Procedural position. The difficult situation with the Tobacco Products Directive is summarised very well by Martin Callanan MEP – here. The only way to reverse some of the absurd, impractical and excessive regulation of e-cigarettes now built into the Tobacco Products Directive is to have the MEPs vote for/against individual parts of the directive, in what are called ‘split and separate votes’ in which Article 18 or some part of it can be voted down so it can be done again, properly. It seems that even at ‘first reading’, it is not possible to amend this text because it has been blessed by the ENVI committee. We know with reasonable confidence that the various weird restrictions, prohibitions and burdens will diminish the appeal of e-cigarettes and protect cigarettes, while doing almost nothing for health. If it is not possible to treat the harmful text with sensible amendments, then surgery is required to remove it. And the time to press for that is now…
Write a letter… soon! This won’t be easy, not least because the decision on whether to allow split or separate votes rests with one man, the President of the European Parliament, Martin Schulz MEP. But if you feel strongly about this, then you should be relentless in pressing for the right measures to the very end – this is what tells politicians you are serious. So I have written to Mr Schulz and the political group leaders, and I hope you will too… soon! My letter is below, but as always: you are free to draw on this, but please use you own words and experience; keep it polite and constructive – I want good regulation not no regulation; avoid expounding conspiracy theories; and assume the people you are writing to will read it in good faith and are willing to be persuaded. I’ve written to Martin Schulz and the leaders of the main political groups: click this link to send an e-mail to the President, CC: Political Group Leaders and also to my MEPs via via writetothem.com (UK only). And don’t forget Twitter: @MartinSchulz.
Timing update. Latest rumours are that they are running towards first reading (= last reading) in Strasbourg 24-27 February (not yet definite, previous assumption was 10-13 March). This means key decisions will be taken in the group week before, and possibly the decision on split vote taken before that – ie. very soon.
_________________ TEXT OF LETTER __________________
To: President of the European Parliament:Martin Schulz MEP (S&D) [contact form for President]
CC: Political Group Leaders: Joseph Daul MEP (EPP); Hannes Swoboda MEP (S&D); Guy Verhofstadt MEP (ALDE); Rebecca Harms MEP & Daniel Cohn Bendit MEP (Greens-EFA); Gabrielle Zimmer MEP (GUE-NGL); Nigel Farrage MEP & Francesco Enrico Speroni MEP (EFA)
CC: My own MEPs
Re: Tobacco Products Directive and e-cigarettes –
Dear Mr Schulz
I am writing to ask you to use your authority and experience to address a serious problem regarding the regulation of e-cigarettes through the tobacco products directive. As it stands, Article 18 of the directive contains a number of measures that will cause more harm than they prevent. Many MEPs have come to understand these products well over the last year and recognise their great potential to reduce smoking related disease and death. This potential will be squandered, and lives lost as a result, if badly designed regulation is agreed by the European Union. I would like to urge you therefore to allow split and/or separate votes on Article 18 at the European Parliament’s first reading. I also hope you will lead by example, by voting against Article 18 so that better regulation for e-cigarettes can be developed while the rest of the tobacco products directive can proceed to a conclusion. In support of this, I would like to invite you to consider the following concerns:
1. No consultation. E-cigarettes and related products are used by 8-10 millions Europeans, now involve thousands businesses and are the subject of intense research efforts in the expert community. It simply is not credible to produce 4,500 words of new regulation in a closed and insular process between October and December 2013 with no consultation with these stakeholders. Not only has that led to poorly designed regulation, but it violates obligations set out in the EU treaties, which require consultation on legislative proposals (see Article 11 TFEU, Article 2 Protocol 2). On what basis can the Parliament simply ignore these obligations and proceed with poor regulation regardless?
2. Flawed science, inadequate analysis. For EU legislation to be good for public health, and therefore to have a firm legal base, it needs to be based on sound science and analysis. To the extent that science has been used to justify the proposals, it has drawn stinging criticism from the scientists whose work has been cited. See: Scientific errors in the Tobacco Products Directive – a letter sent by scientists to the European Union and follow-up. The supporting analysis for this part of the directive is completely inadequate: there is no impact assessment or credible justification for the measures. The little there is (a one page fact sheet) has been dismissed by experts as a set of scientifically illiterate baseless assertions. Again, the treaties require proper justification and comprehensive impact assessment and none has been done (Article 5, Protocol 2).
3. Measures that will cause harm. There is no logic or scientific basis for imposing a limit to nicotine strength of 20mg/ml – about 25% of users use liquids stronger than this, and there is no basis for preventing the trade in these products. The stronger liquids are important to heavier smokers and to people as they make their first switch into e-cigarettes. The result of this limit will be less switching and more relapse to smoking. The result: more disease and premature death. Further harms are likely to arise from a black market forming in stronger liquids – this will of course be uncontrolled and potentially cause further harm. Measures that restrict the free movement of goods are justifiable under the legal base if they protect health, but not if they increase harm.
4. Measures that invite ridicule. The wide range of flavours is integral to the e-cigarette market and it is good news that flavours will be allowed under the directive. However, convoluted drafting has created a legal fiasco. Vendors can sell flavoured products but cannot say what the flavour actually is on the packaging. This is the sort of ‘straight banana’ regulation that makes the European legislature a laughing stock and feeds anti-politics movements.
5. Measures that protect the cigarette market. The directive bans most forms of advertising, treating e-cigarettes in the same way as tobacco. This will have the highly undesirable effect of protecting the cigarette market from competition from much safer products. It will impede free movement of goods, inhibit innovation and limit the appeal relative to smoking. The justification for banning tobacco advertising rests on the reality that smoking kills over half a million Europeans annually (see recital 3 in 2003/33/EC). No such justification exists for e-cigarettes, which are actually reducing death and disease by reducing smoking. The advertising provisions blatantly fail the ‘proportionality’ test of the EU treaties. A regime more like that used for alcohol advertising would be proportionate, but not outright bans – and the e-cigarette industry has many constructive proposals for regulation of marketing. Similar concerns apply to excessively large and bold warnings and packaging leaflets.
6. Measures that introduce arbitrary clashes with other EU legislation. The directive creates a new approach to handling potentially dangerous substances – by limiting container size, apparently to with the aim of keeping the volume of contents below an (incorrectly) estimated lethal dose. In doing so, it is more likely to have created an increased choking hazard than protected anyone at all. The European Union has a well established approach to handling hazardous substances through the 1272/2008 Classification, Labelling and Packaging (CLP) Regulation, and that is all that is needed for nicotine liquids. Imagine if we controlled the risks from household bleach or drain cleaner by reducing the container size to a few millilitres?
7. Measures that should be included but are missing. It would have been useful to have some standards, or at least a standard-setting regime, for the purity of e-liquids and operational parameters of e-cigarettes. These would build confidence in the products and bring about efficient standardisation.
Insist on a new proposal. This letter is not intended as a full critique of Article 18 – sadly, there is more to say about excessive technical requirements, information demands that have no purpose, and discriminatory burdens placed on e-cigarette makers that are not placed on cigarettes. But I hope this is sufficient to explain why many well-informed MEPs should wish to pause and see the regulation of e-cigarettes done properly. Now is the time to insist on a new Commission proposal that is properly researched and assessed, and, above all, formulated with the benefit of consultation.
Timing. There is no ‘crisis’ that demands immediate action and no manifestation of theoretical problems raised by some opponents of e-cigarettes are visible. The European Parliament was correct to reject an excessively burdensome and ill-fitting medicines regulation regime for e-cigarettes. However, at that point further work was needed to develop an evidence based, pro-health, legally robust alternative.
Given these doubts and controversies, and the public interest in the issue, I can see no justification in denying MEPs the option to vote separately on this part of the directive. If MEPs are concerned – and they have good reason to be – then they should be given to option to make the right decisions at first reading. In October, the European Parliament plenary showed its independence and its willingness to listen to voters and those affected. There is a good case for that to happen again. I hope you will show leadership and allow split and/or separate votes and lend your support to removal of Article 18 so that it can be done properly.
Covering note to copy to my MEPs.
Dear London MEPsAs London constituency MEPs, I thought you would welcome sight of my communication with the president and political group leaders on the subject of e-cigarettes and what an utter mess the tobacco products directive has created. I hope you find this briefing letter useful as you consider how to vote. I would be grateful if you could make a representation to the President to request a split or separate vote on the provisions relating to e-cigarettes, or let me know if you think this is inappropriate.It is distressing to see such poor legislation and egregious violation of the treaties. I hope you are willing to take a principled stand and do something about it.Clive Bates[my address]