Tobacco and Vapes Bill – in a Public Bill Committee am 2:34 pm ar 1 Mai 2024.
Q We will now hear from Dr Laura Squire, the chief healthcare quality and access officer for the Medicines and Healthcare products Regulatory Agency. We have until 3.25 pm for this session. Will the witness please introduce herself for the record?
Dr Squire:
Good afternoon. My name is Laura Squire, and I am the chief healthcare quality and access officer for the Medicines and Healthcare products Regulatory Agency. The objectives of the MHRA are to protect public health and, in connection with that, we have a number of different roles connected with e-cigarettes. We have no role at all with tobacco.
Q Can you briefly describe the regulatory approach taken by the MHRA regarding vaping products? Will this Bill change anything that you currently do?
Dr Squire:
Yes, I can. We have three very distinct roles connected with vaping products. The first is in connection with medical products, which we talked about earlier and I can explain a bit more. That is something that might be prescribed for someone to give up smoking. We have a very different role on consumer vapes—the sort of things that you will find in your local vape shop. For all those products, we also have a role in monitoring their safety once they are on the market.
I will start with the role for vapes as medical products. The Human Medicines Regulations 2012 govern that and define what a medical product is, which is essentially a substance used for preventing or treating disease in human beings or diagnosis. MHRA is responsible for regulating medical products; that includes nicotine-containing products that are used in a therapeutic way, and which would help people give up smoking. That would include the licensing of electronic cigarettes that allow the inhalation of nicotine. In addition, where an e-cigarette is in a reusable form, it needs to conform with the UK’s Medical Device Regulations 2002.
To explain that a little bit more, as with all medical products, before a medical nicotine-containing product can be marketed in the UK we do a robust assessment of that product. We always say that no medicines are entirely without risk, and the question that we ask ourselves as regulators is, are the risks outweighed by the benefits of that product for the patient who is using it? This is done by the examination of evidence provided by the manufacturer of the quality, safety and efficacy of that product. We have mentioned earlier this afternoon the possibility of licensing e-cigarettes. There was one product licensed in 2015, which was an electronic nicotine inhaler. It was never marketed in the UK.
The evidence is really clear—and a lot of people have said it—that e-cigarettes are less harmful to health than tobacco, and that nicotine-containing e-cigarettes can help people stop smoking for good. That was restated very clearly in the recent report by the Royal College of Physicians, which advocates cigarettes being offered as part of a treatment pathway by the NHS. Treating those products as medical products and licensing them would enable that. For that reason, we continue to encourage manufacturers to come forward to us to seek licensing as a medical product. Quite recently—a couple of years ago—we put out some really detailed guidance, because we recognise that not all manufacturers of e-cigarettes would be particularly familiar with the Human Medicines Regulations, so there is specific guidance out there at the moment. The Bill does not change any of that; we would continue doing the same thing.
The second role is our role on vapes as consumer products, which as I have said is different. The MHRA is the competent authority for the notification scheme for e-cigarettes and refill containers, and that covers Great Britain and Northern Ireland. The e-cigarettes covered by the Bill and by the notification scheme are not medical products, and that is very important. It means they are not entitled to make medical claims, so we do not test them for that.
The role in consumer products and the notification scheme is given to us by the Department of Health and Social Care and it derives from the UK’s Tobacco and Related Products Regulations 2016, which were designed to put in place some product standards for e-cigarettes such as nicotine strength, the size of the tank and so on. The checks we undertake for that are really just to make sure that the data fields have been completed, and that a fee has been paid for those products. In contrast to medical products, we do not do a full assessment of the safety, quality and efficacy of those products, nor would we undertake a consideration of whether the benefits of those are outweighed by the risks. Our competent authority role does not include the testing of those products either.
Q Just on that point, the notification scheme is essentially a paper-based process, so anyone sitting in Germany, say, or anywhere in the world, if they want to supply the United Kingdom, simply has to fill out a form, send you a notification form and pay the fee. No physical products are examined or tested to make sure that they are compliant with what is required before they can be sold. Do you think the MHRA should be given the powers to use the notification fee for more than just the administration of the scheme, and request some sampling and testing of products—of course, not all—before they go on the market? I say that because we have seen the evidence of the increase in illicit vapes and we have heard from trading standards as well on that volume increase.
Dr Squire:
Sampling and testing can be done—it is done by trading standards—but you are quite right that that is not before it goes on the market. I think at the moment it is difficult for me to say what the Bill should or should not be. The policy sits with the Department of Health and Social Care, and as we work through the process of consultation and putting the regulations in place, we will continue to work closely with them on what that means for the notification scheme and our role in it.
I was going to talk about our post-market surveillance role, which covers everything. There are requirements for manufacturers of both medical and consumer e-cigarettes regarding post-market surveillance; they have to ensure the safety and quality of their products when they are being used in the intended way. Those requirements include reporting to the MHRA. They are much more stringent for the medical products.
The MHRA yellow card system is a spontaneous reporting system, which anybody can use to report a problem with a product. In 2016, we extended that to enable people to report on e-cigarettes as well. Our vigilance team, when they get those reports in, look at them all to identify any safety concerns, and if a concern is identified they work with trading standards to enable them to do what they need to do, which is sometimes taking the product off the market. They do not just use the spontaneous reporting; they use other parts of intelligence, including literature review, to take these products off the market.
What we are thinking about at the moment is the challenges, particularly with spontaneous reporting, of identifying longer term effects or effects that have a longer lead-in time. That is something our safety and surveillance teams are really thinking about.
Q In terms of your notification process as a regulator, of course there is enforcement, with trading standards removing products, but do you have the powers, and have you used your powers, to remove products from that notification process?
Dr Squire:
At the moment, no; it does not allow us to take things off the register, although I notice in the Bill there is something about exceptions to publication. At the moment we cannot do that, but the exceptions to publication in the Bill—again, this is DHSC legislation rather than ours—look as if they might give an opportunity for that.
Q It seems to me that there needs to be some sort of triangulation between trading standards’ enforcing and removing illicit products from the market and your register. Surely, given your role, you should have the powers to be able to pull that product off the register.
Dr Squire:
Yes. There is a lot of triangulation and a lot of work with trading standards, and the evidence we have gained through the notification is used to support them to do their enforcement activity. But you are quite right that we cannot take things off the actual notification list at the moment, though the Bill has some exceptions to publication.
Q If a product is not compliant—if it is illicit, illegal and so on—does it stay on your register? What happens?
Dr Squire:
Nothing happens on the register, but trading standards will take it off the market. Trading standards take that enforcement activity. We provide them with support from an intelligence perspective and with expert input, and with things such as telephone support if they are doing operations, so we do work very closely with them. The key objective, when these products are found, is to get them out of the shops.
Q Does that mean that you communicate with every trading standards department in the country and get them to go out and remove the product? Is that how it is done?
Dr Squire:
That depends on where it starts. They get their own intelligence as well, so they would lead on enforcement operations. That is their role, not ours, within the UK tobacco products regulations. They do that and they ask for our help to support them, and we will give them intelligence when we do that.
Q Thank you very much for being here this afternoon. Can you talk us through the work you do with some vape companies in order to take non-compliant vapes off the market?
Q So you do not work directly with vape companies?
Dr Squire:
We do not have the powers, no. Our work with vape companies would be from the perspective of their wanting to get a product licensed as a medical product. We would have discussions with them on that, as we would with anybody else who is bringing a medical product to the market for licensing, but we do not have a role in enforcement or in withdrawing products from the market. If we were to identify a safety concern, there would be a collaboration with trading standards to get the products off the market.
Q I think there is still some slight confusion among colleagues about the exact relationship between the MHRA and trading standards vis-à-vis the huge rise in illicit vapes. Could you have another go at explaining it from start to finish? You get a—well, you do not get a request through if it is an illicit vape, presumably.
Dr Squire:
No, if it was an illicit vape, they would not put it on our list. We might work with them if they found a product that had a problem with it—often products are under different brand names but they are the same product—and our notification system would help to understand what products are affected by that. We do not have any powers to do enforcement activity. That is not a power given to us under the tobacco products rules at the moment; it is just a notification scheme. It was never designed as an enforcement tool; it was designed really as a single version of the truth of what is out there. That then enables enforcement because it is information, but we are not the enforcing authority; trading standards are.
Q Thank you—that is clear. Can you also explain the process? You said that you published some guidance for vape companies that want to produce a prescription-only type of vape. You said that one was produced, but then was not marketed in England. Do you know why that is, and whether that might change in the future?
Dr Squire:
I do not know why that is, but I products agree with what was said earlier: those products move and develop very fast. The requirements to obtain a medicines licence under the Human Medicines Regulations 2012 go a long way beyond those to produce a consumer vape. You have to produce evidence of the quality of the product; we also look at the quality of manufacturer, and have requirements around that.
In terms of efficacy, while nicotine is a well understood substance, so there are some things that producers do not have to do, we still need to ensure that the product works in the way we would expect equivalent products to work. We have clinical assessors and quality assessors, and we think about manufacturing as well. To get a product licence, producers have to put together a dossier of all that evidence. Putting together that dossier is both costly and time consuming, because they have to demonstrate that the risks of the product are outweighed by the benefits. The dossier will also describe what we call the indication—that is, how they expect the product to be used. It would be licensed only for a particular use, which would be smoking cessation. Producers would have to go through all that in order to get the product on to the market.
It is difficult to say how the Bill would affect that. When you have two systems, one of which is an awful lot easier than the other, I can see why there was a commercial attractiveness to going down the consumer route, but I think that anything that introduces more controls over consumer vapes has to be a good thing.
Q Would it be reasonable for those of us who are suspicious about, for example, the marketing of vapes to children to suspect that the reason we do not see vape companies coming forward to try to license a medicinal prescription vape is that the products and the manufacturing processes are not good enough, and it would be very hard to meet the bar for a medicinal product, or would that be unfair?
Q I have just one question, which is a particular concern of mine. Vapes are a delivery product for a liquid. I am concerned about the illicit market, which is now utilising vapes for Spice, cannabis and a new generation of synthetics as well. Is there work going on to produce testing kits, so that the liquid can be tested? I understand that testing kits would have to go through a regulatory process with you as well. If not, why not? Surely we need to get ahead of the curve in keeping people safe from a new generation of illicit drugs.
Dr Squire:
I think that would probably be under the consumer products regulations. If it was testing the actual product, that is not something that the MHRA would do as it is not a medical product. What we test is medical products and whether they are safe, effective and made to the right quality, but testing part of the device—
Q But the testing kit would have to come through you?
Dr Squire:
It would depend on what it was defined as. I think we could be going into the medical device regulations. I am thinking on my feet, but I would say that a testing kit to test a product would probably not be “for a medical purpose”. It probably would not be under the medical device regulations because the testing kit itself does not have a medical purpose, but it is quite a fine line. We would need to look at the actual testing kit and its purpose.
Q I want to make sure I have it clear in my head. If someone wants to license something as a medicine or a medical product, they have to go through the more complicated, more expensive process and show you that it is safe, properly made and works as it says it will, and that the risks are outweighed by the benefits of the product. If they want to list something as a product for sale, do they just tell you that they are going to do it and you do not test any of those things?
Q Would they count as listed with and notified to the MHRA?
Dr Squire:
They are notified to the MHRA, and that notification is under the tobacco and related products rules. That is different from the human medicines regulations, which govern medical products. We do not deal with that notification scheme. That is set out by those regulations and the responsibility was given to us as the competent authority. We cannot go beyond those rules.
Q I understand that. Do you think that it is the right authority to do that? Could it be misleading to members of the public, who see that the vaping devices they buy have been listed by the MHRA and presume, because the MHRA is the medicines and healthcare products regulatory authority, that somehow you have tested them? Might it be more practical to say that this has been notified and we call the competent authority something else, to make what you have actually done with the product more transparent to the public?
Dr Squire:
That is an interesting question. As I said at the beginning, our objective as the MHRA is to protect public health. Most of the time we do that by making a decision on whether the risks of a product are outweighed by the benefits. For medicines and medical products, they very often are, and they are if an e-cigarette is licensed and is being used for smoking cessation. However, for vapes, I think we have all said, “If you don’t smoke, don’t vape.” The benefit-risk decision on a lot of products would be that the benefits are not outweighed by the risks. It is an interesting question. I cannot really answer it today, but I would be interested in the public perception of whether having medical and healthcare in the title gives a misleading impression.
Q Could you clarify something else? If I were a vape manufacturer wanting to get full registration as a medical product for one of my vapes, and I did an apple flavour and a gummy bear flavour, would I have to put those products through separately because the apple flavour is a different chemical to the gummy bear flavour?
Dr Squire:
Any product that has different constituents would have to be put through separately, because we would have to test everything. I can see the issue around flavouring is about making it attractive to children, and we are not interested in that, but we look at what the chemicals and substances are in a product, which will be different for different flavours, so we would have to look at those separately and make sure that they all came up to scratch.
I ask more for clarification, if a GP wanted to offer a patient a vape as a means of reducing smoking, would that have to be licensed by the MHRA as a medical device? Would it have to be licensed through your organisation?Q
Dr Squire:
Yes, if you want a licensed product that can be prescribed, that would be a medical product. I know, because I was talking to one earlier, that GPs do recommend that their patients go and buy a vape. They do not have any choices at the moment, because there are no licensed products available on the market in the UK.
Q So they would just suggest that someone go and buy a vape in a shop to help them to reduce their smoking, rather than suggest one that had been through your rigorous process?
Dr Squire:
At the moment, the limiting factor on the availability of licensed products is that we need manufacturers to come forward and apply for a medical licence. We continue to encourage that, including putting out the guidance. If anyone wanted to talk to us about bringing a product to market, we would talk to them about that, but they are not out there at the moment.
Q So there is no obligation on the vape manufacturers to come to you to check the vape?
Dr Squire:
Not if they are putting a product on the market that is not making any medical claims. If they are putting it on the market and not making medical claims, it is a consumer product and they do not have to come to us. If they start to make medical claims, including that it will help you to give up smoking, they need to come and talk to us. They should not be making medical claims without having it as a licensed product.
We have heard various accounts of the impacts of vapes on children and young people—that there are limited direct consequences of vaping on children and young people’s bodies, but plentiful and multiple different indirect impacts of that behaviour in schools and such like. I am starting to hear that it almost feels like an unbearable choice between whether we protect children and young people from vaping, or prevent older people from being able to stop smoking through the use of vapes. I am struggling with making that choice; I can see both sides of the argument. Do you have a view? Could you help the parliamentarians here to understand the choice we are faced with?Q
Dr Squire:
The Bill helps in all ways. The Bill is very clear on tobacco and, as I say, we do not have a role on that, but the proposal is to put more requirements on vapes, and in our experience more requirements add to the barrier to something getting on to the market, which is helpful. One of the problems we have with e-cigarettes is their availability.
I am not sure I see the choice between the two. We are seeing here a Bill that, as people have said before, is balanced. It recognises that vapes are useful for people who already smoke, and it puts in some very big restrictions on people who already smoke, but it also tightens the rules around vapes. I think that is what gives it the balance, which is helpful. The problem, which others are more qualified than I am to talk about, is: if we did not have vapes at all, where would people who smoke go? It is not a good answer, but if you do not smoke, don’t vape. That has been said a number of times, and we definitely agree with it.
Q How many products that have gone through the notification process have been deemed illicit and have therefore been removed by trading standards?
Q It is the process that we are trying to understand. You have a register and a notification process—
But because we are not testing a product before it comes to the market, we are allowing a lot of illicit substances to come in and flood the market. Do you think that companies submit data about their products and say, “Yes, they will meet the regulations,” so that they can get their European community identification, but then actually send to the market products that are potentially illicit and have high nicotine strengths?
Q Do you think those exceptions are strong enough?
Dr Squire:
What the exceptions are is not defined yet. The ability to make exceptions is in the Bill, but what the exceptions are would be a Department of Health and Social Care policy decision, and we will work with it on the development of those regulations.
Q Have you ever asked a Secretary of State to use powers to recall or remove products from the register?
Q Where you were given the role of being the register in the notification process, it says that the powers can sit with the Secretary of State, and I am just wondering, given that we have a growing number of illicit substances, how that information has been shared with the Secretary of State so that they can utilise those powers. I appreciate that we have in the Bill the opportunity to try to look at whether we should be testing products. I suppose my other question to you is this: what happens if, after a product has been notified, the company decides to send notifications of other products? Is it allowed to do so even though it has already supplied illicit substances?
Dr Squire:
There is illicit and there is non-compliant—those are two different things. If a company provided something that turned out to be non-compliant, provided that what they then send us is compliant, there is no reason why we should stop that. I have tried to bring the contrast between the levels of control that we have on medical e-cigarettes and the levels of control that we have on notification. The notification scheme is just that and was designed as just that. The MHRA does with it what we are required to do under the tobacco rules, and that was assigned to us when we left the EU. The strengthening that comes through these regulations—or through the Bill, which will then lead to the regulations—is something that the Department of Health will develop, and we will work with it on that. However, I am not sitting here saying that this is an absolutely robust system that keeps everybody safe. That is why the Bill is important.
If there are no further questions, I thank our witness. We will move on to the next panel.