EU EU Law Expert Calls for Regulatory Policy on E-Cigs to be Guided by Scientific Evidence, not by Ideology

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Tom09

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Alberto Alemanno, international law and regulation expert (see his profile) posted an extended article on e-cigs and regulation at his web page. Good read, actually.

Electronic cigarettes: the future or the end of smoking? (November 12, 2011)

[Introduction:] The battle fought on the regulation of electronic cigarettes, i.e. recreational devices that deliver vaporized nicotine without combusting tobacco, epitomizes the philosophical divide over health policy today. Although initial scientific studies suggest that e-cigarettes are safer than conventional tobacco products, the health and anti-smoking communities seems split over the issue. As summed up by Michael Siegel, one of the few anti-smokers in favor of e-cigarettes, ‘the anti-smoking movement's ideology - which is guided by an abstinence only type of philosophy - just doesn't have room for a product that looks and acts like a cigarette but happens to be orders of magnitude safer’. As a result an increasing number of countries across the world are banning e-cigarettes. It is against this backdrop that the UK government, notably the Cabinet Office’s Behavioral Insight Team, better known as Nudge Unit, surprised the health community by coming out in favor of e-cigarettes.
[...]
[Concluding Paragraph:]Future regulatory policy on e-cigarettes and other alternatives to tobacco should be guided more by scientific evidence, i.e. how these products score as compared to conventional tobacco products, than by an ideological and revanchist approach against Big Tobacco. This is especially the case should e-cigarettes prove capable of reducing toxic exposure and help individual smokers to quit.

Related previous posts by Alberto Alemano on the pending revision of the EU Tobacco Products Directive (this revision of the EU law might erase e-cigs from the EU market, following the WHO guidence): November 28 2010, June 12 2011
 

Tom09

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Something that should ring the alarm bell, though, is the timing of Alemanno’s thoughtful article.

The EU Commission is presently preparing the proposal and impact assessment of the revised Tobacco Products Directive. This emerging law will determine the future of e-cigs in the EU. In this situation, an outstanding EU-law and regulation expert, who is closely following the revision process, and is probably well connected, feels compelled to call for a reasonable regulation.

This timing tells me that e-cigs are very likely about to be doomed in the Commission’s pending proposal. Moreover, since the EU is not exactly known to be sympathetic to harm reduction (snus ban), the legal initiative rests at an appointed, bureaucratic body (sympathetic to supranational institutions), the previous Consultation paper already relied on the programmatic ‘electronic nicotine delivery system’ (ban by definition), stated goal is to “reduce tobacco use”, Pfizer, GSK, Johnson & Johnson, and “health charities”, are active in lobbying (letter 10-2011), and so on.

Dang, dang, dang, this house is on fire.
 

rolygate

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I agree, Tom.

An EU ban would be catastrophic as in practice it would be far more severe than a UK-only or Germany-only ban. With country-specific bans, vendors could go offshore to another EU country, but they can't if the EU directive includes e-cigs. The UK will strictly enforce it, and so will most countries I think. Look what happened with Finland / Sweden in Snus - shipping had to stop.

Worst-case scenario: vendors will need to relocate to Norway, Switzerland, or further afield. However, the MHRA has shown they will open postal packets that may contain 'unlicensed medicines'. That means even postal supplies could be threatened.

I guess the same will happen in Germany, they love their EU regs there as much as the UK agencies do.

The EU admin is totally corrupted by pharma. There is no other way that the ban on Snus could be maintained, since it kills 260,000 EU citizens a year: the 40% of the total 650,000 deaths that would not occur if Snus was legal in the EU.
 

Bill Godshall

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rolygate

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After reading it [ :blush: ] - it's a nicely-written article.

One or two factual inaccuracies and other issues should be pointed out:


-- Although this must be a recent article, the author seems to be unaware of the legal situation in the US, perhaps as a result of reading too much anti propaganda.

E-cigarettes find themselves in a similar legal limbo in the US where the FDA intends to make them undergo scientific vetting before they could be sold in the United States.

Instead, e-cigarettes are legally classified as a tobacco product in the USA, may be freely imported, manufactured and sold, and are regulated by the FDA.


-- The EU have been allowed to get away with the most outrageous lie. The corruption in the EU Health Commission needs exposing, not validating.

.....the European Commission ..... held that ‘at this moment there is not enough scientific evidence available on the efficacy’ of these instruments, snus in particular, as quitting aids.

This blatant lie needs to be flagged up, not approved of. It's as if Sweden didn't get its smoking prevalence down to 12%, didn't reduce its smoking deaths by 40%,and doesn't have the lowest smoking-related death rate in the developed world by a wide margin, all due to the wide popularity of Snus there. There are about 200 clinical trials and surveys, over 25 years or more, with a huge amount of solid data that proves Snus is an effective alternative to smoking.


All in all this an interesting overview with some serious factual issues - not least of which is the fact that pharma pressure and funding drives the opposition to e-cigarettes, as they stand to lose two billion dollars a year. This needs to be pointed out much better, since in nine out of ten cases where you find a voice raised against e-cigs, you will find a recipient of pharma funding or employment in one form or another.
 
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Tom09

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I don't necessarily share Tom's pessimistic view about the timing of Alberto's most recent posting.

Alberto sent me an e-mail yesterday, that included another piece he wrote about six months ago at
5th European Conference on Tobacco or Health - first impressions - Alberto Alemanno - Risk Regulation - EU Law - WTO

Thanks for pointing to another good piece, showing the independent and profound thinking of Alberto Alemanno.

Call me a pessimist, but I am in doubt that the EU Commission would turn out to embrace tobacco harm reduction.
I’d certainly be happy to be proven wrong.
 

Bill Godshall

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There's a lot of wiggle room between embracing tobacco harm reduction and banning the sale of e-cigarettes.

I'd be surprised if the EU banned the sale of e-cigarettes after the US courts have approved their unregulated sale, after the UK government's Nudge Office endorsed tobacco harm reduction products that resemble e-cigarettes, and after a growing body of scientific evidence has consistently found that e-cigarettes are far less hazardous than cigarettes and that many smokers have quit smoking and/or sharpy reduced cigarette consumption by switching to e-cigs.

But I'm no expert on the EU, which I'm hearing in the news everyday has far greater problems to resolve than e-cigarettes.
 

rolygate

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The problem with all governments or federal entities such as the US or EU is that everything in practice is handled by autonomous agencies who rule their own fiefdom. In the EU there are serious economic problems at present but his will not impact the health commission unless they need a large budget increase. If their rulings can be implemented within the agreed budget, they are independent of any external influence.

The EU health commission is, to be charitable about it, 'heavily influenced' by pharma. Like the health department in the UK, they do what's good for pharma, and are unlikely to do much that costs pharma money. Too many of them are funded by pharma in one way or another. They also have that medical mindset: if it worked twenty years ago, it's still good today.
 
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