June 27th, 2013

Tobacco products directive, e-cigarettes & snus – an update

Whats-going-onAn update on  developments in the European Union and UK. Contains notes on…

  • The process – where we are and what next
  • The European Parliament
  • The European Council
  • Summary: you couldn’t make it up!
  • What next? A compromise amendment on e-cigarettes
  • What next? Snus – oral tobacco
  • The MHRA – UK medicines regulator

Comments, corrections, insights, gossip, rumours, plots… all very welcome!

The process – where we are and what next

The Tobacco Products Directive is going through a negotiating process known as the ‘ordinary legislative procedure‘ [nice graphic].   Basically, it is a process whereby the European Commision (the civil service for the EU) submits a  proposal for legislation (it did this on 19 Dec 2012) to the European Parliament (directly elected representatives, the MEPs) and European Council (representatives of the 27 member state governments). The Parliament and Council debate and amend the Commission’s proposal and then try to reach an agreement. The directive passes only if the Parliament and Council can agree. They need to do this before the European elections in May 2014 or the process starts again.  No agreement, no directive.   The first substantial stage after the Commission proposal – the ‘first reading’ in the European Parliament – will be in the week of 10 October 2013. At present, we are in the stage prior to the first reading where the Parliament is scrutinising the Commission’s proposal through its committees and the Council is considering it through its working group and ministerial meetings.

The European Parliament

The European Parliament uses a system of committees and rapporteurs (someone who examines proposals and leads on an issue) so that the Parliament can scrutinise legislation efficiently. The lead committee on the TPD is the Environment, Public Health and Food Safety committee (known as ENVI) and its rapporteur is Linda McAvan MEP, a British Labour MEP.  Other committees also scrutinise the proposal looking at it from different specialised angles – for example, international trade, internal market compatibility, agriculture, industry, and legal affairs – the process is set out in one place, the legislative observatory for this directive. These other committees feed in ‘opinions’ to the lead committee before the lead committee and rapporteur finalises their ‘report’ – and that has been happening in the last week. The next big development is that ENVI committee will debate and vote on amendments on 10/11 July, leading to the finalisation of the rapporteur’s report. This report from ENVI is then used as a basis for the Parliament’s first reading in October.  Each committee involved keeps a ‘dossier’ of documents relevant to the directive – including reports, opinions, drafts, proposed amendments etc.  These are linked below. At the time of writing the opinions from all committees are not yet complete or published – I will update as these become available (updated 1 july 2013):

  • Environment, Public Health and Food Safety (ENVI) dossier.  The key move in this committee was the rapporteur’s ‘simplified procedure’ (amendment 1250) as an alternative to regulation under the medicines directive, though retaining many features of medicines regulation (see my critique of this).  Other MEPs have uncritically followed the Commision proposal and seek full medicines regulation for e-cigs (a dreadful idea).  But the argument is moving towards the more liberal minded MEPs, who include UK Liberal Democrats and Conservatives, who are pressing for regulation of e-cigarettes as consumer products (along these lines). The question is whether a compromise can be found between those favouring Lind McAvan’s ‘simplified procedure’ and consumer product approach, and whether that could gain enough support to overcome those determined to misclassify and over-regulate e-cigarettes as medicines.
  • Legal Affairs (JURI) dossier. The final opinion is very helpful – it require  medicines regulation for e-cigs only where health claims are made and stresses compliance with consumer regulation and proper enforcement, with subsequent review. This would be an excellent amendment to have in the directive.   On snus it suggests an exemption for traditional use of oral tobacco.
  • Internal market and Consumer Affairs (IMCO) dossier – the IMCO final opinion is unhelpful and incoherent.  It retains medicines regulation for products above the low threshold established in the Commission proposal and also specifies in greater detail restrictions on products below the threshold.
  • International Trade (INTA) dossier. The final opinion of INTA limits the use of medicines regulation to only those e-cigarette products where a health claim is made – a valuable point – and excludes medicines regulation in any other circumstances.  It raises the issue of the WTO Technical Barriers to Trade treaty compliance – ie. not excessively or prescriptively regulating to exclude foreign producers.  It also states that the snus ban should be lifted as it is also incompatible with international trade rules.
  • Agriculture and Rural Development (AGRI) dossier – the final opinion classifies all non-tobacco nicotine containing products as medicines, proposes regulation instead of a ban for oral tobacco and limits the notification system for novel tobacco products to situations where a health claim is made.  It reflects the agenda of Europe’s tobacco growers.
  • Industry, Research & Energy (ITRE) dossier – the  final opinion deletes the entire article 18 related to e-cigs, though without much explanation.  It creates an exemption for traditional use of oral tobacco – for example of the loose snus type used in Denmark.

The Council

There was a significant development  on 21 June.  The ministerial meeting of the Council agreed its ‘General Approach’. This is best thought of as an opening negotiating position of the European Council, and is in the form of the amendments they would like to see to the Commission’s original proposal of 19 Dec 2012.  They expose this ‘general approach’ before the Parliament has its first reading (in October) so that areas of potential agreement are more visible. It is also an opportunity for the Irish Presidency to chalk up a diplomatic win – securing agreement on the approach.  The Presidency now moves to the government of Lithuania, which intends to prioritise the TPD.

On e-cigarettes, the Council position follows the Commission proposal, but does three main things differently:

  • Retains the idea of a nicotine threshold, but halves the thresholds to 1mg of nicotine and 2mg/ml nicotine density, and abandons the bizarre one related to blood plasma.
  • Gives more time to secure a medicines marketing authorisation. Nicotine-containing products referred to in Article 18(1) and which are placed on the market before [entry into force + 24 months], may continue to be marketed until [entry into force + 36 months].  If entry into force is, say, May 2014.  Then this means e-cigs on the market by May 2016 have until May 2017 to acquire a marketing authorisation. This is good. It is also a setback for the MHRA, which placed great emphasis on regulating e-cigs by 2016.
  • Adds a more foreboding warning to products below the threshold: “This product contains nicotine which is an addictive substance and can damage your health“.  Of course these products are very unlikely to be addictive given how low the threshold is.

On smokeless tobacco, the main Council position is the outcome of a sordid trade-off. Snus will remained banned outside Sweden, but the lucky Swedes will be allowed to keep flavourings in snus available in Sweden.  Flavourings, such as bergamot or juniper, are integral to the appeal of snus to people who would otherwise smoke – so the Council has in effect threatened to diminish the harm reduction potential, and then dropped the threat in return for Sweden’s subordination over lifting the ban.   There is a danger that the directive will ban acidity regulating additives that assist with the delivery of nicotine through smokeless tobacco, and so make them less viable as an alternative nicotine delivery system to cigarettes – more smoking will be the result.  In addition the warnings on smokeless tobacco are to be made more misleading and much larger – now printed twice instead of once. I have written more about the approach to snus in: Negligence in tobacco policy.

On novel tobacco products, for example products in the pipeline that heat rather than burn tobacco. For these, the Council sticks with the Commission position on Article 17 – a notification regime. I think this is right – they could hardly make something more dangerous than cigarettes.

Summary: you couldn’t make it up!

It’s hard to express just how incoherent the product regulation measures in the proposed tobacco products directive really are.  But here we go….   The least dangerous, most promising, fastest growing products (e-cigs) are to be barred from the market unless authorised as medicines, which they aren’t, and subject to an onerous regulatory regime increasing cost, limiting choice and appeal, holding back innovation and generally making the products less competitive relative to cigarettes.  If someone wants to bring a low risk nicotine product to market, they should just make sure it is a novel tobacco product – they just have to let the authorities have some information about it.  That is unless the tobacco product in question is snus, the least dangerous tobacco product in existence, in which case it is banned completely everywhere but Sweden, where it has delivered a spectacular public health success. This is banned because it is put in the mouth and sucked not chewed, even though it is less toxic that many forms of chewing tobacco.  Cigarettes can be put on the market pretty well at will, as long as they meet some irrelevant tests for ‘yields’, the results of which are no longer to be printed on packs because they are misleading. Except the 5 percent of cigs that are flavoured, mostly with menthol. They will be banned. We have no reason to believe they are more or less toxic than other cigarettes, it’s just that different people like them and these different people are to be protected by switching to unflavoured cigarettes. Something will be done with additives, but no-one really knows what or what effects, good or bad, whatever is done will have on smoking behaviour – less addictive nicotine might mean more exposure to smoke. Who knows?

What next? Proposed compromise amendment on e-cig regulation

The ENVI committee has its important meeting on 10/11 July. This will settle the rapporteur’s report, which will then go to the plenary of the European Parliament on 10 October.  We are aiming to find some common ground between all those now concerned about over-regulation of e-cigarettes. These are the main things we need to press for:

1. Compromise amendment: given that quite a lot of MEPs want almost all e-cigs under medicines regulation and this is the position of the Council and Commission, we are trying to find an acceptable compromise amongst all those who recognise how damaging this would be to the category.  So this compromise amendment aims to find some middle ground. It borrows from the approach that is taken to regulating cosmetics – vendors are required to prepare an independently audited ‘compliance report’ of product information that shows they comply with the main safety and consumer protection regulation in force. In effect, this is trying to find a middle way between the rapporteur’s ‘simplified procedure’ [info on this] and the more liberal approach [info on this], which is favoured by many in the vaping community and backed by Liberal Democrat and Conservatives in the Parliament. If the product dossier wasn’t up to scratch or shows that the products are not compliant they would be taken off the market.

2. Flavours: several MEPs, including the rapporteur Linda McAvan MEP, think it makes sense to ban flavours in e-cigarettes.  We really need to persuade them this would be a terrible error – needlessly limiting the category to tobacco flavours , reducing its appeal to smokers and removing the option to migrate away from tobacco altogether as the user’s experience evolves.

3. Timetable: it is important to give plenty of time for any significant changes. If a light touch regulatory regime comes in, it could be done more quickly.  If they insist on medicines regulation it needs to be 36 to 48 months after entry into force.

4. Review. The Commission proposal was a botch job – medicines regulation is no more than a convenient but inappropriate and legally shaky basis for regulating what is clearly not a medicine – and there are at least 10 reasons why it would be a bad idea.  As was the case with cosmetics, it is necessary to design a specific regime that aligns with the purpose, technology, benefits and risks or the real-world product – not just smash a square peg into a regulatory round hole.  This doesn’t have to happen at once – providing the products are safe enough, the regulatory regime can be developed to be proportionate and light touch.

What next? Snus – oral tobacco

We will keep making it clear that Sweden has the lowest smoking rate in the EU by some distance and it is for one reason only – snus. We want anyone who want to or needs to take nicotine to be able to take it in an almost harmless form. I am not optimistic that the European Parliament will agree to lift the ban on snus and replace it with regulation of ingredient, which is beyond doubt what should happen. The contrast between the regulation of novel tobacco products (ie. notification) and regulation of snus (ie a ban) is obviously absurd and indefensible. I suspect it will end in court.  However, there are some details to take care of:

  • Lift the ban…  we should never stop saying this, whatever the negligence of the the public health community, politicians and bureaucrats.
  • Flavours – there should be no ban on flavours in smokeless tobacco. These are much more integral to smokeless low risk products than cigarettes – it would make the lower risk product much less attractivce relative to cigarettes, potentially reversing gains made in Sweden and elsewhere.
  • Additives – we do not want bans on additives that reduce the effectiveness of smokeless tobacco at delivery of nicotine – and so become a less credible alternative to smoking, potentially reversing harm reduction gains made in Sweden and elsewhere.
  • Member state discretion – member states should be able to allow the product, in effect have the same opt out that Sweden has – especially where oral tobacco has a long tradition, for example in Denmark and several other North European states.

The MHRA – the UK medicines regulator

There was a lot of hype for the MHRA announcement about regulation of e-cigarettes by 2016 and full documentation.   But closer examination reveals something of a climb-down by the MHRA. All the announcement does is to say that they will regulate e-cigarettes in line with the forthcoming EU directive.  They said they support the European Commission proposal and that the Commission had said they expect mandatory medicines regulation from 2016. However, within a few days, the Council ‘general approach’ position had shifted to 2017 (see above for detail).  When the MHRA says we should trust it with this category as a disruptive alternative to smoking, it is worth recalling that in 2010 it wanted all unlicensed e-cigarettes taken off the market within 21 days. So some seven years later, they may get their way… but that will depend on whether the directive is agreed at all, and if it is agreed, whether it applies medicines regulation to e-cigarettes. A couple of other interesting things in the announcement:

1. A paper on ‘proportional regulation’ – this reveals the MHRA’s thinking about what they are now calling ‘right touch’ regulation – an account of what is needed to secure a marketing authorisation for e-cigs and how the product would be regulated once on the market. Some ‘highlights’ (disclaimer: please read the full document if you are professionally involved).

  • Efficacy: the applicant would need to run trials to show the products deliver a certain dose of nicotine to the body, probably with reference to an inhaled NRT product.
  • Quality: pharma grade ingredients would be required and production facilities would need to reach the pharmaceutical  Good Manufacturing Practice standard, which must be inspected by an EU approved inspector. In depth information would have to be provided on every aspect of the manufacturing process, ingredients and raw materials.
  • Availability: they would be generally available ‘general sales list’.  In many EU countries licensed medicines can only be sold in pharmacies.
  • Risk management: the applicant would have to set up a surveillance system to check for use by under-18s, non-smokers and ex-smokers and how the product is being used.
  • Packaging: packaging, branding and names would need regulatory approval.
  • Advertising: adverts would need prior approval by the regulator. Note this is more onerous than for alcohol advertising.

2. An impact assessment to back the UK government support for medicines regulation. Gives costs of up to £2,288,000 (present value) or £266,000 annualised cost of a marketing authorisation per product. However, for inexplicable reasons they haven’t included the cost of upgrading manufacturing facilities to pharmaceutical ‘clean room’ standards – this is a potentially huge cost. Also notes the effect of licensing on electronic nicotine delivery systems (ENDS):

Licensing ENDS is likely to erect a barrier to entry into the market, thus limiting the competition and innovation that would otherwise have driven prices downwards. By itself this would represent a reduction in consumer welfare but if additionally it means that fewer smokers switch to ENDS than otherwise have been the case, then it is possible that the health losses would be significant.

Er… that’s rather important isn’t it?  And innovation isn’t just about money – it’s about better products, niche products and product diversity.

3. A Q&A. Mostly predictable – but two interesting questions. The first is one that wasn’t asked: what happens if the EU directive is not agreed?  The second is Q25, which asks: Why is the MHRA leaving unlicensed medicines on the market if there are no guarantees on safety, quality and efficacy? 

Existing electronic cigarettes on the market, and other NCPs that make no medicinal claim, will not require a medicine licence until the European Commission’s revised Tobacco Products Directive is transposed into UK law. The European Commission has said it expects the new legislation to be adopted in 2014 and for it to come into effect in the UK from 2016. This will allow time for manufacturers to ensure that their products meet the safety, quality and efficacy requirements of a medicine if they wish to continue to market their product.

Hmmm… the problem with this is that the definitions of a medicine are exactly the same in EU and UK law (the latter is governed by the former). So if they aren’t medicines in UK law if no claim is made, they aren’t medicines in EU law either.  The EU institutions can’t just insist on that a directive applies if the products in question fall outside the definitions in the directive – something the courts have repeatedly found in Europe. The reason for this is that e-cigarettes are not medicines… this fact is inescapable, and until it is recognised they will be going up a regulatory blind ally.

21 comments to Tobacco products directive, e-cigarettes & snus – an update

  • Tony

    No worries buddy thought I would just highlight it for you.

  • I’m away with limited connectivity but Akismet is set up on the site to deal with this but perf seems patchy

  • Tony

    Clive you need to do something about moderating posts to stop these nonsensical spam wankers. :-(

  • Same game the Antismokers have been playing against Free Choice advocates for the last 20 years. Vapers need to become familiar with the history and tactics of the antismoking movement and learn where its weaknesses lie and how to fight it. While many e-cig enthusiasts are ex-smokers and were initially fairly antismoking themselves, they’ve begun to realize that they’re destined to be thrown out to the dumpsters along with the smokers unless they ally and fight together.

    In terms of e-cigs giving “the appearance” of smoking to Antismokers, a biblical quote comes to mind: “If thine eye offends thee, pluck it out and cast it away.” Antismokers have always abused our love of children to push their agenda, and now they’re doing the same thing to the Vapers.

  • my blog post … fivehundybymidnight.com (Nichole)

  • […] cigarettes as medicines.  However, the European Council would allow tobacco companies more time to acquire medicines marketing […]

  • No a decision is reached when Parliament and Council reach agreement. Process explained in the post. But probably early 2014 if it happens. It is possible for no agreement to be reached and the proposal falls.

  • So what does it mean by “the first reading” in October? Is that when a decision will be made?

  • I strongly disagree with the plan to ban electronic cigarettes. It will only bring more bad than good. Around the world, millions of active and passive smokers are dying from tobaco-related illnesses.Passive or second-hand smokers are at greatest risk: they don’t smoke but may risk their health and lives from inhaling tobacco smoke. Electronic cigarettes should more readily available to help solve this problem.

  • Alexandrite

    I strongly disagree with the plan to strictly regulate, or even attempt to ban, the distribution of e-cigarettes. Millions of active and passive smokers around the world are either dead or suffering serious illness as the result of tobacco smoking. More smokers should be encouraged to replace their old conventional cigarettes with electronic cigarettes. Decades of smoking habit can seriously endanger one’s health, especially passive smokers. Family members of smokers often become passive smokers: they do not smoke or never smoke at all but at risk of suffering smoke-related diseases. Banning electronic cigarettes will only aggravate this problem.

  • Oh well I will continue smoking my cigarettes then not bothered using e cigs. I will make my own bags and bin packages. Did they start fixing the alcohol products yet? Because I am seriousely crossed having to bare drinking people on the plane beside my kids

  • John

    It is extremely important that e-cigs are essentially banned otherwise tobacco companies would no longer be able to kill millions of people for profit. Medicalizing e-cigs will ensure not only healthy financial outlook for Tobacco but also for Pharma. That is the important issue here.

  • […] Tobacco products directive, e-cigarettes & snus – an update […]

  • Tony.

    Great post Clive, might it also be worth mentioning about the MHRA being heavily funded by Big Pharma and Big Pharma standing to lose a lot of money when people realize that e-cigs work, unlike their own NRT’s that have a very poor success rate?

  • Clive Bates

    It’s probably aggravating your hangover.

    Which smokers are expressing this need for greater confidence? It seems only non-smokers want this… Of course, the point here is that 98% of nicotine is consumed through inhaling a matrix of burning particles of tobacco leaf and toxic hot gases – so why the alternatives have to be produced in pharma clean room conditions, I’m not sure. As far as quality is concerned, we normally allow consumers to decide what works for them – as long as the product is accurately described and works as intended. The great evolutionary engine of consumer preferences, supplier innovation and creative destruction will select the ‘right’ products. Regulators have always shown they are two conservative or don’t understand enough to get this right. For example they think e-cigs are all about consistent nicotine dose delivery.

  • Dodderer

    Just re-reading ASH’s press release re the MHRA proposed regulation of ecigs,it ends with “…but for smokers to be confident about the quality of the products they’re buying such regulation is essential.”

    Is this as ludicrous as it sounds or just my hangover!

  • Jonathan Bagley

    I’m more cynical. I think they every little thing about vaping practice. Someone will have told them, over and over again. They must have talked to the large ecig companies who sell only prefilled, sealed cartidges at high prices but not high strength. These companies aren’t going to invest millions of pounds if there is permanent competition from every man and his dog selling generally perfectly functional and reliable large batteries and refillable tanks, and eliquid easily available online at a fraction of the price. There is something we don’t know, and I think it’s about the liquid. They have to stop people getting hold of high strength nicotine/PG in order for these regulations to work. I haven’t looked into it, but I think anyone can now buy nicotine up to 7.5% strength. This is a chemical safety regulation and nothing to do with ecigs. If this regulation is tightened – how will this affect other industrial users of nicotine? – to cope with ecigs, it will inevitably lead to people messing about with very toxic, almost pure nicotine, possibly not of pharmaceutical grade. A recipe for disaster.

    • Twiglet

      This is exactly what I’ve been saying. If the intention is to provide a product in which smokers can have confidence they can do that without regulating the rest of the market to death. It would mean that the licensed products could have some sort of gold star of approval from the government leaving the rest of us to continue with our substandard inefficient rubbish (ha ha!). But as Jonathan has said, no one is going to invest that kind of money knowing that the gold star users will eventually wise up and switch horses. If the TPD does get though they’re going to find out that we are unregulatable (my made up word for the day) so they’ll try to starve us of liquid. Why they feel the need to do that is anybody’s conspiracy theory.

  • Jonathan Bagley

    “•Retains the idea of a nicotine threshold, but halves the thresholds to 1mg of nicotine and 2mg/ml nicotine density….”

    At first sight this appears to allow 2mg eliquid to be sold in 20, 30, 50 or 100ml bottles as much higher strengths are now. It would then be reasonable to allow the sale of the current devices with refillable tanks and cartridges and large batteries, or something very similar. Vapers would then need only get hold of stronger liquid from somewhere. Some companies have welcomed the MHRA statement, for example Nicolites, which sells only very expensive prefilled cartridges with the highest strength being 16mg – not much good to many of us. A nicolite 20 a day equivalent habit costs £16 a week if you believe their claims. They don’t give the total amount of liquid in each cartridge, but I’m guessing £30 or £40 a week is more realistic. Nicolites has the same business model as printer manufacturers – the ink is incredibly expensive. Are Nicolites anticipating a ban on loose eliquid or the devices themselves?

    • Clive Bates

      Interesting… I can’t help thinking they have a narrow model of vaping practice when they describe their regulatory approach. I suspect completely neglecting the reality of the practice and underlying commerce. An interesting question is the segmentation of different types of user and product – from people mixing their own liquids at one end of the spectrum to people using more commodified sealed cig-a-likes at the other, and also how that segmentation might change if e-cigs reach the scale we might hope. If they make the commodified products less appealing – eg. by banning flavours – will the result be to shift users to the self mixing end of the spectrum, and/or just leave more people smoking. Presumably, the self-mixing end of this is pretty well impossible to regulate, especially if you can buy full strength liquids online (even if illegal) or even make your own… As you can probably tell, I can exhaust my knowledge of this in about two sentences, so would anyone care to comment…?

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