When we’ve decided, we’ll let you know: an update on nicotine negotiations in Brussels

Updated 17 Dec… A secretive, opaque, poorly informed, arbitrary, rushed policy-making process is heading towards an unsatisfactory and damaging conclusion – this is an update.  I have seen nothing to justify changing my view that a proper job is required for regulating e-cigarettes, and that we should have a new legislative proposal with evidence-based justification; a credible impact assessment; the basic courtesy of consultation with users, businesses and public health experts; and proper scrutiny by national parliaments, who are formally part of the process.  The Article 18 text under discussion is entirely new, unrecognisable from the Commission proposal and five times its length.  Yet it has been subject to none of the disciplines required of a new proposal.

 

State of negotiations. The most recent leaked negotiating text I have seen is available here. But there has been significant discussion on Friday 13th on the Council side and a technical meeting of the trilogue.  The process is opaque and insular and the documentation is secret. We rely on leaks and unofficial briefings to find out what is going on – so this assessment has to be taken in that light.  There remain several ares that are still controversial, some that aren’t controversial but should be, and some things that should be included but are not.  The main points of interest surrounds the following:

• Maximum e-liquid nicotine density (in mg/ml) – this seems to be converging on 20mg/ml but many in Council want this lower.  Parliament starting position is 30mg/ml. It should be >50mg/ml if it is specified at all. High nicotine densities may be needed for more effective nicotine delivery, more compact devices and use in innovations we don’t know of yet.
• Maximum nicotine content per unit – now unclear – this has previously been very low at 10mg nicotine, but some recent suggestion that this might change to 10ml of liquid (which means much more mg nicotine). In fact, the focus should be on packaging not the volume of liquid or quantity of nicotine (imagine if we tried to regulate bleach that way?). The whole area is of nicotine limits is bedevilled by confusion over aims (addictiveness? toxicity?) and science – recent data shows it to be much less toxic than previously though (based on 19th Century studies – see article + blog).
• Flavours – the emerging flavour of choice is ‘fudge’ – with possibility of a review or leaving it to member states to decide. This is a harmonising internal market directive – no restrictions should be applied unless and until there is evidence that a certain flavour causes harm. For some reason, the negotiators think ‘children’ (actually adolescents would be a better term) want to use childish flavours, like bubble gum.
• Refillable devices – seems to be some movement towards not banning these 2nd and 3rd generation devices and instead specifying standards for refill containers. No case for limiting refillables – the safety of containers is more important.
• ‘Consistent dosing’ – some movement here as it was previously ‘uniformly and consistently’ – borrowed from the medicines mindset, but potentially immensely difficult and limiting design constraint.
• Testing and notification – requirements for many tests of toxicity in liquid, vapour etc – this should be done, but subject to proportionality and with a clear understanding of what the test data is to be used for
• Nicotine delivery and dosing – purpose unclear – consumers decide which products they like or find satisfying.  But this will require a testing regime (not stated in the directive) and some idea of what will be done with the results.
• Age restrictions – was included by the Parliament, but no longer included as this is not a matter for the EU, but for member states legislation
• Advertising restrictions (on certain types of cross border advertising, TV and radio). Appears to be agreement on this, even though no basis whatsoever for a ban – a similar approach to alcohol advertising could be taken. Note member states responsible for regulating most advertising, not EU and UK regulators are considering advertising rules rather than a ban.
• Purity requirement – requirement that ingredients that ‘high purity and free from contaminants are used in the manufacture of the liquid’. Everything has some contamination in it – in reality a standard setting regime is necessary and should be established in the directive.
• Tobacco branding / brand stretching – a ban on the use of tobacco branding on e-cigs was part of the Parliament’s proposal but that is covered by other directives and not harmonised in this directive
• Warning, labelling and information leaflets – proposals are disproportionate given the risks and by comparison with smoking.
• Medicines regulation – a number of members states have been trying to retain the right to regulate the products as medicines at national level. This is a ridiculous thing to do in a harmonising internal market directive – and seems to fail every time it is tested in member state courts.

In summary – it’s a messy half-baked muddle, but this text is not as bad as it was. (update 16 Dec: even this text isn’t actually agreed, with the Council still insisting that refillables should be banned and a ridiculously low maximum unit quantity of nicotine set).  Furthermore, this text is very far from the public health or consumer optimum.  That would involve finding a balance between managing the minor and implausible risks that the public health community have fetishised and enabling the products to compete effectively with cigarettes, which is where the huge public health dividend will actually be achieved.  Remember for snus in Sweden, amazingly positive health results were obtained with minimal regulation. Of course, the people negotiating this negligently want snus to remain banned, so we can discard the idea that doing the right thing for health is their primary concern. We should also bear in mind that the underlying principle of this legislation is ‘free movement of goods’ – and they should present evidence if they want to depart from that to secure a high level of health protection.  With snus, their absurd ban was negative for health.

Updated 17 December. After hours of negotiation last night, it looks like a provisional agreement has been made on some of the more contentious issues among the negotiators:

• Nicotine density limit settled at 20mg/ml
• E-liquid refill containers no bigger than 10ml
• Single use cartridges limited to 2ml (updated)
• Refillable devices to have mechanism that prevents leakage – technical specs to be defined by Commission
• No ban on refillable devices, but…
  • A study of potential risks to public health be undertaken and complete in 24 months
  • Means to take individual brands/products off the market if serious risk to human health
  • If three members states instigate a ban then Commission is empowered to ban across the EU provided principle of proportionality is respected. Note: not a requirement to ban.

This will be subject to agreement at another meeting of Council officials (COREPER) on Wednesday night.

As you probably know, I think there is something tiresome and absurd about civil servants and politicians sitting in a late night negotiation trying to design e-cigarettes based on their scant knowledge and folk wisdom.

Overall: not a total disaster, just a lot of expensive wasteful evidence-free tinkering that will remove useful products, harm users and businesses, limit effectiveness relative to cigarettes, and block off innovation.

See this summary from Chris Davies MEP.

Where next? On Monday 16th December starting at 18.30 in Brussels, there will be the fifth ‘trilogue’ negotiation between representatives of the European Parliament and Presidency of the European Council – this meeting is aiming to secure agreement on a text for the revised Tobacco Products Directive, and in practice that means agreeing the text for Article 18 on e-cigarettes.  Each side in the negotiations then has to take it back to their institution (Parliament plenary and full European Council) and win support. If both agree with the text, it becomes law. But that agreement won’t be reached until the Parliament has voted on it at its official ‘first reading’.

Process continues into 2014. The Parliament has not yet completed its first reading – the vote and plenary on 8 October kept it open referring it back to the rapporteur and ENVI committee to pursue negotiation with the Council. If trilogue agreement is reached, it then goes back to the European Parliament plenary sometime in early 2014.  The Parliament will vote on a single amendment which captures all elements of the trilogue agreement and then passes a “legislative resolution”. If passed, this would complete the Parliament’s first reading. Once that’s done, the Council can formally adopt the directive (using exactly the same text as EP legislative resolution – that was have pre-agreed with the Presidency in the trilogue). If all that happens, the deal is done and the text becomes law.  This process could be completed in the first few months of next year – but the key political agreement may be struck in the trilogue on 16th December. At least that’s what most involved seem to want.  That doesn’t mean it will pass though: the European Parliament plenary has already rebelled once, and agreement in the Council can never be taken for granted – given domestic politics.  See this interactive guide to the Ordinary Legislative Procedure or more straightforwardly set out in PDF form).

We should note that national parliaments can and should have a say on this… see next post.