Environment, Food and Rural Affairs Committee
Oral evidence: Work of the Department and its arm’s-length bodies, HC 217
Tuesday 30 June 2026
Ordered by the House of Commons to be published on 30 June 2026.
Members present: Mr Alistair Carmichael (Chair); Juliet Campbell; Ben Goldsborough; Terry Jermy; Josh Newbury; Henry Tufnell.
Questions 1 - 67
Witnesses
I: Abigail Seager, Chief Executive Officer, Veterinary Medicines Directorate (VMD); Lea Reynolds, Head of Policy Development and Delivery, Veterinary Medicines Directorate; and Dr Suzanne Eckford, Head of International Office, Veterinary Medicines Directorate.
Witnesses: Abigail Seager, Lea Reynolds and Dr Suzanne Eckford.
Q1 Chair: Good morning, everyone, and welcome to this meeting of the Environment, Food and Rural Affairs Committee. We return this morning to our inquiry into the work of the Department and its arm’s length bodies. This morning, we are joined by colleagues from the Veterinary Medicines Directorate. For the benefit of our official record and for those who are following our proceedings, I invite you to introduce yourselves to the Committee.
Abigail Seager: Good morning. Thank you for having us. My name is Abigail Seager and I am the chief executive at the Veterinary Medicines Directorate.
Dr Eckford: Good morning, everyone. My name is Suzanne Eckford and I am head of international office at the Veterinary Medicines Directorate. I also co-lead the veterinary vaccine availability strategy.
Lea Reynolds: Good morning, everyone. I am Lea Reynolds, head of policy development and delivery at the VMD.
Q2 Chair: You are all very welcome. Before we start, I should place on record that my son is a postdoctoral researcher at Scotland’s Rural College, SRUC, and that a part of his research projects there is funded directly by the VMD. I would not want anybody to go away with the impression that I have any idea at all about what it is he does, but he is a close family member so I think it is appropriate to place that on the record.
Abigail, looking at the VMD’s role within the wider DEFRA landscape, where do you sit in this? You will be aware that DEFRA has this vast array of arm’s length bodies, non-departmental public bodies, regulators, commissions, boards, and whatever else. How effective are you in contributing to the outcomes that DEFRA seeks to achieve?
Abigail Seager: As you know, we are an executive agency of DEFRA and the competent authority for the Veterinary Medicines Regulations. We are slightly unique, I suppose, in some ways, compared to other arm’s length bodies, because we are both the policy unit and the delivery unit together, which may be quite unusual for some of the arm’s length bodies. We sit within the DG group for farming, food and biosecurity, reporting to Emily Miles. The DEFRA outcomes framework, with which I am sure you are very familiar, has a number of outcomes and we feed into a few of those rather than just one particularly. Under the resilience and security banner, we contribute to outcomes on robust biosecurity, good animal welfare and emergency preparedness, specifically in relation to disease outbreaks.
I work very closely with my counterpart director, Anjali Juneja, who is the animal and plant health director sitting in DG FFB, and we work with our Minister, Baroness Hayman. We have a governance structure, which means that I report into FFB, but we also routinely deal directly with the Minister on our policy issues and on our operational delivery. We work in a way that is justly independent as a regulator, so although we sit in the FFB group with colleagues in other arm’s length bodies, we are independent from them. One of our core values is collaboration, and I truly believe it is important that we work together where we have a genuine outcome that is consistent with other outcomes that others are trying to achieve.
Q3 Chair: That must occasionally be quite a delicate balancing act. When are you an independent regulator? When are you a policy adviser or policy formulator? DEFRA has this somewhat littered landscape in terms of arm’s length bodies. We have had the Corry review and the Hancock review, both taking slightly different approaches to the regulatory landscape. How is the reporting consequent to the implementation of Corry in particular working? You give a monthly report to DEFRA Ministers, is that right?
Abigail Seager: Absolutely. We report monthly on the policy aspects of our work. I have a monthly meeting with Baroness Hayman on the policy side, and then we have a quarterly meeting on operational activity and our performance, at which we go through performance against either key performance indicators or our own published standards, for which we have a number that are on gov.uk. That really reflects the rate at which we are working against our regulatory services. Within that landscape, we also talk about a number of our hot topics.
Sometimes there is a blurred line, in fact, between our policy and our delivery. Occasionally, those conversations might end up talking about two things, because we might be developing the policy aspect, for example, on Northern Ireland but also have to talk about the delivery aspects and implementation, so sometimes the same conversation can occur in multiple volumes.
Q4 Chair: How has that changed the way you do the work at the directorate?
Abigail Seager: Corry and Hancock?
Chair: Yes.
Abigail Seager: I think that the reports have delivered for the Department, on the whole, a landscape of making sure we have the right balance of resources, making sure we have the right governance model, and making sure that we are thinking about not duplicating effort. It is encouraging that those conversations are being heard.
In terms of tangible changes for the VMD—
Chair: That was the whole point of the reviews. It was going to see where you could do things better.
Abigail Seager: Yes.
Q5 Chair: Have you done anything better as a consequence?
Abigail Seager: Certainly, our relationship into the core, into the sponsorship team, as I talked about, with Anjali on the animal, plant and health side, is stronger. I can see that continuing in a fashion that is beneficial to all our outcomes. There may be policy, for example, that has been developed in the core—when I say “core”, I mean in the core Department—that is of interest to us, but we may not necessarily need to feed in directly at the beginning, but before it gets to a later stage. That is now happening. Those conversations now happen, so there is a step change, certainly, in terms of bringing us in.
As an arm’s length body, I often describe that the length of the arm varies. I have the right autonomy as a chief executive to be able to deliver what I need to and have the ability to organise the VMD to make sure that we continue to be what I often describe as a mini-powerhouse and a high-performing unit. Equally, the length of the arm can be shorter when we are working in a space where the outcome is shared across a number of either other arm’s length bodies or the core Department if it is a policy issue.
Q6 Chair: Are you getting more face time with Ministers, or a Minister, as a consequence of the review? I do not think that is a bad thing, by the way. I think it is probably quite a good thing.
Abigail Seager: Oh no, absolutely. I completely agree. Baroness Hayman has always been a real champion of ours and if we need the time with her, we find the time with her. I think we have the appropriate level of time with her, for sure. I personally have an increased level of forums within which I interact with the DG group in which I operate.
Q7 Chair: Your chair has raised concerns about what she terms the reporting burden—we picked that up from your minutes. Accountability to DEFRA is important, but that all creates a resource pressure. Nobody goes into a meeting with a Minister that has not been prepared for. Is that in danger of becoming an issue? I remember at the time of starting testing in secondary schools, one of my colleagues said, “You don’t fatten a pig by putting it on the scales every day.” Is there a danger that you are reporting just for the sake of it without actually seeing much change?
Abigail Seager: I think what has been important is that we have been able to create the dashboards for reporting that are relevant to us. There has been a change with that over the last 18 months, I would say, certainly, where the relevance of the requirement for the data that we are producing in a dashboard has to have some material benefit in terms of the conversation, for sure. That has been, I think, an iterative process. I am comfortable with where we are now.
I think sometimes when we are part of major programmes—and we may discuss some of those that we are involved in—that we are not owning ourselves, it can feel on occasion that there is a great swathe of folk in the core who are asking the questions of a very small number of people out in the arm’s length bodies or out in small policy groups. That has been known. That has been heard as a problem statement and there has been a reaction to that, which is to address that problem statement. I think there is an iteration of how we are working so that we do not end up duplicating effort or reporting for reporting’s sake.
Q8 Chair: That is how you go upwards. You go sideways in all sorts of different directions. Looking at the functions around sampling and testing, you have a quite remarkable list of partner agencies that you work with. How does that relationship with these different agencies work? Is it working well?
Abigail Seager: With the number of the agencies on the residues sampling side or even on the surveillance side in relation to AMR, we have either SLAs or contracts with them for how we operate. In any form of contract management there is a process through which we check that delivery is as per expected and, where there is a financial exchange, that we understand what exactly is being delivered for that.
Q9 Chair: I picked up a mild note of irritation from the previous board minutes around the relationship with Fera and the FSA in relation to increased fees. Talk us through that. What does that mean for you and your directorate?
Abigail Seager: In terms of our finances, the fees that we charge are set in secondary legislation. As a result, we have to have a legislative slot in order to amend them. When we find that the cost of any of the work that we are subcontracting has increased but we have an inability to increase the fee that we charge, there is a disconnect. We have had to go through conversations recently with those partners to set expectations about what the fee levels can be at an early enough stage that allows us to take some legislative change through our fees regulation to be able to balance the books.
That has been, I suppose, somewhat testing over the last couple of years, but we are in a better space than we have been in the past. We now have arrangements in place and agreements with those delivery partners whereby they will declare to us the likely costs to themselves in December and then we will set those fees so that we can start the financial year forecasting in the appropriate manner. There has been an improvement with those delivery partners in setting expectations about what the costs will be, so the financial pressure is not something that we have to absorb.
Q10 Chair: Ultimately, it comes down to better communication and lines of sight. Are you confident you have that now?
Abigail Seager: I do.
Q11 Chair: Okay. I have a final point around the coverage that we have seen in some of the veterinary press and some of the public press around Librela. An FOI release indicated that one of your employees had a partner who had shares in one of the companies. There is nothing improper about that, just to be clear, but in the world that we all inhabit it is an issue that can, if not managed properly, be difficult in terms of maintaining public confidence. Talk me through how you manage that.
Abigail Seager: The animal health sector and people who work in it is relatively small, so it is entirely likely that when we are looking for specific skillsets we are likely to recruit, attract and retain folk who may have worked in other parts of that sector, whether in the pharmaceutical industry or research environments or veterinary practice. In fact, we want that diversity of experience. It is valuable to us.
We have an annual declarations of interest process. It obviously commences from the point of employment with us, at the very outset. We review those declarations of interest individually when somebody starts to be employed by us and then annually, assuming that most things have not changed, but sometimes personal situations do.
When something is declared—a personal relationship or a pension, for example, which is again quite normal when you have worked within one sector—we will take steps within our operating processes to address that and to ensure that there can be no conflict of interest in the ways of working. I think the case you are referring to actually is a partner of somebody, but we 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, which really reduces the opportunity for any conflict of interest. As a routine—as we have felt here, I suppose, today—we have agendas where conflicts of interest are asked to be declared at the outset. Standard practice is part of our normal process.
Q12 Chair: To be clear, there is no suggestion of impropriety here, but it is about maintaining public confidence because, as a public regulator, that is important.
Librela is a medicine around which there has been some controversy. Do you approach these medicines in a different way from the way in which you might a less controversial one?
Abigail Seager: We treat all our authorisations in exactly the same way. We respond to reports of adverse events in the same way. The Librela case has been new for us in terms of maybe the media interest, and that has caused us to think about our own communication strategy. It is very difficult to face into a media campaign that is occurring on a number of platforms that we are not party to. I know, for example, that streams of conversations happen in maybe veterinary-only forums, specifically for vets, to which we are not party as a regulator, and neither should we be.
It is important, however, that if information is being amplified that may not be entirely correct we have mechanisms through which we ensure that the right messaging and the right information is out there. It has caused us not to look at the authorisations process any differently, or to re-evaluate the robustness of our benefit-risk science differently; it has actually caused us to look at our communication strategy.
Chair: We will move on now to some questions about staffing and resources from Henry Tufnell.
Q13 Henry Tufnell: Good morning. Thank you for your attendance. You are working across two distinct regulatory regimes in Northern Ireland and Great Britain. Can I ask what impacts that has on your work in practice and whether it affects your core functions?
Abigail Seager: It is challenging; I won’t say it is not challenging. I have individuals who need to, and have done now for some time, be able to put their mind into working on an application that is for Great Britain under one set of regulations, and then—the same people—look at an application for Northern Ireland under a different set of regulations. But we have a very well-embedded quality management system. We have an ISO accreditation that is really important to us, and we have standard operating procedures for the ways in which we work. All those are so well-documented that it allows individuals to almost do that mental shift between two sets of regulations in a way that they are supported with that work.
Nobody works in isolation, and all the work that is undertaken at the scientific level goes through internal scientific review processes, whether it is what we call a SciSec meeting or, on the biological side, a biological comms meeting, where there are reviews of the work that has been undertaken by an individual assessor. There are places in which, if anything was to become tricky for somebody to understand which set of regulations they are working against, there is a peer group in which that could be captured. To date, I have never heard that that has actually been a problem because we have provided for the structure around our staff, but I won’t say it has not been challenging. It certainly has been.
In terms of our operating ability, the robustness of our science is something that we are really proud of, and that has never dipped. We have an independent assessment of our benefit-risk assessments through the Veterinary Products Committee, and we are always awarded the highest level of assurance that our science is sound. I have no concerns about the operations from that point of view.
We have had some resourcing issues over the course of the last two years: the number of applications that we had was greater than the resources that we had to deliver against, and we then had some form of backlog. We do not want that. The pharmaceutical industry does not want us to have a backlog. We have worked through our backlog on an admin basis. We currently have a submission slot system. For the biological applications, a company would need to let us know in advance that they wanted to put an application in. That has to be the case while we are resource constrained.
It is our ambition—it is certainly my ambition—to move out of that so we get to a position where we do not need to have submission slots because we have sufficient resources, physical people resources, to be able to deal with as many applications as come to us. However, that will take time because of the number of people we need to recruit to achieve that level. We are looking for experts in a very small pool, and we have had to shift our ways of thinking on recruitment so that we can grow our own talent in a way, but that will take a number of months and years to achieve.
Q14 Henry Tufnell: What is the turnaround time on the applications?
Abigail Seager: The turnaround time is set in legislation. For new marketing authorisations for a new product, it is submitted to us and we have 210 days to validate the application, initially assess it, ask some questions, and come back and assess it again. There are clock stops during that process whereby we ask a question of the company and effectively we stop the clock because they then have to answer it. They may respond within a month, they may respond within six months, it depends on the question, and it may be that they need to undertake some additional studies or do some other work in order to respond to us. In some respects, therefore, the time is dependent on the quality of the application at the outset and the questions that need to be asked, but the 210 days is set in legislation and we always meet that.
Q15 Henry Tufnell: Can I ask about staffing, which you have touched upon, and particularly recruiting specialist staff? I think in October 2025 you were talking about the recruitment challenges not being to do with financial pressures, but to do with the lack of recruitment in those specialist areas. What are the main factors affecting your ability to fill those roles?
Abigail Seager: Some of the roles that we need are particularly niche specialisms. There are very few people who have the entire range of skillsets and expertise that we are looking for. This is a global problem. I have regular conversations with my counterparts in jurisdictions across Canada, Australia, New Zealand, the USA, and we all say the same thing. We all need more of what we call assessors and others might call evaluators. There are just very few people who have the expertise that we are looking for, which is why part of our strategy on strategic workforce planning has been to bring people in at a more graduate level and train them up to have the expertise that we would like to bring in.
When we want to be able to do more and do more quickly, you want people to come in and hit the ground running. The realisation is that we cannot get those staff, either because the expertise is in short supply or because people who have that level of expertise are quite often working in private industry where the pay comparator means it is to their advantage to stay there.
Q16 Henry Tufnell: You are paying a lot in consultancy fees. I think it has increased from £4 million in 2023-24 to over £5 million in 2024-25. Your total costs for 2024-25, including for temporary staff, are £12.9 million, to give a context to that figure.
Abigail Seager: The majority of the increase in consultancy fees is to do with IT contractors. We operate in a model where we do not take all the group corporate service functions from core DEFRA. We have a number of those services that we deliver for ourselves, and one of those is IT. We have a major transformation IT programme where we have to replace our legacy systems, and some of those were the result of leaving the EU. We were dealing with EU replacement systems. Since then, we have had to replace all our own bespoke modular systems. In order to do that, we have employed specific IT contractors. The majority of the consultancy fees are in that space rather than anything to do with our core business, so none of that is to do with scientists.
Q17 Henry Tufnell: On the national residues control programme, the NRCP, how will the alignment with the SPS, or upcoming alignment with the EU in respect to the SPS agreement, affect the costs and resources required to deliver the work?
Abigail Seager: That is a good question. We are possibly not at the stage yet of being able to determine exactly what that will look like because of where we are with the SPS agreement. Lea, do you want to add anything?
Lea Reynolds: I can add a bit on the residue control plan. The residues surveillance programme is something that we have done for many years. It is actually a requirement for the UK, even after leaving the EU. It is a trade facilitative measure. Essentially, it is showing that our produce of animal origin is compliant with EU rules and international trading obligations. In reality, for the residue control plan, we do a lot of it already.
The resourcing implications for reset will be expected to be relatively low. It is obviously subject to negotiations, but that is one area where we have to do something as a trading partner already, so limited impact is expected.
Q18 Henry Tufnell: Presumably, this is something that you are keeping a close eye on and you are working closely with the Minister.
Abigail Seager: Absolutely. We are integrated with the SPS work that is undertaken in the core Department. When I was referring earlier to major programmes, we are part of that structure and feature as one of the specific projects.
Q19 Henry Tufnell: Finally, how are you working with the devolved Administrations, particularly with Welsh Government and Scottish Government? How does your working relationship with them look?
Lea Reynolds: We have regular engagement with folks in the Scottish and the Welsh devolved Governments. We work very well. We have regular updates and regular conversations with them. Generally, on veterinary medicines, because it is a reserved area, they tend to listen to us and understand that generally it is us leading. On residues and AMR, because it is a devolved area, there is much more detailed conversation in terms of co-ordinating across all four nations. We work very closely with them, but the depth depends on the area and where they lead and where we lead.
Q20 Chair: On the SPS point, you are not sighted yet on what will be required under the SPS agreement, like the rest of us. Is it fair to say, without putting words into your mouth, that a period of implementation would be helpful? What do you anticipate that being?
Lea Reynolds: Again, it is all subject to negotiation, so it is all very unknown. For a lot of our areas—residue surveillance is a prime example— where there is not a massive amount of divergence, the expectation is that we would not need a dramatic amount of time. But as I say, until we know what—
Chair: Until we know what we are dealing with.
Lea Reynolds: Yes, exactly.
Chair: Fair enough. Ben, you have some questions in relation to veterinary vaccine availability.
Q21 Ben Goldsborough: Good morning, everyone. I am from the part of the country with 20% of the pig herd, Norfolk and Suffolk, which means that we have been very aware of the acute problems with supply issues when it comes to veterinary vaccines. What can you briefly describe as the main drivers for the shortages we are seeing?
Dr Eckford: They are complex and multifaceted. Overarchingly, for vaccines in general, a range of factors drive shortages. There are issues around absolute shortages because you may have an interruption in the 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.
Vaccine production is sensitive, it is a biologically sensitive process, and it is probably more vulnerable to issues in manufacture. We know that manufacturers tend to work very much on a forward planning basis in their manufacturing processes. They might, for example, plan their production five years ahead and if there is an interruption with a manufacturing process with one vaccine, the ability to flex and create a new batch might involve significant delays. There are factors around that. There are also factors around therapeutic gaps where there are no vaccines for particular diseases. That can be because it is a challenging disease to produce a vaccine for. It can also be due to concerns about return on investment because ultimately production of vaccines is a commercial practice and if there is not considered to be sufficient return on investment for a particular product, it would deter manufacturers from entering that space.
There are also wider issues over the years around the increased efficacy of manufacturing streamlined production. You may have one site that manufactures an active, one site that manufactures an excipient, and another site that makes the packaging, and that increases the vulnerability because at any one point along that chain you might have a failure. It is hard to say which of these factors applies to pig vaccine specifically, but there is a range of factors that influence vaccine availability and that will, of course, impact the pig sector as well.
We are having conversations in the pig sector. We have a workshop planned where we will engage with pig farmers, vets and SQPs in that area and we are going to be delving into the specifics about which vaccines and at what point they are experiencing challenges with them. That is planned for within the next month.
Q22 Ben Goldsborough: Is one of the issues that has caused this post covid the change of focus within the vaccination creation industry? Has that created weaknesses within the UK as well as for surrounding trading partners?
Dr Eckford: The impact of covid? It is hard to say whether or not covid has impacted veterinary vaccine production per se. During covid, there was obviously a pivot of manufacturing towards human vaccines, but I do not think we would have any evidence right now to say that that is subsequently impacting veterinary vaccine availability.
Q23 Ben Goldsborough: Thank you. Another thing I have noticed is that your statement of intent, which was published nine months ago, has some fantastic things in it that I think we would all support and agree on. One of two points I would like to mention is reviewing the UK manufacturing landscape to assess capacity. From the National Audit Office report of June 2025 we see that you informed the NAO that you had already had meetings with manufacturers in that spot in November 2023 and February 2025. Do you feel that another meeting will solve the problem? What steps forward do you believe you need to take to improve this aspect of the weaknesses?
Dr Eckford: There are a lot of conversations still to be had in encouraging manufacturers to enter this space and address availability issues. We still have significant knowledge gaps in understanding at a granular level where these issues are occurring, in particular which vaccines for which species and for which causes. The first part of what we are doing now is trying to delve down to get that information together and fill those knowledge gaps, because that can specifically inform the conversations we have with manufacturers, saying this vaccine is important for these reasons, asking what challenges they are facing and what can be done for that particular issue. I think that should answer your question.
Q24 Ben Goldsborough: Yes. Another thing that I thought was quite interesting in your statement of intent was about supporting innovation through increased investment in R&D. How do you find the working relationship, not just internally within DEFRA but within other Government Departments—DSIT, for example? Is that where you are pushing at an open door when you are trying to talk, or is this something you are so siloed off from that you do not get a chance to speak to them about R&D investment on this aspect?
Abigail Seager: Recently, that is an improved space. We have had increased interactions with DSIT and with OLS—sorry I am talking in acronyms; please call me out if we are acronym heavy—in relation to animal usage and 3Rs in terms of reducing the number of animals that are used. There is an increased appetite for communication between us, which is an improved position from even a year ago. As we are moving into the space and, of course, facing into vaccine availability as not just a topic where we were dealing with short-term supply issues, we are now looking at this more strategically for the medium and longer term, which is new for us.
This is definitely a space where there are others who are interested in what we are doing because it rubs up against something that they are doing in a positive way in which we can assist each other or look at other strategies. It is definitely an opportunity for us. There is probably more that we can do, certainly with other Government Departments that we work with, including on the human medicine side, because quite often we are talking to the pharmaceutical industry, which may have an interest in both human and veterinary medicine.
Q25 Ben Goldsborough: Is there anything in particular that you feel would be the magic bullet to improve that communication? Is it just trying to raise awareness that you exist as an organisation within the larger body of DEFRA, for example?
Abigail Seager: That is the thing and I am very pleased that we are here today because this is the first time ever that the VMD has been invited, so thank you very much for the opportunity for a bit of a promo.
Absolutely, I think that for the work that we do—it could easily be the same for some of the other arm’s length bodies—you do not necessarily know that you need us until there is a problem that has not been addressed. Quite often the work that we do may well be unseen and unknown. That does not mean that we do not have a dependency on others, and when we do that can be challenging if they do not recognise the value-add that that can bring or the need.
I think that because we are working in a shared outcome space now, it is far easier. The platform is there for us to work in that more collaborative way, especially across the DEFRA group, and I think there is certainly the appetite for that to be true across the science sector outside of DEFRA as well. Certainly, we work in a number of forums that we have created on both vaccine availability and pharmaceuticals, and the environment is another one where I have set up a cross-Government group where we bring in other Government Departments and nobody has said, “No, we’re not attending”.
Q26 Ben Goldsborough: Perfect. Another thing that has been noted before is that you have said you will address the urgent issues in the action plan. What do you identify as urgent and what actions have you already taken?
Dr Eckford: We already had a number of actions in place during the last revision of our Veterinary Medicines Regulations. We put in place a regulatory basis for some of the new technology that is coming out around vaccine production—for vaccine platforms and vaccine antigen multifactorial dossiers—so we had already laid out some of the steps there to make sure that regulation was enabling innovation in the vaccine space.
More recently, we have been 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 set out the specifics for the manufacturers and that is an ongoing process.
We have moved towards a step that we call the stakeholder dialogue platform. When we have a shortage announced to us, we have now run this process several times whereby we bring together not just the manufacturer but the vets who are involved, representatives of the veterinary bodies, representatives of those vaccine users and, of course, the distribution chain, to try to face into what that shortage means and what mitigation steps can be taken to try to address that in the short term. That has been welcomed by those groups as enhancing that communication flow around shortages.
We have always had in place, but are being better about communicating, our special import schemes. So when there is no option—therapeutic or, in this case, vaccines—there is the ability to source a product overseas that we can issue an import permit for. There is also autogenous vaccine production. These are the steps that already existed but we will be clearer in communicating about them with our stakeholders. They are the steps that we already have in place and actions we have taken in the recent months to try to progress this issue.
Q27 Ben Goldsborough: Thank you. My final question is about looking forward. We know there are a couple of things coming down the track that will increase demand for certain vaccines. For example, the one that is on the tip of everyone’s tongue is obviously the bovine TB strategy, where we could see an ambition to deploy the cattle vaccine by 2030. Going back to all politics is local—my neck of the woods has £740 million worth of output in the poultry sector—another aspect is that we know there is a trial going on for a thousand turkeys with a traditional Norfolk poultry company, for example. If the stars align and we have sign-off and we see a greater use, do you see that we will still have an ongoing supply without manufacturing constraints to actually allow these ambitions to be fulfilled?
Abigail Seager: What I cannot control, of course, is how much is made and this is where the work that Suzanne is leading on—our vaccine strategy; our statement of intent—deliberately brings in all the other actors and stakeholders who can affect that and make the difference. What is important is that we give the information as far enough in advance as we can to those who can ensure that the supply matches demand. If we know the demand is going to increase, as you say, how do we get that communication to those who can make sure it is achieved? We do not make it ourselves so I cannot ensure that that is the case.
What I can ensure is that communication about what is important to us is really clear, what the priorities are and where we see the direction of travel. That is the work that we can do. I would love to be able to say that I can 100% guarantee you will have enough. I do not think I can do that. I would be lying if I said I could, but I want you to be more assured that we are doing all we can to get to the space where that is more of a true statement.
Chair: Terry Jermy is going to come in on the situation around access to veterinary medicines in Northern Ireland.
Q28 Terry Jermy: Good morning. We are very pleased to welcome you here to shine a bit of a spotlight on the work you do, so thank you very much for coming along.
In your response to Henry Tufnell’s question, you spoke very openly about the challenges in working across two different regulatory regimes. I suspect that one of the main concerns would be access to veterinary medicine. We are six months on from the grace period ending. How effective are the two schemes for ensuring access to veterinary medicines in Northern Ireland? What are the initial findings?
Lea Reynolds: I am quite relieved to say that our understanding is—this is from a lot of engagement with industry in Northern Ireland and locally—that reliance on the schemes is not dramatic. We are aware of vets needing to use the internal market scheme particularly, so that is where they are sourcing a product from GB, but actually it is relatively few and far between. We know there was a lot of fear and concern that medicines would not be available in Northern Ireland and that they would not be able to source them through the existing routes, but I am very pleased to say that that is not what we are seeing in reality. We are having an inordinate amount of engagement with Northern Ireland. We have been meeting with them over there every few weeks to try to make sure that we pick up on any issues, but I am pleased to say that from what we have seen and from that engagement, normal medicine routes are for the most part effective now.
There have been some minor issues. I chair the supply co-ordination forum that was set up at the end of last year. It has been meeting every two to three weeks since January. It brings together all our vet stakeholders and retailers in Northern Ireland to have those open and frank conversations. We have found that, generally speaking, Northern-Ireland-specific issues are quite few and far between, and we can act quite quickly to resolve them. What we are seeing, however, is that, like in the rest of the UK, where there are shortages they tend to be UK-wide disruption, so not just affecting Northern Ireland.
I am pleased to say that we are not heavily reliant on those schemes, but we are obviously keeping a very close eye and will continue to do so for the foreseeable future.
Q29 Terry Jermy: Thank you. In your response, Abigail, to the Chair, you spoke about a dashboard for reporting. I assume that the availability of medicines forms part of that dashboard, so it would be useful to understand what it looks like. The Committee went to Belfast, to the Balmoral Show, and we picked up some anecdotal evidence. How do you collate and feed that into the reporting system?
Abigail Seager: The supply co-ordination forum that Lea referred to has a number of participants who are really on the ground, as I would refer to it, who probably are the ones who would feed back some of the anecdotal concerns. We have created that platform to get that information up front. Occasionally, something may come through as a supply issue, which is very normal for us, and we are feeling the same supply issue in GB. We can address it in a way in which we would understand whether there has been an issue with the manufacture, or an issue somewhere along the supply chain that will resolve itself and become unblocked in a matter of a couple of weeks, or whether the duration is such that it would cause an animal health or welfare issue that we need to address in another way. It has always been the case that we have addressed that.
What we now have access to through the supply co-ordination forum is really early information from others than the pharmaceutical industry itself—from wholesale dealers and others who are bringing that information directly to us. That means that we can get on the front foot of addressing it. Part of the regular policy meetings that we have with Baroness Hayman will refer to the current supply issue situation. It features in both the policy and the operational delivery dashboards that we talk through with her because obviously it is of high interest, but also we are facing into it through both of those lenses.
Because, as Lea said, there has been very little to report by way 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 stockpiling, and rightfully so in terms of mitigations, and that was something that we encouraged all those years ago through when we were entering into exiting the EU and then in the covid environment. We are aware of that, and we are aware that those stock levels will at some point start to decline, which is why it is really important that we do not become complacent and think, “Everything’s fine. It’s six months in. We can take our eye off the ball.” We are not doing that. We are keeping those forums open so that we get that early information and can face into understanding what we can do about it. Partly, that will then come back to having the conversations I was referring to with the pharmaceutical industry itself to understand what the issues are with supply, and whether there is something we can do from a regulatory point of view to resolve them.
Q30 Terry Jermy: I was pleased you mentioned stockpiling because that was certainly one of the anecdotal bits of evidence that we picked up as a Committee from a number of different sources. Do you expect that problems will emerge as supplies run down over the summer? It is very difficult to quantify how big the stockpiles are and when they might expire. I accept that, but do you think you are well prepared to manage that if and when it happens?
Abigail Seager: I certainly think we have the forums to get the heads-up that that is starting to become a true statement and to understand what those stockpiles might look like. We can then focus if there are specific products or therapeutic groups that we would need to focus in on. For some products, there may be alternatives, and we have to look at whether or not the alternative could be utilised through one of the schemes. Then there is a conversation about whether enough is made of that alternative to be able to support that use. It is all well and good saying there is another product, but if that product was only ever made to support 15% of the market and now we are asking it to support 100% of the market, it is likely there will be a supply issue. It is a careful conversation to be had.
I feel confident that we have set up as many platforms for getting that early heads-up as we can. Of course, until we know exactly what the issue is we will not know how easy it is to resolve, but I think we have a number of tools in our toolbox to be able to face into it.
Lea Reynolds: I agree. Regarding reacting to things, that is the purpose of having the supply co-ordination forum. It is working effectively from our point of view and according to the feedback we have had from the industry.
Regarding future proofing, as Abi says, it is very difficult to understand. Until we know what an issue is, it is very difficult. However, from what we have understood, particularly from the main wholesalers in Northern Ireland, they feel that they are in a good position and they generally are. They do not have massive stockpiles. It is a massive industry so stockpiling is actually very difficult, but they are turning over stock. They are getting new stock in so it does feel okay. We are continuing to monitor very closely.
Q31 Terry Jermy: Lastly, another piece of evidence that we have picked up is about how people might be able to get the medicine they need but not necessarily in the size they want so they are having to buy much bigger quantities, and obviously that has an impact on cash flow. Not everybody can afford to buy and store huge quantities. Are you gathering evidence about vets potentially changing their practice habits to adapt to any of these changes, when they might get what they need but just not quite in the way that they want?
Lea Reynolds: We encourage vets to report that information through the representative bodies, NEVA, BVA, and others on the supply chain forum. We have asked them to approach their members to feed that information to us. Specifically on antimicrobials, we and DAERA are working on that reporting tool for sales and usage, which would also help on that. It is something that we are looking into to improve. There is an open call for that information to come to us so that we can react to it as we need to.
Q32 Chair: On the subject of stockpiles, I am not quite clear. Do we know where the stockpiles are being held? Is it in individual practices? Is it in buying groups? Is it in wholesalers?
Lea Reynolds: We understand that some vet practices have purchased more stock, but again a lot of this was towards the end of last year. If you are looking at medicines, trying to store lots and lots of packages is very difficult when you consider—
Chair: I am thinking of things going out of date.
Lea Reynolds: Exactly.
Q33 Chair: Northern Ireland, as I recall from what we were told at the Balmoral Show, still has a greater preponderance of independent practices. The corporates have not taken hold in quite the same way as they have in other parts of the country. These are small businesses working on very tight margins. We know, in particular because of the amount of agricultural livestock that there is in Northern Ireland, that there is a heavy bias towards farm practices, and that is where we have seen a lot of practices on this side of the water going out of business or just giving up. Are you mindful of the impact on individual practices?
Lea Reynolds: We monitor and we talk to the vets. We talk to NEVA and AVSPNI in Northern Ireland to understand exactly that point: to understand what the real-world implications are for vets over there. I am pleased to say that from all the reports we are getting it seems to be a stable situation.
On stockpiling, I have spoken to the main wholesaler over there, and they are getting new stock in, they are supplying stock, and they are supplying on that just in time, as they were before the end of the grace period. We are not seeing any of the issues that we are expecting. Whether or not we will, again it is a difficult one to see, but that is exactly why the forum is there: to flag those issues to us as quickly as they can.
Chair: Okay. We move on to questions around the CMA proposals for veterinary practice reform.
Q34 Josh Newbury: As you will all be more aware than I am, the most headline-grabbing story that we have had in recent months on veterinary practice has been the CMA’s proposals around reforms, which some have heralded as a major step forward for customers, but we know that in some of your responses to the proposals you had some reservations. Could you tell us what direct impacts the CMA remedies will have on your work as the VMD?
Lea Reynolds: We obviously support the CMA’s ambitions in this area. Similar to what I have seen previously from the Committee, we do have some concerns that there may be some unintended consequences. Generally speaking, particularly as a pet owner myself, I am happy to see anything that can be done to reduce some of the prices that we pay.
I think the impacts on the VMD will be relatively minor. We have been asked to look at things such as cost and the cascade, and particularly advertising or reclassification, and they are things that we will consider and look into further. Some of it is what we do already in some respects. Our ethos is to ensure that the right medicine is available at the right category, so we endorse the aims. We just need to balance them with our broader policy objectives.
As we spoke about earlier, the availability of medicines is key. As always, the regulatory framework is geared up so that authorised medicines should be the default. There is a regulatory framework set up around that specifically to provide that assurance to owners and animal keepers. When you look at things like the cascade and that side, you have to balance the approvals process with the risks that vets are having to take to use products that are not authorised. That is where we have to have that balance. We are supportive of the aims of the CMA review, but we have to make sure that it ties in with our broader policy objectives.
Q35 Josh Newbury: In making all those judgments of balance, do you think that is going to require greater resource within the VMD, or do you think it is something that you can cope with, with the numbers you already have working for you?
Lea Reynolds: I think it will probably be okay. On the policy side, particularly for my team, we have had to surge and increase staff purely for responding to Northern Ireland, the Windsor Framework, as well as the SPS agreement work. My team has surged and increased to meet that demand so I think we are okay. If we need to, we will consider what we have to do.
Q36 Josh Newbury: Touching on unintended consequences, we picked up on a few, too. From your perspective, with your regulatory hat on, what are the main risks that you foresee as we move towards implementing these remedies? What are you concerned about, even with the final decision, that you want to be wary of?
Lea Reynolds: For me, obviously the push for medicines to be supplied online is a good thing. VMD has supported online retailers for many years. Many of my colleagues have worked with those companies to establish that well-rounded framework. It is not a bad thing to encourage people to buy medicines online. Online commerce is obviously the way the world is going, but like all this, it is not without risks. We flagged prescription misuse and prescription fraud in our report. Generally speaking, the numbers that we have reported to us are quite low but, of course, if it is an area where more of it is happening, there is more potential for it to go wrong. That is the future we have to consider and be alive to.
Q37 Josh Newbury: One concern that we did note in your consultation response was that vets might feel a pressure to prescribe cheaper medications, even if they are not the most clinically appropriate medications, because of this widespread perception now that the CMA remedies are going to result in lower medical costs overall. How big of an impact do you think that will have on prescribing behaviour or clinical decision making? Is it overstated, or are you worried too?
Lea Reynolds: There is always that difficulty. Vets obviously want to do right for their animals but then they have the difficulty of money. Ultimately, people are used to medicines being cheaper for themselves because of the NHS. We do not have an NHS on the veterinary side, and prices are driven by market services. That is not just the price of the medicines; that is the treatments as well, which is also quite often lost in communication.
For me, it is a difficult space for vets to be in, and I think that is where some of our guidance does play a role, to set that expectation about where things are going. Historically, the Government’s position has been that cost is not something that should be taken into consideration. The ethos is that it should be the right medicine for the condition presented to them, and that is ultimately what needs to happen, but it has to be a carefully balanced nuance, noting that vets are the ones being faced by consumers.
Q38 Josh Newbury: Are you concerned that there will be that pressure—that vets will feel that they need to prescribe something, that they are almost cascading themselves in a way and, if something is too expensive or there is pushback from a customer, they might recommend something else? Your view is still that that is not appropriate—that they should be sticking to what is clinically necessary?
Lea Reynolds: I think they are already under that pressure now, if I am honest, because of all the media interest around the CMA review.
Q39 Josh Newbury: Lastly, another issue you raised in your consultation response was that changes to written prescriptions could potentially weaken safeguards against fraud or misuse. Do you think that those concerns have been adequately addressed in the final proposals, or do those concerns still remain for you?
Lea Reynolds: They have been addressed to a degree. We did see that the CMA amended its remedy. I think the difficulty with online prescriptions is that there is potential for abuse in all these systems, and retailers and suppliers are the ones who need to have some of those controls in place. We are very fortunate. The number of reports that we get about prescription fraud or misuse is quite low, but we are encouraging more reporting to help us truly understand the situation. I think there is some risk, but that is a risk with online retailers that we already are aware of and cognisant of. If the number of prescriptions being dispensed online increases, then obviously that risk increases, so we need to monitor and understand that.
Q40 Josh Newbury: One of the things that we, the Committee, have heard is that when people look at this from a broad view, they assume that if people have the option of online retailers that is increasing competition and therefore prices will be driven down. At the same time, a lot of those online retailers are owned by the big groups that own the veterinary practices, so how much real competition is there? Do you think that very close relationship between vet practice groups and online retailers is going to create any tensions around this price question?
Lea Reynolds: It is an interesting point. Some of the work we are doing in the Northern Ireland space is looking at price monitoring. What we are finding across Northern Ireland and Great Britain is that there is massive variance in prices online between different suppliers for the same product. It is incredible. If people do search online and they do it appropriately, they can find medicines cheaper than you would otherwise, so there is a lot of competition already. I suspect that if the CMA does encourage people to search online, that competition will increase.
Chair: We move on now to everyone’s favourite subject: the veterinary medicines cascade.
Q41 Juliet Campbell: Views on the current veterinary cascade are mixed, particularly around affordability; you spoke a bit about that earlier. Can you respond to the concerns that the rules push vets towards more expensive licensed products when cheaper human generics are available?
Lea Reynolds: Like I said earlier, the authorisation process and the framework for veterinary medicines are geared around authorised medicines. There are good reasons for that. When a medicine is approved, it is assessed for safety, quality and efficacy in the animal, the dosage that is given and what is to be used for. That level of assurance is fundamental to what we do in VMD and the regulation of medicines.
When you start to move down the cascade, that assurance drops with each step you go down. It is a risk-based decision tree. The further you go down, the riskier things are. It is difficult to balance the cascade. The cascade is there, is needed and is well used, as we understand, but it is making sure that it has the right balance between enabling animals to be treated and for clinical need, but also not disincentivising the approvals process and ensuring that medicines are available for a need. We spoke earlier about vaccine availability, and that is a prime example. You need to ensure that you have the right medicines available, and that is through the approvals route.
The cascade is an exception from that. It is a needed one, and we think it probably does strike the correct balance, but it does chop and change. As we are seeing, people do have significant concerns about the cost factor, understandably, but then you also have the flipside of the assurance piece. Pharmacovigilance, which is the monitoring of products, is strongest when you are using authorised 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. That is where you have to strike that balance. It is a difficult one, and we think we get it right, but we review it constantly to see and to understand.
Abigail Seager: One thing we are doing is having more conversations with vets to ensure that they are fully aware of everything Lea has said, in that we would like the right product for the species to treat the condition to be available. That isn’t the case; we have 3,000 authorised medicines, but there is not always the product for the species, given that we have such a range of species. It is necessary to use the cascade at times to treat the condition when it might be authorised for dogs but we need to use it, for example, in a cat or something along those lines. We want to make sure that vets are fully aware that the product that is authorised has been through all the robust benefit-risk checks and is authorised for that purpose, and anything they use under the cascade has not been taken through those processes for that species in front of them. That comes with some form of risk.
We want to make sure that that is well understood because, as Lea said, as you go through the cascade and you are using either products that are authorised for other species or human medicines, or other types of products as well, the assurance that any prescribing vet can have about utilising that medicine needs to be well understood.
Q42 Juliet Campbell: It is important that that standard is in place; however, if there is a cheaper medicine that does not have a great risk and the standard of care is not decreased sufficiently, would we recommend that the vets use that too, and that there is some flexibility? The medicine will not do harm. That is the thing, isn’t it?
Abigail Seager: All medicines have a risk associated with them. It is an important conversation right now to be having, of course, because of what the CMA report has indicated. As Lea said previously, to date we have never encouraged vets to consider cost as part of their decision making in the prescribing cascade considerations that they give. However, we are in a space now, of course, where they are facing that pressure from a number of different scenarios. We have to be cognisant of that, and we have to be aware of that impact. As a result, we are having these conversations with the veterinary practice about understanding where they would be with any risk in that decision making.
Q43 Juliet Campbell: Finally, the CMA suggested that cost should play a clearer role in prescribing decisions. Are you planning to review the cascade in the light of those findings and could cost become an explicit factor?
Lea Reynolds: We will certainly consider the CMA recommendations. It is very difficult. Cost has never been something that we have been very keen to ensure because it should be the right medicine. It should not be based on economic factors. As we are seeing, there are ways and abilities to get the medicines that are cheaper without having to go through the vet as well. It is not always appropriate, but it is there.
The other difficulty for us as well, as we mentioned earlier, is about having two regulatory regimes. Northern Ireland is bound by the cascade as it sets out in European law. We always have to make sure that we are not advantaging or disadvantaging when we do that. We have to look at it holistically across the side of things. We will certainly consider it, but what that will look like in the future I do not know yet.
Q44 Chair: Can I tease this out a bit more? You say you will not be driven by cost considerations. The CMA is. That was the whole point of the CMA investigation in the first place. In some examples, a medicine is available under the cascade and then something is licensed, the cascade option falls away, and that licensed product is more expensive than whatever you have been using under the cascade. You lose the opportunity then to use the cheaper product. Tell me if I am getting this wrong. You talked about risk. If something has been in use for a long time, as is quite often the case, any risk would surely have been apparent by that point. Surely you should be looking at cost.
Abigail Seager: I will bring Suzanne in, but certainly to date cost has not been a factor we have explicitly said should be a consideration. This is the moment when we review what that should look like. We are not in a position to say yet whether we should explicitly permit it because we have to ensure, as Lea said, that we do not have any indirect consequences that might cause an issue between Northern Ireland and Great Britain. Additionally, we want the authorised products to be on the market. Suzanne may have a reflection.
Chair: With the passage of time, surely, any unintended consequences would be apparent.
Dr Eckford: I want to make the point, I guess, that when you have a product that has been through authorisation, you have assessed a certain amount of data on the safety and on the risks associated with that product. For products that are used in the cascade, we are not looking at that data and no independent body is collating that data. It is down to the individual vet’s personal experience. You have the experience of what you have done with animals that you have in front of you, but that is not a huge body of evidence. When you have an authorised product, you know what basis your evidence says. You know the basis of that benefit-risk decision.
Outside of that, you are dealing with unknowns. You can take an active substance and, when you place that in a product, it is not just the active substance that implies risk and benefit; it is how it is formulated. All the other parts, the excipients and the other chemicals that are put into that product, formulate that product. We do not measure what is being used on the cascade. We do not collate that data separately. That is an individual vet’s decision to do.
Q45 Chair: You are the Veterinary Medicines Directorate. Should you? Somebody has to, and you are the independent body. If we are focused on consumer outcomes in the way that the CMA tells us that we should be, surely this is a material consideration.
Abigail Seager: Possibly. This is what we have to consider. We are at that stage. We have agreed with the recommendations in the CMA report to the extent of saying we will look into this for sure. We know historically why we have not. We now know we are in an environment where it is important that we do. Suzanne’s point is in reference to your point about whether efficacy is proven by use. That is individual because there is no record of that. As Lea referred to, the pharmacovigilance is not recorded in a way that we can test.
Q46 Chair: Once you have a licensed product, the veterinary surgeon is obliged to dispense the licensed product, not the generic that they might have been dispensing for years. We look at this from the point of view of outcomes for the pet owner and indeed the pet, or not necessarily the pet; it might be a farm animal. You have been given your prescription. The vet does not trot off to the dispensary any more and come back with a bottle of injecting medicine or tablets. You go away and you have to buy your prescription. At that point, cost becomes a factor. You do not control whether the animal is getting the medicine at the end of the day. If the medicine is more expensive, the animal may not get the medicine. That becomes an animal welfare issue, surely.
Dr Eckford: The point I was trying to make before—not very clearly, apologies—was that you do not know that the product that is being used off-licence is equivalent to the authorised product. That dataset is not there. They are not necessarily interchangeable in terms of the overall safety of the product.
Q47 Chair: Surely the test should be a material difference and not just any difference.
Dr Eckford: Again, you do not know whether that is a material difference. If you reformulate a product that is designed for a particular species in a way that is safe for that species, that should be recognised. The product that you are using that is a human medicine is not formulated for, say, a dog or cat. Those species have different metabolisms and will respond differently to different formulations of products. We do not know precisely how that off-label product is formulated and its safety profile in the species that it is being used in, whereas we do know with that authorised product.
Whilst expense, as you said, is an imperative factor for many pet owners, it is also the right of every pet owner to be offered a product that is the safest for their pet because the most is known about it. Vets have to go through that challenge when they are making those choices.
The RCVS does specify contextualised care, and the benefit of the cascade is that it gives the vet surgeon the opportunity to say in this particular circumstance for a number of reasons; for example, ease of administration or the likelihood of the owner complying with the dosage regime. There are lots of reasons why they can look at an authorised product and say, “In the contextualised case of this patient and this owner, I need to make a different decision and utilise the cascade.” I guess the factor here is whether we make it more explicit that we need to look carefully at cost as a part of that contextualisation.
Abigail Seager: Can I add something? Earlier you referred to the term “generic”, but of course, to be clear, that is not the same as using a product under the cascade. Where a product is authorised and there are generics of it, so there are multiple options there for a vet to be able to prescribe, if each of those products included in generics are officially authorised, there is an element of choice. Then, of course, that may well come down to the cost. Some vets prefer one product over another, but cost considerations may come in at a local level at that stage, which is outwith the VMD’s responsibility. There are opportunities where you have a broad market with lots of products. That is in an ideal world where we have as many products as we could possibly need for all the species and all the diseases we are trying to treat.
Q48 Chair: Are we at risk of letting the best be the enemy of the good here?
Abigail Seager: We have to have robust science against authorised products. At no point do we want to—
Q49 Chair: Absolutely, but vets in their surgeries—I should have declared that my wife is a vet and my son is a vet—are not operating in isolation. A whole range of journals report these things regularly, quite apart from the informal traffic that is in the profession. It strikes me as slightly incongruous that on the one hand we have an arm of Government in the CMA saying we must be driving down cost, and on the other hand we have you as another arm of Government saying, “We do not look at cost. We just license what the pharmaceutical companies develop.” At the end of the day, they are the ones who benefit from this financially, aren’t they?
Abigail Seager: When we look at the benefit-risk of the medicine, we are looking at the benefit of treating the animal because good animal welfare and health is important to us. Our outcome is good animal health so that has to be the benefit. The risk against that is risk to the animal, risk to the human, risk to the consumer when we are talking about food-producing species, and risk to the environment. That is the science we look at. If the benefit to the animal and the risks that always exist—because medicines always have risks—can be mitigated, the product is safe enough to be used.
We do not and have never to date undertaken then to say, “Is that economically viable?” That adds a different viewpoint into that and we do not want that to affect the science. Of course, the economic angle is new and we have not had to look at that to date. Should we? Maybe. We have not. We cannot right now. We have nothing to benchmark against. This report and this environment is now telling us that that is important for us to consider. We certainly would not be doing anything to inadvertently create an environment where the cost was prohibitive because that again does not achieve the outcome that we are aiming for in terms of good animal health and welfare.
Q50 Chair: We will move on. I have a few questions around prescription fraud and illegal medicines. Lea, you talked earlier about prescription fraud being low level. Your recent enforcement report identified over 1,800 cases of prescription fraud since 2023, which I confess I was quite surprised by. What is driving this level of fraud? Talk us through what constitutes prescription fraud in the first place.
Lea Reynolds: We tend to split our prescription enforcement cases into two. We have prescription tampering, where essentially someone amends the information on a prescription. Quite often that is around quantity. The other side of things is fraud or complete fabrications where, for example, someone may send a prescription to multiple retailers to dispense, obtaining it fraudulently, essentially.
I referenced the numbers being quite low. The 1,800 reports that we had were over a 29-month period. That is quite a long period of time. The UK has 20,000-plus vets. When you look at the number of vets and the number of animals that are seen daily, it feels like quite a small amount over that period of time. This is part of the trickiness for us.
Q51 Chair: It is a small number, given the overall terms that you are dealing with, but it is highly regulated. Prescriptions come only from licensed veterinary practitioners in a controlled environment.
Lea Reynolds: Exactly, and that is our expectation. It is relatively small in terms of the number of prescriptions. One thing we are keen to do, though, is to encourage reporting of prescriptions and issues because we always have the slight concern that we know how many vets there are and we know how many animals are seen every day, so it does feel a little low. Whether that is just us being cautious, we want to see more reports to investigate. We hope that the numbers are quite low and the majority of people are operating within the framework. That is where the concern is.
If folks are using online retailers more, the potential for fraud and misuse increases as well. We know veterinary medicines are not cheap. That is recognised by the CMA report. That has various drivers. Like I say, medicines online are generally cheaper. We have the evidence to say that across all the different retailers in both Great Britain and Northern Ireland there is a massive difference in certain retailers, certain prices and everything else. If you shop around, you can get quite good deals for the medicines.
Q52 Chair: That would be the economies of scale, essentially. Then we have reports of increasing prevalence of counterfeit treatments for fleas and ticks. What is driving this?
Lea Reynolds: The increase in reporting, we believe, is due to an exercise we carried out with the Intellectual Property Office. We did a campaign highlighting the risks and the existence of counterfeit products. Shortly thereafter, we saw a dramatic increase in the number of reports we had. Again, it is 49 reports. In the grand scheme of how many medicines are authorised and how many packages, that is quite small, but we saw a dramatic increase following the work we did with the IPO.
Q53 Chair: Does this bring a resource implication for the directorate? Do you have sufficient resource to police this?
Abigail Seager: We take a risk-based approach to our enforcement activity, and we need to make sure that we focus our efforts on the breaches of the regulations that have the greatest impact.
One strategic shift I have referred to is about our communications. To help balance the resources that we have, we are trying to consider a shift to greater compliance and compliance through communications. We do not always know why people are committing prescription fraud, for example, or tampering with prescriptions. We might assume that it is for cost reasons, as we referred to. It may also be because they have not cashed it in in good enough time, and they may think it is okay to change the date without the knowledge that it is an offence to do so.
There is a communications campaign and, as we know with the communications campaign we did with the IPO, it was effective. It had that dramatic increase, that 700% increase, which sounds huge but when we look at the numbers it is maybe still slightly small, relatively. We know that communications campaigns can work, and we are shifting our strategy to focus on an element of our enforcement strategy, which is about compliance through communications.
A bit like with any enforcement organisation, I suppose, however many people you have you will never have enough to deal with absolutely everything, but we have to take a risk-based approach and focus our efforts in the area that has the greatest impact on issues with noncompliance.
Q54 Chair: I am intrigued by this. It is coming to me completely new. If you have a flea or tick treatment that you identify as counterfeit, is that still a flea and tick treatment with a different label or are people buying stuff that will not be any good at all?
Abigail Seager: There is a difference with products authorised in other countries. You might assume that, if it is safe enough there, it would be safe enough here. We would say that we need to authorise that. Other types of medicines are false medicines and are not manufactured in that way. You are not using a product that is authorised in another country. It has been put together not in accordance with the right ingredients or in the right way. That can have huge impacts if used, in the same way as if we as humans were using a medicine that had been not formulated in the right way.
Q55 Chair: You have a challenge with social media platforms. We are told that you have removed hundreds of illegal listings from platforms such as Facebook and, quite appropriately, TikTok. Tell us how the experience of dealing with the social media platforms has been. That is not always straightforward.
Abigail Seager: No. It was new for us, of course, to have to go down this route. We do not often say in our stakeholder engagement that when we are talking about other Government Departments and other representative bodies, we also put Amazon and eBay into that group. That was relatively new for us. We have recently increased our meetings with Amazon, and we are engaging with other platforms like eBay. We intend to increase our interactions with, as we referred to, TikTok, Instagram and Vinted. They are the other places that we have recently been made aware of where these products could be listed. The intention with that is to focus on words and phrases that might appear in listings that might not be correct, and removing listings of either unauthorised or illegally imported medicines.
It is an interesting one, as Lea was saying, because there is a place for online purchasing, but there is also a place where that purchasing is detrimental to the health of the animal because it is quite possibly a counterfeit medicine. It is a new area for us that we have been having to face into.
Q56 Chair: That will only get bigger, won’t it?
Abigail Seager: For sure. This is where we have to react and be iterative to the world around us and how things are moving in the pet health sector.
Chair: Okay. Moving on, Terry will lead some questioning in relation to antimicrobial resistance.
Q57 Terry Jermy: I am not an expert in antimicrobial resistance. I can barely say the word. However, it is an important subject; I know that much. Could you explain how it features in your work and how much of a priority it is among all the other challenges, frankly?
Dr Eckford: It is a high priority. We have, together with other parts of Government, published, as you will be aware, a national action plan on AMR that sets out all the different workstreams and the commitments that we have made, through which we will address AMR both within the UK but also looking more internationally around what we can do to support global efforts to address AMR.
The classic phrase is “bugs know no borders”. They move around with people and with animals and with food, and we need to make sure that we do what we can to try to minimise the risk of antimicrobial resistance being developed and transmitted as well.
Q58 Terry Jermy: You mentioned the national action plan. Correct me if I am wrong, but it does not contain specific targets to reduce antimicrobial use. Is that a concern? Are we on track to get to the 2040 ambitions?
Dr Eckford: It does not contain those per se in the last published national action plan, but the NAP board does recognise the targets that have been set by the targets taskforce of the Responsible Use of Medicines in Agriculture—or RUMA—Alliance, which is a non-profit alliance of different industry groups of production sectors. Those evidence-based targets are now in their third cycle of targets. We can see the impact that those targets have had because we have had a more than 57% reduction in antimicrobial use in our animal health sectors over the last 12 years or so. The boards have recognised these targets have been set both for production animals but also more recently, last December, for the first time for companion animal and equine reduction targets as well.
Q59 Terry Jermy: We are all aware of the cuts to the aid budget and the Fleming Fund. How is that affecting your work? Are you being sufficiently resourced to give this the attention it needs?
Abigail Seager: It has been challenging, of course, when there were cuts to budgets where activities were being delivered, and we have had to be mindful of how to appropriately close off any of those programmes. A lot of the Fleming Fund was delivering work internationally, which is important because we have to solve AMR globally, not just locally.
Certainly, every Government Department that has been facing into AMR—and of course it is cross-Government activity—has had to react to the resource that is available. That has driven prioritisation exercises and, in relation to the national action plan, looking at where we can have the biggest impact and where we can make sure that the work that is prioritised is the work that will deliver tangible results. That has been important, and we have had to do that prioritisation exercise regardless of the topic, facing into the resourcing and financial constraints that we have.
For the VMD specifically, we had a concern at the end of last financial year about how we could continue some of our important surveillance work. We were successful in securing funds through the Integrated Security Fund to continue some of our private labs initiative work, which is fruitful in terms of getting access to a whole bunch of privately held data that can help inform aspects of our national action plan and our work on understanding the aspects of surveillance that we are trying to consider.
Because we have had that fund and that has been successful, the impact has been minimised for us, but we are mindful that we are going through future spending reviews and there may be future impacts. The strategy that we have put in place for looking at the prioritisation and ensuring that the money that we have available and the resource that we have is spent in the place that can deliver the best outcomes and the most likely success is important.
Q60 Terry Jermy: It is fair to say that there is industry-wide acceptance that we need to do better when it comes to AMR. Farmers, in my experience, want to do as much as they can within constraints of finance, normally.
You sit within DEFRA, which has other issues supporting farmers with sustainability and profit. How do you see those informal relationships and voluntary measures that farmers are undertaking to tackle AMR? What more can DEFRA do globally to focus on this issue?
Abigail Seager: It certainly was a risk to us that we flagged. Others had felt as well that where we were reliant on the farming community voluntarily, where that community was feeling not well supported by Government through maybe decisions that were taken in other Government Departments, the impact could well have been felt in terms of their voluntary contribution to what we are asking them to do under AMR or for any other aspect of animal health. That risk was heard and not felt just by us and not reported just by us, and of course some remedies were then put in place.
I do not feel that, therefore, the risk became an issue in the intervening period from when we had flagged it to when there was a remedy as such. However, our relationship with all our stakeholders, certainly stakeholders who are contributing to our outcomes voluntarily, is important. That is why, as I might have said at the outset, that one core value for the VMD is collaboration, and we have to ensure that our stakeholders know that we value them and that we engage them at the right time in the right way.
We also have to be honest and transparent. We do not always have the answers. We cannot always deliver. Lea referred earlier to an NHS for animals. I would love that to be the case. I cannot deliver that.
However, if we work in a way that is understanding of a shared problem and 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 is important to us, and so is maintaining that. We have had such great success specifically in AMR and driving down unnecessary use over the course of the last 10 years. That has primarily been through a voluntary approach and an understanding of that shared problem.
Q61 Terry Jermy: Is there a risk that if farming continues to be unprofitable and if one natural reaction to that is intensification, it will drive towards a practice that would be counter to what we are trying to achieve through the VMD?
Abigail Seager: It is important that we are aware of all the pressures that farmers will have from various angles and from changes that happen, which is why the collaboration that we have with the core Department, specifically in the directorate general for food, biosecurity and trade, we are aware of changes that may have an impact elsewhere and that we can face into that so that we can counteract it.
A lot of the conversations we have been having over the years with farmers and with vets in relation to AMR has been focused on using vaccination as a tool, but we also know that we have a shortage of supply of vaccines. We have to be clear that we are not driving people down a route that will not deliver an outcome because of another problem statement. That wide horizon view of policies that may have an impact elsewhere can help us not necessarily stop those things happening, but be on the front foot of helping to mitigate those and understand where an impact could have, at that moment, an unintended consequence that we flag to ensure that that is still the right decision to take from a policy point of view by colleagues, given that it may well drive another problem further down the road.
Chair: Thank you. We have a final round of questions in relation to pet parasitic treatments in waterways.
Q62 Josh Newbury: As you probably know, as a Committee we spend a lot of time talking about water quality, including the country’s growing awareness of the presence and impact of various chemicals that we use in our everyday lives in our waterways. You will be aware more than I will about the increasing awareness of tick and flea treatments getting into rivers and streams. You recently gave evidence to the Lords Environment and Climate Change Committee on that. Without pre-empting its conclusions, is the VMD preparing for any changes in policy or guidance to address those environmental risks?
Abigail Seager: This has been one of our hot topics for quite some time. I was keen that we address this when the issue was first brought to our attention that the levels that were detected were higher than were flagged by the Environment Agency and following some of the reports that were published by other groups.
We have published our road map of activity that we are taking in this space. It is important that we take a measured approach because 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 that is detrimental to animal health because the products are there to treat an animal health situation and a human health situation, indeed, when we are talking about fleas and ticks. As we know, ticks are increasingly a problem. We have a lot of evidence that we need and questions that we need to have answered. We do not need to know everything. As I was referring to earlier, we do not need to have perfection in all the evidence that we have gathered, but we at least need to make sure that we balance all the information that we might need and can ask those questions 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 the environment. It is a group that I set up, as I referred to earlier, a cross-Government body to look into this and understand what those impacts may well be. There could potentially be regulatory change in the future, for sure. We are currently running a call for evidence. It has just closed. We will take 12 weeks to do the analysis. We had a significant amount of evidence presented to us, which is great. Hopefully, that will come at the same time as the report from the Environment and Climate Change Committee, and we can take all that aspect into consideration.
We know that one of the issues is that these products do not go through a phase 2 environmental risk assessment. There is no modelling for that to happen. We are in the process of trying to develop what that model should look like so that we can be in a position to then request that in future.
Q63 Josh Newbury: A lot of work is already being done on this, but it is a long, iterative process. It will not be a quick fix to move to something else or completely change guidance overnight. You have to work through a lot of issues.
Abigail Seager: Absolutely. We work in this space as well and in an international capacity. One conversation I had with my counterparts in jurisdictions globally was to understand whether this was a problem statement they were also facing. Interestingly, North America and Australasia were not concerned about it. The only other continent concerned was Europe. We are, as much as possible, working in a space where we understand what is happening in the European space with this problem statement as well. We know that Europe is looking to some of the R&D that we are publishing as a result.
We have to understand how the pharmaceutical industry works. It will not develop a product and just put it into Great Britain. It will put it into a whole bunch of countries. Working against international standards is important to make a product viable enough to even be put on the market in the first place.
Q64 Josh Newbury: I appreciate that you are still working through this, but we have noticed that the BVA has updated its guidance to suggest a move from a blanket treatment to a more risk-based approach. Are you considering that as well?
Abigail Seager: A risk-based approach has not been agreed across all sectors, and we are looking into that, absolutely. That is a necessary step to take effect, such as the BVA proposes.
Q65 Josh Newbury: Yes, I agree that that is important. If different practices in different parts of the country are taking a different approach, you will see the effects on waterways inevitably being quite different as well. That is a concern for us in other areas of water quality. It is good to know that work is being done to benchmark what a risk-based approach looks like.
Some environmental stakeholders have suggested that focusing on proper use of topical treatments does not fully address how those products get into waterways in the first place. What do you see as your responsibilities as the VMD in raising awareness of those risks? How will you help pet owners make informed choices? This is not about just the regulatory question but that education piece as well.
Abigail Seager: You might be aware that we have just launched a Be Spot-On Aware campaign. It has made ITV News in Meridian East, which was very exciting for us. We do not often get the promotional opportunities, but that was somewhere.
We also know that not all pet owners, possibly a few of us in the room, always read all the product leaflet. Maybe inadvertently, otherwise honourable citizens are contributing in a way that they do not anticipate being true, whether it is, for example, washing out pipettes or putting them in the recycling because they think that that is the right thing to do.
We have had a Be Spot-On Aware campaign that is through, again, our communication strategy ensuring that we get to the right people in the right way and we hit the communications in a style that they will receive and will be absorbed, knowing that reading a product leaflet is not always how we will get that information across. It has been important that we know our target audience and we have taken some steps to help educate in that space.
Again, we need to do more and we need to understand more social behaviour. This is a new area for us that is not normally part of our regulatory remit. This is where some of these hot topics across the range that we have talked about have taken us in a different direction. It is important that we do that in a way that is educated, of course, and that we have 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, will deliver and realise the benefits and those tangible results we want to see.
Q66 Josh Newbury: Yes. Is the advice to not wash your pet or let them swim for a week after they have the treatment? Is that the best way to prevent it?
Abigail Seager: I wouldn’t ever wash your cat. I can definitely tell you that.
Josh Newbury: That is a challenge. I have tried to do that before. It is not a good idea.
Q67 Chair: On the other hand, keep a labrador out of the water for a week and you are doing well.
Can I take you back briefly to the question of social media companies? The MHRA was concerned that it was unable to get through and to get product information taken down. What has your experience been? Have you been more successful in getting misleading or inaccurate stuff taken off the platforms?
Abigail Seager: Yes, we have had success in that space. Of course, it has taken a little while to get maybe the right people to understand the problem statement. Certainly, we have had success with platforms such as eBay and Amazon. Like I said, we now want to extend that to other platforms where we think there could be a genuine benefit to do so.
Chair: Okay. Unless anyone has anything else screamingly urgent to raise, that covers the material that we have for you today. I hope it has not been too traumatic an experience. Part of the strategy of the Committee in this Parliament is that we agree to take evidence from bodies like yours. The work that you do is important. It has a direct impact on the constituents that we are all here to represent and the sectors that we are charged to scrutinise. Your attendance here has been very much appreciated. Hopefully, you see it as the start of a process rather than just an event in itself, and we can keep these lines of communication open now that we have established them.