E-Cigarette Summit - Prof. JF Etter
Chair: So our final speaker this morning, it gives me great pleasure to introduce Professor Jean Francois Etter who is Professor of Public Health at the University of Geneva who is also talking about the regulation of e-cigarettes. Thank you.
Prof. Etter: Good morning, ladies and gentlemen, and thank you to the organiser for inviting me today.
This is my disclosure slide. I have no conflicts of interest with the tobacco and pharmaceutical industry and the e-cigarette industry paid for our plane tickets and a few hotel nights to visit them in China and also to meet in London.
I’ll speak about how e-cigs should be regulated. Briefly coming back to how they are regulated today and then about future regulation if there’s tobacco products, medications or consumer products or a specific category. To start with, a summary of the evidence that has been presented to you as I understand it.
Ecigs are used currently by smokers, either current or former smokers as they’re cheaper and safer than tobacco. Most of the users report that e-cigs helped them quit smoking. There are only three studies published in peer review journals that looked at whether non-smokers used e-cigarettes regularly and none of these studies showed daily or regular use in non-smokers. It’s true that there is experimentation at increasing rates in kids but no regular use is documented for the moment. It doesn’t mean that it’s not going to occur in the future but for the moment it doesn’t occur.And e-cigs are probably much less addictive than cigarettes and you’ve been presented much of the data on toxicity this morning.
The aims of a regulation in my perspective is first to decrease the number of cases of disease and death which are caused mainly by smoked tobacco, not just tobacco but smoked tobacco, and also I think that protecting the freedom of choice of citizens is something important, it shouldn't be limited without a good reason. And regulation should govern not just e-cigs but also next generation products that will come up in the future.
Around the world e-cigs are regulated currently as consumer products or tobacco products are seldom regulated as medicine, and the upcoming EU and FDA regulations will be extraordinarily important and influential I think, and once written these laws I think will be hard to change, they will be influential worldwide, so it’s quite important to follow these things. And there’s no reason to expect that regulation will be the same in each country, on the contrary I think regulations will differ country by country because they will depend on local things like the stage of the tobacco epidemic, the history of tobacco regulation, the political process, the weight of lobbies and the state of develop of the e-cig market.
In the US currently ecigarettes are largely unregulated at the federal level, it doesn’t mean that they are unregulated completely because there are many states and countries which regulate like vaping in public places or sales to minors. A court decision barred the FDA from regulating e-cigarettes as drugs and the FDA will come out this month of November in the next days with what they call the deeming regulation, the proposal is probably going to cover advertising to minors, sales to minors, general advertising. Will they ban flavours? Will they ban internet sales? Will they require a probation for new products? We’ll see. It’s going to be very important.
In the UK the process has been described to you. The MHRA was interested with this file. After public consultation it announced that e-cigarettes will be regulated as medicine with a light touch regulation. I don’t think there is such thing as a light touch regulation, medicines regulation is not light touch at all. The UK wants to set an example for the rest of Europe but it’s also important to distinguish the UK and US markets from the rest of Europe. You don’t have such a well-developed OTC market in Europe. In continental Europe medicines are sold in pharmacies mainly, it’s not like in the UK, so it’s very different and the UK regulations cannot apply to the rest of Europe. And also by asking MHRA rather than any other agency to come up with e-cigarette regulations one could not expect any other outcome I think, from the beginning.
In the European Union the votes against the amendment 170 was quite close actually, only 51 votes above the threshold it was required to pass, so it was quite unexpected and the result I think of intensive lobbying from the vapours and the e-cigarette industry. A few months before the vote I think no-one expected this outcome. Currently you’ve been explained that there’s a trialog going on, but the Council and the Commission are in favour of the medicines regulation and many member states also want title regulation that the current EU proposal, so the final outcome is not decided yet.
I think that as a general rule governments and parliaments are excessively responsive to special interest rather than to the general interest and almost any regulation that will come out at the end probably will favour those who are best at lobbying, most experiences, like big tobacco and big pharmacists if they step in, and detrimental to those who invented the product, those who are most innovative and come out every week with new products, I mean the Chinese inventors and manufacturers. And even before these regulations have been drafted a financial analyst will follow them very closely. I’ve already said that future regulations will probably be favourable to big tobacco, in particular because they have the best expertise to evolve in a regulated environment, they have lots of money, they also have a list of customers, mandatory shelf-space in shops, so they have bigger sales.
Currently nicotine is regulated in a way that I think for public health is a disaster. It’s only available in smoked tobacco in many countries, in most continental Europe countries smokeless is banned, or in medications, in patches and gums. So the most deadly product is cheap and available everywhere. Nicotine replacement therapy works, it’s not that it doesn’t work, it does work, but in the long-term after several years the impact, the difference in quit rates between people who receive nicotine patches or gums and those who receive a placebo is only a few percentage points, so these breaks are not very appealing, they have not been very innovative also, and they are affected by that very much. So the success of e-cigarettes challenges this approach, the regulation of nicotine needs to be changed, the question is how.
Is it a good idea to regulate it as a tobacco product with things like bans in public places, restrictions on advertisement, sales, restrictions to minors, etc?
They are regulated as tobacco products in some countries, even though they do not contain tobacco. Nicotine is extracted from tobacco but they do not contain tobacco, so it’s not very logical. I think that current measures to control tobacco are excessive. They are disproportionate. Bans of vaping in public places, I think, would require much stronger evidence that passive vaping is toxic. We have not spoken much about passive vaping, but I think we would need much stronger evidence that it is toxic before prohibiting vaping in public places, and also we would need evidence that vaping in public places encourages smoking. It’s more likely to think that it will encourage vaping, not smoking. Advertising bans also would require stronger evidence that e-cigs are toxic. As I said, there’s no evidence for the moment that non-smokers become regular vapers and also consumers have a right to be informed by advertisements. Some restrictions to minors, everyone seems to agree on that, but it’s not that straightforward, I think, because minors currently who use nicotine or plan to use nicotine have no other choice but to smoke in many countries, so providing them an alternative way of getting nicotine is perhaps a controversial idea, but one that need not be rejected without thinking. Minors can buy nicotine gums and patches at least if they are above sixteen. Doctors can prescribe gums to minors, and if e-cigs protect adults against smoking, why wouldn’t they protect children against smoking? So these things need to be thought about a little bit more deeply than just rejecting, agreeing that e-cigs should be banned from minors.
Regulation as medicines, covering things like efficacy, safety, quality requirements, stability of the product and the protection of young consumers, well, I see a number of problems with this. I don’t mean that these problems are going to occur in every country. They may not occur here in the UK because you have a different approach to OTC regulation in particular than in many European countries, but still these things are not medicines. As long as there is no therapeutic claim they are not medicines so in countries where courts can verify the constitutionality of laws, these regulations will be discarded.
It occurred already, I think, in Germany. Mostly it creates an inequality with tobacco. You cannot expect one team to win the football match against the other team if you bind the legs of the first team. They should be able to compete with tobacco at least on equal terms. And also the cost associated with obtaining drug approval is very high. The application to have a product approved as a drug is 10,000 pages. A pile of paper almost up to the roof, 10,000 pages, it’s huge, and so only large companies will survive in this environment. I think big tobacco and big pharmaceuticals will step in. So many products and most innovative ones, perhaps, many manufacturers and retailers will disappear, in particular Chinese ones.
Another problem with medicines regulation is that I do think it will kill innovation. Take nicotine gum and patches, they have been invented in the 1970s and 80s and have almost not evolved since then. Perhaps it’s the fault of the pharmaceutical industry but also it’s the fault of the regulation framework which makes it so costly to improve a product. Also if flavours are banned then e-cigs will be less attractive, and what do you do with the unlicensed products? They will not disappear by a miracle once you declare that e-cigs are medicines. These products and providers are here and they will not disappear from one day to the next, so these products will remain on the market, perhaps on the black market. Internet sales will continue in unlicensed products, and then you cannot have a mandatory quality control on an unlicensed product. You cannot tax it, and anyway have you thought about enforcement of this thing? Enforcement will be costly and ineffective. Will judges and policemen bother to take on people who use these products or import them? Enforcement will be impossible, I think, or very difficult, or not effective.
And also medicines regulation I think is contrary to constitutional free-market principles because it unnecessarily excludes a competitor. There’s a lack of popular support for medicines regulation, which in the long term may not be viable everywhere, and also it unduly protects big pharma, which have not been very innovative with the nicotine products. So the two main consequences of tobacco or medicines regulation, I think, are that there will be fewer e-users, because of higher costs and all the barriers that I mentioned. Fewer smokers will quit and more will die, and it may also give the entire e-cigarette market to the tobacco industry, because they are the only ones currently who are ready with products, who are almost ready to be approved. This is not a desirable outcome, I think.
There are other frameworks, like the regulations for consumer products. I don’t think it’s true that these things are unregulated. They are already regulated by a range of national laws and EU directives that apply to consumer products that are listed here. Thank you, Clive, for the content of this slide. So you already have a number of directives. You have the RAPEX system for alerts, directives on chemical safety, electrical safety, packaging, advertisement, data protection etc. So first I think we should apply and enforce existing laws and EU directives, the law for plenty of controls that are not done currently on e-cigarettes, and if this is not sufficient, and only if this is not sufficient, then we should create a specific category for nicotine-containing products, that is e-cig and next-generation products, with norms for these recreational nicotine products, for manufacturing components, advertisements, sales to minors etc, and this is not require regulation as medicines or tobacco.
I also think that we should create an earmarked tax for research, for independent research and for education of the public, of doctors, journalists, policy-makers etc, like the Tobacco Prevention Fund in Switzerland, for instance. Each smoker, when he buys a cigarette pack in Switzerland, pays two cents for the Tobacco Prevention Fund and this fund then pays for research and prevention projects. To conclude, e-cigs, I think, are a major innovation, a revolution in our field that has the potential to save many lives. For regulators, I think we should always keep in perspective the huge number of deaths and disease and misery caused by smoke tobacco, and, as Clive says, relative risk is relevant compared with cigarettes because these products are used by smokers, not absolute risk. They don’t need to be 100% safe, only much safer than cigarettes. Regulation as medicines or tobacco I think is disproportionate, and the prohibition of unlicensed products will not be feasible, neither is it desirable.
So the main danger for public health currently is excessive regulations not e-cigs, but excessive regulation is a great risk and danger for public health. So the current laws about nicotine cannot survive. They know nicotine only in tobacco which is deadly when smoked and it cannot be used otherwise in many countries and medication, so these laws need to change. The question is how, but they need to change to accommodate these very popular products and also next generation products. So I think that one of the most important public health debates in recent decades, really, since the debates in the 1980s and 90s about drug injections, etc, about drug policies that are now common but were not at that time, for those old enough to remember. I think that the debate about redefining the place of nicotine in society and in the law, and making room for recreational nicotine products, is really a key topic, even addictive ones or ones that result in compulsive use, because in the definition of addiction, you have two elements, compulsive use and harm for the user’s health or family life or social life. But the second element is largely lacking for e-cigarettes so we should speak of compulsive use.
But clearly our laws need to be changed to make room for recreational nicotine products, even if they are used compulsively, and this is, I think, one of the most important things we have debated in public health in recent decades. Thank you very much for your attention. [Applause]
Chair: Thank you very much, Jean Francois. Another very thoughtful presentation, and also giving us an overview on the European and international dimensions of regulation as well, which are incredibly important. We do have time for any questions, clarification for Jean Francois before we move into the open session, so I can see somebody with a hand up towards the back.
Rebecca Taylor: Hello, my name is Rebecca Taylor. I’m a Liberal Democrat Member of the European Parliament. As one of the people responsible for drafting…
Prof. Etter: Speak slowly because I’m not a native English speaker, so speak slowly and distinctively.
Rebecca Taylor: Sorry, Rebecca Taylor from the European Parliament, one of the people responsible for drafting Amendment 170. In defence to a number of criticisms, I agree with part of them, but politics is the art of the possible and we had to table an amendment that would actually be supported by the Parliament. For the Liberal group, the key point is that it’s not medicines regulation, other things are open to negotiations, we hope, and thank you very much for your presentation. I think your point that e-cigarettes are not really medicines and not really tobacco is the key issue. Thank you.
Prof. Etter: Thank you very much. Chair: Okay, one more question I think. [Applause] One more question before we go into the panel.
Tony Price: Tony Price, Volcano. I understand in Switzerland, which is from where I believe you come from, e-cigarettes are regulated as medicines or rather the liquid is, and you said once laws are in place they’re very difficult to overturn. Is it ever possible in Switzerland as an example to overturn that classification of e-liquid as a medicine?
Jean Etter: Well, yes, we’ll see. The tobacco laws are being changed currently. It’s a process that will take three to five years. Then it’s all a matter of the political weights on each side, on both sides. Politicians will not move unless there is pressure upon them, and unless they fear they will lose votes or they fear scandal in the press. These are the only things that make them move, so if vapers are not organised and put pressure on their politicians, on their MPs, then there is no reason why the current regulation which prohibits nicotine in e-cigarettes will change, but we’ll see.