Independent report

Assessment of Veterinary Medicines Regulations (2013) revisions

Published 1 March 2024

The Animal Sentience Committee (ASC) is a statutory committee established by the Animal Welfare (Sentience) Act 2022 in May 2023. The ASC has a remit to assess whether, or to what extent, the government has given all due regard to the ways in which a policy might have an adverse effect on the welfare of animals, as sentient beings.

This report summarises our findings following assessment of the associated policy and, where relevant, contains recommendations in relation to any further formulation or implementation of the policy.

Policy assessed

Revision of the Veterinary Medicines Regulations (2013).

Grounds for ASC engagement

The Veterinary Medicines Regulations (VMRs) provide the legal framework for the licensing, prescribing and utilisation of veterinary medicinal products within the UK. As a result, they affect the provision of medical care for millions of animals every year. While the revision of the regulations focuses largely on improving the long-term sustainability of medicines, animal welfare, food safety, and progression of ‘One Health’, the ASC wished to examine policy elements which may inadvertently lead to reduction of animal welfare.

Evidence provided

The Veterinary Medicines Directorate (VMD) policy team provided the initial draft Veterinary Medicines Regulations that were made available for the public consultation.

After initial assessment by the ASC and provision of written queries, the policy team provided opportunity for policy discussions via an online meeting, and also gave written responses to ASC’s specific queries and areas of concern. Because of the late stage of ASC’s requests in the policy process (the committee having only been recently formed), policy progression deadlines and available resource precluded the provision of cost-benefit analyses by the VMD for ASC’s assessments on this occasion. At the time of writing, ASC had not been provided with the contemporaneous draft Statutory Instrument (SI). However, during our correspondence, the VMD helpfully indicated where draft amendments were planned with respect to our specific queries.

ASC also contacted key stakeholders in the veterinary, farming and animal health industries to gather any welfare-related concerns related to information shared during the consultation process.

Areas of focus

There were several parts of the Statutory Instrument identified by the ASC which were considered likely to have negative (unintended) effects on animal welfare, and where justification of due regard or cost-benefit analysis was requested. These areas are summarised in the Appendix at the end of this report for reference.

As a result of public consultation, the ASC was informed by the VMD policy team that a number of these provisions have been revised or reworded, in order to mitigate risks, and are no longer of concern. The VMD policy team also indicated that inputs from stakeholders and the Animal Sentience Committee will help shape future guidance notes which also help ensure the correct interpretation of the SI and mitigate risks to welfare.

Recommendations

The ASC has some reservations regarding the cost-benefit of the new SI that states that ‘A person must not encourage or facilitate use of the cascade …’.

There are a number of industry farm assurance schemes that set out requirements for pain relief for certain procedures that go beyond the legal minima. For example, mandating use of some pain-relieving drugs in the castration of calves. While these products may be licensed for other similar indications in the same species (for example, managing pain associated with horn disbudding), and published scientific literature exists to prove their efficacy. They do not have a specific license claim for the required or mandated purpose and require cascade use, nor is there significant commercial incentive for manufacturers to do so. The proposed provision potentially leaves assurance organisations in a legally dubious position which may result in such Standards being removed from their schemes, to the detriment of animal welfare.

The ASC recommends that the VMD engage with key organisations who may be affected by this provision and help ensure wording of related Standards meets legal requirements, while still promoting best-practice pain management. This may include engagement with Defra’s Animal Health and Welfare Pathway team, which has indicated improved pain management will form part of its ‘payments by results’ initiative. 

The ASC is supportive of restrictions on the advertising prescription only medicines (POM) to certain lay audiences to ultimately prevent misuse or abuse of medicines. However, in the case of suitably qualified persons (SQP) responsible for the supply of POM-VPS (prescription only medicines that can be dispensed by a veterinary surgeon, pharmacist or SQP only), a greater awareness of relevant POM-V (prescription only medicines that can only be dispensed by a veterinary surgeon) alternatives may deliver better health and welfare outcomes. We would encourage the VMD to further clarify their guidelines on what constitutes unacceptable advertising vs. appropriate educational material for continued professional development with SQP-regulatory organisations and continuing professional development (CPD) providers.

Conclusions

The ASC was not able to review all the relevant documentation relating to policy progression (including cost-benefit analyses) due to our formation very late in a nine-year policy development process. However, after review of the draft SI, and following productive liaison with the VMD, the committee is satisfied that adequate due regard has been given to animal welfare in this process. The two areas highlighted above carry some unintended risk to animal welfare, which the committee considers have the potential to be mitigated through appropriate communication with relevant stakeholders during the implementation phase.

Governance

Committee members who were responsible for developing this report:

• Richard Cooper
• Professor Anna Meredith

Date report was agreed:

This report was produced in December 2024 and agreed in February 2024. Read more about the Animal Sentience Committee.

Appendix A: areas highlighted and addressed

Ref. refer to Consultation Draft SI.

Re. Schedule 3:61B & 7A, preventing antibiotic dispense where used to compensate for poor hygiene, inadequate animal husbandry, or poor farm management practices

The ASC is satisfied that the wording amendments communicated on 20 October 2023 addresses any significant negative impacts on animal welfare.

Re. Part 1, Schedule 7A (1), relating to increased restrictions on prophylactic prescriptions of antimicrobials

The ASC is satisfied that the wording amendments communicated on 20 October 2023 address the majority of risks to animal welfare initially highlighted. The cost-benefit provided shows due regard has been given, and the implementation plan should mitigate most remaining risks (specifically the transition to national selective dry cow therapy).

Re. Part 3, 24(g), relating to restrictions on future antimicrobials ‘reserved to human use’

The ASC is satisfied that the wording amendments communicated on 20 October 2023 address any significant negative impacts on animal welfare.

Regarding mixing and distribution of some oral antibiotic products in milk substitutes

The ASC are pleased to hear that VMD is aware of potential issues and is providing industry guidance, as per communications on 20 October 2023.

Regarding prescription validity periods and the number of permitted medications in medicated feed

The ASC is satisfied that the wording amendments communicated on 20 October 2023 address any significant negative impacts on animal welfare.

Re. Schedule 3 4(1), relating to veterinary ‘clinical examination or other proper assessment’

The ASC welcomes the rewording discussed in communications on 17 November 2023, and is satisfied that due regard has been given.

Re. definitions of blood banks and potential implications for immediate transfusion

The ASC thanks the VMD for their explanation of relevant linked legislation and is satisfied there are no significant issues relating to immediate transfusions.

Re. Regulation 11 relating to POM-V and POM-V advertisement to professional animal keepers

The ASC understands that the change in wording discussed in communications on 17th November 2023 will address the issues highlighted.

Re. regulations to prevention of cross-contamination of medicated feedstuffs

The ASC are satisfied with the response on 17 November 2023, but would encourage best practice guides to be provided to industry re. disposal of medicated feeds.

Re. automatic classification of novel immunological, hormonal, antibiotics or beta-agonists as POM-V medicines

The ASC understands that the change in wording discussed in communications on 17 November 2023 will address the main issues highlighted.

Re. removal of marketing authorisations for parallel imports

The VMD provided evidence in communications on 17 November 2023 that due regard had been given.  

Re. labelling requirements and immediate packaging

The ASC accepts the VMD’s response in communications on 17 November 2023, and accepts that due regard has been given.