Correspondence

Review of antibody licences: letter from Lord Sharpe

Published 10 August 2023

Lord Sharpe of Epsom OBE
Parliamentary Under Secretary of State
2 Marsham Street
London
SW1P 4DF

www.gov.uk/home-office

Professor David Main
Chair of the Animals in Science Committee
Animals in Science Committee Secretariat
40 Wellesley Road
London
CR9 2BY

21 July 2023

Dear Professor Main,

Response to review of antibody licences

Thank you for your letter of 17 October 2022 enclosing the Animals in Science Committee’s report on a strategic review of antibody licences. This follows a commission from the Home Office in April 2021 requesting a review of antibody licences granted under the Animals (Scientific Procedures) Act 1986 (ASPA). The Committee were asked to provide advice on strengthening the application of the 3Rs (replacement, reduction, refinement) in project licences for antibody production.

My predecessor wrote to you on 17 August 2022, with a forward look commission for advice to the end of 2023, which included a request for advice on the use of animals in the development and production of antibodies. I consider your report responds to this request and note that responsibility for the development and promotion of new scientific methodologies that replace the use of animals in the development and production of antibodies, rests with the Department for Science, Innovation and Technology.

The report’s recommendations are relevant to project licence applicants and establishment governance structures including Animal Welfare and Ethical Review Bodies (AWERBS), and I encourage careful review and adoption of the Committee’s recommendations.

The Home Office, as the government department responsible for the regulation of the use of animals in science, accepts the Committee’s recommendations. The Home Office, through the Animals in Science Regulation Unit (ASRU), will therefore implement changes in order to strengthen the requirement for robust justification for any proposed use of animals to produce antibodies, allowing the Regulator to carry out its duty of assuring compliance with ASPA.

These changes will be implemented through both a short and a long-term approach. The short- term approaches address the need for immediate measures to action the Committees’ recommendations. These actions focus on raising awareness of the recommendations and ensuring licence assessors take account of the report during licence assessment; these build on the steps already taken by the Regulator to respond to the report. The longer-term approach will involve a more holistic strengthening of the Regulator through its regulatory reform programme.

As part of the programme, the Regulator plans to review the processes it has in place to provide assurance of compliance with the principles of replacement, refinement, and reduction.

A more detailed response outlining actions that will be taken following the committee’s recommendations is attached to this letter.

Lord Sharpe of Epsom

Recommendations provided by the ASC:

The Committee’s report^{[footnote 1]} makes recommendations across 6 areas to strengthen the application of the 3Rs (Replacement, Reduction, Refinement) in project licences for antibody production. See the ASC report for further detail on these recommendations.

1. Replacement
2. Reduction
3. Refinement
4. Application of the 3Rs more Broadly
5. Purpose and Benefit
6. Governance

Home Office actions following these recommendations:

Short Term Actions:

In the short term, the Home Office, through the Animals in Science Regulation Unit, will act on the recommendations outlined in this report through the following measures.

Communication of the report findings with Regulator staff and integration of the report’s findings into the project licence assessment process.

Recommendation(s) Covered: 1,2,3,5,6

• This report has been reviewed by ASRU, including licence assessors, for implementation of its recommendations. Licence assessors will carefully consider the need for further evidence on the following areas during their review of future antibodies licence applications:
  • Full consideration of the 3Rs including exploration of alternative methods;
  • Justification for, and benefits of, the programme of work;
  • Effectiveness of establishment governance.
• The assessment form used by licence assessors when they review an antibodies project licence application will be updated from July 2023 to include strengthened standards for justifying the use of animal testing for antibodies. It will include specific reference to the Committee’s report to ensure the lessons identified continue to be taken into account.

An additional condition will be added to all new antibodies project license applications.

Recommendation(s) Covered: 1,2,3

• This condition will make more explicit the need for licensees with authority to produce antibodies to justify that they have considered the recommendations of the report. The Regulator will assure that animals will only be used where there is robust legitimate scientific justification; including the need to show robust searching for replacement methods and robust consideration of refinement and reduction

• The condition will also make it easier to hold licence holders to account against this condition once the licence has been granted as audits are performed against licence conditions.

• The addition of this licence condition will not lengthen the licence, and therefore avoids creating additional burdens on licence applicants.

Communication of the findings of this report externally to the regulated community, informing them of the need to consider the recommendations of the report when applying for antibodies licenses.

Recommendation(s) Covered: 1,2,3,5,6

• The ASRU operational update, which will be sent to the Regulated community in July 2023 will highlight the findings of the report, the need for licence applications to action recommendations when applying for a licence, and that ASRU staff will be referring to the report when assessing antibodies licences.

• This ASRU operational update is published on Gov.uk to facilitate openness and transparency of compliance requirements.

Longer Term Actions:

The Regulator is embarking on a programme of reform. This programme aims to ensure the Regulator can most effectively meet its purpose of protecting animals through maintaining compliance with ASPA, while providing an excellent service to the science sector and delivering best practice regulatory standards. This programme will involve:

Reviewing and refining the licence application process for efficacy.

• This will include consideration of how the licence application form can be most effectively targeted towards gaining the most meaningful information and all the necessary information, while avoiding duplication, unnecessary length, and providing an accessible and useable reference point for licence holders in the future.

Reviewing the Regulator’s overall assurance processes for the 3Rs.

• It is the responsibility of the regulated community to comply with the law regarding following the principles of the 3Rs. As part of the reform programme, the Regulator will review its processes for assurance of compliance with these legal requirements to check whether any new or strengthened processes would be beneficial. This review will consider the need for licence applicants to demonstrate:

  • Robust search methods for alterative methodologies.
  • The identification, incorporation, and future dissemination of 3R advances during licence applications;
  • Effective establishment governance, including the functionality of the AWERB;
  • Any ‘lessons learnt’ from previous work.

Reviewing and updating the guidance documents available to the public to ensure maximum clarity and useability for the regulated community on aspects including:

• Requirements for licence applications and licence conditions (including procedures involving antibody production);
• The roles and responsibilities of named persons/AWERBS;
• The audit process and how compliance will be assessed;
• Current best practice and how this can be achieved.

Recommendations Covered by the Delivery of the Reform: All

Continuing Actions:

In addition to the short-term actions and the reform programme actions, the Home Office and other Government departments undertake regular work that contributes to meeting the report’s recommendations, as outlined below.

The Home Office will continue to work with partners (DSIT and NC3Rs) to fully support the development and validation of alternatives to animal raised antibodies.

Recommendation(s) Covered: 4

The Government remains committed to open access to the products of publicly funded research, which facilitates the sharing of 3Rs advances. Responsibility for disseminating 3Rs advances primarily rests with DSIT and the NC3Rs.

Recommendation(s) Covered: 4

• The Home Office agrees that the regular and consistent publication of data and population of databases by the science sector can support the aims of the 3Rs and encourages the sector to proactively do so.

• UK Research and Innovation’s (UKRI) Open Access policy2 aims to ensure that findings from research funded by the public through the UKRI can be freely accessed, used, and built on by the research community.

• The National Centre for the 3Rs (NC3Rs) receives its core funding from two of UKRI’s research councils MRC and BBSRC and is therefore committed, through these policies, to wherever possible making the products of its research freely available to other researchers thus supporting them in their efforts to replace, reduce and refine the use of animals in research.

• ASRU produces several publications to openly communicate with the public and the regulated community, including its annual report and non-technical summaries, which provide overviews of all project licences authorised each year. Through non-technical summaries, ASRU aims to contribute to the sharing of 3Rs advances with the regulated community.

ASRU will continue to implement an audit programme that assures good governance in establishments.

Recommendation(s) Covered: 6

• This includes assessment of the AWERB role in reviewing prospective licence applications and ensuring they apply the latest learning and approaches.

1. ASC Report on the Review of Antibody Licences ↩