Asked by: Patrick Grady (Scottish National Party - Glasgow North)
Question to the Department for Environment, Food and Rural Affairs:
To ask the Secretary of State for Environment, Food and Rural Affairs, what steps his Department is taking to end the use of LD50 testing on animals.
Answered by Mark Spencer - Minister of State (Department for Environment, Food and Rural Affairs)
The UK supports work to develop New Approach Methodologies which can provide information on chemical hazards and risk assessment without the use of animals.
The Veterinary Medicines Directorate (VMD) is the UK regulatory authority for veterinary medicines. The VMD assesses applications submitted by the veterinary pharmaceutical industry in line with national and international regulations and guidance to ensure safe and effective veterinary medicines of good quality are marketed. These requirements may therefore necessitate animal testing either to develop and register new veterinary medicines or for routine product quality control, to ensure the continued quality, safety and efficacy batch to batch. Non-animal tests are not always available. The VMD is committed to phasing out the use of animals for testing purposes where possible, in accordance with the principles of 3Rs (Replacement, Reduction, Refinement). Furthermore, the UK is a signatory to the European Pharmacopoeia (which sets minimum quality standards of medicines) and the European Convention for the Protection of Vertebrate Animals used for Experimental and Other Scientific Purposes. This commitment to the 3Rs is also enshrined in the UK’s Animals (Scientific Procedures) Act 1986 under which scientific procedures in animals are regulated.
For veterinary medicines significant progress in non-animal testing has been made in recent years, including the possibility of replacing animals by in vitro suitable cell cultures in LD50-type testing methods, and the relevant regulatory quality standards and testing requirements have been revised accordingly for these specific medicines. Many Marketing Authorisation Holders for these specific medicines have already, and more recently, introduced these changes to their authorised medicines, which will reduce the number of animals used. Implementation of new tests for existing products can be a complicated process, requiring extensive validation and it is not always possible to replace all of the existing animal tests with in vitro non-animal replacements for each existing authorised product. The relevant UK Competent Authority for regulation of these medicines will continue to monitor the use of animals in these tests and to recommend use of non-animal tests where possible.
The Minister of State for Science, Research and Innovation (the hon. Member for Arundel and South Downs, Andrew Griffith) recently announced that the Government will publish a plan to accelerate the development, validation and uptake of technologies and methods to reduce reliance on the use of animals in science, which will be published in the summer. He also requested that we double our investment in research to achieve these approaches next year to £20 million across the system in 2024/25.
LD50 testing is not required for preclinical development of novel medicines. Quality control testing of some authorised medicines relies on LD50 testing to ensure each batch meets expected quality standards. UK regulators follow the principles of the 3Rs. Significant progress has been made on validating alternative methods which do not use animals, including the possibility of replacing mice by in vitro suitable cell cultures in LD50-type testing methods, and the relevant regulatory quality standards and testing requirements have been revised accordingly for these specific medicines.
Asked by: Baroness Hayman of Ullock (Labour - Life peer)
Question to the Home Office:
To ask His Majesty's Government, following the publication of the Animals in Science Regulation Unit's Annual Report 2022 on 25 April, what assessment they have made of the adequacy of sanctions such as inspector advice and compliance letters in response to animal welfare failings, including animals dying because of a lack of food or water.
Answered by Lord Sharpe of Epsom - Parliamentary Under-Secretary (Home Office)
The Home Office takes non-compliance with the Animals (Scientific Procedures) Act 1986 very seriously. The Animals in Science Regulation Unit responds to and applies sanctions in cases of non-compliance in accordance with its compliance policy, which aims to reduce the risk of future non-compliance. More rigorous sanctions are used in cases where animal welfare is impacted or there are significant systems failures.
The Animals in Science Regulation Unit will continue to assess the proportionality of its responses to cases of non-compliance.
Asked by: Henry Smith (Conservative - Crawley)
Question to the Home Office:
To ask the Secretary of State for the Home Department, how many licences were active that authorise use of the forced swim test as of 3 May 2024; and how many licences were amended to no longer authorise use of this test since the letter from the Parliamentary Under Secretary of State to the Animals in Science Committee on 1 March 2024.
Answered by Tom Tugendhat - Minister of State (Home Office) (Security)
The Home Office committed to review all licences authorising the use of the forced swim test (FST) under the Animals (Scientific Procedures) Act 1986 by the end of March 2024 and has subsequently liaised with licence holders where necessary to implement the recommendations of the Animals in Science Committee.
Since 1 March 2024, three project licences have been amended to remove authorisation of the FST, one project licence that authorised the FST has expired, and two project licences that authorised the FST have been revoked.
As of today, three project licences authorise the use of the FST. The Home Office is engaging with the relevant licence holders to ensure the recommendations of the Animals in Science Committee are implemented in full for those licences.
Asked by: Christian Wakeford (Labour - Bury South)
Question to the Home Office:
To ask the Secretary of State for the Home Department, with reference to the Animals in Science Regulation Unit annual report 2022, published on 25 April 2024, if he will make it his policy to initiate an investigation into the reasons for the rise in non-compliance cases since 2021.
Answered by Tom Tugendhat - Minister of State (Home Office) (Security)
The Home Office takes non-compliance with the Animals (Scientific Procedures) Act 1986 very seriously. The reasons for the increase in the number of non-compliance cases in 2022 include the introduction of a risk-based audit programme and the drive to improve governance within establishments, including self-reporting.
The Animals in Science Regulation Unit will further evaluate trends in non-compliance as its regulatory reform programme develops. Every case is investigated, and remedies and sanctions applied, using more rigorous sanctions in cases where animal welfare is impacted or there are significant systems failures.
Asked by: Tracey Crouch (Conservative - Chatham and Aylesford)
Question to the Department for Environment, Food and Rural Affairs:
To ask the Secretary of State for Environment, Food and Rural Affairs, if he will make it his policy to replace the lethal dose 50 test with non-animal testing methods.
Answered by Mark Spencer - Minister of State (Department for Environment, Food and Rural Affairs)
I refer the hon. Member to the answer given to the hon. Member for West Derby on 24 April 2024, PQ 22419.
Asked by: Dean Russell (Conservative - Watford)
Question to the Department for Environment, Food and Rural Affairs:
To ask the Secretary of State for Environment, Food and Rural Affairs, whether his Department is taking steps to help encourage companies to transition away from testing products on animals.
Answered by Mark Spencer - Minister of State (Department for Environment, Food and Rural Affairs)
Animal testing of chemical substances is permitted under UK REACH only as a measure of last resort; this principle is reinforced by the Environment Act 2021. Moreover, UK REACH states that test methods should be regularly reviewed with a view to reducing animal testing and it encourages the use of alternative methods. Testing and assessment of final products is not a part of UK REACH.
The Veterinary Medicines Directorate (VMD) is the UK regulatory authority for veterinary medicinal products. The VMD assesses applications submitted by the veterinary pharmaceutical industry in line with national and international regulations and guidance to ensure safe and effective veterinary medicines of good quality are marketed. These requirements may therefore necessitate animal testing either to develop and register new veterinary medicines or for routine product quality control, to ensure the continued quality, safety and efficacy batch to batch. Non-animal tests are not always available and the VMD is committed to phasing out the use of animals for testing purposes where possible, in accordance with the principles of 3Rs (Replacement, Reduction, Refinement). Furthermore, the UK is a signatory to the European Pharmacopoeia (which sets minimum quality standards of medicines) and the European Convention for the Protection of Vertebrate Animals used for Experimental and Other Scientific Purposes and this commitment to the 3Rs is also enshrined in the UK’s Animals (Scientific Procedures) Act 1986 under which scientific procedures in animals are regulated.
The Minister of State for Science, Research and Innovation (the hon. Member for Arundel and South Downs, Andrew Griffith) recently announced that the Government will publish a plan to accelerate the development, validation and uptake of technologies and methods to reduce reliance on the use of animals in science, which will be published in the summer. He also requested that we double our investment in research to achieve these approaches next year to £20 million across the system in 2024/25.
Asked by: Ian Byrne (Labour - Liverpool, West Derby)
Question to the Department for Environment, Food and Rural Affairs:
To ask the Secretary of State for Environment, Food and Rural Affairs, if he will take steps to end the lethal dose 50% process for testing of substances on groups of animals; and if he will have discussions with the Secretary of State for the Home Department about increasing funding for non-animal methodologies in substance testing.
Answered by Mark Spencer - Minister of State (Department for Environment, Food and Rural Affairs)
The UK supports work to develop New Approach Methodologies which can provide information on chemical hazards and risk assessment without the use of animals.
The Veterinary Medicines Directorate (VMD) is the UK regulatory authority for veterinary medicines. The VMD assesses applications submitted by the veterinary pharmaceutical industry in line with national and international regulations and guidance to ensure safe and effective veterinary medicines of good quality are marketed. These requirements may therefore necessitate animal testing either to develop and register new veterinary medicines or for routine product quality control, to ensure the continued quality, safety and efficacy batch to batch. Non-animal tests are not always available. The VMD is committed to phasing out the use of animals for testing purposes where possible, in accordance with the principles of 3Rs (Replacement, Reduction, Refinement). Furthermore, the UK is a signatory to the European Pharmacopoeia (which sets minimum quality standards of medicines) and the European Convention for the Protection of Vertebrate Animals used for Experimental and Other Scientific Purposes. This commitment to the 3Rs is also enshrined in the UK’s Animals (Scientific Procedures) Act 1986 under which scientific procedures in animals are regulated.
The Minister of State for Science, Research and Innovation (the hon. Member for Arundel and South Downs, Andrew Griffith) recently announced that the Government will publish a plan to accelerate the development, validation and uptake of technologies and methods to reduce reliance on the use of animals in science, which will be published in the summer. He also requested that we double our investment in research to achieve these approaches next year to £20 million across the system in 2024/25.
LD50 testing is not required for preclinical development of novel medicines. Some authorised medicines in the UK include (LD50) quality control tests which require the use of animals, conducted to ensure the quality, safety and efficacy of specific medicines. UK regulators follow the principles of the 3Rs. Significant progress has been made on validating alternative methods which do not use animals, including the possibility of replacing mice by in vitro suitable cell cultures in LD50-type testing methods, and the relevant regulatory quality standards and testing requirements have been revised accordingly for these specific medicines.
Asked by: Baroness Redfern (Conservative - Life peer)
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.
Asked by: Baroness Redfern (Conservative - Life peer)
Question to the Department for Science, Innovation & Technology:
To ask His Majesty's Government what plans they have to accelerate the development, validation and uptake of new technologies and methods to reduce reliance on the use of animals in science; and what is their timetable for the publication of any such plans.
Answered by Viscount Camrose - Parliamentary Under Secretary of State (Department for Science, Innovation and Technology)
On Monday 19th February, Andrew Griffith MP, Minister of State for Science, Research and Innovation announced that the government will be publishing a plan to accelerate the development, validation, and uptake of technologies and methods to reduce reliance on the use of animals in science. This will be led by a cross-government group that will consult stakeholders in industry, academia, and charities to develop a detailed plan, which will be published in the summer.
Asked by: Baroness Redfern (Conservative - Life peer)
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).