This New Year, government should resolve to do more to enable the use and development of animal-free research and testing
Whether it was first espoused by Einstein or Franklin or Rita Mae Brown, the definition of insanity has always been to do the same thing over and over and expect different results.
We have been relying on animal experiments for drug development for many decades and, as a 2022 report by the All-Party Parliamentary Group on Human Relevant Science[1] said, “Lack of efficacy and safety are major contributory reasons why 92% of candidate drugs fail when tested in clinical trials despite having undergone extensive investigations in animals prior to human trials”. Despite decades of animal research, many debilitating and life-threatening diseases still lack effective treatments. It’s time to stop doing the same thing over and over, advance the regulatory acceptance of human relevant non-animal testing and prioritise investment in the development of more and better New Approach Methodologies (NAMs).
Doing so would not only be good for animals and human health, but also for the UK economy nationally and regionally, including its life sciences sector. Already, the UK’s non-animal testing sector is expected to contribute £2.5 billion to our GDP by 2026 – an increase of 700% since 2017[2], and there is scope for so much more.
This is despite acutely limited funding for NAMs which, in the UK in 2019, amounted to just £2 million per year. The All-Party Parliamentary Group for Human Relevant Science report illustrated that this is less than 0.2% of the total budget for the Medical Research Council, Biotechnology and Biological Sciences Research Council, and Innovate UK combined; and approximately 0.02% of the UK’s total R&D expenditure of £10.45bn.
The major structural and physiological differences between humans and animals mean that data from animal tests cannot be a reliable basis for predicting the likelihood of specific effects in humans. And that 92% failure rate of medicines in human trials even though they passed preclinical tests including animal tests includes 55% which simply do not work as intended, and 28% which are found to be toxic in humans. For drugs aimed at treating complex and poorly understood conditions, failure rate is even higher: for drugs designed to treat Alzheimer’s disease, it is estimated to be higher than 99%.
One important cause of failed drug development and drug withdrawal is Drug-Induced Liver Injury (DILI). DILI is the leading cause of liver failure in the UK, with major complications ranging from liver transplants to death. An extensive study comparing the performance of a Liver-Chip model with animal tests in predicting DILI found that the chip could improve patient safety and reduce small molecule clinical trial failures due to liver injury by up to 87%.
Despite the potential of NAMS, across Europe and the UK, investment in non-animal methods such as laboratory-grown tissues and mini-organs, organs-on-chips, and advanced computer simulations, remains a vanishingly tiny percentage of scientific research and development budgets [3].
In November 2022, £4.7 million was invested in 24 projects developing new non-animal technologies and building confidence in existing alternatives, by the National Centre for the Replacement, Refinement and Reduction of Animals in Research, the Biotechnology and Biological Sciences Research Council, and UK Research and Innovation[4]. Welcome though this is, this remains small beer in the world of scientific innovation and is far less than we continue to spend on animal tests that we increasingly know are unreliable and untransferable.
Six animals are still used in research and testing every minute of every day in the UK. Yet, as Dr Carol Treasure, Founder and CEO of Cheshire-based animal-free testing laboratory, XCellR8, says in our video: “There is definitely a momentum building, and a level of interest increasing in this field of science. The UK needs to become a global superpower in terms of our science and taking an international lead on animal-free science is such a critical part of our economic strategy. Laboratories like XCellR8 are supporting levelling-up across the country, so I think that this level of science is one that really merits a lot of investment and attention from government.”
The APPG report makes recommendations to help reach these targets. Alongside a diversion of existing funds from animal testing programmes to NAMs, it also suggested the prioritisation of NAMs in the allocation of research budgets, the use of tax relief for animal-free research projects, a legal shift away from animal use, and requirement that funding bids for projects which use animals demonstrate that animal-free alternatives are not available.
To track and report the funding of NAMs, the APPG report proposed the creation of a robust definition of ‘New Approach Methodologies’, including its incorporation into the Medical Subject Headings (MeSH) life sciences language, which would allow them to be included in the UKRI database of funding decisions.
Some of these proposals were recently echoed by Matthew Burnett, Head of Science and Technology at influential centre-right think tank Onward, who said: "We are still lagging behind the leading tech economies, and business R&D is what will allow us to catch up. The Government should reform R&D tax incentives to make sure they are up to date, incentivising cutting-edge research methods, supporting the most effective spending... Businesses need confidence that the UK is a great place to invest in science and technology – reforming R&D tax incentives… will only boost that confidence.” [5]
Those incentives should include businesses, especially SMEs in the regions, focusing on the development of NAMs. As well as tax incentives, to support start-ups and growing firms in the NAMs field, cash credits could be made available, through Research and Development Allowances (RDAs), to make long-term investment possible even for currently loss-making companies. The definition of ‘Research and Development’ itself should be updated to reflect advancements in animal-free science.
Investment in failing animal experiments must be urgently redirected into humane and human-relevant medicine. Greater investment and more focus on what NAMs can achieve would help us all – as well as boost the UK economy - and the British public wants their government to accelerate the availability of these alternative methods[6] too.
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[1] www.humanrelevantscience.org/wp-content/uploads/APPG-report-March-2022.pdf
[2] www.animalfreeresearchuk.org/wp-content/uploads/2021/09/Animal-Free-Research-UK_Economic-Report-2.pdf
[3] www.altex.org/index.php/altex/article/download/318/311
[4] www.nc3rs.org.uk/news/bbsrc-nc3rs-and-ukri-invest-ps47m-development-non-animal-technologies
[5] www.ukonward.com/reports/incentivising-innovation-tax-credits
[6] 68% of people want a government-led investment strategy to accelerate the availability of non-animal test methods. YouGov Plc. Total sample size was 1,765 adults. Fieldwork was undertaken between 13th - 14th September 2021. The survey was carried out online. The figures have been weighted and are representative of all GB adults (aged 18+)
