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MHRA Announces Decision To Regulate E-Cigarettes

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Not really. In fact the MHRA are doing nothing. They have issued a press release that indicates their support for the EU ban process, and I suspect that this is the main reason for the announcement.

What they have said they will do is regulate e-cigarettes at a later date, which might be any time from 2014 to 2016, and it depends on the EU decision to some extent. This part is not clear at present. The exact wording in the PR is:

"The UK Government will press for EU law to create a Europe-wide legal position on NCPs as medicines through the revision of the Tobacco Products Directive.  The European Commission has said it expects the new legislation to be adopted in 2014 and for it to come into effect in the UK from 2016. From that point, all NCPs will require a medicine licence."

So the options at this time (which may change) are:

1. Wait for the EU process. If ecigs are banned (i.e. a de facto ban by requiring a pharmaceutical license for the refill liquids), then the MHRA will do nothing because EU law will have provided the regulatory law needed.

2. Or, if the EU ban comes into effect, the MHRA will also enact a similar or identical regulation here, to reinforce the EU law.

3. Or, if the EU ban comes into effect, the MHRA will additionally require a pharmaceutical license for the hardware, as well - thus banning both the hardware and the refills.


If the EU ban fails
What we cannot guess is how it will play out if the EU process fails, and currently it is experiencing some difficulties since many people are not happy that the pharmaceutical industry can buy a ban to protect its income at the expense of millions of EU citizens's lives. Let's guess:

1. The MHRA will go ahead anyway, with either a nicotine-containing liquid ban only, or a full hardware and refill ban.

2. The MHRA will give up as the process failed in the EU so will certainly fail at law in the UK.


Licensing or ban?
I refer to pharmaceutical licensing as a ban, because it is. There are at least 5,000 products on the market now, the majority being refill variants. All will need to be removed from the market immediately licensing comes into force (within 21 days is the usual requirement). A license can only be applied to one product or product combination: a single hardware model, or a single liquid type/flavour, or a single device plus one liquid type. There is no possibility of a single license for several products. Each single product takes at least 3 years and at least £2m to achieve a license for (as that is what it has cost Intellicig in time and money to get their license so far, with no result as yet). Intellicig famously underestimated the cost and timescale, and have had to modify their time plan by a factor of 2 (initial estimate was <2 years), and their cost estimates by a factor of 20 (initial budget was £95,000). And it's not over yet.


Outcome
If either the EU or the MHRA achieve a ban via the pharmaceutical licensing or tobacco product classification routes, legal e-cigarette sales are finished in the UK, and a huge black market will ensue.

A medical ban means that perhaps one or two products will be available in the next 5 years: beginner-style minis with prefilled sealed cartos, through a pharmacy, at about £30 - £40 per single unit (to take a guess; remember the nearest candidate has had to spend about £2m so far).

A tobacco product classification at EU level, in contrast, means that about 95% of products will disappear, followed by a 99% removal in time (as web sales, flavours, and any new products will be prohibited).


Who is behind this?
The regulatory process is owned and operated by and on behalf of the pharmaceutical industry in order to protect their income. They make the same as the tobacco industry does from smoking: £2bn or more a year in the UK.

The introduction of a Tobacco Harm Reduction product that will attract 50% of smokers (at least) and will result in the same reduction in disease (as ecig use has no apparent disease vectors) will therefore cost them at least £1bn a year in the UK, eventually. This is what happened in Sweden and they are absolutely desperate to stop the Swedish scenario spreading elsewhere: a 50% drop in smoking and then disease; a disastrous result for pharma.

Smoking and all its income generators is one of their most important income channels (principally, the vast drug market for treating sick smokers, such as chemotherapy and COPD drugs; then the boost to many other drug sales such as diabetes treatments; then the boost to OTC meds; then the smallest of all these: the smoking cessation market), and is protected aggressively at the highest level of government.


Conclusion
Pharma has obviously decided that the EU process needs some pressure applied, as things look as if they are slipping in Brussels; and this is the result. If all goes to plan, they will maintain their iron grip on health regulation and keep the money flowing in. The status quo must be protected; interlopers who will cut disease by half are not welcome.

Hundreds of thousands will die as a direct result, but who cares? The little people don't count.

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