Animal Testing

George Freeman Excerpts

Monday 25th October 2021 Westminster Hall

[The Parliamentary Under-Secretary of State for Business, Energy and Industrial Strategy (George Freeman)]

It is a great pleasure to serve under your chairmanship in my fifth week in office, Ms Elliott. I am hugely grateful to the hon. Member for Linlithgow and East Falkirk (Martyn Day) and other colleagues for raising these important issues today, not least in the week in which the comprehensive spending review will be settled. I will then have a chance to look at the overall allocation of funding within the ecosystem for which I am responsible as Minister for Science, Research and Innovation.

I reassure colleagues, and those in the Public Gallery and elsewhere, that I take this issue very seriously, and I will explain my background in the sector.

I echo the comments made by a number of Opposition colleagues: if we are to provide a legacy for Sir David Amess, we ought to come together on this issue. I welcome the tone of everybody’s contributions, in particular that of the shadow Minister, the hon. Member for Newport West (Ruth Jones), which highlights the lack of partisan politics in this matter and the need to seek cross-party consensus. I welcome her reference to this Government’s 2015 ban on cosmetics tested on animals and the 1997 Labour Government’s ban. This country has taken and will continue to take the matter seriously, and we should be proud of that.

I was asked about 36 questions, which I will try to cover, but I want to flag in particular the important opening points made by the hon. Member for Linlithgow and East Falkirk, who spoke about the moral and legal considerations at the heart of the issue—he is right: this is not just a utilitarian argument, but a moral and legal issue about the values that we hold as a country—and about the importance of recognising that sentience confers an additional responsibility, which is enshrined in legislation but merits saying. Our obligations to mammals, for example, are much greater than our obligations to insects. That might be controversial in some places in this country, but I think that in this Chamber, people will understand the difference. I think that was an important and well-made point.

The number of signatories to the petitions indicates the strength of the public view on the matter. I sincerely thank all hon. Members for the quality of their contributions. I suspect the reason that there are not more colleagues on the Government Benches is that the main Chamber is currently debating the Second Reading of the Animal Welfare (Kept Animals) Bill, and while hon. Members have been speaking in this debate, I have been watching Conservative Members speaking in that one. It is fair to say that there is strong cross-party support for getting the framework for animal research right.

I thank and pay particular tribute to those who have spoken, including the hon. Member for Putney (Fleur Anderson), who raised the issue of values and the important role of companies such as the Body Shop and campaigns such as PETA—I echo those considerations. Transparency for consumers when purchasing goods is quite an important factor in driving the culture change that we need to see, and I support her on that point. She, like other Members, mentioned the importance of technology and the human-on-a-chip and organ-on-a-chip technologies that may hold the opportunity for us to completely liberate ourselves from reliance on animals.

The hon. Member for Stockport (Navendu Mishra) raised the important issue of force-feeding and factory farming. I think the whole House would like to move away from any reliance on factory farming, but while there is such a reliance, it is important that that activity is carried out to the highest standards and that public trust is supported by sufficient accountability.

The hon. Member for Rutherglen and Hamilton West (Margaret Ferrier) raised an interesting point about why no applications are turned down, which I will come to. The hon. Member for Slough (Mr Dhesi) mentioned the importance of complex cell models and highlighted the need for us to review the workings of the legislation. The hon. Member for Easington (Grahame Morris) highlighted quite powerfully the big difference between the amount of money—around £3 billion—spent on broader life science and medical-related research compared with the £100 million, or £10 million a year, spent on this issue. He made an important point about ensuring that the matter gets enough attention.

[Grahame Morris]

The Minister is being very thorough on some of those points. We are not, as he alluded to in his opening remarks and again just now, arguing for the outcome of the comprehensive spending review to be huge additional resource. It is about skewing the huge sums of money that are available towards this particular area. That would be more efficacious and beneficial for everyone concerned.

[George Freeman]

The hon. Gentleman makes a good point. I was about to say that the National Institute for Health Research—for which I was responsible in my previous ministerial role but one, as Minister for life sciences—puts about £1 billion a year into research on the practice of health. I will happily raise the issue with the relevant Minister at the Department for Health and Social Care, because quite important part of the NIHR’s remit is to build confidence in health research.

The hon. Member for North Ayrshire and Arran (Patricia Gibson) raised the important issue of accountability on the rate of progress, and the opportunities arising from the UK’s departure from the EU. I will try to come to all those issues in due course, and if for any reason I miss any, I will happily write to Members with the answer that I would have given had I had time.

I am personally passionate about this agenda for a whole raft of reasons, not just because I have a much beloved cat and dog as pets. Like everyone in the Chamber, and I think most people in this House, I feel very strongly that we have a duty of care as human beings to the animals around us. Also, having had a career in medical research before coming to Parliament in 2010, I have seen for myself the importance both of using every piece of technology to try to remove dependence on animals in the development of medicines and of carrying public trust in the research process with us.

As hon. Members have set out, in the life science sector a quiet revolution is going on, in which the traditional model of drug discovery—which typically takes 15 years and $2 billion, and has an 80% failure rate—is being quietly transformed by revolutions in genomics and informatics, allowing us to move from a paradigm in which the industry would typically try to develop one drug that suits all through a long and complex cycle of theoretical drug discovery targeting, in silico chemistry, then through into in vitro models, animal trials, human trials, and marketing and National Institute for Health and Care Excellence approval.

The revolution in genomics and informatics allows us to begin to target patient groups, develop drugs around particular blood types, genotypes and phenotypes, and cut out a lot of the long, traditional drug discovery process. It is a revolution that I am passionate about, not just because it will in due course reduce, and possibly even eradicate, the need for us to rely on often unreliable animal models. Members will have heard me talk in other places about the need to move away from necessary but imperfect models of human disease.

[Mr Dhesi]

The Minister is being generous with his time. I take on board his points about the quiet revolution in genomics and medical science more generally, but while that is taking place, millions of animals are being terrorised and killed. It is not benefiting us or them, so when will we set some deadlines and targets for the elimination of animal testing?

[George Freeman]

I understand the hon. Member’s point and I will come to it. I could not quite agree that our reliance at the moment on animal testing is of no use at all; it is of important use in defining certain elements of toxicity and safety. It is not perfect, but to say that it has no use is not fair. I will come to his point about how quickly we need to make progress.

Part of my passion for this is that I tried to found a company developing toxicology artificial intelligence—predictive software that would predict the toxicology of compounds so that we do not have to rely on animal models. I care sufficiently about it that I took the trouble to do that. Let me share with colleagues one thing that I discovered in that process, which speaks to the delicacy sometimes around transparency. Passions in this sector understandably run very high. I know that colleagues will be shocked to discover that, in the course of putting together a company to develop toxicology software, one needs to be able to understand the experiments that are currently being done in order to model them better using software. That meant that on the board of the company we had somebody from Huntingdon Life Sciences so that we could understand the processes that we were having to replace.

The presence of that person on the board was alone sufficient to attract huge and violent attacks from Stop Huntingdon Animal Cruelty. Of course, who on the board did they pick on? Was it any of the eight men, of whom I was one? No. They picked on the company secretary—the member of the board least responsible for the company. She lived alone in a cottage in the fens, and woke in the middle of the night to find 20 people in balaclavas daubing her house with red paint, calling her a bunny killer. I flag that story because it speaks to the passions and the need for a balanced approach, in the way that colleagues have raised the issue today.

If we are to be transparent and accountable, we need to ensure that that transparency and accountability can be shared, and that we are not putting particular people at risk. However, I share the point that we need to do everything we can to ensure that the quiet revolution accelerates, and that we reduce the reliance on animals for research as fast as we possibly can and to as great an extent as we can.

Allow me to describe briefly the framework that we have in place. Why is the use of animals in scientific research justified at all? It is justified because, at the moment, it is vital for identifying benefits to humans, animals and the environment. We have to try to balance that dependence with our commitment to the highest animal welfare standards. That is the basis on which the current law is drafted. The balance between those two elements is reflected in the fact that we have a dedicated Act to make sure that animal welfare and animal research are properly integrated. The responsibility for managing that Act lies with the Home Office and the Home Secretary, not with me, but I will raise the issues mentioned today with the Home Office.

The Act specifies that animals can be used in science only for specific limited purposes where there are no alternatives—a crucial point—and provides protection for those animals through the requirement for application of the three Rs: replacement, reduction and refinement. Today’s debate raised three related but separate issues that contribute to the Government's overall strategic direction and policy: first, the benefits derived from the use of animals in science where there are, as yet, no alternatives; secondly, the regulatory regime that facilitates such use; and thirdly, our support and commitment to the funding of the three Rs in order to accelerate progress away from reliance.

Let me take each in turn. At the moment, animal testing research plays a vital role in understanding how biological systems work in health and disease. It is crucial to our understanding of new medicines and cutting-edge medical technologies for both humans and animal health, and it supports the safety and sustainability of our environment by helping to reduce dependency on chemicals. Animal research has helped us to make life-changing discoveries for new vaccines and medicines, transplant procedures, anaesthetics and blood transfusions —not least the development of the covid-19 vaccine, which was made possible because of animal research.

While I accept that we need to try to move away as quickly as possible, one must remember that we are using animals only because it is the way we have evolved towards minimising exposure of human beings to dangerous drugs. I assure hon. Members that if we were to completely remove all animal use from medicines research, we would expose our own kith and kin to much higher risks. That would quickly be seen as irresponsible.

We need to find a way of substituting those pre-human tests as quickly as possible. Although much research can be done into non-animal models, there are still purposes for which, sadly, it is essential to use live animals, as the complexity of whole biological mammalian systems cannot always be replicated using validated non-animal methodologies. That is especially the case where human medicines are developed.

[Grahame Morris]

The Minister is being generous, and he will want to make progress. An example of a drug that went through extensive animal testing through the established processes is thalidomide. Animal testing is not infallible. We have discovered subsequently that some drugs that have been through established animal testing can be repurposed. We have now discovered that it is an extremely effective drug against leprosy and other conditions. There is rightfully scepticism about statements that animal testing will ensure that drugs are completely safe, because that is not the case.

--- Later in debate ---

[George Freeman]

The hon. Gentleman makes an important point. I am not suggesting that the current system is 100% perfect at all. In fact, I made it clear in my earlier comments that, often, animal models are not perfect predictors—he is right to say that. But it is equally the case that, without the animal models, an awful lot of drugs would be taken forward into humans with hugely damaging side effects and no benefits. The point is not that once something has been through animal testing it is a perfect drug. Going through animal testing prevents exposing humans to potential drugs that are simply unsafe. It is not perfect, but that is the situation. He is right to point out that animal testing itself is not a guarantor of efficacy.

The truth, sadly, is that without testing of medicines using animals at the moment, we would not know whether medicines are safe or effective for use in humans or animals, and that would limit the availability of medicines to treat disease and of chemicals that could be used for a wide range of purposes in many industries. There is a human health and safety part to this. In order to protect workers in the chemical and agricultural industries, we need to ensure that we understand any toxicity of those chemicals before they are used. Without the testing of chemicals on animals, where no alternative methodologies are available, we would not know what hazards they present. Many products that are not safe in humans or the environment are detected through animal testing, thus avoiding harm downstream.

[Ruth Jones]

Will the Minister give way?

[George Freeman]

Yes, but I do have to make some progress.

[Ruth Jones]

I thank the Minister for giving way. None of us would disagree that we want to keep humans safe, but a lot of people have concerns about the repetition of unnecessary tests, and about Constant, ongoing testing for chemicals, cosmetics and such. It would be great if the Minister could address that issue.

[George Freeman]

The hon. Lady makes an interesting point, which I will come on to. Animal testing is required by all global medicines regulators. I want to be clear that this is not a UK phenomenon, but it does include the UK’s Medicines and Healthcare Products Regulatory Agency, which is widely held to be setting the global benchmark, not least in vaccine discovery. Animal testing of chemicals is sometimes required under UK law, often relating to the quantity manufactured to protect the safety of workers exposed to those materials in large amounts and the environment when chemicals may find their way into the waterways, soil or atmosphere. All testing of chemicals on animals under REACH, the EU regulation on the registration, evaluation, authorisation and restriction of chemicals, is subject to the “last resort” principle, which means the manufacturer must always—it is a legal duty—consider alternative approaches first and, in some cases, secure the agreement of the regulator before proceeding.

In order to obtain these benefits that accrue, it is necessary to exempt such animals from the Animal Welfare Act 2006 and put in place specific protections for them in a dedicated Act. A number of colleagues raised the question of why this is not covered by the 2006 Act. It is actually the other way round. We have specifically put the use of animals in research into their own legal framework under the dedicated Animals (Scientific Procedures) Act 1986, known as ASPA, which, as I say, is the responsibility of the Home Office. The underpinning principle of ASPA is to protect animals which are sentient, in terms of their capacity to experience pain, suffering and distress. Therefore, protection of animals on the basis of their sentience is the very principle established in the legal framework.

ASPA protects animals in a number of ways. It requires a three-tier system of licensing for individuals conducting procedures on animals, the programme of work that will use animals and the place where animals will be used. Licence holders are required to undergo training and a competency assessment, and to have legal responsibilities to have systems in place to protect animals, in compliance with ASPA. Licences are granted only if the scientific purpose is permissible under the law and the research is conducted in line with the three Rs. That means work can be conducted in animals only if there are no alternatives, the minimum number of animals are to be used to meet the scientific objectives, and the level of harm caused must be limited to the minimum needed to achieve the approved scientific outcome. Thus, it is illegal in the UK to use an animal in science if the scientific objective can be practicably met using a validated non-animal alternative.

ASPA requires that all animals need to be housed and cared for in accordance with the code of practice published for this purpose. The regulator enforcing the Act operates a system to assure compliance of licence holders with the Act and the conditions of their licence, including inspection, audit, review of reports and managing cases of potential non-compliance. Under ASPA any testing required by another UK regulator is permissible. The requirement for such testing is set by the relevant expert regulator, such as the MHRA or the Health and Safety Executive.

With regard to testing of cosmetics, animal testing has been banned in the UK since 1998, and it is illegal to test cosmetic products or their ingredients on animals to meet the requirements of the 2009 regulations for cosmetics. However, ingredients used in cosmetics may require animal testing under other legislation, including REACH, for example to assess the safety of workers in manufacturing plants. Such testing can be lawful in the UK and is not in conflict with the bans under the cosmetics regulations. Under UK regulations to protect the environment and workers from the risks of chemicals, animal testing can be permitted under REACH where required by UK regulators. Again, however, such testing can be conducted only where there are no non-animal alternatives.

That brings me to the importance of the development of those alternatives, which, as the Minister for Science, Research and Innovation, I am also committed to, because it is a huge sector for this country to lead in. In the report on post-Brexit opportunities that I wrote for the Prime Minister earlier this year, I argued that the UK should use our freedoms from the EU regulatory bloc to reach for the top and to regulate in these emerging areas of technology in order to build consumer and investor confidence. This is one of the areas where we could set the gold standard—we could set the benchmark for international groups to follow. That is why the Government actively support and fund the development and dissemination of the three Rs—replacement, reduction and refinement—programme. This is achieved primarily through funding for the National Centre for the Replacement, Refinement and Reduction of Animals in Research—NC3Rs—which works nationally and internationally to drive the uptake of technologies and to ensure that advances are reflected in policy, practice and regulations on animal research.

It is fair to say that the NC3Rs is viewed as being world-leading. Since its launch in 2004, we have committed £100 million through its research, innovation and early career awards in order to provide new three-R approaches for scientists in academia and industry. I am delighted to say that the relevant research council has increased funding by another 8% in the last year. That includes almost £28 million in contracts through its CRACK IT Challenges innovation scheme to UK and EU-based institutions, mainly focusing on new approaches for the safety assessment of pharmaceuticals and chemicals.

I checked earlier today, and it is not fair to say that nothing has come of that work. There is a whole raft of very important incremental improvements, including the development of in silico models of cardiotoxicity with Professor Rodriguez and in vivo models of liver tox and kidney tox, as well as the development of virtual dog modelling as part of the £2.5 million programme for the digital dog, to substantially reduce dependence on dogs in research.

The NC3Rs and the MHRA work to bring together stakeholders in academia, industry, Government and animal welfare organisations in order to facilitate the exchange of information and ideas and the translation of research for the benefit of both animals and science. That has led to changes in international regulations, and the NC3Rs has just recently launched a new £2.6 million call for the development of the virtual dog, to draw together technologies across the country. Building on the work of the NC3Rs, UK Research and Innovation is also funding a portfolio of research involving humans, animal models and non-animal technologies.

As hon. Members have highlighted, breakthroughs in stem cell research, cell culture systems, lab-on-a-chip, organ-on-a-chip, new computer modelling and imaging technologies, and the place of AI all provide a powerful nexus for technological approaches that will reduce, and in due course eliminate, the need for us to rely on animal models, but we have to move at a pace at which we can guarantee human safety in the development of new drugs. In 2015, the non-animal technologies road map for the UK was published by Innovate UK and the NC3Rs, in partnership with the research councils and the UK’s Defence Science and Technology Laboratory. The NC3Rs and Innovate UK are currently reviewing the impacts of the investments that were made—a review in which I will be taking a keen and close interest.

In the time available, let me try to respond to some of the specific questions that were raised. The hon. Member for Easington raised the statistics on the number of experiments, but the number of experiments is not the same thing as the number of animals. One of the metrics that we are driving is to reduce the number of animals used—I just wanted to flag the difference between those two.

Animal sentience is already enshrined in law. It is a very important principle, which is precisely why we have a separate legal framework.

Various Members asked why we are not doing more to promote alternatives. I want to highlight that the existing law prevents the testing of animals, if there are alternatives. I am keen to make that very clear and to ensure that the whole industry understands that obligation.

The hon. Member for Easington raised the issue of the failure of medicines in humans, which I have tried to address. Nobody is suggesting that the use of animals is a guarantor of efficacy and safety in humans, but it is an important barrier to the unnecessary exposure of humans to unsafe medicines. I agree with him that we need to move as quickly as possible to find alternative ways to do that.

A number of colleagues mentioned the statistic that 90% of animal experiments fail. That is the same point, really. If “failing” means that those experiments do not perfectly predict efficacy and safety in humans, that is true, but the point is the other way around: those experiments are done to make sure that those things we know will not work in humans are prevented from going near humans. They are not the definitive and final test. The hon. Member for Putney mentioned that work is being done to improve the predictive quality of animal tests, which is a really important point, and we need to continue to manage that work. International bodies such as the OECD and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use are working on that issue, but following this debate I will be asking for reports on what progress has been made. I will be happy to share that information with colleagues who are here today.

Colleagues asked whether the funding for human-based research has been increased. The £100 million figure is over 10 years. The Biotechnology and Biological Sciences Research Council has increased that figure by 8% for this year, and I assure Members that, following the comprehensive spending review, I will be looking to make sure that number is not reduced and, if possible, is increased. That is important, primarily for animal welfare and trust in research, but also because moving away from unnecessary and avoidable animal experiments and towards more accurate models as quickly as possible is good for UK life science, research and drug discovery. The hon. Member for Putney raised the issue of the balance between animal and non-animal testing, and I reiterate that using animals is allowed only where there are no non-animal alternatives.

Colleagues raised the issue of animal testing establishments breaking the law. There is a very robust system of licensing and inspection of such establishments, and any non-compliance is appropriately dealt with through a range of remedies, which start with advice, letters of reprimand and retraining, but ultimately lead to fines and prosecutions. I reassure Members that, from my point of view, any evidence of malpractice needs to be treated with the very highest degree of urgency, because public trust in this system is absolutely key.

The hon. Member for North Ayrshire and Arran raised the issue of botulinum. To reassure the public, that was only the case for botulinum as a registered medicine being tested before it goes into humans. The issue of force feeding—which is a controversial term—was raised. I have checked the reason for that, and it is about making sure that the correct dose is administered, but again, the point is well made: we need to make sure that is being done in the most humane and sentient-friendly way. The hon. Lady also raised a question about the tightening of regulations. Those regulations are always being reviewed. This year the Home Office commenced a regulatory reform programme to ensure that leading regulatory practice is followed, and again, following this debate, I will be asking for an update about what improvements have been made. Finally, the hon. Lady raised the issue of tightening of regulations for cosmetics post-EU exit. We are now in the same position as the EU: testing on animals for cosmetic marketing is allowed only if no non-animal alternatives exist. The controversial case of Symrise is currently with the European Court of Justice.

In conclusion, some excellent points have been raised today. I will not repeat them all; I think I have set them out. I will be raising them with the Home Secretary and the Home Office, and while I do not believe we are yet at the point where we can completely move away from reliance on animals, I make it very clear that we need to move faster. We need to reiterate to the public that that is our intent, and that we have a duty of care and a commitment to better drug discovery. I believe deeply that genomics, phenotypics and data are key to that, and I hope all Opposition Members will join me in making the case for better use of data in the NHS to support drug discovery, because that is a key argument that is often not made. I am very happy to accept the challenge of providing a personal guarantee to the hon. Member for Newport West that, as Minister for Science, Research and Innovation, I will make every effort to avoid all unnecessary suffering.