On 30 November, the draft EU Tobacco Products Directive was circulated for inter-service consultation (ie. sent round all other Directorates General in the European Commission). Its contents are not yet public, but it is widely thought to maintain the ban on snus and to impose strict restrictions or even bans on reduced risk non-combustible tobacco products, e-cigarettes and novel electronic nicotine devices. I cannot sufficiently stress how wrong and harmful that would be, given the role these products play as alternatives to smoking. I remain ever hopeful that good science, ethics and law (and common sense) will eventually prevail. To that end, I have written to the new Commissioner, Dr Tonio Borg, to suggest he makes five changes to the Commission’s approach. Here’s the letter:
Dr Tonio BorgCommissioner for Health and Consumer Policy
CC: Chief Scientific Adviser, Dr Anne GloverChef De Cabinet, Ms Joanna Darmanin
5 December 2012
Dear Dr BorgRe: Tobacco Product Directive – policy on snus and nicotine regulation
May I congratulate you on your appointment as the new Commissioner for Health and Consumer Policy. It is a role in which a capable public servant can do a great deal of good for the health of European citizens. Alternatively, the wrong policies can cause a great deal of harm. With that in mind, I am writing to ask you urgently to reconsider those aspects of the draft Tobacco Products Directive that deal with snus and nicotine regulation. I was director of the UK health organisation Action on Smoking and Health (ASH-UK) between 1997 and 2003, and I am concerned that the directive, as reportedly formulated for inter-service consultation, will cause more ill-health than it prevents by denying smokers access to products that are far less risky than cigarettes.
The ban on oral tobacco or ‘snus’The issue is straightforward: there is no scientific, ethical or legal justification for banning nicotine products that are much less hazardous than the dominant market leader, namely cigarettes, but that can act as effective substitutes for smoking. The risks arising from snus are of the order of 95-99% lower than those arising from cigarette smoking. The widespread use of snus as an alternative to smoking is, beyond doubt, the reason why Sweden has by far the lowest rates of tobacco-related cancer, respiratory illness and cardiovascular disease in Europe. No scientific justification for a ban has been attempted – and much of the analysis of the Commission’s SCENIHR report on smokeless tobacco supports a harm reduction strategy rather than a ban on snus. The ethics are just as clear: what sort of public authority would deny a smoker, at great risk of personal harm, a viable low-risk alternative? There are no precedents for denying citizens safer alternative products. As for legality, a ban clearly fails tests of discrimination and proportionality, and violates single market principles by protecting cigarettes from competition, indeed competition from far less dangerous products. I have summarised the arguments on snus in greater detail and with evidence at the following posting, Death by regulation: the EU ban on low risk oral tobacco. I hope you will read this document or request advice on it, and form your own view.
Excessive regulation of novel nicotine devices and e-cigarettesThe scientific, ethical and legal arguments for new nicotine devices such as e-cigarettes are very similar to those for snus. These products are already proving very popular and have great potential to reduce the cancer, lung and heart disease caused by smoking.They give those who are unable or unwilling to quit smoking an alternative source of nicotine with negligible risk, and many users testify eloquently to the positive effect these products have had for them. The danger is that the new directive will impose excessive and ill-conceived regulation that marginalises these products by making them unattractive to smokers, by preventing clear communication about reduced risks, by making them hard to access, or by forcing product changes that make them inadequate substitutes for smoking, for example by limiting the nicotine delivery of these products. There is a place for regulation, but it should be to create an ‘enabling framework’ for these new, much less risky, alternatives to smoking to enter the market in a way that gives consumers confidence in switching from smoking.
The harm reduction philosophyThe underlying idea is ‘tobacco harm reduction’. It is a key public health strategy, and it should be encouraged, not obstructed, by the new directive. I am not alone in believing this. I recently wrote an open letter on tobacco harm reduction to delegates of the WHO Framework Convention on Tobacco Control. Twenty two of the most respected scientists, epidemiologists and tobacco policy experts in Europe and beyond followed up with supportive comments, giving their own views. It is simply not correct to assume that the entire public health community favours a ban on snus or obstructive regulation of nicotine products. I invite you to read this open letter and to consider the comments before proceeding further with a directive that embodies a ‘quit or die’ philosophy, with no middle ground to accommodate smokers who cannot or will not quit.
What should happen – five changes necessaryI believe the following policy changes are necessary to prevent the directive causing harm and to reorientate EU internal market policy on tobacco towards health.
1. The new directive should remove the ban on snus. On scientific, ethical and legal grounds it was not justified in 2001 and all the evidence that has accumulated since suggests it is even less justifiable now. No-one has provided an adequate justification for the ban, and no-one will. In effect, the ban protects the single market for the most harmful products of all.
2. Introduce regulatory toxicology standards for all smokeless tobacco products. WHO’s expert committee (TobReg) advises this approach and many health organisations would support it. It would potentially remove from the market the worst forms of smokeless tobacco, whilst leaving better products, such as snus, to compete with cigarettes in the internal market, with health as a consumer driver.
3. Seek further advice and analysis before making any regulatory interventions concerning novel nicotine products and e-cigarettes. The major health benefits of these products for existing smokers should be given great weight in EU policy. If there is to be regulation, it should have the objective of creating an ‘enabling framework’ to build confidence in these products as alternatives to smoking. The 2001/37/EC directive has provisions to respond to emerging scientific understanding. It would be better to use a similar approach in the new directive to address novel nicotine products rather than rush to an ill-conceived and counter-productive regulatory intervention at this stage.
4. Publish the scientific and legal analysis underpinning the directive. Anyone should be able to see the advice on which credibility, lawfulness and expected health impact of the draft directive is based. This sort of transparency and openness to scrutiny is central to building citizen confidence in decision making and strengthening official accountability in the European Union.
5. Commission an assessment of the tobacco harm reduction potential for European public health. As the newly appointed Commissioner, you should expect high quality advice free from ideology and instinctive defence of past positions. You should insist on a better assessment of the potential for harm reduction strategies in tobacco control and then reorientate the underlying philosophy of European tobacco policy to embrace this approach if you are convinced. I believe you would be.
Your role has great responsibilities, with consequences measured in countless lives and much potential suffering. I hope the advice and links I have provided will help you to shape internal market policy for tobacco in a pro-health direction by encouraging competition for low risk alternatives to the dominance of cigarettes. I would welcome your views on these important issues, and I would like to request a meeting with you and your officials to discuss this issue in person, and to respond to concerns or objections you may have.
[Signed: Clive Bates]
Disclosure. I have no conflicting interests, in particular no financial or material links with the tobacco industry, nicotine device industry or pharmaceutical industry, or their agents. I am writing in a personal capacity.