30
Examination of witnesses
Baroness Hayman of Ullock, Abigail Seager, Francine Fernandez and Dr Robert Bradburne.
Q43 The Chair: Good morning, and welcome to the Lords Committee on the Environment and Climate Change. Today will be the final session of our inquiry into pet parasite medication. We are very pleased indeed to have with us the Defra Minister, the right honourable Baroness Hayman; the Veterinary Medicines Directorate; and the Environment Agency. I extend a warm welcome to you all. I thank you for finding the time to be with us during London Climate Action Week, which I know is a busy time for us all.
Before we start, may I remind everyone that the session will be webcast live on Parliament TV and that a transcript will be taken and made public? Witnesses will have an opportunity to review the transcript and make minor amendments if necessary. Members are reminded that any relevant interests must be declared the first time they speak; this applies equally to our witnesses. I will take the opportunity here to say that I am a director of Peers for the Planet. Before we start, may I ask each of our witnesses to introduce themselves briefly, starting with the Minister?
Baroness Hayman of Ullock: Good morning. Thank you very much for inviting us to your session. My name is Sue Hayman. I am the Parliamentary Under-Secretary of State in the Department for Environment, Food and Rural Affairs with responsibility for this area of policy.
Dr Robert Bradburne: I am the chief scientist at the Environment Agency, where I cover science across all of the agency’s functions. I am also responsible for managing the monitoring of the environment that the Environment Agency does.
Abigail Seager: Good morning. I am the chief executive of the Veterinary Medicines Directorate. We have policy and delivery responsibility for the Veterinary Medicines Regulations.
Francine Fernandez: I am the senior environmental safety assessor in the pharmaceuticals team at the VMD. I am an assessor day by day, but I also work on the Pharmaceuticals in the Environment Group.
Q44 The Chair: Excellent. Thank you again for being with us today. The first question is a straightforward one because we want to understand the level of concern around these chemicals. What is your understanding of the robustness of the scientific evidence that the chemicals in pet parasite products are accumulating in the environment? Are they now present in quantities that are of concern? Dr Bradburne, could you address that first?
Dr Robert Bradburne: Certainly. The Environment Agency has been monitoring the two prime chemicals that we will be discussing today—fipronil and imidacloprid—since before 2014, when we instigated a new liquid chromatography mass spectroscopy method for measuring them. I will refer to 2014 onwards, generally speaking, which is the time from which we have comparable data.
We have picked those chemicals up in sites across the country in water—in surface waters, estuarine systems and groundwater—some in a particularly high proportion of sites. We are picking up fipronil in surface waters in over 90% of the sites that we monitor. For imidacloprid, it is slightly lower, but still between 70% and 50% in surface waters. The percentages in groundwaters are down in the teens and twenties.
We monitor these in a semi-quantitative way. This is one of the chemicals we scan for when we do a wide chemical scan of our water samples. That scan takes into account about 1,600 different chemicals, so, rather than taking a lot of effort to do precise quantifications for each of those chemicals, we take a broad approach, which tells us whether they are present in the environment and gives us a rough idea of the concentrations.
Bearing the levels that we see in the environment in mind, it is safe to say that, when we pick these things up in the environment, they will be at levels that, when you look at the evidence that has been scanned for impacts, suggest that they are at concentrations that could have an impact on invertebrates in the environment. So when we say that we have picked it up, it is at a level where we would assume that there could be some impact on the environment.
I make clear, however, that we do not have any strong evidence of cause and effect on invertebrate populations in the environment. Our evidence does not allow us to do that scientific experiment because there are so many things that will impact invertebrate populations in our river systems. You will have heard in previous evidence that these chemicals are more common downstream of wastewater treatment in urban areas; there are many chemicals that are also impacting the environment in those systems. So, yes, these chemicals are present in the environment at levels where we would expect to see some sort of ecological impact, but I cannot say that there is a cause and effect of their presence in the environment.
The Chair: Quite a lot of these chemicals were banned for agricultural use and limited in their use, no?
Dr Robert Bradburne: Yes. The chemicals started to be removed from agricultural use several years ago—I can find you the dates—although the dates when the bans took place have buffers around them to allow use-up, et cetera. They have been successfully removed from uses where they are widely applied in the environment, such as agricultural uses, as you say, so they are now restricted to few uses, such as flea treatments on companion animals.
The Chair: Would anyone like to add anything?
Abigail Seager: In answer to the question of how seriously we are taking this, when we were made aware, through Buglife’s report many years ago, that there was concern around the levels of fipronil and imidacloprid detected, we absolutely faced into that. We know no medicine is risk-free; that is the nature of authorised medicines. However, the VMD has looked at what questions we need to ask to fill those evidence gaps. Many years ago, we instigated the research and development that was necessary to answer some of those questions.
Additionally, I set up the Pharmaceuticals in the Environment Group, bringing together a number of stakeholders across government, the devolved Administrations and expertise in order to bring this conversation to the fore so that we can address much of the problem statement. We understand that there are many things that we do not yet know, so how can we get further forward in understanding what those answers may be? They can then indicate any regulatory activity that we should take as a result. So we take this very seriously.
Francine Fernandez: We commissioned the Rosemary Perkins research, which was key to advancing our understanding of this issue, along with the formation of the Pharmaceuticals in the Environment Group and the road map. We have already taken action across all three workstreams in the road map so we have taken, and continue to take, this issue quite seriously.
The Chair: Before we move on to Lord Ashcombe’s question, I want to ask you a bit about the metabolised breakdown products of fipronil and imidacloprid. Academics at Imperial College have said in written evidence that the products into which they break down “can be an entire order of magnitude more toxic, yet they remain poorly understood and are not part of the current formal risk assessment protocols for veterinary parasiticides”. Who would like to comment on that?
Abigail Seager: We know that fipronil and imidacloprid are very toxic; that is the nature of what they are designed to do as parasiticides. When we are looking at authorising medicines, we look at quality, safety and efficacy. On safety, we look at safety for the animal, the human and the environment. When we look at the environmental risk assessment, which is Francine’s area of expertise, there are phase 1 and phase 2 risk assessments. Traditionally and historically, any product for a companion animal will end at a phase 1 risk assessment.
We now understand that we may need to do more and take those products forward to a phase 2 risk assessment, which has always been reserved for food-producing species. However, in order for us to do that, we have to develop the exposure models. We cannot ask companies to submit data to us without us understanding how we would evaluate that. That is exactly the work that we are doing currently. We are developing those exposure models so that we will be in a position to move into a phase 2 risk assessment for these types of product in future.
Francine Fernandez: That was well described. We do not currently have a regulatory framework to carry out phase 2 risk assessments for companion animals. We need to ensure that that is in place so that we can assess all these parasiticides for small animals in the same consistent way before we make any decisions. That is the first step; we are working to figure that out.
Q45 Lord Ashcombe: Good morning, and thank you for coming. I am a bit concerned that there is certainly no evidence or data collected on invertebrates, because that has a whole-trail effect going down to the rest of everything. Perhaps you would like to address that. The road map for the Pharmaceuticals in the Environment Group has set out evidence-gathering activities in the medium term, as I understand it. What progress is being made on gathering this required data, including product sales data, which we think was lacking in what we heard last week?
Baroness Hayman of Ullock: One of the main ways in which we are gathering evidence is through the road map, which was mentioned by Abi, from the VMD. The VMD and the Pharmaceuticals in the Environment Group have already made a lot of progress across the three workstreams that they have set up as the priority areas to get more evidence and take more action. The first is on communications and education. The second—it is important for your question—is on gathering evidence. The third is on regulatory action, based on the evidence that has been gathered.
We now have some robust studies confirming that pet parasiticides are not just a potential source but a likely contributor to environmental contamination, as the Environment Agency has been saying. We are also generating new insights into real-world use because, unless we know how things are actually used, we cannot get a clear picture. We know that routine monthly treatments are now commonplace across all distribution channels and that risk-based prescribing lacks a clear definition and consistent application.
In order to know what to do next and to get things into a situation where we can make the right choices that are based on evidence and fact but are also proportionate—because this is a One Health issue: it is about the environment and animal and human health—we are also looking at the exposure models, as Abi mentioned. We are taking some practical action around reviews of distribution categories, for example, but, importantly, we are also working to fill the evidence gaps that we will need to fill if we are to move forward in a proportionate way that will tackle this problem.
Lord Ashcombe: How far down that road of gathering evidence are we?
Baroness Hayman of Ullock: There are a number of different things going on. The call for evidence concluded on 11 June; we are currently assessing that. Once we have assessed that, we will have a better idea as to where we are, but, as the Environment Agency has already mentioned, there are a number of evidence gaps.
Abigail Seager: We receive sales data from marketing authorisation holders, but that is through the periodic benefit risk report that is submitted as part of the pharmacovigilance requirements under the Veterinary Medicines Regulations. They are submitted for a different purpose than the questions being asked here: the purpose is statistical analysis of adverse events to understand the volume of a product in comparison to the frequency of an adverse event that is reported.
We have some data. I will not read it out, because it is quite a large table—we are happy to provide that to you subsequently—but, in general, we know that, over the past decade, sales of fipronil peaked in around 2021 and have dropped off since then. We have to compare that to an increase in the past five years of around 1 million more dogs as pets in the UK. In relation to imidacloprid, use has been steadier, with perhaps less in the past few years. We can give you the specific data if you would like to see a year-by-year breakdown; it is collected for a slightly different purpose, as I say, but it will give you an insight in the way you are asking for.
Lord Ashcombe: Do you think that you can amend it so that it can be collected for this purpose as well?
Abigail Seager: It would take a legislative change to mandate sales data being collected in that way; we would have to consider that as part of any review of the Veterinary Medicines Regulations. If we are asking for the data on a voluntary basis, that is something we can consider, but it may not end up being complete. With any data collection, we have to understand what we want to use it for and whether the burden we are asking for, in terms of it being submitted and us collecting it, is justified.
Dr Robert Bradburne: On invertebrate data, I apologise; I do not wish the committee to think that we do not collect invertebrate data. We collect an enormous amount of data on invertebrates, largely as part of understanding our progress on the objectives of the water framework directive, which has been transposed into UK legislation. We have around 13,000 water quality sites from which we collect data from every year, not only on which invertebrates are present but on their population levels, so we have very detailed data across the country on invertebrates.
The reason why I say that it is hard to prove causation is because we collect that data driven largely by the requirement of the water framework directive to see whether we are making improvements to the water environment that would be reflected in the biology. When the water framework directive came into force, the major determinants of invertebrates were some of the macro-pollutants—the nutrients going into the system, such as the ammonia coming out of wastewater treatment works, as they were at the time. We designed our collection of invertebrate data to pick up on species that are sensitive to those pollutants. We know from studies on the toxicology of many of these chemicals that different species respond differently at different levels. We have not designed our monitoring system to pick up every individual chemical; that is why it is hard to prove causation. It is not impossible, though. Someone with a lot of time could mine the data and start pulling out some of those correlations.
Lord Ashcombe: Might AI help?
Dr Robert Bradburne: AI might help. As the chief scientist at the Environment Agency, I am always suitably sceptical; AI needs to be trained very well so that it does not give strange results.
Lord Ashcombe: Would this research consider chemicals other than fipronil and whatever the other one is? I am thinking in particular of isoxazolines, which seem to be replacing those. Are they in the equation?
Baroness Hayman of Ullock: Yes, fundamentally. Do you want to add anything, Abi?
Abigail Seager: The Pharmaceuticals in the Environment Group was set up to look at pharmaceuticals in the environment in totality. The first aim was to look at fipronil and imidacloprid because they are a hot topic for us; as we said, we are taking this seriously, in terms of the data provided so far. However, the group will look at any other chemical that it is necessary for us to look at. May I refer to the other product to which you referred?
Lord Ashcombe: The one I cannot pronounce?
Abigail Seager: Yes—it is quite a tongue-twister. We have to be cautious. As I said originally, no medicine is risk-free; there will always be some risk because that is the nature of the benefit-risk assessment. Although isoxazolines are effective and important treatments, there are still some evidence gaps that we need to understand fully around the environmental and longer-term effects. These are what we describe as PFAS—they are persistent in the environment—so, obviously, we have to consider that as well.
Their benefit-risk assessment has been sufficient for us to enable them to be authorised as a veterinary medicine. However, we continue to be aware of where there is more evidence that we need to gather or there are reports that we need to consider. We know that there will always be a side effect from the summary product characteristics of these products, which are available online for vets to consider when looking at a range of products to use on any companion animal that is brought to their practice—or for the general public to look at as well, of course. With these types of product, there are also concerns around the neurological effects.
In our view, the Veterinary Medicines Directorate is here to ensure the wide availability of products in terms of both accessibility, for all to achieve them, and range of choice.
Francine Fernandez: My colleague is referring to the neurological effects on pets, not insects.
Lord Ashcombe: I am interested in the fact that these are PFAS products. I work in the insurance industry. PFAS is not much liked by insurers, and I am a broker trying to get insurance for it, so I am surprised that pharmaceutical companies find a way to get it insured. That is interesting.
Abigail Seager: I cannot comment on insurance, I am afraid.
Dr Robert Bradburne: May I clarify further the earlier evidence that the committee received? We monitor for some of these newer chemicals. They have been coming online as part of our targeted monitoring, so we are starting to look for them in water samples. Generally speaking, at the moment, the numbers are much lower than fipronil and imidacloprid, but we have been monitoring them for a short time.
Lord Ashcombe: You would expect that if they were new, would you not?
Dr Robert Bradburne: You would. They are also administered in a different way and are very different chemicals that will partition differently in different aspects of the environment. It is not a surprise that we are finding them in fewer samples, but I assure the committee that we are looking for some of these newer ones.
Lord Ashcombe: Do you think that they are ending up somewhere else?
Dr Robert Bradburne: I cannot know that; at the moment, all I know is where they are not ending up, because we are monitoring them in the water. They will certainly have a different pathway through the environment from something you put on the external part of an animal.
The Chair: We may come on to alternative pathways later.
Q46 Lord Krebs: I have a brief question for you, Dr Bradburne, initially. You talked about the lack of evidence for a cause-and-effect relationship between fipronil and imidacloprid and insect or invertebrate populations in fresh water. Whose job is it to commission research to fill the knowledge gaps, and who is carrying out the research?
Dr Robert Bradburne: The research base is building all the time. A lot of very new papers looking at the relationship are coming out. Frankly, it is being funded through a wide range of routes, some in this country and some abroad, as well as a wide range of research groups. I am not aware of specific targeted work other than the work that has been set up through the PiE programme.
Baroness Hayman of Ullock: A study at the University of Plymouth is ongoing at the moment—that is one to look out for—as well as the research that we are doing through the Pharmaceuticals in the Environment Group.
The Chair: Will the PiE group be leading the research?
Baroness Hayman of Ullock: The PiE group is overseeing, if you like, as the overarching group; it will look at where the evidence gaps are. We have a list of evidence gaps that we are working to fill at the moment, but the committee’s report will also be helpful in looking at how we move forward.
Baroness McIntosh of Pickering: Does the panel think that manufacturers and pharmaceutical industry should pay for this research before the product is launched on the market?
Baroness Hayman of Ullock: That is an interesting question.
Francine Fernandez: If phase 2 assessments become obligatory, the onus will be on pharmaceutical companies to provide us with the data to carry them out. As it stands, we are still figuring out how to do a phase 2 assessment; we are doing some preliminary research. As Baroness Hayman highlighted, we are doing a multidisciplinary study with the University of Plymouth. We have also done quite a bit of behavioural science to understand drivers of use, et cetera.
The Chair: The PiE is looking into only fipronil and imidacloprid at the moment. Isoxazolines are not being covered at all, as we understand it, and the responsibility rests with the PiE to make sure that research is commissioned to fill the gap. Is that correct?
Abigail Seager: The VMD has a research and development budget.
The Chair: But the VMD is part of the PiE group?
Abigail Seager: It set up the PiE group, yes.
The Chair: So we can expect to see some movement on that front— excellent.
Before we move on, I want to address something. It has been brought to our attention through a number of different routes, most recently through written evidence from Water UK, that there is an underestimate of the real-world risk because the indicator species—Dr Bradburne, you referred to them indirectly—are not reflective, if you like, of the sensitivity of the real-world environment and real-world invertebrates in water. You are looking at the water flea—Daphnia magna—and some earthworms as well. I understand that our native earthworms are very sensitive, yet the research is being done on a species that is not so sensitive. This whole causation and correlation issue is important. Are we looking at it correctly?
Francine Fernandez: You are correct. On imidacloprid specifically, Daphnia magna, which is the default lab species that we use to test toxicity in surface water, is not particularly sensitive to neonicotinoids. However, the predicted no-effect concentrations we have been using to gauge toxicity have been based on chironomids, which are much more sensitive.
Dr Robert Bradburne: When we look at the levels, where we draw a line and say that we would expect to see an effect, we use two levels to assess the effect. One is an EU environmental quality standard that has recently been set for imidacloprid. That is a rigorous process looking at a range of species across trophic levels and at varying degrees of the effects of different concentrations, so it is not based on one species. The PNEC, which was just mentioned, for fipronil follows a similar process, so those levels should be robust reflections of where we would expect to see them.
The Chair: Are you confident that you are doing all that is necessary and that you are showing sufficient curiosity about the impacts in the environment in trying to draw the distinction between causation and correlation? There is real concern out there. We are seeing the accumulation of these chemicals in birds’ nests, for example, let alone along the food chain on which humans depend.
Dr Robert Bradburne: Again, as a scientist, I always welcome new evidence coming along. There is a lot of new evidence coming along in this area. The PiE group is commissioning some of that, and some of it is being driven and funded externally. We have to keep looking at the growing body of evidence to assess when we can make more certain conclusions on the impacts. Some of the evidence is very new. I know that some of it uses our data as though it were fully quantitative, which pushes the limits of what you might use our data for. People are being curious about this and are putting in a lot of effort. I appreciate that from the research community.
The Chair: We are particularly interested in understanding the scale of use. The argument that we have heard from some pharmaceutical representatives is that the PPMs used on domestic pets are immaterial because there is not a huge amount being used. That is why we are very interested in getting the volume of sales data: it will really help that causation/correlation question, help us see what the trends are and help us try to match them up. Do you think that that is a sensible way forward?
Dr Robert Bradburne: I am not sure that I understand. Which bit of evidence are you saying is missing?
The Chair: The volume of these substances, the scale of use and the way in which the scale of use has changed since a decade ago, when these substances were banned in agricultural use.
Dr Robert Bradburne: Sorry, yes—you are talking about the reduction in the use in the wider environment, in comparison with the use we see now.
The Chair: Yes, and where this is coming up in the environment.
Dr Robert Bradburne: Seeing how that changes is very important. That is why we try to pick a variety of freshwater sites when we look for these substances in our monitoring; we look in rural and urban areas so that we have a representative idea of where these things are turning up. Over time, we might expect to see shifts and changes in that pattern, but, I have to say, when you look at the year-on-year data, it bounces around quite a lot because these are spot samples. So it is not easy to spot trends.
Baroness Hayman of Ullock: We are looking at this from a pet treatment point of view, but we know that that is not the only source of these chemicals. We need to make sure that we understand the overall picture so that we know what percentage is likely to be coming from pet treatments, in order to see what else we need to be doing.
The Chair: What sources are there other than pet treatments?
Baroness Hayman of Ullock: We understand that imported textiles are a particular issue. That is fairly new, so we are looking at that as well. If we are serious about tackling the pollution of these chemicals, we need to understand the full picture.
Baroness McIntosh of Pickering: That would come out in the washing, would it?
The Chair: We do not have time to go into that further, but written evidence on what information the department has about these chemicals from imported textiles would be useful for us to use, possibly as an appendix. We have now heard about them from more than one source; it is really important to understand to what extent they might be impacting on the work that we are doing.
Q47 Lord Jay of Ewelme: Thank you very much for being with us today. The first question is for the Veterinary Medicines Directorate, perhaps Abigail Seager. Can you tell us what information you need from manufacturers about products before they are authorised? That would be helpful.
I have a second question, perhaps for Baroness Hayman. Do you think that that process is sufficiently transparent? A number of us here have doubts about the transparency of the process; we think that there might be a case for rather more transparency than there is at the moment.
Abigail Seager: Our authorisation process for any medicine requires a dossier with a set of data to be submitted. This is the same as would be the case in Europe, as many of the companies that are putting products into the UK are looking to market their products on a continental level.
We ask them to submit data in various sections. The first is quality: in effect, the ingredients of the medicine, how it is manufactured and the robustness of that against good manufacturing practice. The second is efficacy: will it do what it says on the tin in terms of the pharmacokinetics and pharmacodynamics? The third is safety.
The safety aspect has a number of lenses through which we look. One is safety for the target animal species, one is user safety and user risk assessment safety—I can come on to more detail about that—and one is environmental safety. So it is broken down into three lenses, which reflect the One Health approach that Baroness Hayman referred to earlier.
That is the set data package that we require from companies when they are putting forward a medicine for authorisation. The level of data and studies in that will vary depending on the number of species they want the product to be indicated for, or the number of indications they want to have on the product in terms of what it is there to do. So a varying degree of data is provided, but it is generally within that structure. The data is commercially confidential to the company; we treat it as such, and we will assess it in a benefit-risk way.
At the VMD, we look at each of those packages concurrently and bring the assessors—Francine is one of them—together to determine whether the overall benefit-risk ratio of the product is positive. The benefit of use of the product has to be for the animal, and for the disease or whatever we are trying to treat, balanced against the risk that we are mitigating through risk mitigation measures. Much of those will be the descriptions that are put in the summary product characteristics, in the labelling or on the packaging around either contra-indications or user risk assessment for use. That is how we balance it out so that we can say, “The value of this product is still beneficial. We know that there are some risks, but this is how we are counteracting them”.
On how we summarise that, we produce a data package on GOV.UK under the product information database—the product information section—with a summary of the assessment report. That is not the data package in totality, which is commercially confidential, as we said. However, a summary of it is provided, setting out our considerations, a summary of those studies and where we have landed with our benefit-risk assessment.
Lord Jay of Ewelme: If the key part of it is commercially confidential, how do we know that you have challenged the manufacturers? Or is it about working together with them to get a result that suits you all?
Abigail Seager: We do not authorise everything; we do not say yes to everything. We absolutely will refuse products that we do not feel are sufficiently beneficial. We have a number of stages in that process whereby we go back and ask questions. We run on a clock timetable, in effect, and we will stop the clock until we have sufficient information that we deem enough for us to consider the product further. We do not always authorise them. They are not always provided with a licence, or they are not always provided with the indications that the company originally wanted to put on there. We may not agree, and, as a result, we might have a reduced number of indications or other considerations that are then put in place.
On the independence of the VMD, we have the Veterinary Products Committee, which is an independent advisory group that sits separately to the Veterinary Medicines Directorate. It reviews the robustness of our science on an annual basis. It looks at a number of our assessment reports against the data and determines whether we have been excellent in the way we expect ourselves to be. It has always marked us at the highest level of assurance for the robustness of our science.
Lord Jay of Ewelme: Are the independent advisory group’s conclusions and analysis made public?
Abigail Seager: It does not look at every single product. It looks at a volume of products as a sample. It does not look at every single one that we look at, but it is also the group for appeals; there is an appeals process if a company feels that it does not like the outcome.
Lord Jay of Ewelme: If the company feels that way?
Abigail Seager: A company can take an appeal to the Veterinary Products Committee if it does not agree with the outcome that we have determined.
Lord Jay of Ewelme: Thank you for that. Baroness Hayman, going back to the point about transparency, I can see that it is a complicated process and that there is some challenge there, but the rest of us need to know that this is going on, that there is transparency and that it is more open than it sometimes appears. Has that bothered you as a Minister?
Baroness Hayman of Ullock: I can see where you are coming from. The difficulties in dealing with pharmaceutical companies are the commercial confidentiality around the products they are developing, the data they use, and so on. I have met regularly with a number of pharmaceutical companies to do with the supply of veterinary medicines in Northern Ireland since I became a Minister. Initially, it was very difficult to get those meetings because of the commercial confidentiality aspect; that is something about which they are particularly sensitive. I would be happy to work with the VMD to explore whether there are any options on greater transparency, but it would have to be done with commercial confidentiality.
Lord Jay of Ewelme: Chair, that might be a helpful way forward to ensure that there is clarity on the process for the rest of us.
Baroness Hayman of Ullock: I am happy to pick that up to see if there are any options.
Lord Jay of Ewelme: Thank you very much; that is all from me.
Q48 Lord Krebs: I have a brief question for Abigail. You said that, when a pharmaceutical company submits its dossier, there are different elements, including the environmental risk assessment. I am missing something here. You approve these products on the basis of the dossier, which includes an environmental risk assessment, but the Environment Agency has told us that there is an evidence gap linking cause and effect to putative environmental damage. How do you square that circle?
Abigail Seager: With the environmental risk assessment that we undertake for companion animals, it ends at a phase 1 assessment of environmental impact. That has been internationally approved and agreed, and that is how we have always worked. We recognise that that is possibly not enough now and that we need to move into phase 2, which is the risk assessment level that we undertake for all other product types of food-producing species, where the transmission may be different because of the nature of how those animals are farmed.
We cannot move into doing that without having a basis for the exposure model to assess against. That is what we are actively developing; we are leading the way on that. We know that there are others, certainly across Europe and internationally, who are interested in the work that we are doing. We are leading on and driving those international standards, which are being amended and reviewed to allow for that second phase of assessment in the environmental space for companion animals. As I said, we need to have something to validate the data that the companies will be producing against; that is what we are currently developing. Francine, this is your area of expertise. Do you have anything specific to add?
Francine Fernandez: No. It is as you said. We historically assumed negligible exposure from companion animals to the environment. Also, the last fipronil and imidacloprid products were authorised in 2021, I think; as a side note, that was before more confirmatory evidence was published.
Lord Ashcombe: The drug—let us call it that—gets a tick in the box and gets approved. Do you ever go back and reassess it, if further evidence comes to light?
The Chair: We will come on to that question. Earl Russell, do you have a question that has not already been covered?
Q49 Earl Russell: I think so; if I have made a mistake, correct me. I thank you for your evidence. I really welcome the move from phase 1 to phase 2. In relation to applying the precautionary principle, does that need to move from one phase to the other show that, for whatever reason, when these products were originally approved, we either did not fully understand the pathways or were not fully aware of the impact? I wonder whether there are be lessons to be learned from past decisions in this space in relation to these kinds of medicine.
Baroness Hayman of Ullock: That is a very good point. Francine made the point that, with companion animals, evidence that veterinary treatments has been causing these environmental problems has not been there until now. We are now in a different space, where we are getting a lot of evidence that demonstrates that there are environmental impacts for medicines that are used regularly. That is why we need to consider a new approach, as Abi was saying. The phase 2 aspect has always been with farmed animals because there is more concern around the chemicals that are used in that space. So, again, it is about looking at how we can increase the checks and balances, if you like, for the new medications that are coming through for pet use.
The Chair: Before we move on to the next question, I want to raise a point that was made to us by academics from Imperial College. They, too, were very concerned about the transparency around these assessments, user exposure and toxicological risk; we have more or less covered that. However, they also expressed some concern about the quality of the revised assessments as of 2018, saying that they were “not applied retrospectively to existing products, or to generics … approved after this date, leaving much of the existing market and the genuine sector assessed to the pre-2018 standard. Instead, in many cases approval relies on limited and inconsistent user risk assessments that may not reflect current standards”. Can you comment on that?
Francine Fernandez: Are we talking about user safety?
The Chair: Yes.
Francine Fernandez: All veterinary medicines undergo a human safety assessment, which has historically been—and is—very rigorous. They consider all those who may come in contact with the medicine, including adults and children. The process involves identifying the hazards of the medicine, then the likely exposures, and comparing those hazards to the exposures and any identified risks.
The Chair: May I stop you there, because we have covered that? The issue is that we do not have that information in the public domain.
Francine Fernandez: It will be in the product literature. If there are user safety warnings in the product literature, those will have come from doing a user safety assessment.
The Chair: Are you saying that the outcomes of those assessments are fully reflected in the user safety information in the leaflets?
Francine Fernandez: Yes.
The Chair: We discussed this previously; we do not think that many people read those leaflets, so that information is not accessible, but we may come to that issue further down the line.
I have a further question. There is an emerging area of research on the inhalation of contaminated dust in the home; there is a dearth of information on the impact of that. Is that a research gap that the PiE group will also be able to address?
Francine Fernandez: That is an emerging area of concern about which we have recently heard. I do not know whether the Pharmaceuticals in the Environment Group is the correct platform for that because it focuses more on the end-user as opposed to the wider environment, but it is certainly something that we will consider.
Q50 The Chair: We will now move on to the next question; I will ask it, given that Lord Lennie is not with us yet. We have heard evidence to suggest that the risk of environmental harm from chemicals in pet parasite medication warrants pharmaceutical companies conducting phase 2 environmental risk assessments. We have touched on that already. Will the Government commit to ensuring that phase 2 assessments are carried out on all existing and future parasite products?
Baroness Hayman of Ullock: That is what we are looking to work towards. We finished the call for evidence on 11 June, as I said. Once we have finished assessing all of that, we will look at exactly how we want to take forward any recommendations. That will include looking at phase 2. The evidence that that is the direction of travel is strong; it is certainly something that I will be picking up with the VMD.
The Chair: Can you give us an indication of the timelines?
Baroness Hayman of Ullock: The call for evidence is a 12-week cycle, is that right?
Francine Fernandez: We have 12 weeks to publish the findings from the call for evidence, but that is feeding into the wider review of the distribution category, which is likely to take longer because it is also looking at the benefits, the environmental risks, et cetera, and collating everything into an overarching decision.
Baroness Hayman of Ullock: That will be when we have the final response. I am doing a lot of work with the VMD on what we can do in the meantime, without necessarily waiting for that final outcome to be published.
The Chair: We will take that decision independently of the EMA—the European Medicines Agency—and the VICH. There is some concern that we may have to have our decision approved by the VICH. Can we have an assurance that that will not be the case?
Abigail Seager: It would be beneficial for us to work in an international way against internationally adopted guidelines, but we are happy to be the leader in taking those changes to that forum. We do not have to wait for anybody else to agree the guidelines for us to impose them in the UK.
We have to be mindful of where products from pharmaceutical companies are being marketed, however, because one of the aspects of the VMD’s responsibility is looking at not just the quality, safety and efficacy of those products but their availability. We have to understand that, for a pharmaceutical company that is making commercial decisions to put a product into Great Britain and Northern Ireland, especially when Northern Ireland is working under EU regulations, having two different sets of regulations is not necessarily beneficial or conducive to warranting those products coming on to the market. This is something we have been working on separately to ensure the continuation of products in Northern Ireland. We must take that into account, but we do not have to wait for anybody else in order to proceed with looking at the evidence we would need in developing those exposure models to enable us to have a phase 2 risk assessment.
The Chair: Excellent. We will plough ahead. There is a however clause in our agreement with the VICH, which will allow us to do that and take a leadership role, but I hope that that will not be necessary.
Francine Fernandez: I am still of the strong opinion that we need some guidance on how pharmaceutical companies should carry out a phase 2 assessment before we invoke the however clause. Otherwise—
The Chair: Who is responsible for that?
Francine Fernandez: We are. That is what we are doing now that we have the exposure modelling research.
The Chair: Would anyone like to add anything on how we can move forward with phase 2?
Q51 Lord Krebs: One of the points that was made to us by earlier witnesses is the fact that, as we have touched on, Daphnia magna are generally less sensitive to these chemicals than other invertebrate species. Are you able to commit to the suggestion that, if you implement phase 2 assessments, which I understand is the direction of travel, you will look at a wide range of invertebrate species, not just one single species?
Abigail Seager: Once we have the exposure model, which will enable us to look at companion animals in that phase 2 environmental risk assessment space, it would be possible for us to look at a range of either chemicals or product types because it would give us that platform to work against. This is Francine’s area of expertise.
Francine Fernandez: I can answer this. It is very interesting when you do environmental risk assessment. You usually start with the Daphnia magna and, if a risk is highlighted, you have to do higher-tier testing, which generally considers more subtle toxicities, longer-term exposures, et cetera. You find that, if a product is truly toxic, this pattern continues as you progress through the tiers. Yes, we look at a range of species. By the time you get to tier C, you are looking at species sensitivity distributions, which look at a whole range of invertebrates. You then do stats to find a suitably protective predicted no-effect concentration.
Lord Krebs: I am not sure whether that is a yes or a no.
Francine Fernandez: It is a yes.
Abigail Seager: Our commitment is that, when we assess the safety of a product, we look at the safety of the product for the animal, the target species, the humans—the user—and the environment. If we have an ability to look at any one of those components to a greater extent—in this case, of course, we are referring to the environment—we absolutely will do that.
The Chair: Before we move on to Baroness Whitaker’s question, I want to put something to you. The Environment Agency has also worked with the VMD through the PiE group to develop a strategy to manage the impacts of veterinary medicines and pharmaceuticals on unintended receptors, such as wild fauna. The outcome of this work has not yet been published. When can we hope to see that?
Abigail Seager: I am not sure what work is being referred to.
Dr Robert Bradburne: No. Where are you getting that information from?
The Chair: From written evidence from Water UK.
Dr Robert Bradburne: I will have to check what it means by a strategy. I expect that it is referring to the broader work of the—
Baroness Hayman of Ullock: It could be the road map; we are not sure.
Dr Robert Bradburne: If it is the road map—
The Chair: I hear what you are saying. You will have the transcript, so I ask you to take that away. I will double-check my source, which is written evidence from Water UK. It will be on our website, so you will be able to refer to it. It is important work; it is in the public domain.
Baroness Hayman of Ullock: If it is the road map, we can come back if we have clarification around that, if that would be useful.
The Chair: Excellent—thank you very much. It was a piece of work that caught my eye. I thought that it would be very useful for us to have some information about it in the public domain.
Q52 Baroness Whitaker: Thank you very much for coming in and for all that helpful information. We have heard a fair amount of evidence that the process of pharmacovigilance reporting is not working—these are questions for the directorate—such as that new evidence is considered only if it is provided by the manufacturers and that there is a reliance on only the end-user to report treatment failure, so there is an underestimate. There has also been a certain amount of disquiet about the way in which commercial interests seem to impede freedom of information requests on pharmacovigilance data.
Tell us how you would respond to the criticism. How frequently environmental risk assessments are reviewed post authorisation? If you have any information on this, I would also like a remark on human health, not as caused by parasites but as possibly caused by the treatments, which appears to be relatively uncovered—quite a task, but tell us what you can.
Abigail Seager: All authorised veterinary medicines are kept under continuous review through the pharmacovigilance system that you referred to and through any emerging scientific evidence. That information can trigger regulatory evaluation, including reassessment where that is appropriate; we would look at the product again. Pharmacovigilance encompasses the collection and assessment of reports across a range of outcomes, including lack of efficacy, adverse events in animals, impacts on human health, to which you referred, and environmental effects.
Baroness Whitaker: Is this human health not from the parasites, though?
Abigail Seager: From the treatment, yes. For user safety, we have current pharmacovigilance data that indicates that fewer than one adverse event in humans is reported per 10,000 doses administered for fipronil and imidacloprid spot-on treatments. We are working with other environmental agencies to consider monitoring more data alongside those pharmacovigilance reports because we recognise that there are limitations in the consistency, coverage and attribution of environmental monitoring data. We are working with partners to establish that better.
General pharmacovigilance reporting can be through a number of sources, such as the companies themselves, vets or end-users—pet owners, in this case. We collate a number of those reports. We have various signal detections that we look at to understand whether there is a trend that we need to investigate. At that point, we would have a number of steps that we could take, which may well end up being a regulatory change or a change to that product. This could be an extra line on the summary of product characteristics, an additional warning or a change that would require something more substantial, including removing the product if we felt that there was a significant safety concern. That is how we would be monitoring any product, post authorisation, through a number of those lenses and a number of ways in which we gather that data.
Baroness Whitaker: Do you also use your own research?
Abigail Seager: At the VMD, we have a research and development budget, which we utilise across a range of subject areas, depending on the policy question or the surveillance area that we need to focus on at the time. The VMD’s remit is quite broad and includes antimicrobial resistance as a very important topic. A number of our research projects are in that space but we also have research projects with the University of Plymouth, as has been referred to, which we fund to look at answering questions where we know there are evidence gaps for this exact purpose. If we feel that we need to ask the company something specific in relation to a raised concern, we will do so and perhaps ask it to undertake additional specific studies. We would not fund that. It is different from research and development; it would be on the company to undertake that at its own cost.
Baroness Whitaker: I have two quick supplementary questions. Can you tell us how many authorisations have been withdrawn, either year to year or for any period? You could choose to mention A and B. What do you know about the effect on human health from these three main substances?
Francine Fernandez: Again, I am an environmental risk assessor, not a user safety specialist, but, from what I know, fipronil and imidacloprid have an incredibly high mammalian safety threshold. That is why they are authorised for use on cats and dogs. They are designed specifically to kill insects, and we do not have the same sensitivity as mammals.
Baroness Whitaker: How many authorisations have been withdrawn, if any?
Abigail Seager: I do not have that figure to hand but I can definitely commit to write to you to set it out. We have about 3,000 authorised medicines, but we can set out exactly how many have been withdrawn or refused over a period of time.
Baroness Whitaker: That would be very helpful; thank you very much.
Q53 Lord Trees: On pharmacovigilance, that would normally be a reactive process where animal owners, in this case, would report an adverse reaction. How do you gather any environmental insults through that system? Do you have a system of alert to environmental damage? We will come on to monitoring and so on in a minute.
Abigail Seager: We have a system whereby environmental incidents can be reported, but we recognise that there is a data gap here. Perhaps some more evidence can be garnered through us working collaboratively with other agencies, which may well have access to that data, because we need the bigger picture to enable us to take the correct course of action in the light of all the information that is presented to us.
Francine Fernandez: I agree. One of the main foundations of initiating the PiE group was to collaborate with the environment agencies and ensure that we know what they are finding in the water.
Lord Trees: We will come on to that a bit more.
The Chair: I put this to you because it is something that is on my mind. We have heard from several sources that there is no process of continuous, ongoing benefit-risk assessment review. Guy Woodward from Imperial College said that he is concerned that there is no curiosity, reflection or looking back at the massive accrual of huge amounts of environmental and scientific evidence in the interim, which clearly shows that these things are present in the environment in high concentrations and are leaking into the environment. Can you just respond to that concern?
Abigail Seager: We have a process by which we collate information and a process by which we respond to that. Exactly this pharmaceuticals—
The Chair: It is not in the public domain. There is no openness or transparency. As Lord Jay asked earlier, where do we see it? How do we know that it is happening?
Abigail Seager: When something has been noted as an environmental concern, just as this topic has been, there has been no hiding of the work that we have been doing to face into it. That is why we publicly set up the Pharmaceuticals in the Environment Group: to bring everybody together to make sure that all those voices are heard. We publish the minutes, notes and actions of those meetings, as well as the road map from that.
In terms of us not facing into an environmental concern when it is raised, I would counter that. We are. This is evidence of exactly what we are doing. We are not hiding behind anything. We have a pharmacovigilance system by which we gather that information.
The Chair: You can appreciate that, from the point of view of scientists, they do not want to see the distilled information through you; they want to see the raw information that you are assessing. Let me leave that there. They are not getting the information that they need; they are getting the information through a lens, and that is an issue.
Q54 Baroness McIntosh of Pickering: I welcome the panel. I should declare that I am an honorary associate of the British Veterinary Association. I was probably in the European Parliament when the original water framework directive was adopted, so I have taken quite an interest in it since then. I would like to ask a question in two parts, initially to Dr Bradburne; if anyone else wants to pitch in, that would be great.
We seem to have identified another research gap in our evidence. A lot of the unpronounceable isoxazolines—I have been rehearsing that—go to the bottom of the riverbed and, for that reason, present themselves with difficulty. Do you have plans to increase the scale of monitoring in waterways, soil and sewage sludge for these chemicals of concern? Are we testing and monitoring at the right levels? In response to the first question from the Chair, we heard some pretty graphic percentages on what you are finding. If we were to reduce that, might we be even more horrified than we already are?
Dr Robert Bradburne: I will take that question in two parts. It is a very good question because every chemical in the environment behaves differently. Pathways into the environment are different, and where the chemicals end up in the environment is different. Regarding the chemicals in question here, we have some ongoing research at the moment into fipronil and imidacloprid to understand how those are travelling through the environmental system.
There is a great programme called the Chemical Investigations Programme; the committee may have heard about it. It is the water industry’s response to emerging threats and problems that might be having an impact on the water system. It does that collaboratively with the regulators and UK Water Industry Research. It started looking at imidacloprid and fipronil in around 2020, but one of the projects we have running with it at the moment is looking specifically at how those chemicals partition between different things—between sewage sludge and the water that goes through the sewage system—then what happens when it is in the river, looking into the sediment, et cetera. It is a good thing to do. It is quite a big programme of work.
As far as I am aware, we have not yet started to look at the newer chemicals on the market in such detail. Using and working with the Chemical Investigations Programme might be a good way to do that because it gives you access to real-life sewage works and situations, so you can see what is really happening rather than doing it in a laboratory. That is certainly something we can explore. As I say, it is collaborative, so it sets some research requirements, but we work with it on that.
On monitoring, my question is always around the utility of the information that we get out of the monitoring. In most areas that I end up talking to people about, I will almost always get asked, “Why don’t you do more monitoring?”, somewhere in the conversation. If I added that all together, we already spend around £90 million a year monitoring the water environment. It is a huge amount of effort, employing about 1,000 of our staff. It is an enormous programme. We have added these new chemicals to that wider watch list. Should we increase the number of sampling sites? I am not currently sure that it would give us further information to enable us to take a different step or set of actions.
Baroness McIntosh of Pickering: Are we setting the monitoring at the right level?
Dr Robert Bradburne: We have representative samples from across the various sources. As we were explaining earlier, we are looking in urban and rural situations. We are trying to pick the points where we can get the most information. We have a system called the Harmonised Monitoring Scheme, for example, which looks at a small subset of rivers but is designed in a way that captures the overall picture of rivers. Depending on measurements, there are 200,000 kilometres of watercourses in England, so there is a lot of water to measure. We try to do that statistically.
For these watch list chemicals, it is not a statistically designed survey. We take opportunities where we are using monitoring in other places. At the moment, I feel comfortable that we are getting a good picture. I am not sure that we need to throw lots more sampling sites at it. We will keep that under review as new chemicals come along.
Baroness McIntosh of Pickering: Before I move on to the next part of the question, this issue has caused great concern in areas such as north Yorkshire, where sludge is put on fields. It appears from the evidence we have received that it contains that lovely substance—iso-whatevers. Should we end the practice until we know what damage has been caused? I am sure that Baroness Hayman will be aware of this; it causes a lot of grief in rural areas. Should we have a moratorium until we know more?
Baroness Hayman of Ullock: Sludge spreading is one of those issues on which a lot of people have quite strong views. Obviously, it is currently permitted. There are also rules around using it, as you know. As we get more evidence on the chemicals that could be present in sludge, we need to look at that very carefully.
Q55 Baroness McIntosh of Pickering: For those interested, CIWM did a study on what we could use other substances for. I chaired it; it was a very good study. Can I move on to the water framework directive? The environmental quality standards that are set are legally binding, substance-specific concentration limits for pollutants in water. We have heard that the lack of an agreed EQS for fipronil and imidacloprid in the UK indicates that there is still uncertainty here. Do you share that concern? Obviously, the EU has updated the water framework directive to introduce a predicted no-effect concentration for fipronil and imidacloprid. Do you think that we should go down the EQS path?
Before you reply, let me flag up some evidence that we have just received, as we were preparing for this week, from Water UK and Yorkshire Water. Obviously, I declare an interest as a former Yorkshire MP. The figure that Water UK put on treating this, particularly if you were to remove PFAS from the waterways, has been estimated by the UKWIR to have a net present value cost of £21 billion for the UK. I would argue that we should not be putting these substances in the water in the first place and asking water companies and customers to dig them out. Water UK says that the current wastewater treatment processes are able to partially reduce concentrations of parasiticides but do not fully remove them. It would put an enormous responsibility on water companies, their customers and everybody else if that were to change. You alluded to the Northern Irish situation as well, so there is a lot in that question.
Dr Robert Bradburne: There is an awful lot in that question. I will try to give as much of an answer as I can. You are right. Let us deal with imidacloprid and fipronil. At the moment, water treatment—
The Chair: We do not need to spend too much time on this; it is not a core question.
Dr Robert Bradburne: Okay; I will treat it more briefly, then. EQSs are tools that we use to enable us to set things such as permit limits on what can come out of a company or water treatment sites. As such, where we know that there are particular limits we do not want to be breached in the environment, they can be very powerful tools. We then have to monitor very quantitatively for those substances to ensure that those permit limits are being respected. You hit the nail on the head when you said that primary and secondary treatments are not going to remove a lot of these chemicals. Putting in the tertiary and quaternary treatments is going to be very expensive; I know that this is something you are looking at.
The Chair: That is going down the rabbit hole.
Baroness McIntosh of Pickering: It was in the evidence. Can I ask two quick questions?
The Chair: We have 16 minutes remaining.
Baroness McIntosh of Pickering: Why are vets not giving these substances to their pets? I will end with that. Is there a reason why vets are not treating their pets with these pet medicines?
Baroness Hayman of Ullock: Presumably, that is from the evidence from the vets who came here. Do we know that all vets do not use them?
Baroness McIntosh of Pickering: It is anecdotal from the panel.
Baroness Hayman of Ullock: It is important to look at access here because most vets have easy access to alternative treatments. For example, I understand this better; I would rather give my dog a pill than use a spot-on. However, many people do not necessarily have access to that, have the ability to go and see the vet or have the funds to start paying for prescriptions, which is part of the reason why we need to understand this situation better and understand any unintended consequences. If we ban them, we do not want to see a lot of people stopping using it so that we have an issue with fleas and ticks going forward. We need to do it in a proper, considered way. When we move forward to make decisions on what to do about these chemicals and try to move usage into a different area, we need to consider that properly.
Q56 Earl Russell: Thank you very much for being with us on such a warm morning. My question is about information for pet owners—sorry, I cannot use companion animals. I declare my interest in this space because I have a couple of dogs. Obviously, the VMD has updated its information for pet owners, and you have increased the time that you suggest pet owners do not allow their dogs to go in the water from two to four days.
However, in terms of understanding the pathways for these medicines, is that advice good enough, when there seems to be pretty clear evidence that these treatments can last for longer periods of time? There is some suggestion that it could be for 28 days or more in the home. Obviously, as we know, dogs go on beds, sofas and all sorts of other stuff, and humans interact with them. Then there is an issue about the waterways. I have a second question, but I will start with this one.
Baroness Hayman of Ullock: This is something that we have been discussing. It is clearly an important part of the call for evidence. Reading the leaflet came up earlier. There is plenty of information on the packets and in the leaflets. How much notice do people take of it? Do they act on what is put on the leaflet? Do they stop their dog swimming? It is all very well providing information, but you need to understand how people use it—or whether they even recognise the information that they are being given.
Then you look at whether to provide information at the point of sale. How does that work with online sales? Do you work with vets to do more? It is a complex area because, sometimes, the things you think people are going to take account of do not work. You have to think quite openly. This is something that the VMD and I have been talking about in some detail; it will be an important part of our response to the call for evidence.
Earl Russell: I welcome that; that is an important part of this space. A lot of dog owners do not know about this and do not have access to good evidence. You cannot read a 2.6-metre leaflet. Nobody opens it up. Would you push for more visuals on packaging? Should we also be moving away from the manufacturers pushing people to use these medications monthly? Should we be looking at increasing the length of time that we encourage people not to be overly interacting with their pets or having them sleep on sofas? Is all that active in your space for consideration?
Baroness Hayman of Ullock: Absolutely. It is not just about how you use it; it is about how often you use it. It is about looking at the bigger picture of usage and why people use it in the way they do. As you say, there is advice to use it monthly. Is that necessary? We need to consider all these questions. We will look at that as part of the call for evidence, as well as whether we need revised guidance and what we would say in that space.
The Chair: Shall we move on? That topic has been covered and will be covered again later by Lord Trees.
Q57 Lord Krebs: I thank our witnesses for coming this morning. One of the things that has struck us in the past few weeks, in taking evidence, is how the industry is closely involved in the regulatory process. For example, the VICH has two UK representatives, the VMD and NOAH, which represent the pharmaceutical industry. We have become a bit worried about regulatory capture here. I would like to hear your view on that, Abigail.
The Responsible Use of Medicines in Agriculture Alliance-Companion Animal and Equine—RUMA CA&E—is a voluntary, cross-sectoral alliance of stakeholders. Note that the treasurer is the chief executive of the industry body, NOAH. My experience is from the food industry: I chaired the Food Standards Agency. We tended to keep the food industry at arm’s length, whereas it seems to be a warm embrace here.
Abigail Seager: We work in a collaborative way, absolutely. I stand by that as a value of the VMD in terms of how we co-operate with anybody, whether the pharmaceutical industry, other government departments, stakeholders or veterinary associations. The animal health sector is relatively small; it is about 3% of the size of the human health sector, for example. We have to understand what is happening, the nature of the products that are being developed and the nature of the disease incursion that we are facing with greater speed because of climate change. It is important that we work together and understand the regulatory barriers to pharmaceutical companies delivering the products we need at the supply level we need.
One of the other issues we have faced at the VMD, on the vaccine side, is concerns around shortage of supply and innovation. We are facing into that by addressing it directly with the multi-stakeholder group, which includes the pharmaceutical industry. We are independent of them, though, and, as I referred to earlier, we will refuse applications. We do not blindly send through any data package that is sent to us. We are renowned globally for the robustness of our science. I absolutely stand by the fact that all of the scientists at the VMD will look at the science based on the data that is provided and challenge it, regardless of who the applicant is.
However, we work in a way that is not as much at arm’s length as other sectors you have experience of because it is important for us to have a common goal here: having safe medicines available on the market. It takes a number of parties working in the same direction to achieve that.
Lord Krebs: I have a very brief second question. In some other areas of risk assessment and informing regulation, there are independent scientific committees, such as the Committee on Toxicity and the Committee on the Medical Effects of Air Pollutants. Does the VMD have an independent scientific committee, populated by academics and other experts, which helps to summarise and inform it on scientific advice?
Abigail Seager: We have access to the Veterinary Products Committee, which is an independent group made up of academics with specific scientific expertise who work in various fields. It also includes veterinary prescribing nurses and veterinary surgeons from large animal practices and various species groups, so that we can get a whole-sector response when we ask it a question. We may take issues to the Veterinary Products Committee and ask it to consider them. As I referred to earlier, it is possible that that committee could be asked to look at a decision we have taken. If the company does not agree with it, it can look at it as an appealing body.
We have access in that regard to an independent group, but we also work with other scientists across other government departments when we need to do so. Notably, we work with the Food Standards Agency when that is required—obviously, not in the pet space—and others as we need to. When we recognise that we might need to tap into some scientific expertise, we are absolutely able to do that, not necessarily through specific committees in the detail you described, but certainly with the Veterinary Products Committee, which exists for that purpose.
The Chair: Can you say a little more about the Veterinary Products Committee? I am not familiar with it. Can you say whether it is really independent of the industry?
Abigail Seager: No industry representatives sit on the Veterinary Products Committee. It is made up of experts who are either species group experts, vets in practice—equine vets, large animal vets and small animal vets—the distribution category channel and anybody else who works in the animal health sector. No representatives from the pharmaceutical industry sit on that committee.
Q58 Lord Trees: I want to come back to monitoring because it is hugely important. You sample over 1,000 sites regularly, do you not? You archive those, freeze them and make them available to other researchers, right? That has produced all of the valuable data that we have on the concentrations of various chemicals, including fipronil and imidacloprid. However, do you have any remit—indeed, does anybody?—to sample and measure the amount of animal life, particularly invertebrates, in the samples you are taking and can take, and to look at that geographically, spatially and temporally? We have lots of evidence of pollution with the chemicals, but we are trying to get to the basis. What is the effect on the real environments in waterways, ponds, lakes and rivers?
Dr Robert Bradburne: We do not store all of the water samples that we take. Physically, that would be impossible, because most of the samples are around a litre of water. If we take up to 100,000 samples a year, you can imagine that it would be impossible to store them. We store certain aspects of the samples that we take. If we have passed water through filters, we can store and freeze those, so there are some places where academics can go back. We make the data open as quickly as we can.
Lord Trees: Do you look for living organisms in the samples?
Dr Robert Bradburne: Yes.
Lord Trees: Do you quantify them?
Dr Robert Bradburne: Yes. When we go to sites, we take a water sample, and we can do the chemistry on that sample. At the same site, we will often do what is called a kick sample, which is where someone physically gets into the river, kicks up the base of the river and catches all of that in a net. That goes off to one of our area labs, usually, where it is spread out into big trays. Someone will physically go through it and identify and count all of the invertebrates in those samples. It is a very laborious process.
We are also looking now at new technologies, such as environmental DNA. All of these animals emit DNA into the environment; we can pick that up and measure it. We are testing that as well. We are really trying to get a very good view. We also do this for plant species, including microscopic plant species. We are trying to understand—
Lord Trees: Are those results openly available, or is that some of the data that we are waiting for under PiE?
Dr Robert Bradburne: No. We put out the data as soon as we can. We have to do certain safety checks as some of this data is sensitive because it is about our water supply—I do a risk assessment on that—but, as soon as it is available and we have quality-assured it, it goes up on the Defra open data website. However, we usually have to spend quite a lot of time turning that into useful information because knowing that there is a certain amount of phosphate in a water sample, when you do not know anything about the river, does not tell you an awful lot.
Understanding invertebrates for the water framework directive will take three years of sampling different samples in that water body in the spring and the autumn, which then get combined through a statistical tool to produce an overall value on how good that ecology is. It is quite an involved process, but, yes, all of the data is open. You can go and download it in spreadsheets. We are investing at the moment in IT to make that much more available and more readily accessible to a wider audience. We also encourage citizen scientists to engage, especially in invertebrate monitoring; we have new protocols for them. So we are gathering more data on the biological effects all the time.
Lord Trees: I know that you cannot associate cause and effect, but, in a nutshell, what is it telling you? Is the biodiversity getting better or worse?
Dr Robert Bradburne: We have done some studies looking back. Over the past 30 or so years, there has been a significant improvement in invertebrate quality of life in most of our rivers. Some of the major pressures from some of our sewage works, which have been cleaned up over that time, have decreased; that has produced a substantial improvement in biodiversity. In some places, it has levelled off. We could do more, but it is an awful lot better than it was a couple of decades ago.
Q59 Lord Trees: My next question is for Abi or the Minister; it is about labelling. We recently did a little mystery shopping and bought imidacloprid online. It is a non-food animal product, for veterinarians, pharmacists or SQPs, but the purchaser received no direct advice on using it. No prescription is required, apparently. We do not know what the SQP has said or done, nor how they have been trained. Is that a satisfactory way of distributing products that are potentially harmful, at least to the environment?
Baroness Hayman of Ullock: Are you referring to online sales specifically?
Lord Trees: This was online, yes.
Baroness Hayman of Ullock: Online sales are absolutely part of the call for evidence and something we are looking at, because they cause problems in a number of areas. It is not about just labelling; it is about making sure that you have proper checks in place and that people understand what to look for when they are purchasing online. It is absolutely something that we need to do more work on because people do not necessarily know what they are buying. In looking at medication, it is critical that we have clear understanding from purchasers as to what they are purchasing.
Lord Trees: We realise that there are arguments for greater and cheaper availability, but is there a risk-benefit to be considered?
Abigail Seager: Absolutely. Distribution categories allowing for any product to be distributed other than directly through a veterinary practice were first introduced to enable that wider accessibility. However, we appreciate that we now need to look at those categories, which is exactly what the call for evidence that has just closed was for. We need to understand whether they remain appropriate and whether the point-of-sale advice we are expecting to be given is happening in practice or whether, in some cases—perhaps for a range of products—greater point-of-sale advice needs to be provided. That is the exact question. In answer to your question, it is not necessarily sufficient; that is why we are asking more broadly for evidence to support us looking into that.
Lord Trees: It was said earlier that people do not read the inserts. We are hearing, and have heard from other witnesses, that some information now needs updating, in terms of the longevity of these compounds on hands, fomites or bedding.
Abigail Seager: Absolutely. We appreciate that this is about a societal behavioural shift. We appreciate from a number of sources that, although writing something on a leaflet is how we have traditionally handled a change, it may not deliver the benefits that we need to realise. As a result, we are looking at how we can better that, which is why one of the strands of our road map is about communication and education.
We currently have a campaign, the “Be Spot-on Aware” campaign, which reaches people in an informative way through the media and in other channels, so that they understand the risks to the environment associated with these products in a greater capacity than they would have done if we had just relied on them reading the leaflet. We absolutely appreciate that it is a challenge. That is why we are addressing it through a multitude of ways outwith our normal regulatory activity, which would be to ask companies to change labelling, which may not have the material impact that we are looking for.
Francine Fernandez: The communication campaign is focusing on appropriate use, as opposed to risk-based use. Although some research—specifically Perkins’s research—has shown that down-the-drain emissions happen throughout the time the product is on the animal, our own behavioural research and research with Plymouth has shown that compliance with product literature is very inconsistent. A lot of people do not do what they should do. It is very much a first step to raise awareness and get people to start using these products more responsibly.
The Chair: I have a quick follow-up question. Are the registered online retailers required to undergo any SQP training?
Abigail Seager: Absolutely. There is training for SQPs. We work with associated bodies to ensure that the training is sufficient. Again, our call for evidence may well help us in this case to understand whether further training is needed or specific areas of expectation need to be set, in terms of how that communication happens at the point of sale.
Q60 Lord Krebs: I want to come back to a topic that we touched on earlier: the isoxazoline medications that seem to be replacing fipronil and imidacloprid to some degree. Will the consultation exercise that you are undertaking, and any action you propose to take as a consequence, include the possible effects of these newer drugs, which are taken in pill form rather than spot-on?
Baroness Hayman of Ullock: In a nutshell, yes. We are looking at new products and their implications as well.
Lord Krebs: Are you undertaking any research to look at their potential environmental impacts?
Abigail Seager: Yes. With isoxazolines, we recognise that there are evidence gaps, particularly around the environmental impact, as I referred to earlier. We need to understand the PFAS aspect of that. Once we have undertaken the analysis of the data that we have received through the call for evidence—of course, I hope that that will land at a similar time to your report—we will be able to bring things together and understand what our next steps may look like in the regulatory space, including whether that will cover a range of products or whether we will focus on spot-ons specifically. This is in Francine’s area.
Francine Fernandez: I point out that that is a very good example of why it is so important to have standardised phase 2 guidance so that we can look at these products comparatively and across the board.
The Chair: It is 11.38 am. I apologise profusely.
Baroness McIntosh of Pickering: What about pesticides for agricultural use?
The Chair: We have covered those.
Baroness McIntosh of Pickering: What about how long they stay in the—
The Chair: Do we have your permission to put more questions to you in writing? It is 11.38 am.
Baroness Hayman of Ullock: Yes, absolutely. We would be very happy to receive any further questions in writing.
The Chair: Baroness McIntosh has an important question on agricultural use.
Q61 Baroness McIntosh of Pickering: Briefly, we have heard from the industry that a lot of this is due to pesticides that were used in agriculture and which have been banned for 10 years. What is the lifetime of a pesticide that was used in agriculture? Could it possibly be 10 years?
Baroness Hayman of Ullock: Does anybody know the answer to that?
Francine Fernandez: I cannot give exact statistics, but this is a really interesting issue. Originally, we thought, “It’s been 10 years, so surely the historical levels from agriculture will have gone down”, but new research is now showing that imidacloprid specifically is still present in soil. A recently published study—I can send it to you as part of our written evidence retrospectively—showed that, even on an organic farm, imidacloprid was present in the soil.
Baroness McIntosh of Pickering: Thank you; that is very helpful.
The Chair: Thank you for your patience with us. I had hoped that we would come in on time, but it was clear that we were not going to do so. I thank all four of you very much for being with us today; your patience with our questioning is much appreciated. I now bring the public session of this meeting to a close.
