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.

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.

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