Question to the Home Office:

To ask His Majesty's Government what plans they have (1) to review the standard duration of licences for animal research, and (2) to introduce more challenge into the system for granting such licences, given the pace of technological change in the sector.

Answered by Lord Sharpe of Epsom - Parliamentary Under-Secretary (Home Office)

The Home Office is going to conduct an internal review in relation to the duration of project licences for animal research under the Animals (Scientific Procedures) Act 1986 (ASPA), as announced in the parliamentary debate on 19 February 2024.

The use of animals in scientific procedures is only authorised by the Home Office Regulator where there is clear scientific benefit, to people, animals, or the environment. The regulatory framework has a rigorous approach to the application of the 3Rs (Replacement, Reduction and Refinement) in all applications for programmes of work involving animals. Establishments conducting research must have robust internal governance systems and processes that ensure the regulated activities carried out at the establishment are undertaken in accordance with the principles of the 3Rs. Our application of the 3Rs principles continuously evolves with scientific developments.

Question to the Home Office:

To ask His Majesty's Government what plans they have (1) to increase the fees for licences to use animals in scientific research, and (2) to seek to reduce the use of animals in such research.

Answered by Lord Sharpe of Epsom - Parliamentary Under-Secretary (Home Office)

The Government has laid a Statutory Instrument in parliament to increase the fees payable for licences under the Animals (Scientific Procedures) Act 1986 (ASPA) to come into effect on 6th April 2024.

The Government recently announced that it will double investment, from £10m to £20m per annum, in research to achieve the three Rs (replacement, reduction and refinement) and develop non-animal alternatives. The Government will also publish a plan to accelerate the development, validation and uptake of technologies and methods to reduce reliance on the use of animals in science.

The Government is committed to opportunities for reducing the use of animals in scientific research. Specifically, this Government has recently accepted the recommendations of the independent Animals in Science Committee to further restrict the use of the forced swim test and apply enhanced scrutiny to any proposal to use it in research. However, we intend to go further and have set an aim to completely eliminate its use, thus driving the development and validation of suitable alternatives (see: www.gov.uk/government/publications/advice-on-the-use-of-the-forced-swim-test-letter-from-lord-sharpe/letter-from-lord-sharpe-of-epsom-responding-to-the-asc-forced-swim-test-report-accessible).

Question to the Home Office:

To ask the Secretary of State for the Home Department, what steps his Department takes to ensure that an equivalent test is not available without the use of animals before issuing a licence for animal experimentation.

Answered by Tom Tugendhat - Minister of State (Home Office) (Security)

The use of animals in scientific procedures is only authorised by the Home Office Regulator where there is clear scientific benefit, to people, animals, or the environment, and only when all aspects of the Animals (Scientific Procedures) Act 1986 have been fulfilled.

Licence applicants are required to robustly evidence their consideration of alternative methods. The Regulator reviews all licence applications and will only issue a licence once it is satisfied there are no practicable alternative methods.

Question to the Home Office:

To ask the Secretary of State for the Home Department, if he will recall all licences for companies to carry out animal testing.

Answered by Tom Tugendhat - Minister of State (Home Office) (Security)

This Government recognises that scientific research using animals plays a vital part in our understanding of how biological systems work in health and disease. The use of animals in science supports the development of new medicines and cutting-edge medical technologies, for humans and animals, as well as supporting the safety and sustainability of our environment.

The Government is also clear that animals must be protected. The legal framework in the UK requires that animals are only ever used in science where there are no alternatives, where the number of animals used is the minimum needed to achieve the scientific benefit, and where the potential harm to animals is limited to that needed to achieve the scientific benefit.

The Government has no plans to ban all animal testing but is committed to fully implementing the 3Rs (Replacement, Reduction and Refinement), and promoting non-animal alternatives wherever possible.

Question to the Home Office:

To ask the Secretary of State for the Home Department, how many applications for project licences to conduct experiments on animals under the Animals (Scientific Procedures) Act 1986 were refused permission in the period between 1 January 2022 and 31 December 2022.

Answered by Tom Tugendhat - Minister of State (Home Office) (Security)

From 1 January 2022 to 31 December 2022, no applications for a project licence under the Animals (Scientific Procedures) Act 1986 have been refused. The number of applications refused is not an indicator for the robustness of the regulatory regime.

The Government publishes extensive guidance for the regulated sector on applying for project licences. Applications are internally reviewed by an establishment’s Animal Welfare and Ethical Review Body before being submitted to the regulator for assessment.

Applications received by the regulator are frequently returned to the applicant for reconsideration. Applicants may amend or withdraw an application in response to feedback from the regulator.

Question to the Home Office:

To ask the Secretary of State for the Home Department, what progress her Department has made on legacy licences for animal testing.

Answered by Tom Tugendhat - Minister of State (Home Office) (Security)

The Government is engaging with the relevant companies to review and determine a way forward on the remaining active licences.

Question to the Home Office:

To ask the Secretary of State for the Home Department, if she will take steps to increase the transparency of licensing applications for the performing of scientific procedures on living animals.

Answered by Tom Tugendhat - Minister of State (Home Office) (Security)

The Government publishes extensive information about the use of animals in science in Great Britain, including: guidance on the operation of ASPA (https://www.gov.uk/guidance/guidance-on-the-operation-of-the-animals-scientific-procedures-act-1986); and national annual statistics on the use of animals in scientific procedures (https://www.gov.uk/government/collections/animals-in-science-statistics).

For each project licence granted under the Animals (Scientific Procedures) Act (ASPA) 1986 a Non-Technical Summary is published, available here: www.gov.uk/government/collections/animals-in-science-regulation-unit#non-technical-summaries.

Question to the Home Office:

To ask the Secretary of State for the Home Department, how many project licences were granted under the Animals (Scientific Procedures) Act 1986 that involved the use of the Forced Swim Test in each year since 2018.

Answered by Tom Tugendhat - Minister of State (Home Office) (Security)

The number of project licences granted under the Animals (Scientific Procedures) Act 1986 that authorised the use of the Forced Swim Test in each year since 2018 are as follows:

Question to the Home Office:

To ask the Secretary of State for the Home Department, what assessment has she made of the potential merits of establishing an advisory independent committee, comprising of specialists in new approach methodologies, to review project license applications for animal testing prior to the granting of Home Office approval.

Answered by Sarah Dines

The Home Office Regulator will only grant licences to use animals in science where there are no alternatives, where the number of animals used is the minimum needed to achieve the scientific benefit, and where the potential harm to animals is limited to that needed to achieve the scientific benefit. Applicants seeking a licence are required to robustly evidence their consideration of alternative methods.

The Government is supporting and accelerating advances in biomedical science and technologies to reduce reliance on the use of animals in research. UK Research and Innovation provides core funding for the National Centre for the Replacement, Refinement, and Reduction of Animals in Research (NC3Rs), which works to drive the uptake of new methodologies, including alternatives to animals.

The Government has no plans to establish an independent committee to review project licence applications.

Question to the Home Office:

To ask the Secretary of State for the Home Department, what steps her Department is taking to ensure that (a) new approach methodologies and (b) non-animal methods are considered as part of the licence approval process for animal use in science.

Answered by Sarah Dines

The Home Office Regulator will only grant licences to use animals in science where there are no alternatives, where the number of animals used is the minimum needed to achieve the scientific benefit, and where the potential harm to animals is limited to that needed to achieve the scientific benefit. Applicants seeking a licence are required to robustly evidence their consideration of alternative methods.

The Government is supporting and accelerating advances in biomedical science and technologies to reduce reliance on the use of animals in research. UK Research and Innovation provides core funding for the National Centre for the Replacement, Refinement, and Reduction of Animals in Research (NC3Rs), which works to drive the uptake of new methodologies, including alternatives to animals.

The Government has no plans to establish an independent committee to review project licence applications.

Question to the Home Office:

To ask the Secretary of State for the Home Department, between 1 January 2018 and 31 December 2021, how many project licences have been granted to conduct experiments on animals under the Animals (Scientific Procedures) Act 1986.

Answered by Jeremy Quin

The use of animals in science supports the development of new medicines and the safety of our environment, for the benefit of humans and animals, and is only permitted when there are no alternatives.

The Home Office regulator has granted project licences under the Animals (Scientific Procedures) Act 1986 as follows.

• In 2018, a total of 540 project licences were granted.
• In 2019, a total of 481 project licences were granted.
• In 2020, a total of 471 project licences were granted.
• In 2021, a total of 493 project licences were granted.

Question to the Home Office:

To ask the Secretary of State for the Home Department, if her Department will carry out a review of the procedure for granting licences for animal experiments to help ensure that the provisions of the Animals (Scientific Procedures) Act 1986 are being enforced.

Answered by Damian Hinds - Minister of State (Education)

The Regulator for the use of animals in science fully implements the provisions of the Animals (Scientific Procedures) Act 1986 by following a published procedure for the granting of project licences.

The regulator has recently improved its processes and systems through a regulatory reform programme to assure compliance of establishments with the legislation.

Question to the Home Office:

To ask the Secretary of State for the Home Department, how many applications for project licences to conduct experiments on animals under the Animals (Scientific Procedures) Act 1986 were refused permission between January and December 2021.

Answered by Tom Pursglove - Minister of State (Minister for Legal Migration and Delivery)

I refer the Honourable Member to the answer to his previous question 13235 given on 14 June 2022.

Question to the Home Office:

To ask the Secretary of State for the Home Department, how many applications for project licences to conduct experiments on animals under the Animals (Scientific Procedures) Act 1986 were refused permission between January and December 2021.

Answered by Damian Hinds - Minister of State (Education)

No applications for a project licence to conduct experiments on animals under the Animals (Scientific Procedures) Act 1986 were refused between 01 January and 31 December 2021.

The Government publishes extensive Guidance on applying for licences. Applications are internally reviewed by an establishment’s Animal Welfare and Ethical Review Body before being submitted to the regulator for assessment. During the application process applicants have the opportunity to amend or withdraw an application in response to feedback from the regulator.

Question to the Home Office:

To ask the Secretary of State for the Home Department, what role animal welfare and ethical review bodies are expected to play in the formal evaluation of project licences under the Animals in Science Regulation Unit's Change Programme; and what steps she is taking to help ensure that those bodies are (a) suitably independent and (b) adequately resourced for that role.

Answered by Kit Malthouse

The Animal Welfare and Ethical Review Body (AWERB) is an essential part of establishment governance to ensure compliance with the Animals (Scientific Procedures) Act 1986 (ASPA). All applications for a new project licence must be evaluated by the local AWERB, as described in the Operational Guidance of ASPA published at: https://www.gov.uk/guidance/guidance-on-the-operation-of-the-animals-scientific-procedures-act-1986. Specifically, the AWERB is constituted to advise on how effectively the applicant is applying the 3Rs (Replacement, Reduction and Refinement).

Standard Condition 6 of an Establishment Licence requires the Establishment Licence Holder to constitute an AWERB with specified membership requirements. The effectiveness of an AWERB is evaluated by the Regulator as part of the audit process, the framework for which is published at: https://www.gov.uk/guidance/animal-research-technical-advice.