The EU’s Tobacco Promotion Directive

I can’t stand do-gooders using the law to manage my lifestyle. Okay, smoking is unpleasant and (mildly) dangerous to others; I would accept smoke-free restaurants and offices. But what gave politicians the right to stop me smoking in private clubs and small bars? The self-righteous just don’t recognise compromise.

Galling though such bans are, they could become moot thanks to a better and healthier alternative to smoking that has emerged in recent years: electronic cigarettes. I first tried e-cigarettes in 2009. I found they were nearly as good as the real thing, I could use them anywhere and they were cheap. I haven’t smoked a cigarette since and I feel great. Starting with a little white stick, emulating a fag, I soon moved to something more satisfying – there’s a great choice of devices, improving all the time. At a recent Westminster meeting, one MP compared my current favourite with Doctor Who‘s sonic screwdriver!

E-cigarettes deliver nicotine without combustion. Nicotine is relatively harmless, comparable to caffeine – a mild stimulant. Conventional cigarettes are dangerous because they burn, filling our lungs with tar and smoke particles. E-cigarettes produce a fine vapour, without all the carcinogens and chemicals found in cigarette smoke. The risks from e-cigarettes are insignificant compared with smoking tobacco. Nor is there any ‘Wild West’ of unfettered selling going on: e-cigarettes are already heavily regulated in the UK, just like most other consumer products.

However, in a typical example of snatching public-health defeat from the jaws of victory, in December 2012, the EU accepted a proposal to revise the Tobacco Products Directive (TPD), which was first adopted in 2001. Among the many provisions in the revised TPD is a rule that would allow the sale of e-cigarettes ‘only if they have been authorised as medicinal products on the basis of their quality, safety and efficacy, and with a positive risk/benefit balance’. Perversely, the Tobacco Products Directive would heavily regulate a potentially invaluable product that doesn’t actually contain tobacco. The upshot would be to restrict the sale of e-cigarettes unless they had gone through the lengthy and expensive testing processes that medicines are subjected to, reducing choice and increasing cost.

Since e-cigarettes appeared in 2006, the UK market has flourished. Products are continually refined, with better battery technology, new delivery mechanisms and a variety of styles and flavours to appeal to diverse tastes. Sales have grown rapidly – the UK Medicines and Healthcare Products Regulatory Agency (MHRA) estimates sales have been rising 34 per cent per year, with some 700,000 UK users last year and perhaps a million ‘vapers’ in 2013.

Yet the MHRA itself has been at the forefront of pushing for greater regulation. In June 2013, MHRA confirmed plans to regulate e-cigarettes as medicines in a way that, from its own analysis, threatens thousands of lives. This is despite the fact that the Commission on Human Medicines (CHM), which the MHRA offers as authority for its e-cigarettes policy, equates 34 per cent annual growth in e-cigarette usage to saving 2,000 smokers’ lives. Every year of growth at these rates will save more.

This push for medicinal regulation also flies in the face of public opinion. In 2011, the MHRA consulted the public on the issue. The overwhelming majority – 78 per cent – of respondents opposed medicinal regulation – but the MHRA proceeded with the policy anyway. As a result, the UK has backed the TPD. As for our elected representatives, they were never consulted. Anna Soubry, the minister of health responsible for this area, simply voted to back the plan without referring to parliament. Soubry then squirmed as MPs on the European Scrutiny Committee asked her to justify her decision afterwards, a session which only revealed Soubry’s ignorance of the directive she had voted for. (Soubry has now been shuffled off to the Ministry of Defence.)

How has this mad policy been justified? The phrases ‘insufficient evidence’ and ‘requires further research’ appear throughout the MHRA/CHM material. Despite strong indications that e-cigarettes are far less harmful than the tobacco variety, there isn’t enough proof that they are completely harmless and insufficient evidence that they are effective in reducing smoking. Medicinal regulation’s mantra is establishing quality, safety and efficacy. Through twisted logic, MHRA concludes that doubts about evidence and efficacy can only be resolved through testing, control and monitoring as medicines.

A single strand of the MHRA/CHM argument is reasonable. Testing a few e-cigarettes, they found variances between advertised and actual nicotine content; one sample had trace toxins. Medical practitioners cannot recommend a product as a substitute for smoking or an aid to quitting unless they know it’s safe. Yes, the MHRA should regulate devices provided by doctors. But these observations by no means demand that all e-cigarettes should require medicine-level regulation.

Far better to regulate e-cigarettes as consumer products and to encourage the development of voluntary testing and labelling schemes as already done by the Electronic Cigarette Industry Trade Association (ECITA).

There are some rational voices in the European Parliament who want to overturn this aspect of the TPD. Conservatives and Liberal Democrats sought a balanced compromise on the directive – products marketed as medicinal would be regulated as such; other e-cigarettes would need warning labels, a ban on under-age sales and specific quality standards. This compromise was out-voted by the Socialist Group in the Parliament’s Health Committee, backed by the UK Department of Health briefings for MHRA’s ‘regulate everything as medicine’ stance.

Martin Callanan MEP, leader of the European Conservatives & Reformists group, and a prime mover for sensible regulation explains: ‘It would be the greatest folly to classify e-cigarettes as medicinal products. This would limit their availability when a lethal alternative (tobacco) remains available in every corner shop. Treating all e-cigarettes as medicinal products would raise costs, reduce product diversity, slow down innovation, inhibit creativity and make the products less appealing to the very people we hope will switch to them.’

MHRA regulators are well-meaning but have tunnel vision – their business is medicinal approval and, not surprisingly, that’s their answer to the question of e-cigarettes. If we continue down this path, the tunnel comes out in a place where I can’t get the products that keep me off cigarettes. Years of experience with governments preaching ‘just say no’ show that endless lectures do not work. Deprived of e-cigarettes, a million people in the UK may return to smoking regular cigarettes.

Well, at least each pack sold will shove another £4 in tax to the government’s much-strained coffers. Frankly, I hope they choke on it.

Craig Arnall is an accountant and management consultant living in London.