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.
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.