Clive Bates: Disclosure – no competing interests, and particularly important to say, I of course no longer speak for ASH or for the British Government, quite the contrary in fact. (Laughter) Clive Bates: Here we go. Right. Before I get stuck into the regulatory issues, let me just, a few words almost personally about why I think this is important. I think everyone in public health, everyone involved in the smoking industry needs to keep an eye on the prize. And the prize relates to this one billion deaths that the WHO is estimating for the consequences of smoking in the 21st Century. Now, it’s actually quite hard to find out where that number comes from but let’s just keep it as an approximate sense of the impact of smoking in the 21st Century. If you want to know what a billion looks like, it’s five piles of pennies about the size of a bus, basically. It’s a huge number of people, it’s a huge number of personal storage, it’s a huge amount of suffering is embodied in that number, a billion, that we toss around. And I want to go from the large-scale number just quickly to the sort of thing I get left on my blog and if you search the forums and the internet you can find these testimonies. Just digest that for a minute. But basically, if you’re in public health, this to me is the sort of thing that ought to get you out of bed every day. I find these sort of testimonies really moving. They’re people whose lives have been changed and transformed by switching from smoking to a new technology. They’re empowered, they feel much better about themselves, about their lives and everything, and there are literally thousands of these all over the internet. So the question we should be asking is: how do we get more of this? How do we get fewer of the billion and more of these great personal stories? I just want to go back and investigate that billion a bit more. It’s hard to find much information on this but the kind of last time anyone seems to have looked hard about what the future outlook for smoking in the world was was 2003 in a World Bank study which then got turned into these projections in the tobacco atlas which showed a number of smokers on current trends going to 2.2 billion by the middle of the decade, and then if some measures were taken dropping down to 1.5 billion in the world. Okay? And to be honest there isn’t much more than that. So what I wanted to do, just to illustrate the start of this talk, was to take those numbers, use some actual data, recreate them slightly. So start with the growing adult population. This will all make sense in a minute, believe me. We start with the growing adult population, so these are the UN projections for people aged over 15, and it grows faster than the general population. There will be an extra 2.6 billion adults by 2050. If the current rate of smoking prevalence was to continue we’d have around 2.2 billion smokers by 2050 in the world and that’s roughly the number that WHO was using. So let’s re-plot that so we’re just looking at smokers, so keep your eye on the black line. Re-plotted on a different axis. That’s the number of smokers that there would be on current smoking prevalence worldwide taking account of population growth. Now the WHO’s numbers in the tobacco atlas implied this trajectory which is actually consistent with achieving a 15% smoking prevalence worldwide by 2050, okay? And that’s what they’re sort of estimating might happen worldwide. Now let’s look at this in a different way. What they’re sort of saying here is that they think that’s the kind of performance that can be achieved by tobacco control. Might be more, might be less, who knows? But what they’re kind of implying is that that wedge, the yellow wedge up at the top there is the sort of thing you could achieve with tobacco control, and under it is harm. This is person years of people continuing to smoke basically, billions of people continuing to smoke. Now, the interesting thing about a supply-side response, different types of nicotine, is whether it can eat into that big, harmful area, and what I’ve drawn here is the idea that the top wedge is there kind of contested by tobacco control, and that’s what you kind of get from the traditional package of measures which I very strongly support. And then you've got this big rump of continuing smoking that you might be able to address with a different strategy. What I’ve done here is suggest that you might be able to get this green wedge in there, you might if you’re really optimistic get a very large number of people to start to switch, and this additional strategy might reduce the area under this curve which is important for public health. Okay? That’s the boundary that matters most for public health. If you think e-cigarettes are not particularly dangerous then it’s the number of people smoking, not the number of people that are using nicotine that really matters in terms of cancer, heart disease, respiratory illnesses and all the other nasties that come with smoking. Okay? Now, you might say, well these are just basically made up numbers, they’re projections, they’re in a model, but how realistic are they? Well, I’m just drawing on this as quite a bullish commentator from one of the investment banks, and her view is that e-cigarettes might overtake traditional cigarettes in the next decade, and by that she means in the United States and by 2023. Okay? So there’s people here in serious business who are looking at this industry think there is the possibility of a very disruptive revolution in these products, that would be an enormous impact on the cigarette market, on the tobacco industry if that did. I mean tobacco industry will be in the game, of course, but still extremely disruptive. So if we just take that sort of thinking and let&rsqu
o;s say it’s 2030 instead, that’s the curve I showed before and that’s the point at which e-cigarettes would overtake cigarette consumption, that would happen around 2030. So my whole point here is that we should be thinking really about how we get that green wedge. How do we get that green wedge to be as big and effective as possible and how do we minimise any of the unintended consequences that would come with it? And if I have a single message today it’s focus on the opportunity, focus on the huge opportunity, don’t become obsessed with the relatively minor risks, we’ll come back to that. So here we go onto the regulatory piece of this. This is the sort of thing you hear people saying. “We need clean and safe nicotine delivery.” And this is Mitch Zeller now of the – he didn’t say this when he was there but he’s now of the FDA and in charge of the tobacco booth there. Okay? “Clean and safest as form of nicotine delivery.” Is that actually right? I don’t think it is right, actually, that we need the cleanest and safest form of nicotine delivery. Not if we’re concerned about that green wedge, the one billion, and getting as many people to switch. So I have created this bespoke harm-reduction equation which I’m going to use. It’s a very simple thing, don’t worry, to try and illustrate what I think is a really simple idea behind this. Okay? We’ll do a modification on this later to take account of population effects, but basically what you’re trying to do is get reduced risk products. You want the reduction in risk to be as large as possible and you want the number to switch to be as large as possible. And the actual public health impact is the product of those two things. So if you have a really, really safe product that nobody wants to use, that’s no good because nobody switches. If you have something that everyone switches to but doesn’t do much to reduce harm that’s no good either, and that might apply to some of the combustible harm-reduction strategies. Okay? Now the elements of this, let’s start on this, really are a function of the product to some extent. The number who switch is a function of how attractive the product is and what consumers actually want to buy. Okay? So people aren’t going to quitting centres or getting behavioural treatment for this. Buy them in shops instead of cigarettes. So it’s not about an intervention, it’s about what people choose to do, it’s about consumer choice here. So let’s just examine the first of those arms, the reduced risk side of it. Who knows what the reduced risks? I tried to get the panel earlier to say roughly what they thought the reduced risk was. There’s some work coming out from David Nutt fairly soon, but roughly speaking we’re talking about one to two orders of magnitude reduction in risk compared to continued smoking, probably 95%+ reduction, whether it’s for smokeless tobacco or for e-cigarettes; very hard to imagine these things just from the physics or chemistry being more risky than that. I’ll try and illustrate this. Let’s imagine this is a continuum of risk, and that should read 100 up there, for ecigarettes, and a regulator comes along and says, “Look, I can make these products ten times safer by regulating them, by increasing the cost, make it more difficult, and so on, but I can make them ten times safer. Is that a good thing? Is that actually a good thing? Back to Mitch Seller’s comment. So an unregulated e-cigarette would be the risk of 100, and a regulated e-cigarette with a risk of ten. Sounds good, regulator’s really done the job well there, but actually I don’t really think it’s worth doing, and this is the reason why. Because when you plot them on a risk continuum with cigarettes, basically there’s almost no difference between something that’s 99% and something that’s 99.9% less dangerous than smoking. Okay? The whole thing here has to be about getting the risk in perspective and not spending a fortune, damaging the industry, restricting choice, making the products less attractive because you’ve tried to go from 99 to 99% less risky. Okay, let’s go to the other column now, product attractiveness and consumer preference, and let us look at the unintended consequences of excessive regulation. And just remember what the analysts say about what’s driving the growth of these products, and the growth of these products is largely good, it’s largely an alternative to smoking and a good thing. They’re talking about the rapid pace of innovation, stepped-up advertising and a lot of internet buzz. Mostly these are things that regulators suppress, by the way. They don’t really do these sort of things that increase the interest and excitement around these products, and that’s a Wells Fargo thing. So regulation comes at a price and I just want to go through some of the unintended consequences of regulation that affect that second arm of my equation, the things that potentially reduce appeal. Greatly increased cost, huge investments needed in the supply chain, manufacturing regime and so on. Greatly reduced variety, it’s expensive to get a product approved, niche products it won’t be worth doing it, there will be only a certain number of things that will pass through a medicines regulation filter. So you would expect the cost to go up and the range of products to contract very dramatically, probably mostly towards those cigalike products that are produced by the larger companies. You would slow the pace of innovation, it isn’t worth going to a regulator too often when it’s expensive and very time-consuming to do it, and actually you get a bit of the censor in the head who says, “Actually it’s not going to be worth it. I can’t be bothered proving all this to the regulator.” Fewer dollar innovations, so a lot of the buzz would go. I mean a lot of the excitement around e-cigarettes is around flavours, around mods and about special devices, again perhaps not really worth doing for the market. Less personalisation. You might see one of the attractions of e-cigarettes as being able to configure it in a way that you seem really suits you. Now personalisation in medicine isn’t actually a very common idea at all. So potentially thousands and thousands of different combinations of things making a product, how do you pass them all? The tendency to make the branding and marketing resemble the branding and marketing of haemorrhoid creams or NRT even is something that comes with the deadening hand of the regulator. A number of trusted brands and goodwill and choices would be destroyed by this, there’s no question of that, and it’s there in thei
r impact assessment. We would tend to see dramatic concentration, so both at the product level and the firm level. A far smaller number of larger players who are able to clamber over the regulatory barriers to entry that they would create. And then finally, users are not stupid, they would take countervailing measures and there would be a growth and a thriving black market and DIY, all of which comes with more of the risks that you were trying to stop in the first place. So reduced appeal, the appeal is the key element in how we regulate e-cigarettes, we don’t want to kill the product, we don’t want to make it boring and bland. So there are trade-offs here. You could go a long way with the reduced risk, but you might reduce the number who switch, so the perfectly risk-free product that noone wants is very poor on the harm reduction equation. What you’re really after is a diverse range of products, substantially reduced risk, let each smoker decide which is best. Did I mention that medicines regulation is probably illegal? It’s a disproportionate, discriminatory, it’s been struck down by five courts in the European Union, so even if you think it’s going to bring certainty and everything it doesn’t really because somebody will challenge it and it will fail in court later. So what should you do from a regulatory point of view? Just this sentence is quite… I was toying with this this morning. Tough on harm reduction. It’s a lovely triple negative involved in this and if you think that tough regulation of harm-reduction ideas is a good idea you’re basically being easy on harm, when you work through the triple negative that’s behind this, and that’s kind of the point that I really want to draw out in the next thing. Before I do that, just people trip off the tongue, words like, you did it Linda, safety, efficacy, quality and everything. These have specialised meanings in medicines regulation, okay? They’re not the way we mean it normally. So safety, is really primarily about adverse drug reactions, quality is about consistent drug dosing, and efficacy is about treating or preventing disease. Okay? Now when we’re talking about e-cigarettes we’re really talking about something different. So what would getting tough on harm reduction mean? Here’s a few of the dimensions of regulation. On the left, I’ve listed the counterproductive touch on harm reduction style of regulation, on the right the harm reducing. So you want it safe enough is right. You don’t want huge, expensive process controls, you want proportionate standards that the companies can meet. You don’t want the regulator deciding what a good product is for goodness sake, what do they know? They don’t even use the product. So you want the consumer to decide that and the trusted mechanisms of creative destruction to work out what products are actually sold. Labelling, we’ve got a massive problem with excessive labelling. We want to encourage switching. We want to be marketing like consumer lifestyle products. People are fretting that ecigarettes look a bit like they’re marketed as cigarettes. It’s not surprising, they’re trying to appeal to the same people doing roughly the same thing but with vastly reduce risk. Fear of normalisation. To be honest we want to normalise harm reduction, we want these products out in the world and people switching to them. We want cigarettes to look like old technology and these to look like the new thing. Retail, we want them available everywhere. Age restrictions? If you must, doesn’t make much difference, and taxation you want a fiscal incentive to switch rather than big excise duties. Heavy regulation, what do analysts think? They think it’s a big win for the tobacco industry, and those who think it’s clever to raise high regulatory barriers to entry in the cigarette industry need to reconcile themselves with these kind of statements. These things advantage the big players with deep pockets that will profit from a dramatic, violent consolidation of the industry. This is the thing that parliament’s created instead. I won’t go into it because it makes me feel a bit like that. There’s a lot of things wrong with it, it’s ridiculous. It doesn’t conform with my harm-reducing idea of regulation. Why would you want to prevent advertising of e-cigarettes? Ridiculous thing to do. Why would you introduce a 30mg/ml threshold? Absolutely no point to it and probably means that the products will be less attractive to heavy smokers. Why do you want to cover them with huge warnings when actually they’re much better than cigarettes and so on. So I think you could learn from cosmetics regulation, and I’ve written a piece on this. There’s a lot in common between cosmetics, they’re fast-moving consumer goods, they pose risks to people, they can cause harm, they have to be high quality products and all the rest of it, and I think what we need to do now is move to purpose build regulation that is designed not to fit something that it isn’t, not a medicine, not a tobacco product, not a cosmetic, not anything, but e-cigarettes and nicotine containing products. For goodness sake, there’s enough regulation produced in the world for them to do something that is specific to the actual product that they’re trying to regulate. So these are the kind of elements that I think you need. Some of this is borrowed from cosmetics regulation. Down at the bottom, marketing, the idea that you have to ban advertising, you can put control on it, we have controls on alcohol advertising, nothing wrong with that. Retail sales restrictions matter for member states. Public vaping in my opinion absolutely no place for the law in this. This is a matter for the operators of spaces, etiquette to develop over time. Finally, very finally, the harm reduction equation extended for population effects, this is a big thing in the States. FDA, we’re going to regulate these around population effects, which might mean you get some extra smokers or you get some extra quitters. They tend not to focus on the extra quitters by the way; they’re more worried about these here. And I can’t go into this now, we’ll probably come back to it in the discussion later, but basically there’s a bunch of population effects that could derail this sort of idea. However, for every one of them there is another population effect which is beneficial and my contention is that the beneficial pathways through these population effects are much more likely, much, much more plausible and there are more of them, because
you’ve introduced a much safer product into this kind of tobacco ecosystem, and we should stop the focus on them, and anyone who wants to raise those population effects shouldn't be raising it without thinking about what the consequences would be for the population effects that are actually highly desirable. And the last thing to say about this is this has all been worked through with Snus and the people who are worried about population effects say, “It’s a gateway, it’ll cause extra smoking.” When none of those things actually happened they didn’t change their mind about having a ban. So I think these things are often raised tactically rather than as a genuine concern. Right, my final points. Be positive about the vast potential. The job of people in this room is to go after that green wedge, go after those testimonies. Keep the minor risks in perspective, don’t over-regulate and therefore throw the baby out with the bathwater and make the products much less appealing and boring, and regulate really as if the one billion matter most. Thank you. (Applause) Chair: Okay. Thanks very much, Clive, for that very provocative talk. Those people who know Clive wouldn't be disappointed. I did you a bit of an injustice actually because you do have a few more minutes, so I can take a question of clarification from the floor. Deborah. D Arnott: Deborah Arnott, current chief executive of ASH. And I do wonder why you keep mentioning it, Clive, if you no longer speak on behalf of ASH, but that’s another matter. Clive Bates: So people know who I am. D Arnott: But I do have a serious point which is that you talked about the costs of regulation and you came up with your alternative, but there’s no attempt there to calculate what the costs would be of actually setting up a purpose-build regulatory system for e-cigarettes. Because actually it’s not cost free, and I’ve never seen you do that calculation. Clive Bates: No, I mean the actual costs of the regulators themselves and the sort of regulatory interactions are really quite small in this. I mean the real costs of regulation comes from what the regulation requires the companies in the market to do. So it’s costs of compliance basically, building pharmaceutical-grade factories to produce this stuff and having big IT systems, huge numbers of process controls and all the rest of it that goes with meeting the pharmaceutical, medical definitions of safety, quality and efficacy. So the way I’d look at it, Deborah, I mean these things aren’t particularly… I haven't done a cost/benefit analysis on how much this would cost, but because I’ve been drawing on cosmetics regulation, which, it’s not risk-free cosmetics by any means, I would say that we’ve got a very successful cosmetics industry, we’ve got a large number of brands, large, fast-moving consumer goods, a lot of innovation. Actually the Commission itself when it proposed to include these in the directive back in 2010 said in its consultation that they would set standards for safety and quality, and that’s what I’m advocating. It was a subsequent change where they decided that they would come back and classify these things as medicines which they plainly are not. So I think there will be costs of regulations and I think the costs should fall on the manufacturers, but the question is to keep those as low as possible consistent with the risks. I mean I don’t really think that much regulation is really needed at all, but if we want regulatory red meat because that’s what the European Parliament wants or the Council wants, then there are more proportionate and more modest forms of regulation than regulating these things as medicines. Chair: Okay. I suggest we move on. Thank you very much, Clive, thanks again for your talk.
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