The case for regulating e-cigarettes as medicines – a line by line examination

4 October

Dear colleagues,

Next week you will be asked to vote on electronic cigarettes as part of the Tobacco Directive.

We all agree that e-cigarettes have the potential to help smokers quit smoking, and save lives. The question is how should they be regulated? There are two options on the table: a light-touch medicines framework (amendment 71), and a tobacco framework (amendment 170).

Comment: Amendment 71 does not provide for a ‘light touch’ framework. It provides for medicines regulation and authorisation under the medicines directive 2001/83/EC. The TPD cannot modify that directive or change the way it is applied. No clinical trials for drug efficacy are necessary given that nicotine is a widely used drug, but that is true under any other regime and it certainly does not make medicines licensing ‘light touch’.  The burdens associated with regulating these products as medicines are formidable.  They do not simply provide a quality mark for the producers and products on the market today. They will create a ham-fisted and damaging restructuring of this market. Medicines regulation will create costs and burdens that will put most producers out of business, take most products off the market, slow innovation and weaken the competitiveness of these products relative to cigarettes.  Professor Gerry Stimson and I examined the issues in our report: Costs and Burdens of Medicines Regulation for E-cigarettes, which I attach.  I hope you will at least read the summary of this and come to your own view of how ‘light touch’ medicines regulation would be in reality.

Why we support medicines regulation 

·     National governments want to regulate e-cigarettes as medicines – in the same way as nicotine gums and patches.

 Comment: The appropriate comparator is not nicotine gum and patches.  These NRT products are classed as medicines and used for treating nicotine withdrawal while a person quits smoking and nicotine use.  It should be obvious that e-cigarettes are highly competitive alternatives to cigarettes, and used as low risk-way of taking recreational nicotine. The huge health benefit that arises from the switch from cigarettes to e-cigarettes is the great public health prize – but it comes from persuading smokers that e-cigarettes are a better way to take nicotine than smoking, not that e-cigarettes are are better way of quitting than using NRT.   Given that the vast majority of nicotine consumed in Europe is delivered in tobacco smoke,  a toxic aerosol of smouldering tar particles and hot gases, it is absurd to require hugely expensive exacting standards for their most effective competitors that go far beyond what is necessary to safeguard a smoker choosing these alternatives. The European Parliament is a distinct part of the legislature directly representing voters – member state governments are represented in the Council.

·      Medicines regulation is not “over-regulation”. We are talking about “light touch” medicines regulation – as nicotine is a well-known substance like paracetamol and aspirin. This means no expensive clinical trials. Manufacturers just have to prove quality and safety. 

Comment:  the main costs are not in clinical trials for this type of drug – this is a distraction.  The main costs are in: wholesale replacement of the manufacturing supply chain (not possible for most companies);  the unnecessary design changes required to make an e-cigarette a medical drug delivery system; the enforced requirement for suppliers to adopt a pharmaceutical company business model for IT, process controls, and qualified personnel;  the costs of licensing hundreds of flavour and strength combination; unnecessary pharmacokinetic and pharmacodynamic testing as a proxy for customer satisfaction (which should be a matter for consumer preferences); and a risk management and surveillance system, which is unnecessary and not applied to much riskier products.  None of these costs fall on tobacco companies marketing cigarettes.

·     We want to encourage good products which are safe and effective. There are many poor quality products on the market, which do not help people quit smoking. Also, just because smoking is so much more harmful doesn’t mean we shouldn’t set safety standards for e-cigarettes to ensure they don’t contain carcinogenic and other toxic substances.

Comment:  it is possible to set standards for e-cigarettes to cover residual contaminants (which are in practice extremely low). There are perfectly good legislative routes available if standards are necessary – and these offer a better approach to internal market harmonisation than medicines regulation.  In fact, when the Commission consulted on revising the TPD in 2010, it proposed to do exactly that.  It asked for views on the following proposal: an extension of the scope of the Directive could be envisaged to include novel forms of oral tobacco, herbal cigarettes, and electronic nicotine delivery systems, insofar as they are not already covered by other EU legislation (food, pharmaceutical). Specific safety and quality requirements would be developed for ENDS. (emphasis added).  It would be better for the Parliament to be pressing for this framework to be reinstated.  As an aside, it is worth noting the the Commission has never consulted on the proposal to force e-cigarettes into a medicines regulatory framework.

·     Long-term safety would be monitored – little is known about long-term effects.

Comment: surveillance is worthwhile but better conducted at the level of the whole market and as an independent scientific exercise, outside the licensing process.  ‘Surveillance’ for medicines safety is focussed on detecting adverse reactions emerging in large populations following prolonged use, for example the emerging signs of neuropsychiatric events (such as suicidal impulses) in the licensed smoking cessation drug Varenicline.  No such issues arise with nicotine use.  Of course ‘little is known about long-term effects’ now, but just by looking at what is in these products we can have some confidence they will not be serious, even if not zero or even negligible.

·     It is up to Member States where e-cigarettes could be sold. 18 countries already allow some medicines to be sold outside pharmacies – e.g. in corner shops, supermarkets and petrol stations. The other countries have the opportunity to amend their national law when they transpose the Tobacco Directive.

Comment: This refers to a significant issue with medicines licensing – that in many countries (in fact, those with the largest populations other than the UK) medicines are only available in pharmacies.  Among the 18 referred to here not all have ‘general sales’.  So the application of the TPD will significantly reduce the places and times at which most people in Europe would be able to access e-cigarettes compared to cigarettes.  It is simply wishful thinking that member states will adjust their medicines legislation to accommodate a single new products.

·     Flavourings would be allowed. There are already nicotine gums and inhalers on the market in different flavours. But flavourings which are clearly aimed at kids, like bubble-gum and ice-cream would probably not be approved by regulators…

Comment: This is highly misleading.  Flavours would be allowed if approved, but the approval process would be immensely costly and burdensome, and it would not be economic or possible for most flavours provided by most companies.  It amounts to a de facto ban on most flavours.  In fact, there are only a very small number of flavours that are approved for use in inhaled products (eg. asthma inhalers) in the European Pharmacopeia, yet there are hundreds of flavours on the e-cigarette market and these are intrinsic to the appeal to smokers.  Of course the concept of a medicine coming in 200 flavour varieties is absurd and medicines regulation is not set up to cope with that. But this is a good illustration of why e-cigarettes are not medicines.

·     Advertising would be allowed. But regulators would be able to control advertising to make sure it is only aimed at smokers.  

Comment: This can be addressed without medicines regulations – for example using the approach taken for alcohol advertising. We should also recall that e-cigarettes cause very little harm and the case for curtailing advertising beyond protecting children is weak. In the UK, medicines regulation would mean advertisements for e-cigarettes would have to be approved by a pharmaceutical industry interest group, with obvious conflicts of interest.

·     Companies would not be able to market e-cigarettes as a fun, recreational product. This is important as tobacco companies are already moving into the e-cigarettes market.

Comment: This illustrates perfectly the misunderstandings behind the proposal to regulate these products as medicines.  The health benefit of the these products arises from their appeal to smokers as an enjoyable alternative to smoking.  Perfectly safe, bland products with insipid branding and dull marketing are unlikely to appeal to many smokers. in this situation, risk averse regulation simply favours the much more dangerous product.

·     The e-cigarette market has the potential to grow so much more. We need a regulatory framework that protects public health first and foremost and makes sure only products which are safe and effective reach the market.

Comment: The proposal to regulate as medicines will smother an emerging disruptive industry in red tape and retard its development as an alternative to cigarettes, while most likely concentrating ownership into the hands of the tobacco companies. Many of those supporting medicines regulation see it as a way of suppressing rather than growing this important new market. The mostly like effect is to protect cigarettes and to gift control of the e-cigarette market to pharmaceutical affiliates of tobacco companies.

Problems with the ECR, EPP and ALDE amendments on e-cigs (tobacco framework)

Comment: Amendment 170 is not regulating e-cigarettes as tobacco, though it draws on aspects of tobacco regulation.

·     This is weaker regulation which puts the burden on authorities to identify sub-standard products and remove them – rather than on companies to prove their products work before they put them on the market.

Comment: There is nothing wrong with this – it is the way regulation works for almost everything.  In fact the Commission and Council positions allow low-risk nicotine products to be placed on the market through a notification process, if they contain tobacco (Article 17).  For cigarettes there is even less to stop a new product: merely some easy and long established but misleading yield standards to be met (Article 3 & 4).

·     There would be a total ban on advertising. It does not make sense to ban the advertising of products that have the potential to improve public health.

Comment: This is an excessively restrictive and I believe the intention is to signal some limits on advertising, most of which should properly be the responsibility of member states.  Suitable wording that meets the concern expressed here could easily be agreed in the negotiations with the Council and Commission that would follow agreement to amendment 170.  Amendment 170 also keeps open the option of having products regulated as medicines – it simply requires the vendor to make a claim.

·     Governments may be tempted to tax e-cigarettes like cigarettes. France and Italy are already considering this. This could add up to 80% to the price. On the other hand, some countries have a special low VAT rate for medicines.

 Comment: Member state governments determine their tax base and VAT regime within some limits set by EU law.  If they wish to tax these products to recover lost tobacco tax revenue that is a matter for them and their taxpayers and their views of the how valuable e-cigarettes are as a public health strategy, it not something the Parliament can or should try to prevent.

Issues not discussed in this letter

1. Legality.  That the medicines approach is highly vulnerable to legal challenge. The JURI committee’s opinion found it to be unlawful. The medicines classification has been struck down in five courts in members states based on EU law and jurisprudence. Counsel’s opinion for a trade body demonstrated a sound legal rationale for challenging the measure as disproportionate. It helps no-one for the European legislature to proceed undaunted by legal advice.

2. User views. The voices of thousands of users who strongly oppose these proposals have been ignored and even dismissed, even though the users are supposed to be beneficiaries or regulation. This conflicts with all good practice in public health.

3. Innovation.  No insights at all into what medicines regulation would do to the pace and quality of innovation. Pharmaceutical innovation follows a long cycle of drug discovery, approval and then 10-15 years patent-protected monopoly. Generics do not, by definition, involve much innovation. E-cigarettes in contrast are more like ‘tech’ gadgets – with products refreshed every 8-12 months and a frenetic pace of innovation driven by consumer pressures.

4. Consultation. There has been no formal or meaningful consultation on medicines regulation with those affected. It was not proposed in the Commission’s 2010 consultation on the revision of the directive (see above) and the Commission has not found time to consult in the intervening two years.

5. Alternative approaches. The absence of any consideration of alternative forms of regulation that could be developed post-2014. The regulation of this category should be purpose-built and fit for purpose – not tobacco or medicines, but and appropriate light touch ‘enabling’ framework for nicotine containing products.

6. Small business impact. No meaningful assessment of the impact on thousands of small businesses now operating in this new industry throughout the EU

7. Problem definition. No coherent definition of the problem that highly expensive and burdensome regulation is supposed to address. In fact, the market is functioning very well, growing rapidly and appears to winning over thousands of smokers and decreasing cigarettes consumption.

8. Unintended support for smoking. The extent to which these proposals protect the cigarette market from competition and so support the tobacco oligopoly. The perverse consequences arising from these proposals will be exactly what MEPs on all sides wish to avoid – more smoking than there would otherwise be.

9. Black market. There is no recognition that users will not be passive takers of bad policy harmful to their health. Black market trade, home mixing and brewing – with increased danger to health and rising criminality- are the likely result of medicines regulation.

10. Oral tobacco. The letter ought to cover harm reduction more broadly – not least by explaining why oral tobacco (snus) should be banned when it is largely responsible for the greatest tobacco and health success in Europe: the low rate of smoking in Sweden (13%) compared to the EU (28%).

In reality snus should be treated as any other smokeless tobacco, but the rapporteur has refused to consider anything but continuing the ban, regardless of the huge weight of contrary evidence showing it is protective to health and functions as an alternative to smoking and aid to quitting. As a very minimum please support amendments 131 and 134 (very similar) that would allow oral tobacco to be authorised where it has been used traditionally.

I hope you find these views useful as you prepare for the debate and vote.

Yours sincerely