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EU ENVI Committee Votes to Ban Ecigs

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The 10th July vote to ban e-cigarettes, yesterday, by approximately 44-25 (depending on the amendment voted on), was carried by a voting bloc agreement between the Socialists (Labour, in the UK), the Greens, the government seats and the commercial seats that achieved 44 votes; Conservatives, LibDems and public health supporters voted against the ban (and probably the single UKIP ENVI member), gaining 25 votes. Both sides will also have gained votes from non-aligned committee members.

The vote was on the Tobacco Products Directive, and the main financial implications were for the tobacco industry due to the scale; e-cigarettes are seen as a minor issue although they clearly produce more community engagement than any other topic area covered by the TPD. The ecig-related amendments beneficial to public health were defeated, leaving the main e-cigarette provisions of the new TPD intact: this means ecigs will become a medically-licensed product. This is a de facto ban, as perhaps two or three products will be legally available by the time the regulation comes into force, and many thousands will be banned. There is no real point in examining the detail here, for two reasons:

- The EU are determined to ban e-cigarettes or give them to the pharmaceutical industry (which amounts to the same thing); no matter what details prevail, this is the intended result of the provisions of the TPD.
- In any case, the likelihood is that the trade will unite to defeat the ban, at the European Court of Justice. Pharmaceutical licensing of ecigs has been overturned by every court hearing a challenge.

The following, therefore, is a listing of the theoretical effects of the TPD if it were to prove impossible to overturn at law.

In terms of percentages, it would mean that about 0.0001% of products will be legally available for sale within the EU, and 99.9999% will be banned. In addition the legal products will be of no use to most, in the long term: we know that 92% of the community have upgraded from the obsolete products that will be licensed. There are some long-term vapers who use such products (perhaps because they are occasional / light / social users who essentially simply require something to hold in the hand) but who prefer the alternative flavours (as now anything other than tobacco flavour will be banned). So perhaps if this is half of the 8% in the community who use minis, then it totals up to 96% of the community who will see their chosen products banned.

This figure ignores those who are outside of the community (those who do not know of, or do not engage with, the online and vapemeet participants who we refer to as the 'community'. They are far larger in size as mini ecigs have about 75 - 80% of the market. A proportion of these will be forced to abandon their preferred flavours (as the minis that will be licensed as medical devices will only come in tobacco flavour, at least at first). We think that most long-term users eventually gravitate to the community in search of an upgrade, or relapse to smoking, since mini ecigs can only satisfy a small percentage of users in the long term (their performance is only about a quarter of that provided by more modern hardware, which is always larger than a mini, due to the restrictions caused by the tiny battery size).

Minis are first-class as an entry-level product used as proof of concept at minimal cost. They are satisfactory for social smokers; but 92% of community members upgrade, so something that works much better appears to be required. All such products would be banned.

The implications for public health

This is a massive blow to public health as it protects cigarette sales, together with the pharmaceutical industry's income for the treatment of sick smokers. My calculations show that it will be associated with about 15 million deaths of those alive today. This could be phrased in different ways, according to preference:

  1. The new TPD will be associated with 15 million deaths of EU citizens alive today: the smokers who would have switched to safe alternatives, if such options were widely available, effective, attractive and economic (the few TPD-created medical versions will be none of those).
  2. The new TPD will prevent the saving of 15 million lives of EU citizens alive today: those smokers alive now who would have survived if able to freely access good, safe alternatives to cigarettes.
  3. The new TPD will cause 15 million deaths in EU citizens alive today: the smokers who will die because they could not freely access better alternatives.

You could use any version you prefer, according to taste. All are accurate although only one version apportions the blame correctly.

Why would they do that?

What is abundantly clear is that a bloc agreement between the pharma seats, the cigarette seats, the government reps concerned about the economics, the non-aligned committee members who wish to appear in their home constituencies as 'anti-tobacco', and the tobacco control industry seats, together outvoted the pro-public health seats by about 2 to 1. Keep in mind we are not talking about cigarettes or tobacco here, simply the amendments that would have saved e-cigarettes from a ban; all the anti-cigarette/tobacco measures could have proceeded without affecting e-cigarettes at all.

It would be facile to assign one motive to all those who voted to ban ecigs, since it is clear that many different reasons exist, and banning ecigs is one way for all the different groups to agree. The majority of committee members belong to some sort of voting bloc, all of which have a different agenda. It would be impossible to identify the pharma seats and so on without seeing these people's voting history; that information would probably clarify matters - but be assured that all major industries in addition to governments have control of voting seats in committee. We just don't know, at this time, who is who.

There are plenty of clues of course. If an MEP is forced to admit that, in essence, they are funded by Pfizer - as one very experienced political campaigner had to recently, probably to pre-empt this information being revealed by others - then things become clearer.

Here are some of the reasons why votes were cast against ecigs, and who this benefits. The most important reasons are always financial and to say otherwise reveals the most absurd naivety - we are discussing the smoking money machine here, and it generates hundreds of billions of Euros for the players. If anyone tells you that all MEPs vote independently on such a matter, you can write them off as clearly more naive than a nursery school child. The major industries all have voting seats in EU committees.

  • Banning e-cigarettes protects cigarette sales - this pleases the cigarette trade's seats, pharma's seats (smoking makes them as much money, in some countries, as it does for the tobacco industry), and the government seats (because of the economic timebomb threat from ecigs). These are among the largest voting blocs.
  • It protects cigarette sales from the probable 60% reduction in volume that e-cigarettes will effect. The cigarette trade owns voting seats in committee and they did their job.
  • It protects pharma income in multiple ways: principally their vast income from the treatment of smoking disease, but also numerous other channels such as the boost to multiple other drug sales due to smokers being more ill than the rest of the population, and often in specific ways: diabetes, thyroid, and cholesterol drugs just as an example. The income from smoking cessation interventions is likely the smallest channel of all (only a couple of billion Euros; the other channels are worth multiple tens of billions of Euros annually). Keep in mind that in Western countries with State medical systems, pharma makes as much as tobacco does from smoking. In less developed countries smokers simply die quicker; in Europe, States pay pharma to keep sick smokers alive. Pharma owns voting seats in committee and they did their job.
  • It protects governments from the economic timebomb effect that e-cigarettes will have: the removal of huge tax revenues; the removal of multiple additional income channels; the removal of early death for the potential 60% of the 700,000 smokers a year who die in the EU but would have switched and therefore lived, and thus the imposition of a need to pay pensions, health and all other support for those people in old age, for an average of 10 years longer; and other hits on government budgets that total in the hundreds of billions across Europe. Governments own voting seats in committee and they did their job.
  • It aligns with the Socialist desire to control, regulate and tax all products and to control production and distribution where possible. The State takes precedence over the citizen, whose job is to assist society, which is represented by government. Government is best served by protecting cigarette sales, for multiple reasons. The Socialists are either in power (in some countries) or expect to be in power soon (in the other countries). People are not as important as Socialism, and especially those people who are not committed supporters of the State in all respects; therefore members of free citizens' movements that cost government a fortune are of no importance (and indeed should be removed if possible, to minimise contagion). The Socialists own voting seats in committee and they did their job.
  • It aligns with the desire of Greens, religious fundamentalists, and tobacco control zealots to remove all sources of relaxing drugs or other similar materials: society should be pure and clean in all respects. There is no place for any therapeutic assistance except in the form of medicines and then only if vital. These are expensive and impractical for regular use, so pharmaceutical licensing is the ideal way to remove all such materials from the marketplace or make them unattractive and expensive. Smoking is protected by people far more powerful than this ragtag assortment of voting seats, so it can't be got rid of; but anything similar, especially a replacement for smoking that allows its continuation without harm, is a fair target and should be banned. These groups all have voting seats in committee and they did their job.

EU procedure

Next is a vote in the Council, followed by a vote in Parliament (there is a plenary before these to agree the precise format of the TPD - an agreement procedure between the committees and the MEPs - but we can assume that the TPD will go forward in its current form, since otherwise it must go back to the committees and this seems unlikely as that implies a failed procedure up to this point).

The Council, in this case, will be a council of the 28 Health Ministers from each country. They will certainly vote to pass the TPD.

The Parliamentary vote will go the same way as the ENVI committee vote: the TPD will be passed, as the voting blocs are the same.

The new TPD will come into force some time from next year onward; maybe late 2014 or 2015 - 2016. Any guess as to when is pure speculation, but it is likely that the TPD will get past all votes, and those backing it are pushing as hard as possible to get it implemented as soon as possible. This will be aided by the EU top echelon as they are clearly fully behind the TPD; it means that early implementation is a possibility and cannot be excluded - a fast track process might be used. Everyone involved is either subject to the public image factor and has to be seen to support 'anti-tobacco' measures, or is paid to kill ecigs.

Public health has few friends in the EU, it doesn't pay.

What is the future?

It is rather foolish to assume they did not know that all bans of e-cigarettes are overturned by the courts, and so we have to work out what other motives are in play: what is the real agenda?

Firstly, we can assume that they approve of making sales more difficult (perhaps impossible for a brief time after the regulations come into force, if an injunction has not yet been obtained); and making the products more expensive (because the cost of overturning the ban at the ECJ in Strasbourg will impose additional costs on the trade; this will be reflected in higher prices).

Secondly, we can assume they are not stupid. This means they probably have a Plan B. It isn't hard to find this: tobacco product classification. This is implicit in the new TPD in addition to the medical classification; therefore if medical licensing is overturned at law, the fallback position is tobacco product classification of e-cigarettes.

So now we can see what the plan was all along: make e-cigarettes and all ancillaries a tobacco product. This will allow them to be eliminated without interference from the courts; or at least that is their hope.

And now we know that there will be two separate battles:

  1. Overturn the medical classification. Probably not too difficult - though expensive.
  2. Overturn the tobacco product classification. Probably very difficult indeed.

It is hard to see exactly how a tobacco product classification will be defeated. We have plenty of case law on defeats of pharmaceutical classification; but that is a very different matter. It is obvious that e-cigarettes are not a medical product; but perhaps it is not so obvious that ecigs are not a tobacco product (legally speaking).

Prepare for a black market

As far as I can see a large black market is now inevitable while the tobacco product classification is fought over (after the medical classification is defeated - assuming that goes to plan); some vendors may have to shut down once the new TPD is adopted, if the tobacco regulations are immediately applied to ecigs. This is because legal 'tobacco products' will not be able to have flavours (and therefore no proper e-liquid could be sold legally); and so on. Apparently there is a delay on the 'no web sales' provision but we can expect that at some stage. You have to remember their purpose is to eliminate e-cigarettes, whichever voting bloc they belong to: the corrupt and the crazy own anti-ecig seats by a proportion of 2 to 1 versus the public health seats (represented currently by Con, LibDem etc).

If we look forward three decades ahead, the problem will have been resolved: governments that don't support ecigs will be voted out (20% to 25% of the population working as a voting bloc will be able to ensure this). The problem now is the time between when the new TPD comes into force, and three decades after that point when governments are forced to stop killing people for money. Those years will be tough.

The ecig trade, at least in part, might need to go offshore and products might need to be imported into the EU illegally. There are so many negatives to this situation that they cannot be listed here.

Start to plan now?

Not if you are a consumer: we probably have at least a year to prepare.

Some in the trade, though, may need to start thinking about the actual provisions of the TPD separate from the medicinal licensing issue: if these do include the power to classify e-cigarette products as a tobacco product, and if these clauses can be implemented fairly soon after the adoption of the new TPD, then there will be a problem for some vendors immediately (and eventually for all). This is because the first of the tobacco provisions that is likely to be applied is the 'no flavours' rule, which will ban almost all e-liquid. In this case, the e-liquid vendors will probably need to go offshore.

No one knows exactly how this will all play out, especially in the next three years. We have to assume, though, that the anti-THR camp have a fallback plan, since they must have known from the beginning that a pharmaceutical classification is likely to be overturned by the ECJ (and most/all national courts). Believing that the pharmaceutical industry are complete fools is not very productive; they have unlimited funds to apply to this issue and must have employed some very capable people on this project. Assuming that those very highly-paid people are incompetent is not sensible; therefore, there must be effective tobacco classification clauses in the TPD.

Eventually (after several years, when they can fully organise the process) we can expect that web sales of 'tobacco products' will be prohibited; only 2-piece minis are likely to survive (as anything that works well or is refillable will be banned by tobacco regs designed to restrict options to the maximum extent survivable from legal challenge); only tobacco-flavour minis may be permitted - if that is even allowed (as all flavours will be banned); only selling whatever max nic strength they allow as a 'tobacco product' handicapped as much as they can manage (maybe 12mg); and paying €20,000 a year in license fees for tobacco product manufacturers/importers for whatever scheme they can come up with to reduce the number of players. (As an aside: all these tobacco regs will be supported by tobacco firms that buy into e-cigarettes, since such regulations will remove competitors.)

Think that's a bit pessimistic? I really hope so. At this point in time it is impossible to say exactly what a tobacco classification means but it certainly isn't good news. It will take some time for them to apply the TPD and to deploy an enforcement plan to utilise the tobacco provisions to act against specific ecig products and specific vendors.

Right now I'm hoping against hope that I've made a mistake somewhere and am wrong. No one will be happier than me if this scenario is too pessimistic.

 

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Footnotes

1. Rebecca Taylor MEP reports that the flavour ban was adopted but the web sales ban was not. That gives internet sales a breathing span, but we need to recognise that the EU's aim is to ban e-cigarettes, so it probably won't be too long before they find a way to ban web sales of 'tobacco products'. Another TPD rewrite in a year or so, most likely.

2. Because everyone was rightly trying to get the pharmaceutical classification prevented, nobody appears to have looked at the underlying provisions to classify ecig products as tobacco products. It needs someone experienced in legal statutes to interpret the full implications. At this time we just don't know what it means or how things will play out.

3. It would be naive to think the pro-ban camp is stupid. As they (a) ignored the JURI committee opinion that pharmaceutical classification of ecig products would not stand up to challenge, and (b) pharma already knows that the ECJ won't play ball (the attempt to make garlic pills a medicine failed), there must be a Plan B. Millions have been spent so far on this process so it simply isn't reasonable to conclude they made a complete mess of it.

 

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