What’s your initial reaction to the title of this article? Are you thinking that phasing out animal experiments is a desirable goal that could eventually be achievable, given the ongoing progress with Non-Animal Technologies (NATs)? Perhaps you believe it’s feasible in some areas, such as regulatory toxicology protocols involving one tissue type, but wouldn’t be possible in your own work, and could be hopelessly out of reach where multiple organ systems are involved? Or maybe you view it as a risky concept that could impact important research?
Whatever your views as a pharmacologist, support for the concept of phasing out animal experiments - coupled with a phase-in of NATs and New Approach Methodologies - is rapidly gaining pace, and you need to be part of the conversation.
The phase-out concept was first formally set out in Directive 2010/63/EU, which regulates animal use throughout the European Union (EU), and includes a Recital stating that the Directive ‘represents an important step towards achieving the final goal of full replacement of procedures on live animals ... as soon as it is scientifically possible to do so’.
Since then, an increasing number of initiatives have set out phasing-out strategies in the EU and beyond. One example is the Netherlands Transition Programme, which takes a multi-stakeholder approach to stimulate innovation with respect to NATs. Another is the US Environmental Protection Agency ambition to eliminate all mammal study requests and funding by 2035.
And this September, the European Parliament overwhelmingly adopted a Resolution that called on the European Commission to ‘publish an Action Plan with concrete proposals and objectives for phasing out reliance on the use of animals in research, regulatory testing and education in the EU’.
But despite these positive initiatives around the world, the UK currently has no explicit ambitions in place to phase in NATs. This does not sit well with the objective of making the UK ‘a global science superpower, turning world-leading science and ideas into solutions for the public good’ set out in July’s UK Innovation Strategy.
The RSPCA shares the EU’s goal of replacing animal experiments, and we know that many within the scientific community also recognise the potential scientific, economic and ethical benefits. We also understand that views and beliefs differ regarding the desirability and feasibility of a UK phase-out, and we wanted to help identify some common ground and ways forward.
In July, the RSPCA held an online debate on the feasibility of phasing out animal experiments in the UK. The panel included Professor Sir Chris Evans - Excalibur Healthcare Services, Professor Martin Knight - Queen Mary University of London and Emulate Organs-on-Chips Centre, Dr Julia Fentem - Unilever Vice President, Safety and Environmental Assurance Centre, Professor Andrew Jackson - Newcastle University, and Professor Dominic Wells - Royal Society of Biology. This article summarises some key conclusions; for the full report please see rspca.org.uk/ukphaseout.
First, we asked the panel ‘which research fields are most promising with respect to replacement?’ The answer was that regulatory testing shows particular promise. For example, Unilever now believes that product safety can be effectively assessed without animal tests. The EU Scientific Committee on Consumer Safety, which advises the European Commission on health and safety risks of non-food consumer products, has also recently incorporated NATs in its Guidance Notes.
Advanced in vitro models, such as organoids and organs-on-chips, are increasingly available in medical research and pharmacology. For example, the lung-on-a-chip was part of the test battery to develop COVID therapeutics, successfully predicting long-term performance. These models have the advantage of using human cells and tissues, increasing translatability, although more work is needed to ensure diversity of the human source material regarding gender, age and ethnicity.
As members of the British Pharmacological Society will be well aware, the current drug pipeline includes in silico, in vitro and animal models and tests, and human clinical trials, with significant attrition at every stage. NATs could reduce this attrition rate by enabling more effective screening out of harmful or ineffective candidate drugs and facilitating more translatable tests that are based on human cells.
Next, we asked ‘what are the key ongoing obstacles to replacing animal use with NATs, and how might these be overcome?’. The answer varied between fields. In safety science and regulatory testing, there is a significant gap between the already available and advancing scientific capabilities of NATs, and the current regulatory requirements - so this relates to mindset rather than science. Fundamental research is clearly more challenging if a complete, functioning organism is required.
An ideal vision would be to develop medicines from bench to bedside without animal use, although the timeframe, cost, and regulatory overhaul would be significant. It would be well worth achieving though, not only for ethical and animal welfare reasons, but also because it is logical to use human cells and tissues to develop drugs for humans.
The final question was ‘what would a feasible ‘phase-out’ plan look like for the UK?’ The European Commission Policy Coordinator has discussed positive and constructive approaches to implementing the EU’s goal of full replacement. These include analysing and prioritising efforts and ensuring that resources are available, including education and training in replacement. Research funding programmes would also be needed to develop scientifically sound research tools bridging between different disciplines.
Polls show that 75% of people in the UK want more to be done towards replacing the use of animals in science. The Government could reflect this desire by setting out a statement of commitment, and policy intent, towards a ‘phase out’. This should involve a clear ambition, strategic roadmaps, and practical action plans in key areas likely to be most successful. Investment in building capability and driving the application of NATs would also be needed, with large-scale academia-industry-clinician-regulator partnerships, like those initiated by the NC3Rs CRACK IT programme. George Freeman, Department for Business, Energy & Industrial Strategy (BEIS) Minister, recently announced that the NC3Rs and Innovate UK are reviewing the impacts of investments made with respect to the 2015 Innovate UK NAT Roadmap, which is a positive development.
A UK phase-out could not (and should not) be an instant 'ban', but a constructive process with stretching, yet realistic, milestones towards the ultimate objective. It should also avoid unintended consequences for animal welfare, e.g. arbitrarily reducing animal numbers could lead to greater severity for individuals or poor experimental design, wasting animals’ lives.
A serious UK vision and strategy to phase out animal use will therefore require political will and commitment from Government departments, industry, academia, research funders, and individual scientists, as well as adequate funding and resources. Open minds and willingness to accept a phase-out of animal use, with a phase-in of NATs, will be essential.
As pharmacologists, you will know the limitations of animal models, as set out in the core learning outcomes in the Society’s curriculum for research animal use. But do you receive adequate training, guidance, and CPD in searching for NATs? Would you be supported in transitioning to non-animal methods over time, or would there be obstacles? We were pleased to welcome the British Pharmacological Society to the audience for our debate - are you ready to join the conversation too?
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