Question to the Home Office:

To ask the Secretary of State for the Home Department, what assessment her Department has made of the potential merits of enhancing the regulatory oversight of the harm-benefit analysis process for service licences issued by the Animals in Science Regulation Unit.

All project licence applications under the Animals (Scientific Procedures) Act 1986, including those for regulatory testing are assessed on a case-by-case basis by trained Home Office Inspectors. Licences are granted only where the likely harms to animals are justified by the expected benefits, and where the principles of replacement, reduction and refinement have been fully considered.

Inspectors consider the scientific purpose of the proposed studies, the regulatory questions they are intended to address, and whether suitable non-animal alternatives are available. These studies apply standardised methods to generate evidence required to support the safe development and use of medicines and other products, meaning the benefits of the work are clearly defined in advance.

Authorised work must remain within the scope, severity limits and conditions of the licence, and it is subject to ongoing oversight by the Home Office Regulator, including through inspection and compliance activity.

Animal Welfare and Ethical Review Bodies (AWERBs) at establishments also have an important statutory role to continually advise on the application of the 3Rs and regularly review projects to ensure the scientific objectives are met. The Animals in Science Committee has been commissioned for advice on strengthening the role of AWERBs in order to further enhance review mechanisms within the regulatory system and standards of animal protections.

The Government is also taking forward the Replacing animals in science strategy, published in November 2025. This contains commitments to accelerate the development and regulatory acceptance of non-animal alternatives, including the creation of a UK Centre for the Validation of Alternative Methods (UKCVAM).