March 22nd, 2013

The Economist backs e-cigarettes – but frets about excessive regulation

the-economist-logo…a couple of interesting pieces on e-cigarettes in The Economist magazine.

No smoke. Why the fire? and E-cigarettes: Vape ’em if you got ’em

What to make of this…?

Summary. The Economist writers are very enthusiastic about the potential of e-cigarettes to displace the cigarettes, and they take aim at health lobbyist objections ‘driven by puritanism‘. They argue that it is wrong to classify them as medicines, to ban them or to restrict them in public places – arguing that “the right approach is not to denormalise smoking, but to normalise e-smoking“. They see red tape, taxes and patents as barriers to the growth of the category and suggest that Big Tobacco’s deep pockets may ultimately prevail.

Also, it’s unusual to see anyone recognise that nicotine use actually has benefits to its users… I liked this simple risk-benefit formulation:
People smoke because they value the pleasure they get from nicotine in tobacco over the long-term certainty that their health will be damaged. So it seems rational to welcome a device that separates the dangerous part of smoking (the tar, carbon monoxide and smoke released by the process of combustion) from the nicotine.

As The Economist says: “what’s not to like?”  This prompts a few observations from me…

Legal basis for regulation. Behind their concerns is the question of what the legal status and correct regulatory approach should be. On this subject, I have updated my briefing: Are e-cigarettes medicines? to include the fourth legal case in Europe that has rejected the classification of e-cigarettes as medicines by medicines regulators – this time in Estonia.  The strategy of pursuing medicines regulation for these products when they plainly are not medicines is potentially damaging for three reasons:

Firstly, ‘light touch’ is unlikely.  The likelihood of this being ‘light touch’ in any meaningful sense of the words is hard to imagine given the constraints imposed by the governing directive. Excessive regulation would create implicit regulatory protection and advantage for cigarettes – the main rival. I’ve set out the dangers in an earlier posting: Medicines regulation for e-cigarettes – when caution can kill.  I don;t think anyone in the companies already trying to get medical marketing authorisations think this is light touch.

Secondly, distraction from doing the job properly.  Applying an inappropriate regulatory framework is a distraction from designing regulation that is appropriate to the way the product is made, sold and used. This can be done through a mixture of general and specific consumer product regulation or a sector specific regulatory regime: this has been done for example for cosmetics, which are neither a food nor a medicine, but pose risks to human health. Either would be better than the contortions necessary to classify e-cigarettes as medicines, and the burdens costs and restrictions that would result.

Thirdly, it is legally flaky. National courts have repeatedly struck down as unlawful, disproportionate and discriminatory attempts by national medicines regulators to classify e-cigarettes as medicines under the directive 2001/83/EC – the medicines directive. But this what the Commission has proposed under the Tobacco Products Directive.  The ECJ has developed case law that quite narrowly confines scope-creep for medicines definitions too. We should remember the TPD is not primarily a health measure,it is part of the development of the single market (though taking a high level of health protection as an objective).  EU institutions are required to meet health objectives through the development of single market legislation in the least burdensome way they can – but they have barely considered the alternatives (same with our own MHRA). So we have the danger that all this effort will go into supporting the wrong type of regulation when perfectly viable alternatives are available, and then it will fall apart in the courts.

Can someone please explain why they think medicines regulation is the right thing to do? When considering the right thing to do, the science is only one part of the picture. The economists and lawyers have valid insights too – and it has to be considered within a risk-benefit framework that encompasses the super-risks of cigarettes.  If someone has made a properly considered and rounded case for regulation of e-cigarettes as medicines, I would welcome sight of it – I am not aware of one. Even though this is apparently the preferred option of many health lobbyists.   I’m not interested in arguments from authority: the position-taking and assertions of important-sounding health organisations. I already know that lots of people support medicines regulation, I’d just like to see some reasoned arguments for it and carefully weighed judgements on its potential downsides.

2 comments to The Economist backs e-cigarettes – but frets about excessive regulation

  • Simon

    @Rursus, I’ll tell ya why. It’s very simple. For every person that moves from smoking tobacco products to e-cig products, its removing the revenue stream for the tobacco companies for that particular person. It is also removing the taxation stream for the government, for that particular person.

    E-cigs are becoming increasingly popular due to their cost to run and also the health benefits. I’m not saying they are healthy, but damn, they are not as dangerous as tobacco. I could also go on about the fact the government want to control population and smoking does that. There is of course the fact pharmaceutical companies won’t be able to sell as many drugs if less people get cancer.

    Take me as an example. I quit smoking tobacco and changed to e-cigarettes. So now out of the £2900/year I spent on tobacco products the government are getting no tax on that anymore. I will also hopefully live longer, and hopefully also not get cancer. So when I retire I will live longer and the government will have to pay my pension for longer (if a pension actually exists when I retire). As I hopefully won’t get cancer I won’t be using up some of those millions of drugs available to cancer sufferers.

    It’s the same reason we don’t have cars and vehicles that run on water. Engines have been developed that can run on water, but where are they? And also the same reason Nicola Tesla never got his ‘free electricity’ out to the people.

    So that’s why. They want you to pay them in taxes to get cancer, use lots of drugs then die before your retirement. Its a load of bureaucratic BS!

  • Can someone please explain WHY?

    Why are “they” fighting the ECigarette?

    They´re fighting for fewer additives in tobacco – Trying to lower the addictive and harmful substances!

    To paraphrase Prof. Dr. Michael Siegel:

    The stupidity of the discussion, crafted by “Health Lobbyists” and supported by the major anti-smoking groups, is that in response to the harmfull ingredients of tobacco, the EU-Commission has the authority to eliminate every single ingredients of them …

    … except for the tobacco!

    This may come as a surprise to the Commission, but the one ingredient in the cigarettes which makes them the most hazardous consumer product on the market is …

    … the tobacco.

    HEY TOBACCO CONTROL: We have it! We have the solution! We have left behind not only the additives and most toxic substances in the smoke but also the tobacco!

    We´ve left tobacco and there it is: The Cigarette without additives and lower addictive substance – The most harmless cigarette in the world: The ECigarette!

    Why are you fighting it?

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