The Parliamentary Under-Secretary of State for the Home Department (Lynne Featherstone)
I am grateful to my hon. Friend the Member for Southend West (Mr Amess) for securing this important debate. He has a long and honourable track record in campaigning on these issues. I am also grateful to others who have contributed to this debate, albeit through interventions.
Before I deal with the detailed points that my hon. Friend raised, I would like to assure him that I share his concern for the welfare of animals. Indeed, I take the responsibilities in my portfolio in that regard extremely seriously. As the Home Office Minister responsible for the regulation of animal experiments, I am in no doubt that we should license the use of animals only where it is essential and where there is no alternative. That is also Government policy. The Government recognise that the regulation of animal experiments is of significant public interest. In fact, I am sure that Members across the House receive many letters on the issue. We are therefore strongly committed to ensuring the best possible standards of animal welfare and protection for animals that are used for scientific purposes.
Current legislation provides a high level of protection for animals that are used, as I am sure my hon. Friend knows. Work cannot be licensed if it could be carried out without using animals, and the procedures must cause the minimum possible suffering to the smallest number of animals of the lowest sensitivity. I believe that this approach reflects closely what the public want and expect. In addition, the Government have made two specific and important commitments in respect of animal experimentation. The coalition agreement commits us to work to reduce the use of animals in scientific research and to end the testing of household products on animals. The commitment to work to reduce the use of animals is being delivered through a science-led programme led by the National Centre for the Replacement, Refinement and Reduction of Animals in Research, and the commitment to end the testing of household products on animals will be implemented using our licensing powers under the Animals (Scientific Procedures) Act 1986.
Roger Williams
I, too, am greatly concerned about animal welfare and the Minister will know that I have asked a number a questions on the issue. I recently visited Cardiff university to see how the animals kept for scientific experimentation were looked after. The key thing for me was that the relevant science departments were open to inspections at any time—night or day—as a particular inspector could ask to visit at any time. I thought that that provided a real safeguard for animal welfare.
Lynne Featherstone
I thank my hon. Friend for that intervention. He is indeed a frequent writer of questions to me on this issue. One of the key factors in holding standards so high is that the inspectorate can come in, at any time and in any place.
I shall touch briefly on European directive. The directive strengthens the protection of animals used in scientific procedures and harmonises regulation across the 27 states of the EU. We have very high standards in this country, and the ask is that we maintain them. I cannot give a specific commitment on specific issues until I have received and considered advice following the large response to the consultation exercise.
Margot James
I wonder whether the Minister is absolutely certain on the point about the EU directive. It is widely reported that that directive will remove the responsibility of scientists to review all other possible methods of research prior to testing on animals. Publications, including The Economist, have widely reported that; it may be erroneous, but I wanted to raise it.
Lynne Featherstone
I thank my hon. Friend and I can assure her that it is erroneous—and I hope those at The Economist are listening to this debate. We must be factual and ensure that we talk only in realities about this sensitive and important issue.
Nic Dakin (Scunthorpe) (Lab)
I very much welcome the Minister’s comments about the high standards of animal welfare that the UK Government uphold. I take it from what she says that in carrying out the transposition of the EU directive to this country, every effort will be made to maintain our high standards.
Lynne Featherstone
The European directive provides an opportunity to reduce some of the bureaucracy, but when it comes to animal welfare, I am looking closely at anything that might suggest any reduction in standards.
Paul Flynn (Newport West) (Lab)
Other forms of animal abuse involve small numbers—hundreds or thousands—of animals, but in comparison animal experiments involve them in their millions. Will the Minister tell me how many animals are subjected to experiments now and what she hopes the numbers will be in 2015?
Lynne Featherstone
I will have to write to the hon. Gentleman on the absolute numbers. I am not sure whether he means every animal in every experiment. What I am looking at in respect of the coalition commitment is whether we can use absolute numbers, how we should count genetically modified animals that receive no other harm, and what impact would be made if this country’s scientific community were to attract more investment. I am looking for something substantive, so that we can know exactly where we are with animal usage in experiments and so that I can deliver the coalition commitment in real terms.
Let me deal with some of the specific issues raised by my hon. Friend the Member for Southend West. He asked about thalidomide. At that time, there was much less animal testing, and thalidomide was tested only on rats. The toxic effects, however, are seen in rabbits. That tragedy led to the current system of testing, which is more robust.
Paul Flynn
If the Minister looks at the research findings, she will find that thalidomide was tested on rabbits, and tested on pregnant rabbits. Only when it was tested again on a particular strain of rabbit did the deformities appear. That is an example of a major failure of animal testing.
Lynne Featherstone
I accept that it was a major failure, as was the testing of Vioxx, notably in the case of the six gentlemen who went for trials. However, I am sure that if I asked my officials to find examples of test results that have been beneficial to mankind and saved many lives, we would see the other side of the coin. I do not think absolute policy should ever be based on specific and exceptional incidents, but we all work constantly to improve the situation.
Vioxx was licensed for clinical use on the basis of a battery of tests, including non-animal tests, animal tests and clinical trials. The problems were extremely rare, and came to light only when tens of thousands of patients were prescribed the medication. However, it is now alleged that the manufacturer, Merck, suppressed some safety-relating findings. I do not know whether that is the case, but if it is, there may be no substance in the belief that animal test data were misleading.
Let me now deal with the key issues raised by my hon. Friend the Member for Southend West about the usefulness of animal models as a means of investigating human disease. I have some sympathy with his arguments, to the limited extent that I think we should look critically at the animal models that are used and replace them with new or better models and technologies as and when they are developed. I believe that that is what happens in practice, but if there is complacency, I will do—indeed, I am already doing—my level best to challenge it, and so, I believe, will the National Centre for the Replacement, Refinement and Reduction of Animals in Research. I have visited laboratories and met representatives of the centre, and I think there is a general consensus that good science results from the best research, whether it involves animal models or human trials. We want good science, because there is no point in coming up with results that do not lead people to want to do their work in this country and obtain the best results.
Lynne Featherstone
I fear that the hon. Gentleman is more of an expert than I am.
Paul Flynn
The Minister has been very generous in giving way.
In the case of Vioxx and Seroxat, both of which have had major adverse side-effects, the problem seems to lie with the regulatory body. The Medicines and Healthcare products Regulatory Agency is funded entirely by the pharmaceutical industry. Until we have some independent control, the suspicion will always be there that the one who pays the piper calls the tune for commercial gain.
Lynne Featherstone
The hon. Gentleman has raised an interesting point, but my hon. Friend’s main point seemed to be that the human trials of Vioxx revealed an issue of which no one took any notice.
I think that my hon. Friend went a bit too far in suggesting—if I heard him aright—that animal models could not, or perhaps could only rarely, be used effectively to find treatments for human diseases. I believe that they have contributed hugely to the development of drugs that have saved lives.
Jim Shannon
What is sought by Members, and by many outside the House, is an assurance that any potential or suggested changes, or improvements, made by the Minister would not affect experimentation on animals to provide new medication that could save lives. It is clear that the medicines that have been perfected through such experimentation have saved not just hundreds of thousands but millions of lives. Can the Minister assure us that it will continue?
Lynne Featherstone
I can assure all Members in all parts of the House that the Government want the development of those medicines to continue, as long as a responsible and careful attitude is adopted to the animals that are used in the quest for better medicines. Those who conduct such experiments must adhere to the stringent standards to which I have referred, and search further and harder for alternative technologies. When I visited University College hospital recently, I saw some of the machinery that it is using instead of animals. The advances that have been made, have almost been made or will be made in the near future are amazing, and I am sure that any institution, whether a university, a scientific research establishment or a commercial venture, will want to provide the best conditions for their animals in order to get the best results.
Chris Williamson
On that basis, will the Minister assure us that we can look forward in the next few years to a significant reduction in the use of animals in experimentation, given that alternative methods are now available and more are coming on stream?
Lynne Featherstone
My intention and job is to push as hard and as far as I possibly can. In that, I have to be advised by the scientific community, my advisers, the Animal Procedures Committee and other groups, and I often meet animal rights and welfare groups to ensure that I get the balance right. I cannot give a definitive number, but the intention is to secure a reduction, as promised in the coalition agreement, in the use of animals. The NC3Rs is doing some amazing work and incentivising scientists to be innovative and to come up with good things that people will want to use. I have not brought the brochure with me but it was incredibly impressive on some of the changes that it is delivering. However, we can only go at a pace that can be gone at because, as the hon. Member for Strangford (Jim Shannon) said, I would not wish to inhibit genuine advances in what we can do to preserve human life.
Although there are differences between animals and humans, there are also many similarities, and it is these similarities that scientists seek out when choosing and developing animal models. In most cases, because body systems in other mammals tend to work in similar ways to those in humans, animal tests can predict how the human body will react to a new drug. Otherwise, they would not be used. It would be useless.
On the safety of medicines, which goes to the heart of this debate, animal studies are considered to be an indispensable component in the assessment of the safety and efficacy of a new medicinal product. Without animal testing, it is highly likely that a large number of potentially dangerous medicinal products would have to be tested in healthy volunteers and patients in clinical trials. That would be quite unacceptable. I shall mention micro-dosing in a moment.
For a medicinal product to be granted a licence, European and international legislation requires that the toxicity profile of a new drug be defined. In part, that entails the use of animal studies. Nevertheless, I accept the point made by my hon. Friend the Member for Southend West that the earlier a potential new drug can be safely tested in humans the better. Companies are pursuing this through methods such as micro-dosing, but that approach does not replace animal tests entirely.
On the use of new technologies and non-animal tests, I can assure my hon. Friend that, contrary to his fears, the testing of medicines has evolved and that new scientific methods, including those using human tissues, are being used and do have a place in safer medicine testing.
Today’s approach to drug development has evolved on a rational and scientific basis over more than 30 years and involves an integrated programme of computer-based work, in vitro studies, animal testing and clinical trials. I can report from my own observations on a recent visit to one of our leading universities that modern researchers use a variety of in vitro and computer-based methods alongside animal methods.
My hon. Friend mentioned adverse drug reactions. This is a far more complex matter than it at first appears. Like other Members, I have personal experience of this, as I am allergic to some common drugs that most people can take without difficulty. I attribute that not to an inherent fault in the drugs, which seem to work perfectly well for millions of other people, but rather to a quirk in the way my body reacts to them. I am allergic to certain antibiotics.
More generally, I think it is going too far to suggest that the occurrence of adverse drug reactions can be attributed to flaws in safety testing using animals. It has been estimated that 76% of adverse drug reactions are what are known as type A reactions, in which the medication has a predictable, but exaggerated, effect. Of the remaining, unexpected type B reactions, most are the result of allergies, such as mine, or individual susceptibilities that are difficult to predict in any trial.
On the attrition rate in the development of new drugs, new drugs are first tested in batteries of computer-based and in vitro tests. Refinements of these tests, including by using human tissues, are making them increasingly predictive. Many compounds are rejected as a result of findings from these tests before they are even tested in animals. It is true that at the next stage, as a result of adverse findings from animal studies a large number of drug candidates never progress to being tested in humans. However, as I have already mentioned, companies hope that this attrition rate will be reduced by using human material.
Finally, on the value of animal research, it is at present the case that without the judicious use of animal studies we would have no modern drugs, and we should acknowledge that the national health service would be unable to function effectively were it not for the availability of medicines and treatments that have been developed, or validated, through research using animals.
As I have explained, the Government are committed to minimising animal testing and to encouraging the development of other non-animal methods in place of animal testing where possible. The National Centre for the Replacement, Refinement and Reduction of Animals in Research brings together stakeholders in academia, industry, Government and animal welfare organisations to facilitate the exchange of information and ideas and the translation of research findings into practice that will benefit both animals and science. We will continue to give the work of the national centre our wholehearted support.
My hon. Friend the Member for Southend West asked the key question at the end of his speech: on what basis do the Government refute the evidence that a number of human biology tests predicted adverse drug reactions that animal tests failed to predict? The Government do not doubt the value of human biology tests in the testing of the safety of medicines, but it is important to recognise that all medicines have the potential for unwanted effects. There is not one in vitro test, or one series of in vitro tests, specifically for adverse drug reactions. It must be recognised that even extensive clinical trials in humans do not always predict the adverse drug reactions seen later when drugs are in widespread use.
If I have omitted to answer any of my hon. Friend’s questions, I will write to him. I thank him and all Members who have participated. This has been a valuable and thought-provoking debate, and I am grateful to my hon. Friend for securing it.
Question put and agreed to.