Thank goodness, electronic cigarettes will never be regulated as medicines, despite what the recent headlines might say.
The MHRA’s announcement on Wednesday was the latest in an alarmingly long line of government proposals that have no hope of ever reaching the statute books. Remember HS2, the high speed rail proposal? It was much touted in the press, with the government describing it as practically having already happened (sound familiar?), but the business case for HS2 was described by Margaret Hodge, Chairwoman of the Public Accounts Committee, as “clearly not up to scratch”. She said there was “virtually no evidence” to support the claims that HS2 would deliver regional economic growth, going on to describe some of the Department of Transport’s assumptions as “just ludicrous”. The National Audit Office also pointed out fatal flaws. As a result, HS2 is now unlikely to make it onto the statutes.
And what of the press attention, also on Wednesday this week, concerning the Health Secretary, Jeremy Hunt’s proposals to close several children’s hospitals? Umm… now that’s not happening either, following scrutiny from the much-needed Oversight Committees.
It is sadly and shockingly easy for the government to propose legislation by press release, and the detail of any robust research or evidence to support such proposals be damned. The absence of any such evidence usually comes to light later on, often after several months, since the legally-required scrutiny of the various Oversight Committees is a long-winded and intricate process; by which time, the public has already adopted the idea that whatever the proposal is (however ludicrous), is happening – and must already be legally binding.
This is what we have once again seen happening since Wednesday’s MHRA media circus: the pharmaceutical peripherals industry has been circling like vultures around the supposed corpse of the electronic cigarette industry, offering various products and services to assist us with getting in line with incoming medicines regulation, as if it has already happened, while the tobacco industry rubs its hands with glee, believing they have successfully seen off the biggest threat yet to its cancer-causing sticks. Well, we’re sorry to disappoint them all, but this corpse is far from dead yet. In fact, it’s vibrant, successful and will continue to actually address the huge public health problems caused by the combined efforts of the tobacco and pharmaceutical industry to ensure that 25% of UK citizens remain trapped on the ‘quit or die’ tobacco/pharma cycle.
The reality, as confirmed in the MHRA’s own documentation ‘supporting’ this flawed proposal, is that: “Current evidence on the size of the [Nicotine Containing Products] NCP market in the UK suggests more than 7% of all UK smokers (around 700,000 people) are now regularly using electronic cigarettes in some form.”
Actually, this is dramatically underestimated. Even the anti-public-health organisation ASH, in a briefing also (and coincidentally?) released on Wednesday “estimates that there are 1.3 million current users of e-cigarettes in the UK”, and goes on to confirm that “this number is almost entirely made of current and ex-smokers; with perhaps as many as 400,000 people having replaced smoking with e-cigarette use. There is little evidence to suggest that anything more than a negligible number of non-smokers regularly use the product.”
Again, this dramatically underestimates the number of smokers who have completely switched.
ASH also points out that: “growing evidence suggests that e-cigarettes are becoming more reliable in their nicotine delivery and that they have a beneficial impact in reducing subjective cravings and, in turn, number of cigarettes smoked.”
So where exactly is the problem then? The MHRA’s quoted 7% smoking prevalence reduction is actually more like 10%, bringing the UK’s smoking prevalence rate down from 25% to 15% – one of the lowest in Europe, and comparable to Sweden’s – with their so-called ‘Swedish Miracle’ of Snus.
And yet, the MHRA and the UK Government, in its ‘wisdom’, seeks to remove from the market every single product currently in the hands of those “current and ex-smokers”, because, as Jeremy Mean announced in his press release on Wednesday:
“Our research has shown that existing electronic cigarettes and other nicotine containing products on the market are not good enough to meet this public health priority.”
So the products that have already successfully reduced smoking prevalence more dramatically than seen anywhere else in the world (outside Sweden) are apparently not good enough, and should be taken away completely, redesigned as ‘medicines’, and offered alongside the existing Nicotine Replacement Therapy (NRT) products, (with their dismal failure rate of over 90%) which the Tobacco Control Industry (and the MHRA) continues to peddle:
“People should used licensed NCPs – gums, patches, mouth sprays etc – to reduce the harms of smoking.”
To put that in context: either we can continue to enjoy the significant decrease in our smoking prevalence which is currently happening thanks to the wide range of electronic cigarette products, which clearly appeal to smokers and make them very willing to make the switch, or we can effectively give them up and sentence about half of that 25% of the population who continue to smoke to a slow and painful death from a smoking-related disease, since smoking is known to kill about half of smokers.
The MHRA even admits, in its Impact Assessment:
“59. The calculation reveals that very few additional successful quit attempts would be needed in order to justify the costs borne by a single UK Medical Authorisation holder. Given the uncertainty of our estimates, we think that the precise result (between 1 and 3 additional successful quit attempts a year) is much less important than the orders of magnitude of our estimates. These suggest that the policy would only need to be marginally successful (generate very few additional successful quit attempts) for it to be justified.
60. However the reverse might also be true. The policy might only need to be marginally unsuccessful for it to be considered a costly failure. If the design and implementation of the policy has the effect of reducing access to NCPs (particularly ENDS) then it is possible that the number of successful quit attempts could decline. If there were no substantial countervailing health gains from improvements in safety, the policy’s overall impact could be highly negative.” (our emphasis.)
How true – and how very likely!
Fortunately, as confirmed by the MHRA (albeit much more quietly, while they tried to dictate public policy by press release) this decision is actually being made at the EU level; the MHRA is nothing more than a watchdog in this, with no teeth whatsoever.
Clive Bates, a staunch public health advocate and former director of ASH (UK) has raised his own concerns about the global Tobacco Control Industry’s behaviour, as it feeds into the EU processes:
“1. That the depth of denial about harm reduction (in this case snus, but also e-cigarettes) is deep and shocking, as it amounts to a casual disregard for health and a nasty authoritarian instinct that in Europe denies people access to products that can save their life and improve their health, and are proven beyond doubt to do so in Sweden (and Norway).
2. That ‘experts’ have been brought in to advise members of the European Parliament on what works in tobacco control at a critical time in the development of legislation, but they did nothing to show scientifically what does work – the presentation was full of assertions and cherry-picked data, followed by flawed advice on which countries are the best models to follow.
3. That agencies like WHO are losing scientific credibility as sources of public health advice, and have come to resemble activists and ideologues. That is no good for public health, but it also erodes trust in WHO and international institutions more generally. Member states will increasingly ask what they are paying them for.”
So for now, let us leave you with a few facts:
Electronic cigarettes will never be regulated as medicines;
- A licensed electronic cigarette would no longer be an electronic cigarette as we know it;
- Only the tobacco industry has applied for medical marketing authorisations for ecigs;
- No medical marketing authorisation has ever been granted for an electronic cigarette to date;
- 4 courts in the EU have already ruled that reclassification of electronic cigarettes as medicinal products is illegal.
We look forward to the Regulatory Policy Committee’s report on this proposal, which we are confident will be as damning as their last one was.