Question to the Home Office:

To ask His Majesty's Government, further to the Written Answer by Lord Hanson of Flint on 1 July (HL1346), how the level of pain expected to be experienced by animals is measured within the harm-benefit analysis.

Under the Animals (Scientific Procedures) Act 1986, project licences cannot authorise procedures that may cause the animal severe pain, suffering or distress that is likely to be long-lasting and cannot be alleviated. The earliest project licence application data currently available to the Home Office Regulator on the current e-licensing system dates from late 2021. No project licences have been refused on the grounds that a proposal would involve unacceptable levels of harm beyond the lawful category of severe since that date.

The number of formal refusals is not, however, a meaningful indicator of regulatory rigour. All applications go through multiple review stages before reaching the Home Office Regulator, and guidance is available to assist applicants in preparing submissions that meet all legal requirements. Applicants may also revise or withdraw an application in response to feedback. Only applications that fully meet the requirements of the legislation may be considered for licensing authorisation.

Home Office Inspectors assess the likely pain, suffering, distress and lasting harm that animals may experience using the information provided in project licence applications. They consider factors including the nature, severity, duration and frequency of adverse effects, the number and proportion of animals likely to be affected, and the measures proposed to minimise those harms.

Each planned procedure, or series of procedures, is assigned a prospective severity classification (non-recovery, mild, moderate or severe) which reflects the greatest level of pain, suffering, distress or lasting harm likely to be experienced by any animal after all appropriate refinement measures have been applied. As part of the statutory harm-benefit analysis, a Home Office Inspector considers the expected harms and the anticipated benefits of the programme of work. A licence will not be granted unless the Inspector is satisfied that the likely harms are justified by the expected benefits, and that the requirements of the 3Rs — Replacement, Reduction and Refinement — have been met.