Monday 19th February 2024

(2 months, 1 week ago)

Westminster Hall
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George Eustice Portrait George Eustice (Camborne and Redruth) (Con)
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This is an incredibly important debate, which has been brought about by these two petitions. In 1986, this country introduced the Animals (Scientific Procedures) Act. At the time, it was seen as world-leading and as the gold standard, with its three Rs principles: to replace animal testing wherever possible; to reduce animal testing where it was not possible to replace it; and to refine it to reduce suffering where it occurred. However, it is increasingly clear that a review of the legislation is now needed and that we need to make further legislative improvements. We have always been ahead of the United States on animal welfare issues, but this is one area where, arguably, we have now fallen behind them. Until recently, the US required animal testing for certain product authorisations, but it has now brought forward legislation to modern its statute and make it explicit that there is no need for animal testing for any of those products.

In the UK, we have a degree of ambiguity. The Medicines and Healthcare products Regulatory Agency does not explicitly require animal testing, but there is a degree of ambiguity because it is equally cautious about saying that there should not be animal testing. I will come on to that later.

In debates such as this we should always give credit where credit is due, and it is important to note that the Government effectively banned the use of animal testing in the development of cosmetics in 2023, or at least made it clear that there would be no new licences for such activities. That followed the huge progress made by companies such as Unilever and others to phase out the need for animal testing on their products. However, the greatest concern for me is that despite exponential growth in non-animal methods and huge leaps in that technology over 20 years—with the development, for instance, of organ-on-chip technology and bioprinting—the number of animals used in animal tests remains stubbornly high, at around 4 million per year, principally mice.

The 1986 Act is deficient in some minor but quite obvious ways. When it was originally drafted, it simply covered invertebrates, which was consistent with the animal welfare legislation we had at the time. In 2012, the coalition Government decided to add cephalopods to the legislation—for those not familiar with that terminology, it essentially means species from the octopus family—but they did not add decapods. As the Minister will know, the recent Animal Welfare (Sentience) Act 2022 now recognises both cephalopods and decapods as being sentient species. At the very least, therefore, we should bring the 1986 Act into line with our current animal welfare legislation, which would require the addition of decapods as protected species.

My more important concern is that if the three Rs had been applied correctly, given the exponential growth in technology that we have seen in the last 20 years, we would have expected to see a correlation and a sharp reduction in the number of animals being used, as the replacement principle was applied. Instead, over the last 20 years the number has really drifted along sideways. I appreciate that it has dipped at times, but it is telling that in the first year of lockdown, when the number of animals being tested fell quite significantly, it was said that it had fallen to the lowest level since 2004. That is quite damning in itself, because if an anomaly year, when the amount of testing was at an all-time low, meant that the level had still got back only to the level it was at in 2004, that suggests that something is going wrong and that the application of the three Rs is not having the effect originally intended by the 1986 Act.

I am afraid that it is hard to avoid the conclusion that what started out in 1986 as a robust regime—perhaps the most robust regime in the world—has probably drifted and coalesced into a rather unsatisfactory system of self-regulation. We have to ask ourselves why those three Rs principles are not being effectively applied. Ultimately, I think it is because everybody defers to process but no one really takes proper ownership. We have ended up with cultural attitudes around the use of animals in scientific procedures that masquerade as science, when actually the science does not require those animals to be used in such numbers at all.

Kerry McCarthy Portrait Kerry McCarthy (Bristol East) (Lab)
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I have always thought that one of the problems—as a former Secretary of State for Environment, Food and Rural Affairs, perhaps the right hon. Gentleman will have insight into this—is that animal welfare sits with the Department for Environment, Food and Rural Affairs but the Home Office is in charge of licensing. Usually it is in the hands of a Minister who has 101 other things on their plate, and it is a small part of their brief. Today, we have the team from the Science Department here, and I hope they are looking at the more progressive view. Is the problem that there is no one Minister who can take ownership of the issue?

George Eustice Portrait George Eustice
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That is part of the problem. I am sure that the Minister has a busy diary, and there is an argument that the issue falls partly on the Science Department and partly on the Home Office. At the moment, the unit that processes the licences sits in the Home Office but, as I will say later, there is a strong case for a machinery of government change that relieves the Home Office of that burden, which it is not really qualified to carry out, and transfers it to a Department such as DEFRA, where there are vets and where the legislation can be treated, rightly, as a piece of animal welfare legislation, rather than a piece of scientific licensing.

I want to explain why we have this problem. Three types of licence are needed to carry out these scientific procedures. An individual has to have a licence, and there is a licence on the establishment, which is fairly uncontroversial. The difficulty comes with the project licences. Universities and research institutions have internal animal welfare and ethics boards, which assess applications before they go to the Home Office. But how hard do they challenge requests from academics working in their institutions? Perhaps they occasionally ask a few questions and challenge a bit, but it appears that they, effectively, defer to the judgment of the academics who put in the requests, and the academics then agree. The ethics board agrees to the application, which is then submitted to the Home Office.

Let us bear in mind that the team in the Home Office have to process around 4,000 project licences a year. They are overworked and stretched. They will see that an ethics board, with professors and people with “Dr” in front of their names, has assessed that the project is necessary. They will defer to the scientific knowledge of those boards—and perhaps wrongly so. Although scientists are qualified to give good technical analysis, they are not, by and large, qualified to make good decisions, least of all when it comes to decisions relating to policies underpinned by laws made in this House. Only the civil service, backed up by Ministers, can make those kinds of decisions.

I suspect that there is, in the Home Office, a large degree of deference, which is possibly misplaced, to those animal welfare and ethics boards. That is why the Home Office almost never refuses a licence. I understand that, in response to parliamentary questions on this issue, Home Office Ministers will say, “You cannot really judge the fact that we have not refused a licence as evidence that we are not applying ourselves with voracity to this task, because we will often question things and send applications back for further consideration.” I completely understand that, and it is a fair point, but we have over 4,000 project applications a year. Are we really saying that the Home Office might not judge it appropriate to refuse even one in order to create some boundaries and parameters and to inject some vigour and rigour into the system?

A further cultural problem stems from the MHRA, which regulates medicinal and pharmaceutical products in the UK. Although it has confirmed that it does not require animal testing, and that it is open to individual companies and research establishments to decide what type of research they need, a perception exists within industry and academia that experiments carried out using live animals have greater credibility and acceptability. A clear statement from the MHRA that it is not neutral or indifferent, but will take a dim view of products brought before it that have used animal experiments when they might not have been necessary, would sharpen the process and focus minds as to the need for using animal experiments.

How can we get to a position in which the three Rs are being applied as the original Act intended? One of the petitions calls for more funding for non-animal methods. In the UK, we are blessed with some of the world’s best researchers in this area. The Blizard Institute at Queen Mary University of London, which I visited a few months ago, hosts an animal replacement centre of excellence. It is doing some extraordinary work on organ-on-chip and bioprinting. In dermatological research in particular, there is now no doubt that such non-animal methods are far superior to using live animals.

I have a probing proposal for the Minister. As a way to raise money, sharpen the incentives in the current system and get the three Rs enforced, I propose that we consider applying a levy on the use of each individual animal in testing, as part of the project licence. In some ways, it feels quite incongruous to have to put a monetary value on the life of a mouse to get people to take it seriously, but if researchers are not taking the intrinsic value of that mouse’s life as seriously as they should, let us consider some other incentives that might reinforce the original three Rs. Let us consider applying a project licence levy of £100 or £200 for each mouse used, and see whether that focuses minds on the animal welfare and ethics committees. Let us see if it makes them think twice before saying that they need 100 mice for something when they could do it with less. We should consider something like that. The other advantage of a levy is that we could ringfence all its proceeds and put them directly into research on non-animal methods. That is my suggestion to the Minister.

I was a Minister myself for nine years, and I know that it is very easy for people to call for more money for things, but it is not straightforward to be the Minister who has to go to the Treasury and say, “By the way, we’d like just a little bit more money for this one thing that is quite important.” Traditionally, 20 years ago, the Treasury did not like levies and saw them as a hypothecated tax, but we are in different territory post the financial crisis and the many other problems since then. I am sure that if the Minister went to the Treasury and said that he was going to apply a levy of £200 per mouse used in experiments, the faces in the Treasury would light up. They would see the potential to do something useful with that.

Finally, where should responsibility reside for the 1986 Act and the policy under it? I know that that discussion is ongoing within the Government. My view is that the Home Office is a very busy Department and has a huge amount to contend with, and it is very unlikely that its Ministers would be able to give this issue the attention that it deserves. The right thing would be to make a machinery-of-government change transferring full responsibility for animal testing, the 1986 Act and the regulatory regime under it to DEFRA, which has the vets, the scientists and people who would approach this issue as an animal welfare issue. Equally, it has people who understand the importance of science. As our vets have proven on multiple occasions, they are not squeamish about these matters: they will take difficult decisions if need be. Most importantly of all, if the policy were within DEFRA, veterinary science could challenge medical science. Often, we find in veterinary science a better understanding of vaccinations, epidemiology and medicines, with a body of technical expertise that can challenge the medical expertise sitting in other Departments. That is why I think that such a machinery-of-government change should take place.

I hope that the Minister will look favourably on some of those suggestions. I appreciate that it is very unlikely that he could bring forward a levy that might sharpen the implementation of the three Rs between now and the general election, but all parties will be able to think about these issues as they draft their manifestos for the general election ahead.

--- Later in debate ---
Chi Onwurah Portrait Chi Onwurah
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I thank the hon. Member for her intervention. I was not implying support for a specific type of testing, but making a general point: some have argued in the past that animal testing has been necessary to save human lives, and groups such as Understanding Animal Research argue that currently. Understanding Animal Research also gives the example of Duchenne muscular dystrophy, a lethal childhood disease, as a condition where canine models are effective.

Science and innovation can show the way out of this moral maze. To take the example of testing on dogs, NC3Rs, the UK’s National Centre for the Replacement, Refinement and Reduction of Animals in Research, has established a project to develop a virtual second species—a virtual dog—using historical data. On toxicity testing, the UK-based company XCellR8 has developed the AcutoX test as a humane alternative to the LD50 test, which involves giving increasing doses of toxic substances to groups of animals until 50% of them are killed.

Just this month, Newcells Biotech, a spinout from Newcastle University based in my constituency, raised over £2 million from the North East Fund for its models of the retina, kidney and lung, which are used in drug development and which reduce reliance on animal testing. The chief executive officer, Dr Mike Nicholds, told me:

“Over the last 10 years, advances in stem cell biology, 3-D bioprinting and high-content analytical methods such as transcriptomics have revolutionised our ability to build laboratory mimics of human tissues that can reduce the use of animals in the early stages of drug discovery. Pioneered in academia, these approaches are now established in mainstream biotech and importantly the regulators have moved to increasingly accept these non-animal models as reliable. Innovations such as retinal organoids, produced by Newcells Biotech, are being used globally to support the development of drugs that cure blindness, demonstrating the power of these new alternatives.”

He went on to say:

“While the prospect of fully replacing animal testing is likely to be at least a decade away, that prospect is no longer beyond the horizon and certainly significant reductions in animal testing will be driven through innovation and awareness within this timescale.”

George Eustice Portrait George Eustice
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The hon. Lady makes an important point. Although these technologies are developing year on year, they have been around for some time. She said 10 years, and some would say that some of them have been around for closer to 20 years. Why does she think we have not seen a corresponding fall in the number of animal tests to date? Does she believe that the current project licensing regime is rigorous enough?

Chi Onwurah Portrait Chi Onwurah
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The right hon. Gentleman makes a good point, and I thank him for it. In his speech, he talked about some of the challenges around the existing regime. We have seen a huge growth in science, and in biotech specifically, which may, unfortunately, have led to increases in animal testing. But it is also true that the regulatory regime needs to reflect the advances in technology, and I will go on to talk about that.

As well as chips and organoids, we have techniques such as proteogenomics, single-cell sequencing and access to human cell types that we did not previously have. For example, bit.bio, a leading UK cell-coding company, is able to manufacture human neurons that were previously available only through brain surgery. With such advances, I am certain that our brilliant scientists and innovators can help provide workable alternatives to animal testing. Given our country’s strengths in artificial intelligence and data science, Britain can be at the forefront of this scientific revolution, which will make animal testing a thing of the past.

I would, however, like to ask the Minister whether he considers that a priority. Estimates show that NAMs receive as little as 0.2% to 0.6% of UK medical research funding. Being a first mover in this field will bring with it jobs, investment, economic growth and better animal welfare. Will he therefore explain what the Government are doing to support British scientists and to incentivise them to proactively seek to use NAMs in British labs, creating a customer base to pull through new labs?

Before I entered Parliament, I worked for the regulator Ofcom, so I know that regulation can drive innovation and open up competition—or be a barrier to it. Labour is proposing a regulatory innovation office to help ensure that regulation does the former, not the latter. We need to take a proactive approach to ensuring that regulation reflects emerging methods of research if we are to drive forward scientific discovery and trials while reducing animal testing.

With these new technologies, there is a huge opportunity to create new drugs much faster and for less money. Today, in the US, it takes an average of 12 years and $1 billion to create a drug, from initial filing with the FDA to FDA approval. These tools can provide significantly better possible targets for a therapy, reducing time and therefore costs.

Responsive, proactive regulation will help to improve the uptake of new NAMs in accordance with the current regulations’ principles of replacement, thereby eliminating avoidable tests as soon as is practical. That would help to assure the public that their Government are moving in the right direction and doing things proactively.

At the same time, our pro-innovation approach will create opportunities for entrepreneurs and innovators to develop and bring to market new NAMs, with a stable business environment and a path to market. Our ambition is clear, and the views of Members here today are well known. The opportunity is there to support NAMs development, drive the replacement of animal testing and support the welfare of all life—animal and human alike.

That will not happen overnight, and animal testing in human health has long been embedded in our pharma sector. However, we will not advance human therapies and cures, as we should, if we continue to rely on animals that do not get the diseases that humans suffer from.

Andrew Griffith Portrait The Minister for Science, Research and Innovation (Andrew Griffith)
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It is a pleasure to serve under your chairmanship, Dame Caroline, and I thank my hon. Friend the Member for Carshalton and Wallington (Elliot Colburn) for opening today’s important debate. As this is the first time I have spoken since, let me also commend him for his personal bravery when he spoke at the most recent Prime Minister’s questions.

The number of signatories to these petitions—I think almost all hon. Members have mentioned it—indicates the strength of public feeling on this matter. This is not the first time that this issue has been debated, although it is my first time. Although I think none of us would want such a debate to become an annual event, this is absolutely the right forum in which to debate these important matters. I therefore congratulate all those who have contributed and everybody who has signed the petitions.

I completely understand that the use of animals in science, including in toxicity testing, is a sensitive issue. More than that, I believe that everyone here would share my view that the day cannot come quickly enough when we are able to end the practice of animal testing. It is to hasten that moment that, as hon. Members have observed, the UK is one of the world’s leading nations in the development of non-animal methods. The Government are keen to ensure that those are utilised wherever possible, and I heard some frustration or concern from colleagues about the pace of adoption where the scientific methods exist. It is fair to say that most hon. Members accept—I have met charities and organisations working in the sector, including Animal Free Research UK—that we are not quite at that moment when we can fully replace animal testing.

To a degree, we are all in what my hon. Friend the Member for Chatham and Aylesford (Tracey Crouch) eloquently called that “mess of complexity”, but that does not mean that we are not clear about the direction of travel and the goal that we seek over time. As the Science and Research Minister, I take extremely seriously my responsibility within the multiple Departments that my right hon. Friend the Member for Camborne and Redruth (George Eustice) talked about.

The Government are supporting and accelerating advances in biomedical science and technology to reduce reliance on the use of animals in research. When we hear data points about the percentage of research money that is spent, it is important to remember that not all of that research is clearly labelled as non-animal research. Developments in respect of artificial intelligence, cell cultures, cell research, understanding the function of human organs, and better imaging can all contribute to the advance of non-animal methods that can be put to work in this space. Indeed, we heard from the hon. Member for Newcastle ex vivo analysis upon Tyne Central (Chi Onwurah) about the very successful spin-out from her university, and we are seeing that sort of development elsewhere. As my right hon. Friend the Member for Camborne and Redruth said, the rate of growth has been exponential, and this is an amazing moment in science of all kinds. There have been extraordinary advances in non-invasive techniques, such as medical imaging, sensing and ex vivo analysis, which are revolutionising human healthcare.

Through UK Research and Innovation, the Government are actively supporting and funding the development and dissemination of the three Rs, and I will have more to say about that later. Anyone who was not familiar with the three Rs when they came here today is probably more familiar with them now. They stand, first, for the replacement of the use of animals where it is not necessary for research, which I think is the aim we all share. Then, there is the reduction in the use of animals in the meantime, and the latest figures I have, which are slightly more recent than the ones my hon. Friend the Member for Carshalton and Wallington referred to, show a 10% reduction in the use of animals in research. I do not want to over-weight any particular year’s numbers, and we will have to look through and see the continued reduction we all seek. However, the latest data I have, for 2022, showed a 10% reduction. Finally, in addition to replacement and reduction, there is refinement to eliminate or reduce distress to those animals that are involved. All of that is achieved primarily, but not exclusively, through the approximately £10 million of funding per year that goes to NC3Rs, the national centre for the three Rs. We heard of other examples, including Queen Mary University of London’s centre for animal research, which is also doing great work in this area.

We have also heard that the use of animals in science lies at the intersection of two important public goals. There are the benefits to humans and animals—a lot of the research benefits animals themselves—and to the environment, as we seek to have the very highest standards of environmental protection. But we must also balance that with the UK’s proud commitment to the highest possible levels of animal welfare. That is why, as we heard from a number of Members, the use of animals in testing is strictly limited to specific purposes, including assessing the safety of medicines or chemicals, protecting human health and protecting the environment—a lot of research goes on into compounds to understand their downstream effect on our rivers, lakes, oceans and natural habitats.

We also heard that the use of animals in scientific procedures is permitted only if there is no non-animal alternative available, and I will try to address some of the remarks that have been made specifically about the way in which that legal principle, laid down by Parliament in legislation, is applied in practice and whether it is as effective as my right hon. Friend the Member for Camborne and Redruth would like.

Despite the general legal protections, some animal testing of chemicals is required under UK law to protect the environment, but such testing is permitted only once it is established that no alternative exists, and it is dependent on the chemical and quantity being manufactured.

As I said, we are world-renowned for our leadership in this space, and we should continue to be alive and open to what other countries are doing. The example of Canada was mentioned, and some of the work I have done and the meetings I have had have focused precisely on how we can ensure that the UK remains the best place in the world in terms of the legislative framework and the science and how we can ensure that non-animal technologies and the constant advances in them are reflected in policy, practice, legislation in this place and animal research regulations.

Since it was established, the NC3Rs has invested in total almost £90 million in research and £27 million in contracts through its CRACK IT Challenges innovation scheme for UK and EU-based institutions, with that funding mainly focused on approaches for safer assessment of pharmaceuticals. The UKRI Biotechnology and Biological Sciences Council—a different body—supports research aimed at developing and applying innovative methods to study human and animal physiology, including in silico approaches, organ on a chip, and organoid and other advanced cell culture systems.

Despite that funding, I believe that more can be done. Ahead of today’s debate, I asked UKRI that we double our investment in research to achieve the three Rs and develop non-animal alternatives. I can announce that, from £10 million this year, that investment will reach £20 million per annum across the system in fiscal year 2024-25, which is a doubling of what is given to research in this space. In addition—I hope this is welcome across the House—I can announce that this summer, following on from work done by my predecessors and across other Departments, the Government will publish a plan to accelerate the development, validation and uptake of technologies and methods to reduce reliance on the use of animals in science. The former Minister, my right hon. Friend the Member for Camborne and Redruth, will recognise some of the impedance on a Minister at the Dispatch Box, but I can see no reason why that plan could not at least consider some of the machinery-of-government changes that he talked about.

George Eustice Portrait George Eustice
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I think everyone will welcome the significant increase in funding that the Minister has pledged today to support research on non-animal methods, but is his Department at all curious why the number of animals used in experiments has not gone down, despite huge increases in technology in this area? As part of a review of the licensing process for projects, would he consider trying to get us some analysis of whether the decision to grant a licence is objective, or subjective and based on something that some ethical committee claims?

Andrew Griffith Portrait Andrew Griffith
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My right hon. Friend makes a very good set of points, and that is something that we will look at further. I am already in discussion about the efficacy of the licensing regime with the noble Lord Sharpe, who is the Home Office Minister responsible.