vaping community is quite a close knit community, we’re all have to what we’ve done up till now, using word-of-mouth, social-media and generally pulling together, and fuck anyone that gets in our way, look how well we’ve done already with millions of lives potentionaly saved, it might take longer but there’s millions of more lives to save !! Fuck the EU they can’t beat the PEOPLE 😀

    • John Walker

      Martin my gut feeling is that the EU provably would not care , what really happens, as long as it gets the reporting boxes ticked. After all if it was not for some independent US researchers, the VW cheating biz would have never been unearthed, the EC was quite happy with VWs self reporting, yes?

  • Martin Smith

    Yep, there all to busy playing I’m a super-hero ruling all the ordinary people, to worry about what the ordinary are doing, like ya say John as long as the boxes are ticked they can carry on saving the world, they’ll probably destroy the world in the process but they can pat each other on the back on a job well done, we just need to do to them as they do to us, ignore them !! If comes to it, we’ll buy and sell stuff illegally, we’ll make our own juices and give them to people, we’ll keep spreading the word, whatever it takes to get people off cigarettes, they will not win because they cannot stop the will of the people, at best all they can hope to do is slow it down, but it can’t be stopped.

  • Dear Clive Bates,

    I have read most of your brilliant articles on the TPD, but one thing escapes me: your assumption that regulators and high ranking politicians don’t understad the issues. I think that is a mistake. They probably understand them perfectly well – much more likely is the case that they are bound by unofficial partnership deals with the pharmaceutical giants. Deals that cover other issues than tobacco and E-cigs also.

    This may explain why Big Pharma gets its way so easily in all tobacco legislation and why most is based on bad science. An article casts some light onto these other issues and how Big Pharma runs the lobbying process: “How ‘Big Pharma’ bamboozled Brussels”:

    http://www.iol.co.za/business/international/how-big-pharma-bamboozled-brussels-1910911

    The mentioned report about Big Pharma and the EU is here – note box 7: http://corporateeurope.org/sites/default/files/20150904_bigpharma_web.pdf

    In light of this, it is quite interesting to read the correspondance between the Commission and the industry lobbyists from late 2013:

    http://www.asktheeu.org/en/request/sanco_correspondence_with_indust#incoming-4147

    According to annexes 1 and 37 the pharmaceutical gigants were lobbying for medicines regulation and tough legislation on E-cigs – well of course: To Big Pharma E-cigs are an annoying competitor. As we know the pharma proposals became the final directive.

    At the same time the tobacco industry (in annexes 16, 22 and 29) opposed regulating E-cigs as medicines and were also opposed to lowering the nicotine
    threshold from 30mg/ml – to no avail.

    For a deeper view into why and how Big Pharma always gets its way with the political world, please see these articles:

    http://www.washingtonpost.com/wp-dyn/content/article/2006/06/09/AR2006060901310.html

    http://www.theguardian.com/world/2012/sep/14/french-doctors-drugs-useless-dangerous

    Best regards

    Klaus K. – researcher

  • Martyn Butler

    One glaring omission from the directive is listing all the chemicals and compounds found in cigarettes should be listed on the packaging in helvetica. Admitidly this will inevitably make it very difficult to carry a packet of 20 around now that the package will have to be roughly the size of an A3 sheet. However I do think that a level playing field is the best way forward

  • I understand the requirement for regulation of electronic cigarettes, but the European Governments need to pay attention to the purpose of such laws. The statement for example “e-cigarettes are a gateway to nicotine addiction and, ultimately, traditional tobacco consumption” is an opinion that studies contradict. The tight regulation will reduce the variety and innovation of the devices, which in turn will lead the millions of ex smokers who are now vaping back to traditional cigarettes.

    Ask yourself a question, if your child was a smoker, what would you rather they smoked? A traditional cigarette or an electronic cigarette? The answer is simple, with e-cigarette you can slowly reduce the nicotine content and have less (actually zero) exposure to the hazards of tar!

    The high level of nicotine in e-liquid that they propose is fine, after all, the majority of vapers I know vape about 3-6mg of nicotine, but they do this using sub ohm tanks, this basically means that they produce a lot more vapor than the traditional e-cigs, but because of the volume, the amount over the day is probably the same as someone smoking occasionally with 20mg! Nicotine addiction therefore cannot be summarized by the amount of nicotine in e-liquid!!

  • I just wanted to chime in and say that you are a remarkable resource for information. I was ignorant to the current dealings in regard to the European Union on electronic cigarettes.

    I think every vaper has accepted that the fight for our right to vape is something that will last a long time. I can’t speak for everyone, but I do know most of us are dug in and will continue to fight.

    Thank you Mr. Bates

  • aikanae

    Want to add to your list?
    * Development of dark net like internet buying and selling of vaping components
    * Bans tend to advertise substances and products to youth groups. How’s that drug war going?
    * Alternative payment systems, grey markets that can’t be tracked.
    * Credibility of all health science recommendations as public figures out they’ve been lied to.
    * Empowering the pharmaceutical sector by eliminating competition for successful cessation products.
    * Banning technology that might work elsewhere, such as helping obese and diabetics with their sweet tooth using zero nic vaporizers.
    * Fraud with illicit devices and liquids.
    * The sale of liquids not suitable for inhalation. Industrial nicotine, bio diesel VG, questionable sources, manufacture, additives, age, no particulate testing and escalating prices.
    * Are they really going to throw people in jail for illicit vaping? Add those expenses.
    * Increasing smoking rates that’ll need explanations.
    * Millions of lives with needless suffering and loss due to impulsive banning the most important public health discovery of the century. I hope everyone involved looses sleep, at the minimum.
    * Allowing junk science to set public policy has far reaching effects into every industry.
    * Foster’s anger and mistrust that gov’t is trustworthy or “for the people”.
    Good luck!

  • Guy Eaton

    Clive

    has the Advocate General not viewed the PHE report? This provides most of the information needed in one accessible source. It now forms Government Policy. EC use for smokers is now even encouraged on NHS websites for smoking cessation with pictures of products that will be banned by the Directive!

    I have had to take a break from all of this with the risk of losing my sanity and have too much other work to do. However, the TPD2 as it relates to EC is simply wrong on every level; business, health, social context and against EU principles themselves! To make matters worse EC have been incorrectly categorised as TP. This whole fiasco is preposterous and is akin, it would seem to getting a monkey to regulate nuclear power stations.

    Further you cannot take away a product from millions of people overnight and tell them it does not work etc. when it has worked, or take this course of action in a Democracy. This is perhaps an important aspect that Democracies have no right whatever to stop people using a safer alternative or effective quitting device to smoking. They would have a right to ban smoking though (eventually).

    Lastly, in terms of updating the Directive, the Directive itself will render EC ineffective so future studies of efficacy of EC will show they are not particularly effective, etc.

    I must be missing a ‘trick’ here or these are just concessions to the tobacco and pharmaceutical industries and other multinationals as well as tobacco tax or ‘corporate death tax’ (i.e. corruption). Otherwise, I cannot believe that a group of professionals could be so unintelligent.

  • Guy Eaton

    Forgot to mention, that to add to the stupidity of Article 20 the regulations increase the risk associated with EC not simply because of the black market, but because it will increase exposure to inhalation of chemicals that could pose long term minor risks! This would be due to compensatory puffing. It is know that there are not significant long term risks associated with nicotine use due to long term users of NRT. However, the same could not be said about the use of some other chemicals used in particular liquids although minute in comparison risks of cigarettes use. Thus, the Article is not only disastrous because it will render EC less effective and thus increase smoking prevalence but it will make the very devices more risky.

    This is due to an obsession with nicotine and conflating this with smoking and EC with smoking! The basic principle that you smoke for nicotine but die because of the smoke seems to be an impossible concept for many EU officials to grasp.

    Can the public see a copy of Wicked Liquids legal case? The press really do have a lot to blame for distorted facts and lies – they have been a major vehicle in driving corruption through propaganda.

  • Guy Eaton

    Hi Clive
    something rather obvious has occurred to me. That is even if vaping was as harmful as smoking the TPD, Article 20 would not be justified re. providing an unfair competitive advantage to TC. Thus, considering EC should not even be categorised as a TP, those in Brussels are completely taking the piss. It can only be concessions to Government tax revenue, Big Pharma and Tobacco otherwise it would be utterly ludricous and they have very, very low intelligence.
    I am completely baffled by all this. It makes the Hollywood film the ‘Insider’ staring Al Pacino look like nothing! This whole business will be a movie one day after millions of preventible deaths!

  • Clive Bates

    I fear you are giving them too much credit… it’s incompetence rather than calculation

    Clive

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  • […] Escaping the EU directive on e-cigarettes […]

  • […] Escaping the EU directive on e-cigarettes […]

  • It seems that the UK is the only country that’s actually working for the people. Governments weren’t there when Big Tobacco was spreading lies and played games with our health. Why are they interfering now?

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