what the UK’s new strategy means

Animal use in biomedical research remains one of the most contested issues in modern science. Animals have long been used in safety testing and drug development and remain a requirement in many regulatory frameworks. In recent years, questions about how reliably animal studies translate to human biology, alongside ethical concerns and public expectations, have increased scrutiny of their continued use. Advances in human-relevant technologies are now offering alternative approaches, leading regulators in several regions to review how safety and efficacy are assessed.

The UK government has published a strategy to support the replacement of animals in scientific research and testing. The document outlines measures to promote the development, validation and regulatory acceptance of non-animal methods, placing the UK among a small number of jurisdictions with formal plans to reduce animal use in science. We spoke with Dr Emma Grange, Director of Science and Regulatory Affairs at Cruelty Free International, about what this could mean for early drug discovery, regulation and research practice.

A career focused on humane science

Dr Emma Grange leads the Science and Regulatory Affairs team at Cruelty Free International, an animal protection NGO focused on replacing animal testing. She heads a team of scientists and regulatory specialists working on scientific assessment, regulatory engagement and policy development to support the adoption of non-animal approaches in research and testing. The team works with governments, regulators and industry to address technical and regulatory barriers to replacing animal use.

Cruelty Free International operates across multiple sectors where animal testing remains routine, including cosmetics, household products, chemicals and medicines. According to Grange, the organisation’s work focuses on two related areas. The first is supporting the scientific development and application of non-animal test methods. The second the phasing-out of animal tests, including through addressing regulatory and systemic barriers that can limit the adoption of non-animal methods, even where they are scientifically robust.

“A key focus of our efforts is to promote the development and application of non-animal test methods,” Grange says. “We also push for systemic and regulatory change so that, eventually, tests on animals are fully replaced by cruelty-free non-animal approaches.”

The scale of the challenge remains significant. Animal testing is still used to support the development and regulation of a wide range of everyday products, as well as in basic and applied biomedical research. Grange points to recent figures that illustrate the extent of animal use in the UK alone.

“Animals are also used in other types of experiment. Overall, there were 2.6 million uses of animals in laboratories in the UK alone in 2024, leading to an incredible amount of suffering and death,” she says.

Assessing the UK’s replacement strategy

In 2024, the UK government published its strategy ‘Replacing animals in science: a strategy to support the development, validation and uptake of alternative methods’. The document sets out a framework intended to reduce and, over time, replace the use of animals in scientific research and regulatory testing. Grange describes Cruelty Free International’s response to the strategy as cautiously optimistic.   

“We are broadly positive about the UK strategy as a starting point for phasing out animal testing,” she says.

She points to the inclusion of specific commitments, targets and timelines as a key strength, while emphasising that the publication of a strategy alone is not sufficient.

“There are a number of commitments within the strategy with clear targets and deadlines; however, it is now essential that the UK follows up with a detailed and transparent workplan on how these commitments will be met,” Grange explains.

Grange says the strategy has the potential to move research practice away from routine reliance on animal tests and towards greater use of human-relevant approaches.

“If implemented well, we believe that the strategy will drive a shift away from habit and tradition and toward more modern, human-centred science.”

At the same time, she is clear that replacing animal testing across the pharmaceutical sector will require sustained effort over many years. Some tests may be phased out relatively quickly, but others will take longer to address.

“It’s important to recognise that the change won’t happen overnight. While some types of tests could be replaced in the near term, the full replacement of all uses of animals in the pharmaceutical industry is a long-term goal which will take sustained effort,” Grange notes.

Implications for UK research and industry

The UK has historically played a leading role in the development of non-animal methods, contributing to internationally recognised alternatives for regulatory testing. Grange notes that following Brexit, there was concern that the UK might lose influence in this area. She sees the new strategy as a signal that the country intends to remain an active participant in global efforts.

“The UK has a long-standing reputation as innovators in non-animal science, having already made major contributions towards internationally-recognised modern and scientifically robust non-animal test methods for regulatory testing.”

By aligning itself with initiatives underway in other regions, including the European Union and the United States, the UK has an opportunity to strengthen collaboration and maintain scientific leadership.

“With the release of their strategy, the UK has joined other international players, including the European Union and the United States, in committing to expand this work and drive forward progress globally, to make real and lasting change,” Grange adds.

Grange expects the strategy to encourage further development and use of non-animal approaches across academia and industry, particularly in early drug discovery where human-relevant technologies are already in use.

Regulatory priorities and early wins

From a regulatory perspective, Grange identifies two parallel priorities. The first is to eliminate animal tests for which validated non-animal alternatives already exist. In such cases, the remaining barriers are often procedural or regulatory rather than scientific.

“There are some types of animal tests which could be ended relatively soon, because there are already appropriate non-animal approaches available. It’s imperative that the final hurdles are overcome and these needless tests on animals are ended.”

She points to the government’s commitment to end routine animal testing for Botox batch release by the end of 2027 as an example of targeted, time-bound action.

“By the end of 2027, only the non-animal method will be used to routinely test the strength of Botox products in the UK before they are sold for use in medical and cosmetics treatments.” 

The second priority is to invest in areas where non-animal equivalents do not yet exist. Developing alternatives for complex, systemic tests will require long-term funding, collaboration and regulatory support.

“We do know that there are routine tests on animals which do not have non-animal method equivalents – it’s also urgent to work on these too, because development of alternative approaches is going to take sustained effort.”

Barriers to change

Despite growing scientific consensus around the limitations of animal models, significant barriers remain. One is the need to demonstrate the reliability and relevance of new methods, particularly in safety-critical contexts.

“One barrier, understandably, is the need to demonstrate that any new test aimed at ensuring safety or efficacy is reliable,” Grange says.

She welcomes the establishment of UKCVAM, a national centre dedicated to validating new test methods, as one of the UK government’s commitments detailed in the Replacement Strategy. Similar institutions exist elsewhere, but until recently the UK lacked its own dedicated body following Brexit.

Slow regulatory change is another major obstacle. Many testing requirements are embedded in legislation or international guidance, making them difficult to revise even when scientific understanding advances.

“Although confidence in new approaches may grow, replacement of animal tests will only be solidified through the evolution of regulations and the associated guidance,” she explains.

Collaboration and stakeholder engagement

For Grange, effective implementation of the UK strategy will depend on close cooperation between government, regulators, researchers and civil society organisations.

“Having a strategy is an important first step, but it is crucial that the UK follows up with a detailed and transparent workplan on how these commitments will be met,” she says.

She also calls for regular progress reviews and clear public communication. While the UK’s National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs) is well positioned to contribute, Grange notes that animal protection NGOs currently lack formal stakeholder status within some UK structures.

“NGOs such as Cruelty Free International have a vital role to play and it’s crucial we are well connected to other stakeholders and institutions in the UK, as we are in other regions.”

Emerging alternatives to animal testing

Grange highlights a suite of technologies that she believes offer genuine alternatives to animal testing in drug discovery and safety assessment.

“The most promising technologies are modern, human-relevant approaches built around human biology that can better predict disease mechanisms, drug effects and safety in people,” she explains.

These include advanced human cell-based systems, organs-on-chips, organoids and computational or AI-based models built on human biology. Together, these tools provide insights that animal models often cannot, particularly in the context of personalised medicine where individual variability matters.

“They also align with the shift toward personalised medicine, recognising that people respond differently to drugs and that these differences between individuals and patient sub-populations cannot be modelled in animals.”

Rethinking scientific assumptions

A growing number of scientists now question whether animal testing represents good science. Grange argues that high failure rates in clinical trials reflect fundamental limitations in the predictive value of animal models.

“Despite extensive animal testing, more than 90 percent of new drugs that enter clinical trials fail, most often because they do not work in people or cause unexpected toxicity,” she says.

Modern human-relevant methods, she says, challenge the assumption that whole-animal models are inherently superior.

“By focusing directly on human cells, tissues and data, these approaches can be more reproducible, can produce insightful information on disease-causing mechanisms and can be more predictive of patient responses.”

For Grange, the issue is no longer technological capability but implementation. The tools exist, but they must be properly resourced, validated and integrated into routine practice.

“In short, the issue is no longer a lack of technology. We now have sophisticated, innovative tools capable of transforming drug discovery and safety testing.”

As the UK moves from strategy to implementation, attention will focus on how commitments are translated into regulatory change and research practice. In early drug discovery, this will include whether non-animal approaches move beyond development and are applied more consistently in safety assessment and decision-making.