Question to the Home Office:

To ask the Secretary of State for the Home Department, whether harm–benefit analyses are undertaken for each individual toxicity study carried out under a service licence (involving multiple generic projects) issued to a contract research organisation.

All project licence applications, including service licences covering multiple generic projects, are subject to the harm–benefit analysis (HBA) process required under the Animals (Scientific Procedures) Act 1986 (ASPA).

This process is undertaken by the Home Office Animals in Science Regulation Unit (ASRU) to ensure that harms caused to the animals is fully justified by the expected benefits for humans, animals or the environment and evaluates whether a project licence application can be legally authorised.

The HBA is not undertaken for each individual study, because ASPA authorises project licences (programme of work), rather than requiring separate regulatory authorisation for each individual experiment. Individual studies carried out under a service licence must remain within the scope, severity limits and conditions of the licensed programme of work and are subject to scrutiny by the establishment’s Animal Welfare and Ethical Review Body and inspection by ASRU.