This has been bugging me since early December when it was announced that BAT's arm's length (uh-huh) subsidiary Nicovations was granted an MA (Marketing Authorisation for Medicines) for its e-Voke electronic cigarette. Under the Tobacco Products Directive (TPD) which passed into law over a year ago, and which has to be implemented by all member states by May 20 this year, there's a two-track approach. While, overtly, Ecigs are primarily a consumer good under the TPD, it also allows for manufacturers, importers and distributors to seek a medicines license for them, and the U.K. Medicines regulator, the MHRA (Medicines and Healthcare Regulatory Authority) has been keen to persuade Ecigs businesses to sign up for medicinal Ecigs.
Moreover, in just about every news article you read on Ecigs, the journalists involved will tell you that "from May 2016, Ecigs will be licensed as medicines, and will become another form of NRT".
Now, whenever I've seen that, I've fumed, gashed my teeth and uttered something along the lines of "NONONONONO - that's NOT what the TPD says! There's a two track system!"
And yet, I keep seeing the Department of Health encouraging the seeking of an MA, posts from the likes of ASH and CRUK championing Ecigs gaining an MA and so on.
I've given it a bit of thought. Apparently, the BMA is still very skeptical (OK, I know, they're ideologically opposed to anything that looks like fun when it comes to nicotine) and has said, in numerous press pieces, that they don't think doctors will prescribe the e-Voke or any other ecig with an MA, really. Why? Because, even though an MA means that an ecig is of "good quality, safe and of good efficacy", they just don't buy it. Does this mean they don't trust the MHRA?
Well, I'm not sure I do - let's face it, they have to have lowered the bar in order for the e-Voke to get an MA. Under the rules prior to this "light touch" approach, we all knew that it would be all but impossible to get a license for an ecig. Now, suddenly, it is. I've made an FOI request to find out how many Ecigs had been proposed for an MA and why they failed prior to 2015. They won't reply. Confidential info, apparently.
So, is it right that there should be medicinal Ecigs? You know, I'm not sure, and here's why:
In 2007/8 the Royal College of Physicians and ASH and CRUK all pulled together to suggest that government scrapped the medicinal status of NRT and, instead, institute a Nictoine Regulator of some sort. The idea was to acknowledge that there were "safe enough" forms of nicotine usage (perfectly correctly, in my view) and that the continuum of risk could be acknowledged by a system of taxation vs promotion of safer products and continued "sin taxes" on those acknowledged to be more risky.
In other words, NRT would cease to be a medicine and would, instead, become a consumer good, and a preferred route for nicotine usage. We, the people, would be given the "right" information and allowed, basically, to choose. Unfortunately, it didn't happen. Had it done, the vast majority of the nonsense we've seen this past five or six years would not have happened, and there'd be no such thing as a medicinal ecig.
And, frankly, I think that's how it should be. The BMA seems not to want medicinal ecigs, ASH, the RCP and CRUK didn't want them in 2008/9 and I'm betting that the majority of smokers would avoid them like the plague - they (we) are not "patients". Even veteran SSS advisors appear not to want them. So, why encourage them?