Correspondence

Commission of policy advice from the Animals in Science Committee (accessible version)

Published 18 December 2024

Leading Practice for the Animals in Science Sector

21 November 2024

Policy summary

Recommendations sought for strengthening the development and sharing of leading practice throughout the regulated sector.

The effective development and dissemination of leading practice on the 3Rs (replacement, reduction, and refinement) is critical for the regulated sector to fulfil their regulatory obligations under the under the Animals (Scientific Procedures) Act 1986 (ASPA), and to support new developments in protecting animals used in science.

This scope follows the ASC Commission of this work where we provide greater detail on the request for advice.

Policy issue

Through a regulatory reform programme, the Home Office Regulator for animals in science (the Animals in Science Regulation Unit (ASRU)) has better defined the overall purpose of regulation as:

Protecting animals in science by maintaining compliance with the Animals (Scientific Procedures) Act (ASPA).

The Regulator has a responsibility to assess compliance of duty holders against minimum standards. However, it is an aim to strive for leading practice that enables the achievement of outcomes ‘beyond compliance’ and supports a drive towards new baselines of compliance. In this context, leading practice is largely focussed around maximising the delivery of the 3Rs, and specifically Reduction and Refinement.

Several areas have been identified surrounding leading practice in the protection of animals in science that could be strengthened. The Animals in Science Committee (ASC) are asked to provide advice on how to establish a more cohesive and more effective network of organisations/actors to develop, share and implement leading practice in the welfare and protection of animals used in science to reduce barriers to animal protections. The ASC are also asked to advise on system(s) that could be implemented by ASRU to encourage regulated entity buy-in and uptake of leading practice.

Areas of potential improvement with the current system around leading practice include:

• Greater clarity is needed on the roles and responsibilities of both the key actors in the system involved in the use of animals (e.g. establishments, representative organisations etc.) and of the Regulator with regards to leading practice. This would assure that leading practice is being disseminated and employed as effectively as it could be, resulting in greater protections to animals.

• The ‘leading practice’ standards currently associated with the Animals in Science Regulation Unit (ASRU) within the Home Office are those contained within section 3 of ASRU’s 2014 Code of Practice (CoP)^{[footnote 1]}; for which some of this information is becoming out of date. The Code of Practice also refers only to standards of care and accommodation and, arguably, is not dynamic enough to maintain pace with ever-evolving leading practice.

• ASRU’s Code of Practice is Government-owned; examples of governance from other sectors suggest that sector led leading practice may be more effective in driving uptake by the regulated sector. The Regulator would likely, though, have a role in recognising examples of and championing leading practice.

• Some sources suggest that Animal Welfare Ethical Review Bodies (AWERBs) may not always be utilised to their full capacity within establishments. AWERBs play a vital role in the sharing of leading practice between and within establishments, as set out in their duties under Schedule 2C(6) of The Animals (Scientific Procedures) Act 1986 (ASPA).

• ASRU audits only recognise compliance and non-compliance, but do not have a means of recognising establishments that go above and beyond. This may mean missed opportunities to incentivise establishments for adopting leading practice.

• An overall framework is required that develops a cadence for leading practice to be incorporated into the regulation, once it is embedded and socialised. In this way, there is a continuous raising of the standards of regulation to a new baseline as leading practice becomes the new minimum.

Context

What is the legal requirement under ASPA?

ASPA describes the role of the AWERB and of the ASC in leading practice (Schedule 2C and Section 20 and respectively). However, ASPA does not explicitly describe the role of the Regulator, the licence holders, or other actors in the system in relation to leading practice.

Establishments conducting research must ensure the regulated activities they carry out are undertaken in accordance with the principles of the 3Rs of animal research (replacement, reduction and refinement). All licences issued under ASPA are subject to Standard Conditions^{[footnote 2]} which require the application of these 3Rs to the use of animals in scientific procedures.

What is the leading practice?

‘Leading practice’ in this commission refers to all practices surrounding the use of animals in science which, in the context of the delivery of the scientific outcome, are considered to be at the forefront for the protection and welfare of the animal based on scientific evidence and understanding at the present time, aligned with 3Rs principles. Leading practice continuously evolves, and so it is essential for those seeking to adopt leading practice to maintain knowledge of ongoing research and current techniques.

This document refers to ‘Leading practice’ as opposed to ‘Best practice’. The term ‘Best Practice’ is often used to endorse a single agreed best technique whereas ‘Leading Practice’ is more commonly used to refer to a range of desired behaviours and practices which may evolve over time. In the field of animals in science, there is often no single technique/practice that is best for all animals and/or circumstances. Moreover, the term leading practice is contextualised within the scientific outcomes i.e. whilst aligning as far as is practicable with the principles of the 3Rs, the delivery of leading practice should not fetter the work that is required to be completed.

Evidence

Rawle Report

The Rawle report^{[footnote 3]}, an independent report assessing the 3Rs landscape and making recommendations to support implementation across the academic community, was published by the National Centre for the 3R’s (NC3Rs) in February 2023. The report identifies current areas for improvement within existing 3Rs processes and explores lessons to be learned from examples of particularly effective practice.

One of the recommendations of the report is to strengthen the role of the AWERB specifically related to leading practice: “AWERBs should be clear on the expectations for their role in promoting the 3Rs on a facility-wide basis outside the process of PPL review, including the importance of spending enough time and attention on this part of their role and what constitutes good practice”. This suggests that all AWERBs could benefit from clarity on their roles and responsibilities surrounding leading practice.

Survey of The Regulated Sector

A survey conducted of the regulated sector found that the majority of respondents supported greater regulatory incentives. Some form of recognition or award was the clear, preferred incentive, with many noting this would showcase regulatory excellence to stakeholders, whilst also serving to drive leading practice This survey was run over August and September 2023, and had 232 responses – one response was requested per licenced establishment from the Home Office liaison contact in that organisation.

Stakeholder feedback

Feedback has been received from stakeholders that the AWERB hub model currently in use is not being utilised to its full potential by all groups, and that most information on leading practice advances is shared via personal contacts within the industry.

There is also significant variation between establishments in how their AWERB is utilised, and so clarity on the roles and responsibilities of an AWERB surrounding leading practice is required.

Advice sought from the Animals in Science Committee

The government wishes to receive advice from the Committee on the following:

• To conduct a review of how leading practice is currently developed, shared, and used across the animals in science system, identifying the role of key actors, any current gaps/opportunities for improvement and recommended areas of focus.

• To provide recommendations on how the sector can collaborate to create a landscape and culture in which leading practice is effectively developed, shared, and adopted at pace.

• To provide recommendations for the role of the Regulator in leading practice, and how it might recognise establishments demonstrating leading practice and incentivise uptake of leading practice through the audit framework.

The Committee may wish to make other recommendations as it sees appropriate. However, the Home Office is not asking the committee to define what the leading practice standards for animals in science currently are.

The Committee is asked to provide written advice on the questions set out above by 30 September 2025.

Process

How will the Committee provide advice?

The Committee will provide written advice to the UK government in line with its statutory remit, as set out in ASPA Section 20:

1. The Committee must provide advice to the Secretary of State and the Animal Welfare and Ethical Review Bodies on such matters relating to the acquisition, breeding, accommodation, care and use of protected animals as the Committee may determine or as may be referred to the Committee by the Secretary of State.

2. In its consideration of any matter the Committee shall have regard both to the legitimate requirements of science and industry and to the protection of animals against avoidable suffering and unnecessary use in scientific procedures.

3. The Committee must take such steps as it considers appropriate to ensure the sharing of best practice in relation to the acquisition, breeding, accommodation, care and use of protected animals.

In developing advice, the Committee will wish to gather relevant evidence by engaging with relevant stakeholders concerned with science and industry, animal protection, and regulated establishments.

1. Code of practice for the housing and care of animals bred, supplied or used for scientific purposes - GOV.UK (www.gov.uk) ↩

2. www.gov.uk/government/publications/personal-licence-standard-conditions, www.gov.uk/government/publications/project-establishment-licence/project-establishment-licence, www.gov.uk/government/publications/establishment-licence-standard-conditions ↩

3. The role of review and regulatory approvals processes for animal research in supporting implementation of the 3Rs (2023), NC3Rs ↩