Human-specific Medical Research Techniques

Steve McCabe Excerpts

Tuesday 4th July 2023 Westminster Hall

[Steve McCabe (Birmingham, Selly Oak) (Lab)]

I beg to move,

That this House has considered human-specific medical research techniques.

It is a pleasure to see you in the Chair today, Sir Charles. I want to briefly address the issue of how and why we might end the practice of using animals to test potential new drugs and treatments.

Like many others, I have in the past defended the use of animal experiments. I believed that the benefits, in terms of cures and treatments for human conditions, were worth it, despite the ever-increasing protests of people associated with the animal welfare lobby. Bringing new drugs to the market can be slow and expensive. Since 1950, the cost of developing a new drug has doubled approximately every nine years. Many of those drugs fail, and a major contributor to that failure is the problem of translating the results of pre-clinical trials to human beings. Over 92% of drugs that show promise in animal tests fail to translate into safe and effective medicines for humans.

Increasingly, researchers are relying on what are known as new approach methodologies based on human biology and utilising artificial intelligence, organ-on-a-chip methods, and the advanced use of human cells and tissues. I am grateful to Animal Free Research UK for a recent briefing at the Institute of Translational Medicine at the University of Birmingham and for its support in advance of this debate. It is a key organisation that is involved in funding and promoting the use of such methods in the UK.

We are beginning to see some exciting things. At Queen Mary University of London, researchers are using human-specific techniques to study the spread of various cancers. The University of Nottingham is developing stem cell models to better understand heart disease. Great Ormond Street Hospital is working with a three-dimensional model of the infant lung to help in treating RSV, which I understand stands for respiratory syncytial virus, and bronchiolitis, which is a life-threatening lung infection.

Animal Free Research UK also partners with the lifETIME—Engineered Tissues for Discovery, Industry and Medicine—Centre for Doctoral Training on developing animal-free technologies. Young researchers are trained in the use of advanced human-specific techniques. One experiment I saw in Birmingham involves a lab model of the human cornea, which researchers hope will make tremendous advances in treating various eye conditions and in helping people who may have lost their sight already. Another crucial development is the innovative liver-on-a-chip technology, which is proving to be a much more reliable predictor than any animal test of whether a new drug could be toxic to the patient’s liver.

There is a fast-growing market for human-specific techniques. The global market for 3D cell culture technologies grew to nearly $2.9 billion this year, and it is expected to exceed $5.5 billion in four years’ time. British universities and research units are at the forefront of much of that research, but trends suggest that we could fall behind. I know from work at the new Precision Health Technologies Accelerator in my constituency in Birmingham that human-specific technologies could be a game changer. By concentrating on them, Britain could secure a strategic advantage as a global life sciences superpower. Several leading companies are based in the UK, but the United States is making huge inroads with the work it is already doing with those companies, its regulatory framework and its plans for the future.

Evidence provided to the all-party parliamentary group on human-relevant science indicates that the Medicines and Healthcare products Regulatory Agency is open to exploring alternatives to animal tests, that animal tests should not be used by default and that that should be made clear to sponsors of clinical trials. The public supports that. A YouGov poll in 2021 revealed that 65% support ending animal testing and replacing it with new methods, and 70% would like to see all animal experiments phased out by 2040. If we are to make real progress in this area, we need to adopt a strategy similar to that used for the Climate Change Act 2008; we need a human-specific technologies Act to provide a new legislative framework.

Just today I saw a letter from Professor David Main, who chairs the Animals in Science Committee, in which he suggested that we should transfer responsibility for new approach methodologies and ending animal testing from the Home Office, where it currently resides, to the Department for Science, Innovation and Technology. There is probably a good historical reason why responsibility resides with the Home Office, but it seems strange, if we are talking about a new technology that could make a massive difference to the British scientific community, that the Department for Science, Innovation and Technology is not taking the lead on the subject. I hope that the Minister—I realise this is not wholly his brief—will report that back and ask for such a change to be considered. That seems sensible, the Government having gone to the trouble of setting up the new Department.

Professor Main also makes the case for a clear strategy to underpin a human-specific technologies Act. I do not want to say exactly what should happen, but, as I say, we could learn from the experience of the Climate Change Act, so we might include an expert advisory committee to keep us up to speed with the science. We could establish a milestone by which the transition to human-specific research could be accomplished. Obviously, that would have to be agreed after consultation with industry and academia to ensure that the timescale was realistic. Of course, the Government would need to take responsibility for developing and maintaining a comprehensive action plan and for regularly reporting progress to Parliament.

It goes without saying that it will require consistent and predictable funding—I hope that is part of the new Department’s intention—and other practical assistance if we are to help the scientific community achieve the transition. The benefits in terms of animal welfare, the development of new medicines and treatments, new jobs and a leading role for the UK would all be worth it. I hope that I can rely on the Minister to assure me that the Government stand ready to make this change a reality and that we can look forward to updates in the very near future on the steps they are taking to advance these new technologies and help us put an end to wasteful, sometimes pointless and often very ineffective animal testing.

--- Later in debate ---

[The Parliamentary Under-Secretary of State for Science, Innovation and Technology (Paul Scully)]

It is a pleasure to serve under your chairmanship, Sir Charles. I congratulate the hon. Member for Birmingham, Selly Oak (Steve McCabe) on securing this debate on human-specific medical research techniques. I also thank the hon. Member for Linlithgow and East Falkirk (Martyn Day) for his thoughtful words, and the hon. Member for Glasgow North West (Carol Monaghan) and the shadow Minister, the hon. Member for Newcastle upon Tyne Central (Chi Onwurah). There has been a lot of food for thought and important points raised in some insightful contributions, and I will try to cover those. However, at the heart of today’s discussion has been what it takes to build world-leading science—science that does not just top global rankings in league tables, but changes British people’s lives for the better.

Earlier this year, the Government set out our plan to cement the UK’s place as a science and technology superpower by 2030. Backed by a commitment to increase public expenditure on R&D to £20 billion per annum by 2024-25, we are investing in the areas where we have the infrastructure, experience and insight to lead the world. Indeed, it was interesting to hear the shadow Minister talk about bioengineering, because that is one of the priority emerging technologies that the new Department for Science, Innovation and Technology has identified as something we want to back.

Life sciences is one of the areas that is crucial not just to grow the economy and create high-skilled, well-paid jobs today, but to ensure that British people can live longer, healthier, happier lives tomorrow. Our life sciences vision sets a strategy for the sector to solve some of the biggest healthcare problems of our generation. In May, we announced an ambitious policy package in support of the life sciences sector, backed by more than £650 million in funding, including £121 million to improve commercial clinical trials to bring new medicines to patients faster.

Clinical trials, which were raised in the debate, are not necessarily directly related to animal testing. That said, the UK led the world in trials during covid, providing both the first vaccine and the first treatment. That has wider impacts on the clinical research system, and, as we saw from the recently published review by Lord O’Shaughnessy, that provides the clear path for us to regain our world-leading position.

As the vision makes clear, research is at the heart of that. Research is critical to ensuring that we are providing the best possible care for everyone now and in the future. It is thanks to bold research by brilliant scientists that we can win the battle against life-threatening conditions by equipping our NHS with a new generation of innovative treatments. Extraordinary advances in non-invasive techniques, such as medical imaging, sensors and ex vivo analysis, promise to revolutionise human healthcare. However, to unlock that promise, many of the research questions that those technologies have opened up must be explored directly in humans. It is only by doing so that we can quickly and efficiently translate medical discoveries out of the laboratory and into our hospitals, where they can make a real difference.

UK Research and Innovation, as the UK’s national science, research and innovation funding body, plays a vital role in supporting the development of human-specific research techniques. For a number of years, UKRI has prioritised experimental medicine research, in which studies are undertaken in humans, to identify the mechanisms that drive diseases and provide early evidence for the validity of new discoveries and treatments to fight them. The Medical Research Council’s translational funding strategy pioneers that work, taking the most exciting ideas from discovery science into research using humans, with a clear focus on early clinical application.

The experimental medicine panel is a core part of that strategy, backed by an annual budget of £10 million. Since its establishment in 2020, the panel has invested more than £19 million to support 16 world-leading projects across the UK that could rapidly lead to major benefits for human health. That includes a project from Manchester Metropolitan University that aims to unpick how a region of the brain stem functions and signals to the rest of the brain. The university’s researchers hope that by using the innovative technology of deep brain stimulation, they will gain insight into the neural mechanisms that cause Parkinson’s, a particularly cruel disease, whose devastating impact will be all too familiar to many of us. That project shows just how transformative human-specific research techniques can be.

The hon. Member for Birmingham, Selly Oak talked about animal testing not working, and I think the hon. Member for Linlithgow and East Falkirk said the same. Animal studies are used as the basis for extrapolation, to indicate possible risks to humans. Very few drugs that enter human clinical trials prove to pose an unacceptable risk to humans. There are many reasons why drugs that are assessed as potentially effective and safe in animals do not progress to market, including commercial reasons, but should animal testing not occur, more potential medicines would not progress to market. Resources would be spent on potential medicines that would have been excluded through animal testing, and the risk to humans in clinical trials would be considerably higher. We have heard a lot about the three Rs, and I will come back to that point—we actively support that approach.

Let me just take the opportunity to make clear this Government’s position on animal testing. There was discussion earlier about which Department has responsibility, and, clearly, we work on this across Government. The Home Office regulates existing animal testing, but it does not oversee the ending of it. That sits with the research undertaken under the auspices of the Department for Science, Innovation and Technology. That is why there are dual regimes. Clearly, as we move towards more advanced research and innovation, the responsibility increasingly comes under the auspices of DSIT.

Through UKRI, the Government actively support and fund the development and dissemination of the three Rs, which were set out more than 60 years ago by two English scientists in a programme for a more ethical approach to animal testing. As we have heard, the three Rs are: replacement of the use of animals where they are not necessary for research; the reduction in the number of animals needed to obtain the same amount of information; and the refinement of testing methods to minimise the pain, suffering and distress of the animals involved.

That is achieved primarily through funding for the National Centre for the Replacement, Refinement and Reduction of Animals in Research. World-renowned for its leadership in this space, the NC3Rs works nationally and internationally to drive the uptake of non-animal technologies and ensures that the advances in these technologies are reflected in policy, practice and regulations on animal research.

Since its launch in 2004, the NC3Rs has committed £100 million to its research, innovation and early career awards to identify new and more ethical approaches for scientists in academia and industry. It has set out its strategy to increase the focus on animal replacement technologies, as well as championing high standards in animal research.

UKRI’s Biotechnology and Biological Sciences Research Council also supports research into developing and applying innovative methodologies to study human and animal physiology, including in-silico approaches—organ-on-a-chip, as we have heard—organoid and other advanced cell culture systems. That includes a recent £4 million BBSRC and NC3Rs programme that focuses on supporting the next generation of non-animal technologies that mimic the physiological environment, enabling a whole-system/multi-system approach for discovery and translational science across the life course.

Much research can be done in non-animal models, as we have heard, but there are still purposes for which it is essential to use live animals. The dizzying complexity of whole biological systems means that they cannot always be replicated using validated non-animal methodologies. Therefore, although we very much recognise the need to replace the use of animals in scientific procedures with non-animal alternatives where we can, the carefully regulated use of animals in scientific research remains absolutely necessary at this time if we are to protect humans and the wider environment, whether that means improving our understanding of how biological systems work or accelerating the development of safe and effective medicines, treatments and technologies.

[Steve McCabe]

I appreciate that this is not the Minister’s brief—I am not trying to be difficult, and I am listening with interest to what he is saying—but I and others watching the debate will be curious to know whether it is Government policy and the Government’s intention to move to phasing out animal experiments, or is the Minister telling us that the Government think there will always be a place for animal experimentation?

[Paul Scully]

I have talked to the hon. Gentleman about the three Rs. Essentially, nobody wants to be using animal testing where it is absolutely not needed. If innovation, such as computer models and new research, can find new ways of edging that out, why would any Government not want to do that? It has to be based on the evidence and the best science, and done on what is best for humankind, and that is what we will keep in mind. It is not done for the sake of animal testing in itself; it is very much evidence-based, as I said. That is why the current approach is to actively support and fund the development and dissemination of techniques that replace, reduce and refine the use of animals in research and to ensure that the UK has a robust regulatory system for licensing animal studies and enforcing legal standards.

Our legal framework is absolutely clear: animals are only ever used in science where there are no alternatives, where the number of animals used is the minimum needed to achieve the scientific benefit, and where the potential harm to animals is limited to that needed to achieve that scientific benefit. Under UK law, there are three main purposes for which animals may be used in science: for basic research to understand biological processes and systems; for translational research to understand how biological systems apply to real-world applications, such as the development of medicines; and to test the safety and efficacy of medicines and chemicals.

In each of those instances, the rationale is clear. Without basic research using animals, we would limit our ability to make the kind of scientific discoveries that could transform medicine for the better. Without translational research using animals, we would limit our ability to develop new medicines not just for humans, but for animals. Without testing those medicines using animals, we would not know whether those medicines were safe or effective for use in humans or animals, unnecessarily limiting the availability of medicines to treat life-threatening diseases. Many medicines that prove ineffective in humans are detected earlier through animal testing, too, enabling us to focus valuable research funds on medicines that will be effective.

To be clear, this Government are unapologetically ambitious in our mission to make Britain a science and technology superpower. We understand just how much world-leading research matters if we are to succeed and translate that success into real benefits for our people and our NHS. That means investing in the next generation of tools and technologies that provide alternatives to animal research, and it means, where animal research remains necessary, maintaining those rigorous principles to put ethics at the heart of that research. I thank Members once again for their insightful contributions to the debate, and I look forward to our working together in the months and years to come.

--- Later in debate ---

[Steve McCabe]

Thank you, Sir Charles. I am grateful to everyone who has taken part in the debate. As I said earlier, I appreciate that this is not the Minister’s main brief, so I am grateful to him. I am a trifle disappointed that, towards the end, I thought I detected a “steady as we go” message, rather than one that was actually going to progress to phasing out animal testing, which is what everyone else would like to hear. I am pleased to hear about the investment and plans that the Government are making. I will conclude by simply urging the Minister again to take back the mood of the debate, so that people realise there is an alternative.

Question put and agreed to.

Resolved,

That this House has considered human-specific medical research techniques.