Amending the Tobacco Products Directive

Amending the Tobacco Products Directive

The harm reduction agenda

This document focuses primarily on tobacco harm reduction. It is concerned with those parts of the proposed Tobacco Products Directive that regulate products that present substantially lower health risk than cigarettes. It does not discuss cigarette packaging, cigarette additives and labelling, distance selling or anti-fraud measures.

Introduction and summary

Reason to amend the proposal: the case for tobacco harm reduction

Scale of the challenge and trends

The WHO anticipates one billion premature deaths from tobacco on current trends would arise this century, and there are already 700,000 deaths per year in the EU. Tobacco use is widespread and growing around the world – there are approximately 1.45 billion smokers in the world today, and if current trends continue, that number is expected to increase to 1.6 billion by the year 2025. Despite years of action at all levels, 28% of EU citizens still smoke. But the European Commission's estimate of the impact of the proposed directive is that it will reduce consumption by just 2% (equivalent to about a half percent fall in smoking prevalence). That response lacks the ambition and the bold leadership needed to make deep and rapid inroads into one

Fast-acting health and welfare gains

The harm reduction approach addresses the health riskstothose who cannot or do not wish to give up using nicotine. The fastest way to address the health consequences of smoking is to decouple use of the drug nicotine from the poisonous smoke that is conventionally used to deliver it to the body. Nicotine itself is addictive, but has only minor direct health impacts - similar to caffeine. The illnesses associated with smoking are caused by inhalationofsmoke - hot gases and smouldering particlesofburning tobacco – deep into the lungs. Smokeless tobacco, e-cigarettes and future novel tobacco and nicotine products may provide a satisfying 'hit'ofnicotine, but without the toxic burdenofthe smoke and much lower health risks – 90-99% lower. Health and welfare benefits begin within days of a smoker switching to a lower risk product.

Significant flaws in the proposed Tobacco Products Directive

A flawed directive for both the single market and for health

The legal base for the directive makes it a measure to improve the functioning of the internal market, with the objectiveoffree movement of goods but ensuring a high levelofhealth protection. As both an internal market and a health measure, the Commission’s proposal is very poorly designed. It is important to recognise that the products regulated by the directive have very pronounced differences in risk to the user. Smokeless tobacco like Swedish snus is at least 90% less dangerous than smoking (probably 95-99%). E-cigarettes are likely to be around 99%) less dangerous. A credible internal market directive would promote competition between high-risk and low-risk products in a way that reflected the health advantagesofthe low-risk products. In fact the directive does the opposite: it adds disproportionate burdens, costs and restrictions to the lower risk products, and in effect shelters high-risk cigarettes from competition.

In all the main areas of harm reduction product policy, there are serious flaws in the Commission’s proposal. Each has the effect of providing competitive advantage to the cigarette category, and therefore increases harm.

1. Nicotine containing products

E-cigarettes and other non-tobacco nicotine containing products have astonishing potential to disrupt the business model of the established tobacco industry. But rather than encourage this, the directive subjects them to disproportionate and discriminatory regulation by misclassifying the vast majority as medicines, thus increasing costs and compliance burdens, imposing restrictions, and driving out innovation and potentially destroying the existing supply chains. The right approach is to draw on the highly developed body of existing consumer protection legislation and regulate them as consumer products, and only as medicines where the vendor claims the product is for the treatment or prevention of disease. See briefing: Amending the Tobacco Products Directive: E-cigarettes and Other Nicotine Containing Products.

2. Smokeless tobacco

Despite the obvious and large public health success of Sweden’s experience with smokeless tobacco, the least dangerous form of tobacco (oral tobacco or ‘snus’) is banned and a ban on characterising flavours in smokeless tobacco provides more competitive advantage to cigarettes. There is no case for such an arbitrary and counterproductive ban on any known scientific, ethical or legal grounds. The right approach is to lift the arbitrary ban on oral tobacco and regulate the toxicity of all smokeless tobacco products, as recommended by the WHO’s expert panel. See briefing: Amending the Tobacco Products Directive: Smokeless Tobacco.

3. Novel tobacco products

New products that would heat tobacco to vaporise nicotine, rather than burn it, hold out the prospect of very significantly lower risks than smoking. However, the Commission introduces the option of an ‘authorisation’ process for these, and the ENVI rapporteur would make authorisation mandatory. Neither can say what the authorisation criteria would be, and it is hard to imagine what they could be. So this simply opens up a promising harm reduction development to arbitrary decision-making, adds political risk and would achieve nothing. The right approach is to retain a notification system, but allow member states to withdraw novel tobacco products only if they believe them to be more dangerous than cigarettes. See briefing: Amending the Tobacco Products Directive: Novel Tobacco Products.

4. Combustible tobacco / cigarettes

For several decades cigarette emissions have been characterised by ‘yields’ measured by smoking machines using a standardised smoking regime. In fact, these yields provide no useful information on health risks because real people adjust their smoking patterns to get the nicotine they want. With the assistance of legislators, these numbers have for years mislead smokers about into believing ‘light’ products pose a lower risk to health. Elements of this system are inappropriately retained, but the main weakness is a failure to include any emissions standards that would be meaningful and useful. The right approach is to introduce standards that reduce toxic exposure rather than mislead consumers. See briefing: Amending the Tobacco Products Directive: Cigarette and Combustible Tobacco Emissions.

5. Coherent regulation of nicotine products

The proposed directive is a muddle of incoherent and counterproductive regulatory interventions, largely unsupported by evidence or principle. Most of the proposal weakens the harm reduction agenda, providing implicit competitive protection to the cigarette category and thereby likely to induce more harm than would otherwise be the case. A thorough review of nicotine regulatory policy is recommended. This is overdue and should have been done by the Commission before publishing the current proposal. See briefing: Amending the Tobacco Products Directive: Nicotine Regulation.

1. E-cigarettes and other nicotine containing products

Reason to amend the proposal

The proposal imposes disproportionate regulatory burdens on almost all e-cigarettes by wrongly classifying them as medicines, even though they are not remotely like medicines and are really consumer alternatives to cigarettes (see:Are e-cigarettes medicines?). The medicines regulatory regime set out in Directive 2001/83/EC will impose significance andcomplianceburdens, heavy costs and numerous barriers to innovation (see:Medicines regulation for e-cigarettes – when caution can kill) with no justification on health grounds. The growthofe-cigarettes has astonishing potential to erode the market for cigarettes and to meet the demand for nicotine with products that are likely to be two ordersofmagnitude (99%) less dangerous. One veteran Wall Street analyst, Bonnie Herzog of Wells Fargo Securities, predicts that e-cigarettes will overtake cigarettes in a decade. If that becomes even close to reality, millions of premature deaths would be avoided as a result. Yet it is likely that the directive would wipe out or drive out manyofthe innovative firms currently supplying these products to the EU – either limiting supply or opening up a black market. By imposing burdens on e-cigarettes that do not apply to cigarettes, this measure also provides discriminatory anti-competitive support to the cigarette market. It is also likely to be unlawful - four courts in the EU have struck down decisions by national medicines agencies to regulate e-cigarettes as medicines. It is likely that the Commission’s proposal will be overturned for being disproportionate, discriminatory, against the free movement of goods and proposed without adequate consultation or reasons.

How to amend the proposal

The main changes required are as follows:

1.  The thresholds defined in the existing article of no practical value and should be removed.

2.  The default approach should be to regulate e-cigarettes as consumer products, not medicines. The exception would be where a vendor wishes to claim implicitly or explicitly that the product is “for treating or preventing disease” (ie. it complies with the appropriate definition of a medicine). There is an extensive body ofexisting consumer protection legislation (the General Product Safety Directive etc) available to ensure that e-cigarettes are acceptably safe, work as intended, are properly described and fairly marketed. Additional safeguards can be added if necessary. They are not ‘unregulated’ products as some have claimed (see: E-cigarettes are unregulated, right?for a list of applicable EU law).

3.  The health warnings placed on these products should become health messages designed to communicate relative risk and to encourage smokers to switch.

4.  Finally, theCommission should be givena mandate to study and evaluate the regulatory arrangements and develop further proposals as appropriate. This could be contained within article 18 or become a new article depending on its terms of reference.

Proposed amendments

Article 18.1 – Nicotine Containing Products
Reason to amend: clarify application of medicines directive is required only when a health claim compatible with definition of a medicine is made
Commission proposal / Proposed amendment
1. The following nicotine-containing products may only be placed on the market if they were authorised pursuant to Directive 2001/83/EC:
(a) products with a nicotine level exceeding 2 mg per unit, or
(b) products with a nicotine concentration exceeding 4 mg per ml or
(c) products whose intended use results in a mean maximum peak plasma concentration exceeding 4 ng of nicotine per ml. / 1. (a) If nicotine containing products are presented as having properties for treating or preventing disease in human beings, other than through any message specified in paragraph 3, they may only be placed on the market if they were authorised pursuant to Directive 2001/83/EC.
(b) This Directive shall not apply to nicotine containing products authorised pursuant to Directive 2001/83/EC
(c) For nicotine containing products where 1.(a) does not apply, the products may be placed on the market if they comply with this Directive
Justification:
·  1(a) makes a medicines marketing authorisation mandatory if a health claim is made using strictly the definition in the medicines directive: ‘presented as having properties for treating or presenting disease’ is quoted from the first part of the medicines directive definition of a medicine 2001/83/EC Article 1.2(a). This wording is also intended to prevent member states requiring a marketing authorisation where no health claim is made.
·  It is possible that the mandatory message (para 3) on an NCP package may evolve (as proposed) to provide an officially sanctioned health claim relative to cigarettes, so this wording exempts any health message mandated by this directive from the requirement for a medicines marketing authorisation.
·  1(b) makes it clear that provisions of the directive do not also apply to NCPs regulated as medicines.
·  1(c) ensures that the TPD applies to all other NCPs, and limits the application of medicines regulation to those vendors making health claims consistent with the medicines regulation definition. It rules out member states classifying NCPs as medicines under Article 1.2(b) of 2001/83/EC – the ‘functional’ definition based on changes to physiology – an approach that has been repeatedly struck down in courts in Europe and clearly does not apply to the dominant nicotine product, cigarettes.
·  For NCPs where no health claim is made – those falling under 1(c), a floor standard is established though application of existing consumer protection legislation (see new clauses below).
·  Thresholds make no sense as the products above and below still need to be regulated appropriately – the distinction between whether medicines regulation or consumer regulation is applied rests on whether a therapeutic health claim is made, not on an arbitrary threshold.
Article 18.1a (new) Regulation of nicotine containing products
Reason to amend: emphasise application of existing legislation to NCPs and require Member States to report on implementation
Commission proposal / Proposed amendment
a. Member states shall ensure that nicotine containing products comply with European Union consumer protection, safety and other relevant legislation in force.
b. No later than 12 months from entry into force of this Directive, each member state shall provide the Commission with a report on the measures it has taken to implement and enforce the legislation set out in [new Annex A] as it applies to nicotine containing products and the effectiveness of those measures.
Justification: Member states should apply the body of existing consumer and safety regulation to nicotine containing products. The requirement to report will mean a more systematic approach is taken, and will form the basis of a Commission review to be completed by April 2017
Annex A – Nicotine containing products applicable legislation (new annex)
Reason to amend: to list main legislation applicable to NCPs already
General safety
General Product Safety Directive 2001/95/EC
The RAPEX system - notification and alerts of dangerous products
Packaging and labelling
Dangerous Substances Directive 67/548/EEC
Dangerous Preparations Directive 99/45/EC
Classification, Labelling and Packaging of Substances and Mixtures - the CLP Regulation 1272/2008 applies from 2015.
Chemical safety
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation (EC) 1907/2006
Electrical safety
Low Voltage Directive 2006/95/EC
Electro-Magnetic Compatibility Directive 2004/108/EC
Restriction of Hazardous Substances (RoHS) Directive 2011/65/EU (where appropriate)
Waste Electrical and Electronic Equipment (WEEE) Directive 2012/19/EU
Batteries Directive 2006/66/EC
Weights and measures
Making-up by weight or by volume of certain prepackaged products - Directive 76/211/EEC