By Tom Pruen, Chief Scientific Officer of ECITA
The lowest estimate they have generated for an imported product is a one-off cost of £252,000 and an annual cost of £65,000.
The highest estimate is a one off of £390,000 and annual costs of £249,000.
This, according to their figures gives annual costs of £87,000 (low) and £266,000 (high).
The problem is that this averages the cost over 10 years. However, based on my knowledge of the e-cig market, I would arrive at rather different figures. The pace of innovation in the electronic cigarette market is remarkably rapid, and my estimate is that at a minimum, a new product hits the market about every three months. Even for companies that use a small range of products, I would anticipate a minimum of one new product every year.
What does this do to the MHRA estimates?
The annual cost of a company that tries to keep up with innovation, and stocks the latest developments would have 4 new products a year, so would be expected to pay:
(4 x £252,000) + (4 x £65,000) = £1,268,000 (low estimate)
(4 x £390,000) + (4 x £249,000) = £2,556,000 (high estimate)
So, that’s a cost of between £1.2 and £2.5 MILLION extra per year added to the cost of doing business, just for new hardware.
For a company that conservatively has one new product a year:
£252,000 + £65,000 = £317,000 (low estimate)
£390,000 + £249,000 = £639,000 (high estimate)
An extra cost of between £300 and £600 thousand per year, just for new hardware.
Does the MHRA really think that this will not have a significant effect on the development of the market, made up as it is of mostly small to medium enterprises? Is anyone going to invest an EXTRA £2 million a year, just to introduce new products?
I very much doubt it.
This doesn’t even account for all the costs – the MHRA haven’t even decided if there ARE other costs involved.
“Our MA cost estimates assume that applicants would not have to conduct expensive animal and post-market-authorisation human clinical trials to satisfy MHRA that the risks to health from long term inhalation of ENDS vapour are acceptable. However this may not be the case and MHRA assessors might ask for these additional trials.”
If the MHRA doesn’t even know how much the cost of regulation is, what use is its impact assessment?
Then of course, there are the liquids to use in the hardware; most vendors have more than one flavour (even if it is only tobacco and menthol), and some have literally hundreds. Not only will a cost of between £87,000 and £266,000 per flavour, per strength, per year be a major disincentive to having flavours (and indeed having different nicotine levels), the MHRA has made clear that it views flavours as a potential problem, due to an evidence-free assertion that these only appeal to children. (After all, adults don’t have any interest in things that taste nice; everyone apparently eats bland food and drinks only water).
And all of this completely ignores the fact that e-cigs are currently not designed to operate as medical devices – they are designed to closely mimic the physical and psychological actions of smoking.
Despite this the MHRA concluded that:
“The cost of regulation need not affect price or competition…”
“Regulation as medicines can make such products more widely available.”
So, what justifies these huge costs?
According to the MHRA itself – NOT VERY MUCH AT ALL!
“However, as yet there is an absence of scientific evidence that shows long term harm to health is occurring in reality because of product safety”
“While contaminants in ENDS have been identified, and the long term health effects of inhaling ENDS vapour are unknown, so far there is an absence of evidence that shows that these problems create significant harm to health.”
“Safety concerns have been reported. Given the extent of use, however, and despite the lack of a formal reporting mechanism (such as the yellow card scheme), these do not of themselves suggest a major public health concern.”
“There is little risk that EC deliver toxic levels of nicotine.”
“Given the low toxicity of nicotine at the doses observed and the fact that long before any dangerous levels of nicotine concentration could be reached, an over-enthusiastic user would be warned by nausea, there is little concern that e-cigarettes can harm their users by delivering toxic nicotine levels.”
So, given that the costs are massively higher than the MHRA estimates, and they themselves suggest there is little evidence of risk, where exactly is the justification for such heavy-handed and expensive regulation?