What does the phase out plan mean?

If you cast your mind back to last year, Labour, in their manifesto for the 2024 UK General Election, stated that ‘we will partner with scientists, industry, and civil society as we work towards the phasing out of animal testing.’

Then elected as the new Government, the news came in September 2024 that Lord Vallance (Minister for Science, Innovation and Technology) would be leading on the development of a roadmap to phase-out animal testing, alongside ministers from the Home Office and DEFRA, to be published by the end of 2025.

On 11^th November, the Government published their long-awaited plan, titled ‘Replacing animals in science: A strategy to support the development, validation and uptake of alternative methods.’

Now that we have the strategy, this blog felt like the perfect opportunity to dive into what the plan contained, our thoughts, and what else we would like to see as the plan develops.

Key points of the plan

There is a lot of information contained within the strategy, spanning basic research to regulatory research, and capturing many stakeholder groups and audiences. We’re still digesting much of the strategy, but some of the top level commitments that we’re pleased to see are:

Accelerating uptake in alternative methods through reform of animals in science regulation

Much of this work sits within the Home Office, with the Animals in Science Regulation Unit (ASRU), the Animals in Science Committee (ASC), and the Animals in Science Regulation Policy Unit (ASRPU). This includes ongoing work around ASRUs regulatory reform programme to improve performance and implementation of the legislation, and commissions to the ASC on specific topics, such as improving leading practice of the 3Rs and best practice for review bodies.

The strategy outlines future commitments in this area, which also highlights the importance to cross-departmental working, including

• Commissioning the ASC to recommend corporate responsibility reporing by establishments who use animals on their use of alternatives
• DSIT working with the Home Office to review additional statistics, including genetically altered animals and guidance on efficient breeding practices, and how statistics can lead to replacement opportunities
• The full implementation of recommendations within the Rawle Report by the end of 2026, which will improve the approval processes around animal research, and ensure that animals won’t be used where there is no available alternative.

Increased training and guidance on Replacement

There are several commitments around increased training and guidance in Replacement, the 3Rs more widely, and in non-animal methods throughout the strategy, across different stakeholders and sectors. This includes:

• Specific training, guidance and resources to support funding panels in promoting Replacement and making informed decisions on alternative methods
• Providing foundational training for early career researchers in alternative methods, including 3Rs training for all PhD and early career scientists who are starting careers in using animals and alternative methods by the end of 2026

Funding commitments

In total, the Government have pledged £75 million in funding within the strategy. This includes:

• The establishment of a preclinical translational models hub, supported by £30 million, by the end of 2026
• Increased Government research funding on the specific development and adoption of robust alternative methods for discovery research
• £30 million to establish a UK centre for the validation of alternative methods (UKCVAM), to drive validation efforts that are necessary for the acceleration of regulatory acceptance and industry confidence in alternative methods.

Timelines, milestones and responsibilities

The strategy outlines a ‘basket’ system, categorising priorities for targeted replacement of animal tests.

Basket 1 is for animal tests/models where replacement technology already exists and could be applied in all but exceptional circumstances. Tests currently in this basket currently include:

• Replacing the rabbit pyrogen test by the end of 2025
• Phasing out preclinical animal testing of biologicals where no pharmacologically relevant animal models exist, with guidance to permit human first clinical trials applied by the end of 2026
• Replacing in vivo skin irritation testing by the end of 2026
• Replacing animals used for eye irritation testing by the end of 2026
• Replacing animal use in skin sensitisation testing by the end of 2026
• Replacing animals in botulinum toxin batch potency testing by the end of 2027
• Replacing adventitious agent testing in animals by the end of 2027
• Replacing animals in the development and quality control testing of veterinary medicines and vaccines as soon as feasible, in alignment with international authority acceptance

Basket 2 is for animal tests/models where viable alternative methods could be developed and adopted in the medium term, including:

• No longer granting licences for the forced swim test as a model of depression, and aiming to support validation of alternatives for the forced swim test in the screening of antidepressant efficacy and neurobiology of stress by the end of this parliament
• Replacing fish acute toxicity tests for chemicals by the end of 2028
• Reducing the use of dogs and non-human primates in pharmacokinetic studies for human medicines by at least 35% by 2030
• Reducing the use of non-human primates and dogs in cardiovascular studies by at least 50% by 2030
• Phasing in the use of non-animal derived antibodies and affinity reagents by 2030

Basket 3 is for animal tests/models that focus on ‘more complex endpoints’, where using alternative methods are longer term aims. This currently includes:

• Reducing the use of fish in assessing endocrine disruption by the end of 2035

As well as outlining specific tests within timelines, the plan also outlines which organisations and bodies are responsible for the delivery of the commitments. Alongside this, a publicly available KPI dashboard will be available online to show progress on objectives within the strategy. This will allow the relevant departments to be held fully to account as the strategy develops and work gets underway.

Strengthening the commitment of journal editors to publish research using alternatives

The Government have committed to working with journal editors and publishers to ensure they incentivise well designed and reported alternative methods, without requiring comparison with an animal model. Editors will also need to provide guidance for peer reviewers on effectively assessing article submissions that use non-animal methods.

The good news

We were very pleased when the strategy was published to see several commitments that we have been continuously calling for, many of which are in our policy approach.

Much of our policy work is around strengthening existing regulations. This is to ensure stronger oversight of animal use in research and clearer requirements for Replacement, particularly as ASPA is the only legislation or regulation around the use of animals in basic and applied research. So we were very pleased to see commitments around this, including the implementation of the Rawle Report recommendations to strengthen the review process of animal project licences, and a review of the statistics to aid in improving transparency and replacement opportunities. Other commitments that we have been calling for in this area include:

• Improvements to the statistics, which would further increase transparency and aid in knowing exactly where animals are being used and where there are opportunities for replacement. You can read more about our specific requests for the statistics in our policy approach and letters to the Home Office.
• Further consideration of GA animals use. This has specifically been mentioned in the strategy in relation to improved statistics and efficient breeding practices, which is a great step in the right direction, and an area of transparency that we have called for in our policy approach. We have also been calling for a full assessment on the use of GA animals, as one of the largest areas of animal use in Great Britain, to review ethical concerns, training needs and further replacement opportunities.

In terms of training requirements, we have been calling for increased training and resources for researchers and review panels, and have produced resources for this purpose. Our Replacement Checklist is a simple tool of questions and prompts to help researchers, reviewers and other relevant stakeholders effectively search for, apply and assess Replacement robustly. We have already provided training and advice on Replacement using our checklist and other replacement training resources at numerous establishments, symposiums and other events over the last 12 months, and believe these resources would be well-suited to the training commitments outlined in the strategy.

Although as a charity we focus on basic and applied research, we consider all areas of animal use in science in our work, including regulatory testing for medicines and safety purposes. Much of the Governments strategy is focused on the replacement of animals in regulatory testing, with the majority of tests outlined in the baskets with timelines sitting within this area. In our policy approach, we have called for a phased, test-by test removal of animal regulatory tests, prioritising those with validated alternatives, so seeing this laid out in the strategy, with timelines for each test, is fantastic.

What else would we like to see?

Whilst we are pleased with the contents of the strategy, there are several other areas we hoped to see included that aren’t at this stage. We also appreciate that this is very much the start of the Governments phase out work, so here are some other areas we would like to see included as plans develop:

• The prioritisation of Replacement for all animals: Currently, the legal definition of Replacement includes using non-protected animals under ASPA, such as invertebrates, as well as using non-animal methods. However, with growing evidence of invertebrate sentience, legislative change is required to ensure that Replacement practices no longer permit suffering to animals, and full Replacement is prioritised. This would also ensure that all animals are included in future phase-out plans.
• Improved transparency: The strategy already outlines the aim to review the statistics of animals used in science, however there are other aspects of transparency that also require review to ensure that we have a clear picture of exactly what is happening with animal research in Great Britain, and in the use of non-animal methods. This includes repealing Section 24 of ASPA, which prevents the release of confidential information, so that we have greater access to documents like full project licence applications and licensing reviews.
• Clearer focus on basic and applied research: Whilst it’s great to see that basic and applied research has been considered in the plan at all, we would like to see a clearer focus on phasing out these areas of research within the strategy. As it stands, the strategy mainly focuses on regulatory testing, particularly in the baskets of which tests will be phased out and when. As the strategy develops, we would want to see more information on the specific replacement of animals in basic research, including specific areas of focus and objectives around these.

So what’s next?

It’s important to remember that this is the very start of the Governments work to phase-out the use of animals in research and testing. This strategy is a great jumping off point, and whilst we are optimistic about the contents, a lot now depends on the next steps and how the plan is actioned.

Given the commitments outlined in the strategy to developing KPIs, the publicly available dashboard to measure by, and the deliverable organisations named on many of the commitments, we will be able to easily hold the relevant departments to account and see the work progressing. We’re feeling hopeful that this is the start of a solid commitment from the Government, and a cultural shift in the way that animal research is now being considered.

In terms of our work, we will continue to be in contact with policymakers and relevant departments, to push for change in both the areas that have been highlighted in the strategy, and in those areas that aren’t yet included that we believe are equally as important.

How do you feel about the strategy? Is there anything else you would like to see included? Let us know in the comments!