MHRA Marketing Authorisation
Tuesday, 1 May 2018
In one of our recent posts, we mentioned that e-cigarette use has been stalling lately at a little less than 3 million active users in the United Kingdom. There are as many explanations for this as there are people using vapes, and industry leaders have been scrambling to find the magic spark to reignite the engine of adoption, to no apparent avail.
The pace of industry innovation continues strong—see the recent explosion in squonk devices—but many people think that the problem is out of the vaping industry's hands. Namely, that vaping is still seen as a recreational activity and not as a genuine medical aid for those trying to quit smoking. And in fact, across much of public opinion, vaping isn't even perceived as safer than smoking at all. What's worse is that in recent years, the perceived relative harm of vaping is actually increasing.
So what can be done about it?
Encouraging the public perception of vaping as a legitimate form of stop smoking aid, rather than a simple habit, would be a good start. This could include putting e-cigarettes in pharmacies, which we covered a few weeks back; but it could also include something as simple as educating medical professionals on the use and value of e-cigarettes so they can pass that information on to their patients.
Unfortunately, there's one big hurdle for any e-cigarette that hopes to be recommended as a medical product: the MHRA marketing authorisation application.
For a product to be licensed as a medication in the UK, it has to apply for its license at the Medicines and Healthcare products Regulatory Agency, or MHRA. And the MHRA actually has rules in place for the license of what they call 'nicotine-containing products', so the option to license e-cigarettes and related products as medical aids is available.
So it may confuse you that there are currently no e-cigarettes on the market—not one!—licensed as medical aids under the MHRA licences. One product actually has made it through the MHRA licensing process—it was called e-Voke and was produced by Nicovations, a British American Tobacco-owned subsidiary; but it was never actually brought to market.
Why haven't any market products been licensed yet, then?
This is predominantly a question about the requirements and steps needed to license a product. There are different requirements for different products, but for the purpose of proving that a mass-marketed product isn't going to have any adverse effects on people, all of the requirements are exceedingly strict.
For example, if you're looking to license a new e-liquid, or maybe a new vape tank, or anything that aids to dispense nicotine, you're going to have to build a 5-part dossier detailing things like 'Regional Administrative Information', studies both clinical and non-clinical (as well as executive summaries thereof), and an extended module on 'quality.' If you have any questions, the dossier on the construction of this dossier is 303 pages, so you can be sure it's comprehensive.
That module on 'quality' is also a bit of a doozy. It requires you to prove that no part of the product is remotely dangerous and that it can't be used to create anything dangerous, either. If it's an e-liquid, you have to prove that it has never lived any part of it's like within 95 radial miles of any diethylene glycol, basically. If it's a tank, you have to prove that gnawing on it like an animal won't shatter the glass in your mouth. If you don't have any studies proving any of this, run them yourself.
Many of these quality evaluations have to take into account any products already on the market in the category under which you're applying. That means any e-liquids seeking a license must compare themselves to currently licensed e-liquids; any mods must compare themselves to currently licensed mods.
Unfortunately, there aren't many currently licensed nicotine-containing products on the market to compare to. The MHRA instead puts forward the Nicorette Inhaler as a good comparison for any e-cigarettes seeking a licence.
You also have to provide evidence that the manufacturer of the product lives up to some pretty stringent rules outlined by the principles of Good Manufacturing Practice. Also, guess what? An inspector is actually already on their way to your manufacturing plant.
Don't mistake this for criticism of the MHRA's licensing process—forcing companies to take ownership for the effects of the drugs that we put into our bodies is necessary for a smooth-running healthcare system. But there's a small problem that makes this normally-totally-reasonable process less than viable for the e-cigarette industry.
The problem here
See, licensing a medicinal product with the MHRA isn't much trouble to most of the petitioners for medicinal licences. Most medicine manufacturers are huge multinational pharmaceutical corporations like Bayer or Novartis (or otherwise huge multinational tobacco corporations like British American Tobacco or Philip Morris) with legal battalions and cash to spare. Throw enough of one or the other at the MHRA and eventually you'll get what you want.
We've already seen this in action: the e-Voke from earlier was funded by British American Tobacco, and the MHRA's gold standard for inhaled nicotine-containing products—the Nicorette Inhaler—is owned by Johnson & Johnson.
On the other hand, many e-cigarette and e-liquid manufacturers are small, grassroots businesses. They don't have the legal or bureaucratic clout to produce the necessary dossier. And they certainly don't have the funds to pay for it—the application itself can run up to nearly £400,000.
And at any rate, the pace of innovation is so quick that it wouldn't pay off to undergo the lengthy licensing even if the money was available. The MHRA claims that a licence application can be processed in under 200 days—but that might as well be 2 years in the vaping industry's terms.
But there's hope
All is not lost in the e-cigarette world. Already there is talk about provisioning short-term licences through the MHRA with relaxed bureaucratic and financial requirements. After all, this was the same thing that happened with NRT licences prior to the harm reduction licence was added in 2010.
The bottom line is that the e-cigarettes industry is still rapidly developing, even if adoption has stalled. But it needs the help of regulators to find its way into the hands and pockets of people trying to quit tobacco everywhere.
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