Is medical regulation the best way forward? Open floor questions and answers Chair: Prof Ann McNeill
Chair: Okay, I’ll take your question but perhaps while you’re speaking, could the other three speakers from the session come up to the front please for the panel? Thank you.
Male: Right now in the European Union there are these negotiations between the Parliament and the member states, there are two approaches you didn’t like. One is the tobacco-orientated approach, the other one is like this medical approach or medicine approach. Which one, Mr Etter, is according to you the lesser of the two evils because we’ll see one of the two evils, because this is what the negotiations are about?
Prof. Etter: Predicting the future is not a scientific discipline so all these financial analysts who predict the future, financial analysts have not been able to predict the major financial crisis recently, so I don’t know whether we should believe them. It’s really the result of a political process. It can’t be predicted.
Male: Sorry, I didn’t ask you about the forecast, but what according to your view would be a better outcome?
Prof. Etter: As I said, I think the preferable way would be to have a specific category. If current laws applying to cosmetics, electrical appliances, etc, are not sufficient once and first on e-cigarettes, then perhaps creating a specific category with proportionate rules and tobacco and medicines regulation are disproportionate, I think, would be the best possible outcome but it may take many years before we reach this point.
Chair: Okay, while we look for other questions from the floor, I think Clive wanted to address that as well.
Clive Bates: Just a quick, and also following up Rebecca Taylor’s point, the Amendment 170 isn’t exactly as I would like it, as I think I made clear, and it has some things in it which really are counterproductive from a health point of view, but in my view it’s vastly superior to regulating these products as medicines or as tobacco products. The amendment itself doesn’t do either. It basically says these are the rules that apply to e-cigarettes so it sort of falls in between. It does borrow some of the bits of the regulation that apply to tobacco. I think as Jean Francois says that some of that is disproportionate, for example banning cross-border advertising of e-cigarettes makes no sense to me, but as Rebecca says you’ve got to work with the art of the possible and as an outcome it was vastly preferable to what was there before, and hopefully it will shake the Council and the Commission out of its complacency, it will start to listen to the people that have made the representations about this and understand just how damaging medicines regulation will be and we will actually get a change.
Chair: Okay, right, can we then open this up now for a wider discussion on anything that you’ve heard in the last session but bearing in mind this is the question that we’re looking at in terms of medical regulation.
Farrell Delman: Yes, TMA. I have a question for Jeremy Mean. I’m struggling, I guess, to understand the framework and I thought you provided us with a great argument as to why we ought to have a framework, and yet at the same time I’m understanding and I think my own perception appreciating the concept of a specific framework that would be unique for e-cigarettes. So I guess what I’m trying to understand is, and I’m not familiar, and you’ve probably gathered from my accent I’m not a Brit either, the MHRA itself has certainly been regulating lots of products out there and while your address tended, as I read it, to focus on the OTC end as potentially applicable for e-cigarettes, at the same time I’m trying to understand what other products MHRA has regulated in the past that have dealt with issues as unique as population risk. For example, are there any products that you have regulated that address the issue of another generation of Brits with athlete’s foot, for example?
Chair: Thank you. I notice some people have got their questions waiting, so I’m sorry, I missed your affiliation?
Farrell Delman: TMA.
Chair: Tobacco Merchants Association. Okay, thank you.
Jeremy Mean: Thank you for that question. Thinking about how medicines regulation works or perhaps it’s better to say how medicines regulation is applied, because it is a framework and it can do things with different products in very different ways. A cutting edge biological product is not the same as an over the counter one, so that’s why the framework is flexible. There are flexibilities within it, so for example, for a new product coming onto the market for the first time, it does require to be tested on animals, to have toxicological testing to it, before it is exposed to a small group of people in clinical trials, and that’s the expensive and difficult end of the medicines regulatory framework. OTC medicines are the other end. We’re not requiring clinical trials. We don’t want testing of the product. All we want to do is show that it delivers nicotine in a reasonable amount. Now in terms of types of products, we do think this product is revolutionary, in the same way that vaccines have wiped out diseases in the UK and Europe and we think this is potentially as important as a vaccine. We want the product to be safe enough, and medicines regulation works, rather than absolute standards, about risks and benefits. Risks and benefits change over time. They change with how we learn about the product, but also they change in relation to the risks that you’re trying to manage so it’s a flexible framework that can change over time.
Chair: Okay, the next question I saw was here.
David Cohen: Hello, my name is David Cohen from Green Smoke. This is for Jeremy the question. I read the Q and A part of the regulations that MHRA has published on the website to get more insight about how to do this process, and I have a question regarding the manufacturer side of it. The medicinal product manufacture which is the e-liquid, as I understand it, is to be prior approved by an EU competent authority for the CGMP. I’d like to understand under this umbrella will it include like the level of the GMP is the level of medicines tablets or medicines of creams, because as you know even to get inside these facilities is pretty hard? That’s the first one, the second one there is a mention of the PK study that will be needed as a comparative analysis to Nicorette inhaler. I want to hear more about that in your thoughts.
Chair: Just before you answer, can anyone who’s got a mobile phone on them just put it far away from the microphones please because there’s some interference? Thank you. Female: It’s actually best to switch them off or you get feedback on these. Chair: Yes, or switch them off. Thank you. Jeremy, I think that question was for you.
Jeremy Mean: Thank you. So dealing with those two issues, let’s start off with GMP or Good Manufacturing Practice. There’s a lot of shroud waving around GMP. Everybody says, “GMP, it’s such a terrible thing. It’s such a high hurdle. It’s such a terrible burden.” GMP is simply a quality standard is all it is. It’s like the ISO 9000, in fact it’s not that different from ISO 9000, except you need to document more what you’ve done so that you can demonstrate to a regulatory authority that you have procedures in place to identify where your supplies came from, that you can recall them if necessary, that there are batch numbers, actually the sorts of things that any good manufacturer would want, and actually lots of manufacturers outside the medicines world adopt GMP and the feedback they give is that it’s much better to have a documented process, to be sure about your manufacturing process and be able to prevent problems before they’ve even begun than it is trying to engineer something at the end of a process with your finished product. So GMP is just a quality standard. It applies differently to different circumstances, whether it is the particular risks around manufacturing liquids, it might be around the level of contaminants, for example, and how you have to have a clean room to manage that particular risk. So it’s those sorts of things. It’s not an absolute standard. Moving onto your question about PK studies is an important one, thank you for asking it, because what we want to do here and perhaps this is the most important aspect of medicines regulation, we talked a little earlier about the safety, about the quality of the liquid, about contaminants from batteries or solder and all those sorts of things, and I agree in the scheme of things they are risks but they are relatively small risks, in particular in relation to continuing to smoke tobacco. Perhaps the greatest risk is failure of efficacy of these products. We want products that work that will help people to stop smoking. That’s the single most important thing that medicines regulation can do and that isn’t in any other framework, not cosmetics, not food, whether the thing actually works, and that’s the most important thing. So these PK studies we’re looking for, we’re looking for studies in perhaps 12 to 20 people, which show how the product delivers nicotine, and it shows the blood levels over a period of time. Now they’re relatively small studies. They’re not like a full randomised clinical controlled study. You can get any lab to do them and any pharmaceutical company does them on a very regular basis on their products, so they shouldn’t be a high hurdle.
Chair: Okay, some of the other panel want to address that point.
Linda Bauld: Can I just add one thing to emphasise the importance of the PK studies, we’ve heard a lot about recreational use today. A lot of people have used that term, but when you look at the survey data and some of the studies of people who are using e-cigarettes, many of them are using them genuinely to try and stop smoking completely, and many of those people do not intend to continue using e-cigarettes for a long period. That is not their wish. Now in order for them to achieve that goal, the products have to be, as Jeremy just said, they have to work, and many of these products are not effective cessation aids, and in the UK in particular, smoking rates as you know and in most developed countries are highest in the poorest communities in our country and those are the people that we want to support to stop smoking if they make that choice. Now those people need cheap effective products, and ideally they also need a product that’s available on prescription that in many parts of the UK would be completely free, and those are the people for whom e-cigarettes may have a particularly important role to play. But in the current framework we can’t make them as available as we would like, certainly through our healthcare system.
David Cohen: I just wanted to ask, because I’m not sure it’s been addressed, Jeremy, regarding the manufacturer side of the GMP. I know what GMP is. I’ve worked in pharmaceutical companies for eight years, so I know GMP from the manufacturer side of drugs of APIs. I’m trying to understand is the manufacturing facility, because it needs to be prior authorisation to be given, it is written inside the Q and A that it needs to be a site that has to have passed an inspection of a competent authority, so I’m asking there is a difference between a site that manufacturers creams under GMP and there is a site that manufactures drugs, tablets, under GMP? I’m trying to understand if the MHRA is aiming towards GMP of tablets or creams. That was the question.
Chair: I’m not sure if you want to come back on that one or not. I’m keen to get as many people in as possible.
Jeremy Mean: Perhaps we could speak afterwards. I’m not entirely clear.
Chair: Did you want to come in on any of those points, Clive?
Clive Bates: Just a couple of quick remarks. I mean, there’s a good reason why there are no regulators working on the efficacy of food, and that’s because we don’t have official taste testers to tell us what good food is. We allow consumers to do that and we allow essentially market forces to drive what makes a good product and what counts as good innovation. I think all the objections, or many of the objections to medicines regulation simply would melt away if it was a genuine light-touch process, if it was something that just generally slightly upped the game of the people in the market, improved the quality of the products and everything, but as far as I can tell, the lived experience of going through this process by one of the companies who’s been doing it, it’s been unbelievably arduous. So there’s a sort of disconnect between the story that actually there are all these creams on the shelves and everything, it’s all been straightforward, and the actual experience of doing it by any cigarette manufacturer, which seems to have run to millions of pounds, many years and huge investments in people and IT, infrastructure and all the rest of it. It might be quite straightforward if you’re already a pharmaceutical company, to produce an additional marginal new pharmaceutical company but if you’re not already a pharmaceutical company, becoming one is a very large barrier to entry, and that’s part of the issue here, and things like GMP are not at all straightforward, if you’re not manufacturing like that, and you should only require that if it really is required from a point of view of proportional protection from risks, and there’s no sign that that is actually the case.
Chair: Okay, Jean Francois?
Prof. Etter: Yes, if you look at surveys of users, and you look at the proportion of smokers or former smokers who try e-cigs and then convert to daily use, there are two studies who provide figures. In one study, 12% and in the other study 14% of triers converted to daily use. This is very small. It means that the current products are not satisfactory, and they need to improve and if you freeze their development in their level where they are today by medicines regulation then we never achieve the full potential of these products. They can improve, I think, in particular by delivering more nicotine and more quickly and being more addictive, they will be also more effective, and this will come from control of the pH, like the controversy of Marlboro cigarettes and ammonia like twenty or thirty years ago. They need to control the pH of the vapour in order to improve the proportion of nicotine that is more pharmacologically available. This is one.
Chair: Thank you. And then you wanted to just come back on your point?
Jeremy Mean: Yes, well, just a couple of points really. The first is these products are not a food. You can’t compare them to something that you taste and you might or might not like it.
Clive Bates: But like your point, you said there’s no efficacy test for food.
Jeremy Mean: Exactly, because there doesn’t need to be. In relation to these products there’s a real public health cost if they don’t work. Many people will try many times to quit. It’s a very, very difficult thing to do and each time they fail to quit, it will be a considerable amount of time before they try again and they will look for different ways of support. Now if we’ve got effective products that work, that earlier success will have public health benefit. If the product doesn’t work, then there’s a public health cost to the time that’s lost between now and when they quit. Just in terms of upping the game, medicines regulation is very flexible. If you go to a supermarket, you can pick up a packet of paracetamols for 16p. It’s not hugely burdensome. It’s a proper market that works effectively, and medicines regulation can actually support innovation. The pharmaceutical industry is the most innovative in the world, if you count it by number of products or number of patents or new developments that are coming out of medicines all the time, including over the counter medicines.
Chair: Okay, let’s take some more questions from the floor because there are a lot of people who want to come in, so there are two people with a mike, so we’ll take both questions together actually. Go on.
Fraser Cropper: My name is Fraser Cropper, I’m representing Totally Wicked, a UK manufacturer of e-liquid and electronic cigarettes. Principally to Jeremy, firstly forbearance it’s quite a long question but it’s quite an important one. Perhaps it would have helped the audience if right at the start of Jeremy’s presentation he would have been able to lay out the reasons why he’s presenting today. I struggle very much with the question of jurisdiction and authority, and I think it’s very pertinent to this debate as to why the MHRA is presenting to us. So the first question jurisdiction. Right at the heart of generic consumer regulation, as Jeremy knows as he wrote it in his document, is that governments should only intervene when there is an overwhelming risk to consumers, that consuming a product outweighs the risk and benefit that may be accrued. From what I’ve heard today, I don’t know where that overwhelming risk is, why 10 million ecigarette users I don’t know of one chronic condition, thankfully no deaths from that usage, so that’s empirical, that’s anecdotal, but there hasn’t been any convincing evidence to date to prove that there’s an overwhelming risk. That’s a fundamental question of jurisdiction. The second one is a much more pertinent one related to the MHRA, which is of course the MHRA is an agency that has a responsibility to take regulatory oversight and control as and when a product fulfils one or both of the basic tests, which is presentation and function. E-cigarettes, the vast majority, do not make any claims and they are fundamentally not fulfilling the functional test, because if they do, then of course conventional cigarettes fulfill that functional test and actually more effectively than e-cigarettes. The second one is authority in this debate. We heard from Linda and Jeremy today that one of the reasons why we want intervention from the MHRA is to improve efficacy. For 40 years of course, the MHRA has been supporting the regulation of NRT which we know has a 7% success rate. One in every 14 people who use an NRT regulated product, do not receive the benefit that is purported by the regulation that oversees it, and the final point is this. I struggle also with how the UK government can ask an organisation that receives in excess of 90% of its funding from the pharmaceutical industry to identify the most appropriate regulation for electronic cigarettes. That’s quite a difficult one to square as well. It’s not surprising, therefore, that pharmaceutical regulation rather more objective-based consideration is the one that is falling down on as the most appropriate. [Applause]
Chair: Thank you, I’m going to take the other question. If we take your question as well, and then we’ll just get feedback from the panel, and just remember that there is another session on this same issue in the afternoon for those of you who haven’t managed to speak.
Craig Arnell: Craig Arnell, no particular affiliation. Clive presented an interesting harm reduction equation, and warned against regulation stifling the attractiveness of e-cigarettes. One thing that did stand out in Jeremy’s presentation, Jeremy, you’ve spoken with 20 or 30 e-cigarette suppliers, but there are only two applications in the pipeline. In the MHRA’s June publication, you referred to a 34% exponential growth in the UK e-cigarette market. My question to you, Jeremy, is whether you’ll guarantee that growth continuing if e-cigarettes are regulated in the way that you want them to be.
Chair: Okay. Jeremy, sorry, all these questions are aimed at you, if you want to go first.
Jeremy Mean: Surprise. Can I pick up on the questions from Fraser Cropper to start with and then move onto that one? In terms of why I’m presenting, it’s part of my job to explain government policy. That’s what civil servants are required to do. In terms of the remit of the MHRA, the MHRA was asked by ministers to lead this work. That doesn’t mean to say that the MHRA has focused this work entirely within the MHRA. We have met with every government department that has an interest in this area. We’ve worked very closely with the Behavioural Insight Team, the Nudge Unit in Number Ten, who in its very first report back in 2010 identified this is an important area where it was important to get regulation right. So we’ve worked across government. I should say, as I said in my presentation, this is not simple. It’s not easy. That’s why governments have struggled with it around the world, and I’m not pretending that the UK government’s position is the only answer, but it is an evidence-based one, informed by a process from an expert working group that’s published all the materials on the MHRA website, all the data it looked at, in a very transparent way. I was asked about function, and whether regulation by claim and function was appropriate. Now in medicines regulation there are two limbs to medicines regulation. The first is claim, to prevent the sort of snake oil claims, and the second is function. Is it actually a medicine by what it does? Now the UK government’s position has always been that we think nicotine is medicinal by function or could be medicinal by function, that it is a highly active, potent, pharmacological substance, that impacts on craving, and that’s a medicinal indication. What the UK government has chosen to do is not to impose regulation based on that part of the medicines regulatory claim. We haven’t banned products. We haven’t required them to have a license to date. But we do think they are medicinal by function. In terms of the growth, the UK government absolutely wants this product area to grow and to grow exponentially. We want to support that and we believe that medicines regulation can do that. Now I can’t guarantee what will happen. The market, we saw some references to market predictions, we don’t really know what will happen. We suspect that the marketplace is likely to consolidate with or without medicines regulation. It may be harder for niche products to find their way with or without medicines regulation. We can’t really tell that. We regulate products from government, we don’t regulate markets, so we don’t want regulation to stifle it, but we can’t predict what will happen to the market.
Chair: Presumably there’ll be some sort of monitoring of the marketplace as well as medicines regulation. Clive, you wanted to come back on that?
Clive Bates: No, it’s okay.
Chair: Yes. There are two people apparently who’ve got the mic, so we’ll take those two questions with quick responses before we break for lunch.
Johnny Lavery: Thank you, Mr Mean, thank you very much for coming…
Chair: Sorry, can’t see you, and name and where you’re from.
Johnny Lavery: Oh, sorry. Mr Mean, thank you very much for coming today…
Chair: Name and where you’re from.
Johnny Lavery: My name’s Johnny. I am a vaper of electronic cigarettes and I have a small retail shop in London.
Chair: Thank you.
Johnny: Just to contextualise my question very quickly, I was a very happy and committed smoker of 25 cigarettes a day for about 14 years, with no intent to quit. I haven’t smoked in three and a half years. I started vaping as an alternative because I wanted to continue smoking with lower risk. I have this product which is tailored to the flavour and strength that I choose, and at the power that I require based on my personal taste and stress level. This product is as safe as my mobile phone and as effective as my cigarettes were. I am the regulator for my product. If it’s not available to me anymore, I’ll be forced to return to smoking or to the illegal black market. Questions are this: one, can you confirm that this product will still be available to me following your regulatory approach? And two, how do you intend to attract happy smokers to medicines intervention or do you not care about them at all?
Chair: Okay, thank you, and we’ll just take the next question. [Applause]
Male: It’s a very similar question. Jeremy, I am sure you are under crossfire here but one thing that doesn’t really connect with this framework is the level of nicotine, the threshold level. If every smoker self-titrates, what’s the rationale for setting that threshold level?
Chair: Thank you.
Jeremy Mean: Can I start with the question about whether I can guarantee a particular product will be on the market? I can’t guarantee whether a particular product will be on the market. We regulate products on a case by case basis, and that’s, if you like, part of the strength of that regulatory framework. We don’t set a series of hurdles or a series of absolute tests. We adjust the consideration of risks and benefits according to the particular product. In terms of the black market, it’s a spectre that’s been raised several times in presentations, but if you look at the OTC medicines sector, there is no black market for any OTC medicine. There are no counterfeit OTC medicines because they’re available. People can get them and they work. What creates an incentive for those sorts of things if people don’t have access to them? We want people to have access to licensed products that work and are effective, which kind of brings me onto the threshold point. The MHRA hasn’t set any threshold. It hasn’t said that there should be an upper one or a lower one. We don’t endorse the approach taken in the European directive for its lower threshold or for the upper one. A threshold that simple refers to a strength, well, you could have a bucket-load of something that was only just a little bit less strong. It doesn’t mean anything in safety terms. We need to look at it on a case by case basis. We need to look at the effectiveness of the devices. Many devices are not currently very effective. They’re about as effective as NRT. We want ones that are very much more effective that will be a real alternative to smoking. We don’t want to stifle that market. We want to enable it.
Chair: Okay, the rest of the panel is sort of standing between this audience and their lunch, so keep your comments short, please.
Linda Bauld: Just very briefly, I just wanted to comment on Johnny’s comment about his own experience, which is very useful to hear. You used the term safe and effective, you said the product you use is safe and effective. That’s great. So you’re an informed consumer, you’ve come to that decision, the problem we face is that there are thousands of people out there who don’t believe that e-cigarettes are safe and effective, are looking for guidance and a framework. Sorry?
Clive Bates: Half the public health community’s running around, creating fear about them, that’s why. Frankly, if the public health community piped down on it, it would all be….
Chair: Clive, don’t interrupt, please let her finish and then you can comment.
Linda Bauld: So if you have people who genuinely are afraid of these products and that is the case out in the public. They’re concerned about their use. One of the reasons why you need some sort of framework to give people reliable information about those products so they can make decisions is exactly the kind of discussion we’ve been having. People need to know what’s in them, to know whether they work or not. And also, as I’ve said before, health professionals need to be able to be given the option to recommend them and they can’t do that.
Chair: Okay. Clive?
Clive Bates: Well, there’s a load of things to say about this. There’s a massive amount of fear-mongering going on by, they know who they are, and some of them are here, and they should just stop. They should stop. They’re harming public health by doing that. I just want to concentrate just a quick word on the supposed consensus that there is for medicines regulation. It was very interesting when Jeremy was presenting the findings of the 2010, he said there was a consensus in public health. There was a massive rejection of the approach that was approached my MHRA at the time, which was to take all the unlicensed products of the market within 21 days, by vapers. It was vapers that made the case here. They made very passionate visceral statements about their own experience, and turned the Page 62 of 102 intended government policy around. A committee of experts was appointed to look into this but they were experts within a very narrow range of expertise, largely health, largely pharmaceutical. Actually to know what the right form of regulation is you need to understand about how the supply chain operates, what the innovation model looks like, a whole series of things outside the scope of competence of the people who made these decisions, which is why we’ve ended up in the wrong place. [Applause]
Chair: Jean Francois?
Prof. Etter: The best incentive for innovation and improvement of the product is not medicines regulation, it’s market competition, and the competition has to this date come to the outcome of many, many different products that are improved week by week. The problem with medicines regulation is that big tobacco will register their cigarettes products which are not very effective, way less effective, I think, than the Ego models etc, or the mods. The manufacturers of the these more effective models that deliver more nicotine will not have the means to register their products and they will be excluded, so we’ll have not better quality but the lower quality product, the worst products licensed at the cost of excluding better products. [Applause]
Chair: Okay, thank you. Okay, so I’d just like to remind you what Jean Francois said at the end of his presentation, that this is one of the most important public health debates in recent decades. It’s good that we haven’t got agreement because that gives us plenty to discuss in the afternoon. I need my lunch and I’m sure you do, so please come back promptly whatever time it says on the agenda and thank you once again to all the speakers and for your questions from the floor. [Applause] Thank you. I’m sorry, Jeremy, that you got quite some grilling.
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