Jon Spring | 1 December 2013

All quotes attributed in the following piece are from the transcripts of the E-Cigarette Summit, held at the Royal Society in London, on November 12, 2013 [i] The Summit provided a vital and timely meeting for scientists, policymakers, public health professionals and e-cigarette stakeholders to come together and debate the future of e-cigarettes in context of health, efficacy and regulation.

Common Ground

Many interesting examples of apparent common ground emerged through the presentations at the event, such as:

…this is about getting the most effective products out there… – Deborah Arnott, Action on Smoking and Health (ASH)
…more and better products. That’s exactly what the UK Government wants… – Jeremy Mean, Medicines and Healthcare Regulatory Authority (MHRA)
…the vision is for high quality products that people can access anywhere… – Jeremy Mean, Medicines and Healthcare Regulatory Authority (MHRA)

As a consumer association we share these objectives. We also want to see high quality, accessible and effective electronic cigarettes available. Mean’s stated vision is closely aligned to our own. It is remarkable that we all appear to have the same outcome in mind. This was further reinforced when he said that there was no need to remove existing devices from the market:

…when the safety evidence doesn’t support that sort of action…

He also accepted that:

…we’ve [the MHRA] never said we must regulate for safety purposes…

And proposed another objective that we fully support:

…what we really want to achieve is safe and effective products … we don’t want regulation for its own sake. We don’t want to impose something for no reason…

Despite these positive statements from the MHRA and ASH we find ourselves on opposite sides of a divide - why?

We disagree with each other on a number of points. The MHRA & ASH claim that e-cigarettes are a gateway to smoking; that e-cigarettes are marketed at children; that the market is unregulated; that user experience is less important than measured dose; that the variety of flavours and devices are an unnecessary part of the switching experience.

However, whilst important, these arguments are not at the crux of the real debate. As Robert West, Professor of Health Psychology and Director of Tobacco Studies at University College, London said:

…does anyone here really believe that we have a problem right now in England with an unregulated market? Smoking prevalence is falling, quit rates are rising, electronic cigarette use is showing a huge increase. Are we seeing a problem? I think probably the answer is, ‘No.’…

We support this position - there is no problem with the current market that requires it to be replaced by regulated medicines only.

The Divide – Claim and Counterclaim

The MHRA, Public Health organisations and the Government believe that none of the devices currently available on the market are good enough. We do recognize that some devices may not be good enough, but as the consumers of the products we struggle to understand how such a generalisation can realistically be made on the basis of examining only a handful [ii] of the hundreds of devices available. There are almost one and a half million people in the UK who use them and obviously think they are good enough.

Products are evolving and improving all the time and we believe that market forces will sort the wheat from the chaff.

There is also a belief amongst the MHRA, some people in public health and Government that medicinal regulation will result in a better set of products being available for consumers. We dispute that. We believe that medicinal regulation will stifle innovation, restrict choice and result in sterile, dose controlled devices with no appeal to smokers. The length of time it takes to obtain regulatory approval means that any device that successfully receives authorisation to be placed on the market will, at best, be using technology that is at least one year out of date and more likely 18-24 months.

However, Mean asserts:

…the pharmaceutical industry is the most innovative in the world, if you count it by number of products or number of patents or new developments that are coming out…

A medicinal framework might provide better products. However, do we need to regulate against the existing products to determine that? Ethically, should we regulate against the existing products before we know that any medicinal offerings are truly better or more effective?

This is the current situation and the reason we find ourselves at odds. The MHRA have already proposed, with the support of Government and Public Health organisations, to regulate e-cigarettes as medicines from 2016 and to remove all the existing products from the market.


Bridging the Divide

There is an obvious way forward that would allow both sides to test their positions and ultimately allow informed and proportionate action to be taken.

Mean, Arnott et al. claim that medicinal e-cigarettes will be a significant improvement on existing products. We don’t support that view. We believe that the existing products are good enough; that existing regulations, properly applied, are proportionate to the risk; and that normal market forces will result in faster product innovation and better products. Mean, Arnott et al. disagree.

These differences of opinion will not be resolved by one group imposing, via regulation, their view on the other. However, there is a way forward that allows both groups to test their views without adversely impacting each other. An approach that supports our common objective of “… getting the most effective products out there…” - We simply need to place the medicinal products on the market alongside the existing ‘unlicensed’ devices and let the market decide.

The medicinal products will have advantages – inbuilt demand through NHS stop smoking services, availability via prescription and lower VAT – even so, we contend that new users will migrate away from medicinal products to unlicensed products. If we are wrong, and the medicinal devices are better and more effective, existing users of unlicensed devices will migrate to the medicinal products. Few would oppose regulation if this were to occur.

Everything is in place for this test to occur – Mean told us that:

…we stand ready to license products now, there’s a couple going through the system. I’ve met with between 20 and 30 companies interested in pursuing a licensing route…

Once these licensed products hit the market, we should stand back and watch the market develop for 18 months. Let market forces decide who is on the right side of the divide and, with that knowledge, we can then take action appropriately and proportionately.

Imposing medicinal regulations without providing the opportunity for the competing positions to play out is regulation by guesswork. The MHRA impact assessment [iii] recognises (in paragraph 60) that if the effect of medicinal regulation is to reduce access to devices, the policy would be a costly failure with a huge negative impact. Why take that risk by regulating the existing products out of the market?

Very little needs to be done to allow the UK to lead the harm reduction debate in this way:

· Support the European Parliaments decision (MEPs have already voted against medicinal regulation)

· Improve the enforcement of existing regulations (necessary regardless of the eventual outcome)

· Monitor potential safety concerns (via the existing RAPEX alerting system)

The information available at the end of this 18-month trial period can inform decision making throughout Europe.

As Robert West said

…we don’t have a problem; everything is going in the right direction…

There is absolutely no need to rush to regulation based purely on assertion and theoretical risk.