Amendments to achieve the maximum public health benefit from the Tobacco Product Directive

  MEPs on the European Parliament’s ENVI committee are about to consider 1,360 amendment proposals to the revision of the […]

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MEPs on the European Parliament’s ENVI committee are about to consider 1,360 amendment proposals to the revision of the Tobacco Products Directive.  I’ve written to them with suggestions on what to do and what not to do to get the best deal for consumers and public health.


Date: 29 May 2013

To: ENVI Committee MEPs

From: Clive Bates

This week  the ENVI committee begins consideration of 1,360 amendments (all in one merged PDF here) to the Commission’s proposed Tobacco Products Directive   The task is both formidable and fraught with danger. The lives of many thousands of real Europeans will be either enhanced, blighted or possibly ended by what is finally included in this directive. I have already suggested detailed amendments: so I write now to suggest guiding principles for those members genuinely trying to secure the maximum public health benefit from the directive.  The concept of ‘harm reduction’ is where the big public health gains can be made (or lost), and it has the support of many highly respected experts and advocates, despite what you may hear from noisy but misguided activists based in Brussels.  I will propose some guiding principles, followed by specific recommendations. This letter has been posted to the Counterfactual blog, where you see comments or comment yourself.

Guiding principles

1. Concentrate on lowering the death and disease.  With 700,000 smoking-related deaths annually in the EU and many more cases of disease and disability, what would be the fasting acting way of reducing the death toll? The answer is to reduce harm associated with continuing nicotine use in adults, but without having to rely on people giving up nicotine too. Total smoking/nicotine cessation is a much harder and slower process that leaves many who wish to quit continuing to smoke.    The critical issue in the directive is the encouragement of low-risk nicotine products that compete with cigarettes: these include e-cigarettes, smokeless tobacco and potential novel tobacco products. Everything else is secondary.

2. Consider the ethics.  What is the ethical basis for the EU intervening to prevent or obstruct a smoker having access to products that could potentially save his or her life?  Every barrier placed in the way of e-cigarettes, smokeless tobacco or novel tobacco products should be viewed in this light and with consequences for health.  The ban on snus has no ethical basis, especially given the thousands of deaths it has prevented in Sweden. Excessive restrictions on other low risk products are also unethical, promote ill-health and increase health inequalities.

3. Please try not to protect the cigarette industry. This is an unusual market. The dominant product, cigarettes, is very harmful and but its toxicity is barely regulated with only peripheral measures regarding additives and flavours etc.  Over-regulating the low-risk alternatives will protect the cigarette industry from competition and contribute to death and disease. That should worry every MEP proposing restrictions on these products in the name of health and safety.  Despite almost uniform opposition from the users of these products, a number of MEPs seem determined to regulate e-cigarettes as though they are medicines. If they wish to do that, they are doing valuable work for the cigarette industry – it cannot be stated more simply. I have set out this argument in detail as a critique of the rapporteur’s proposed amendments for a ‘simplified procedure’ for regulating e-cigarettes (amendment 1250): The road to hell is paved with good intentions… and poor amendments.   Many proposals pile regulatory burdens and costs onto the low risk alternatives to cigarettes. They help the cigarette makers and are actively harmful.

4. Respect the treaties and keep proposals within the law. Proposals should be judged against established legal principles in the EU and international treaties. These require that measures are not discriminatory or disproportionate and that they have a valid legal base. In this case the legal base relates to the development of the internal market with a high level of health protection. The burdens and costs imposed by regulation must be the minimum necessary to secure the public policy objectives. Where free movement of goods and services are to be restricted for health or other reasons there should be reasonable evidence-based cause.  Proposals should be subject to consultation and reasons given.  Many proposed amendments do not respect these principles of EU law-making, grant excessive discretion to the Commission, or allow member states to impose stricter controls that do not comply with the EU treaties

5. Protect young people by reducing adult smoking. It is a good objective to reduce the number of young people starting to smoke, though this will have no significant effect on the 700,000 smoking-related death toll for many decades. But it is far from straightforward: most younger people take it up because adults smoke and it is a rite of passage into adulthood. Many measures to protect children simply reaffirm the image of smoking as adult habit and so make it more attractive to young people. The most effective approach to youth smoking is to reduce the adult smoking population as rapidly as possible. Low risk alternatives to cigarettes are the fastest way to do this and pose minimal risk to young people.  Harm reduction strategies provide gateways out of smoking, not gateways in.

Specific recommendations

E-cigarettes and other nicotine containing products (article 18)

E-cigarettes have emerged as a rapidly growing low-risk alternative to smoking cigarettes, but rather than encourage this development to proceed as fast as possible, many lobbyists are exaggerating risks, pretending little is known, and calling for excessive regulation.  This has more to do with prohibitionist instincts that genuine concern for public health.

1. Only regulate of e-cigarettes as medicines at EU level where a health claim consistent with the definition of a medicine is made – they are not medicines (eg amendment 1150)

2. Do not allow the regulation of e-cigarettes as medicines by member states, unless a  health claim is made – this is intended to be a harmonising internal market directive (eg. 1167)

3. Do not support prohibition by default – ie. an authorisation process – as no such process applies to cigarettes. Allow e-cigarette products onto the market unless there is a case to remove or restrict them. (Reject 1250 and support amendments 1167, 1168 and 1360)

4. Call on the extensive body of existing consumer protection legislation to ensure e-cigarettes are sufficiently safe, safely packaged, work properly and are marketed fairly (eg. amendments 199, 1168 and 1360)

5. Where necessary add provisions to create specific standards (purity of e-liquids) or information (labelling) to e-cigarettes (eg. 1229, 1233).

6.  Require member states to report on their regulatory activity and enforcement regime (eg. 1169)

7. Require the Commission to undertake a thorough regulatory review covering the full continuum of nicotine products and to come back with with coherent proposals that have been properly assessed and consulted on, with a credible impact assessment – with the aim of minimising harm to health. (eg. 1218, 1248, 1249)

8. Add a three year lead in date to any new significant regulation of e-cigarettes. (eg. 1329 & 1334)

9. Do not agree to measures that would reduce the attractiveness of these products relative to smoking… for example banning flavours, restricting where they can be sold, limiting marketing and branding (Reject 1250).

10. Drop the Commission’s proposal to have a threshold for nicotine liquids and regulate all liquids as consumer products, drawing on existing directives to require safe packaging and labelling. Many MEPs have recognised the absurdity of the Commission proposal (eg. 1156)

11. It would be better to do nothing and simply withdraw e-cigarettes from the directive than to impose ill-considered excessive regulatory burdens. The rapporteur is right to reject the Commission’s proposal, but wrong to try to draw up a new regulatory framework as a set of amendments, without consultation, without an impact assessment, without options appraisal and based on poor understanding of a rapidly evolving technology (Reject amendment 1250)

Smokeless tobacco (article 15)

Snus use is around 95-99% less dangerous than smoking. Despite the success of snus in Sweden in reducing smoking prevalence to the lowest rates by far in Europe (13% vs average of 28%), it remains banned outside Sweden. The Commission wishes to continue this, but has no credible rationale and is legally exposed.  Looking at all the available evidence, there is no scientific, ethical or legal justification for the ban.

1. Remove the arbitrary and unjustified ban on oral tobacco (eg. 250) and replace this with regulation of smokeless ingredients to reduce toxicity of all smokeless tobacco products on sale in the EU (eg. 1024, 1027 and 1359). This is in line with proposals by the WHO’s expert advisers, Royal College of Physicians and others.

2. Do not agree to measures that would reduce the attractiveness of these products relative to smoking… for example banning flavours (eg. 461, 476). Flavours are much more important in smokeless tobacco than in cigarettes.

3. Be realistic about relative risks when labelling these products – Europeans deserve information that is true and in context (eg, 799)

4. If it proves impossible to lift the ban, then at least allow each member state to decide if it will opt-in to the ban providing it can be justified on health grounds and is therefore consistent with the legal base Art 114 (eg. 1023).

5. Do not put the significant public health gains from smokeless tobacco in Sweden at risk by imposing ill-considered measures on snus in the face of opposition from the Swedish government.  If Sweden has an opt out, leave it to Sweden (eg. 172, 1026)

Novel tobacco products

Novel tobacco products – using heat rather than burning to extract nicotine from tobacco – could greatly reduce risk and appeal to smokers in large numbers.  It would be perverse to place barriers to bringing these products to market, when anyone can put new cigarettes on the market at any time.

1. Do not create a default prohibition of these products by requiring an authorisation process (Eg. Reject amendment 10, 16, 48, 49, 50, 51, 53).  No such process applies to cigarettes, so why to safer products? An authorisation process with no authorisation criteria has no value and creates arbitrary regulatory risks – it is certainly not consistent with the single market.

2. Establish that the only grounds for preventing access of a novel tobacco product to the internal market is if there are reasonable grounds to believe it is more dangerous than cigarettes or other combustible tobacco products. This is unlikely ever to be the case.

3. Maintain a notification requirement as in the Commission proposal

I hope you find these suggestions and insights useful, and that you will help secure a directive with a high positive impact for public health.

Yours sincerely

Clive Bates
London, UK

Disclosure: I have no competing interests. I am former director of UK-based Action on Smoking and Health (1997-2003) and a former civil servant (2003-2012). I now run a small consulting company and the Counterfactual blog. Views expressed here do not necessarily represent views of any former employers.

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10 thoughts on “Amendments to achieve the maximum public health benefit from the Tobacco Product Directive”

  1. Vince Wooll

    Dear Clive,

    Please accept my heartfelt thanks for the ongoing effort you’re making on this subject. I agree 100% with what you’re saying.

    I am not involved in the ecig industry at all, except as a user of ecigs who’s now managed 6 months without smoking tobacco and who’s converted several other people to ecigs. I haven’t felt this good since my teens (and that was a looong time ago).

  2. Gordon Beard

    An excellent analysis and MEP crib sheet , as above many thanks for your continued efforts on this topic .

  3. Thank you very much for all of your time and effort to help people that use e-cigarettes.

    I smoked for 45 years and tried every NRT product available, none of them worked. I continued to smoke even though my health was getting worse, resulting in COPD and using oxygen daily.

    September 2011 I discovered e-cigarettes and they worked. It was like someone handed me a miracle. In less than a week I stopped using regular cigarettes. I haven’t had a tobacco cigarette since.

    I wish the MP’s and MEP’s would understand how much e-cigarettes have helped thousands of people just like me.

  4. Pingback: Directive sur les produits du tabac : Amendements pour maximiser les gains en matière de santé publique | Avis sur la cigarette électronique

  5. Thank you for reading through the amendments in such detail. I think, however, that you’ve made a mistake about amendment 1156. You say:

    “10. Drop the Commission’s proposal to have a threshold for nicotine liquids and regulate all liquids as consumer products, drawing on existing directives to require safe packaging and labelling. Many MEPs have recognised the absurdity of the Commission proposal (eg. 1156)”

    I can’t claim to follow the logicical outcome of the proposed amendment 1156, but the justification seems to be aimed at classifying ALL nicotine products as pharmaceuticals:

    “The only justification for allowing the marketing of nicotine containing products (NCPs) is for cessation purposes. It is very difficult to assess the nicotine delivery of NCPs. An intensive use of NCPs with a low level of nicotine could still lead to significant nicotine intake. It is
    thus appropriate to subject all NCPs to pharmaceutical legislation. This would ensure the quality, safety and efficacy of NCPs, as well as a
    level playing field for all nicotine containing products”.

    Your interpretation of this amendment is important to me (so do tell me if I’ve misunderstood), because one of its sponsors is one of my MEPs who I’m writing to!

    1. Clive Bates

      Hi there – thanks for this. I was trying to illustrate that even the people who favour medicines regulation think that the threshold approach dreamt up by the Commission doesn’t make sense. So I wasn’t endorsing this amendment, more pointing out that it highlights how little support there is for the Commission’s proposal.

      1. Hi

        Many thanks – that’s clear now that you’re not recommending we support 1156. I was particularly struck by the opening sentence “The only justification for allowing NCPs is for cessation purposes”, since that’s the polar opposite to my view!

  6. Pingback: Tobacco products directive, e-cigarettes & snus – an update « The counterfactual

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