Environment, Food and Rural Affairs Committee

Tuesday 30th June 2026

(began 3 weeks, 6 days ago)

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None Portrait Speaker 1
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Um.
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None Portrait Speaker 1
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So the, the animal health sector and people who work in there actually is relatively small. So it's entirely likely that when we're looking for specific skill sets, we are likely to recruit, attract and retain folk who may have worked in other parts of that sector, whether it's the pharmaceutical industry or research environment or veterinary practice. In fact, we we want that diversity of experience. It's really valuable to us. We have an annual annual declarations of interest process. Um, it's obviously commences from a point of employment with us at that very outset.

We review those declarations of interest individually. When somebody starts to be employed by us and then on an annual basis, assuming that most things haven't changed. But sometimes personal situations do, when there is something that is declared a personal relationship or, um, a pension. For example, which is again, quite, quite normal for when you've worked within one sector will take steps within our operating processes to, to address that and to ensure that there can be no conflict of interest in the ways of working.

So, for example, I think the case you're referring to actually is a partner of somebody. Um, but we do certainly have individuals who have worked for a pharmaceutical company within the five years that they have then come to work for us. What we will then do is not permit them to work on applications from that company. So it really reduces the, um, the opportunity for any conflict of interest. And we as a routine, as we have felt here, I suppose today have agendas where conflicts of interest are asked to be declared at the outset.

So standard practice is absolutely part of our normal process.
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None Portrait Speaker 1
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It's challenging. I won't, I won't say it's not challenging. I have individuals who need to and have done now for some time, had to be able to put their mind into working on an application that is for Great Britain under one set of regulations, and the same people looking at an application for for Northern Ireland under a different set of regulations. Um, but we have a very well embedded quality management system. We have an ISO accreditation that we are is really important to us.

And we have standard operating procedures for, for the way in which we we work. And all of those are so well documented that it allows individuals to almost do that mental shift between two, two sets of regulations in a way that they're supported with that work. Um, nobody works in isolation. Um, and all of the work that is undertaken at the scientific level goes through internal scientific review processes, whether it is, um, a, we call a cysec meeting on the biological side, a biological coms meeting where um, there are reviews of um the.

The work that's been undertaken by an individual assessor. So there's, there's almost places by which if anything was to um, become. Tricky for somebody to understand which set of regulations they're working against. There's a peer group in which that could be captured to date, I've never heard that. That has actually been a problem because we've provided for the structure around our staff. But I won't say it's not been challenging. It certainly has been, um, in terms of our operating ability, um, the robustness of our science is something that we're really proud of and that has never dipped.

We have an independent assessment of our, um, of our benefit risk assessment through the veterinary products committee. And we're always awarded the highest level of assurance that our science is sound. So I have no concerns about the operations from that point of view. Um, we have um, had some resourcing issues over the course of the last two years, um, whereby the number of applications that we had was greater than the number, the resources that we had to deliver against. And we, we featured then having some form of backlog.

We don't want that the pharmaceutical industry don't want us to have a backlog. We've worked through our backlog on admin basis. We currently have a submission slot system. So for the biological applications, um, so a company would need to let us know in advance that they wanted to put an application in. Now that has got to be the case. Whilst we are resource constrained it is our ambition. It's certainly my ambition to we move out of that.

So we get to a position where we don't need to have submission slots because we have sufficient resources, physical people, resources to be able to deal with as many applications that come to us. But that will take time because the number of people that we need to recruit, um, to achieve that, um, that. That level is, um, is something that we are, we're looking for experts in a very small pool. And so we've had to again, shift our ways of thinking of recruitment so that we can grow our, our own talent in a way, but that will take a number of, of months and years to achieve.
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None Portrait Speaker 4
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Yeah.
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None Portrait Speaker 6
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Yeah. For sure. Um, complex and multifaceted. Um, um, so overarchingly for, for vaccines in general. Um, there's a range of factors that drive that. So you've got issues around absolute shortages because you maybe have an interruption supply of a particular vaccine that can be due to factors such as increased disease outbreak somewhere. So unexpected uptake of vaccine, it can be due to failures in manufacturing process. Um, vaccine production is sensitive for biologically sensitive process, and it's probably more vulnerable to issues in manufacturer.

Um, we know that manufacturers tend to work on a very kind of, um, a very much a forward planning basis in their manufacturing processes. So they might, for example, plan their production five years ahead. And if there's therefore an interruption with a manufacturing process with vaccine, then the ability to flex and create a new batch might have significant delays involved with that. So there's factors around that. There's also kind of factors around, um, I guess therapeutic gaps where there aren't vaccines for particular diseases.

And that can be because it's a challenging disease to produce a vaccine for. Um, it can also be due to um, concerns over return on investment because ultimately production of vaccines is a commercial practice and there's not considered to be sufficient return on investment for a particular product. Um, it would deter manufacturers from entering that space. Um, there's also kind of wider issues, I would say around, um, over the years. Um, increased efficacy of manufacturing streamlines production. So you maybe have one site that manufactures an active one site that manufactures an excipient, another site that makes the packaging and that increases the vulnerability because at any one point along that chain, you might have a failure.

Um, so there's, it's really hard to say for pig vaccine specifically, it's these factors, but there's a whole range of factors that influence vaccine availability. And that will, of course, impact the pig sector as well. And in fact, we're having conversations with the pig sector. We had a workshop, um, where we engaged with um, pig farmers and, and vets and in that area, um, planned and we're going to be um, delving into the really specifics about which vaccines and at what point are they experiencing challenges with them.

So that's kind of planned within the next month.
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None Portrait Speaker 6
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So we already had a number of actions in place during the last revision of our veterinary medicines regulations. So we put in place um, a regulatory basis for some of the new technology that's coming out around vaccine production. So for vaccine platforms, um, for vaccine antigen, um, multilateral, um, dossiers. So we've already had, had laid out some of the steps there to make sure that regulation was enabling innovation in the vaccine space. Um. More recently we've been, um.

Proactively setting out for manufacturers more clearly what information we expect them to report to us on shortages. And when that basis was in our regulation, but we needed to kind of set out the specifics for manufacturers. And that's an ongoing process. Um, we are have. Moved towards a step which we call stakeholder dialogue platforms. So when we have, um, a shortage announce to us, we've now run this process several times whereby we bring together not just the manufacturer, but the vets that are involved, representatives of any bodies and representatives of those vaccine users.

And of course, the distribution chain, um, to try and face into what that shortage means and what mitigation steps can be taken to try and address that in the short term. Um, and that's been really welcomed by those groups is just enhancing that communication flow around shortages. We've also, um, do have kind of have always had in place, but are being better about communicating our special import schemes. So when there is no option, um, therapeutic or in this case vaccines, there's the ability to source a product overseas that we can issue an import permit for.

There's also autogenous vaccine production. So these are steps that were already existing but were being more clear about communicating those with our stakeholders. Um, so they're the steps that we've already got in place and that we, uh, actions we've taken in, in the recent months to try and progress this issue.
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None Portrait Speaker 5
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Thank you.
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None Portrait Speaker 7
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Thank you.
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None Portrait Speaker 4
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I'll take that. So um I'm actually quite relieved to say that um our understanding is and this is for a lot of engagement with industry in Northern Ireland and locally that actually reliance on the schemes is not dramatic. Um we are aware of um vets needing to use internal market scheme particularly. So that's where they're sourcing a product from GB. Um, but actually it's relatively few and far between. So um obviously we know that there was a lot of fear and concern that medicines would not be available in Northern Ireland and that they wouldn't be able to source them through the existing routes.

But I'm very pleased to say that that's not what we're seeing in reality. Um, you know, we are doing an extraordinary amount of engagement with Northern Ireland and we have been, um, we've been meeting with them sort of every, every few weeks over there to try and just make sure that we pick up on any issues. But I'm pleased to say that actually, from what we have seen and the engagement that actually normal medicine routes are for the most part, sort of ineffective. Now, there have been some minor issues, uh, like I say.

So I chair the, the supply chain coordination forum that was set up at the end of last year. Uh, that's been meeting sort of every two, every three weeks since January. Um, that brings together all of our sort of vet stakeholders and retailers in Northern Ireland to actually have those open and frank conversations. And actually what we've found is, generally speaking, Northern Ireland specific issues are quite few and far between. And we can act quite quickly to resolve them. Um, but what we are seeing is, is like the rest of the UK where there are shortages, they tend to be sort of UK wide disruptions.

So it's not just affecting Northern Ireland. So um, yeah, I'm pleased to say that we're not heavily reliant on those schemes, but we are obviously keeping a very close eye and we'll continue to do so for the foreseeable.
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None Portrait Speaker 1
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So the, the supply coordination form that Leigh referred to, um has um has a number of participants who are really on the ground, as I probably refer to it, who probably are the ones who would feed back some of the anecdotal, um, concerns. And so we've created that platform to get that information up front. Um, we occasionally there may be something that comes through, which is a supply issue that is very normal to us. And we're feeling the same supply issue in GB and we can address it in a way in which we would understand whether there has been an issue with manufacture, whether there's been an issue somewhere along that supply chain that is going to resolve itself and become unblocked in a matter of a couple of weeks, or whether or not the duration of it is such that it would cause an animal health or welfare issue that we'd need to address in another way.

That has always been the case that we've addressed that what we've now got access to through the Supply Coordination Forum is to really early information from others than the pharmaceutical industry themselves. So this is from wholesale dealers, um, and others who are bringing that information directly to us. Um, so it means that we can get on the front foot of addressing it. Part of the regular, uh, policy meetings that we have with Baroness Hayman will refer to the, the current supply issue situation. It's actually something that features in both the policy and the operational delivery dashboards that we we talk through with her.

Um, because obviously it's a high interest, but also we're facing into it through both of those lenses. Um, so because as Leigh said, there's been very little to report in terms of tangible, specific issues. We can focus on one particular product if we need to have a conversation about that. We are very aware that there has been, um, and, you know, rightfully so in terms of mitigations, uh, a degree of stockpiling. And it was something that we encouraged all those years ago through when we were entering into, um, exiting the EU and then in the Covid environment.

So we're aware of that and we're aware that those stock levels will at some point start to decline, which is why it's really important that we don't become complacent and think everything's fine. It's six months in. We can we can take our eye off the ball. We're not doing that. Um, we're keeping those forums open so that we get that early information and that we can face into understanding what we can do about it. Partly it will then come back to having the kind of conversations I was referring to with the pharmaceutical industry themselves.

Um, to understand what the issues are with supply and if there's something we can do from a regulatory point of view to resolve that.
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None Portrait Speaker 4
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Exactly.
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None Portrait Speaker 4
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Um, we obviously support the CMA's ambitions in this area. Um, I think similar to to previous I've seen from the committee, we do have some concerns that um there may be unintended consequences for some of this. Um generally speaking, particularly as a pet owner myself, I'm happy to see, you know, anything that can be done to reduce some of the prices that we pay, um, in terms of sort of impact on, on the VMD, I think there'll be probably relatively small, um, some of them, obviously, they've asked us to look at things like cost and the cascade and particularly advertising or reclassification.

So those are things that we will absolutely consider and look into further. Um, some of it is, is what we do already in some respects. So, uh, you know, our ethos is to ensure that the right medicine is available at the right category. So, um, you know, we absolutely endorse the aims. Um, we just need to balance it with the broader policy objectives that we have. Um, like we saw earlier, you know, medicines availability is key. Uh, as always, you know, the regulatory framework is geared up to authorise medicines should be the default.

There's a regulatory framework set up around that specifically to provide that assurance to owners and animal keepers. So when you look at things like the the cascade and that side is you have to balance the, the approvals process with the risks that vets are having to take to use the, the, the products that are not authorised. And that's, that's where we have to sort of have that balance. So yeah, we're absolutely supportive of the aims of the CMA review, but we just have to make sure that it ties in with our sort of broader policy objectives.
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None Portrait Speaker 8
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Thank you chair.
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None Portrait Speaker 4
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So like I said earlier, so the, the authorization process and the framework for veterinary medicines is geared around authorized medicines. And there's very good reasons for that. So when a medicine is approved, it's obviously assessed for safety quality and efficacy in the animal and the dosage it's given and what it's to be used for, that that level of assurance is fundamental to what we do in terms of MD and the regulation of medicines. So when you're starting to move down the cascade, the that assurance, uh, drops with each, each step you go down.

So it's a risk based decision tree. So the further you go down, the more risky things are. Um, it's very difficult to sort of balance the cascade. So the cascade is there. It is needed and it's well used as we understand. Um, but it's making sure that it does the right balance between enabling animals to be treated and for clinical need, but also not disincentivizing the approvals process and ensuring that there are medicines available for what they need.

We spoke earlier about vaccine availability, and that's a prime example where you need to ensure that you have the right medicines available, and that's through the approvals route. And the cascade is an exception from that. It's a needed one. And we think it probably does tie the correct balance, but it does chop and change. And like we are seeing, you know, um cost is a factor that people do have significant concerns about understandably. Um, but then you also have, you know, the flip side of the assurance piece.

So we have something called pharmacovigilance, which is the monitoring of products. Now that is strongest when you're using authorized products as you go down in terms of using it for different reasons or for using human medicines, that assurance disappears a little bit each time. And that's where you have to strike that balance. So it's a difficult one and it's one that we we think we get right. But it's something that we do review constantly to see and to understand.
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None Portrait Speaker 6
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Don't know whether that's a material difference or not. So if you reformulate a product that's designed for a particular species in a way that is safe for that species, then, then that should be recognised because the product that you're using, that's a human medicine isn't formulated for, say, a dog or a cat. And those species have different metabolisms and will respond differently to different formulations of products. So we don't know precisely what that off label product is formulated and how its safety profile is in a species that's being used in.

Whereas we do know without that authorised product and whilst. Expense, as you said, is an absolutely imperative factor for many pet owners, it's also the right of every pet owner to be offered a product that is the safest for their product, because the most is known about it. And that's the challenge that vets have to go through when they're making those choices. The Rcvs does specify contextualized care, and there are the benefit of the cascade is that it gives many. It gives the vet vet surgeon the opportunity to say, in this particular circumstance for a number of reasons.

For example, ease of administration, um, or the likelihood of the owner complying with the dosage regime. There's lots of reasons why that can look at an authorised product and say, actually, in the contextualized case of this patient and this and this owner, I need to make a different decision and utilize the cascade. And I guess the factor here as to whether we make it more explicit that cost is a part of that Contextualisation is something that we need to look at really carefully.
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None Portrait Speaker 8
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I.
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None Portrait Speaker 1
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I mean, we take it we take a risk based approach to our enforcement activity. Um, and we need to make sure that we are focusing our efforts on the breaches of the regulations that have the greatest impact. One of the, um, strategies and strategic shifts I've referred to is about our communications and what we're really trying to do in order to help balance, um, the resources that we have is to consider a shift to greater compliance and compliance through communications. Now, we don't always know why people are committing, um, prescription fraud, for example, or tampering with prescriptions.

You might assume that it's because, uh, for cost reasons, as we refer to, it may also be because they just haven't, um, cashed it in in good enough time. And, you know, changing the date may be something that they think is okay without the knowledge that it is an offence to do so. So there's a communications campaign and as we know with the communications campaign we did with the IPO, it was really effective. You know, it had that dramatic increase, that 700% increase, which sounds huge.

But obviously when we look at the numbers is, you know, is maybe still slightly small, relatively. Um, but we know that communications campaigns can really work and we're shifting our, our strategy to focus on, um, an element of our enforcement strategy, which is about compliance through communications. Now, a bit like, I suppose with any enforcement organization, you know, you can have as many people, um, and they'll always not be enough to deal with absolutely everything. But that's where we have to take a risk based approach and focus our efforts in the area, which have the greatest impact in terms of issues with non-compliance.
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None Portrait Speaker 6
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For sure.
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None Portrait Speaker 1
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To answer.
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None Portrait Speaker 1
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Yeah, I think that it was, um, it has been challenging, of course, when there are cuts to budgets where there were activities that were being delivered and we've had to be really mindful of how to appropriately, um, close off any of those programs. A lot of the, um, Fleming Fund was delivering work internationally. Which is important because, you know, we have to solve Amr globally, not just locally. Um, I think that we certainly, every, every government department who has been facing into Amr and of course, it's cross-government in terms of activity, um, we've had to react to the resource.

Um, that's available that has driven prioritization exercises. Um, and in relation to the National action plan, looking at where can we have the biggest impact?Where, where can we make sure that the work that is prioritised is the work that's going to really deliver tangible results?Um, and that's been important and that's a prioritisation exercise we've had to do regardless of the topic, you know, facing into the resourcing and financial constraints that we have. Um, for the VMD specifically, we had a concern, um, the, the end of last financial year in relation to how we could continue some of our really important surveillance work.

Um, we were successful in securing funds through the Esaf Integrated Security Fund to continue some of our private labs initiative work, which is really fruitful in terms of getting access to a whole bunch of data that's held privately that can help inform, um, the aspects of our national action plan and our work in terms of, um, um, understanding, uh. The, the, the, um, aspects of surveillance that we're trying to consider. So I think because we've had that fund and that's been successful, the impact has been minimised for us, but we're really mindful that we are going through, um, future.

Reviews and there may be future impacts, but I think that the strategy that we've put in place of looking at the prioritisation and ensuring that the money that we have got available and the resource resource that we have is spent in the place that can deliver the best outcomes and the most likely success is important.
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None Portrait Speaker 1
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It certainly was a risk to us that we flagged. Um and um others had felt as well that where we were reliant on the farming community in a voluntary capacity, that where that community, um, were feeling, um, not well supported by government through maybe decisions that were taken in other government departments that the impact could well have been felt in terms of their voluntary contribution to what we're asking them to do under Amr or for any other aspect of animal health?Um, I think that obviously that was heard that risk and not just felt by us and not, um, not just reported by us.

And of course there were some remedies then put in place. I don't feel that therefore the risk became an issue in that intervening period from when we had flagged it to then when there was um there was a remedy as such. Um but it's really important our relationship with, with all of our stakeholders, but certainly stakeholders who are contributing to our outcomes in a voluntary capacity is really important. And that's why I think I might have said at the outset, you know, one of our core values for the VMD is collaboration.

And we have to ensure that our stakeholders know that we really value them, that we engage them at the right time in the right way. Um, we also have to be really honest and transparent. We don't always have the answers. We can't always deliver. You know, I think Lee referred earlier to an NHS for animals. I would love that to be the case. That isn't what I can deliver. Um, but, um, we, if we work in a way that is understanding of a shared problem and understanding of a shared outcome that we want to have and where each of us, us as a regulator, them as a stakeholder or other partners can contribute to delivery of that.

That's what's really important to us. And I think maintaining that we've had such great success, specifically in Amr and driving down, um, unnecessary use over the course of the last ten years. And that has primarily been through a voluntary approach and understanding of that shared problem.
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None Portrait Speaker 5
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Um.
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None Portrait Speaker 7
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Thank you chair.
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None Portrait Speaker 1
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So we have been, um, this has been one of our hot topics for quite some time. I was really keen that we addressed this when um, the issue was first brought to our attention that the levels that were detected were higher than um, we were, were flagged effectively by the Environment Agency and following some of the reports that were published by other groups, um, we have published our roadmap of activity that we are taking in this space. It's really, really important that we take a measured approach because, um, if we knee jerk and make a change either to availability of products or to products, even being authorised at all, we will have an unintended consequence, which is to detrimental to animal health, because the reason the products are there are to treat an animal health situation and human health situation.

Indeed, when we're talking about fleas and ticks, as we know, ticks are increasingly a problem. Um, but we have to we have to find out. We have a lot of evidence that we need and questions that we need to have answered. Now, we don't need to know everything. And I think as referring to earlier, we don't need to have to have perfection in all of the evidence that we've gathered, but we at least need to make sure that we are balancing all the information that we might need, and we can ask those questions in, in the way that we should in relation to our R&D programme.

We have put a number of projects into that space. I call it pharmaceuticals and environment. It's a group that I set up, as I referred to earlier, across government body, to look into this and understand what those impacts may well be. So there could potentially be regulatory change in future. For sure. One of the aspects, um, we've currently run a call for evidence. It's just closed. We will take the 12 weeks to do the analysis.

We had a significant number of, of, of evidence presented to us, which is great. And hopefully that will come at the same time as the report from the Environment and Climate Change Committee. And we can take all of that aspect into consideration. Um, we know that, uh, one of the issues is that for these type of products, they don't go through a phase two environmental risk assessment. There is no modelling for that to happen. Um, and so we're in the process of trying to develop what that model should look like so that we could be in a position to then request that in future.
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None Portrait Speaker 1
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You might be aware that we've just launched a bee spot on aware campaign. I think it has made ITV News in Meridian East, which was very exciting for us. And we don't often get the promotional opportunities, but there was somewhere, um so we also know that um not all pet owners and possibly a few of us in the room always read all of the product leaflet. Um, and so maybe inadvertently, um, although, um, very honorable citizens are contributing in a way that they don't anticipate being true, whether it is, for example, washing out pipettes or putting them in the recycling because they think that that's the right thing to do.

So we've had a be spot on aware campaign that is through, um, again, I refer to our communication strategy, ensuring that we hit the people, hit the people, we get to the people right in the right way. We hit the communications in a style that they will receive and will be, um. Um, absorbed, knowing that reading a product leaflet is not always the way in which we get that information across. It's been really important that we know our target audience, and we've taken some steps to help educate in that space.

Um, again, there's more that we need to do. Um, and there's more social behavior that we need to understand a new area for us that's not normally part of our regulatory remit. And this is where some of these hot topics across the range that we've talked about have really taken us in a different direction. And it's important that we do that. Um, in, in a, in a way that is educated, of course, and that we've addressed using academics, using R&D, using specialists in that space so that we can make sure that any change we make, including a communications campaign, is going to deliver and realise the benefits and those tangible results that we want to see.
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None Portrait Speaker 10
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Order.
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