Veterinary Medicines (Amendment etc.) Regulations 2024

Lord Trees Excerpts

Thursday 18th April 2024 Grand Committee

[The Parliamentary Under-Secretary of State, Department for Environment, Food and Rural Affairs (Lord Douglas-Miller) (Con)]

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.

[Lord Trees (CB)]

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?