21
European Affairs Committee
The Windsor Framework Sub-Committee
Corrected oral evidence: Veterinary medicines and the Windsor Framework
Wednesday 17 January 2024
4.20 pm
Members present: Lord Jay of Ewelme (The Chair); Lord Dodds of Duncairn; Lord Empey; Lord Godson; Baroness Goudie; Lord Lexden; Baroness O’Loan; Baroness Ritchie of Downpatrick; Lord Thomas of Gresford.
Evidence Session No. 2 Heard in Public Questions 12 - 23
Witnesses
I: Dr Simon Doherty, Senior Lecturer, Queen’s University Belfast; Mark Little, Honorary Secretary Northern Ireland Branch, British Veterinary Association; Dr Esther Skelly-Smith, President, Northern Ireland Branch, British Veterinary Association.
Dr Simon Doherty, Mark Little and Dr Esther Skelly-Smith.
Q12 The Chair: Good afternoon and welcome to this public meeting of the sub-committee on the Windsor Framework. We are now holding the second evidence session of our inquiry into veterinary medicines and the Windsor Framework. We are joined by three veterinary experts. Esther Skelly-Smith is president of the Northern Ireland Branch of the British Veterinary Association; Mark Little is the honorary secretary of the Northern Ireland Branch of the British Veterinary Association; and Dr Simon Doherty is a senior lecturer at Queen’s University Belfast. You are all very welcome and we are very glad to have you with us today. We would be grateful if you could introduce yourselves briefly the first time that you speak.
Today’s meeting is being broadcast and a verbatim transcript for subsequent publication will be sent to you shortly after the end of the session in order to check for accuracy. Could I also refer to the list of Members’ interests as published on the committee’s website?
Having said that, I will ask the first question. How were veterinary medicines managed and regulated in Northern Ireland before the UK left the European Union? In your views, what immediate impact, if any, did Brexit have? I do not know which of you has been chosen to answer this question.
Dr Esther Skelly-Smith: Thank you. That is me. I am the current president of the British Veterinary Association Northern Ireland Branch and the North of Ireland Veterinary Association. I am an equine vet by background. Thank you very much for taking the time to deal with an issue that we are very passionate about and as a veterinary profession we are very concerned about.
To answer your first question, the Veterinary Medicines Directorate, an executive agency sponsored by Defra, regulates the medicines within the UK and sets out the controls on manufacture, authorisation, marketing, distribution and post-authorisation surveillance of veterinary medicines. It is also there to assure safety, quality and efficacy of the veterinary medicines, thereby safeguarding animal health and welfare and protecting public health. This was the situation prior to the UK leaving the European Union, and Brexit has had no immediate impact on that. However, access to a product has the same guidelines in place, and we are under the impression that under the new Veterinary Medicines Regulations guidelines we may not diverge significantly.
The Chair: Thank you very much for that. Do either of the others want to add anything, or are you happy with that?
Mark Little: I have a quick point. I am a Royal College of Veterinary Surgeons specialist vet. I work as a consultant in preventive health in a cattle and sheep practice in Northern Ireland. I am a past president of the British Veterinary Association Northern Ireland Branch, which is also known as the North of Ireland Veterinary Association, and current BVA NI Branch honorary secretary.
I totally agree with what Esther has said about the situation prior to the UK leaving the European Union and that Brexit has had no impact on this whatever. We are aware of a recent review into veterinary medicines in the UK. It is due out imminently—very soon—and we understand that under that recent review we may be even more aligned to EU regulations.
The Chair: When you say “we”, do you mean—
Mark Little: The UK.
The Chair: The UK, not Northern Ireland.
Mark Little: The UK could be even more aligned to the EU regulations. The point I really want to make is that divergence is not an issue in terms of veterinary medicines and UK and EU regulations.
The Chair: Thank you. Dr Doherty, do you want to introduce yourself and perhaps comment on those answers if you would like to?
Dr Simon Doherty: Yes, sure. As you mentioned, I am based at the Institute for Global Food Security at Queen’s University Belfast. I am a past president of both the Northern Ireland Branch of BVA and the British Veterinary Association UK-wide. Within Europe, I am the co-chair of the Federation of Veterinarians of Europe veterinary public health and sustainability working group. FVE is a pan-European body. It does not recognise just the EU 27; it recognises about 39 member countries across the entire continent. I am currently the European director of the World Aquatic Veterinary Medical Association, so I have dipped my toe in aquaculture. Just for the benefit of the committee, I previously sat on the standards working group of the Trade and Agriculture Commission as well.
I have nothing to add particularly to this question that has been addressed by Esther and Mark. One area that would particularly have applied in the aquaculture sector would have been the mutual recognition piece that you heard about from the previous panel. When a product is licensed within a European member state and recognised by the competent authority within that member state, it can be used across other member states, but, again, it has had minimal effect even within the aquaculture sector post-EU exit.
The Chair: Thank you very much.
Q13 Baroness Ritchie of Downpatrick: What are the main outstanding issues in relation to veterinary medicines in the context of the Windsor Framework? I know that you have probably allocated that to one of your colleagues.
Dr Esther Skelly-Smith: I will answer that. The British Veterinary Association has broadly welcomed the Windsor Framework as a positive step. However, on a point of clarification with regard to veterinary medicine, it is only mentioned in point 47 of the Windsor Framework, which states that the original protocol, the Northern Ireland protocol, failed to take account of the overwhelming reliance of Northern Ireland on veterinary medicine from Great Britain. It also states that the UK has put in place a grace period until the end of 2025, and further states that the Government are clear that the only practical solution will be a solution, as with human medicines, to guarantee the existing and long-established flow of trade between Great Britain and Northern Ireland.
Therefore, veterinary medicines are covered primarily by the Northern Ireland protocol, but the Windsor Framework recognised the need for a solution and proposed a solution similar to human medicines. The BVA has welcomed the statement on the Windsor Framework and urges the Government to fulfil the statement to safeguard the health and welfare of all animals in Northern Ireland and public health.
Baroness Ritchie of Downpatrick: Thank you.
The Chair: Do either of the others want to add anything to that?
Dr Simon Doherty: I have a quick comment. I have a particular interest in what has now been termed “one health”—the interconnectedness between the health of people, animals and the environment. One area discussed in the previous panel was the link between the similarities in the licensing of human medicines and veterinary medicines. The previous panel highlighted that that aspect related primarily to agri-food products and the fact that veterinary medicines are used in food-producing animals.
There is a broader piece to this certainly from my interest in relation to fish, and I know Esther will mention some of the aspects in relation to horses and companion animals.
There is potential resistance in worms, fluke and bacteria—what we now refer to as antimicrobial resistance. That goes across all species, so, as Esther mentioned at the end, the veterinary public health aspect is important. It is not just transfer in food but the broader burden of the use of antibiotics and anthelmintic products in people and animals that we have to be concerned about. We would have concern about the disruption to the balance that could be brought about by the existing framework.
Baroness Ritchie of Downpatrick: What is the solution?
Dr Simon Doherty: We will come on to talk about some solutions. In the broader piece, setting aside everything that we are discussing today, there is a much greater move within Governments holistically to move towards “one health” approaches. I have done a piece of work recently with Innovate UK where we have been looking at the trade and innovation angles around human health and animal health together in relation to antimicrobial resistance. I have been involved in a couple of missions to the United States and India looking at that “one health” piece. The people who were involved in those missions were very much looking across the board at human health, the biomedical sector, the veterinary medicines sector and animal health, at how antibiotics, anthelmintics and vaccines are used. We saw a lot of that during Covid as well. That “one health” approach is really coming through now.
Lord Godson: By “one health”, you mean thematically as opposed to geographically or via polities.
Dr Simon Doherty: Yes. It is looking at that cross-sectoral approach to how we use antibiotics, vaccines and so on.
Q14 Baroness Goudie: Good afternoon. Thank you very much for coming to see us today. In the absence of any alternative agreed solutions, what will be the impact on the supply of veterinary medicines from Great Britain to Northern Ireland if the current grace period ends on 31 December 2025? Further, what requirements in EU law, if fully implemented, would have the most impact on supply of medicines to Northern Ireland?
Mark Little: First, I have to state that the British Veterinary Association, the BVA, is a membership association for veterinary surgeons. It is difficult for us to give a firm figure, because the Veterinary Medicines Directorate, the VMD, conducted work on veterinary medicines that will be discontinued. It holds information, a lot of which is commercially sensitive, as you have heard from the previous panel. We do not know all the details, but we are prepared to share those that we have.
If the current grace period ends and there is no agreed solution, as was stated in the previous panel, the VMD’s work conducted in the February 2023 list states that 51%—or 1,700—of veterinary medicines are at risk of discontinuation. To put that in context, for a vet and small animal practice or a vet and large animal practice, half the medicines to treat and prevent diseases—or half the toolbox—will disappear.
It was nicely explained in the last panel that this is due to three reasons. First, veterinary medicines stored in warehouses in GB will have to go through a batch release or, as I call it, a further quality check, before coming to Northern Ireland, even if they have already had a batch release previously, which they all have; and this extends even to veterinary medicines manufactured and batch released previously in the EU and transiting through GB.
Second is the marketing authorisation holder location or the registered address on the data sheet. That is the piece of paper inside every pack of veterinary medicine. That address will have to be located in the EU or Northern Ireland. Of course, before Brexit, the GB address was within the EU, but after Brexit it is not, and that is the issue. Due to the relatively small veterinary market in Northern Ireland, the pharmaceutical industry has stated that the investment required to implement the changes will not be economically viable for such a small market, leading to discontinuation of vital veterinary medicines.
Thirdly—and this applies only to a small number of veterinary medicines—currently the VMD allows some import of veterinary medicines from countries such as the USA and Australia under strict conditions: special import certificates or special import licences. Some of those are vaccines that are not licensed in the UK or Europe and have important roles in controlling diseases in Northern Ireland such as the disease of botulism, which has no cure whatever, so prevention is key. Medicines from outside the EU will not be allowed to be used in Northern Ireland at the end of the grace period.
Since this February 2023 list, we are aware that the VMD has completed a further survey with the pharmaceutical companies, so our 51%, or 1,700 products, may have changed due to the VMD information. In other words, it is asking the pharmaceutical companies, “What do you plan to do? Do you plan to change the licence? Do you plan to reroute the products?” It is highly sensitive, and we are not aware of any of the information, but 51%, or 1,700, is from February. There is some further information from the VMD that we have no access to.
You also asked which, if fully implemented, has the most impact on supply of veterinary medicines to Northern Ireland? Again, to quantify 1,700 discontinuations, or 51%, if you open the boot of your car or the cabinet in your small animal clinic, half the medicines have disappeared. Some 1,400 of those are due to the licence location—marketing authorisation holder location—and many are due to the warehousing and batch release.
Even though that is a small amount, numbers are not always key. I make the example of the small number of products manufactured in Australia or the US. It sounds like a small number, and it will only be a handful of products. However, that small number has a large effect. For example, 25,000 cattle every year are vaccinated with a botulism vaccine in Northern Ireland, a disease that has no cure, which is why vaccination is so important.
Where an address is located on a data sheet inside a pack of medicine does not put food safety at risk for the EU. Re-batch testing will not increase food safety for the EU. Those two changes will have a significant impact in Northern Ireland and due to EU legislation will not increase food safety going from Northern Ireland to the EU.
Q15 Baroness Goudie: On the basis of what you have just said and information that we already know, what plans has the Northern Ireland Office, or anybody, made with you to get further medicines that are required? The agriculture industry is vital to Northern Ireland and to the families who require it. Have talks begun about how we are going to move on from this situation?
Mark Little: We are involved in a delegation for the Northern Ireland Office. I met with the Northern Ireland Office in November. I was highly aware that, because of a lack of public solutions coming forward from the Northern Ireland Office, we had started to come up with our own solutions. I did not want to come up with our own solutions if they were pulling in a different direction from what the Cabinet Office solutions may be. A working group has been set up with the Cabinet Office, including the VMD and Defra, to work with the British Veterinary Association Northern Ireland Branch, Esther and me, and we work closely with it. Since that, we have had two meetings, one in December and one in January, so there are efforts. It is very much feeding into it at the moment and feeding in what we feel the implications on the ground will be. I am aware there are solutions, but I am unaware what those solutions are.
Baroness Goudie: That is very helpful.
Q16 Lord Dodds of Duncairn: You mentioned the 51%—1,700 products—to be discontinued. The grace period, as you say, has been given not for the purpose of finding another solution but for adaptation to EU standards and regulations. It was once asked why we do not just get the supplies from the European Union instead of the UK and GB. How feasible is that? That was said, I think, by a leading European Union official and an Irish politician, and it seemed to be shot down at the time. Can these products be replaced easily from the European Union?
Mark Little: First, they cannot be obtained from GB because it is outside the European Union. Can they be obtained from any other European Union member state? They can, but, again, all veterinary medicines in the UK are licensed by the Veterinary Medicines Directorate, so we will have to go through what is called a special import certificate to import them into Northern Ireland from another member state because they are not licensed in Northern Ireland.
We are all aware of the workforce issues in vets in Northern Ireland at the moment. In fact, they have recently come off the workforce shortage list. We are asking vets to write special import certificates for medicines for each case in each farm for each animal—individual special import licences for half the cats and half the dogs that come in through the clinic door from all the farms but with half the medicines. That is a lot of bureaucratic work. The workforce is under pressure at the moment. It slows work down and it will add cost to the farming industry, unfortunately. We do not want it to be, but the cost will have to be passed on.
Lord Dodds of Duncairn: That is very helpful. Thank you.
Baroness O’Loan: Before I ask my question, can I just come back to you, Mr Little? You have mentioned botulism twice and that 25,000 cattle are vaccinated in Northern Ireland against botulism. Is it not a problem in the rest of the UK?
Mark Little: Botulism is a problem in the rest of the UK. It seems to be a particular problem due to the farming model in Northern Ireland where we have a high density of the poultry industry, and a lot of family farms have a poultry house and grazing stock. What do you do with that poultry litter? I suppose the rest of Europe spreads the poultry litter on arable ground. In Northern Ireland, we do not have a lot of arable ground, so we spread it on grazing ground, so you have potential contact with grazing cattle. That is why it is more of an issue in Northern Ireland than potentially anywhere else in Europe.
Baroness O’Loan: Did you say that vaccine came from Australia, or did I mishear you?
Mark Little: There are two sources of it, correct: Australia and the USA.
Baroness O’Loan: Did you say that they will not be permitted to be imported after January 2026?
Mark Little: Correct. The European legislation is very nuanced. You would have to confirm with the Veterinary Medicines Directorate, but medicines manufactured outside Europe are not allowed to be used within Europe, including Northern Ireland. Sorry, I made a mistake. The two sources are Australia and South Africa.
Q17 Baroness O’Loan: I just wanted to be very clear that I understood what you were saying because I see the significance of it.
My question is: what are the wider consequences for Northern Ireland and the rest of the UK if the supply of veterinary medicines is disrupted in the way in which you have previously indicated? How would you assess the risk to food supply chains on the island of Ireland and to Northern Ireland’s access to the EU’s single market for goods? First, what are the wider consequences if veterinary medicine supplies are disrupted?
Mark Little: We will split that up between us. I will cover the large animal side of things. For Northern Ireland, the loss of 51% of veterinary medicines will have a disastrous impact on animal health and welfare across the species. I have some examples, and the following examples are due to our own work because of the commercial sensitivity of this data. We have looked through the data sheets where those marketing authorisation holder location addresses lie.
In sheep, for example, there is the loss of what is called a clostridial disease vaccine. These bacteria are soil-borne, and of course sheep are grazing close to soil. It is an essential part of the flock health programme. These soil bacteria cause death. There is no cure for them, and it is completely prevented by a vaccine. That may be one of the vaccines that are discontinued, and there are severe implications for not only flock health but farm profitability.
There is the loss of cattle vaccines such as one of the two available BVD—bovine viral diarrhoea—vaccines. There is the loss of veterinary medicines to prevent diseases in cattle such as leptospirosis and salmonella. These are easily preventable diseases with vaccines, and for them to be discontinued due to strict EU legislation not allowing them simply because of an address on the data sheet inside the pack is unthinkable.
We have spoken to the British Medical Association and told it about these potential discontinuations with leptospirosis and salmonella. Why do I bring up these two in particular, and why did we bring them up with the British Medical Association? Both are zoonotic diseases, so they can pass to humans, particularly farm workers and farm owners who are working with animals. That is why we have asked it for its opinion. It has given us permission to say that the loss of vaccines that prevent diseases will cause a public health emergency in Northern Ireland.
The World Veterinary Association has produced an essential veterinary medicines list. These veterinary medicines are key and must be available in all countries to control diseases. Many of the veterinary medicines to prevent and control diseases in Northern Ireland that will be discontinued appear on this World Veterinary Association essential veterinary medicines list.
Bryan Lovegrove brought up the rationalisation of pack sizes. If a product is available in pack sizes of 1 litre, 2 litres and 5 litres for treating cattle against worms, to protect against disease and increase profitability in the farm, we do not know whether pharmaceutical companies will pick a small pack size or a large pack size, which one they will continue to supply, because each pack size will require that relicensing. If it is a small pack size, they will be less economical. If it is a large pack size, a farmer with 10 cattle may need to buy 5 litres of products, which will last them for 10 years and, in fact, will go out of date before they use it all. The wrong thing to do for antimicrobial resistance is to use the same product again and again, because that drives antimicrobial resistance.
Even with poultry vaccines—salmonella in poultry was mentioned previously—there are implications for production, health, and animal health and human health, as well as the market for GB, because eggs sent to GB must be declared salmonella-free. There are also implications for the Northern Ireland market sending eggs to GB.
Baroness O’Loan: Can I just stop you at that point? I think you just told us that you have been permitted to say that if we cannot import these vaccines it will cause a public health emergency. Is that what you said?
Mark Little: We have met with the British Medical Association Northern Ireland Branch, and it has given us permission to say that it could cause a public health emergency.
Lord Godson: What is “it”? I just want to follow up on Baroness O’Loan’s point.
Mark Little: You are correct; apologies. I should have detailed more. It is the loss of licensed vaccines to prevent diseases in cattle such as salmonella and leptospirosis. These are zoonotic diseases and can spread to humans. Because of that risk and the loss of these preventive vaccines, the BMA has said that it could cause a public health emergency.
Lord Godson: To be absolutely clear—sorry to be pedantic—loss deriving from what? What is the source of the loss? It is sort of a “who/whom” question. What public policy decision led to said loss?
Mark Little: These vaccines appear in the 51% or discontinuations in 1,700 products. These vaccines appear in that list.
Baroness O’Loan: Thank you very much, Mr Little.
Q18 The Chair: Following up that point and Lord Godson’s question, you have talked about 51% and 1,700 products, I think. Of those products, roughly how many are what you called essential veterinary medicines? In other words, of the 51%, how serious is that, if you see what I mean?
Mark Little: It is difficult to quantify. We do not have the list, because it is not publicly available information. I can highlight some of these products because of the work we have completed ourselves looking at the data sheets inside the packs and the publicly available information on the sites and trying to piece it together. We do not have the full 1,700 product list—that is commercially sensitive—so I cannot put a figure on that, unfortunately. However, some of the easily preventable diseases appear on that list. Some of the medicines and vaccines that appear on the World Veterinary Association essential medicines list appear on that as well. I am sorry, I cannot quantify it any more.
The Chair: That is okay. On what basis is 1,700 products and 51% calculated? You cannot tell us what they are exactly, but how is it calculated? How do we know that it is 51%, and how do we know that it is 1,700 that we will not be able to get from Great Britain to Northern Ireland if there is no agreement by the end of 2025?
Mark Little: This is work carried out by the Veterinary Medicines Directorate. Those figures came from it. It is solid work carried out by the VMD, the executive agency of Defra.
Lord Godson: Just for the public, where is that directorate based?
Mark Little: Defra. It is an executive agency of Defra.
Lord Empey: You mentioned botulism and 25,000 cattle and so on, and that the products currently come from places like Australia. What was happening before we left the EU?
Mark Little: Those products were and are coming into Northern Ireland at the moment.
Lord Empey: Yes, but they have to have a supplemental certificate or something because Northern Ireland has been treated as part of the EU under this route when the whole country was in the EU. Why is there a difference now? What happened before? We are being treated as part of the EU in one sense, yet that product that came in previously all of a sudden becomes something else.
Mark Little: If I understand, I think it is due to full implementation of the EU legislation in Northern Ireland. I think I understand the question.
Lord Empey: I am just saying that, if these cattle had been treated by a product from outside the EU beforehand, you are saying that that was fine because we were in the EU, but we were also told earlier that we are being treated in many respects as part of the EU, so why has this product become an issue all of a sudden?
Mark Little: Why has it become an issue all of a sudden? Due to full EU legislation, products that are manufactured outside Europe such as in South Africa or Australia are not allowed to be used within Europe. Previous to that, they were allowed to be used through the Veterinary Medicines Directorate, through strict conditions and checks, and following where the product was used. On the special import certificate, for each farm we have to write the address and the number of animals and adhere to strict meat and milk withdrawal periods. They were allowed to be used in strict circumstances. However, full implementation of EU legislation does not allow that to be used, because products outside the EU are not allowed to be used in the EU.
Lord Empey: Are these products still being used in the rest of the EU?
Mark Little: In the rest of the EU, this botulism vaccine, to my knowledge, is not being used.
Lord Empey: It is not?
Mark Little: It is not being used, no. It is being used in GB. It is being used in the UK, including Northern Ireland, at present. As far as I know, it is not being used in the EU.
Baroness O’Loan: I only got part of the way through my question when I interrupted it. I think we have heard from the sheep and cattle, and we go back to hear from the horses. Is that right?
Dr Esther Skelly-Smith: Absolutely. From our perspective, we focus rightly on the ag-food side, because that is a huge contributor to Northern Ireland industry, but we have two other industries that are significant from an equine and companion animal perspective. We know that the equine industry contributes about £200 million. Although it is a smaller industry, it is quite important to Northern Ireland. We are concerned that we might lose certain pain management products. For horses, we have very few licensed painkillers—pain management products—so to lose any of those would be a huge welfare concern.
As we have already mentioned, preventive health measures are very important to the veterinary industry through vaccination. The flu and tetanus vaccinations for equine influenza and tetanus in horses are hugely important. I will explain why. Equine influenza, like human flu, can affect the weak and the vulnerable or in bigger crowds. If we lose access for example to two out of three or maybe all those flu products, that will affect the herd immunity within the industry.
It will also affect horses being able to travel to competitions. It is mandatory for horses to have equine influenza vaccination to compete at a lot of major shows or any local shows to protect the local herds. Although it will not necessarily affect every individual, it will affect the ability of the industry to continue. It will affect the horses being able to compete internationally. If they are going to perform an Olympic sport and they do not have their mandatory vaccines, they cannot compete. Those vaccines will lapse quite quickly. Those horses are required to be vaccinated every six months to protect the herd.
The other side of it is tetanus. Tetanus is an individual horse problem. It is life-threatening. If we lose tetanus vaccine access, potentially we will have avoidable equine death if they contract tetanus. Other vaccines may be of interest to the committee that we would potentially lose. In the equine breeding industry, the equine herpes virus vaccine is used to prevent abortion in broodmares. When you have a group of broodmares together, you can get an abortion storm, so that obviously has an animal welfare impact. It also has a huge economic impact. We must not forget the human side of this as well—the trauma. If you have ever seen an abortion storm, it is pretty horrific. That is difficult for the vets and the owners. We would also fail to comply with the HBLB international code of practice on equine herpes virus. We would not be managing ourselves at a high standard, so it would put us in a place of weakness.
Moving on to companion animals, an example to take from there is the potential loss of insulin. If you have a diabetic dog, you may not be able to get insulin. We know that it controls blood sugars to help a diabetic dog. If you lose that, there are issues with having to use human insulin, which could also restrict supplies on the human side. We know that in the past occasionally there have been insulin shortages. So there is also that aspect to it. I will pass over to Simon to talk about the trade.
Baroness O’Loan: Before we get to the trade—I am sorry, this goes back to Lord Empey’s question—cattle in Europe suffer from things like tetanus and are vaccinated against it. If the tetanus vaccine can be used in Europe, and Northern Ireland for this purpose is part of Europe, why can we not get it into Northern Ireland?
Dr Esther Skelly-Smith: We are looking separately at equine tetanus here. It comes back to the MAH location, the location of the address on the data sheet, and not being able to use it under EU regulations if potentially it is part of the 51% of veterinary medicines.
Baroness O’Loan: What is going on here? Clearly, horses in the rest of Europe require the tetanus vaccine, and they get it from within Europe.
Dr Esther Skelly-Smith: There are two aspects to this. Say we have three vaccine groups available. We know from the history of vaccinations that a batch can go wrong very quickly, and we have seen that we have had no access. In fact, there have been shortages of equine vaccinations that have nothing to do with Brexit but are purely to do with commercial pressure and production issues. If we lost access to the two that were available, and the one that was available had not been available, we would lose access to it.
Baroness O’Loan: Is your point that Europe is not producing sufficient vaccine to sustain the supply in the way you would need it to allow for such disruption of supply? Is that your point?
Dr Esther Skelly-Smith: Yes.
Baroness O’Loan: So you need these third-country suppliers in order to fill that gap.
Dr Esther Skelly-Smith: Yes. You also have to be aware that, as in humans, we can have a vaccine reaction. Certain horses can only have certain products, which limits my choice as a vet to be able to administer a product that is suitable to that animal.
Baroness O’Loan: You will forgive these detailed questions, but I feel a need to understand.
Dr Esther Skelly-Smith: No, they are good questions.
Dr Simon Doherty: To follow on from that, a certain element of this again comes back to the fact that veterinary medicines in Northern Ireland are regulated by the VMD. If we had all these European products becoming available for use in Northern Ireland, they would all need to be regulated by the VMD, which currently they are not being. The VMD currently is managing the portfolio of products that are currently available. If we lost 51% of those and there were other European vaccine manufacturers in Spain, Portugal or Italy that wanted to flood the Northern Ireland market for some reason, those products would need to be regulated under the current Veterinary Medicines Regulations through the VMD. There would be a time element to having those products available. It is because we are in this Catch-22 situation: the EU wants us to have EU tick-the-boxes product available in Northern Ireland, but the VMD also needs to have that oversight of products that are available in Northern Ireland.
I will pick up on a few of the aspects. You heard from the first panel about the size of the market in Northern Ireland. I suppose, for us as vets, we would also have some contention with the size of the market. There are only 1.8/1.9 human animals in Northern Ireland, which represents about 3%—
The Chair: Is that 1.9 million?
Dr Simon Doherty: It is 1.9 million. Sorry, what did I say?
The Chair: You said 1.9.
Dr Simon Doherty: It represents 1.9 million humans, which represents roughly 3% of the UK population that is in Northern Ireland, but we have 18% of the cattle, 7.5% of the sheep, probably about 15% of the pigs, 13% of the poultry, and 4% of the horses.
The Chair: Are all those figures a percentage of the whole of the United Kingdom?
Dr Simon Doherty: Yes, for the whole of the United Kingdom. Five per cent of the dogs in the United Kingdom are in Northern Ireland. You can argue that for all the animals that I have mentioned—cattle, sheep, pigs, poultry, horses and dogs—there are proportionately more per human person than there are elsewhere in the UK. There is certainly that element of the fact that we are livestock dense in Northern Ireland—when I say “livestock”, I am talking about farm animals, horses and companion animals—so the importance of those products cannot be underestimated.
The other point is that in Northern Ireland—again, I am stating something really obvious here—we are the only part of the United Kingdom joined on to a European member state. There are diseases in companion animals. So to take your dog up to Donegal for the weekend, to take cattle and horses that are moving backwards and forwards across the border for shows, sales and breeding purposes, and in the equine sector for events, we are a single epidemiological unit. Setting politics aside, disease does not stop at Newry, Armagh, Strabane or Londonderry. Therefore, these medicines and vaccines need to be available for us to maintain the health status of all the animals we have in the Province.
I will pick up on a few examples here to illustrate the point. Traditionally, we have had some excellent breeding bulls that will go to sales in Carlisle, Perth and elsewhere. If we are disrupting bovine viral diarrhoea virus vaccine, as Mark mentioned, the leptospirosis vaccine or the IBR vaccine—IBR is another herpes virus that causes infectious bovine rhinotracheitis—and if we cannot stand over the health status of those bulls, they will not be welcome in Perth or Carlisle. We are talking not just about the supply and the sale of medicines and vaccines, but about the supply of breeding animals and the effect that could have in putting other animals at risk.
There is another piece to be played out here. If we look at our agri-food products in terms of poultry, meat, dairy products, beef and lamb and so on, we certainly export a lot through the Republic of Ireland directly into Europe. We also export a huge amount from Northern Ireland into GB, but what is the end destination of that? A lot of those are then being compounded into what we now refer to post EU exit as composite products. Whether that is a chicken sandwich with mayonnaise in it or a frozen pizza, in order to go into the European market each product of animal origin needs to have a health attestation associated with it. If you are making a frozen pizza in Leicestershire and exporting it into the European market but the chicken has come from Northern Ireland, you need to have a health attestation from Northern Ireland.
You have already heard the examples in relation to things like salmonella and whether there would be a deterioration in the health status that will affect our agri-food trade. Based on the numbers I gave you when I started talking a few minutes ago, you will see that we are an exporting nation. We are very proud of that heritage and we have very high standards. As Mark mentioned earlier, we are probably the region of the UK that is absolutely ahead of the game in the control and eradication of bovine viral diarrhoea virus, and we are at risk of jeopardising some of that if we do not look very carefully at it.
I will not mention names, but we also potentially risk our third-country exports if we have a deterioration that has been caused by a breakdown, or whatever you want to call it, between the UK and the EU in relation to the supply of veterinary medicines. We have a manufacturer not that far from where I live that provides UHT milk portions and milk powder literally across the world. It provides a lot of milk powder to China. If our health attestations are potentially affected by a deterioration in our health standards in our livestock, we need to be very careful of that. There is a real market reputation risk here for our agri-tech and our agri-food products that would be associated with the loss of the products that you have heard about this afternoon.
The Chair: Thank you. That has been really helpful. We have spent quite a lot of time talking about the problems. We will now move towards the solutions. You have half an hour before you have to go to catch your plane. Martin, over to you. Lord Thomas, lead us on to the solutions.
Q19 Lord Thomas of Gresford: I am addressing you from north Wales because of the weather. You have painted a daunting and dangerous picture of what will happen unless there are solutions. Mr Little talked about solutions that he is sharing with the Cabinet Office. I am not quite sure how far that has gone and whether he is prepared to share solutions with us. What in your view would solve the problem of veterinary medicines supply to Northern Ireland? What can we do?
Mark Little: Indeed, I am very happy to share some of my brainstorming and some of my potential solutions. You heard from our colleagues in the last panel about a deal similar to human medicines. I suppose, thinking about this quite pragmatically, that the VMD, the Veterinary Medicines Directorate, assesses veterinary medicines to the same standard as the EU. In terms of batch release, which is one of our issues, it would make sense if the EU accepted GB warehousing so it does not have to go through another batch release. It also makes sense not to get caught up with an address on the inside of a label inside a packet of veterinary medicines, because an address is not the problem here.
I do understand the point about a deal similar to human medicines. It may be a bit of an ask for the EU; as with any negotiations, there is a bit of give and take. This is where I have come up with a few solutions to solve the marketing authorisation holder issue—the address issue. That could be resolved with a solution such as the introduction of a grandfather rule. As the VMD licensed veterinary medicines to the same EU standards before Brexit, the grandfather rule would allow for the continued supply of veterinary medicines that were supplied to Northern Ireland pre Brexit. It would make sense to continue supplying those veterinary medicines, so that only newly licensed products would be required to go through EU checks. There may be issues and nuances with this, and I would urge you to check with the VMD, but to me it seems like a very simple solution.
Speaking to the BMA, the British Medical Association, and finding out some of its solutions, another solution that it came up with and helped it was simply a sticker placed on the pack of the veterinary medicine saying, “Not for EU”, which would seem very sensible.
To solve the warehousing issue, there could be a solution similar to the SPS agreement where there is a bonded warehouse where veterinary medicines destined for Northern Ireland could be stored without having to go through additional unnecessary batch release.
Lord Thomas of Gresford: I see a distinction between human medicines consumed by the ultimate consumer with a view to get him or her well as opposed to the veterinary medicines to cure or ward off diseases in animals that may very well become our food product exported back to the EU. Is there any sense in the distinction that I am making?
Mark Little: I completely see where the EU is trying to protect its food product, but I would reiterate that the VMD assesses veterinary medicines to the same standard as the EU, so there is no divergence at present. I would ask the EU whether losing 51% of the veterinary medicines in its aim to protect the EU standards for food quality is the bigger risk, or whether the bigger risk is simply losing half the veterinary medicines in Northern Ireland with the resulting impact of having a disease outbreak, and that disease outbreak then threatening because of food products such as milk and meat going across to the Republic of Ireland. I think the biggest risk to the EU would be restricting veterinary medicine supply to Northern Ireland and the potential disease outbreaks associated with that.
Lord Thomas of Gresford: That is a very powerful argument. Is that what you are discussing with the Cabinet Office?
Mark Little: We have discussed it.
Lord Thomas of Gresford: Has that point been made to it, and is it making it to the European Union?
Mark Little: I am unaware of how many conversations the Cabinet Office is having with the European Union, but I would urge it to make that argument.
Lord Thomas of Gresford: Are you satisfied with progress on this issue? You are having discussions. You have had two meetings of the body that has been set up, but is this sufficient? Would you want us to put more pressure in that direction?
Mark Little: I would urge you to put more pressure because, as we heard from the pharmaceutical industry, it takes time for it to adopt these changes. Although we have lost one year out of a three-year extension to the grace period, I can see that time is needed to adopt these changes or for future dialogue. So, yes, if there is any pressure you could put on for future dialogue between the Cabinet Office and the EU, I would greatly appreciate that.
Lord Thomas of Gresford: Is any other structure of consultation needed? You have your body. You are talking to the Cabinet Office. Can anything else be done?
Mark Little: Open dialogue between the Cabinet Office and the EU is vital. I do not think that is happening as much at present. We heard from the previous group that the EU is considering the three-year extension time to adapt to the European regulations, and that is what it considers this to be about, I would urge talking rather than hoping that things are going to change.
Lord Thomas of Gresford: Do your colleagues have any observations on that?
Dr Simon Doherty: I would like to make a quick point. I mentioned earlier how the UK Government as a whole are taking a much more progressive approach to “one health” than they have been previously. Another area where there is potential to have a real impact is to have that joined-up approach, bringing in some of the human health aspects and veterinary public health aspects as part of the argument as well.
For us sitting here as three veterinarians covering farm animals, equine and, for me, livestock and aquaculture, one of the big principles that we talked about with our farm clients and I talk about at the university with my students is prevention being better than cure, and the importance of the holistic consideration of vaccine products as well as what we consider to be medicines or pharmaceuticals. That joined-up approach, as well as the joined-up approach between the use of these products in animals and the public health aspect, is really important. While we can continue our conversations—Mark and Esther are very involved in those conversations with the VMD, the Cabinet Office and the Northern Ireland Office—bringing in that human health and veterinary public health element is incredibly important as well.
Lord Thomas of Gresford: You do not have the force of Stormont behind you at the moment, unfortunately, but what about the Northern Ireland Office? Does that give you full support in what you are trying to do?
Mark Little: We are actually the instigators of the working group between the Cabinet Office, Defra, VMD and us as part of the BVA on the ground. During a meeting with it, it was the instigator of this group, so it has been very helpful.
Lord Thomas of Gresford: Excellent. Thank you.
The Chair: Thank you very much. There are some very interesting answers there and some very good ammunition for us in the evidence we shall have from Baroness Neville-Rolfe from the Cabinet Office in a couple of weeks’ time.
Q20 Lord Godson: I am sorry, but I will just follow up and deviate slightly from your injunction in this session of evidence about solutions rather than diagnoses. I want to come back to one thing from Mr Little that piqued my curiosity. It has been hinted at in some of the answers so far that we could in future in this terrain be more aligned with the EU. I just want to understand exactly what you meant by that for this purpose.
Mark Little: I am not sure when I talked about being more aligned.
Lord Godson: It was in your opening statement that you said, “We’re more aligned”; “We’re presently and could in future be even more so aligned”.
Mark Little: We continue to be aligned.
Lord Godson: In what way were we before, and in what way would we be more so going forward, as was implied? Maybe I misheard you.
Dr Simon Doherty: I think it is the fear that we are talking about. When I was BVA president in 2018-19, we were in the run-up to EU exit, and one thing we highlighted at that point was the potential for divergence. What we have actually seen in that five-year period is very little divergence, or, as Mark alluded to, we are actually almost more closely aligned than we have ever been.
Therefore, some of the fear around using the products that we have been using is almost a non-argument. As we have heard, it is about bonded warehouses and bits of paper inside cardboard boxes. That is why we want to get to a point where there is recognition both from the UK Government and from the EU that this ought not to be a big concern for animal health or human health or, indeed, the market as a whole of veterinary medicines and vaccines.
Mark Little: Absolutely. I think I get your point. Apologies.
Lord Godson: It sounds as though you were making a proactive further decision—not a leap in the dark, but a further move in that direction. That was implied in your opening statement.
Mark Little: The VMD assesses veterinary medicines, and they are to the same standard, I suppose, except for the address inside a data sheet and the batch release. My point possibly is that the standards are the same. However, it is important not to go for any divergence, and for any future products licensed in the UK we would make sure to meet European demands of the address in the correct location and taking the route taken by the product into consideration.
Dr Esther Skelly-Smith: My only comment on that is from the perspective of how we assess a product and how we assess a drug. It is just good science. That should be the same regardless of whether we are in the EU or the UK. That kind of comes back to your point.
Lord Godson: I am grateful.
Q21 The Chair: Going on again into potential solutions, what role do you think a UK-EU sanitary and phytosanitary, or SPS, agreement could play in finding a solution to the issue of veterinary medicines? What do you think the chances are of such an agreement?
Mark Little: That is an interesting question, because veterinary medicines are not an SPS product, but an SPS agreement would be welcome. It would only solve the warehousing issue. A solution similar to the SPS agreement where there is a bonded warehouse where veterinary medicines destined for Northern Ireland could be stored without having to go through these additional and unnecessary batch release issues would solve some of the problem. This has already been agreed with SPS products. The book does not have to be rewritten, because this is a solution that the EU has already agreed to. It could be extended to veterinary medicines. In fact, I would urge the EU to see this as a very sensible, practical, cost-effective solution that it has already agreed to, just for another product.
The Chair: Thank you. That is very helpful.
Q22 Lord Dodds of Duncairn: I suppose what you are saying about divergence makes it all the more incomprehensible in a way that the EU would not agree to deal with this batch issue and addresses. It has refused to engage so far, which is what we have heard from other sources even in our previous inquiries.
What is your level of understanding about discussions and negotiations happening at the UK Government-EU level? We are a year into the three-year grace period. As you say, the EU view is that grace periods give you time to adapt, so we are not talking. What are the UK Government doing at this moment to negotiate with the EU to sort this out, to your level of knowledge?
Mark Little: To my level of knowledge as a working vet on the ground, they are fulfilling the EU requirements. We have heard that the February 2023 list of products has been furnished to the EU. There was another list in September 2023. We are aware that the VMD has fulfilled its requirements to the EU and met that goal as well. There is another deadline at the end of this month, and it is working towards that deadline. It is working with the EU to meet its deadlines in following through a process that would hopefully allow the pharmaceutical industry to adapt to supply veterinary medicines to Northern Ireland.
Lord Dodds of Duncairn: Fulfilling those is a necessary compliance to ensure the grace period continues.
Mark Little: Yes.
Lord Dodds of Duncairn: I understand that. Is there anything going on to actually say, “We need to move from this grace period thing to a more sustainable, sensible position”?
Mark Little: Rather than meeting the EU needs?
Lord Dodds of Duncairn: Yes.
Mark Little: Negotiation and talks?
Lord Dodds of Duncairn: Yes.
Mark Little: As far as I am aware, no, but I cannot speak for the—
Lord Dodds of Duncairn: You have not heard that from the NI working group. There is no discussion of that happening.
Mark Little: No, not that I have heard of.
Lord Dodds of Duncairn: Again, that is something that we can push on.
Mark Little: I would urge that this needs dialogue.
Lord Dodds of Duncairn: Thank you.
Q23 Lord Empey: To some extent, my points about the engagement between the UK Government and the EU have been covered. Basically, you are not 100% sure, but you are not personally aware of much of this. This is material for the Minister when she comes to speak to us. If the issue is that you were given time to comply, and it is up to the industry to comply, but you are not actually sitting down negotiating because we would be negotiating something different from that, until that negotiation takes place there is not much happening, is there?
Mark Little: No.
Dr Esther Skelly-Smith: We have covered a lot of the ground on that question, but we would say from a vets’ perspective that the BVA met with the EU during a visit and an online meeting prior to the end of the grace period, but we have not had any contact within the veterinary association since then.
Dr Simon Doherty: I have nothing further to add to that.
The Chair: If you were now charged with negotiating a way through on this, what are the three main issues that you would think are the most important ones to focus on?
Dr Esther Skelly-Smith: I will ask my colleagues to support me on this, but from my perspective, first and foremost, we need to understand the wider context to the issues. This is not a regulatory or a political problem: this is an animal health and welfare, human health and public health problem. From my perspective, we need to remember that this sits there. This does not sit at legislation level; this sits at how we manage to keep animals well and keep legislation.
Mark Little: What is more important—an address on a data sheet inside a pack of veterinary medicine and an additional batch release that is unnecessary because it has been batch released already, or animal health and welfare in Northern Ireland, or public health in Northern Ireland? That is what I would ask you to consider.
Dr Simon Doherty: Certainly, Esther and Mark have enjoyed a lot of conversations over the last six or nine months with the Cabinet Office and even with the EU. Like the first panel, we absolutely welcome the opportunity to come and talk to you about this today. I guess a challenge back in the absence of a Northern Ireland Assembly is that the Windsor Framework has talked about an awful lot, but, as you have heard from my colleagues, only one or two points in the Windsor Framework directly relate to this issue.
Looking at the Northern Ireland protocol and the Windsor Framework together, this is a critical issue for animal health and welfare in Northern Ireland. There is some communication to be done on that with our local politicians in Northern Ireland, which we have attempted to do in the absence of an Assembly. We have had good engagement with some of our MPs, which is part of the reason why this is here today. We absolutely welcome that so that you, hopefully, can push some buttons with VMD, Defra and DAERA in Northern Ireland.
Ultimately, VMD has that regulatory role. DAERA in Northern Ireland has that delivery-type role alongside the VMD and making sure that medicines and vaccines are used correctly. There is that piece, as well as the trade implications and the veterinary capacity issues linked with that. To sum up, that “one health” approach, taking that link between human health and public health, has to be at the crux of this.
The Chair: Thank you very much indeed, all three of you. That has been really helpful. We are very much looking forward to our visit to Northern Ireland in a couple of weeks’ time where we will be able to continue discussing a number of these issues in a farm and with you and with us. Thank you very much indeed for being with us.