We are approaching make or break time of the revision of the Tobacco Products Directive – the ‘first reading’ of the proposal is coming up. Here’s my take on the process.
What is the overall process? The TPD is following the ‘Ordinary Legislative Procedure‘. This is a process whereby the European Commission makes a proposal and then the European Parliament (elected MEPs) and European Council (representatives of 28 member state governments) go through a process of amending the Commission proposal and reaching agreement with each other. By the end of the process, Parliament and Council must agree or it doesn’t pass. The process has three stages in which views are batted back and forth between the two institutions:
- First reading: The Commission submits the legislative proposal to the Council and the European Parliament (EP). Both institutions conduct the first reading – which is without time-limits – and if the Council approves the EP’s position at first reading, the legislative act is adopted. We are approaching this stage.
- Second reading:Â If the Council rejects the EP’s position, it adopts its own position at first reading and submits it to the EP for a second reading. If the EP approves this position, the legislative act is adopted. In the event of rejection, the dossier may be resumed only on the basis of a new proposal from the Commission. If the EP proposes amendments to the Council’s position, the Council’s second reading is conducted. If all the amendments are approved, the act is adopted; in the event of rejection, the Conciliation Committee is convened.
- Conciliation and third reading:Â The representatives of the EP, the Council and the Commission have six weeks to reach an agreement and approve the joint text.
This is a simplification –  informal negotiation between the readings goes on to try to reach agreement, understand red-lines etc.  Want to know more? The formal process is set out in Article 294 of the Treaty on Functioning of the European Union and in this very detailed guide aimed at those directly involved.
What has happened so far? The Commission made its proposal for a revised Tobacco Products Directive on 19 December 2012.  On behalf of the European Parliament, the Environment, Public Health and Food Safety (ENVI) committee, led by its chosen rapporteur, British socialist Linda McAvan MEP, has scrutinised the Commission proposal. This culminated in a vote in the ENVI committee on 10 July (accompanied by protests from vapers). The outcome of that vote is the report of the ENVI committee, which though dated 24 July has only just been published on the web on Friday 30 August.  The report is in the form of a series of amendments to the original Commission proposal that the ENVI committee has voted for.  It is also presented with opinions of other committees, many of which take a different view to ENVI on some crucial matters.  Meanwhile, the European Council has not been idle…  to signal its intent, it has agreed a ‘general approach‘, or its own views of what amendments should be made to the Commission’s proposal.  The general approach is an informal position designed to move its members towards agreement and to signal its intent so that the European Parliament can start to look for areas of common ground with the Council. The Council adopts its formal position at its first reading later in the year (probably 10th December- see below).
So to summarise, there are now three texts in play: the Commission proposal; the ENVI committee report; and the Council general approach.
What will happen next? The next important stage is that the report of the ENVI committee is debated and voted on by the European Parliament plenary (ie. all MEPs, not just those on the ENVI committee).  This is the first reading referred to above. The plenary will take the ENVI report as its starting point and consider what, if any, amendments it wants.  It is possible for MEPs to put down amendments to the ENVI report for voting in the plenary  – but each amendment needs 40 signatures or the backing of a political group, so it takes some organisation and time to get amendments down.  The ENVI report is full of incoherent policy and law so amendments will be critical if it is to have a positive impact on health.
When will first reading in the European Parliament happen? Updated 5 Sept. As of today (5 September) the TPD plenary debate and vote is scheduled for consideration in the week of 8 October in Strasbourg, France.  It was important that the date was put back from September to October.  We wrote to the Conference of Presidents to explain why. There is a chance that the rapportuer will try to add it to the agenda at the last minute on 9 September. It is a gesture likely to fail.
After that? After the first reading in the EP, it’s back to the Council. The EP will emerge from the forthcoming plenary with its position – its preferred version of the directive –  with which it can then start  discussions with the European Council.  The TPD is considered by a ‘configuration’ of the European Council called the Employment, Social Policy, Health and Consumer Affairs Council.  ‘Configuration’ means it is still acting with the full authority of member state governments, but they typically send appropriate ministers (eg health) instead of prime ministers or presidents.  The calendar for the Council meetings in its various configurations  is here. This Council configuration meets informally and regularly as an officials working group but formally with ministers present on two occasions in the remainder of 2013 – 15 October and 9-10 December.  The agenda for the rest of this year (ie. the Council meetings under the Lithuanian presidency) shows the tobacco directive tentatively scheduled for discussion on 10 December (see ‘any other business’ on p.44). That would be the Council’s first reading…
- The Council could agree with everything the EP decided at its first reading at that point (voting on a qualified majority basis) and the directive would become law.
- Much more likely is that Council will not entirely agree the EP position. Â So they will use the time between the EP plenary (updated: currently scheduled on 8 October) and Council first reading (currently scheduled on 10 December) to try to negotiate common ground between the EP and Council. Â The Council could then adopt its own position at first reading and submit this back to the EP, hoping that they have done enough negotiation for the EP to clear the Council position at the EP’s second reading, which could happen early in 2014. The EP currently has six plenary sessions scheduled for 2014, before the European elections 22-25 May 2014.
- If EP doesn’t agree with Council’s position at an EP second reading, it goes back to the Council for its second reading. If still no agreement it goes into the conciliation stage with up to six weeks to find agreement. Given the May 2014 election, they will want to schedule the EP second reading no later than  February I guess. [see detailed process]  There may be other things that shape the agenda at the end of a parliamentary term too… if anyone has insights let me know.
What about scrutiny in the UK? The UK parliament reserves the right to scrutinise the positions the UK government takes in many European Union negotiations, and  House of Commons European Scrutiny Committee and House of Lords EU Sub-Committee F do this for the TPD. There’s been a storm over the Minister for Public Health, currently Anna Soubry MP, sidestepping the Commons European scrutiny reserve when she participated in the forming of the Council General Approach on 21 June.  This committee was clearly incensed and has said it will return to the issue.  I have written to the Chairman Bill Cash with concerns about the incoherence of the directive. Note that the Committee can’t veto a government position, but it can call for full Commons debate (more).  The UK government would be reluctant to change its mind following Anna Soubry’s unscrutinised endorsement of the Council General Approach, but it’s not impossible – particularly if there is a debate, or if those charged with supporting business finally wake up and realise the health department is about to snuff out a pro-health disruptive sunrise industry in a thicket of pointless red tape.
Legal action to follow? Almost certainly.  There’s a lot of posturing politicians lined up behind damaging and poorly judged proposals, and they may well get through the Ordinary Legislative Procedure and be passed into law as a new directive. But the EU legislature cannot just do what it likes.  The treaties limit the powers of the EU and require conformity with important principles such as non-discrimination, proportionality, adequate legal base etc.  I’m working on a full posting on this, but for now I would direct you to the legal opinion provided by Sir Francis Jacobs QC for ECITA, and the legally orientated briefing by TVECA.  The JURI committee opinion found that regulation of e-cigarettes as medicines was without proper legal foundation and proposed a much better amendment (no 65 in its opinion along with 13-15 in the recitals and 74 to create an annex).  For snus, JURI also included a sensible amendment for traditional use (no 62, with 29 for the recital) – probably the most we will get.
Conclusion and action. Everything to play for, nothing to lose – keep pressing MPs and MEPs, especially EPP members if you are outside the UK. No pressure is too great – but remember always keep it personalised, polite and on the point. Every politician has grown weary of mass form letter mailings, foaming ranters and conspiracy theorists. Also every MEP is now involved – many have been relying on ENVI colleagues to do the work so far.  From now on, their involvement, and their responsibility, is just as important as any ENVI committee member. So keep up the letters to MPs and MEPs (use write to them) and consider writing to Anna Soubry (while you still can).
Note:Â Many readers are more expert than me on the machinations of the EU – please add insights or corrections in comments or email me directly. Â Ill update as developments unfold.
Q&A. If you have a question about any of this or anything to do with the TPD, don’t keep it to yourself – many others are likely to have the same question… Â put it down in the comments and I’ll try to get you an answer…
I think the publishing of the report so late – end of August when the meeting is in the middle of September, is deliberate. A recent experience makes me believe that. We have fought here in our village, for five years to stop a communication pole/mast being erected directly in front of people’s houses. On bank holiday Friday, the people in the houses got notifications the mast was going up – and on Tuesday, the day after bank holiday Monday, it was up! It was deliberately planned so no more resistance could occur.
The publishing of the report so close before the meeting is of the same ilk. No time to think or do anything. Weasels!
Oh – not even the middle of September – nine days! That should be fought.
Great informative post Clive – thanks. Considering the time scales that MEPs have and also the lack of knowledge many of them have regarding the finer points would I perhaps be right in surmising that potentially the easiest aspect to write to MEPs and focus on is the legal challenge and in particular the JURI committee amendment. In that it’s logical to keep e-cigs as they are as a general product with the existing 21 EU product and safety directives that already cover such products, but any company/suppler/product that wants to make health claims has every right to do so on the understanding that they would then need to obtain medical regulatory approval.
In other words if no health claims are being made, than there is absolutely no need for medical regulation.
Roger – thanks… You are right, the Legal Affairs (JURI) opinion, is very important. JURI says:
… and in a footnote:
So they aren’t medicines and there is no legal base for regulating them this way. Apart from that, it’s fine!
Thanks again for all your hard work Clive. You provide a glimmer of hope where all we see is corruption at the highest level. Everyone seems to be jumping on the band wagon and the heath and safety mob seem to be closing ranks to make themselves look as if they are looking after our best interests when it is clear to us all that they will in effect be killing us if they get their way.
Clive, Excellent post. The incredibly late publication of this document is very disturbing indeed. What is possibly more alarming, if my understanding is correct, is that any amendments that MEPs wish to submit to this complex piece of legislation, have to be submitted by Wed 4th September. Is this your understanding? http://www.europarl.europa.eu/sides/getDoc.do?type=AGENDA&reference=20130909&secondRef=SIT&language=en#DL127
Definitely 4 Sept 12:00 – on current timetable (at the ‘deadline’ tab)
Thankyou for all this information, set out so clearly, it is very useful.
I would like to ask what you think regards mentioning the topic of vested interests of those on advisory panels. You mention that politicians are weary of conspiracy theorist views and so I wondered whether you think that is a subject to stay clear of when speaking to my MP, or whether it does have some relevancy and could be brought up safely?
I refer to the article in the Times by Alex Ralph, who detailed the various vested interests of the MHRA advisory panel. http://www.thetimes.co.uk/tto/business/industries/consumer/article3852342.ece (its behind a paywall, but details the names and interests of the various panel members)
I was going to mention this to my MP, as I thought it may have some bearing, but what do you think? So far the only response I have had from my MP, is a stock letter he forwarded me from Anna Soubry, that I believe is the same letter that many others have received.
I don’t think conspiracy theories work unless there is some evidence of wrongdoing – and no one provides it. It’s mostly just opinion asserted as fact, or innuendo. Most of the people on MHRA panels etc are pretty highly respected and knowledgable – that why they are hired as consultants. But you have to work hard to show they left their integrity at the door and are acting as paid shills for Big Pharma.
Despite mountains of evidence justifying scepticism, pharma companies still have good reputations (saviours). Of course this is different for tobacco and probably e-cig companies (pushers). So a gross conflict of interest with pharma is overlooked and a slight sign of involvement with tobacco or e-cigs seized on as a cardinal sin. Ricardo Polosa’s treatment is a good example.
I do think Alex Ralph’s piece is important and the things he raises matter, but I think it is unlikely to change anyone’s pre-existing views.
Mostly I think the conflict arise from cultural osmosis – if you work with people it is easy to assimilate their world view and framing biases. There is very little deliberate cash-for-influence – it’s all much more subtle and frankly less evil than that – everyone involved believes they are working together to o the right thing.
Yes I absolutely agree with you on that, that any bias is subtle based on general exposure to certain environments, rather than direct, cash incentive type bias. Indeed the choice of those advisors is probably no surprise either, considering that the licensing director of MHRA Dr Ian Hudson (soon to be chief exec) previously worked for the makers of Nicorette himself. These will be the people on hand, no ill intent maybe, yet still unfortunate for the ecig industry, as these people will have it engrained that nicotine is a medicinal product from the offset.
Dr Ian Hudson did state in a letter to the times in response to the article, that they had a hard job finding experts from outside the industry. I imagine it is easier to use people from within existing networks and as you say, that is not evil, but it is maybe a system fault that has led to an unbalanced directive.
But I think they are using the wrong sort of expertise in this case – and that is because this isn’t a medicine. But the mindset of those involved regards it as another smoking cessation medication. None of the doctors pronouncing on this have the first idea about innovation in fast moving consumer goods, the views and motivation of consumers in this market, or the business models of the hundreds of ompanies in this industry. No wonder they decided medical regulation is the right thing… What else do they know…?
But it should also be noted that most of those in Tobacco Control and Smoking Cessation – who are not doctors – and supposedly have expertise regarding ‘real’ smokers – are equally convinced they should be regarded as medicines.
They know,but rarely admit to, the failure of their current efforts(the’jewel in the crown’was actually an admission of ineffectiveness). Surely, they cannot all be so economically naive not to have worked out by now what impact this regulation will have in real life?
Someone has an agenda and someone is writing their scripts.
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Thanks! I totally agree.
I already posed questions in this direction to Martin Schulz (current president of the EP) on the german platform “abgeordnetenwatch.de”. Rough translation (summary):
And when the report finally appeared I posed a follow-up question:
And something the same vein for Mr. Groote (chair man of ENVI):
Well, if this sounds a bit like “Jeopardy” … abgeordnetnwatch insists on questions … ;)
Finland has only 13 members of the EU parliament, so I send the same message, personalized thou, to all of them. I impressed my concerns about Big-P’s influence about controlling the market and driving ecigs out of that scene.
Letter in Finnish is visible at
http://www.vapers.fi/2013/08/31/kirje-europarlamentaarikoille/
Due to NRT products having been available for so long in chemists etc, quite alot of people mistakenly associate nicotine with medicine. That seems to be a hard barrier to get past, so I was pondering over how to get past that when speaking to my MP.
I was thinking that maybe I should point out to him, that the major difference between NRT and other NCP such as ecigs, is that NRT is a process, not a physical product. Nicotine doesnt cure people of smoking. What the experts say cures people of smoking, is the process of gradual withdrawal from nicotine. It is that gradual withdrawal therapy, that is sold as a quit smoking product. In my mind, that is the distinction between NRT (a medical product) and other NCP( consumer products).
Does that sound right?
I read recently, someone had posted on a forum about a few proposed revisions to the directive, whereby only NCPS sold with medical claims, would require licenses. That sounds like a step in the right direction, but I am not sure whether that was correct information or not?
The distinction I normally draw is that NRT is mostly intended to be used to relieve cravings and withdrawal during an attempt to quit smoking and nicotine completely. E-cigs are an alternative to smoking, a different and much less harmful way to use nicotine, with most of the benefits and few of the costs. NRT manufacturers make claims that these products are effective in quitting smoking and it is only very recently and only in limited cases that NRT is sold for ‘nicotine maintenance’ or harm reduction.
Dr. Etter said at the workshop at 14:41:48 (transscript page 21) that about 1% of smokers who quit smoking using nicotine gum stay addicted to the gum. About one third of all sales are to them.
But nobody makes a fuzz about them and Dr. Etter sees no reason to, since this is much less harmful.
I like to compare my switching to ecigs to when I switched from drinking coffee to the digestively less harmful green tea. I still get all the coffein I want but avoid the heartburn and other side effects from drinking a lot of coffee.
The information was correct. See the JURI opinion, footnote 2 (page 5) and amendment 65 (page 37)
Thanks for the update Clive.
As usual clear and very informative!
Great explanation of what lies ahead thanks Clive. Now we all need to put pressure on MEP’s to make a reasonable decision.
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As this is a World Health Organisation, Framework Convention on Tobacco Control, proposal (WHO, FCTC) and all EU member states have signed into, the FCTC treaty, the European Union, Tobacco Products Directive, is basically unstoppable, but best of luck.
And also the WHO FCTC treaty is legally binding. (Did anyone vote for them to make our laws, the answer is no)
Here is a Summary from the EPHA.(Link at bottom of page)
“Directive 2001/37/EC1 has been the framework regulating the manufacture, presentation and sale of tobacco products in the 27 Member States of the European Union (EU) since 2001. The 2001 Directive(the Tobacco Prodicts Directive) had two established objectives: facilitating the functioning of the internal market in the tobacco products sector and ensuring a high level of public health.
In 2005, the EU ratified the World Health Organization’s Framework Convention on Tobacco Control (FCTC). In 2012, all 27 Member States of the EU had signed and ratified the text, therefore renderingthe provisions of the FCTC applicable to them. The 2001 Tobacco Products Directive was adopted prior to the EU commitment under the FCTC, and therefore, the revision of the Directive presents an opportunity for the EU to bring its main tobacco policy framework in line with its international obligations”.
http://www.epha.org/IMG/pdf/EPHA_position_on_the_TPD_May_2013.pdf
Roght, Greg, but FCTC mandatory elements are ONLY the articles in the Convention and the Protocol on Illicit trade of tobacco products. teh guidelines are NOT binding, and these are the only ones addressing the e-cigs.
Hope this helps
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The Health and Safety Executive are legally obliged to look at all worldwide data, to make sure that the Health and safety of people under the Health and Safety at work act, is maintained. At the time the smoking ban went through legislation in the UK, the HSE, made this statement in article 9 of OC255/15 in 2006.
9 “The evidential link between individual circumstances of exposure to risk in
exempted premises will be hard to establish. In essence, HSE cannot produce epidemiological evidence to link levels of exposure to SHS to the raised risk of contracting specific diseases and it is therefore difficult to prove health related breaches of the Health and Safety at Work Act”.
This manipulation of science, has created a scenario where even products (E-Cigs) which do not cause even insignificant harm such as SHS, are evaluated as harmful. how do we put the genie back in the bottle?
I agree Joe that the illicit trade of tobacco products,is mandatory by parties of the FCTC, you also find in article one, on this link that E-Cigs will come under a binding agreement, http://www.who.int/cancer/prevention/tobacco_implementation/fctc/en/index.html
“Protect public health policies from commercial and other vested interests of the tobacco industry”. (See article 30 in the link below)
Ann Soubry did not circumvent protocol, on E-Cigs because she is stupid.
This is the relevant document from the FCTC, note article,s 27,30,33,34.
http://apps.who.int/gb/fctc/PDF/cop5/FCTC_COP5_13-en.pdf
Greg, as I see it the problem stems from the Antismokers’ willingness to take the purported risk from the heaviest normal type exposures (such as the EPA’s 19% increase over a base rate of about .4% after 30 to 40 years of daily workplace exposure to the very heavy concentrations of workplace smoke in the 1940s through 1970s) and then magnify that risk in people’s minds by constantly harping on the idea that “Exposure to…” (i.e. ANY exposure, no time or concentration considerations involved) “… secondhand smoke…” (again, no considerations of concentration) “… increases … ” (not “may increase,” or “is correlated with an increase” or “is associated with an increase”) “…your chances of lung cancer…” (with the base rate of those chances being quite deliberately and specifically left undefined) “…by 19%.” (lending an aura of exactitude that in no way reflects the uncertainties of the studies and calculations involved.
Think about it: in reading a story headlined “Beach Ban: Second smoke dangers cited!” you see the statement “Exposure to secondhand smoke increases your chances of lung cancer by 19%” do you think the average person is more likely to walk away with the impression that:
A) that translates into one extra lung cancer for every 40,000 worker-years of exposure to 1960’s style workplace smoke levels, a period when even nurse’s stations in the center of the ward floors in hospitals were usually surrounded by a blue haze?
or
B) that if I have dinner in a restaurant where someone is smoking, or walk by a smoker at a doorway or on the street, or even see someone using an electro-fag ten feet away from me on the beach … that I’m “at real risk” of lung cancer to such an extent that I should put real effort into consciously avoiding such exposure?
It’s the distortion in thought, furthered by consciously structured and carefully worded propaganda that has fertilized the soil for the current rejection of e-cigs.
Clive, I also have a specific question. Your outline at top notes, “Conciliation and third reading: The representatives of the EP, the Council and the Commission have six weeks to reach an agreement and approve the joint text.”
What happens if they don’t reach agreement? Is the FCTC then annulled in the UK?
:?
Michael J. McFadden
The TPD directive proposal (not FCTC) would fall. The UK would still have to meet its obligations as a party to the FCTC. Running out of time is a possibility for this proposal mainly because of the May election, but its unlikely… They will throw everything into finding agreement – but that might mean contentious issues are dropped or fudged as they get closer to the wire.
Clive, thank you for a fast and informative response!
What happens in a case like the WTO is facing with the US though? In the US case, we are refusing to allow the import of clove cigarettes, theoretically in violation of WTO treaty. If the UK refused to follow certain FCTC mandates would it be a similar sort of situation? Or are FCTC mandates more (or less?) powerful/enforceable than WTO mandates? Any idea?
:?
MJM
All this is making JTI’s ploom look like the smartest guy in the room.
Maybe… under the current proposal it is certainly easier to bring a reduced risk nicotine product to market if it contains tobacco (Article 17) than if it doesn’t (Article 18 – medicine designation). But being defined as a tobacco product brings on a lot of potential difficulty – no flavourings, no additives other than essential, possibly no internet sales, participation in he tracking and tracing regime – and in some countries bans on advertising, promotion and sponsorship.
Michael,
looks like FCTC are legally enforceable through EU directives, here is a document from 2009 stating the relationship with the FCTC.
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ%3AC%3A2009%3A296%3A0004%3A0014%3AEN%3APDF
Thank you Greg. That is certainly a remarkable document. Just looking at the first few items, we can see such things as ETS killing 7,300 adults, with 66% of the victims being smokers. Clearly something needs to be done to protect smokers from breathing in stray wisps of smoke in the air. Unfortunately the document does not cite the actual evidence of these deaths, but I’m sure they must be properly toe-tagged and filling the graveyards, right?
It then goes on to tell us that exposure to secondary smoke is causing children to take up smoking. I’m guessing that’s based upon the astounding addictiveness of nicotine. However, the amount of nicotine absorbed from secondary smoke by children is probably less than the amount they absorb from eating pizza, spaghetti sauce, and eggplants. The EU should concentrate on saving our most young and vulnerably by eradicating the deadly nightshade plants entirely: our children will grow to prefer soybeans and not fall into addiction.
And we see ETS is classified as a known human carcinogen. I believe tapwater should also properly be given this classification as it almost universally has traces of such elements as arsenic, chlorine, and other arguably carcinogenic elements: remember… there is no safe level of exposure. Children should be kept safely out of the reach of solar radiation at all times, in dark caves, and fed mushrooms with their soybeans. They’ll thank us later.
That’s items 4, 5, and 6 dealt with. All I have time for today. Sorry. My bill will be in the mail.
– MJM
Clive, I’ve tweeted this however I’ve just found out that the UK EU scrutiny committee held a meeting on 4th Sept and recommended a debate at the House of Lords sub committee C, which is external affairs and not even Health.
http://www.parliament.uk/business/committees/committees-a-z/commons-select/european-scrutiny-committee/news/meeting-summary-04-september-2013/
No date yet known, but certainly not what one would expect considering the massive health issues at stake and maybe some shenanigans at play here too?
Thanks Roger – I’d heard that they were returning to this, but thought they would recommend a Commons debate and I’m a bit surprised by this outcome. The choice of EU Sub-committee C is peculiar – perhaps they think it is an international trade issues because of the standardised packaging or track and trace issues. No-one has an easy ride in the Lords – they less prone to grandstanding and posturing.
“The choice of EU Sub-committee C is peculiar – perhaps they think it is an international trade issues because of the standardised packaging or track and trace issues.”
Or perhaps they have a couple of friends on that committee that they can count on to sway the vote count?
– MJM
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