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July 19, 2013

A Sober View – the Trend to Medicalisation Threatens to Stifle E-cigarette Growth

Shane_MacGuill

Analyst Insight by Shane MacGuill, Analyst - Tobacco, Euromonitor International

It is, for some, a nightmare scenario with which one could imagine Milton Friedman terrorising his grandchildren: that of over-eager regulators choking off the growth of a free market solution to a free market engendered problem. With last week’s EU Parliament ENVI (Environment, Public Health and Food Safety) Committee vote on the Tobacco Products Directive, it is rapidly becoming a reality. There has been an outpouring of media coverage on the stellar growth potential of e-cigarettes in recent times which has for the most part obscured a trend towards the medicalisation, or prohibition of these products which threatens to render the most hyperbolic of these projections so much of yesterday’s click-bait. So, what is the current state of e-cigarette regulation globally and what implication does current regulatory thinking have for the future development of the industry?

 

E-cigaretteRegulationresized

Major regulatory decisions label e-cigarettes as medicines

While the final text of the EU Tobacco Products Directive has not yet been agreed, barring an unexpected reversal in September’s plenary session, it is likely to deem that all e-cigarette products, regardless of nicotine content, be classified as medical devices, meaning that they must undergo costly and lengthy clinical trials and sale will be restricted, in the main, to pharmacies thereby diminishing consumer access. This scenario, echoes (and in fact goes further than) guidance given in late June by the UK’s MHRA (Medicine and Healthcare products Regulatory Authority) that it would take on the regulation of e-cigarettes as medical devices, on the lines of the TPD and has encouraged manufacturers to begin medical licensing application processes. E-cigarettes are already treated as medical devices in New Zealand, South Africa, Sweden and Estonia, amongst other territorities. 

The clear and present danger for the nascent e-cigarette industry is that a regulatory framework as substantial as the Tobacco Products Directive will act as a body of persuasional gravity of inescapable force and set the agenda for future regulation of the industry in other markets. The risk of the licensing approach, to the sector, centres on efficacy and access. Proponents of e-cigarettes argue that precisely because they are not operating under a medical rubric of ever-decreasing nicotine consumption, they are effective in bridging smokers away from combustible tobacco use. Medicalisation seeks to restrict nicotine content, in line with an honourable goal of eliminating its consumption, while it logically also places the distribution of such products in the hands of professionals, in the pharmacy channels. The end result, in the worst case, is narrower access to a product of fractional potency.

Hype surrounding e-cigarettes downplays or ignores many markets

The majority of current global e-cigarette sales come from the soon-to-be medicalised EU and the massive, as yet unregulated US market. The optimistic vaping frenzy which is sweeping the business media therefore rests to a large extent on the US market and appears by corollary to ignore developments elsewhere.

E-cigarettes are currently banned in several major cigarette markets such as Brazil, Japan and Mexico and there will be others to come. One might justifiably suggest that combustible tobacco is too important to governmental interests in other huge markets such as China, Indonesia and the Philippines for non-combustible e-cigarettes to be allowed to gain traction. China will happily manufacture the technology but I would suggest that its enthusiasm for e-cigarettes will, at least for the moment, exclusively manifest in the cheery waves it gives to exports leaving its shores. 

In other markets, the health awareness and price incentive which drive growth in Europe and the US, are significantly weakened factors. E-cigarettes enjoy substantial use in South Korea but are taxed as heavily as tobacco products and see much less vertiginous growth rates. Indeed, it is not uncommon in Asia-Pacific for standard e-cigarettes to cost 5 to 10 times the price of an average pack of cigarettes. 

Uncertainties still proliferate in US

There remains then in these cornucopian visions, a huge and by no means solid assumption – the robustness of the US market itself. Certainly, growth has been astonishing: the market roughly doubling in value every year since 2007 or 2008. With Altria rolling out its Mark Ten brand (why not Marlboro, one wonders?) all of the major players now have an e-cigarette. Some cities and states in the US (such as Boston and the proposed SB648 Bill in California) treat e-cigarettes as tobacco products, something which has its own share of restrictions but is on balance less damaging to long term development than medicalization. 

However, the federal FDA has yet to rule on how these products will be regulated. It should not be forgotten that this is an agency which sought to ban the importation of e-cigarettes in 2009 and has consistently proven itself reluctant to engage in the harm-reduction dynamic. Deeming that Section 910 of the FD & C Act applies to e-cigarettes would make it illegal to sell any such product not on the market before February 2007 – a de facto ban. Short of such a nuclear measure any element of medicalization in the US would severely impair future growth, particularly given that the key to the category’s current success is its relatively wide distribution in the market.

Medicalisation may not benefit anyone

On a final note, a received wisdom appears to have grown up (perhaps made current by disgruntled supporters of e-cigarette liberalisation) that increased medicalisation is of benefit to the tobacco industry. This to me seems a short-sighted and erroneous view. In fact, from here it seems that medicalisation is prompted precisely by the existence of the tobacco industry. The e-cigarette clearly represents a dramatic, disruptive change in nicotine consumption but equally it is no more than a change in format and to a great extent, the tobacco industry has been here before - with the advent of Bonsack’s machine and the filter, amongst other innovations. 

As an industry too, it has sought reduced harm alternatives, often comically but never without ambition and foresight. It is, in the final analysis, a nicotine industry and the e-cigarette (and all of the next generation of such devices) is merely a  technologically advanced iteration of an age-old behaviour. It is one that from the industry’s point of view ought to be eagerly embraced and it appears that that is precisely what regulators and those who seek to minimise and eliminate nicotine consumption are planning for. Medicalisation risks dampening or reversing e-cigarette growth and therefore becoming a costly exercise in the art of pleasing no one.  


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The reason we will believe it will benefit the tobacco industry is:

* few current, non-tobacco e-cigarette companies will be able to afford medicilisation license. Most e-cigarette companies have dozens of flavours and several e-cigarette model, medicilisation costs would run into ten of millions of pounds without any guarantee of success. (The only company that tried to build a compatible device failed after investing two million dollars and several years). So competition would be removed.

* consumers are increasingly moving away from disposable and two part e-cigarettes towards refillable systems which would probably not comply with the regulated nicotine delivery likely to be part of the licensing. Tobacco companies will find it easier to compete if these innovative devices are removed from the markets and they can roll out electronic versions of their traditional products.

Hi Shane.

Your information may need an update in some areas, as (1) e-cigarettes are fully and effectively regulated in the UK, and (2) the UK does not regulate e-cigarettes as a medicine, will not be doing so for some time even if the DoH may want to, and probably will not be able to do so in any case. Even if both the EU and the UK DoH introduce medicinal licensing for ecigs, there is a 99% certainty that such statutes will be overturned by the courts, as they have universally done so already and there is a mountain of case law. In addition, the EU's own law committee (JURI) says that medicalisation of ecigs will not withstand challenge.

For current country-specific info, please see:
http://www.ecigarette-politics.com/electronic-cigarettes-global-legal-status.html

The blue-box graphic for regulatory status is very smart. It needs another block though: Fully Regulated As A Consumer Product

This is the current status of ecigs in the UK, and it may be the only country where e-cigarettes currently are fully regulated: (a) they must comply with 17 statutes (see Clive Bates' blog for the list) and (b) there are inspectors in every area who check for compliance. No possible reason for changing to pharmaceutical regulation has been demonstrated; indeed, such a change would reduce safety standards (since no evidence for the need for change has been given; since consumer products are enviably safe compared to pharmaceuticals; and since smoking cessation drugs such as varenicline that are proven to kill and harm on a significant scale cannot be removed from the market).

Note that both the tobacco and pharmaceutical industries opposed e-cigarettes until around two years ago, when a silence descended over tobacco, leaving the opposition to pharma (because when ecigs take 50% of the cigarette market, as they will, then disease requiring expensive treatment will fall by about 49.75% - see what happened in Sweden). The fact is that tobacco can mitigate their losses in multiple ways, but pharma has nowhere to go but fight. Current opposition to ecigs mostly depends on pharma funding in one way or another. For example, one of the EU's key figures driving the TPD through committee just revealed they are funded by Pfizer.

Chris Price
ex-ECF Manager
ex-ECCA UK Secretary

Hi James,

No question that tobacco companies will find it easier to afford and comply with stricter, medicalised regimes. But this applies to any large, highly profitable company and is why I described suggestions that medicalisation benefits the tobacco industry as 'shortsighted'.

Whether it be by organic competition, or acquisition (or by default as a by-product of medicalisation) tobacco companies will seek to enter and are likely to gain a large share of the e-cigarettes segment. It should be looking to so under a non-medicalising regimen in which future growth potential is the least restricted and where marketing environments are closest to the those in which they already, for better or worse, operate with aplomb. The benefit to the tobacco industry of 'medicalisation' may well exist, but its not a benefit that is specific to it and it doesn't outweigh the wider disadvantages.

Hi Chris,

While I'm aware of the JURI committee's finding on the TPD (I tweeted about it at the time) and the broader view that medicalisation is legally questionable, the piece only reflects stated policy intentions rather than legal hypotheticals.

I have some sympathy for your assertion that the framework in the UK currently constitutes 'Full Regulation' but again, the graphic was intended to reflect the, as far as I can see, widespread belief amongst regulators that there is something unique to e-cigarettes as a class of products which needs additional scrutiny, meaning that by definition current, 'by existing consumer code' regimes are 'incomplete'.

What factors are driving that additional scrutiny I cannot say with any certainty but I can try to assess what impact I feel increased medicalisation would have on the segment itself and consumers.

My mistake Shane - I didn't realise the the blue box graphic represents a possible future scenario.

I think it unlikely that medicalisation will succeed at either EU or UK level given the case law, and the fact that the ECJ overturned the garlic pill medicalisation law. The courts in general do not seem to think that the law should be used as an easy tool to remove pharma's competitors.

It seems far more likely to me that the EU will eventually move toward tobacco product classification for e-cigarette products, as that will be 99% as effective for them (to exert control/restriction); and as far as I can see this is the fallback plan (or even the main one, since the people running the show must know that pharmaceutical licensing won't fly).

This means no flavours (so basically no proper e-liquid business), etc.; although the no web sales reg failed in committee this time round. They'll get around to that soon enough.

Hi Chris,

Really enjoyed your reading your feedback to Shane's post.
Can you please PM me - chromesmic@hotmail.com.

Regards
Mark

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