Laboratory Animals: Animal Welfare Act

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Monday 7th February 2022

(2 years, 2 months ago)

Westminster Hall
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Kit Malthouse Portrait The Minister for Crime and Policing (Kit Malthouse)
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It is a pleasure to appear before you, Mr Paisley. I thank the hon. Member for Linlithgow and East Falkirk (Martyn Day) for securing the debate, as well as all Members who have made contributions. The Government recognise that this is a challenging and important policy area, with a huge amount of public interest.

The use of animals in science lies at the intersection of two important public goods: the benefits to humans, animals and the environment from the use of animals in science, and the UK’s proud history of support for the highest possible standards of animal welfare. The balance between those two public goods is reflected in the UK’s robust regulation of the use of animals in science through a dedicated Act: the Animals (Scientific Procedures) Act 1986, or ASPA. That Act specifies that animals can be used in science for specific limited purposes only when there are no alternatives, and it provides protection for those animals.

I will structure my comments around three key themes: the relevance and benefits of using animals in science; how animals used in science are protected in law through specific legislation and with oversight from dedicated regulators; and, specifically, the breeding or use of dogs in science, which has been mentioned by a number of Members.

The use of animals in science never occurs in isolation. Scientists use and integrate data from a wide range of different methods, including in test tubes, computer modelling, the use of animal or human tissues, and clinical trials in healthy volunteers or patients. Funding is seldom solely for one type of research, but rather for all relevant methods to answer particular research questions. It is therefore not a matter of choosing between different scientific methodologies, but of using the best method for the specific experiment, and ensuring that animals and humans are not used when other methods can give the information needed.

As part of the entire research system, animal testing and research play a vital role in understanding how biological systems work in health and disease. They support the development of new medicines and cutting-edge medical technologies for humans and animals, and the safety and sustainability of our environment. Animal research has helped us to make life-changing discoveries, from new vaccines and medicines to transplant procedures, anaesthetics and blood transfusions. The development of the covid-19 vaccine was possible because of the use of animals in research.

Although much research can be done in non-animal models, as a number of Members have outlined there are still purposes for which it is essential to use live animals, as the complexity of whole biological systems cannot always be replicated using validated non-animal methodologies. That is especially the case where the safety of humans and animals needs to be ensured.

Animal models are constantly improving to become more accurate and predictive, and scientists understand progressively more about which biological systems in which animals offer the most scientifically valid results. Improvements in understanding the genomes of animals and humans have been critical to ensuring that scientific research in animals is understood and applied appropriately. Data from animal experiments are fed into computer models that analyse their predictivity and enable scientists to use animal models in smarter and more predictable ways.

There have been reports in the media and claims in the debate that 90% of animal tests fail. That is incorrect. There is a high attrition rate in drug development, but there are many reasons why drugs that are assessed as potentially effective and safe in animals do not progress to market. It is an incorrect assumption to suppose that an experiment that failed was otherwise pointless. In many ways, that is the point of experimentation: to work out what works and what does not.

Information from animal studies has an important function throughout the drug development process. It allows for the identification of factors that can be monitored to assess adverse effects from potential new medicines in their first clinical trials and helps to establish the first dose that can safely be given in these human trials. That is a critical part of protecting the safety of the participants in those trials. Results of animal studies are used as the basis for extrapolation to indicate and manage possible risks to humans. 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.

I turn to the legal framework. ASPA is a specific Act to enable the use of animals in science while ensuring that there are specific protections for those animals. An assumption in the debate seemed to be that there are no protections for animals used in experimentation, but that is not the case. While animals used in science are excluded from the Animal Welfare Act, that does not mean that they are not protected in line with the underlying principles of the Animal Welfare Act.

To be clear, should this House seek to include animals in science in the Animal Welfare Act, as a number of Members have requested, no animals could be used for scientific purposes at all. That would result in increased risk to human and animal health and to the environment and a significant negative impact on the role of the UK in innovation and scientific progress. As my right hon. Friend the Member for North Thanet (Sir Roger Gale) pointed out, that could increase global harm, as much of that testing would be offshored. In certain jurisdictions that have restrictions, evidence of such offshoring is clear.

ASPA protects animals used in science by requiring the operation of a three-tier system of licences: licences are required for each establishment in which animals are used in science, each project that uses animals in science and each person who performs regulated procedures on animals. In addition, the regulators operationalising and enforcing ASPA operate a system to ensure the compliance of all those who hold licences under the Act.

Since January 2021, the Government have been implementing a reform programme, which has resulted in improvements to the way compliance is assessed by the Animals in Science Regulation Unit, which is the regulator in Great Britain. That includes systematically reviewing reports required under ASPA and conducting systematic team-based audits, thematic audits across all establishments, inspections based on specific triggers and investigations of potential non-compliance. Collectively, the reforms seek to improve compliance and therefore the protection of animals used. We will continue to oversee the implementation of further improvements and monitor and report on the regulatory outcomes achieved.

Patricia Gibson Portrait Patricia Gibson
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As the Minister will be aware, and as I said in my speech, section 24 of the Animals (Scientific Procedures) Act makes it a criminal offence for the information about how the animals are treated during experiments to be disclosed. It seems that the Home Office consulted on section 24 in 2014, but has not published the outcomes. Does he know why?

Kit Malthouse Portrait Kit Malthouse
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I am not aware of why we have not published the outcome of the consultation. Section 24, however, only blocks public officials from releasing information given in confidence, and it came into place before the Freedom of Information Act 2000. It has never been used alone since the Freedom of Information Act came into effect, and information is released on a regular basis—a couple of times a week, in frequency terms—under the terms of that 2000 Act, so it is not correct to say that it is section 24 that is restricting access. I understand, from my officials, that the consultation response will be issued later this year, as part of the work of the policy unit, which I will say more about shortly.

I turn to the use and regulation of dogs in science. The use of purpose-bred dogs for research in the United Kingdom is not prohibited under the ASPA. However, the use of stray dogs is prohibited. Under ASPA, dogs, together with cats, horses and non-human primates, are specially protected species. That means that greater oversight is required of establishments holding those species, and of projects using them.

No dogs are authorised for use within the United Kingdom if the scientific objective can be achieved without using animals, or by using animals of less sentience. As with all projects approved under ASPA, all projects proposing to use dogs in research must justify why any animals need to be used, why dogs need to be used and why the specific number of dogs and exact procedures are required.

Most dogs used in science are required for the safety testing of potential new medicines, in line with international requirements designed to protect human health. Dogs are a species often used in research because of their genetic similarity to humans, which means that they suffer from similar diseases, such as diabetes, epilepsies, and cancers. The dog genome has been sequenced and mutations mapped, so dogs are incredibly important in basic research such as on muscular dystrophy, where there is a known mutation in dogs.

Research using dogs has been instrumental in the development of more than 95% of all new chemical medicines approved for use in the European Union in the last 20 years. That has included medications for use in treatments for cancer, heart disease, diabetes, and specific genetic disorders. Establishments that either breed dogs for use in science elsewhere or conduct regulated procedures on dogs are required to provide care and accommodation to those dogs in line with the published code of practice for that purpose. Adherence to that code of practice, and to all other standard conditions applied to any establishment licence, is assessed by the regulator as part of its compliance assurance programme.

Establishments breeding, supplying or using dogs in science are contributing to critical activities to protect human health and advance scientific progress. They are operating legally within a regulatory framework that requires licensure and assessment of their compliance.

John Nicolson Portrait John Nicolson
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That is a long litany of justification, but perhaps the Minister would address just one specific point, which my hon. Friend the Member for Linlithgow and East Falkirk raised: what is the scientific or ethical justification for pouring chemicals into the stomachs of puppies without using anaesthetics? Could he address just that point?

Kit Malthouse Portrait Kit Malthouse
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The hon. Gentleman obviously uses emotive language to describe a practice that, I understand, is called gavage, where the feeding of compounds into the stomachs of dogs is done in such a way as to ensure a consistent dose at a consistent time for a consistent assessment. As the hon. Gentleman will know, very often the use of those chemicals is to assess two things: first, dosage and efficacy, and secondly, toxicity. I understand that that is the best method, scientifically.

John Nicolson Portrait John Nicolson
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And if that was your dog?

Kit Malthouse Portrait Kit Malthouse
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During the debate, a series of claims have been made about dogs being bled or force-fed, and I would be more than happy to correspond with Members on the scientific basis for those activities. While I understand that this is a very emotive and difficult issue—these are not pleasant practices that anybody would necessarily enjoy—there are sound, scientific reasons for their being employed. I would be more than happy to correspond with Members to explain how and why.

Tanmanjeet Singh Dhesi Portrait Mr Dhesi
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I thank the Minister for giving way; he is being generous with his time. As hon. Members have pointed out, the language may be emotive but it is the truth. I fear that the Minister has failed to answer the question why anaesthetics cannot be given to those animals suffering.

Kit Malthouse Portrait Kit Malthouse
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There are lots of circumstances in which anaesthetics are administered. Obviously, everybody is under an obligation to minimise whatever suffering may be incurred as part of an experiment. For example, reference was made to beagles being bled for scientific purposes. As I understand it, that happens from time to time but under terminal anaesthetic, and is not to be confused with the taking of small blood samples, akin to a human being giving a blood test.

The UK’s aim is to become the world leader for the development, access and update of new and innovative treatments and technologies. We also need to protect the health of humans, animals and the environment. To achieve these important outcomes, we will continue to need to use animals, including dogs, in science, until such time as alternatives are achieved for all purposes.

The Government remain committed to robust regulation of the use of animals in science. That continues to be achieved by a specific, targeted exemption from the Animal Welfare Act and the operationalisation and enforcement of the Animal (Scientific Procedures) Act, which exists specifically to regulate and protect animals in science.

We are committed to supporting and funding activities to replace, reduce and refine the use of animals in science. We accept that continuous improvement is always necessary, and therefore we are sponsoring a change programme to optimise the performance of the regulator for the use of animals in science in Great Britain. Additionally, we have established an integrated policy co-ordination function, currently in the Home Office, across the whole of Government to bring greater strategic oversight to the policy area of the use of animals in science. That will give the Government more effective management and assertive control over that area.

To conclude, Members have raised a number of issues, some which are historical, some of which, I am afraid, they are mistaken about and some of which require clarification. I am more than happy to correspond with all the hon. Members here today and answer many of those questions.

However, I finish with three points. First, it is currently the case that no human medical trials are possible anywhere in the developed world without safety testing in animals first. Notwithstanding the claims made by a number of Members today about comments made by particular scientists, that reflects the global scientific consensus at the moment, as I understand it.

Nevertheless, it is necessary for us to work on our three R’s strategy, to move towards less animal testing. Since 2015, we have had a three R’s strategy in place, devised by organisations such as the Defence Science and Technology Laboratory and medical research organisations. That is doing great work across the industry and ensuring that we get this right.

Rachael Maskell Portrait Rachael Maskell
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Will the Minister give way?

Kit Malthouse Portrait Kit Malthouse
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No, I am just drawing to a close.

Finally, I urge hon. Members to recognise that it is possible to be both an animal lover and accept the need for experimentation on animals, in the greater cause of human and animal health.