Commercial Breeding for Laboratories

Patricia Gibson Excerpts

Monday 16th January 2023 Westminster Hall

[Patricia Gibson (North Ayrshire and Arran) (SNP)]

Thank you for calling me to speak, Mr Efford, and I am delighted once again to lead for my party in this debate on calls to ban commercial breeding for laboratories and to implement reform to approve non-animal methodologies. I thank the hon. Member for Carshalton and Wallington (Elliot Colburn) for opening it so comprehensively.

Like many of my constituents in North Ayrshire and Arran, I am one of the majority of people who believe that we need to act on what is widely accepted as the unethical, cruel, immoral, counter-productive and damaging use of animals in experiments, as has been explained by Members from across the Chamber. We have, of course, debated the subject before, most recently, I think, in October 2021. We have debated it many times, but it keeps coming back to us via the Petitions Committee, because it simply will not go away. The huge number of people who repeatedly sign petitions about the matter ensures that it will keep coming back for debate unless and until common sense prevails—until science prevails, as inevitably it must. However, we need that to happen as soon as possible for a whole range of reasons, many of which we have heard about today.

Before I go any further, I must thank all the organisations that have provided such excellent briefings for today’s debate, such as the Betsy, Beagle Ambassador For Life On Earth campaign; the Fund for the Replacement of Animals in Medical Experiments, or FRAME; the RSPCA; People for the Ethical Treatment of Animals, or PETA; and a whole range of other organisations that have campaigned on this issue for decades.

Animal experiments fail in the search for human treatment and cures. Penicillin stayed on the shelf for over a decade because the tests done on rabbits by that great Scot, Alexander Fleming, led him to believe that it would be ineffective in humans. There is a mountain of evidence to show that failure and that is why we need a rigorous public scientific hearing to demonstrate it. Anyone who wishes to argue the opposite, without any confidence or credibility, should relish the opportunity to demonstrate their views in the forum of a public scientific hearing.

We know that some Members of this House and some on the Government Benches would argue in support of the status quo, yet in the repeated debates that we have on the issue they never seem to turn out to defend that position, except for the Minister, of course, who has little choice in the matter. We have MPs in this House who believe that the current situation is the correct one. If that is genuinely a held view, it should be able to be defended. If it cannot be defended, these things ought not to be happening.

While we wait and push for change, the opportunities for the treatment of and search for cures of terrible diseases such as cancer are, according to the USA’s National Cancer Institute, being lost, because studies in rodents have been believed. Far from assisting and advancing the treatment of and cures for terrible human diseases, which is what we all want to see, the use of animals in experiments is actively frustrating that end.

The problem with the petition calling for the NAMs specialist committee is that the fear is that it would be able to act in only an advisory capacity, whereas a public scientific hearing would require animal researchers to prove their claims about the efficacy of the use of animals in animal testing. A rigorous scientific hearing would show that the arguments being made for animal testing simply do not hold up to scrutiny.

Reducing licences and the range of animals on which tests can be carried out is all very well and good, and they are important steps, but we need to be much more stringent. The best way forward—the only way forward—is a robust public scientific hearing to secure the overhaul of the industry that so many of us want to see. Of course, such an overhaul is challenging, because we know that interests have grown up around it that, which defend it even in the face of evidence that it is not really the best way forward. It is certainly not the best way forward for treating diseases or, indeed, for animals.

It is widely reported by experts that 90% of new medicines fail to pass human trials because animals cannot predict human responses. The former editor-in-chief of the British Medical Journal has indicated that it is almost impossible to rely on most animal data to predict whether an intervention will have a favourable clinical benefit-risk in human subjects and, if that continues to be the case, endorsement and funding of pre-clinical animal research seems, at the very least, misplaced. That chimes with the conclusions of Dr Richard Klausner, director of the National Cancer Institute, who was mentioned by my hon. Friend the Member for Rutherglen and Hamilton West (Margaret Ferrier), that we have cured mice of cancer for decades, but it simply does not work in humans. In the world of science and in the pharmaceutical industry it is openly acknowledged that animal models on drug development simply do not work.

We should have cause for optimism, however, because on 4 January the Prime Minister delivered a speech. In that speech, he set out his priorities for 2023 and declared that he wants to

“make this country a beacon of science”.

The UK of course comprises four nations, so I will generously assume that he meant to say “the UK” and not “this country”. Putting that aside, I look forward to his Government making good on that commitment, following the science on the issue, taking note of and acting on the significant body of science that tells us that animal experiments are not helpful and, worse, can even be obstructive as we seek to treat and cure a whole range of human diseases.

It is worth recalling the remarks of Dr Lindsay Marshall, the UK’s biomedical science adviser for the Humane Society International, who said:

“The UK cannot expect to have world-leading science innovation whilst we rely on failing animal-based research methods that are rooted in the past.”

She said that,

“animal models are really bad at telling us what will happen in a human body”

and are sometimes “dangerously misleading”. That is despite the UK Government response to the petition indicating:

“The UK’s strengths in research and innovation put it at the forefront of global science. The Government is committed to supporting this science base”.

If we are following the science, there should not be a problem after we have a robust scientific public hearing.

There was much excitement among campaigners recently when President Biden signed into law the Food and Drug Administration Modernization Act 2.0, which removed the mandatory requirement that US-based animal tests are used in human drug development. That is a hugely significant step forwards, but animal data can still be used if those who are developing drugs choose to use them. There is no way round the fact that a public scientific hearing would be enormously helpful and useful as a global reference point for drug development.

The Animals (Scientific Procedures) Act’s three Rs— replacement, reduction and refinement—established in 1959 for humane experimental techniques on animals, are a concept developed decades ago to benefit individual experimental design, not to address the need to understand and develop treatments for many human diseases. The three Rs policy, as we have heard from hon. Members, is not fit for the purpose of advancing scientific progress through a shift to innovation without using animals.

A significant body of scientific thought believes there is urgent and pressing need to modernise UK research to keep pace with advancements. Far from the Prime Minister talking about being a world leader, we need to modernise for that to be the case. That requires redirecting resources from unreliable experiments on animals and shifting to a focus more fully on superior, non-animal methods that will benefit humans, animals and the world of science. Otherwise, both animals and patients who are waiting for treatments for terrible diseases will continue to be failed by outdated methods. Could anybody argue that this picture is compatible with the Prime Minister’s vision of the UK becoming a “beacon of science”?

This Government have accepted that animals are sentient beings, and that principle is enshrined in law. However, it is a source of deep frustration, disappointment, concern and even anger that that recognition of sentience does not appear to extend to animals in laboratories, which are subject to painful, cruel and distressing procedures that are not necessary, and following which the vast majority are killed. The recognition of sentience must be extended to all animals through the Animal Welfare Act 2006 and the Animal Welfare (Sentience) Act 2022, so they can be protected by the unnecessary suffering clause.

We are often told that the experiments to which animals are subjected are not crucial to the development of any new human medicines. On the contrary, those experiments are failing the search for human treatments and cures, as is shown by unequivocal evidence and is widely reported in the peer-reviewed medical literature. We have heard today that the regulatory requirement that animals be used in tests before proceeding to human trials was first established in 1946 in the Nuremberg code. Since then, science has advanced by 77 years, so why are we still using outdated laws to govern human medical research practice? Where else has that happened—that there has been no change in 77 years? It is nonsensical and indefensible.

Our EU partners are moving away from animal experiments. We need a rigorous, public, scientific and transparent hearing, so that we can have a full scientific debate on the reasons for banning animal experiments, where those who disagree can present their evidence for doing so in a transparent and public forum. As I keep asking, why would those who defend the current position shy away from that level of transparency? If those of us who wish to see an end to animal experiments are correct in our views and beliefs and in the evidence that is presented, that will accelerate the arrival of human treatments and cures, while also freeing animals from the cruel and unnecessary fate that awaits them in laboratories.

I hope that when the Minister gets to her feet, she will have taken full cognisance of the very powerful and reasoned arguments made across the Chamber today, and will respond by telling us how her Government have every intention of moving away from the use of animal experiments, as our EU neighbours are doing. I hope that she and her Government will mandate a rigorous public scientific hearing on this matter, which will show transparently and beyond doubt that lab animal models are not capable of predicting the response of human patients, as well as the need to ensure that all creatures are recognised as sentient beings in the Animal Welfare and Animal Welfare (Sentience) Acts. That is what the vast majority of the population across the UK wants to happen, and it is long past time that this Government acted.

--- Later in debate ---

[Miss Dines]

With the greatest respect, the Government are not saying that humans always benefit from animal testing. It is in the nature of testing that it has to be rigorous. Sometimes what is being tested works, and sometimes it does not, but testing can take place only if it is necessary. No one wants unnecessary harm to animals, which is why the Government have the aim of replacing live animals in scientific research and testing with non-animal alternatives wherever possible. Perhaps we can all agree that that is the aim.

[Patricia Gibson]

Will the Minister give way?

[Miss Dines]

I will make some progress first. Our approach has two fronts. First, robust regulation will ensure that animals are not used where a non-animal alternative could deliver the benefit sought, and secondly, our strategic aim is to facilitate and promote alternatives to animals in scientific research and testing. I therefore believe that we have a shared aim of fully replacing live animals as soon as possible, where that is safe and scientifically possible.

A number of Departments have a stake in the use of animals in science, including: the Department for Business, Energy and Industrial Strategy, which leads on science, research and innovation, including alternatives to the use of animals; the Department of Health and Social Care, which is responsible for the regulation of medicines; and the Department for Environment, Food and Rural Affairs, which is responsible for chemical safety and veterinary medicine regulations. The Home Office does not require or commission the use of animals in science. Instead, we regulate to ensure that all proposals for work are authorised only where there is justified benefit, that animals are used only where there is no alternative, that the minimum number of animals is used, that harm is minimised, and that the animals are appropriately cared for. I reject the narrative suggesting that that is not the case. My colleague Lord Sharpe has ministerial responsibility for this work.

By way of background, the debate on animals in scientific research has at its centre three critical strategic imperatives: first, the delivery of the benefits of the use of animals in scientific research; secondly, the delivery of a rigorous and robust regulatory system; and thirdly, the development of alternatives to the use of live animals in procedures. Taken together, these imperatives drive the Government’s policy on the use of animals in science. I will focus my comments on the issues raised by Members in this interesting debate.

--- Later in debate ---

[Miss Dines]

I really must make progress.

In all these instances, the drive has never been to use animals, but to deliver benefits through the justified use of animals. There is significant public concern around the ethical and moral case for the use of animals in science. Animals are expensive to use and difficult to work with, and their use carries a burden of regulation. Animal experimentation is something that people, including this Government, do not like. It is therefore not a matter of choosing to use animals, but of using the best method for the scientific experiment, and ensuring that animals are not used when other methods can give the information needed.

Although much research can be done with non-animal models, there are still purposes for which it is unfortunately essential to use live animals. In many instances, that is because the complexity of whole biological systems cannot be replicated simply using validated non-animal methodologies. However, the Government are committed to looking at alternatives, especially where the safety of humans and animals needs to be ensured—a point that is central to some of the concerns we have heard today. The data from animal testing and research has an important function in the human drug development process, which primarily concerns the safety of new medicines. The use of animals is required by international regulators to assess any adverse effects before clinical trials. Such testing is crucial to protect the safety of participants and the public. If we were to remove the requirement for animal testing, many potential medicines would not progress on to the market, and the risk to humans in clinical trials would be considerably higher.

Under the UK’s regulation pertaining to the use of chemical substances—the REACH regulations, mentioned by Members—industry participants must understand the hazards and risks of the chemicals that they manufacture, place on the market and use. That is to protect human health and the environment from the effects of harmful chemicals. For some chemical hazards, there is no immediate prospect of developing a non-animal alternative test method that could be used as the standard test method across the full range of chemicals. These hazards include reproductive toxicity and bioaccumulation up the food chain in the environment. REACH contains the “last resort” principle for vertebrate animals. That means that an animal study can be carried out only once all other ways of assessing the chemical’s hazard have been exhausted.

The Government are clear that when animals are used in science, they must be protected. The use of animals in science is therefore highly regulated. A licence is required for every establishment, project and individual involved in performing regulated procedures with animals. All establishments are required to have dedicated individuals, including veterinary surgeons, with legal responsibility for the care and welfare of animals, and an ethical review body. Establishments are required to comply with published standards for the care and accommodation of all animals bred, supplied or used for scientific purposes.

[Patricia Gibson]

Will the Minister give way?

[Miss Dines]

I apologise to hon. Members for not allowing interventions, but I want to leave time to respond directly to comments made.

We continue to develop our approach to regulation, so that we can continually improve compliance with the Animals (Scientific Procedures) Act 1986. We are modernising our approach to ensure that all establishments deliver stronger internal governance systems and processes.

If we are to achieve the benefits of the carefully regulated use of animals in science, there must be a supply of animals bred specifically for that purpose, as my hon. Friend the Member for Carshalton and Wallington said. Establishments that breed or supply animals for use in science contribute to activities that are critical to protecting human health and to making advances in science. Moreover, they are operating within a regulatory framework, set out under the 1986 Act, which requires an establishment licence and assessment of their compliance with regulation. In the UK, under the Act, establishments that breed animals for use in science are also required to provide care and accommodation to those animals in line with the published code of practice. Adherence to the code of practice and the requirements of the Act are assessed by the regulator as part of its compliance assurance programme.

I recognise the strength of feeling shown today on the subject of breeding animals, particularly dogs. It elicits an emotional response, and I understand that. However, I must be very clear that while we fully uphold people’s right to peaceful protest within the law, recent events at the dog-breeding site that was mentioned have gone beyond peaceful protest, leading to criminal investigations and sanctions. The tactics of protestors have included intimidation, direct action against staff doing their job, and the criminal theft of animals from the site. I confirm that sites are regulated and regularly inspected, so we can assure ourselves that such companies are conducting their work in a manner that complies with the law. It is important that we agree that individuals doing legal business, under an Act of Parliament made in this place, should have the freedom to continue to do that without threat.

The call for a ban on commercial breeders appears mainly focused on the breeding of dogs. It is important to recognise that under the Act no dogs can be authorised for use if the scientific objective can be achieved without using those animals or by using animals of less sentience. The majority of dogs used in science are required for safety testing potential new medicines, in line with international requirements designed to protect human health. Research using dogs has been a step in the development of more than 95% of all chemical medicines approved in the European Union in the last 20 years, including medications for use in treatments for cancer, heart disease, diabetes and specific genetic disorders.

Banning commercial breeding of dogs for scientific purposes could prevent potential new medicines from being tested in Great Britain. If that happened, safety testing work to assure public protection would no doubt have to be offshored to other countries. We cannot guarantee that such testing, or the treatment of animals there, would be carried out to the standard that we expect in the UK. Moreover, having exported that work, we may then be importing it back by means of new medicines. Seeking to close commercial breeders is not the answer. We must continue to address the issue on other fronts.

In supporting and accelerating advances in biomedical science and technologies, the Government are led by the Department for Business, Energy and Industrial Strategy. We seek to reduce the reliance on research and work that involves the use of animals, and to avoid some of the scientific limitations mentioned by hon. Members. Such advances include stem cell research, cell culture systems that mimic the function of human organs, imaging and new computer modelling techniques.

The UK has a world-leading reputation for the delivery of the 3Rs, which are the replacement, reduction and refinement of the use of animals in science. Our framework is replicated internationally. We lead the way in various areas, and I do not accept the characterisation of the framework as defunct, old fashioned or out of date; we are leading on this work. The national centre received core funding of multiple millions of pounds, and the Government are committed to investing appropriately in that centre.

Since it was established, the centre has invested £77 million in research and £27 million in contracts, and it has recently published its new strategy to increase the focus on animal replacement technologies; it also champions high standards in animal research. We are seeking proper funding to move away from the use of animals. The UK contributes significantly to the development and embedding of non-animal methods in chemical testing internationally, for both human and environmental safety, through participation in a number of collaborative research and development programmes. That includes both leading on and supporting projects undertaken with the OECD to introduce internationally harmonised tools and guidance for new approaches.

I will mention briefly the points made so eloquently by the Members who spoke. I agree with the hon. Member for Kingston upon Hull West and Hessle (Emma Hardy) that we must grip the new opportunities to move away from animal use, if we can. We are spending money, and we seek to move forward. To the hon. Member for Bristol East (Kerry McCarthy), I point out that we regularly commission independent work; the Animals in Science Committee gives valued advice on the development of policy. I can confirm that we have commissioned advice on the rabbit forced swim testing that was mentioned. She may want to look further at that important work for more information.

My hon. Friend the Member for Carshalton and Wallington mentioned that the statistics in this area are not as informative as they should be. We have the most comprehensive system in Europe for the publication of statistics, via the Office for National Statistics. For example, we know that in 2021, the use of dogs decreased by 3%; last year it decreased by 7%. Over the past 10 years, advances have been made. Inspections were mentioned; there are regular inspections. The regulator publishes the number of inspections in its annual report, and we are running a modernisation programme focused on improving those inspections.

The hon. Member for Rutherglen and Hamilton West (Margaret Ferrier) mentioned, with eloquence, her desire for improvements in this area. I agree that we are a nation of animal lovers. We believe in high welfare standards. As a nation, we believe in public safety, environmental safety and the protection of animals where possible. That is why the Government’s approach focuses on alternatives that get us away from using animals. Animals will be used only when absolutely necessary. There were many other very useful contributions, which I value and have considered. It would be unfair if I took up all the time, but if there are any specific issues that I have not addressed, I would welcome any letters, to which I will respond when there is more time.