Draft Veterinary Medicines (Amendment etc.) Regulations 2024 Debate
Full Debate: Read Full DebateGreg Knight
Main Page: Greg Knight (Conservative - East Yorkshire)Department Debates - View all Greg Knight's debates with the Department for Environment, Food and Rural Affairs
(4 months ago)
General CommitteesI beg to move,
That this Committee has considered the draft Veterinary Medicines (Amendment etc.) Regulations 2024.
It is a pleasure to serve under your chairmanship, Dame Maria. The draft regulations, which were laid before the House on 4 March, will amend the Veterinary Medicines Regulations 2013 in respect of Great Britain to ensure that our legislative regime for veterinary medicines is fit for purpose to protect animal health, the environment and public health, including the people handling the medicines or the treated animal and those consuming produce from treated animals.
It is estimated that more than half of our households have companion animals. Many of those households will rely at some point on veterinary medicines to keep their pets healthy and well. Farmers also rely on veterinary medicines, including vaccines, to prevent disease and protect the health and welfare of, for example, more than 9 million cattle and 21 million sheep. That, in turn, helps to protect our food chain.
Veterinary medicines are necessarily highly regulated goods. The 2013 regulations set out controls on their marketing and manufacture, as well as their supply, prescription and use. Those regulations, which have not had a major update since 2013, now require amendment to reflect advances and developments in the industry. The draft instrument will make the biggest change to them in a decade. We received strong support from our stakeholders across the supply chain in response to our public consultation in 2023 on the proposed changes to the 2013 regulations.
Given the length and the technical nature of the draft regulations, I will focus on the key changes in them. They will ensure that safe and effective veterinary medicines of high quality continue to be available to treat our animals. They will also encourage the appropriate and responsible use of veterinary medicines, which is especially important for medicines to which bacteria and parasites can develop resistance, making them harder to treat.
The draft regulations will modernise the regulatory requirements for veterinary medicines and ensure that they are fit for purpose by reflecting technological advancements and developments, for example by allowing electronic package leaflets or QR codes on packaging and by adopting a flexible approach to novel therapies. The latter will make it possible to deal with their novel nature, in respect of the data required for the technical dossier supporting an application to market such a medicine.
With these amendments, we can ensure that the most innovative veterinary medicines can be brought to our market without unnecessary regulatory barriers and without compromising our assurance of their quality, safety or effectiveness. We will maintain the UK as an attractive market for companies by removing the renewal requirements for marketing authorisations, increasing certain data protection periods and harmonising across the UK the requirements for post-authorisation monitoring of adverse events related to the medicines, such as side effects.
In respect of the supply of veterinary medicines, paragraph 7.8(d) of the explanatory memorandum notes the requirement for
“online retailers to register with the regulator.”
Will a registration fee be payable?
My right hon. Friend asks an interesting question. There is no fee to register, but it is important that those who are selling these medicines into the UK market take the trouble to register so that we can guarantee the safety of our pets, our farm animals and our consumers.
When we were part of the EU, officials in my Department contributed to the development of new EU laws on veterinary medicines, with the main aim being to reduce the regulatory burden. It has always been the expectation that the requirements will also apply in the UK. We are making changes to the regulations in respect of Great Britain, which will, for example, make it easier for businesses to apply for licences for medicines on a UK-wide basis, reducing the regulatory burden for pharmaceutical companies. These companies, which are often global companies, are set up largely to serve the European market as a whole. Changes will also enable common labelling and packaging to be used across the UK. Altogether, this will encourage companies to continue marketing much-needed veterinary medicines here in the United Kingdom.
We are maximising our ability to take appropriate action in the case that a safety concern arises about a product or an active substance—the ingredient that gives a medicine its therapeutic activity. We are doing so by introducing simple registration schemes for manufacturers, importers and distributors of active substances, for online retailers of veterinary medicines, and for manufacturers of exempted medicines for small pet animals. That will improve our regulatory oversight in those areas, without creating an unnecessary burden.
This draft regulations will require pharmaceutical companies and wholesale dealers to report information on supply shortages, which will help us to secure the supply chain and maximise our ability to take action when there is a shortage and maintain the availability of treatment options for our animals.
We are progressing the Government’s plan to tackle antimicrobial resistance through a further reduction in the unnecessary use of antibiotics in animals. The draft regulations make it clear that antibiotics must not be used routinely or to compensate for poor farming practice, while still allowing for preventive use of antibiotics in critical cases in which animal welfare is at risk.