TPD timeline, what happens next and what we vapers can do…guest post by Martin Callanan MEP.

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As with most trilogue meetings between the Parliament and the Council (in this case represented by the Lithuanians in the rotating chair), the tobacco talks started in the evening and concluded in the early hours. What came out of them was perhaps better for vapers than we first feared, but it is still far too prescriptive and restrictive for me to be able to support it.

The infamous Article 18 is now so long it is practically a directive in itself. In many cases it will allow national governments to maintain the status quo and classify e-cigs as medicinal products, and potentially even ban flavourings.

Refillables will be hardest hit. An EU ‘elf and safety review will take place in 2016. But it probably won’t be needed as the legislation allows the Commission to extend a ban across the EU if just three Member States apply a ban. This dagger hanging over the industry’s head is unacceptable.

Products will also be limited to a nicotine strength of 20 mg/ml. For someone moving off of a serious habit, such a small dose risks just sending people back on to hard cigarettes. We would want to see at least the 30mg limit set out in parliament’s vote in 2013.

Ok, so that’s what we don’t like. Unfortunately this agreement was agreed by representatives of national governments a few days after our meeting. Personally, I was disappointed to see the LibDem MEPs – who had fought alongside us to date – claim that this deal was a good one for e-cigs. It’s not too late to change their minds. And with elections coming you may be able to sway others too. But it will need the vapers of Europe to really step up their pressure on MEPs. The timeline is as follows (although it isalways likely to change):

1) In accordance with the Parliament’s Rule 70.5, the single vote on this compromise agreement will be scheduled in the environment and public health (ENVI) committee on 22 January 2014. A simple majority of MEPs is needed for the committee’s consent on the negotiated text.

2) Following the vote in the ENVI committee, the agreed text must then undergo a further legal-linguistic verification, which can take several weeks before the recast TPD is translated into the 24 official and working languages of the European Union.

3) The compromise text is then expected to go the plenary in Strasbourg inMarch 2014.

4) If the report is adopted in the ENVI committee with fewer than one-tenth of MEPs voting against, the report will go under Rule 138 at plenary. This means that the report shall then be subject to a single vote unless, before the drawing up of the final draft agenda, political groups or individual Members who together constitute one-tenth of the MEPs have requested in writing that the item be open to amendment, in which case the Parliament’s President shall set a deadline for tabling amendments.

So we do have options open to us. As it’s unlikely we will get sufficient votes to reject the whole directive outright in committee, the best course of action, in my view, would be to collect enough signatures (76) to enable amendments to be tabled at plenary, and then to reopen Article 18 with amendments to make it more sensible. Getting these amendments passed would require a Herculean effort from vapers right across Europe. You’ll be fighting against enormous and powerful lobbies from big tobacco to national governments. Conservative MEPs and the ECR Group will be on your side and we will keep working to bring other support behind your campaign. But we can’tdo this alone. This battle is not yet lost.

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Lets face the truth, decisions in the area of tobacco products are always and exclusively made for financial and not health reasons.

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Guest post by Dr Riccardo Polosa.

I was positively surprised when Members of European Parliament voted  against the pharmaceutical regulation of e-cigs proposed by the European Commission, during the first reading of Tobacco Products Directive (TPD), on 8th October 2013. It seemed as if they finally figured out the risks of over-regulating a product designed to reduce the health damage caused by tobacco smoking. Or so I thought.

 

Hurriedly, behind closed doors, and with restricted consultation, the EU legislators managed to introduced substantial modifications in the revised TPD, producing a profoundly mutated document that takes a completely different approach for e-cigs. The newly approved document is riddled with many arbitrary and disproportionate measures. And it could have been much worse thanks to the determination of a handful of brave MEPs who have fought hard to limit the damage.

 

In essence, this new document makes e-cigs much less attractive for those tobacco smokers contemplating to switch to a much reduced risk product. In particular, introduces the arbitrary limit of 20 mg/ml on the max strength of nicotine allowed in e-liquids, advertising bans as stringent as those currently in place for conventional cigarettes, plus several (yet, poorly defined) lab testing, reporting and compliance requirements.

 

Unfortunately, no consideration was given to setting up useful agreed purity standards for e-liquids or operating standards for devices. A simple regulatory framework that ensures consumer protection and product quality and that may work for these products already exists.

For example, e-liquids may be marketed as dietary supplements or cosmetics, whereas marketing and safety of e-cigarettes’ electronics, batteries, and spare parts are already regulated by the existing directives about electronic products design.

 

The minor or implausible health concerns that have constituted the main obsessive focus of EU legislators in the e-cig debate may sound like stupid excuses, when in fact they are not stupid at all. To tell the truth, they are clever excuses. So clever that they succeeded in their purpose of dictating rules in line with the precautionary principle. Hence, the fact that the new document makes e-cigs much less appealing for new smokers is deliberate…

 

Lets face the truth, decisions in the area of tobacco products are always and exclusively made for financial and not health  reasons. After weeks and weeks of fierce debate with the EU “legislators” I came to the conclusion that this has very little to do with a medical issue or science, it is a political and financial one. I briefly addressed this point in the concluding paragraph of my opinion letter

in the Lancet:

http://www.thelancet.com/journals/lanres/article/PIIS2213-2600(13)70175-9/fu

lltext

 

Similar conclusion can be drawn from the current situation in Italy.

From 1st January 2014 e-cigs will be regulated as tobacco products. Measures will include: excise taxes, lengthy bureaucratic process to obtain marketing permission from the national tobacco authority, vaping bans in public places, and advertising bans. No scientific debate was allowed, no input from vapers and their families was taken into consideration, the political agenda being “destroy e-cigs as soon as possible”. These draconian measures are already driving the prosperous and active national e-cig industry outside Italian borders, thousands of vape shops are closing, and current vapers will either have to turn into black market to stay off tobacco smoking or return to their own tobacco brand. Italy is well known for its lengthy legislative processes. For the e-cigs this was completed in less than 6 months ! A word to the wise is enough….

 

Clearly, the rapidly expanding popularity of e-cigs represents a threat to the interests of many, including national governments – because of the fat revenues generated by tobacco excise taxes. Only if these obstacles can be overcome, a truly sensible and rational regulation of e-cigs will be agreed upon, and millions of lives saved.

 

 

Whatever happened to the concept of the informed individual?

An article published today (10 November) calls into question the motives of thousands of e-cigarette users throughout the EU, suggesting that these individuals are only campaigning against EU proposals to medicinally regulate e-cigarettes because they are in the “pay of the electronic cigarette industry”.  The article also questions the legitimacy of grassroots campaigns, speculating that they are little more than fronts for the e-cigarette industry.  One of several campaigns smeared in this article is our very own Save E-cigs campaign.

Without directly accusing our campaign of being a front for an e-cigarette manufacturer, the journalist wrote, “The website (Save E-cigs campaign), however, was not quite the grass-roots effort it claimed to be.  The text of the letter it asked people to sign was drafted by a London lobbyist hired by Totally Wicked, an e-cigarette company. The website had been set up by a British woman living in Iceland who had previously worked for the owners of Totally Wicked.”  We never tried to hide this information, in fact that very reason the journalist was able to write this was because we told him!  At our press conference in Brussels, prior to the handover of our letter, at which this journalist was present, we also made very clear who had provided the funding for the said press conference.

 Our campaign is a genuine grassroots campaign, working with limited financial support which to date has come from SWOF (Smoke Without Fire), Totally Wicked, Knowledge Action Change, and Vapour Trails TV, to fund administrative, consultancy, and event costs. These groups/businesses have received nothing in return for their funding and have no input in the direction of the campaign.  Our steering committee members are all volunteers and do not benefit financially from any campaign funding.  The people who took the time to sign our petition were all genuine e-cigarette users or the friends and family of e-cigarette users.  Knowing that those opposed to e-cigarettes would try and discredit our efforts, we asked those signing the petition to e-mail us individually and to include their address details so that we could prove the legitimacy of our petition.  All these points were made to the journalist; it is a shame he chose not to report them.

The assertion that e-cigarette users were only campaigning against the proposed medicinalisation of electronic cigarettes because they were either encouraged or paid to by industry is worth exploring in more detail.

Switching from smoking tobacco cigarettes to using e-cigarettes is a life-changing decision.  Those making this switch do not do so without having carried out a significant amount of research.  Following their initial switch they will often carry out further research in order to find an e-cigarette, flavour, and nicotine strength that suit their needs.  Consequently ‘vapers’ are very well informed about the products they use.  Part of this research will involve talking to other vapers on the numerous online fora that exist; many even regularly attend local groups to meet up with fellow vapers in their community.  Each year, in the UK, several thousand vapers even attend Vape Fest, a weekend-long gathering of vapers from around the country.  There are even internet based television channels such as Vapour Trails TV, dedicated to keeping vapers informed about the latest product and regulatory news.  It should therefore come as no surprise that vapers are well informed, not just about their e-cigarettes, but about the regulatory environment in which they exist.

When the European Commission brought forward proposals to regulate electronic cigarettes as medicinal products, vapers knew what this would mean.  It would see the e-cigarettes that they rely on to avoid going back to smoking tobacco cigarettes being restricted or banned; no wonder then that thousands of them across Europe, without any encouragement or financial inducement from industry, decided to make their voices heard!

 Many policy makers, wishing to become more informed about e-cigarettes, even advertised on their websites and in local newspapers for vapers to write to them with their views and experiences.  What is possibly wrong with any of this?  This is democracy in action.

 Certain MEPs and journalists have been quick to look for malevolent motives to those campaigning in favour of e-cigarettes.  These politicians and journalists though do not question the motives of campaigners when the issues concerned are those they favour.

Linda McAvan MEP has been one of the more vocal critics of those campaigning against the medicinal regulation of e-cigarettes.  In this article she is quoted twice, firstly asking if vapers are in the pay of e-cigarettes companies (“Are these people all in the pay of e-cig companies?”) and secondly stating that vapers anger at these proposals was not genuine, but was actually “fed” by the electronic cigarette industry.  Now imagine for one moment that we were not campaigning in favour of e-cigarettes but were in fact campaigning with equal passion against the Common Agricultural Policy and the damage it does to communities in the poorer parts of Africa, or that we were campaigning in favour of a new cancer treatment that would prolong our lives.  Would Linda accuse us of being in the pay of a major charity/NGO or in the pay of a pharmaceutical company?  Of course not.  If we had been campaigning for the medicinal regulation of e-cigarettes she would not have asked if we were funded by the tobacco industry or the pharmaceutical giants, two sectors who have much too loose from the rise of e-cigarettes.

 The author of this article was clearly looking for a smoking gun that would confirm his and others view that there is no such thing as the informed individual.  That people cannot have opinions of their own.  That people cannot be motivated by self-interest.  That individuals do not know how to campaign.  We find this level of cynicism very sad and rather depressing.

 As one commentator wrote under today’s article the article, “I assure you my anger is not “fuelled” by the lobby groups.  They merely supply a vehicle to express it through.  After trying e-cigarettes two years ago I have not had a cigarette since.  I began with ultra-light menthol – .6mg nicotine – and am now in fact doing a 0mg version of the brand.  So what’s left?  Basically, water vapor and propylene glycol which is approved as a moisturizer in asthma inhalers.  Sound the alarm bells!  And as far as 2nd hand vapor concerns, nicotine is not a carcinogen – it is a mild vaso constrictor which has also been shown to reduce the risk of Parkinsons and is generally regarded as comparable to caffeine.  So perhaps the danger to others might be comparable to burping after a cup of coffee? The resistance to this invention is a great illustration of group think of the masses and of course business interests of big pharma.”

 In spending so much time looking for a smoking gun that does not exist journalists like the author of today’s article are missing the bigger story – What motivates policy makers to intervene to prevent or obstruct a smoker having access to products that could potentially save his or her life?  Every barrier placed in the way of e-cigarettes has significant health consequences.  Why are policy makers and journalists, with a few notable exceptions, not looking into the links between certain policy makers and the pharmaceutical industry?  Why are they not questioning those campaigning for the medicinal regulation of e-cigarettes to the same degree as they question those campaigning against it?

It is very sad, and rather depressing that vapers are being seen as pure astroturf rather than the genuinely informed citizens that they are.

Policy makers must not reintroduce medicinal regulation of e-cigarettes via the back door

On Tuesday the 8th of October in Strasbourg a majority of MEPs from across the political spectrum voted against the medicinal regulation of electronic cigarettes.

 This result was welcomed not just by electronic cigarette users across the EU, but also by their friends and families.

 It is important to note that in voting for amendment 170, MEPs were voting for proposals that would put in place a very strict regulatory regime for the sale and manufacture of electronic cigarettes, this was no soft option.  Amendment 170 proposes banning all advertising of electronic cigarettes and also restricts the sale of electronic cigarettes to under 18s.

 This result, whilst welcome, is not the end of the story.  We now enter a process known as trilogue where Parliament, Council, and the Commission will come together to see if they can iron out their respective differences and agree on a final text.  There is a strong desire in Brussels for this process to be concluded before the end of this year.

 As the triloge process begins electronic cigarette users, their friends, and their families wish to make it very clear to all involved in the process that amendment 170 was a compromise, it was however a compromise many were willing to accept.  What will be unacceptable however would be any attempts to strengthen amendment 170 or to try and reintroduce medicinal regulation via the back door.

 Amendment 170 must be seen as a red line and all those MEPs who did the right thing last week in Strasbourg must hold firm and reject any attempts during trilogue to reintroduce the medicinal regulation of electronic cigarettes.