Veterinary Medicines (Amendment etc.) Regulations 2024

Baroness Hayman of Ullock Excerpts

Thursday 18th April 2024 Grand Committee

[Baroness Bakewell of Hardington Mandeville (LD)]

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.

[Baroness Hayman of Ullock (Lab)]

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.