Tommy,
The MHRA press release is probably not actually about regulating e-cigarettes, it's more about putting pressure on the EU. I'd bet that if the TPD had got a smooth ride through committee at the EU, the MHRA's PR would have looked very different - perhaps something like this:
"The MHRA welcomes the decision by the European Union to regulate e-cigarettes both as a medicine for the refills and as a tobacco product for the hardware and ancillaries. This will ensure that consumers are fully protected and have access to safe and effective smoking cessation products."
Instead, the TPD is being kicked from pillar to post by people who either don't like that much safer alternatives to smoking are being blocked (perhaps when they don't have any appreciation of the reasons behind it), or don't like the pharmaceutical industry being able to protect its income, remove competitors, and write the death certificates for millions of people (if they do in fact realise what this is all about). As a result, the MHRA are trying to inject a little backbone into the EU committees, who aren't earning their benefits as they've allowed the plebs to affect decision-making - the biggest possible sin in EU politics.
I don't think the MHRA have any intention to regulate e-cigarettes as a pharmaceutical since they will get their .... kicked hard in court if they try. Instead, they are banking on the EU doing it for them; but they are aware that they need to help the process along a bit. Now if the EU *do* succeed, then the MHRA can also regulate in addition, and stand a much better chance of their regs surviving; because first the EU decision would need to be reversed at the ECJ in Strasbourg, and that is a much harder task than winning at national level in an EU country. This appears to be relatively easy to do, as it has been done multiple times by the ecig trade, and without a failure.
Regarding a medical license for an ecig: the first applicant was Intellicig (now BAT), who put have been working on this for nearly three years. They will presumably be the first to receive an MA as they tick all the boxes: quality-minded management; pharma lab grade facilities; oversight by senior academics from all round Europe from the get-go; use of glycerine as the excipient and therefore backed by Dow Chemical and others who have multiple pharmaceutical licenses for its use as the principal excipient in inhalable medicines and who are moving clients away from PG toward glycerine for all inhalable therapies; pharma part ownership of the company; majority ownership by a giant tobacco company who have practically unlimited funds; etc.
The terms 'safe and effective' are always of interest when discussing pharmaceuticals and never more so than in the smoking therapy area (see the entry on this page:
E-Cigarette Terminology ). The use of the term 'effective' when applied to medical *licensing* (in the UK) is of especial interest; and so is its application to ecig refills and their 'effectiveness'.
Firstly, I had an at-length discussion with June Raine and Jeremy Mean of the MHRA about the meaning of the term when applied to therapies related to smoking and nicotine. I can assure you that they repeated again and again that a nicotine therapy of any kind does not need to work, at least in the manner that you and I would expect the word to mean. Its effectiveness for the purpose it is licensed and sold for is immaterial, according to their repeated statements. It must be demonstrated to supply the specified drug in a form that is demonstrated to be bioavailable - but it doesn't actually need to work. It will neither be required to show this at the licensing stage and neither will they test its effectiveness at a later date, on patients or subjects, by any methodology, to determine that the therapy is effective for the purpose for which it is sold. They repeatedly stated that they will not ask for proof of its effectiveness at the licensing stage nor will they themselves check its effectiveness at a later date. Let us be absolutely clear about this: this was stated repeatedly in a meeting where many other people were present, and I have a transcript. What they *do* require is proof that the drug is delivered.
Now we look at the question of the demonstrated delivery of the drug - which *will* need to be proven. Intellicig, like several others (notably Bullen at al, Vansickel et al [which we refer to as 'Eissenberg 1'], and others), found that that a mini ecig with an average refill will deliver zero or very little measurable nicotine to the user, who in tests is required to be ecig-naive (this means a first-time user). The buyer of a medicine is not expected to be an expert in its use. Zero or little nicotine was found in the bloodstream in all these tests (not just some of them); extremely low amounts such as 1.3ng/ml were measured. This is just above the background noise and in fact is so low that dietary sources could be responsible (such levels were certainly measured in the past when people's diet was better and they ate more vegetables, many of which contain nicotine and which may be beneficial as the nicotine is co-located with nicotinic acid - vitamin B3).
As a direct result of these tests, Intellicig introduced a 45mg refill strength (4.5%), because it is the minimum strength that actually works for many buyers of a mini, who can be expected to be beginners (or they probably would not buy a mini). If in fact they are experienced, then they will very soon find (within about 90 seconds) that their refill is too strong, and they can subsequently reduce the delivery efficiency by multiple means.
So to actually 'work', an ecig will need to deliver a measured blood plasma nicotine level above 8ng/ml; and probably between 8ng/ml and 15ng/ml. A delivery of 20ng/ml might be seen as anomalous, therefore excessive, in this situation. For all practical purposes the Intellicig 45mg refill is a very good choice for mini ecig users; in fact, it may even be necessary in order to receive an MA.
(From a personal perspective I would also supply a refill of half that strength and/or some way to dilute the refill, for those who are exceptionally sensitive to nicotine - we have demonstrated here on ECF that there is a factor 10 difference in tolerance to nicotine between individuals. Some are rather sensitive to it, while others seem as if they can almost drink it.)
The MHRA PR also has an additional benefit, for them, as it is probably also designed to force ecig vendors to apply for an MA. This is hugely more expensive and time-costly than is appreciated. I would budget 4 years and £2m for it; and would not be shocked to find it went over-budget. On the other hand, the MHRA strongly hinted (but refused to put in writing) that some costs could be shared. For example, a competitor's previous documentation might be used by the next applicant; applicants might share licensing costs and badge-engineer the product for the marketplace (i.e. make and sell the same product under different names). They would not confirm this offer in writing. I regard their approach as unreliable from a commercial point of view.
Finally, you mention ".....the incompetence and hypocrisy of the MHRA". I think this is wrong. They are as efficient as it is possible to be as the pharmaceutical industry's government partner and protector. Let's leave it at that.
To recap it will be a very hard industry to 
