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Veterinary Medicines (Amendment etc.) Regulations 2024

Volume 837: debated on Thursday 18 April 2024

Considered in Grand Committee

Moved by

That the Grand Committee do consider the Veterinary Medicines (Amendment etc.) Regulations 2024.

Relevant document: 18th Report from the Secondary Legislation Scrutiny Committee

My Lords, these regulations were laid in draft before the House on 4 March. They seek to amend the legislative regime for veterinary medicines set out in the Veterinary Medicines Regulations 2013 in respect of Great Britain. The amendments will ensure that the law is fit for purpose to protect animal health, public health and the environment.

We are a nation of animal lovers. Veterinary medicines play a vital role in helping vets and those looking after our animals to maintain their health and welfare. As well as benefiting our much-loved companion animals, medicines also play an important role in supporting the farming industry to maintain the health and welfare of their livestock. This is pivotal to the UK’s food supply. Veterinary medicines are, by necessity, highly regulated goods. Their quality, safety and effectiveness are assured by controls on their manufacture, marketing, supply and use, which are set out in the Veterinary Medicines Regulations 2013.

However, these regulations require updating to reflect changes and technical advances in industry, to future-proof the regulatory regime and to reduce regulatory burden where possible. I believe that the length of this instrument, at 89 pages, gives an indication of the necessity of such an update. I hope noble Lords will forgive me if I do not go into the full details of all the changes, many of which are very technical; instead, I will summarise the rationale behind some of the most significant amendments.

To market a medicine in the UK, a pharmaceutical company needs authorisation for that medicine from the regulator. A large number of the amendments relate to changes in the requirements for companies that hold such authorisations. These regulations apply in Great Britain but will also facilitate the UK-wide marketing of products. The changes will bring Great Britain’s regulatory regime closer to the EU’s, but it is not simply the case that we are just accepting EU rules. My department actively proposed and participated in the discussions on changes to the EU law when we were a member state and it was always the expectation that these changes would apply in the UK too. Leaving the EU, however, has allowed a more flexible approach to updating our legislation.

The changes to marketing authorisation requirements have been requested and are supported by the pharmaceutical companies themselves. They will allow those companies to submit a similar dossier supporting their application for marketing authorisation to my department, to the European Medicines Agency and to EU member states in order to obtain authorisations in both the UK and the EU. This provides for a consistency in technical and data requirements and is vital in ensuring that the UK remains a competitive and attractive global market for veterinary medicines.

The amendments will also make it possible for companies to use common packaging across the UK. This will reduce unnecessary administrative and regulatory burden on industry and will help ensure that these companies continue to market medicines across the UK.

The instrument also amends the requirements related to where such companies must be based to reflect the current practice of global companies having a European base to market medicines across the European region. This provides a regulatory pathway in the regulations that will allow companies based in the EU to continue to market medicines in the UK to ensure the continued availability of medicines here.

For manufacturers, wholesalers and distributors of veterinary medicines, amendments include, for example, the introduction of a registration scheme for manufacturers, distributors and importers of active pharmaceutical ingredients. This will ensure that we have greater oversight in the use of these important, but potentially hazardous, chemicals, which in turn will maximise our ability to take appropriate action in the case of a safety concern or supply shortage.

We encourage appropriate and responsible prescription and supply of veterinary medicines with the amendments, for example, by enhancing the information that must be recorded by prescribers when prescribing medicines. A number of these changes form part of the Government’s plan to tackle antimicrobial resistance to protect human and animal health. Our changes are intended to secure the UK’s significant reductions in antibiotic use in food-producing animals. The legislation will make it very clear that antibiotics are not to be used routinely or to compensate for poor farming practices. The changes will prevent the general use of antibiotics in healthy animals, with exceptions made for where the risk of disease is very high and the consequences likely to be severe. The Third UK One Health Report showed that in 2019 about two-thirds of antibiotics in the UK were for use in humans, compared to one-third in animals. Our antibiotic usage in animals is already lower than in all other European countries with comparably large agriculture sectors. We are keen to maintain a collaborative approach with vets and farmers to ensure a continued and sustainable reduction in antibiotic use. This approach has already led to a 59% reduction in use since 2014.

Other changes include updates to the fees that the regulator charges to industry to undertake its functions. The regulator, the Veterinary Medicines Directorate, is a cost-recovery agency, and it is right and proper that the fees are amended to reflect the true cost of providing its regulatory services. These fees have not been updated in more than 10 years.

In conclusion, veterinary medicines are essential to the health and welfare of our animals and to supporting the farming sector in rearing food-producing animals. I hope noble Lords will agree that this instrument is vital to ensuring the continued supply of safe and beneficial medicines while ensuring that my department continues to have effective oversight of how these medicines are manufactured, supplied and used. This includes changes to support our efforts to reduce the development and spread of antimicrobial resistance by further reducing unnecessary use of antibiotics in animals. I hope noble Lords will support these changes. I beg to move.

My Lords, first, I say a warm welcome to these new regulations, which are in general welcomed by the veterinary pharmaceutical industry and, I should also say, by the veterinary profession in general, because they are the first major revision of veterinary medicine regulations since 2013. Given the pace of change, technological innovation, pharmacological developments, environmental awareness and, particularly, our increasing awareness of the importance of antimicrobial resistance, these regulations are very timely and welcome.

According to the National Office of Animal Health, the umbrella organisation covering 97% of the UK veterinary pharmaceutical market, the annual sales of veterinary drugs in the UK amount to about £745 million. That is a substantial market and of critical importance, of course, to the health and welfare of animals, food safety and public health. But it is important to recognise as well that, in global terms, this is a relatively small market; thus our alignment, as far as possible, with international standards and requirements is very important to ensure that a full range of products—not only drugs but, critically, vaccines as well—is able to be marketed economically in the UK for the benefit of animals.

In this respect, a general feature of these new regulations is that they rationalise and improve alignment with many aspects of international practice. They attempt to reduce the burdens and obstacles to the global pharmaceutical industry in making veterinary products more readily available on the UK market, which is a very good thing. More specifically, they improve alignment with EU regulations. I hope that this will have a positive effect on the imminent negotiations with the EU to ensure the continuing supply of veterinary medicines to Northern Ireland, for which there is no agreement yet under the Windsor Framework, and which are subject to a temporary grace period. That expires at the end of 2025, which potentially will have quite serious repercussions and lead to quite serious reductions in the availability of veterinary pharmaceutical products for both livestock and companion animals, unless a new agreement is reached.

The regulations involve a number of changes with regard to market authorisation application. Those changes should increase the alignment to facilitate the submission of one dossier to more than one territory, while simplifying labelling and packaging requirements. This should help to optimise the availability of products across the devolved nations of the UK and, indeed, across Europe. A major feature of the regulations is to update controls with regard to antimicrobial marketing, prescribing and classification to help reduce the risk of the development of antimicrobial resistance. There will be further restrictions on the prescription of antibiotic veterinary medicines, so that they are not used routinely as compensation for poor hygiene and low standards in animal husbandry and management practices. That is all an extremely positive development.

It is worth repeating, though, that antibiotics have been banned for use as growth promoters in the UK since 2006. Critically, and of specific importance, is the prohibition of antibiotic usage for any prophylactic purpose except in exceptional circumstances. There is a requirement in these regulations to justify the prescribing of antibiotics in such exceptional circumstances by recording them and making it necessary to conduct a veterinary review of management practices to ensure that there is no recurring need for antibiotic use, where possible.

With regard to antibiotic usage in medicated feed, there is a limit prescribed in the regulations on the time between antibiotics being prescribed and treatment being started, which has been set at no more than five working days. It has been pointed out to me by the aquaculture industry in Scotland, for example, that, given the distances between medicated feed manufacturers and, say, the needs of a salmon farm in the northern Shetland Isles, that five-day period is rather restrictive and may be challenging. I ask the Minister: could such practical issues be taken into account when interpreting that requirement?

I strongly welcome the requirement that:

“No person must supply or offer to supply”

veterinary medicinal products,

“by means of the internet to persons in Great Britain, unless”,

the supplier is “established”


“has an address within Great Britain”.

This will enable our authorities to have some control over the quality and nature of veterinary products offered online within the UK.

However, I note that it places no restriction on an animal keeper in the UK buying and giving to animals any product obtained online from any supplier anywhere in the world. I am not a lawyer, but does this not constitute a serious loophole that could threaten animal health and welfare?

I suggest that there are some other missed opportunities with the new regulations, which one hopes may be addressed in time and indeed remedied. First, with respect to antibiotic resistance, the regulations, unlike those in the EU, do not require mandatory recording of antibiotic usage. While there is recording of usage in the UK, it is voluntary and patchy, and data on sales is required to be collected and provided by the pharmaceutical companies. This does not provide accurate data on usage, and what we can measure, we can control better. However, the prescribing of antibiotics, which must be by a veterinary surgeon, is always recorded for the purpose of billing clients. What consideration have His Majesty’s Government given to collecting antibiotic usage data through the clinical recording systems that every practice has and uses for the purposes of charging its clients?

With regard to drug resistance more generally, we have widespread problems and problems of environmental contamination with regard to anthelmintic worming products, ectoparasiticides and systemic products for the control of fleas and ticks and so on. What consideration have the Government given to restricting further in these regulations the classifications of these valuable pharmaceuticals in a way similar to the regulations for antimicrobial medicines?

In that context, I note the Government’s concern about the environmental contamination of aquatic environments with companion animal ectoparasiticides and the formation of a cross-governmental group called pharmaceuticals in the environment. However, I look forward to future measures to reduce the pollution of aquatic environments with ectoparasiticides such as fipronil and imidacloprid.

In general, and in conclusion, these regulations are to be welcomed, and I am pleased to support them.

My Lords, I thank my noble friend for presenting the regulations before us this afternoon, which are very welcome. I have one issue to raise with him. I declare my interest as an honorary associate of the British Veterinary Association.

The British Veterinary Association’s response to the original consultation touches a little on the demands being made on veterinary practices in the context of the regulations, which the noble Lord, Lord Trees, referred to. It responded on the requirement to provide information that, essentially, the Government should be mindful of the pressures on smaller practices that have limited administrative resources and that while vets are willing and happy to provide information, the cost and administrative burdens need to be taken into account. I hope that is something that my noble friend will give me some reassurance on in the Committee this afternoon. We learn from paragraphs 12.1 of the Explanatory Memorandum that the annual net direct cost to business of the regulations is expected to be £2.5 million. Paragraph 12.3 states that as the level of impact is less than £5 million, it was agreed to carry out a de minimis assessment not a full impact assessment. What assessment has the department made of the pressure on small practices, in particular, in applying the new provisions in the regulations? Who will end up paying the ultimate price for this?

I am grateful to the Secondary Legislation Scrutiny Committee for its analysis of the regulations. It also refers to the fact that the direct cost to business will be £2.5 million per year and asks whether this will lead to higher prices for veterinary medicines. What impact do my noble friend and the department think this will have on the end user, in particular, either the small pet owner or, more specifically, the farmer, bearing in mind that farmers, particularly since 2001, have faced an increase in other on-costs? They are under great pressure, and many of them, particularly smaller and mixed farmers and those who specialise in livestock production, are going to find it very difficult to fund this.

We are speaking at a very happy time of year when we see lots of lambs and calves being born, but there are veterinary costs associated with that. I am mindful of this, having recently sat next to a local farmer who called out the vet for a stillborn calf and obviously had to pay all the veterinary costs. The mother survived, but they lost the calf. I would be grateful if my noble friend could respond on those two specific points: whether small practices have been considered when it comes to bearing the costs and whether farmers are expected to carry the additional cost of £2.5 million per year going forward.

My Lords, in rising fairly briefly, I should declare the support I receive from the British Society for Antimicrobial Chemotherapy, as set out in the register. I join the noble Lord, Lord Trees, in welcoming further restrictions on antibiotic use in that context. I do a great deal of work with BSAC on antimicrobial resistance. I remain concerned about any exception for prophylactic use. We are talking in a context where factory farming organisations have said that they need to keep using antibiotics because their operations cannot operate without them. I have a direct question for the Minister. We are coming up to the refresh of the national action plan on antimicrobial resistance after its five years in operation since 2019. Are the Government prepared and thinking about how, working with that plan, there may need to be further restrictions, particularly on the use of antibiotics in veterinary medicine in the light of the threat that antimicrobial resistance presents? This is reflected in the fact that the General Assembly is having a high-level meeting in September on antimicrobial resistance. It is a huge global issue. I acknowledge that the UK has been leading on this. None the less, it is still very clear that we are not anywhere near where we need to be to save the antibiotics that we desperately need for human health. We have to approach all this from a One Health perspective thinking of human, animal and environmental health all going together.

In the light of that, there are a couple of things that I particularly want to raise. One is anthelmintics and their impact on environmental health, particularly insect life in streams and rivers and indeed in the soil, dung beetles being the obvious example here. I do not know whether the Minister will be able to comment on any steps that the Government are planning to take to address that One Health issue.

The other issue that is fast rising up the agenda is spot on flea and tick treatments, which are a significant source of pesticide pollution in rivers. I can cite a recent study from the University of Sussex and Imperial College published in Science of The Total Environment, looking in particular at fipronil and imidacloprid—forgive my pronunciation—both of which have been banned from outdoor agriculture but are still used in spot on flea and tick treatments. This study and others found significant wastewater that had passed through sewage treatment works and was extremely harmful to wildlife; these are potent neurotoxic insecticides. One study found fipronil in 98% and the other chemical in 66% of fresh water. I am aware that the British Veterinary Association has brought out some new guidelines and is seeking at least to reduce somewhat the usage of these treatments but, given that we have about 22 million dogs and cats in the UK, are the Government really looking into this?

Finally, I also reflect the concern expressed by the noble Lord, Lord Trees. We all know now that we are in a global market for everything through the internet. Are the Government looking at and monitoring the extent to which veterinary medicines that should not come into the UK, or should not be used without proper supervision in the UK, are coming in through that potential internet back door?

I draw your Lordships’ attention to my entry in the register, as I work for a large independent vet group with both companion animal and production animal vets. The vets I work with generally welcome this timely update of the Veterinary Medicines Regulations. They acknowledge that they have been listened too during the consultation process and that changes have been made to update the regulations. Some are disappointed that the regulations have moved further away from the EU regulations. Others have commented that, although the EU regulations appear to be more restrictive, they will be interpreted in very different ways over the 27 countries, and we would have interpreted them in some ways, too.

Some have also commented that we have possibly missed an opportunity to update the regulations with regard to the impact of drugs on the environment, to echo the noble Baroness, Lady Bennett. That refers not only to the relationships between the individual vets prescribing the drugs but to the end-user of the drug and how this impacts on the environment. I reiterate the comments regarding spot on treatments and the result in watercourses. I will not try to pronounce the names of the drugs.

Concern remains regarding the amendment to paragraph 19 on the prescribing of medical products contained within feeds, which the noble Lord, Lord Trees, mentioned. The regulation states that

“the time between a prescription being issued and the course of treatment starting must be no more than five working days”.

This has been changed from the original regulation, which is appreciated, but there is still concern that manufacturers have no control over when the treatment starts, and the logistical challenges that the noble Lord, Lord Trees, mentioned of manufacturing feedstuffs, transporting them to the farms and feeding them to the animals. It is in farmers’ interests to feed this medicated feed to their animals as quickly as possible to treat the respective infection, but it seems unreasonable to create a situation where a manufacturer of feeds could be in breach of the regulations simply because a feed has not been fed to the animal within five working days. A feed manufacturer should certainly be held to account if a feed has not been distributed to the farmer within five working days. Therefore, could the Minister relook at amending the wording to say, for example, “distributed to final location” or “left the manufacturing premises within five working days”?

The second area of concern is new paragraph 7A, which relates to

“Duties in relation to prescribing of antibiotic veterinary medicinal products”

for prophylactic purpose. For some, the wording of this new paragraph does not go far enough; they would have liked a total ban of the prescribing of antibiotics. I know from discussions that other veterinary surgeons in the production animal sector accept that the wording is reasonable in this new paragraph to protect animal health and welfare, but concerns have been raised about how it will be interpreted and set out in the guidelines that will follow the implementation of this statutory instrument, with special reference to the words “exceptional circumstances” and what will be allowed. There are many interpretations of what “exceptional” means, both by individuals and by organisations. This could lead to veterinary surgeons breaking regulations when all they are trying to do is protect animal health and welfare and comply with their professional code of conduct.

Certain infectious diseases, such as strep meningitis in pigs, are very complex and can take many months to be eradicated from herds. Vets acknowledge that the prescription of antibiotics is not the only solution to eradicate infectious diseases in herds of animals. Other changes that can improve the conditions of animals, reduce the spread of infection and reduce the likelihood of infections recurring include husbandry changes, improved building ventilation and the possible building of new housing. All of these actions take time to take effect. In the meantime, vets need to address the animal health of the herd in question, possibly by prescribing antibiotics in a prophylactic way on a regular basis for a few months, as they know that the disease is present and needs to be controlled—sometimes before clinical signs are shown in individual animals or within a herd.

As has been mentioned previously, farmers and vets have moved a long way with regard to the use of antibiotics. Both parties do not want to use antibiotics unnecessarily, but there is a concern that, if a programme of regular use of antibiotics via medicated feed is required for welfare reasons, this may be interpretated as a breach of the regulations by the VMD. Although vets have been given reassurance in the current discussions with the VMD that these situations will not be seen as a breach of the regulations, there is concern that, as time moves on, personnel change and the interpretation of the policy changes. This may result in vets being accused of breaching the regulations, possibly to the detriment of animal health and welfare. Will the Minister raise these concerns with the VMD and his department to ensure that we continue to focus on the reduction of antibiotic use, while still maintaining animal welfare, and ensure that veterinary surgeons can continue to uphold their oath and comply with these regulations without the fear of breaching them?

My Lords, I thank the Minister for his introduction to this important statutory instrument. I am grateful to the Secondary Legislation Scrutiny Committee for drawing it to the attention of the Committee.

This important statutory instrument ensures the quality, safety and efficacy of veterinary medicines as regulated by the Veterinary Medicines Directorate, the VMD. The Veterinary Medicines Regulations have not been updated since 2013, when the fee base was also set, so there is quite a lot of inflation to consider in terms of fees and costs, alongside scientific innovation. The main thrust of the SI is an attempt to reduce the risk of the development and spread of antibiotic resistance, which I welcome. The noble Lord, Lord Trees, has raised this issue many times in the Chamber, as well as this afternoon.

Unlike the noble Baroness, Lady Bennett of Manor Castle, I do not have extensive knowledge of the issues we are debating. Not being a vet or having anything to do with animals, whether domestic or destined for the food chain, my only contact with the veterinary profession is taking my dog to be stitched up after an overenthusiastic race through the woods or going to renew his regular preventive medication. I was, however, privileged to visit a veterinary hospital run by Anderson Moores last October. It was an extraordinary experience. The hospital is extremely modern and does very complex surgery on a range of animals. This particular hospital lent ventilators to the overstretched local NHS hospital during the Covid outbreak.

Although I fully support this SI, I have a number of questions for clarification. Most of them relate to paragraph 7 of the Explanatory Memorandum. Paragraph 7.1 refers to making more than 200 amendments to the VMR, including fee changes. The Secondary Legislation Scrutiny Committee asked whether these changes would lead to higher prices for veterinary practices. The answer from Defra referred to the private nature of veterinary practices. I interpreted that as a “don’t know” in terms of whether Defra actually knew whether the changes would increase prices. I will return to this issue later.

Paragraph 7.2 makes it clear that vets are required

“to provide owners of food-producing animals with records as soon as reasonably practical after administering a medicine”

with a record of that medicine, when it should be taken and the lapse of time after taking the medicine before the animals can enter the food chain. This is clear and reassuring. However, I ask the Minister whether this is what currently happens or less stringent measures are currently in place. Will this change be an additional burden?

Many of the requirements under section 7 place added burdens on marketing, manufacturers, wholesalers and keepers of food-producing animals. These relate mostly to limiting the spread of antibiotic resistance. Paragraph 7.4 of the EM refers to an inspector seizing items that may breach regulations. Can the Minister give an example of where and at what point in the chain this might happen?

Paragraph 7.6 gives a lot of detail. Sub-paragraph (e) removes the need

“to renew a marketing authorisation after five years”.

That is excellent but sub-paragraph (h) requires marketing authorisation holders to submit an annual report. Is this a contradiction or have I misunderstood it?

Paragraph 7.7 deals with Schedule 2 to the VMR. Sub-paragraph (f) extends

“the authorisation and inspection requirements for equine stem cell centres to bring all stem cell centres for non-food-producing animal species under regulatory oversight”.

What happens in those stem cell centres now?

Paragraph 7.8 has a whole list of requirements and changes to reduce the risk of antimicrobial resistance. I fully support these but there is obviously going to be a cost element to this. Sub-paragraph (f) refers to a suitably qualified person being present when medicines are handed over. This appears to indicate that the veterinary profession is suffering from a lack of pharmacy specialists, similar to the experience of high street chemists.

Sub-paragraph (g) refers to

“restricting the prescription of antibiotic veterinary medicines”.

This has been referred to. Does it apply only to animals entering the food chain or to domestic pets as well? Is this restriction likely to lead to unnecessary suffering by some animals?

I fully support sub-paragraph (h), which prohibits

“the prescription of antibiotics for prophylactic purposes … except in exceptional circumstances”.

We have heard two cases of where there may not need to be exceptional circumstances.

Lastly, paragraph 7.12 refers to the VDM as a “cost-recovery agency”. Since it has been 11 years since the fees were set, there is quite a lot of inflation to consider when setting new fees and charges.

That brings me on to section 12, which has already been referred to. It indicates that, as the annual net cost to business is likely to be £2.5 million per year, no impact assessment has been produced. The limit for the production of an IA is £5 million per annum. With such a wholesale overhaul of the treatment of veterinary medicines and the new administrative burdens to be introduced, coupled with the increased cost of the medicines themselves, I would have thought that the cost could be much higher than £2.5 million. The effect on small businesses and large chains of veterinary practices is likely to be considerable. The noble Baroness, Lady McIntosh of Pickering, raised this issue. I admit that I have not read the sections of the de minimis assessment that cover small and micro businesses and the impact on medium businesses—nor do I have somebody working for me who would do this—but I seek the Minister’s assurance that the true effect on businesses involved in veterinary medicines has been carefully and accurately calculated.

I turn now to section 10 on the public consultation, which ran for eight weeks up to 31 March last year and received 188 responses from a wide representation of stakeholders. Although I feel that 74 questions was a considerable number for consultees to complete, it indicates that the consultation was thorough. However, I fear that the areas where the VDM was proposing to be influenced by the consultation or otherwise were confusing. There is this phrase at 10.3:

“The main areas where we have decided to amend or not implement the proposed changes relate to”.

It is followed by a list, including in the first bullet point the phrase,

“we have decided to not implement”.

That is not quite the way I would have put it, but I get the general drift.

Lastly, I note that the guidance will be amended on the changes to the VMR and will be available to stakeholders shortly. I am sure that, given the considerable changes being made, this will be welcomed by those having regard to the implementation of this instrument.

I apologise to the Minister for the number of questions I have asked and points I have made but it would be helpful to have answers to these questions. I believe that this is a very important instrument; I support it, as it will make a real difference to the way in which animal medicines and feeds are administered for the benefit of food-producing and other animals.

My Lords, I start by welcoming this statutory instrument. It makes more than 200 changes to the Veterinary Medicines Regulations 2013; there is a very long list of changes under quite a number of headings. I start by congratulating the Minister on his introduction, which was both clear and succinct. We all appreciated that, I think.

This week, I received an email from NOAH asking for our support in passing these new regulations because it considers them absolutely crucial. We have also heard that from noble Lords today. The reasons why it thinks they are crucial are, first, because the current regulatory framework is not fit for purpose; the noble Baroness, Lady Bakewell, mentioned that it had not been changed since 2013 so this is well overdue. Secondly, animal health businesses and the UK regulatory authority, the Veterinary Medicines Directorate—we heard about it from other Members—really need this legislation to progress in order to support confidence and investment in the sector. The third reason why it is very supportive is because, as it rightly says, the animal health industry is high-value, high-growth and a highly skilled sector that contributes significantly to the UK as a whole. However, until we get these new regulations, its full potential cannot be achieved. We will support this SI.

A number of issues were raised during our debate. The first that I would like to reference is the fight against antimicrobial resistance. This is clearly welcome; anything we can do to support that is really important. The noble Baroness, Lady Bennett, and the noble Lord, Lord Trees, talked about the issues here; indeed, the noble Lord made an important point about practicalities, which the noble Lord, Lord de Clifford, also mentioned. There is no point in having legislation and regulations if, practically speaking, they are not going to work effectively and efficiently. I am interested to hear what the Minister has to say in his response on those matters.

I was pleased to see that there was extensive consultation on this; it is clearly outlined in section 10 of the EM. When we have not had any updates for more than 10 years, it is important that there is serious consultation with the industry. As the noble Baroness, Lady Bakewell, and the noble Lord, Lord de Clifford, said, paragraph 10.3 of the EM details the areas where things have been amended and implemented.

I sometimes complain about the Government and consultation but it is important to give credit where it is due. Doing an extensive consultation then clearly laying out where changes have been made is best practice. I was very pleased to see in paragraph 10.3 that this has been done. That does not necessarily mean that everyone agrees with the decisions but it is important that consultation is done properly and that industry, when it is asked for its opinions, is listened to. That is very important.

Having said that, I am sure the Minister will have picked up that a few noble Lords who took part in the debate had a few suggestions about how things could still be improved. One that I am interested in was initially mentioned by the noble Baroness, Lady McIntosh of Pickering. It concerns small practices and making sure that these extra burdens can be managed by them—as well as making sure that the Government are aware of the burdens and the extra costs—because it is important that they are supported. Vets have had a lot of pressures on them in recent years, so this is really important. I know that, during the cost of living crisis, it has often been difficult for vets to balance fees, for example, with providing care to animals; that is clearly more difficult for small practices.

The noble Lords, Lord Trees and Lord de Clifford, and the noble Baroness, Lady Bennett, talked about drugs. The noble Baroness raised in particular the issue of flea and tick treatment and the damage it does to the environment. You do not have to use spot on; we use a different treatment for our dog, for example. Again, this is something that needs to be picked up and looked at.

We welcome and support these proposals. I finish by sending huge thanks to our local vet—Galemire in Cleator Moor—because, only last week, our elderly Labrador had a major operation. Thanks to our wonderful vet, he is doing extremely well. He is having his stitches out next week so, fingers crossed, he will soon be back to normal.

My Lords, I thank all noble Lords and noble Baronesses for their contributions to this debate. I appreciate that it is large and complicated, and that it is challenging to wade your way through it. I thank in particular the noble Lord, Lord Trees, who has been incredibly supportive of a lot of these changes—indeed, he has been driving a lot of them for quite some time. He is also involved with the veterinary medicine issues in Northern Ireland and the working group there, which met just yesterday; that is another complicated aspect of this issue, so I am hugely grateful for his involvement and all his support.

I will try to take the questions by topic rather than individually because some distinct topics ran through all of them. If I miss anybody, either noble Lords can shout at me at the end or I will write in the normal way.

Antibiotics were mentioned by everybody; everybody wants to know about them. The backdrop to this issue is that the use and prescription of antibiotics must not, and should not, be an excuse for poor animal husbandry. I think we all accept that. They are not for that purpose. However, there are certain circumstances where they might be necessary for the greater good. The provision in this instrument remains to permit that but it is about a judgment call from a professional who has been trained, who knows a lot about the subject and who is connected into local knowledge so that, if they have to apply antibiotics in this way, they then have to follow that up with a report to explain why they have done so. So a lot of thought will gone into that.

This ties in directly with the wider One Health approach, which has been raised by a number of noble Lords and noble Baronesses. In particular, the noble Baroness, Lady Bennett, talked about the need for joined-up thinking. I have watched a number of presentations on the One Health approach; I have been extremely impressed by the level of detail, the knowledge and the way that is being driven.

I am also incredibly encouraged by the drop in the use of antibiotics over the past 10 years. It is a really good news story. The detail that sits behind that in certain areas shows that, in the vast majority of areas, there is a real, long-lasting improvement. It is not perfect, I get the need to drive it forward, and, as was rightly pointed out, another review is coming up; we will look at that very carefully. However, it is important to acknowledge that it is something on which we have led. It has been really successful. It is driving change not just in the UK but elsewhere, and its long-term benefits will be very profound for all the reasons that have been articulated here this afternoon.

There were some specific questions about the five days from prescription to use. There was quite a range of views in the consultation. Some were that it is far too long and others that it is potentially challenging in certain circumstances, such as those the noble Lord, Lord Trees, illustrated, where there might be a fish farm in a remote area, but they tend to hold stores of antibiotics quite close to these areas. I will take that back to the department and look at it again. It is difficult, because one person says this and another says that. We have tried to hit the sweet spot in the middle. I do not know how it will play out in practice, but I cannot imagine for a moment that, if there was a specific issue about getting antibiotics to a remote location and it took six days, somebody will take issue with that.

Moving on from antibiotics, we talked a bit about flea and tick treatments getting into the wider countryside and our waterways. Restricting the way products are prescribed without supporting evidence may end up compromising animal health and welfare because of a change in usage patterns and the additional costs of visiting a vet. In authorising these veterinary medicines, the Veterinary Medicines Directorate takes into account parasite control users’ safety and the environmental risks. In this instance, the medicines play a vital role in treating fleas and ticks, which can lead to harmful diseases in not just family pets but farm animals, and present a risk to humans. I am particularly talking about ticks, which are a growing problem across the UK. The Government are very aware of this issue and, in seeking to try to balance the pros and cons, we are looking at it very carefully.

There were quite a lot of comments from the noble Baronesses, Lady McIntosh and Lady Bakewell, and others on the cost to farmers and smaller veterinary practices, and how that will play out. Where modernisation of farm management practices or infrastructure is needed to reduce the risk of disease and prevent the routine or prophylactic use of antibiotics there may be costs to farmers in implementing these changes or upgrading the farming infrastructure to support them. As part of the Government’s commitment to sustainable farming futures, sheep, pigs, poultry and cattle farmers in England can now apply for capital grants to improve health and welfare on their farms. In the longer term, improved biosecurity management and preventive disease control reduces clinical and subclinical disease rates and has economic benefits for the farmer, including lower treatment costs, improved growth rates and reduced mortality. In England, the animal health and welfare pathway is providing funding for an annual vet visit alongside grants for equipment, technology and infrastructure to support the modernisation of farm management practices and infrastructure.

I appreciate that that does not address the actual issue of the cost increases, but, as was alluded to by a number of noble Lords, it has been a long time since we increased these charges. That is not entirely because we have not been looking at it or paying attention to it, but everybody is very conscious that when these costs and charges are increased it has a knock-on impact on the end-user, usually.

I am also aware from the comments made of the stretched nature, which we have discussed before, of the veterinary workforce across the UK at the moment. I have been in discussion with the noble Lord, Lord Trees, and the Chief Veterinary Officer, as well as quite a few others in other organisations, about that and how we can address this particular shortfall.

The noble Baroness, Lady Bakewell, was inquiring on quite a few issues, some of which I will not attempt to answer this afternoon, otherwise I would be here for a very long time. Perhaps I could refer them to the department and get a letter out with some written answers to her.

With that, I hope that I have answered all the general questions. If anybody has anything specific that they would like to refer to me now, I would be happy to take it, otherwise I will wind up and commend this instrument to the Committee.

Motion agreed.