E-cigarettes represent an amazing market-based, user-driven public health insurgency. From nowhere to €500m in Europe, the market is growing rapidly and already almost equals the market for NRT, according to the European Commission’s consultants (see chart and Matrix report p21). Without anyone in the professional public health field doing anything and without spending any public money, smokers have been quitting, switching and cutting down using e-cigarettes. Enter the regulators…
These new nicotine products deliver clean nicotine – without the tar, carbon monoxide and volatile hot gases of cigarettes – and as a way of taking nicotine they are pretty near harmless to health. For people who switch from cigarettes, they hugely reduce risk, while satisfying any need for the drug nicotine and some of the behavioural aspects of smoking. They also reduce passive smoking, irritation, smell, litter, fire risk… What’s not to like?
Could excessive regulation now put the brakes on these developments and even take these products off the market? Could the concerns of regulators end up harming or killing the very people they are meant to help?
The proposed updated Tobacco Products Directive (TPD) extends to regulating non-tobacco ‘nicotine containing products’ (NCPs), including e-cigarettes. It would do this by classifying the vast majority of these products as medicines. At one extreme, it could mean a de facto ban. At the other extreme, the regulators may take an enlightened ‘light touch’ approach, meaning that the regulation just provides some assurance about product safety and that the products are what they say they are. The former would be a dramatic public health failure, the latter could be a confidence-building benefit. But I fear the likely result of medicines regulation will be excessively restrictive. The lighter touch regulation is perfectly possible without resorting to medicines regulation and can be achieved by general consumer protection legislation.
Here’s my concerns…
Why medicines regulation for e-cigs? The proposed Tobacco Products Directive (Article 18) would place virtually all e-cigarettes capable of substituting for cigarette smoking under the framework for medicines regulation by applying Directive 2001/83/EC - the Community code relating to medicinal products for human use (‘medicines directive’ from now on). Though article 18 of the TPD sets a threshold, this is so low that that virtually all nicotine-containing e-cigarettes would exceed it, and hence come under the medicines directive.
Are e-cigarettes medicines? It simply isn’t the case that e-cigarettes are medicines – they are recreational consumer nicotine products, with superior characteristics to cigarettes that appeal to users. See my note: Are e-cigarettes medicines? for more on this. There are other things that have effects on the body that are a better parallel for e-cigs than medicines – for example alcoholic drink, high caffeine drinks, functional foods, cosmetics. Also, there is not need to define something as a medicine simply because it presents risks: thousands of products do – anything using mains electricity, heat, pressure or could be tampered with by children. Consumer protection regulation deals with all of these successfully.
What if e-cigarettes are regulated as medicines? The medicines directive, 2001/83/EC is a formidable text (over 170 pages), as you would expect given the important benefits and potentially serious risks of many medicines. Some key parts of the directive:
- Article 1 giving definitions used throughout the directive
- Article 6 which requires that any medicinal product must have a ‘marketing authorisation’ (ie permission to market the product) from a medicines regulator;
- Article 8 covering what evidence and information needs to be provided to support an application for an authorisation (notably clinical trials, justification of therapeutic effect and description of risk management system);
- Article 26 specifying the conditions that need to be met before an authorisation is granted (the benefits must outweigh the risks and there must be demonstration of ‘therapeutic efficacy’);
- Article 28-39 deal with the mutual recognition process (approval in other EU member states) – this is important because it may determine what happens if regulators in different EU states disagree
- Article 40-53 covering manufacturing and import – important in the existing e-cigarette market, given that manufacturers are largely Chinese and European firms are mostly distributors and wholesalers at this time;
- Article 54-69 covering detailed requirements for labelling and insert leaflets;
- Article 76-85 covering wholesaling, retailing and distance sales, including through the internet;
- Article 86-100 covering advertising, information and marketing practices;
- Article 101-108 the arrangements for surveillance, detection and response to adverse impacts (‘pharmacovigilance’).
What is the purpose of regulating e-cigarettes? Governments should start with the rationale for any regulation, if any, and then define a regulatory framework to suit the regulatory objectives. Reasons to regulate e-cigarettes and liquids might include:
- To ensure the product is safe – avoids sharp edges, electrical safety, choking hazards, poison risks, child tampering etc
- To ensure it is what it says it is – eg. that a 36mg/ml e-liquid has that concentration
- To ensure that it works – that it doesn’t break, fuse, and generally is fit for purpose
- To provide standardised consumer information and warnings where justified
… and what shouldn’t regulation do? Regulators do not have to ensure the product is a satisfying alternative to cigarette smoking or an effective smoking cessation aid, any more than they need to determine that low fat margarine is a satisfactory alternative to butter (it isn’t for me). Unless the e-cigarette maker makes a claim for some beneficial effect, there is no need for a regulator to become involved in determining its efficacy. Many smokers have found brands that work for them, and competition will sort out the reliable products from the rest – that is the normal default in any market.
What would good regulation look like? Good regulation would build confidence in safety and quality and allow effective communication of benefits. The means to do this already exist outside medicine regulation. Where a vendor wanted to make a therapeutic claim, and believed that to be in their interest, then medicines regulation could apply.
… and bad regulation? The danger is that a heavy duty regulatory regime could impose limitations on new nicotine products making them less attractive relative to cigarettes by limiting their appeal or availability, raising their cost and reducing innovation. Compliance burdens could wipe out or drive out a fledgling industry with no guarantee that larger firms would enter to replace them in every market. Excessive regulation would then have the perverse effect of reducing the temptation to switch and so maintain more tobacco smoking and more ill-health. Any regulator needs to consider this ‘killing through kindness’ effect in the risk-benefit analysis for regulatory controls on the products. Like all good analogies, this one has many fathers (from a comment by Dave):
…they would have the victims of a shipwreck avoid the lifeboats as they hadn’t been fully tested and then give the advice to those already in the lifeboats that they should leave them and swim, as this was the approved survival method
Here, at greater length, are ten possible downsides:
1. Evidence hurdles -the information to support a marketing authorisation is set out in Article 8 of the medicines directive. It requires some formidable compliance information, including the following in greatly abridged form (refer to the directive for the full text):
- Details of the medicine, therapeutic indications, contra-indications and adverse reactions
- Environmental impacts and mitigation
- Description of manufacturing process and certification of good manufacturing practice
- Results of pharmaceutical and pre-clinical tests, clinical trials
- Description of pharmacovigilance system and responsible persons
- The risk management plan describing the risk management system
- Mock up of packaging, warnings and leaflet
- …and more
On the question of trials evidence (see above), it is hard to know what evidence would be expected by a regulator approving an e-cigarette – especially as e-cigarette makers generally don’t make claims. However, a recent academic study [press release / paper] gives some idea of the evidence hurdles considered relevant, at least amongst some prominent members of the research community:
If credible evidence can be provided to regulators, through independently researched, well-controlled studies, that [electronic nicotine delivery systems] reduces the number of cigarette smokers and does not attract use among nonsmokers, then the net public health effect is likely to be positive.
Consider for a moment what sort of studies, and over what period, would be necessary to meet this requirement? Let me just say this: it would be extremely demanding and time-consuming to design and undertake controlled studies to do this. Yet they have implied this information would be provided to regulators – which means it would form part of an authorising process. Yet tobacco cigarettes are on the market without any need for evidence like this – in fact we have plenty of evidence that these do attract use among non-smokers! Amazingly, given the barriers the authors wish to erect, the study above shows that the impact on individuals from e-cigarette use has been very positive.
2. Compliance costs – the costs of securing marketing authorisation or ongoing compliance burdens could be excessive (eg. the directive describes pharmacovigilence obligations, requires manufacturing lines to be up to pharmaceutical ‘clean room’ standard, and would require extensive testing of the product). This could drive many existing companies out of business, raise costs to consumers or cause them to leave the EU market, or leave the field to the a few big companies reducing diversity and innovation, or simply protect the NRT manufacturers from competition from more effective products. The Nicorette Inhalator ‘Statement of Product Characteristics’ gives some idea of the information required. The demands on cigarette makers are far less.
3. Inadequate transition – there will not be adequate transitional time between entry into force of the Tobacco Products Directive and with it application of 2001/83/EC (medicines directive) – at the moment they happen at the same time. It is possible that the Tobacco Products Directive directive will enter force as early as 2013, and likely that it will enter force before European elections in May 2014. See discussion on timing here. A product classed as a medicine can’t be placed on the market unless it has a marketing authorisation. It is far from clear that all, many or any vendors will be able to comply in time and many products in use by smokers could come off the market.
4. Flavours, additives and design features – a danger that the regulators will prevent/limit the use of flavours or other product variants that make them attractive to smokers (perhaps on the basis that this makes them attractive to children and risks ‘abuse’). In fact, the health maximising approach would assist these product in being as attractive as possible relative to cigarettes – and that includes using attractive non-tobacco flavours (of which there are many). The proliferation of flavours reinforces the view that these are recreational consumer products, not smoking cessation aids or medicines. Note that the European Commission included a ban on flavourings in one of the options in its options appraisal (see option PO1 on page 77) and regards it as likely that flavours would be banned under medicines regulation:
In particular NCP with characterising flavours are unlikely to be authorised under the medicinal products’ legislation. (page 81)
However, flavourings are important ingredients in the success of e-cigarettes and in their appeal as an alternative to smokers. David Dorn, a vaper and commentator on vaping, says:
For many it could be disastrous – they’ve moved away from “ciggie” flavours onto any one of dozens, in some cases, or, in many cases, they switch flavours during the day to suit their moods… This, apparently, is to get away from their taste buds becoming used to one flavour, so that every change makes it a “fresh” experience and helps them avoid going back to fags. It’s not something that bothers me, particularly, but I do know that for a very large proportion of folks, it’s a vital part of the e-cig experience. Without it, going back to cigs isn’t too much of a stretch. Folks are worried about it. The thing about e-cigs is that they’re customisable in terms of flavour, nicotine strength, diluent (and therefore vapour density) and temperature – so anyone, given the chance, can sort out for themselves something that gives them a much more attractive experience in comparison with cigarettes, the consequences of which are pretty obvious, really.
5. Unattractive labelling, warnings and counter-productive information (not required for cigarettes). The labelling and presentation of the products will change and become medicalised. However, the users just do not see themselves as in treatment and resent being treated that way. They clearly distinguish between e-cigs and NRT, the danger is that these products start to look like NRT: that is, medical and sterile. Article 54-69 covering detailed requirements for extensive labelling and insert leaflets – you can get an idea from the ‘Patient Information Leaflet’ for the Nicorette Inhalator. The information that must be provided is far in excess of the bald but simplistic information required on cigarette packs – another significant regulatory imbalance.
6. Counter-productive marketing restrictions. The marketing of these products could be curtailed in ways that make the products less compelling to smokers – Article 86-99 cover advertising, information and marketing practices. With e-cigarettes forced into being defined as medicines, the directive would require them to be advertised as medicines (article 87):
2. All parts of the advertising of a medicinal product must comply with the particulars listed in the summary of product characteristics.
3. The advertising of a medicinal product — shall encourage the rational use of the medicinal product, by presenting it objectively and without exaggerating its properties [...]
That seems unlikely to capture the imagination of the many smokers not seeking treatment or defining themselves as patients.
7. Manufacturing standards. Another regulatory imbalance with cigarettes would be application of Good Manufacturing Practice (GMP) standards for pharmaceutical production – standards that are stricter than those required for food. This may reshape the market to domestic production by larger companies, or it may simply kill off the existing suppliers. Bearing in mind most of the exiting supply comes from China, what exactly do the regulators expect to happen? Some questions:
- Will Chinese or other non-EU manufacturers upgrade to comply or go elsewhere?
- Will low-cost non-pharmaceutical e-cigs be supplied in a black market or through internet sales?
- Will new high-spec manufacturers enter the market, and if so will they cover the whole EU and provide an adequate product range?
- What is the appropriate ‘hygiene’ standard for nicotine delivery when most is delivered in a matrix of toxic smoke and poisonous gases?
- Is this a technical barrier to trade, within the meaning of the Technical Barriers to Trade agreement of the WTO?
8. Mutual recognition and the role of other regulators. The UK regulator may take an ‘light touch’ approach (see its Q&A). But what if regulators elsewhere in Europe do not take such an enlightened view. The mutual recognition process, if applied, is more likely to take the regulation in a risk averse, more restrictive definition. If there are disputes, regulators try to forge a compromise, the Commission advises on what constitutes a serious public health risk. If that doesn’t resolve it, the matter is referred to the European Medicines Agency, which seeks an opinion from its Committee for Medical products for Human Use. In the light of that opinion, the European Commission makes a final decision. Articles 28-39 deal with the mutual recognition process – this is important because it could determine what happens if regulators in different EU states disagree.
9. Activism and legal action by threatened interests. Once covered by medicines regulation, it is possible that companies (or organisations) opposed to wider use of e-cigarettes on commercial or moralising grounds could use judicial review, or threat of judicial review, or other forms of advocacy to push regulators into more restrictive application of the regulations. Pharmaceutical companies have a commercial interest in NRT and may consider this threatened by the rise of e-cigarettes. The pharmaceutical companies’ responses to MHRA consultation on regulation on nicotine devices suggested they wanted regulation to be as risk averse as possible, raising many possible evidential hurdles (for example, see the GSK response at the end of this). Imperial Tobacco also demonstrated its hostility to e-cigarettes in its response, and groups like the European Respiratory Society have inexplicably hostile positions: “available research suggests that these products pose a significant health risk to citizens, placing them at continued high risk for disease and negative health outcomes”. The World Health Organisation has been especially short sighted. It has provided a ready-made hostile context in the shape of its recent paper on Electronic Nicotine Delivery Systems – including e-cigarettes (ENDS – see paras 33 onwards).
10. Market stagnation and death of innovation. The danger is that a laborious, time-consuming regulatory process will freeze the market with mediocre products, when what is really needed is innovation and excitement in this field. Remember the big picture – this is about people finding their way out of long-term smoking habits. Note this excellent comment by Vapers Nightly News on the evolving market and importance of hyper-customisation - the exact opposite of the medicines regulatory philosophy.
But will all these bad things actually happen? Some aspects of the directive do not allow for discretion, and some do. So we cannot tell at this stage how medicines regulation will work out in practice for this market. My main concern is that applying medicines regulation will open the door and provide leverage to all manner of prohibitionist and controlling instincts, of the type all too evident in the WHO document.
Are there potential benefits from medical regulation? Yes there are – and these could be important for some vendors in some circumstances, and may provide a framework that would encourage larger companies to enter the market. It could help to legitimise and build confidence in the products – some retailers may like this assurance and it may help health care professionals discuss the potential benefits of switching with smokers (an approach adopted in the draft NICE guidance on tobacco harm reduction). It may clear up some ambiguity about whether the products can be advertised on TV or used indoors, and so remove other counter-productive regulation. If (and only if) medicines regulation is applied in a sufficiently light touch way, these benefits might outweigh the costs and risks for some larger producers able to bear the compliance costs.
What’s the right thing to do?
So enough moaning about how bad it might be, what’s the way ahead?
A better way. The way to deal with this is not to close down the market for novel nicotine devices like e-cigarettes to only those that are approved medicines, but to have a two tier system. This would have a floor standard defined in the Tobacco Products Directive and general consumer legislation, with the option to opt in to medicines regulation for any vendor, if the benefits justify it. So that creates two tiers:
- A standard tier is subject to a ‘floor standard’, which is defined by the ordinary consumer safety protection and a labelling regime defined in the tobacco products directive (this is the approach taken to e-cigarettes below the threshold).
- A premium tier in which vendors opt in to medicine regulation. They would do that if they regard the advantages of a medicines marketing authorisation to outweigh the costs and wish to make a therapeutic ‘harm reduction’ claim. In time, some retailers may demand this standard, health care providers might only recommend products that have this authorisation, so the advantages could be considerable.
Note that the Tobacco Products Directive already creates a two-tier system – nicotine containing products below the threshold are regulated under standard consumer protection legislation augmented by some specific requirements of the proposed Tobacco Products Directive. NCPs above the threshold are regulated under the medicines directive. This proposes a different alignment of the two tiers.
Use the normal consumer protection framework. The first thing to recognise is that thousands of products are placed on the market in Europe and many have the potential to be dangerous, not to be fit for purpose, not to be as described and so on. But we have a general consumer protection regime that works. That is because there is a broad platform of consumer protection legislation, general obligations, specific directives, standards-setting bodies and enforcement regimes designed to protect consumers. It would be best to use this conventional approach to strike the right balancing between consumer protection and developing the market for these recreational alternatives to cigarettes.
The E-cigarette industry has already developed a strong voluntary standard, the Industry Standard of Excellence. This standard could form the basis of a mandatory code. It draws primarily on existing consumer protection regulation protects consumers from dangerous products of all kinds. Some examples of applicable regulation below:
|Regulation applicable to e-cigarettes (various UK jurisdictions)
Some examples of the regulatory tools available…
1. Safety. The EU’s general product safety framework already applies, including Directive 2001/95/EC (Article 1: “The purpose of this Directive is to ensure that products placed on the market are safe“). If more specific guidance is needed, then this could be included in the Tobacco Products Directive or through a Commission Decision made under Article 13 of the general product safety directive, as is the case for example, for the child safety of cigarette lighters (Commission Decision 2006/502/EC).
2. Labelling and packaging. There is already a substantial body of non-food labelling regulation applied by the EU. The proposed Tobacco Products Directive already applies a labelling regime for products that fall below the threshold.
3. Claims. If the claim is for a therapeutic effect or health benefit, then it could be appropriate to apply the medicines directive 2001/83/EC. This should be a matter for the vendor to decide. They shouldn’t be required to make a claim so that the claim they didn’t wish to make can be tested by a regulator using rules that make no sense to them. Simple provisions are applied in other legislation to test other claims, for example for cosmetics, Regulation EC 1223/2009 Article 20 states:
1. In the labelling, making available on the market and advertising of cosmetic products, text, names, trade marks, pictures and figurative or other signs shall not be used to imply that these products have characteristics or functions which they do not have.
4. Quality and fit for purpose. Does the product do what it is supposed to do? The Sale of Goods Act 1979 (s.13 and 14) provides the necessary consumer protections in UK law. As the Office of Fair Trading puts it:
The Act provides that any contract for the sale of goods will include implied terms that the goods are:
- of a satisfactory quality, that is of a standard that a reasonable person would consider to be satisfactory, free from fault or defect, fit for their usual purpose, of a reasonable appearance and finish, safe, and durable. The price paid is an important consideration as a reasonable consumer should not expect top quality at rock bottom prices,
- fit for the purpose, that is as well as being fit for the purpose for which they are generally sold, goods should also be fit for any specific or particular purpose made known at the time of the agreement. For example, if a consumer asks for a food mixer that beats, whisks, and kneads dough then the one the seller gives them should do all of those things,
- as described, that is the goods should correspond with any description applied to them whether this be verbally, through words and pictures on a sign, on packaging, or on an advertisement. For example, a pair of trousers described on the label as being “100 per cent pure cotton” should be just that
Trading standards services and OFT have the necessary enforcement powers.
5. Standards. At European level is is possible to develop specific product standards (often seen with a ‘CE marking‘). This is known as the New Approach (which has been around a while now). Under this approach, essential requirements such as safety and hygeine are drawn up in EU directives and then European standards bodies set out technical specifications to meet these essential requirements – many products are regulated through this system.
Lack of consultation on regulatory options so far is a weakness. It looks as though almost no attention has been paid to the health and commercial consequence of introducing a medicines regulatory framework, nor has there been proper consideration of alternative regulatory strategies. Given this could be part of a long end-game for cigarettes with a billion lives globally at stake in the present century, consultation has been very poor. The Commission’s 2010 consultation for the directive simply asked if novel nicotine products should come within the scope of the proposed new directive. It did not examine the implications of different regulatory approaches and there was no obvious consensus in the responses – see 6.1 on p9. It has not consulted on the options that it set out in the impact assessment for the TPD (see Commissison’s impact assessment: p52-53 and 77-83) and has not taken any views from those affected by these decisions.
How should the directive change to support the development of e-cigarettes as an alternative to smoking?
The overall change required is that these products should be regulated as recreational consumer products with cigarettes as their main comparator, not as medicines for ‘treatment’ of smoking with NRT as the main comparator. To do this, the TPD should be revised do six things differently with respect to NCPs (updated 9 March):
- Drop the requirement for mandatory medicine regulation, and allow this to become an opt-in for manufacturers who want to make a therapeutic claim or see commercial advantages in a medicines license;
- Remove the arbitrary and poorly specified threshold in TPD Article 18.1 – it is not necessary to have a threshold, or alternatively set this at a level that captures only very high strength mixing liquids (>75 mg/ml nicotine density);
- Re-assert the basic framework of European consumer protection applies, and refer to or restate these. Member states all have legislation and institutional capacity to address this need.
- As necessary, create a basis for a future light touch non-medicines regulatory regime, for example through a CE marking, Commission Decision or new regulation or directive specific to NCPs – the consumer protection tools exist outside medicines regulation;
- Add a meaningful mandatory label proportionate to the risk and encouraging smokers to switch;
- Design a proper transitional arrangement that will not destroy or drive away incumbents with no guarantee of adequate new entrants. The EU should not overburden small businesses with regulation where this is not necessary