Welcome to this evidence hearing of the Health and Social Care Committee on food and weight management. This is the sixth session of this inquiry. Today we are looking specifically at GLP-1 jabs, or weight loss jabs as they are more commonly known. Might the panel introduce themselves and what they do?

I am Dr Kieran Seyan, a GP by background. I have worked in digital healthcare for 10 years now, representing Pharmacy2U.

Good morning. I am Claire, the Superintendent Pharmacist for Boots. My remit is to head the professional agenda for Boots pharmacies across the UK. I have been a pharmacist for 30 years and an independent prescriber as well.

Good morning. Thank you very much for having us here today. My name is Dr Simon Doyle. I am also a GP, and I lead public policy at Juniper. Today I am representing a new member coalition called the Coalition of Responsible Digital Health—CoRDH for short—made up of Juniper, Numan, SheMed, eMed, Voy and Simple Online Pharmacy. We are all digital-only providers and we have come together to advocate for proportionate and effective regulation that enables safe access to digital care.

Dr Seyan and Claire, could you give us an indication of the scale of demand for GLP-1s in the private sector and how it compares with prescribing through the NHS?

We know that demand has increased significantly over the last couple of years, with patient interest in the condition and more availability of information to the patient around this particular set of treatments also being effective as well. Patients are seeking this type of medication, so demand has increased rapidly. NHS access is limited at the moment, so patients are seeking this more in sectors outside of the NHS.

What proportion of those who are obtaining your services do you think would otherwise be eligible for NHS services, were access less restrictive?

Going by the licence of the medication, then all the patients who are requesting medication from our service would be eligible through the NHS. That is going by the licence, not by NHS criteria.

Okay—and Claire, through your services?

We know that there are around 1.6 million patients accessing GLP-1s across the UK currently on average. Most of them are accessing them through the private sector because of accessibility and because the wraparound care and what we can provide through the private sector is what they are looking for, with limited access to NHS services. We support thousands of patients every week through the Boots Online Doctor online service. We have just introduced a face-to-face version of that service delivered through our Boots pharmacies as well. We are seeing demand from different parts of the population to access face-to-face care, too, so the demand is definitely increasing.

If I may add to that, it is a complex question because NHS eligibility varies from area to area. We have seen it vary over time as well. We saw the initial NICE guidance and then we have seen the funding variation, then we have seen priority groups, and then within different ICBs we are seeing criteria become more stringent, which is part of the problem that has caused the postcode lottery. If we are talking about our member organisations, if we take the original NICE guidance, what was intended to be implemented over the three years, up to around 20% of our patients meet that criteria, having a BMI of more than 35 and an associated condition or a BMI over 40. That shows that the digital providers or the private sector providers are working alongside the NHS to manage the obesity crisis.

You mentioned earlier the creation of a new organisation, the Coalition of Responsible Digital Health. There is a strong emphasis on the word “responsible” there.

Deliberately so.

Deliberately so. Does that mean that—obviously by definition—those who are not members of your organisation are irresponsible?

Absolutely not. Like I say, we are a relatively new coalition. One of the things we are trying to do is make it clear that not all physical premises are the same, and equally not all digital premises are the same either. I believe there is a role for digital providers to provide responsible and safe care. At the moment, we have set up because we are digital only, and we are working towards three main pillars in our code of conduct. That is around safe prescribing and ongoing care, so we are not just a one-off transaction. We are able to provide ongoing medical support, so that means an element of side effect support, dose titration and education. We are trying to change behaviour alongside the patient’s weight loss experience. The final pillar is around responsible communication. We live in a world where there is, unfortunately, lots of misinformation out there and we are trying to do this correctly. We are keen to work with regulators, with the ASA and with the GPhC to make sure that we are doing it correctly.

We will come on to regulation in a moment, but just in terms of your modus operandi, have you considered applications for membership and rejected them so far?

Not at this stage, because we are very new. We have recently launched our website, which lists our code of conduct. If other members meet those criteria and are willing to work towards that code, then we would consider increasing our membership in the future.

Do you have the resources to act as the gatekeeper to your own standards?

We are not talking about gatekeeping anything here. We are talking about trying to build an environment of responsible health. If more members want to work to the principles that we have set, then I would welcome that, because it will only mean increased safety for our patients.

It is effectively a kitemark that they can put against their name?

It is less about branding and more about how we are working together.

All right. Just coming back to the differentiation, you are a practising GP and therefore you will have patients coming to see you through your surgery who will be eligible for NHS treatment and are able or unable to obtain that treatment. What barriers stand in their way meaning they might seek a private digital provider rather than go through the NHS route?

I think there are multiple factors. I reiterate that where I work may be very different to where somebody down the road works, so that is one—

Where do you work?

At the moment my main job is with Juniper, but I still work in central London as well. I think one of the main barriers is around the variability in criteria. The other thing that I am seeing in practice, and that lots of my colleagues are seeing in practice, is patients are very keen for treatment. They have tried lots of things over years and years without much success. We are now getting to the point where, unfortunately, because of the way the funding has been allocated, patients are being told, “You are not unwell enough yet.” We are talking about this as a piece of the prevention puzzle. However, it doesn’t make sense to me that we are waiting for patients to become more sick before we can start that prevention piece.

In terms of your experience, Dr Seyan, are you still a practising GP?

Not within the NHS.

But you have recent experience.

Yes.

For those on the frontline, what changes do you think will be necessary in order to, if you like, facilitate better the access for patients through the NHS? Obviously, you have a private interest in driving patients to your private practice, but on the other hand you must recognise that it would be better if the NHS was better able and patients did not need to fall more ill in order to access NHS services.

Yes. I would agree with my colleague. This is very much multifactorial and it does depend on the area, and on the patient themselves. The challenge that we face within the NHS is accessibility, so if the criteria were to change, as per the licence, then more patients would be able to access this medication and the consultation that is available. It is not possible for general practice to cope with the volume of patient demand that there is, so we need wider availability of access to care. That could be through digital, pharmacy, or a combination of both, along with general practice. Unless there are more open avenues, it will be very difficult to serve all those patients.

Could I just be clear on the point? You are saying that you provide a licensed service, and we will come on to the regulatory environment in which you operate, but all those patients you are supporting through private digital supply would otherwise be eligible for NHS services. That is what you are saying. It seems to me that you are taking the vast majority of patients and that the NHS is dealing with a very small proportion overall.

Yes.

Approximately what proportions would you say?

Per the estimations that I have seen, it is about 80%.

Eighty per cent of the market. Claire, I have left you out of the conversation on these issues. You are obviously a very large supplier of these services. Is this pattern of activity one that has significantly changed in recent times? What proportion of your sales do the GLP-1s represent?

In our online services for weight management, we have definitely seen significant demand over the past couple of years, since the availability of new GLP-1s on the market. We have responded to that demand and developed clinical services, working collectively as digital providers, to make sure that those services are delivered with the right wraparound care and the right support for patients. It is an important part of our healthcare strategy. It feeds into the ambition that the NHS has as part of its 10-year plan to focus on prevention and weight management as a core and key service that we need to look at to support people to prevent longer-term conditions. It is a service that we can provide safely and professionally online. In Boots we can provide that face to face as well, which helps us to meet the ambition of giving people access to services that help them to stay well and to prevent further long-term conditions. It is a significant focus for us currently as a business.

Finally, Dr Doyle, on the role of the coalition, you felt recently compelled to establish it, presumably because you are well aware of poor practice and irresponsible practice elsewhere. Are you prepared to identify where that irresponsible practice is taking place? Are these UK-based organisations or are they suppliers from overseas?

I think that is probably a role for the regulator to identify or call out specific companies, rather than a role for myself. However, a core principle of what we are trying to do is to show that broad brushstrokes aren’t always correct. There is lots of attention, rightly so, in the media around bad actors in this space, whether that be through regulated providers or unregulated providers through social media, etc. What we are trying to do is to show that that is not the case for all digital providers.

Is there a problem of overseas supply? Is that one of your areas of concern?

To clarify, do you mean patients in the UK obtaining from overseas?

Yes, that is right.

My point of view is that medications in this country should be obtained from a regulated provider in this country so that patients have reliable access to ongoing support, which again is the wraparound part that all our member organisations provide.

First, I have a relatively general question. When it comes to your GLP-1 services, what could the NHS learn from your experience?

The NHS would perhaps gain some knowledge around the scalability and efficiency that digital services can provide, the access to structured longitudinal data, identifying risk at early stages, and the ability to create an environment where patients can access care early. It very much fits in with the digital age that we live in as well.

Yes, I agree. I think what we have learned through our provision and through online services, and through our experience of providing preventive-type services through community pharmacy, is that we know that what is important to patients is access. It is important to be able to access services where people live, delivered by people who can relate to them and build a relationship with them. We have, as I say, supported thousands of patients every week through our online services and we are seeing the support delivered through our bricks and mortar pharmacies also playing a very important role. It is mostly about new pathways of care that allow patients to access these important treatments in a way that works for them and ensuring that wraparound care is available for everybody, regardless of how they want to access these services.

I would emphasise Claire’s point around new pathways and build on that, to be honest. If we look at what the original modelling was for how this roll-out could work in the NHS, we were looking at the equivalent of 21 GP appointments across a year. I think what the NHS could learn from digital providers is that we are in a position to rethink what a model of care looks like. We are able to provide patients more flexibility and more choice. Instead of having one blocked 15-minute appointment, patients may prefer to interact with their point of care throughout the week through asynchronous messaging, which provides a lot more flexibility. The reality of that is if we look from January this year, our member organisations have treated more than 250,000 patients already or have more than 250,000 active weight loss patients. When we compare that with the NHS ambition to treat 220,000 patients over three years, I think it shows what can be achieved by changing the model of delivery.

That is very helpful. Moving on, we have heard in our evidence—indeed, you have re-emphasised it now—about the potential for digital services to improve access to GLP-1s. What are the practical changes that need to come about to unlock that potential?

I think one of the key things is that trust part between the public sector and the private sector. We have spent years building these platforms, learning from the process and creating a large evidence base. All our member organisations are very proud of their evidence and show that they work. For example, Juniper has a paper showing that patients are twice as likely to achieve clinically significant weight loss compared with medications on their own. Voy has similar results, with 21% weight loss versus 17% weight loss at 12 months. I think we have shown that we are credible. The thing that can unlock that is also interoperability. A simple example of that is private companies are blocked out by default from access to summary care records from the NHS. I would point out that doesn’t inherently make private providers dangerous. That is very similar to how a patient may go to a private GP practice and that GP would not have access to the summary care record either. Even NHS services such as sexual health don’t have immediate communications with general practitioners. I think there is something around the interoperability that we would love to see change.

That is really helpful. Ms Nevinson?

I agree on the interoperability point. From a community pharmacy perspective, there is a real opportunity for the Government and the NHS to look at the role of community pharmacy in supporting people to access this type of service—so, delivery through the community pharmacy setting, with the capability of the healthcare professionals who work in our community pharmacies, which is growing over time as we see independent prescribing becoming more mainstream. This type of holistic, preventive service is perfectly placed to be delivered through the community pharmacy network.

Just so I am clear, are you suggesting that the first presentation is the community pharmacy and then they are somehow managed through a digital means, or are you talking solely through the community pharmacy?

There is definitely an opportunity to do both. There is a hybrid model that we should look at, and we have evidence to show that people have very successful weight loss journeys using digital means. Of course, the way people are accessing information, advice and support is typically through digital channels now, so there is a role for community pharmacy to play a bigger part here, but I think listening to what patients are choosing to do and how they are choosing to access healthcare is very important too. There is an opportunity to look at a hybrid approach.

I will only support what my colleagues have said: the interoperability is very important, and a single patient record, which we are looking forward to. Again, I would agree with Claire with regard to the support from pharmacy. If we think of it from a patient perspective, there needs to be access to healthcare from different means. That could be community, or that could be via digital, but it needs to be a hybrid model.

Thank you. You have expressed that you are doing about 80% of the market already, but do you feel you have the capacity to scale up to meet the potential demand if we were to move to the model that you are describing?

The sector is not new. As I mentioned, I have been working in this for about 10 years now and this digital model has been around for at least 20 years in the UK. This is an established way of delivering healthcare and we are very aware of the risks that are associated with it and how to run an operation. I think that, yes, we are able to scale. There will be several other providers that will be able to do the same, but Pharmacy2U is absolutely ready for that.

You would agree with that?

Yes, I would agree with that.

I would agree with that, yes.

Okay, thank you very much. Have you done any modelling to understand how many more NHS patients digital providers could support, or are you suggesting, Dr Seyan, that you have an almost infinite capacity to deal with as many people as possible, given the model you are describing?

I wouldn’t say an infinite model, because there is still a limited number of clinicians, but what digital can do is allow for scale and efficiency, and different to the—

What I am trying to do is get a practical idea of numbers. Have any of you done any modelling to say, “We could treat X number more patients if we did this,” just so the Committee can get some idea of the numbers we are talking about here?

This is something we could provide afterwards, because some of my colleagues will have done that work, but I don’t have those details to hand.

Please write to us afterwards. That is fine.

That is very helpful. This is slightly on a tangent, but in your opinion is the Obesity Pathway Innovation Programme ambitious enough to meet the current demand for GLP-1s?

The first thing I would say is the programme is a great start. It shows thinking differently, which I think is what we would all welcome. I think involving different Government Departments is very helpful, so the Department for Science, Innovation and Technology, rather than just Health and Social Care. I would welcome more of that cross-Department thinking and joined-up thinking, and maybe even bringing in the Department for Work and Pensions as well. The Tony Blair Institute has done some brilliant modelling with Frontier Economics around how different Government Departments can all benefit from this. If you have not seen that, we are more than happy to provide that report for you.

Do not worry.

In terms of the limitations of the OPIP programme, as it is known, my concern is that we already have a postcode lottery. There will be some brilliant pockets of innovation for those who have been successful in the OPIP programme. However, I know lots of ICBs have put a lot of work into their bids and unfortunately have been unsuccessful. I think it is a great start. Do I think it has gone far enough to level the playing field? I am not convinced yet, but I am very excited to see what comes out of it.

If no one else has anything to add to that, I am going to jump a question I had, because you have touched on it, Dr Doyle. In our evidence gathering, we have heard some very strong calls for the weight management services and treatments like GLP-1s to be nationally commissioned. Is that something you support, and what would it mean for your business if that did happen, Dr Seyan?

Pharmacy2U would absolutely support national commissioning but with local flexibility, though. Pharmacy2U would be able to support any commissioned service. We have experience with providing commissioned sexual health services in London and across England. We would absolutely support it.

Similarly, we would welcome the conversations to co-create and establish a commissioned service that will work through community pharmacies and, as I say, give people access to this type of treatment and care in their communities, delivered through community pharmacy.

Do you have a model in your mind of how that service would be designed in terms of the way you operate?

We have introduced an in-pharmacy prescribing service in recent months and we will roll that out. It is private pay because we don’t have a commissioned service to offer. We have plenty of experience and learning. We work with Government regularly on the design of services that work in community pharmacies, so we would have a model that we could share that could be commissionable.

Absolutely. The important point would be to design that in partnership with existing providers. If done well, that can form part of the growth agenda. I think if this is done as a static one-off national commissioning, then we risk blocking new innovators, which then reduces the growth agenda. National commissioning in a dynamic way that enables digital providers to showcase what they have and enables local choice, but without too many barriers in terms of multiple competitive tenders for innovators, could be a big piece of this solution.

How could the funding work and how could that be improved for a nationally commissioned service?

That is a really difficult question. If it was easy, we would already have a fantastic nationally commissioned service. My recommendation would be to consider how Government Departments can come together to tackle this from different angles. I firmly believe different Government Departments can seek benefits from treating obesity, whether that be reducing absenteeism, reducing long-term sick leave or reducing long-term conditions, so I think pooling the funding and rethinking how we commission it could really help.

There probably is learning from existing commissioned services, as I mentioned about the sexual health side of things, but there are others that exist. There is most likely to be learning from them, but I don’t have the answer, I am afraid.

Fair enough. Moving very specifically to you, Ms Nevinson, could you tell me about the decision to pilot an in-store service? What was your thinking behind that, as a company?

We have a good track record of delivering private services within our Boots pharmacies. We have successfully delivered weight loss services specifically through our online Boots Online Doctor service. We recognise that there is an opportunity for people who are perhaps not able to access digital services to access this care. We also have a growing capability within our network of pharmacies of independent prescribers, who are perfectly placed to train and deliver very holistic care to patients, particularly for conditions like weight loss. I think there is room for both. We wanted to give people the opportunity to access these services in-pharmacy. The beauty of the face-to-face consultation is that the pharmacist can also talk to the patient about other conditions. Typically, people living with obesity will have other issues and concerns, and of course we are perfectly placed to support with side effects, nutritional advice and everything else. We knew there was an opportunity there to do face to face. There is definitely room for both. We are seeing different types of patients accessing our in-store service compared with our online service, which proves the point.

May I add to that? I absolutely support Claire in what she is saying there. Having previously worked with LloydsPharmacy and LloydsPharmacy Online Doctor, similar models have existed in the past, for example, with the Gardasil 9 vaccine, the HPV vaccine. There is a portion of patients who will not be wanting to have a digital consultation, but want access. This was not freely available on the NHS at that time, so having that access in the community and digitally provides great access to the patient, basically.

You only started this in February, but what is your anticipation of demand? In the short time that you have had, is demand meeting that expectation or is it below or above the expectation you had?

Demand is growing. It relies on people knowing that we are offering the service. There is more work for us to do to invite people in to access the services in our stores. We are seeing the demand as we would have expected for a pilot of this size. By the end of April, we will be in 75 pharmacies, and we intend to roll out further after that. We expect to see the demand will increase, just as it has done with the online services.

Are you able to give me any numbers on that?

I don’t have the exact numbers to hand, but I am happy to share that with you afterwards, if that is okay.

That would be lovely.

That would be very helpful. This is a final question from me. Again, what we are trying to do is work out what the NHS can learn from all this. From your in-store experience, what do you think the NHS could learn from those pilots? Has there been any input, either from its side or yours, to share that information to improve NHS services?

We, as you might imagine, regularly speak to the NHS and talk to the policymakers about the services we provide. We are always willing to share the information or thought leadership or data to support the development of commissioned services. Like Kieran said, we have years of experience of delivering commissioned services through community pharmacy, so we would like to be able to take our private service and share that with the NHS as a model that could be commissioned. It is being developed in that way. With the success of other services that we provide through community pharmacy—Pharmacy First and the Hypertension Case-Finding Service—it is another service that fits into the service that the pharmacy already provides, so it makes sense for it to be commissionable.

Good morning. The NICE appraisal talked about the importance of wraparound care associated with the treatments, and the NHS England proposal talked about a number of different appointments that people required. Simon, I think you touched on the number of GP appointments. What does the wraparound care offer look like for your patients as part of the service you provide? I do not know who wants to go first; maybe Kieran and move left.

Yes, absolutely. We offer a structured clinical pathway. Every patient goes through a full clinical consultation. We have a multidisciplinary team—nurses, pharmacists, doctors, a nutritionist as well—so there is ongoing support. The patient is able to—

Is the nutritionist, etc, all included in the cost up front?

Yes. We have a patient record, and the patient can access that record at any point. They can ask the questions that they want to. We offer lifestyle guidance and advice during the consultation and post consultation as well. Then there is follow-up with the patient after two weeks. Whether they respond to the follow-up is different, but we offer the follow-up after two weeks.

Is that one-to-one support or signposted?

It is through their patient record, but yes, it is one to one, absolutely.

Human to human interaction?

Yes, that is right. Well, it is digital human interaction, yes. It is through the patient record. On top of that, we are expanding our wraparound service even further. We have a partnership with Reset Health, which is a NICE-approved support wraparound service, and we will be working closely with it to enhance what we have at the moment.

Every patient who accesses our online weight loss treatment service is, as part of that service, offered wraparound care, which includes live webinars, podcasts, resources, information and access to a clinician seven days a week. If they have any queries or questions, they can use our chat functionality to contact somebody and they will get a response pretty quickly. We also have an app that we encourage patients to sign up to, which gives them regular nudge advice on lifestyle, the importance of nutrition and exercise, etc. In addition, people who access our service for the first time have to collect their prescription from a Boots pharmacy, so there is that additional opportunity for the patient to have counselling directly with the pharmacist and again to access any support that they need through the community pharmacy setting. They stay with us for typically up to nine months at a time, and we encourage them to stay with us so that they have that continuity of care.

I will just point out at the beginning of my answer that I am representing five different organisations today. However, one of the pillars in our code of conduct is around that ongoing care. The baseline, even though the wraparound care may vary from organisation to organisation, is ongoing medical support or clinical support, so patients similarly have access to side effect support and titration support seven days a week. Some organisations have hotlines, some organisations do that via messaging, and it varies by patient choice as well. The other element that all our organisations supply is education and behaviour change, and that can be in different formats, depending on which company. That could be webinars, it could be one-to-one health coaching, or it could be an exercise programme, but all those programmes include nutritional support and exercise support as well.

The extra support you provide, is that all benchmarked into the price; there is no additional pricing? Are there additional options you offer to people with varying prices attached?

Everything that I have described is part of the package that everybody gets. We have an additional one-to-one coaching service that people can then add on as an addition to our main service. People have told us that they have had very successful weight loss journeys with that additional one-to-one coaching, so that is also an option if people choose to use it.

How much is that?

If they tag it on to the treatment pathway, it is £32 a month. If they choose not to use treatment but just to go for coaching, it is about £40 to £42. I would need to double-check that exactly, but it is around about that.

Kieran and Simon, is there any similarity in additional structured pricing options, depending on the level of support, or is it just one flat price?

Again, I am representing five different organisations, so there may be variability. There are extra options and they may include blood tests for some patients to be able to understand what is going on inside their body. That is included at a slightly higher price or as an option for patients to purchase separately. That will then also include an ability to go through those results with a clinician and get some real valuable insights.

Is a blood test clinically indicated? Are they recommended as part of the normal treatment pathways?

As a GP, I would argue anybody who meets the criteria—which all our patients do—for medication would benefit from screening for things like cardiovascular risks, cholesterol and diabetes screening. As a GP, if I was to start somebody on these medications for weight loss, I would be doing those baseline bloods.

If any of those issues come back indicative of potential low risk or high risk or diagnosed conditions, what happens to the patient then?

What do we do? Yes, it is a really fair question. We have really strong clinical protocols in place and we have a strong clinical team. All our results are viewed by our clinicians and we have clear escalation processes to senior doctors, and then we work with patients to manage them in the best possible way, including directing them back to their NHS GP.

Would that lead to additional services that you would provide and charge for or—

No, not at this stage.

So you just refer back to the NHS to deal with the issues?

Lots of the things that we identify are things that patients can action themselves. I would be mindful to point out that these are patients who are on a medication, so we may expect their blood tests to improve over time anyway. If we identify anything that is dangerous, that is beyond the scope or appropriateness of a digital model, then we would refer the patient to their NHS GP.

Kieran, Pharmacy2U suggested in its evidence that your sector could provide these services for £300 a year, compared with £1,200 a year. What drives that price differential?

It is a different model of care. It could not be a like for like comparison with the NHS, because digital offers scalable, efficient ways of working and clinically focused pathways. We ensure our practitioners—mainly independent prescribing pharmacists, but as I mentioned before, also nurses and nutritionists—are working to the top of their skill mix. That then frees time for the doctor, who can deal with more complex clinical cases.

Is there a sense that you are underpricing—that you are seeking to present quite a low-cost option, perhaps cutting back some things? I an not saying necessarily that this is what you get if you go straight to your GP, but I think NHS England’s guidance talks about the need for five psychologist sessions. We certainly heard in our evidence from people using the services that they would value more mental health support and more nutrition and dietician advice. Some people just want the medications obviously to get on, but in terms of longer-term, sustained change, not just an inject-and-go model is needed but a properly sustained investment in people and lifestyle change.

I do agree. We do not advocate for, as you mentioned, a jab-and-go type model. I could not comment exactly on the figures here. I am sure we can follow up with that. That is no problem at all. The challenge that we always have within general practice—again, this is not a new model—is I would diagnose someone with diabetes and I would be referring them on to a wraparound service, the DESMOND scheme, for example, when I was in practice. The engagement from the patient is something different. We would inform them of the benefits, the risks, the importance of carrying on with the wraparound service, but it does not mean that they are going to do so. We cannot mandate that you have to have wraparound service. You are right that it should not be a jab-and-go service, but not all patients will want wraparound. These are very well educated patients. They have been dealing with this chronic condition for a number of years and have been trying to fight against it for a number of years, so they know what their options are. Often the things that we offer in wraparound are things that they have done already, so they think, “Actually, I’m not sure that this will support me further”. I am not sure I agree with that, but that is some of the patient behaviour that we have seen.

This is perhaps a question for you all. How do you monitor engagement and take-up in the additional services you provide? Are you confident that the videos that you are providing, the consultations, are being utilised by the patient? We have all done online HR mandatory modules, where we click very quickly to get through to get it ticked off potentially, myself included, but how confident are you that the safety advice you are providing—the guidance, the webinars, the videos—is being used by patients?

I can speak for Juniper specifically. I do not have the exact numbers, but we have published a peer-reviewed paper on this, where we have split our patients into different cohorts of engagement. We have defined that in terms of their interaction with the wraparound care, basically. What that paper showed was those in the most highly engaged group achieved much better results than those in the lower engaged groups. We can forward that on, if you would accept it.

Yes, please.

We have done a similar thing. We can see how many people are accessing. Digitally you can see that; you can see how many people are watching the webinars and engaging with the podcasts. We know with our specific coaching service that patients lose more weight more effectively if they engage in coaching. I think the job of work for us all to do is to educate the public. You cannot force people to do these things, as you say, but we need to help people understand the importance of it. It is about offering what we can and encouraging and educating and coaching and counselling people to engage in the wraparound care, because we know that that really matters.

Can you do that in a light-touch model of prescribing, I guess that more sustained engagement and behavioural change, perhaps dealing with some underlying issues that are quite deep-seated and long term? People might have been battling with, as you say, different diet and exercise programmes, mental health issues or personal issues. Can you do that in a £300 model, where you get some online webinar options and maybe can chat with someone in a chatroom function?

Obesity is a complex condition. People living with obesity, as you say, have typically lots of other challenges that they are living with. Our job is to give them easy access to the support and to educate them through the journey, to provide them with access seven days a week to a clinician for whatever question they might have, to encourage them to come in to community pharmacy to talk to a healthcare professional when they need to. You cannot force people to do this, but you can encourage them to. The benefit of the GLP-1 treatments is that they experience weight loss successfully, more so than they might have done with everything else that they have tried before. What we found with our patients is that gives them confidence, gives them hope and they are more likely to feel engaged because they are seeing the benefits. I cannot comment on prices of different services, but certainly that is our approach—to really stress the importance of lifestyle and engaging in the support that we provide.

I think Juniper also mentioned that people are twice as likely to achieve weight loss in the model, to your point, Claire. What evidence do you have about the long-term and sustained impacts of your approaches around weight loss? I guess this is one of the common questions about these interventions with GLP-1. Are you seeing a year, two-year, three-year data at this point? What does that show compared with traditional prescribing models?

In this entire industry, that is something that we are all very keen to learn more about, whether that be from an academic point of view, clinical or society. I do not have the data right now, but it is something we are conducting at the moment as a research piece. I am not sure if we will have preliminary results by the time this Committee needs it, but if we do, we can send anything.

We would be interested at any time you get them, even if it is after we have published, yes.

Okay, perfect.

The study and data collection is under way. Do you have any sense—

Preliminary results? I don’t have anything that I am able to share at the moment, unfortunately.

I guess this is the billion-dollar question. With a low-touch model where you can get people access quicker, you might see weight loss quicker, but can a light-touch model keep it off longer?

This is a really important question and we really need to have the answer for it. The way I frame this when I have conversations with patients is if you were to do a very good diet with no other changes for six months and then stop that diet, absolutely your weight would regain. I think it is important to note that GLP-1s are not a silver bullet. They are a big piece of the puzzle here, but I do firmly believe that if we are using patients’ positive experience of weight loss to instil behaviour change as well, then my hypothesis is that that is going to have a positive impact in the long term.

Are you collecting any data that indicates that you are achieving behaviour change in terms of diet and exercise?

We have lots of anecdotal stories, and I am sure the other organisations do as well. I can collate some, if it is helpful.

Have any of you had data based on what your patients are sharing with you around that behaviour change point? I think that would be very interesting for the Committee to see.

Would you accept qualitative data?

Yes.

Yes, we can collate some. We have a moderated peer support group, where patients are very keen to share their stories of things that they were unable to do previously but are now able to because of lifestyle changes that they have made, so we can collate some stories for you.

Thank you. I am conscious of time, so I want to touch a bit more on the data-sharing issues, which you have already touched on to some degree, and access to patient records. Can you briefly talk generally about what patient data you have access to now? Is it variable place to place, GP to GP, patient to patient?

It will vary from provider to provider. Independent providers—this is very general—will not have access to the GP record so you are taking a history from the patient and making a clinical assessment as you would do in normal general practice, but you would not have the access to summary care records from that because that is prohibited, as Simon mentioned. It is a risk, and I am sure you are aware of that. It is a risk that has existed within the system for quite some time. For example, you can get a GP referral internally within an insurance company to a consultant but not have access to the GP record there and, as Simon mentioned before, a private GP. It is a known risk, and I think it is becoming more prominent because of the demand.

So none of you at the moment in any locations would have access to any—

Some CoRDH members do have access to the summary care record. There is only a small number of private providers who are granted that through a pilot programme.

In terms of risk around that and trust in the data you are given by the patient, do you hold that risk? Are you responsible for that risk?

Ultimately, yes, if we are providing the care, but that is why we have multilayered processes to verify the information that we receive. If patients meet eligibility based on an associated condition that they are telling us about, then all our member organisations will request proof of that. We are very keen not to increase NHS GP work, so that may include patients uploading their own NHS information, for example, from the NHS app or from their repeat prescriptions, and then one of our UK-registered clinicians will verify that manually through the photographs and cross-reference with the patients.

It goes the other way as well—that we should be informing the GP of any medication that we have prescribed as we would do in a private consultant consultation.

Is it standard practice that GPs would be kept informed?

We operate on a consent-based model across the group. Different organisations may interpret that differently, so some organisations automatically inform general practitioners; however, some operate on patient consent. Again, that is similar to how an NHS sexual health service might prescribe very high-risk drugs needing monitoring but the NHS GP may have no idea because of the patient’s consent. It is an inherent risk. It is not unique to digital or private providers but it is something that we have processes in place to mitigate.

You mentioned a pilot programme. I do not think we are aware of this pilot programme. Would you send us some details about it?

You mean the summary care record?

Yes.

Absolutely we can send you the information.

That would be very helpful. I do not think we have that.

That is helpful. Are you aware of any instances where the incomplete records or medical records have created any issues around prescribing or complications, or any challenges for any of your patients? Has that been an issue?

I cannot think of specific examples or talk to specific examples. However, across all healthcare settings we operate in risk. That is why healthcare professionals exist—to be able to help patients navigate the risk and benefits and make choices that are correct for them. To reiterate the point, that is why we are really strong on multilayered processes of making sure that we have the right patient, making sure that we are happy that their BMI lines up with what they have told us, and making sure that we have as much information as possible to reduce that risk.

I understood from your earlier discussion that you are keen to get wider access, having the single patient record access in future. Is your general position that that would be helpful?

As a GP I would always welcome more information. The more information the better and it would certainly reduce friction for the patient. Ultimately, we are asking patients to do that work for us in the meantime to provide that proof because we will not prescribe without the satisfaction that the patients meet the criteria.

A couple of you have leant upon sexual health services as an example. One of the common complaints in sexual health services is that there is inappropriate testing by private providers that would not be recommended and increased referrals to the NHS through inappropriate tests that are conducted. These could be genetic tests and other things that are not clinically indicated that the private sector often do or tests that are not recommended. Secondly, the private sector also cherry picks the easiest patients—the most educated, I think you talked about—for profit, and the more complex patients, or if there are complications, are then referred back into the NHS system. Do you recognise any of those concerns or questions in this space if the model develops further?

I understand where the concern comes from and it is probably myself who has leant on the sexual health analogy because I used to work in sexual health so I am just very familiar with it. In terms of the question around whether things are indicated, all our organisations do things that are in a patient’s best interest so, as I mentioned earlier, the tests that we may offer to patients would be clinically reasonable to do. That is where I would stand on that point.

Do you have any data around the number of patients you will refer back to the NHS or their GP about matters that you have looked into and tested for? If someone was struggling with their mental health, do you refer them back? I am not saying you should not do that, but do you have any sense of the number? I think someone said you were supporting a quarter of a million people on GLP-1s. What level of additional referrals come from the patients you are seeing?

I do not have that data, but as a group I can go back to the other organisations and see if we can aggregate some numbers for you.

That would be helpful. Thank you very much.

Thank you all for coming. I am now going to talk about the people who probably would never have come had we even asked them and these are the unregulated prescribers and people who are doing inappropriate prescribing. There is huge public concern about this. I have taken a particular interest in it and have met families who have quite literally lost loved ones to receiving illegal jabs. We have had disturbing evidence from organisations such as PrescQIPP CIC that talk about people who have a history of anorexia being prescribed jabs to obtain the bikini body. They have also raised concerns about post pregnancy, especially with mothers who are still breastfeeding—obviously counter-indicated by any of the licence but nevertheless they are getting them. What more needs to be done to ensure that organisations that are prescribing to the licence are not inadvertently tainted by those who are not? Can I urge you to not hold back? You are covered by privilege as we are in these sessions. Earlier you declined to talk about some people who you might be aware are doing this. Please do not hold back. Privilege means that you can speak freely because if we do not get to the bottom of this unregulated wild west market everyone is at risk, in some cases fatally so. I will start with Dr Kieran Seyan.

The challenge that the regulators face is that the scale of innovation for digital providers is so fast, and there is a lot of funding that is behind that as well and able to provide the models that we have been talking about. It is difficult for the regulators to keep up. We do have engagement with them. A similar coalition to what Simon mentioned before is DiCE, Digital Clinical Excellence, which is an industry forum with regular interaction with the regulators to inform them of what, dare I say, good providers feel is best practice. We should be working closely with them on what those guidelines are looking at. The challenge that they face is the speed to be able to look at all the unregulated providers that are out there. That could be from a GPhC perspective, a pharmacy perspective or from an MHRA perspective as well in getting the illicit drugs. My personal concern, which may not be shared across the group just yet, is we have just seen semaglutide, Wegovy, go off licence in places like India. This is going to be manufactured on a wide scale—not that it is a dodgy drug, but access to that illicit market may increase then as a result. Are we going to see more of this and are the regulators ready for this? We have seen it before. We saw it with PrEP. PrEP was not freely available in the UK and even healthcare practitioners were advising patients to get their medication from abroad. We have precedent there that it is going to happen—less likely so because it is cold chain, but that may be removed in the future so it makes it more difficult. I would say it is a regulator challenge without doubt and the resource there and the engagement—

I am looking for specific things that we need to recommend to Government to get ahead of this. Right now we are way behind and the number of families and people who are affected by this, young girls who are finding a way to get this—I will come to how they do that in a moment, but they are getting it illegally from abroad and some people have died. Give me three things that you want to see the Government do, whether it is more resource to the MHRA, which is one I heard. What are another two?

It is across all the regulators, I would say.

All of them?

The regulators keeping up to date with digital practice. We are going to see more and more, things such as artificial intelligence and so on, coming across the board and they are not keeping up to date with that as far as I am aware. Those are my top two, I would say.

Something important that we can all do is cut through the misinformation and the noise on social media by providing better information for patients and educating the public to identify what is the right way to access weight loss medicines and what is not. We need to help the public to understand and identify where they are finding this information and to nip it in the bud through the regulator, but we need to be able to educate people better about obesity and safe weight loss. We all have in our organisations channels to be able to talk about these things responsibly, but we need the Government to bring this to the forefront.

What specifically do you want the Government to help to do?

Better patient and public education on safe weight management services.

Is one of the issues here that the way we see obesity is almost like a beauty issue rather than a medical issue? Many of the people at the roundtables that we heard wanted us to—I think Kieran called it a chronic condition earlier, and one of the conversations we have been having is whether it should be called a condition or a disease. Would you all agree that it should be classified by Government as either a condition or a disease or either/or? What is your preference?

That would be my third thing.

Stop talking about weight loss drugs and talk about obesity.

Obesity as a disease?

As a disease or a chronic condition.

Do you prefer condition or disease? Which one do you prefer? Does it matter?

It depends how the public will relate to it, I suppose, and understand it.

I think the patient voice is very important in that. We have probably fallen into that trap previously with things such as chronic kidney disease, and that causes problems for the patient in how they interpret their own condition. I think involvement from patients rather than just us as providers would be the important missing bit there.

How about you, Simon? What else needs to happen?

To build on those, I think avoid broadbrush strokes, so avoid tarring us all with the same brush. It is about working with responsible providers to build proportionate and effective evidence-based regulation so that we can do things correctly, which leads into Claire’s point around making sure that we are putting out proper and reasonable information so that patients have an alternative choice. If providers like ourselves are removed from that conversation in contemporary media, whether that be online or adverts, then that only leaves space for bad actors who will fill that gap and patients will still find a route to that. The recent report from Lilly UK and the Patients Association a few weeks ago showed that the no. 1 reason patients choose the black market is because of reduced access, so my concern would be that regulation falls on the wrong side of responsible and shuts down the opportunity to provide responsible information and access.

Let’s get to the AI point. One of the ways that we know people get through the various gateways is that they are able to manipulate digital images. It is much easier to manipulate a digital image—although I have yet to work out how to make myself look skinny in real life without some filter on everyone else—so this is the big issue that I think we are concerned about currently. How are we going to get ahead of this? In your own organisations you have given us evidence about what you do. Pharmacy2U spoke about sophisticated algorithms that gather the complete medical history and then scan. Can you give me just one example of how exactly those algorithms work?

Are you talking about verification or the clinical assessment?

Yes, to get it in the first place. Let’s focus on just that very first prescription. How does someone access it? What does that algorithm do exactly?

The structured clinical pathway is basically where the patient would be—if I was doing a history for a patient one answer would lead to the next question that I would have. Our algorithms work in a very similar way. The most important thing I think you touched on, which I feel very passionate about and have for years on this, is around the identification side of things. How do we know who we are treating? Robust identification verification is very important there. As far as the body mass index is concerned, we only do video verification, so real-time video verification where the patient must upload it live. There is no ability to manipulate it at all so we have not come across the issues that I know some other providers have had with AI manipulation.

Did you always do that?

Yes.

Yes, but Boots did not always do that. Was it Which? that looked at how people could access a consultation and it was an upload of a photo, so has that changed?

Yes, it has. That technology allows us to introduce better safeguards. We have exactly the same, live photograph upload so it cannot be manipulated. We have also introduced—

Wait. Live photograph upload—what does that mean?

You must take the photograph live and upload it into the system, just as Kieran has described, so you cannot take an image and modify it and then upload it. It must be done at the time, so it is real time.

It is done through your app or whatever so you can control it?

We also have an additional safeguard. Certainly, for people accessing it for the first time they must go into a community pharmacy, and should a clinician from our online service have any queries or concerns about a patient’s BMI, then they will be asked to weigh them again in the pharmacy. We have introduced that as an additional safeguard.

Similarly, just to be really clear around the difference between video and live photo, all our organisations have also implemented live photos to reduce the chance for patients to be able to upload from their gallery or a photograph from two years ago or something that has been edited by AI. With all our organisations they must open the camera within the flow of the app or the website and take different photos there and then. That cannot be modified by AI. What we have found is that it is different to having a live video with somebody Facetiming, for example. However, we find that to be safe because it reduces or eliminates the chance of AI. That is the type of thing we want to work on with the regulator so that they understand the nuance of digital health and introduce proportionate and appropriate regulation.

Your coalition represents what you are referring to as the responsible pharmacists, which I assume means that they follow both the letter and the spirit of the various regulators’ guidance. Is that right?

Correct, yes.

I was a bit confused because the Advertising Standards Authority does not allow direct to customer advertisement of prescription medication; is that correct?

Of prescription medications, yes.

When I google weight loss drugs, one of the sponsored results is the pharmacy Numan, which is one of your coalition, and it advertises on the basis of a discount for the initial few months that people do it. The headline, when you google, is, “Now £55, was £139. Lose weight from £55 a month.” Do you think that is following the spirit of the guidance?

I think the thing to be mindful of is all our providers are offering a service. We are not a transaction; we are not offering a medication and then no further follow-up. I think if there is any concern that any breaches have happened then we all have processes in place to redact any adverts that the ASA is concerned about. Again, we are very happy and want to work with the ASA to get that right.

You would wait for the ASA to flag it rather than having concerns about what appears to be direct to customer advertisement when you google weight loss drugs?

In terms of advertising a service, I do not think there are any breaches in advertising a service. The concern is around advertising medications. I am not sure of the specifics of the advert you are referencing, but if there is any concern that that is advertising a specific prescription medication, then that should be redacted. However, if it is advertising a service, this is the type of thing where we want to work with the ASA to make sure patients are informed of reliable providers who are regulated rather than being pushed down alternative routes.

Kieran, your written evidence suggested that we need stronger action to prevent unregulated operators. We talked about the top three, but should we not be taking a much more cautious approach to this, where someone must prove that they are doing things properly otherwise they are not allowed to sell these drugs? That would make it so much easier for social media companies and the advertisers to know who to allow to advertise and who to allow to sell it. What we seem to have is a market that is rapidly innovating and we do not even know the size of the unregulated market, but by the sounds of it from the number of whistleblowers and stories that we are getting it is potentially huge. I do not know if you guys have done any work about this because it is a direct issue, I would imagine, for your companies and we would love to hear about it if you have. Should we not just be taking an ultra-cautious approach until we have reached a stage where we know what it is that we are doing and we can properly safeguard people?

Could you clarify ultra-cautious for me? What do you mean?

I am looking to you guys. At the moment the default position for a consumer is that anyone who can sell this is doing it in a way that is right. If you had far fewer people doing it but with a much stronger kitemark endorsed in a way by Government, then they would be able to sort the wheat from the chaff. At the moment there is so much noise out there and there is so little access that they are getting it from anywhere and just assuming that it is a medicine and is therefore regulated and that is the end of it. There is a lot of onus—I think Claire mentioned this—about education on the public. I wonder if that is fair at the moment because there is so much that is new that they are going to the first place that seems to be doing it well. What would you say to that?

In principle I would agree. I go back to what Simon mentioned. It is not a broadbrush approach. Actually it is about working with Government or the regulators on what a good service looks like—what is best practice, basically, within the digital healthcare field, because we are the experts. Reputable providers have been doing this for a number of years, so we should be working together to see what that looks like. Unless you meet these certain criteria, then you should not be practising. Absolutely I would agree with that. That is a challenge and we do not—

What about it is challenging?

The acceptance of innovation. Where we worked with regulators in the past, because the advisers are not necessarily very well informed about the work that digital healthcare providers do, they can go more conservatively, whereas, as I mentioned, we have been practising for 20 years and we know what is safe. We have good risk analysis and robust clinical governance around it. As long as that clinical governance exists and we can advise the regulators on this, then I think the risk reduces.

So you think the regulators are too cautious and by being too cautious they are not allowing the innovation that would be safe to increase access, which itself is a thing that is going to make it all safer. Have I understood that correctly?

Yes.

I think we have definitely moved some way in this space, particularly with the GPhC and the CQC, which regulate our services. The GPhC has issued standards for online pharmacies and for the provision of services such as the services we are talking about, so the rules are there and the standards are there. We have challenged them; we have co-created them; we have presented examples of good practice. We have done that as a collective through the Digital Clinical Excellence network, so I think the regulators are definitely learning and trying to keep up with the innovation. The challenge that they have, to your point, is that there is such a rapid rise in people setting up services and the regulators require resource and capacity to catch up with them. What we do regularly is meet with the regulators as a group and we will tell them where we are seeing or picking up poor practice, or it has been reported or we have noticed it, and we do flag it to them.

Do you know how many companies you have reported?

Not off the top of my head.

Can you get us that number?

We can have a look at that for you.

And write to us about who they are. Could you do that and could your coalition do that, too?

Yes, I can speak to the coalition.

That would be very helpful.

It is about helping the regulator to understand what good practice is and isn’t, and being really clear and helping them on this journey of understanding how technology is evolving and how we need to use it but, as you say, taking quick action when we have a concern.

I think it is about quick action. I agree with that.

Quick action and I am hearing resource as well. Okay. We must end there because we have to speak to the regulators, so thank you very much. Witnesses: Andy Morling, Neha Ramaiya and John Spoors.

Welcome to the hearing. Thank you also for being in the room and I think hearing most of the first panel. Can we start with who you are and your organisation?

Good morning. I am John Spoors, the programme director for commercial, managed access and medicines policy at NICE. It is lovely to be here.

It is lovely to meet you.

I am Neha Ramaiya, lead clinical adviser at the GPhC.

Good morning. I am Andy Morling, head of the criminal enforcement unit at the Medicines and Healthcare products Regulatory Agency. It is good to see you all.

Thanks, panel, for being here. I am going to focus on questions around side effects and NICE appraisal. I will start with Andy and the MHRA. GLP-1s as we know have a long-standing history. They have been used for more than a decade to treat type 2 diabetes so we are well aware of their profile in that regard. In terms of side effects that we are seeing for GLP-1s being used specifically for weight loss, is the side effect profile similar to the side effect profile you have seen for type 2 diabetes or different, and if different how so?

My understanding is it is similar, primarily gastrointestinal—vomiting, diarrhoea, constipation and those kinds of things—generally not severe, although that can be the case in rare cases. Broadly it is the same side effects—in most cases not severe but in exceptional cases there can be severe diarrhoea and gastrointestinal issues. But that is very rare, I am pleased to say.

Okay, so just to be clear, you are not seeing any difference in the side effect profile from a type 2 diabetes patient using GLP-1s to a non-type 2 diabetes person using it for weight loss? The side effect profile is reasonably similar?

That is correct.

Given that GLP-1 products have not been used as weight loss tools for nearly as long as they have been used for diabetes type 2, are you concerned about an increase in side effects being reported as GLP-1s are used more frequently for weight loss?

We have had many reports and those are, one would imagine, to some extent related to the publicity surrounding GLP-1s for weight loss. We tend to find that when new medicines come on to the market or for new indications reports into us of adverse effects go up.

Just to be clear there, you are not seeing more side effect reporting for the new use of this established medicine than you would expect? Is it within expected parameters?

Yes. There is no normal, sadly. I wish I could give you a bit more—

You have data across a wide variety of medicines so you can see the parameters of what you may expect.

We do, but to some extent this is a self-selecting audience of reportees. It does not necessarily indicate prevalence, but we have had a high number, as I said possibly because of the fact that this is widely known and now widely used. It is hard to get causality from this data.

I appreciate that and I appreciate the prevalence issue. While you cannot take an accurate indicator of prevalence from reporting, again given the extensive licensing that MHRA has done over the years, is the reporting that you are seeing, taking into account the self-reporting nature of it and the private prescribing of this medicine, broadly what you would expect to see in terms of the side effect profile and reporting?

It is not outside of the parameters.

Okay. That is helpful. Let’s talk about how you are getting this information. As we have talked about, there is currently large private use of GLP-1s and we have the yellow card system to monitor side effects. Is the private use of GLP-1s having any effect on the return on yellow cards or are you seeing other ways of it being reported in?

We certainly encourage yellow card reporting regardless of the prescribing route. We do not regulate the prescribers, as you are well aware. We would certainly encourage that reporting and we do go out looking for it. We do encourage private prescribers.

When you say you go out looking for it, what do you do?

We speak to the trade bodies to make sure that they are aware of yellow cards. We promote yellow card more broadly within the professions, so we encourage reporting where we can to the yellow card and we have seen that. I do not have figures as to the level, but certainly we do have—

It would be interesting to see those figures.

I will see if we can get those.

The yellow card reporting has been around for a long time and there have been conversations about whether it is fit for purpose or they need to use something else. Your opinion is yellow card reporting is still the best way of assessing side effects coming forward or adverse impact?

I think I would probably say the least worst.

We have heard that before.

It is what it is and I hate that expression normally but it gives us access to information. How reliable that information is, what conclusions can be drawn from it, is another matter but I would certainly rather it was there than not.

That is interesting. We will not go down this rabbit hole too much, but over the years have you found the yellow card reporting system by and large with your licensing of different medications a reasonably reliable indicator of when there are issues that need to be acted upon?

Yes, it has certainly given us signals that we have acted upon in the past.

Neha, do you have any reflections on that from a pharmacy point of view, in terms of the monitoring of side effects and how you are able to report it?

Are you asking in relation to the yellow card?

Yes.

In relation to the yellow card system, as my colleague mentioned we have had conversations with the MHRA about it quite recently as well; not related to weight loss but more broadly we have included it in our emerging concerns letter, which was sent out in December to encourage pharmacy professionals to report any side effects that they see. The last point in relation to yellow card that I had was in our updated guidance for online pharmacies we mentioned yellow card reporting within that, particularly because quite a few of the weight management medicines—and correct me if I am wrong—are black triangle medicines, so they are newer to the market. With the extensive monitoring that is required we felt that it was important to bring that yellow card reporting aspect to the guidance as well.

That is very interesting. In terms of online pharmacies are you seeing a proportionate reporting to the in-person pharmacies or are you seeing lesser reporting?

That is not data that we have direct access to.

Okay. Does somebody have access to that data?

I am presuming the MHRA.

I am afraid I don’t know but I can certainly find out.

If you can find out that would be very interesting. Online pharmacies are becoming more prevalent and people are increasingly using them, so it is good to know if our reporting systems are fit for purpose in the digital world. Thank you. I will move on, John, to NICE appraisals of these weight loss drugs, which are quite interesting in terms of what the understanding is now with NHS provision. For the record, you have basically made a positive recommendation for the use of this medicine now. Just for the record, could you explain very quickly how you have come to make that positive recommendation for GLP-1s?

Yes, sure. I am very happy to do that. We have evaluated three GLP-1s, liraglutide, semaglutide and tirzepatide, which you are referring to. As I am sure the Committee members are aware, NICE uses the QALY, which is the standard health measure that is utilitarian in the way that it resonates with the NHS. So a QALY is a QALY whether it is cancer, whether it is multiple sclerosis or—

Sorry, just to go back, because the public are watching, John, can you explain quickly what a QALY is?

Yes, sure. A quality-adjusted life year, apologies. Then what NICE does is it takes the evidence from the manufacturer on the clinical and cost effectiveness, and then independent and transparent committees assess that evidence with an academic critique of the manufacturer’s submission. We weigh up the health benefits versus what the costs are and the additional costs. I think today we have heard of the importance around the wraparound care that is all included within the appraisal. We also look at things such as the ability for weight gain to come back on post the stopping of the treatment. That is all included in the cost-effectiveness assessment. Then at NICE we have a standard threshold. We say if it is between £20,000 and £30,000 per quality-adjusted life year, that is a cost-effective use of resources. For all three medications we have been able to recommend those for use—

What do they come in at for the QALY?

For the cost per QALY, when the independent committee looks at the evidence it takes a number of things into account. For the weight medications, it looked at the uncertainty of the evidence base. It also looked at the scale of the budget impact. Depending on what that looks like, the committee can go to the top end or the bottom end. To directly answer your question, all three appraisals were at the bottom end of the £20,000 per QALY.

That is very interesting. Again for the record, basically once NICE makes a positive recommendation, NHS service providers are required to make it available to patients within three months as a default, but there is an exception to that. Based on your recommendation, NHS England estimated that 2.8 million patients would become eligible to use Mounjaro within 90 days of the final draft guidance being published. If all these people presented for treatment in the first year it became available, the cost of providing this medicine and wraparound services, as you have indicated, would be £15.2 billion over five years. Going back to your appraisal, John, how much did you take into consideration that particular price tag?

I think particularly at NICE when we create our guidance we are very cognisant of the impact that it has on the NHS. In fact, that is why we have a world-leading process. We involve stakeholders throughout, whether it is patients, clinical experts and indeed NHS commissioners.

So what did your world-leading process think about £15.2 billion over five years?

This is why we worked with NHS England and it requested what is called a funding variation. That has been used very exceptionally in our 25-year history. It has only been used four times and we have published over 1,000 pieces of guidance. For the scale of what you said there, the reason that a funding variation was put in place was to ensure that the NHS had a sustainable and manageable plan to not only manage the cost but also the impact on services. As you are aware, tirzepatide can be used in primary care, while liraglutide and semaglutide were limited to specialist weight management services.

Sorry, John, we are time pressured. You came to an understanding with NHS England, which you have only done four times previously, that all the eligible population will be able to be prescribed Mounjaro for obesity within 12 years.

Yes, and then crucially I think what was important with that is we included a three-year review period, so the funding variation had three parts to that. It had an 18-month period and then up to three years, and I think that three-year period is important because what NHS England was saying is it was looking to prioritise the patients with the highest clinical need. I think it was looking to achieve 220,000 patients on treatment at that point, so that was what was agreed.

I understand that, but over the course of 12 years the highest priority people, who may not be high priority now—I am surmising this—may well become much higher priority in those 12 years. At that three-year review period if we have been reasonably unable to spend £15.2 billion over five years, has NICE factored in the fact that, given we have not been able to address the issues immediately, the price tag may be considerably higher?

I think at that three-year review period there will be data available on the various models that NHS England is trying. There will be data available on the uptake of patients and indeed the costs, and all these things will be factored into that three-year review period. The other thing to mention within that three-year review period is, of course, the market in obesity is not static. We are expecting oral GLP-1s to come and we are starting to appraise those at NICE as well. I think there are various factors moving that will be considered at that three-year review period.

Excellent. I know that you do appraisals on all sorts of things, including other weight management programmes and prevention programmes. With that £15.2 billion, has there been any comparison at NICE to the opportunity cost for investing in other effective weight management programmes or prevention programmes?

Is obesity unique in terms of the size and the scale? Absolutely, but NICE has a remit to evaluate all new medicines and new indications that come before it. I think it is a broader question and this is probably one where obesity does straddle the two between public health and treatment. Of course, in our NICE clinical guidelines and our quality statements we take a broader view, but I do not think that within the NICE technology appraisal it is our job to suggest whether that £15.2 billion should be spent elsewhere.

No, I appreciate it is not your job to have an opinion on that, but in terms of an appraisal looking at the opportunity cost, so how much bang for your buck you get in other areas of obesity treatment—other weight management programmes and/or prevention—is that something that NICE has looked at?

For sure. What the NICE appraisal committee says when it reviews it, and it does take into account opportunity cost, is that with the evidence provided in front of it for the drugs, taking into account things such as weight regain, the NHS and NICE think it is a clinical and cost-effective use of NHS resources, taking into account opportunity costs as well.

So taking into account all the other things that could be put in place to prevent or reduce obesity, NICE still thinks that the £15.2 billion should be spent specifically in this area, or the opportunity cost is taken into account?

When NICE does appraisals it is not just the opportunity cost within obesity. We look at the opportunity cost in the whole of the NHS and that is why we have the cost-effectiveness threshold set at £20,000 to £30,000.

The cost-effectiveness appraisals that you have been talking about have taken into account the benefits—well, you have taken into account weight regain and you have looked at that. Have you looked at individuals with more severe or more complex obesity and looked at the fact that the cost effectiveness may be better for those higher-end obesity cases? I think you have alluded to this in your priority case, but it is just to be clear for the record.

Yes. When NICE evaluates a product, you have the licence from my colleagues helpfully at the MHRA and then they look at various subgroups within the cost-effectiveness assessment. In our appraisal, again to give tirzepatide as an example, those with a lower BMI were not cost effective, which is why our recommendation is for 35 and above plus one comorbidity, so that is built into the assessment. The other thing I would say is that if you look at NHS England’s implementation plan, again the cohorts that it utilises prioritises those with the highest clinical need.

Okay. My final question is around service provision, so perhaps coming to Neha. John has alluded to the potentially overwhelming nature of this around service provision. I appreciate you are pharmacy specifically, but does your particular area have thoughts on whether pharmacies, and primary care if you want to speak about it, will be able to provide this level of input for the number of obesity patients coming forward?

It is difficult to say because as a regulator from a pharmacy perspective the provision of medicine is coming from private sources mainly, so it does not apply to NICE and NICE’s TA. It is difficult to say whether that would be the case.

Given the opening up—the 220,000 patients—it looks like the NHS is saying, “Okay, we will move forward on a cost basis as an agreement with NICE.” Do you think pharmacy providers will be able to undertake some of that?

It depends. Pharmacy provision is in two formats. There are the private ones, which we have heard from earlier today, but there is also NHS provision, so it is dependent on how much commissioning goes towards the NHS pharmacies and whether they can afford to provide those services, and whether they have the right staffing capacity and training to deliver that is dependent on the funding model that supports that.

Is that funding model clear yet?

At present I am not sure if that is clear.

Okay. That is very helpful. Thank you.

India is now rolling out generic Ozempic. What assessment have you made or do you have any general sense of what the availability of generics might mean for that QALY assessment and the £15.2 billion price tag and when that may be applicable?

I am happy to report that I contribute to a biosimilar taskforce, which works across the Department of Health, the MHRA, NHS England and NICE. When the patent expires the prices start to drop, so I think what is really important is that NICE’s guidance is a snapshot at the front end of appraisal, but when a biosimilar becomes available or a generic becomes available, or indeed new clinical evidence for a product—

Do you get a sense of when biosimilars may be available?

I do not have that data to hand but I would be able to get that for you.

Could you write to us?

Of course. We would be delighted to.

Could you give a sense of what that might mean for that £15.2 billion?

Yes. I think there are two elements to that. I think the availability of a biosimilar can produce potential cost savings, but then at the same time, as I mentioned, there are new oral drugs coming on to the market that might offset that. I think liraglutide is coming off patent. The other thing to mention there is that liraglutide is a once daily injection versus semaglutide once weekly, and patient preferences come into account as well. While the potential is there for savings, again there are things that might mitigate that.

John, if I could turn now to wraparound care and NICE guidance on that, during our inquiry we have heard about the importance of wraparound care from those with lived experience and from myriad professionals. Do you have any insights you can share about where and the extent to which the standards are being met for quality statement 6 for obesity treatment?

NICE does not collect individual patient-level data, but when we put these quality statements out, both in terms of our quality statements and our clinical guidance, we regularly expect the NHS to take those into account when making decisions, but we do not formulaically collect individual data in terms of how that is being adhered to. The one thing I would say is that the wraparound care, as you have heard today, is very important. That is why that is prominent in all our guidance, in all our quality statements, in all our clinical guidelines, in terms of pharmacotherapy being one potential option and the importance of the wraparound care to the holistic patient journey.

If you do not collect the data on it, where does responsibility lie for monitoring the quality of that wraparound care?

I am happy to take that back to NICE and write to the Committee in terms of what the actual uptake of that data is and adherence to that, if that is okay.

That would be helpful. Is there more that regulators could do in this space, and what would be needed from the Government to support that?

That is a great question. I would be interested in my colleagues’ views. NICE’s view is that the holistic patient journey is extremely important. What resonated in the last session was the importance of education. NICE is an evidence-based body, and I hope that comes across in our written submissions and what I am talking to you about this morning. Education, and what the evidence shows us, is really important. I was struck by some of the comments made in the first session, and I think support from the Government in terms of what the evidence shows and how we can get that education to potential patients in the NHS is going to be important.

You do not currently collect data around where the extent of wraparound care is taking place?

We do not, but I think as part of the three-year review the NHS should be collecting data on the uptake, not just the drugs, the wraparound care, the uptake, and patients’ experiences. That will all be fed into the three-year review of the tirzepatide appraisal.

Is there a gap, therefore, in the evidence base for this, as you are an evidence-led organisation?

Yes. I think the NIHR, the National Institute for Health and Care Research, also commissioned a study particularly looking at the implementation of tirzepatide. In our written evidence to the Committee we can certainly pick that back up as well. I think the only thing to say, and I think this is quite important, is that sometimes people assume that a NICE recommendation is a mandate to prescribe, and I think that is very important. It is not a mandate to prescribe; it is a mandate to fund, and that should be based on the choice between a patient and the clinician. Likewise, our clinical guidance, whether it is a clinical guideline or a quality statement, is very much to help inform and empower clinicians to take the right decisions for them and their patients.

I am trying to get to the heart of whether you see that guidance being implemented when it comes to the wraparound care side of it. We obviously have data on the use of prescribing, but not necessarily on that holistic side. It sounds like at the moment you do not have data on whether that guidance is being adhered to.

I cannot say today whether we have specific data, but I am very happy to take that question away and come back to the Committee.

That would be helpful, thank you. Moving on to more data-related questions, is there any data that you can share around the extent of inappropriate prescribing, which has come up repeatedly?

I do not think that would be a question for me. That might be a question for colleagues at the MHRA.

We do not hold data on inappropriate prescribing either. What we do have is data on the concerns that we receive, but they would not necessarily relate to inappropriate prescribing. Some of them are related to customer services or other issues in relation to weight management services.

Would it be based on concerns being reported to regulators?

Yes. It is not just concerns reported; it is also information from our inspections, concerns being reported by healthcare professionals, members of the public, whistleblowers—anyone, basically. Anyone can report a concern to us about a provision of any pharmacy service or pharmacy professional.

Are you confident that that data that you are able to collect from this method reflects the accurate situation on the ground?

That is not the full level of what is going on on the ground. As a regulator, our role is to regulate pharmacists, pharmacy technicians and pharmacies, and part of that includes fitness to practice and dealing with concerns that come through.

Are you taking action to address inappropriate prescribing? Is there more that could be done in this space?

Again, as a regulator, one of the other things that we have is an inspection function to inspect pharmacies as well. Our inspectors inspect all pharmacies, but in relation to weight loss services they will inspect pharmacies that provide weight loss services. They will gather information and evidence against the standards that we provide and either pass a pharmacy that is doing it appropriately or fail them, provide improvement notices, etc.

Just to be clear, is that also online pharmacies?

Yes, also online. Any pharmacy that is registered with the GPhC will be regulated by us. To be clear, and to make sure that the Committee understands, some providers are not pharmacies. They are also registered by the CQC and they are providing a prescribing service, and those medicines are then dispensed elsewhere, possibly by pharmacies that are regulated by us. There are different models of—

What do you mean? I am sorry, I am lost.

You can get online pharmacies that are dual regulated by the CQC and GPhC. That is because of the way the provision of the service is happening. CQC would regulate the prescribing service and GPhC would regulate the provision of the medicine. There are other services that are only pharmacies because they are provided by pharmacists and pharmacy technicians only. Then there are other services that are outside of the UK’s regulatory remit, because they are services provided by the EU. Those prescriptions then are legally valid in the UK. The prescriptions are coming over. The prescribing service itself is unregulated by any UK regulator.

Are you co-ordinating between you to make sure everyone is covered?

We cannot co-ordinate with the non-UK regulator, but yes, we work closely with the CQC, the MHRA and others.

Do you feel that there is a bit of a gap then that lots of people can fall through?

Yes, there is a regulatory gap there.

Is there a risk that if the UK online and offline markets are regulated people will then opt to go elsewhere? Does that cause concern for you?

It could cause concern, and it does cause concern. One of the things that we are doing at the moment is working on a social media campaign to help the public understand how to buy medicine safely, making sure that pharmacies are registered and showing them how to check that a pharmacy is registered. We are working on that at the moment to help address that concern as well.

What measures have you got in place to address whether or not the actions you are taking are successful?

In terms of our concerns at the moment, we had a steep rise in concerns between the year 2023-24 and 2025-26. Generally, quarter by quarter, we have seen a rise in concerns related to weight management. We did see that dip over the last quarter, and—we presume this is off the back of our updated guidance for online pharmacies—we are starting to see more concerns related to patients being unable to access medication because they are being challenged on appropriate weight and ensuring that their weight is appropriate, asking for more evidence about their history, etc, which is what we strengthened in our guidance that was published last year.

Is there a worry that people unable to access medication via UK online or offline routes are then going elsewhere?

There could be, but in terms of the UK remit, that is a good thing. We are seeing more concerns raised by members of the public that it is becoming difficult to access medicines because they are being asked the right questions. The concerns in terms of patients inappropriately being prescribed medicines or patients accessing medicines because they should not have received them, etc, has dipped slightly, and we are seeing more of the other ones instead.

In your role in this space, do you have any measures of success regarding whether you are able to clamp down on inappropriate prescribing? Are there more regulations that you are looking to bring forward or where is your—

The MHRA does not regulate prescribing practice, so that would fall to others. There is a spectrum we see when we are looking for the illegal online sellers of these medicines, and that is a very different thing—the far end of the spectrum, if you like. Then there are the genuine prescribers who are private prescribers at the other end of the spectrum. What we see is a bit of a blurring of the lines between the two, where there are illegal medicine sellers purporting to be prescribing, when in fact it is just a front for an illegal online pharmacy. It is difficult for the public to tell the difference sometimes between the two.

What do you think is needed then? Is the regulation fine and sufficient in this space, or is there something different that needs to—

Inappropriate prescribing is a term we do not recognise, because it is not within our regulatory remit. As a law enforcement person, I would prefer the person accessed the correct medicine, the genuine medicine, than had recourse to the black market where they will be getting anything but that. At least what you term as inappropriate prescribing would generally result in the genuine product being dispensed, which is a broadly positive thing.

Would you consider including a contraindication for use on GLP‑1s below a minimum BMI? It seems like what you were saying is that could push more people to go towards the black market rather than—

As I said, I think the issue here is that inappropriate prescribing, although that is its own evil, will result in the person getting a genuine product, and that to me is an important aspect.

Even if it is contraindicated for other health ramifications?

No, I would say it is not good, but it is not the—

Would it be right to say a lesser of two evils? Is that fair?

I do not like to use that expression twice in one session, but to some extent, yes. It is something that we thought about quite a bit within my unit—about the difference between the two, and how accessing through the black market is by far the bigger evil.

What can take place in this space to stop people either getting medications that have potential adverse effects on them, because it is contraindicated for other conditions they have, or that are inappropriate, or accessing drugs that are completely illegal and do goodness knows what?

I can only answer the second part of that because, as I say, the MHRA does not regulate prescribing practice; that is, the law permits this and therefore it is not within our remit. We are making inroads into the illicit trade.

I am going to come to that in quite some depth.

Okay.

I am going to talk a bit about the online advertising world. Direct to consumer drug adverts are banned, but social media is becoming a bit of a wild west, isn’t it? Andy, do you think you have the laws and resources you need to tackle the pharmacies and pharmaceuticals being sold on social media?

Are you referencing specifically advertising of prescriptions?

Yes.

Obviously, advertising prescription medicines is unlawful, illegal, and we publish guidance to help people steer their way through what is lawful and what is not. We take each case on its merits, and social media is not excluded by class from this. Social media adverts can indeed fall foul of the legislation in this area. We recently published guidance to help explain that often subtle, nuanced difference between discourse—which I am sure we would all be happy to accept—and illegal advertising. It is a very fine line sometimes. It is not about resources, it is about that subtlety between the two.

I recently read “Bad Influence” by Deborah Cohen, where she looks at how influencers leverage their parasocial relationships with their followers for GLP weight loss drugs. In it, she mentions that the advertising agency Ogilvy suggests that 37% of TikTok users bought medicines after seeing them on that platform; 71% of those were unplanned purchases on a whim. Given the potential risks around that, do you think that we need more, and are we able to keep pace with the advance of the technology in terms of our regulation?

We work with the social media companies, particularly around the illegal trade, which I am not actually referencing. We work with them to get offending posts and advertisements and accounts removed, and quite successfully in that process. In terms of that fine line—

Okay, you get the posts removed—

And the accounts, yes.

That is great. The posts are usually advertising a specific pharmacy. What do you do to those pharmacies?

Related to the pharmacy, are we talking about illegal or legal sellers?

One assumes they are legal sellers, but they are engaged in what seems to be unethical activity.

We will treat each case on its merits, as I said, because of the subtle difference there can be between the two. We will assess them, and we will take action to bring those into compliance. We work with our colleagues in the Advertising Standards Agency to raise awareness of what is permissible and what is not permissible. When necessary, we will take enforcement action. That is a last resort. Our goal here is to ensure compliance rather than to prosecute. If something falls foul of the legislation, we will prosecute.

I went down a bit of a rabbit hole, which my Committee colleagues are used to. I went through Ogilvy’s website, and I am just using it as an example. It says, “TikTok is winning the battle for attention, which is the ultimate precursor to persuasion. This high attention span, combined with a personalised algorithm, makes TikTok a convenient space to investigate healthcare topics on a peer-to-peer discussion basis”. Social media platforms are exploiting people’s insecurities. Does it worry you that advertising agencies are choosing to specifically advertise, to sell products of advertising in those spaces?

I am not sure I could offer a professional view on that. Social media is a challenge. It perhaps has not been designed to be regulated in quite the same way as bricks and mortar. I am not sure I can help you much on that, but it is something that we are aware of. We work with the social media companies, and we recently published guidance to—

My issue is that a pharmacy is buying the service of an advertising agency that is buying the service of an influencer who is then putting out posts that are at least unethical and, in many cases, go against your guidance. The book that I referenced talks about how discount codes are offered, how people are offered financial inducements to advertise it, so what are you doing to the pharmaceutical companies that offer discount codes to people who then use them in an unethical way?

Again, I might have to come back to you on that. That is outside of my area of expertise, but I can certainly report back to the Committee, if that would be helpful, on the detail of that. We are looking at where these things breach the law. We will take action to enforce the Human Medicines Regulations. That is our statutory responsibility. We will consider each case on its merits and take action where that is appropriate.

Have you taken any cases against a pharmaceutical company that you think is—

I am afraid I do not have that detail, but I can come back to the Committee if that would be helpful.

Do you think that the pharmaceutical companies—we are talking Lilly and so forth, the big producers—should have an obligation not to sell their drugs through pharmacies that clearly seem to break the ASA rules and your rules about direct to consumer advertising?

I think the pharmaceutical companies should comply with the legislation as it is currently drawn up, and where they do, that is not a concern for me.

Do you think we need more legislation?

That is not a decision for me to take. We enforce the legislation as it currently stands.

You talked about it being a developing area. Do you think that the legislation is adequate for this developing area?

Again, we can only enforce legislation as it currently applies, so that is not a question for the regulator.

I am going to continue with you and talk specifically to the black market bit. I thought the two were linked, because the black market is relying extremely heavily on TikTok and social media companies to get their black market wares to—I am a bit surprised that you were not able to give more concrete answers. Can you explain to me who in your organisation we should write to? Who does have that?

I am not sure I fully understand the question, Chair.

Okay, let’s start again. You were saying you work with social media companies to clamp down on this stuff. What does that mean, concretely?

With the illegal trade?

Yes.

My reference was to illegal trade. We have routes into the social media companies to ask them to remove offending posts, where we can demonstrate that an account was being used more than—where we can reach a higher standard of evidence, they will remove the whole account, which then removes many thousands of offending posts. I accept that is a bit like whack-a-mole; I fully acknowledge that. That is the nature of the territory in which we are operating with social media companies and the sheer volume and speed at which these things can be posted. That is not excusing the social media companies; it is just the reality of the world.

In reality, is it you reporting these accounts?

Yes.

Talk me through the chain of how this happens. How much of it is the social media companies going, “Actually, we are concerned with anyone trying to sell any medicine on our platforms and we are actively trying to enforce rules”—that is the gold standard—versus you getting a tip-off from someone that you need to be looking at this account? I noted in a letter the organisation wrote to me not that long ago that you disrupted 190,000 website and social media links last year. How much of that was proactive, you going and seeking this out, how much of that was being told to you, and how much of that is representative of how big this problem is? Give me a sense of the scale here.

I do not have the exact numbers, I am afraid. If it would help, I can get those for you.

Always.

Yes, of course. We proactively patrol, for want of a better word, the internet ourselves. Within my units, we have officers who do that, and we are trying to find those things.

How many officers are in that bit of the unit?

I have a total of 55 at present in total.

Who are trolling the internet, looking for stuff?

That is doing the whole range of duties that we have.

That is your entire unit?

I would say half a dozen dedicated to that area of work. We will find our own, we will get public reporting, and we rely very heavily on public reporting and encourage the public to do so. We will report those to social media companies to get them to remove them. I sense your question is the extent to which social media companies are proactively doing this of their own volition. I guess that you would need to ask social media companies, but I do feel there is more that could be done.

We are not about to ask the burglars how many—that just does not make any sense to me.

No, the point I was saying is—

You are the regulator. You should have a sense of how big this problem is.

On the issue with social media particularly, yes, I take your point, but there is that area between legitimate discourse and selling medicine that is sometimes a very fine line. Where we find these things we will take action, and I think there is more that social media companies could do proactively to remove them at source.

Is the line too fine? Is that the problem here? Do you worry about whether or not it is? Should we be giving you a firmer line?

I think there is some of that. Ultimately, it is up to the social media company to determine whether to take these things down or not, and whether they believe that they are in breach of the law. We can ask them to. We cannot compel them to.

Right. You currently do not have the power. I have examples of social influencers based out of Thailand who are selling to people here in the UK. It turns out that the beneficial owner of this company is a UK citizen. They have several accounts across several platforms. Some were shut down. They just immediately opened up, basically with a very similar output. If you tell the social media companies, “You must shut these down,” they can just say, “Actually, no.” Is that the case of where we are now?

That is where we are now. We can investigate. We can investigate any UK connection to this and we can prosecute the individuals involved in it. Ultimately, the social media companies are not within our control.

Can you act on—

Hold on. Tony Saggers, who was the former head of Drugs, Threat and Intelligence at the NCA, described these drugs as: “the supply is as bad as the illicit drugs like cocaine and heroin”. Would you agree with his assessment of how dangerous some of these drugs are?

We are talking about GLP-1s?

GLP-1s, yes.

That is not my experience. I know Tony, and I understand the point he is making. The profits, I think, are equivalent, if not in excess of in some situations, medicines generally. With GLP-1s—the illegal black market products that we have seized so far—we have seized around 81,000 doses over the last three years that we have been working on this, because that is the duration of the crime in this case. Eighty-one thousand sounds like a huge number, but it is not in comparison to the total number that we seized, which was 20 million last year. That is not to say it is not important. That is not to say it is not a priority for us.

In this country alone, as we have heard, we have millions of people who are eligible on the NICE guidelines, let alone those who are after it for a bikini body who should not be taking it but are turning to the black market to do it. Have you got a sense of the size of the problem? You alluded to it here. Did I just hear you correctly? The financial size of this black market is bigger than cocaine and heroin? Is that what you just said?

Yes, it is. The profit margin—

The profit margin is larger?

It could be greater. Not the overall—

Not the overall size of the market. How big is this black market?

In medicines generally, to the extent to which seizures are a proxy for the size, which is the best that we are going to get because it is a hidden crime like most criminality is, it is hard to get accurate prevalence numbers. If the scale of our seizures is a proxy for the scale of the market, then the medicines illicit market is substantial.

How big?

As I say, we seized 20 million doses, and even at my most optimistic I would say that is certainly no more than 5% or 10% of the total. That gives you an indication. With GLP-1s, it is much, much, much smaller, as I said, so 81,000 in total, and using the same calculations, we are looking at something relatively small—but it is a priority. The point I was making at the beginning, Chair, was that we find with the products we have seized—GLP-1s that are illegally traded—it is the genuine product 99 times out of 100. That does not make it safe. It has not been produced in accordance with general manufacturing processes. The sterility is questionable, the dosage is questionable—all those things we are well aware of. It is absolutely not safe, but it is the genuine product. The side effects that we are seeing from the fake products, or the non-genuine products, are broadly comparable with the side effects of the genuine product. From a purely public safety perspective, this is not keeping me awake at night in quite the same way as other aspects of medicines trafficking is.

I have met with a family—it was Abbie and Ffion McGonigal, whose mother was Karen—and I have written to the MHRA about their case, because they are bravely campaigning through their grief. She turned to the black market. It was a local Botox provider, I believe, who gave her this jab illegally. I understand there is an ongoing investigation with Greater Manchester Police. Are you saying to me that their case is rare? Their concern is that their mother, Karen, is the tip of the iceberg. The number of people out there who are concerned that it could well be—there are still tests ongoing to check whether it was the actual drug itself or whether it was sepsis or whatever. Would you not accept that us not getting a grip of this illegal market is, in part, a contributing factor to Karen’s death?

I have great respect for the McGonigal sisters. I have met them and was very impressed by their work, and it is extremely beneficial to the overall threat that they are out there talking about this. I spoke at a Lilly conference only the week before last, and the message I gave was that the three most important things are reducing demand, reducing demand and reducing demand. Interventions like the McGonigal sisters talking about this publicly, about the sad demise of their mother, is so important to get the message out. I honestly believe that a lot of people who are buying these products from the black market do not know they are buying from the black market. There has been a blurring of the edges between a medicine and a cosmetic over the last 18 months to two years that is extraordinarily unhelpful. Part of my role, and the role of my agency, is to re-establish that boundary. Your point is right: one death associated with these products is one too many. The question you asked was around what we are finding within them, and what we find within them is that it is a genuine product. There can be other factors that play into the bad outcomes that we are hearing.

You have identified—I will look at the transcript to play it back. Maybe you remember better than I what you just said. It is the job of your department to unblur the lines, by which I take it that it should never—if you could turn back the clock two years, what would you have put in place to ensure that those lines were less blurred? Secondly, what do you need to do now both to unpick this and to reassure the public that you are on top of it? I have to be clear with you: I do not feel that the MHRA is on top of it, so reassure me and the public that you have got this.

I genuinely believe we do have it. I know I would say that, wouldn’t I? This began for us in March 2023, when NICE approved semaglutide for weight loss. From that moment on, this has been a priority for my organisation from the day I heard it on the Radio 4 news the morning of the NICE announcement. We have been prioritising this as a unit. The first wave of criminality we saw coming out of this we predicted. We were ahead of the game at that point. We saw it coming, and we saw fake Ozempic products. These are brand-infringing Ozempic products that contained insulin that could kill people. There was no greater priority for us at that point. We seized around 900 individual pens that had been counterfeited, any one of which could have killed somebody, quite frankly. I think we did the legs of that particular model. We were ahead of it. We were equal to, if not ahead of, the criminals on that occasion. Criminals diversify. That is what they do. The money was still there for them. They changed to producing these awful little generic syringes filled with noxious liquids and vials full of powders that they were selling through social media again, through websites and through back streets, to beauticians and those kinds of places. That is where the edges start to become blurred. When these products were not labelled in any sense at all, you essentially went in, you paid your money to your beauty salon, and you came out with a syringe or you came out with a sore arm after having had a syringe. That is where these things ceased to become medicines in people’s minds, I think, or many people’s minds. While they were expensive to buy, for the customers the efficacy of GLP-1s was the thing that was driving that demand at the time. We cracked down on that, and we seized many of those. We were sending officers all over the country to deal with individual outbreaks of this particular model.

How were you being made aware? Paint a picture there.

Through all that I mentioned earlier. We have undercover officers working online. We do all the things you would expect a law enforcement unit to do—uniquely, globally, within a regulator for medicines, I hasten to add. We have dedicated staff who are out there looking for these people and looking for this stuff. I obviously cannot tell you too much about how we do it and what we do, but the point is we are doing the things you would expect us to do. I genuinely believe we are leading the way globally in the UK in tackling this criminality, to the extent that within the last 12 months we identified, built up the intelligence around and raided the world’s first manufacturing facility for the third wave of criminality, which were these highly sophisticated products that you may have seen, through our raids, that had their own branding. It was not pretending to be a brand name. They created their own branding, which is even worse and blurring that line even more. What could we do more of? I think the solution to this, having been in law enforcement for a very long time—we cannot arrest our way out of this—is about educating the public, and that has been a theme throughout the whole of this morning’s session. It is about raising the awareness of the public and we do that. I have spent more time on TV than I spend in my office at the moment doing just that, because I think that is the key to cracking this. I can reassure you, and I can reassure the public, that we are on this. We have the capability we need. We have the capacity we need to address this.

That was my question. You do not need one more extra officer?

I didn’t say that. Of course, there is always more that can be done, and we regularly monitor the size and shape of the resource we put into my unit, and that process is ongoing as we speak. I will always welcome more resources, so please do not get me wrong on that one. At the moment, we are fit for the purpose that we are here to perform.

There is one other issues here. I wrote down “Swiss cheese regulatory model” when you were speaking. You have the CQC, you have yourselves, and you have the MHRA. We talked about a regulation gap. Can you help me out here? We want to recommend to Government how we can get on top of this. It is not just the regular black market; it is also the illegal prescribing. They go together. They go hand in hand, and it might well be that you have someone with not a black market drug but they are prescribing it inappropriately, and that itself will cause harm. If you are going to prescribe it to someone with anorexia, I am not sure the public care which regulator does what, but they want to be reassured that it is safe. Add on top of that the fact that cosmetics are not regulated in quite the same way and you have a bit of a perfect storm. What more can we do, Neha? What do we need to get the Government to do differently?

Over the last year, maybe even a year and a half or so, we have been working much more closely with other regulators as well. I mentioned the CQC. We engaged with DiCE, which you heard in the first session, and with the MHRA and ASA. Relating to the black market and to social media influencers, we have done joint enforcement notices and a joint webinar that we did last year. We are trying to collaborate a bit better and work together so that we fill those gaps and show one approach to the public, because like you said, that is what they care about. We are here to represent patient safety and promote patient safety. Coming together and sharing those learnings, our intelligence, only supports that. We need Government to share that messaging, to help with public education—

What is it you concretely want to see? You want a Government paid for, backed public education campaign about the dangers of badly prescribed drugs. What is it exactly you want Government to do? If you cannot tell us, we cannot recommend it.

One of the first things I would say, rewinding back from that, is access to records. I think that was highlighted in the first session. I am not trying to say that if a private pharmacy or a private provider does not have access to records they are not doing it safely, but supporting that access only helps clinical decision making and safe prescribing choices. That would help with the inappropriate prescribing aspect of it. In terms of the education angle, more education is only going to be good for the public because seeing things on social media, on TikTok, or whatever other platforms people are using, to say that this is how you should access your medicine safely is only going to help people to understand the risks. I know Andy mentioned that most weight management medicines are still GLP-1s, but a small fragment are not, and we do not know what the risk of taking that medicine is. Putting it in a real-life scenario is only going to help in those situations and minimise people accessing those black market routes. Thinking about access to medicines in terms of affordability, we know that the medicines are available on the NHS but for people with a BMI over 35 with one comorbidity, which makes it less accessible for people who are floating over 30 but do not have a comorbidity and cannot afford the medicine. Is that pushing people down the black market road as well? Supporting access might help reduce going down the wrong angles to get it.

There is a safety aspect to that. Andy, you spoke about education. If you had the money to run a Government-backed education campaign in this area, what would it say? What would the tagline be?

That is a big ask. I think what we need to do is speak to people where they are. I think sometimes regulators can come across a little bit condescending and people perhaps of my age do not necessarily know how to speak to some of the people who are accessing these things who might be younger, a different demographic. It is more about how we say it and where we say it, because if there is a social media narrative that is overwhelmingly positive and promoting GLP-1s, then we need to get there and have a similar narrative, and change that narrative about correct access to it. Sometimes we make it over-complicated. It is fairly binary. Certainly, for the illegal trade it is fairly binary. It is about where you have got it from. If you got it on prescription from a registered pharmacist, you’re golden. If you haven’t, you’re not. It is that simple. Sometimes we complicate the messaging, so it is about a simple message delivered to people where they are at, rather than where we would want them to be. We have been saying this for many years: “Do not buy medicines from illegally trading websites.” I am not sure the extent to which that is resonating with people around GLP-1s. We have worked with social media influencers. I personally work with social media influencers to try to get the message out there, to have that counter-narrative. That is the future, I think.

Thank you very much. We have run over. I thank everyone for their patience.