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.