Question to the Home Office:

To ask the Secretary of State for the Home Department, what her policy is on approving licences for the use of live animals for the routine production of antibodies; and how many animals were used for this purpose in 2020.

The data from establishments used for the production of the Annual Statistics of Scientific Procedures on Living Animals in Great Britain does not include information on how many animals were used for the purpose for the routine production of antibodies in 2020.

The Home Office Animals in Science Regulation Unit will only authorise applications that include animals used for the production of monoclonal and/or polyclonal antibodies where there is robust, legitimate scientific justification through the harm benefit analysis (HBA) process required under the Animals (Scientific Procedures) Act 1986.

From a regulatory perspective the position for the use of animals for antibody production is subject to the same standards as for any other application to use animals in science as follows:

• The responsibility for ensuring that any use of animals only occurs if there is no non-animal alternative is the responsibility of the person who applies for a project licence to perform a programme of work involving the use of regulated procedures to protected animals.

• The establishment under whose establishment licence the programme of work occurs also has a legal responsibility to satisfy the establishment licence holder that the strategy and process for searching for and implementing non-animal alternatives is optimised.

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• The role of the regulator is twofold. Firstly, when applying for such a project licence the applicant must provide satisfactory evidence that no non-animal alternative exists and how they will during the licence continuously reassess the availability of non-animal alternatives. This evidence must be satisfactory for the licence to be granted. Secondly, the regulator undertakes a series of compliance assurance activities to ensure those licence conditions are being met and takes appropriate action if they are not.