21 October 2013

The story of the EU’s tobacco products directive shows how difficult policy makers find it to cope with new things. If open policy making does anything, it should enable them to deal with innovation better.

It is very unusual to read a leader in the Daily Telegraph lauding MEPs for stopping a policy endorsed by the UK government. Yet this is what that newspaper did recently, hailing the revolt by Conservative and Lib Dem MEPs which threw a spanner in the works of an attempt by the Council and Commission to regulate e-cigarettes as medicines.

This sounds a pretty obscure subject. And on the face of it, the government’s policy sounds harmless enough. After all cigarettes are very bad for you – and having let the smoking genie out of the bag, surely governments are right to be cautious about something that sounds very like them.

But this is where the story gets interesting.

Even after 50 years of throwing the policy book at cigarettes, around 20% of the population refuse to be priced, persuaded or regulated out of the habit – despite that fact that that habit will end up prematurely killing around half of them. Smoking is increasingly the domain of the poor and the vulnerable e.g. self-medicating schizophrenics.

For years, those concerned about smoking have been seeking a safe(r) alternative – but they were badly bitten by their experience of low tar cigarettes – sounded good but offered few health benefits. E-cigarettes which offer the nicotine (relatively harmless fun, or so I am told) without the smoke (the cause of death and disease) have the potential to be just that breakthrough. If lots of smokers switched to e-cigarettes, there would be very substantial gains to public health. The market in the UK has taken off in a regulatory vacuum – which is where the argument starts.

Within government, e-cigarettes were immediately characterised as a health issue – with Department of Health in the lead. So Department of Health referred the question of what to do about e-cigarettes to their expert committee on human medicines. Despite the fact that no maker had ever claimed the product was a medicine. Not surprisingly, the committee proposed that e-cigarettes should be regulated as medicines.

Then along came the EU – with a proposal for ‘light touch medicines regulation’. But that is – sensibly enough – an oxymoron. Medicines regulation is very heavy duty indeed. And only big existing incumbents can possibly hope to comply. The small start-ups who are driving innovation would be driven instead out of business. But the impact on them was not considered.

One group was completely ignored in the whole process: the estimated 1m plus former smokers who have switched wholly or partly to using e-cigarettes and are very passionate about the issue. They were a new interest group in town. When so-called ‘vapers’ discovered that their lifeline was about to be cut off in the name of health, they took to social media to campaign against the changes.

The entrenched ‘health’ lobby was on the other side. But there was no argument on health impacts: everybody agrees that the risks from e-cigarettes are a tiny fraction of those from the conventional product. Instead they used their medical expertise and authority to opine on regulatory impacts and market consequences – issues not usually covered in medical training.

So the forces of conservatism – the government, the EU Commission and Council and the health lobby locked themselves into protecting a status quo which privileges the most dangerous products – cigarettes – against potential competitors. The European Parliament proved its worth by forcing a rethink.

There is now a new public health minister and this will be near the top of her in-tray. But government not only needs to take the chance to have another look at its stance towards e-cigarettes – but to look at how it copes with innovations. Open policy making could be the key:

•Being open about how to frame an issue – rather than box it from the start in a way that almost predetermines the outcome
•Involving innovators and not just incumbents
•Consulting self-identified potential beneficiaries – as well as self-appointed ‘experts’
•Giving as much weight to potential dynamic benefits as to possibly hypothetical risks.

The alternative is to stick not just with closed but ‘closed mind’ policy making.


Thank you - you may guess I'm a vaper.The arguments in favour are clear and simple yet it has been profoundly depressing to see the continuing attempts of Big Pharma,Big Tobacco,Big Tobacco Control and Big Government to disinform,deceive and ignore.

I think there is more to it than conservatism but it's a good starting point

Jill, as one of those "vapers" you refer to having myself smoked for over 35 years may I wholeheartedly congratulate you on a writing not only an highly informative article (Our Prime Minister wasn't even aware of the TPD and the e-cig issue) but an article that alludes to simple common sense. It's ironic that when now in the NHS more emphasis is being placed on hearing and taking notice of patients views and concerns regarding the treatment that they receive that the views and concerns of the UK's estimated 2 million "vapers" have been wholly ignored by government and in particular the MHRA and Department of Health.

Vapers have been incensed that the government has taken more notice of the scientifically outdated and seemingly biased opinions of the MHRA and Department of Health, than the millions of ex smokers who truly understand the issues and new technology that are e-cigarettes.

Thank you very much Jill for writing such an informative article. I am 62 years old,and have smoked since the age of 14. I have tried everything under the sun to stop, and nothing has kept me from tobacco,that is until I tried an ecig 9 months ago,and I haven't smoked since.My health is so much better,I no longer cough, I can walk without getting out of breath,my home is free from tobacco smells, I no longer smell of smoke, and I am not harming anyone else with my second hand smoke. If the MHRA go ahead with medicalising ecigs then they will be causing the death of millions of people. We elect MPs MEPs to represent their citizens, yet it appears to me they are representing Pharmaceutical and tobacco companies. Shame on them.

It is good to read someone putting across the e-cig consumers view point for a change.

A really informative even handed blog , many thanks for this . I also converted to"vaping" about 9 months ago as an alternative to tobacco cigarettes, to my total dismay I immediately discovered moves afoot in the EU and ultimately the UK to impose medicinal regulations totally out of proportion. Yourself and Clive Bates appear to share similar very sensible ideas on well thought out "product specific" regulation. Hopefully this commonsense approach will eventually be adopted across the EU and not something hastily cobbled together totally unfit for purpose .

Jill - thank you from the bottom of my heart for this wonderful piece. It gives a lot of people a lot of hope.

Refreshing change to read some sense on ecigs! It's hard to believe that we vapers are having to fight so hard to ensure that we have free access to a product that has transformed us from smokers overnight! We are not fighting just for ourselves (experienced vapers will beat any ban) we want others to enjoy the same privilege - the right to choose life. It is sad that so many organisations who should be helping us, CRUK, BHF et al are so heavily funded by the Pharmaceuticals that they choose not to do so. It is, of course, the Pharmaceuticals who are most threatened by the ecig - they stand to lose the NRT market which has cost the tax-payer millions every year for decades, and there is no money for them in healthy people

Well done Jill, what a well thought out article and sooooooooo true thank you .

Oh what a breath of fresh air (just like vaping vs cigarettes)! Confronted with the closed ranks of the established interests, I was beginning to think that I lived on a different planet (albeit with 2 million others)! I can only hope that they take note of your wise words, but I feel that their natural instinct will be to dig in, admit no errrors, and charge for the 'regulation' gate with teeth clenched. At best they will be looking for some face-saving 'regulation-looking' measures.
They have got this so far wrong that it would be best if they admitted their error, wiped the slate clean, and started again - or perhaps just did nothing and waited to see what was needed.
It's unbelievable that they haven't analysed the figures and are prepared to let £millions in savings get buried in the bureaucratic bog.
Wonderful article!

Given that nicotine is patently NOT a medicine (cigarettes, anyone?) and that e-cigs are an effective alternative to smoking, rather than a cure... and given that all sides agree that e-cigs are significantly safer than tobacco-cigarettes and therefore promise a public health bonanza... the motives behind attempts to 'medicinise' e-cigs are questionable.

If the MHRA and DoH either embraced and promoted e-cigs (facilitating safety/quality improvements utilising the existing (and broad) consumer regulatory framework, for example), or (frankly) ignored them completely, then the public health benefit would be both cost-free and widespread. If the target truly were to improve public health, moves to ban the dangerous product would be under discussion... rather than (as is the case) moves to restrict the safer alternative.

Medicines regulations would bring no benefit to e-cigs (or vapers)... they do not even benefit current NRT product-users... as patches, lozenges, gums, inhalators etc simply do not work and can (in the case of Champix, for example) carry significant risk. All NRT products should be released from medicines regulation and judged by the price-paying public based on their effectiveness. Maintaining the current tax-funded NRT system is of benefit ONLY to the pharmaceutical industry.

E-cigs are not NRT. They are NOT a replacement... they offer an alternative to smoking to those people wholly disinterested in quitting nicotine. As such, medicines regulation is wildly inappropriate.

There remains no evidenced cause, reason nor necessity for the MHRA or DoH to turn their attention to e-cigs whatsoever... beyond ideological puritanism, coupled with vested (pharmaceutical industry) interests.

Many thanks for your article!

What a refreshing breath of fresh air, both your assessment of ecig regulation and the improved lung performance I have enjoyed over the past 5 months since switching from cigarettes to vaping; which I should add has been the only viable means with which I have been able to quit smoking despite trying patches, gum, inhalators and lozenges. As a 20 a day smoker, or more, for 25 years, with asthma, ecigs have been a godsend to both me and my family. Do I crave cigarettes still? Not in the slightest, in fact I tried one recently and managed about 2 drags before stubbing the thing out and returning to my ecig, by comparison the taste was disgusting. A point lost on many health campaigners who claim ecigs are a 'gateway' to smoking.

Nonetheless, the threat of ecig medicalisation remains with the MHRA proposals, which if introduced would take away mine and other vapers choices in respect of seeking a personal solution to suit their individual needs and instead impose a generic, ineffective (due to the proposed limitations on nicotine strength) and probably far less enjoyable experience for many. Regulation already exists under the existing system and millions of ex-smokers across the EU have switched to vaping and remain off cigarettes, which somewhat dispels the 'efficacy' argument under which many seek to regulate these devices and liquids.

Jill... very insightful account of this, with many lessons for open policy making. I think the story is being locked into a flawed paradigm and being unable or unwilling to escape as the signs pile up.

The warning signs were there in 2010 when these products were seen by government as a threat and, well, a bit nasty. The government's preferred approach was to ban them within 21 days by classing them as medicines and taking them off the market as unlicensed. The only trouble was that 100s of vapers responded to the consultation in personal and heartfelt terms pointing out that these products had transformed their health. It was no astroturf operation either: unnoticed by the health and medical establishment, consumers, vendors and Chinese innovators had come up with a promising solution to smoking, and all without any call on the taxpayer and with no approval of public health experts. It was and is a fantastic opportunity, but was treated in government from the outset as a threat to be contained.

The key mistake was made at that point. As the vapers' responses could not be ignored or explained away. - Department of Health asked the MHRA to look into it more and to study options. But consider the framing bias in that choice of specialist agency. To a hammer, every problem is a nail, and to the MHRA and its Commission on Human Medicines this problematic development unsurprisingly looked like it needed a dose of medicine regulation. What DH should have done was to look carefully at all options for regulation (and not ask the MHRA to do this); to try to understand these users' experience much better, and to grasp how this nimble highly innovative industry was working in practice. Instead it appeared to indulge in one of the greatest of all civil service vices: continuing undaunted and trying to prove it was right all along, even as the testimonies piled up, the companies piled in and the users piled on the pressure.

The October 2013 reversal in the European Parliament was met with more of the same - MHRA declaring it was still for medicines regulation, but without being able to answer its critics' challenges. What they should do now is (i) pause and reflect on what happened and why; (ii) convene a broader stakeholder group and stop ignoring the user experience and small firms that make up this disruptive industry; (iii) properly assess regulatory options and perverse consequences of excessive regulation; (iv) at UK or EU level design a regulatory framework that is proportionate to risk and fit for purpose; (v) try to do things that won't be struck down in court as disproportionate, discriminatory, or otherwise unlawful.

Other lessons relate to the feebleness of the challenge to all this within the rest of government. Even though MHRA/DH were roasted for their 2010 consultation by the Regulatory Policy Committee, nothing much changed, and BIS continued to be satisfied too easily, doing nothing to assist this promising new industry. The 'better regulation' machinery was bypassed or didn't work. Even the government's 'Red Tape Challenge' appears ineffective even though it supposedly has a strand devoted to 'disruptive challenger industries' and tackling excessive or ill-fitting regulation holding back promising new business areas. E-cigarettes could not offer a better justification for a Red Tape Challenge - but there came none.

Great to see some common sense at last, Thank you Jill.
Before I switched after smoking for 42years I was at the doctors at least twice a year with chest infections, just under 2years of choosing vaping over smoking I have not been near the doctors for antibiotics. Now I call that a result and I have saved the NHS some money add up all the others who with their own money made the choice to swop. Just how much have these people saved the NHS.
We chose to smoke we now choose to vape instead at no cost to the overburdened
NHS. thats how it really needs to stay at the end of the day we paid for our bacca we can pay for our vaping needs.
Nice to have somone on the side of common sense

I cannot thank you enough for making this sane and reasonable assessment. Such thanks ought not to be necessary, but in the last two months - during which I've personally stopped smoking cigarettes altogether thanks to vaping technology - we've heard little but self-interest motivated by those whose revenue depends on tobacco products, tobacco-related tax, or near-useless pharmaceutical 'cessation aids'. One would think that over a million people cannot be so easily ignored, but certain groups, elected and unelected, have been trying their hardest. It's a relief to know someone is listening.

Finally, a wonderful sensible article on the issue. You've managed to succinctly state the ecig situation. Smokers finally have a device that truly offers them an escape from the 1000s of dangerous chemicals in cigarette smoke, and yet govts and health authorities are doing all they can to put a stop to it. It defies belief.

As always you just need to follow the money. Whose interests are threatened? Big tobacco obviously don't want to see profits cut and, since they are now leaping into the e-cig market, the also want to kill off the smaller competition. Big Pharma don't want to see their NRT profits cut, nor profits from other treatments like those for COPD and other smoking related diseases (I, for example, no longer need an asthma inhaler now I'm on e-cigs) Both of these want heavy regulation and are an example of corporatism in all its self-interest. Then there are the anti-smokers, whose sum reason for being anti e-cigs seems to be that a problem is being solved DESPITE them. Though of course, as recent comments by a 'Quit Smoking' clinic manager seem to demonstrate, perhaps they see e-cigs as a threat to their pay packet.

It's great to see more common sense articles such as this one appear, especially after years of knee-jerk nonsense coverage of the technology.

I didn't get an e-cig with the intention of quitting smoking but my tobacco consumption shrank to naught within a month. It did what NRT failed to do almost by accident.

'The Shock Of The New' for me is my growing respect for the European Parliament.

It's worth reading the 2010 consultation that the MHRA ran into the potential regulation of e-cigarettes. The views of vapers, overwhelmingly opposed to regulation, were basically ignored. The usual suspects (ASH, Royal Pharmaceutical Society, etc) came out in favour of regulation of one kind or another, so that's how the MHRA decided to proceed.

Great article by the way.

At last.....an unbiased article, speaking sense....comments above have covered most of mine! Let me just add please. 25/30 fags a day for over 30 years. Started vaping on 1st Nov 2012 and not smoked since. Marvellous! Just an interesting aside...apparently a few days ago on twitter, the BMA said that all evidence relating to e cigarettes, compiled or researched by tobacco or e cig companies would now be dismissed and not used as evidence, which may be a trifle difficult for the MHRA, since the vast proportion of their so called 'argument' uses outdated research by BAT and other tobacco companies....I can't wait to see how the BMA extricate themselves from this one! (For more info, if you are on Twitter, just search Dave Dorn!).

I was a smoker for 40years, nothing worked until I tried an Ecig. Now I have been smoke free for more than a year thanks to vaping, there are close to 2m people now who know how effective these devices are yet no one in the government wants to ask our opinion. A few MEP's did, they got the facts & opinions the EU vote was the result.

Your article is a breath of fresh air, well thought out common sense. The question is why cant the people we elected to represent us see common sense.

Thanks to everyone for their (very kind) and really insightful comments.

Our system makes it very difficult for governments to change their mind and see things differently -- which why opening up an issue and considering it from all angles at the start becomes so important.

Hopefully this provokes some people within government to see value in looking at govt current position in a new way.

Agree totally with David Rawson -- it does put the EP and co-decision in a new light.

Great article. As others have mentioned it's all about protected intrests and money not to mention the lost tax revenues.....

I'd also like to add that I only hope there will be more people who have the open minded attitude of Jill Rutter, and actually take notice of the people who no longer smoke due to their use of Ecigs.

Jill your post reminded me of some of the policy and product making processes we have been going through at the NSPCC/ChildLine with regard to Sexting. Whether we adults like it or not, the sharing of explicit images is increasingly a feature of adolescent relationships. Simply telling young people not to do it and pointing out the long term risks is about as effective as lecturing them as to the dangers of smoking. http://m.huffpost.com/uk/entry/4114122?ncid=edlinkusaolp00000003# This is something I wrote for the Huffington Post about the matter recently.

Once you start involving young people themselves in a debate about combatting the risks of sexting, the solutions look very different. Much of the pressure to sext they tell us comes from peer pressure and from the joy of flirting. So with the help of young people themselves, through ChildLine they have helped us create an App called Zipit, now available in all good app stores. It gives young people funny images, designed by them, to send back in response to sext requests, as well as practical advice and support about the dangers of being on line. This is quite a brave thing for us to do since we are acknowledging that sexting goes on and strictly speaking the sharing of explicit images online by under age children is a criminal offence. The easy response is to preach about the dangers and stop there. Listen to those involved however and it takes you somewhere else.


well I had a heart attack in april this year and im 47 and yes was a smoker fags from 13 years and then onto smoking a pipe from my mid 20s ,since april I have been vaping and not had a proper smoke since ,as a lot of people are taking this route and leaving cigs and tobacco products which include duty and tax in all eu country's so there probably looking at how to generate taxation on vaping products and keeping the tobacco industry happy as they can ,lets face it the advertising of formuler1 racing is still being debated due to the cash being generated and the tax generated ,I will keep vaping as long as available as I have been told we don't know what harm they will do long term ,,but we all know what harm and bad stuff in cigs and tobacco will do

Peter Wanless offers an interesting lateral insight on 'sexting'. Perhaps the unifying idea is 'harm reduction' - improving outcomes for people doing things the government/society disapproves of, or things that are illegal. It's quite likely that the user voice in these circumstances faces greater barriers to accessing and influencing government decision makers. The problem, as Peter states, is that it is 'brave' to get on the side of these people with the implied risk of appearing to condone or accept the harmful behaviour. The instinct is to be 'tough' and to wish the problem away with laws or regulation that absolve the regulator or law-maker of responsibility - after all how can you be blamed if you made it illegal? - but leave the problem untouched or aggravated, and the users marginalised and harmed. Drug users are the most obvious and most excluded, and, by no coincidence, the most subject to evidence-free policymaking and posturing. The controversies of needle exchanges, shooting galleries and heroin prescribing reflect the pioneering work in harm reduction in the drugs field. Others might include sex-workers, illegal immigrants or asylum seekers, drinkers, smokers, porn-users, younger teenagers who want to heave sex, truants and people excluded from schools, prisoners, gamblers, gourmands, hedonists etc.

Under an open policy-making philosophy perhaps government needs new ways to take on the views of the potential beneficiaries of harm reduction strategies, and to be more sensitive to the harm that 'abstinence-only' approaches can do to these people - especially as often supported by vocal ideologically motivated groups. With harm reduction, more control, more regulation, and more safeguards can, paradoxically, mean more harm overall.

However, governments in the UK, Europe and the United States are now gearing up to classify these products as medicines, thus imposing heavy regulatory burdens, costs and restrictions. It would be an appalling paradox if regulators, in the name of safety, ended up smothering the e-cigarette market with red tape, and so tipped the competitive balance back in favour of cigarettes.

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