Despite continuing advances in science and technology, medical research remains reliant on frameworks that were never designed to facilitate a transition away from the use of animals in research and testing. Change has been frustratingly slow, yet this year events at government level in Great Britain have been putting more pressure on the levers that could finally help drive this transition.
Animal research for the purpose of understanding biology and disease has occurred for many centuries. Today in Great Britain the use of protected animals in research and testing is regulated by the Animals (Scientific Procedures) Act 1986 to ensure that animal suffering is minimised and the expected research benefits outweigh the harms caused. Animal tests have also been used for decades to assess the safety testing of chemicals, cosmetics and new drugs after consumer protection laws were introduced in the early 1900s. Today these safety tests are overseen by regulatory bodies that also have the authority to validate non-animal tests or “new approach methods” to replace existing animal tests. Whilst validation processes are slow, and regulators lack ambition to phase out animal tests, there are at least mechanisms to incorporate replacement tests.
If on the other hand we consider modern basic biological or applied research (research to understand or treat specific diseases), there are no regulatory guidelines stipulating what non-animal tests can or should be used.
Academic freedom enables researchers to pursue lines of scientific enquiry using the scientific methods they deem most appropriate. It is then down to the correct implementation of ASPA to ensure animal research is appropriately restricted or replaced. ASPA incorporates a legal requirement for researchers to implement principles known as the 3Rs, the first and foremost is the replacement of animal use with a “scientifically satisfactory”alternative approach. Where this is not possible the principles of reduction and refinement must be incorporated.
The UK government has commonly used the 3Rs as justification for the approval of all animal use in science. Phrases such as “the Home Office assures that, in every research proposal: animals are replaced with non-animal alternatives wherever possible” have often been used in responses to parliamentary questions and public petitions.
Government ministers have also used 3Rs funding to demonstrate government commitment to replacing animal research with phrases such as: “The government funds and supports the development of techniques that replace, reduce and refine the use of animals in research (3Rs). This is primarily delivered by the National Centre for the 3Rs.” The National Centre for 3Rs receives a large proportion of its £10m annual funding from the government.
Whilst true, neither of these have gone far enough to ensure animal research is being replaced. It is promising that events this year have led to high-level acknowledgement of this and raised important questions for the UK government to consider.
Report finds legal replacement requirement is not being met
In February 2023, an independent report produced by the National Centre for 3Rs concluded: “Replacement does not seem to be covered well by any of the review processes.” The report said that ethical review processes and Home Office inspectors, who help implement ASPA, “rarely suggest the use of replacements”. It states that the key reason is a lack of expert knowledge in replacement. Whilst this is understandable as replacement opportunities are often diverse and multidisciplinary, it demonstrates the legal obligation to implement replacement alone will not ensure animals are only used as a last resort. This also presents an interesting catch-22 scenario around utilising replacement expertise within legal frameworks based on animal use.
UK government stops all animal testing for cosmetic ingredients
In May the UK government announced it would no longer issue any animal research project licenses for tests on ingredients/chemicals used exclusively in cosmetics. This has in effect strengthened the existing cosmetic animal testing ban, by preventing animal tests required under chemicals regulation (REACH). This was a step industry experts had been calling for. The European Commission has yet to follow suit, so this could be considered a progressive move by the UK government. It is certainly positive and should be applauded. Continuing to allow regulatory animal tests where alternative approaches can be utilised is unethical and in contradiction to the legal requirement to implement replacement.
In June, Prof David Main, chair of the Animals in Science Committee, a government advisory body, wrote a letter to key ministers. The letter called on the UK government to seize the opportunity to demonstrate scientific and animal welfare leadership by developing a clear strategy in support of new approach methodologies to replace animal tests.
Main called for the Department of Science, Innovation and Technology to take steps to “advance and adopt new methods”, and for policy related to the use of animals in science to be moved from the Home Office to DSIT, alongside other science offices. Finally, he called for ongoing regulatory reform around the regulation of ASPA to ensure it is being fully applied “including a robust assessment of the justification for animal use in each case and ensuring the fullest implementation of the 3Rs”.
Now is the time for the government to seize these opportunities and bring real change to science policy – change that will benefit humans and animals alike.
Amy Beale is head of policy and programmes at medical research charity FRAME. Details of its newsletter can be found at frame.org.uk. Contact email@example.com to join its mailing list for MP briefings