“With rare exceptions, the answer to this is likely to be negative.”

The process before clinical drugs come to be tested on a human being should be well understood, but I am not sure that it is. Anyone who hopes to get a new drug on to the market must first put it through a series of tests on various animals. It is that reliance on animals as a final safety screen before products go to clinical trials that concerns me, for that “safety screen” is no such thing. Animal models are not a reliable indicator of how a human being will react to a drug.

My hon. Friend the Member for Stourbridge (Margot James), who has just taken her place, will be glad to hear that I have already raised the European directive that she is concerned about, and that the Minister nodded. I am therefore optimistic that Home Office officials will be working on the advice right now.

The safety of medicines is an issue of increasing concern. Every year, 1 million Britons are hospitalised by prescription medicines. That costs the NHS up to £2 billion a year. The Safety of Medicines Bill, which I introduced earlier this year, is intended to safeguard against this growing problem. I believe that the Bill has widespread support—but then I would say that. However, it has been misrepresented, although not intentionally I am sure, and it has certainly been misunderstood. Although my opposition to cruelty to animals is well documented, it is important to make it absolutely clear that the Bill does not call for animal tests to be replaced per se. It is about determining the best means to ensure the safety of medicines and to protect patients against adverse drug reactions.

It could be argued that the use of animals is ethically and morally wrong. Many people would argue that strongly. However, in this debate the criticism of the use of animals focuses not on the suffering of the animal, which can be quite shocking, but on the fact that animal models are not accurate indicators of human responses. That in turn creates risks for volunteers, patients and sufferers during and after human clinical trials. I believe that there is ample evidence to support the argument that animal models do not function properly in their role.

Jim Shannon (Strangford) (DUP): I do not often disagree with the hon. Gentleman or question him. However, there are many examples of medicines that have been perfected by their use on animals and have saved lives. How will he ensure that that continues to happen, given what he has been setting out? My concern is that there is some goodness in this practice. Let us not lose that.

Mr Amess: The hon. Gentleman and I do not disagree on many things, and it would be a shame if we fell out on this issue. I hope to prove by the end of my contribution that there would certainly not be the adverse impact that he fears.

Chris Williamson (Derby North) (Lab): I congratulate the hon. Gentleman on bringing this issue before the House, and I very much support him. I am sure that he is going to come on to this point, but my response to the hon. Member for Strangford (Jim Shannon) would be that in an infamous case, thalidomide was proven safe

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for use on animals, but we all saw the tragic consequences of that. There has been a lot of publicity about that, but there are many other examples that have not had the same level of publicity. As the hon. Member for Southend West (Mr Amess) pointed out—before the hon. Member for Strangford came into the Chamber, I think—1 million people a year are hospitalised as a result of taking prescription medication. We must consider that problem, and I hope that the Minister will listen to the contribution of the hon. Member for Southend West this evening.

Mr Amess: I welcome the support of the hon. Gentleman, whose maiden speech I was privileged to follow. I am going to mention two or three cases that enforce what he says.

There is ample evidence to support the fact that animal models do not function in their role. That is a very important matter for the Home Office to consider. In my time here many Ministers have held the relevant responsibility, and of course those advising Ministers are also very important. I do not expect the Minister to give me a firm yea or nay during the debate, but I hope she will write to me about the points that I make.

Experiments on animals cannot predict the mechanisms of the disease in question, risk factors or potential adverse reactions. According to the US Food and Drug Administration, the world’s largest drug regulator—I hate to keep using America as the example, but it seems to have the latest data—92% of potential new drugs fail in human trials. We cannot just dismiss that, because it is huge number, but no publicity is given to it. The drugs fail either because they do not work on, or are not safe for, humans. I will come later to one famous and disastrous incident. After appearing safe and effective in animal tests, those drugs fail completely.

Communities of senior scientists are very much aware of the dangers of using animals as human indicators. The Safer Medicines Trust, the patient safety charity of senior scientists, including Sir Ian Wilmut, the renowned “father” of Dolly the sheep, has expressed its concern. It is clearly not opposed to animal experimentation per se, but it is concerned for patients and for science in general. Indeed, it has sent open letters to the Prime Minister and the Secretary of State for Health stating that the current system for ensuring the safety of medicines before clinical trials is inadequate and results in harm to volunteers and patients.

These are difficult times, and I know that people are paid to volunteer for trials, but there have been a number of well-documented disastrous consequences. The danger to human beings from the use of animal testing is clear. Even in pre-clinical stages, lives have been lost because the results have misled scientists.

I wonder how many people realise that penicillin stayed on the shelf for more than a decade because the results in the rabbits on which Fleming tested it led him to believe that it would be ineffective in humans. That was quite the wrong outcome—and we can think of the number of lives that could have been saved all those years ago.

Lives are threatened in the human clinical stages of trials. In March 2006 six young men took part in a clinical trial at Northwick Park hospital and were nearly killed by a drug that had been tested on monkeys and shown to be safe, even at 500 times the dose that the

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men were given. That is not a trivial matter, and I can remember clearly when it happened. Again, I do not expect the Minister to respond now, but I hope that after she has taken advice she will be able to discuss what happened in that trial.

Clearly, the results from the monkeys created a false sense of security, yet the risk carries over even when drugs pass to market. Any number of hon. Members will have had constituents lobby them on the painkiller Vioxx, which was eventually withdrawn in 2004 after the biggest drug disaster in history—it killed more than 100,000 people worldwide in its five years on the market. Clinical trials of Vioxx revealed up to a fivefold increase in the risk of a serious reaction such as heart attack, heart failure or stroke, but tests on animals indicated that it was safe, and in some instances that it was protective to the heart, which supported the manufacturer’s decision to market the drug. I am currently dealing with two or three constituents whose loved ones were affected by the drug, and who are trying to get compensation, which, as hon. Members know, is quite a tough battle. One hundred thousand people were affected worldwide.

Why should animals be indicators of human response? Animals and humans are evolved complex systems and as such should be expected to demonstrate different responses to drugs and disease.

Margot James (Stourbridge) (Con): A number of drugs registered for humans are effective in animals. Dogs in older age respond very well to Prozac if they are a bit down, and a hypertension drug for humans has proved effective in restoring the vitality of apes in zoos in Britain.

Mr Amess: I apologise to my hon. Friend in case I was going too far on one side; my argument needs to be balanced.

Mutations that cause genetic disease in humans are the norm in some animals. Johnson et al found in 2001 that out of 39 anti-cancer drugs tested on xenograft mice, only one mimicked the response in humans. I say to the hon. Member for Strangford (Jim Shannon) that that cannot be much to rely on.

Jim Shannon: We need balance in the debate because we are getting one side of the argument but not the other, which is that drugs have been successful in saving lives. I am not taking away for one second from those who have died as a result of inappropriate drugs but, with respect, we need that balance, but we are not getting it.

Mr Amess: Frankly, one life lost is too many, but we could have a big argument—

Jim Shannon: One life saved is worth it.

Mr Amess: Yes, I agree with the hon. Gentleman that it is a question of balance, but I hope to prove that animal experimentation is completely unnecessary and that we can achieve the same results through different methods.

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There is a variation of response within humans—African Americans are more susceptible to lung cancer than Caucasians—so how can we expect animals to be reliable models?

Using animals as human indicators is also expensive, for it can keep cures off the market, hence the large cost of modern drugs to consumers and the health service generally. In the words of Robert Weinberg, from the Massachusetts Institute of Technology, the use of pre-clinical tests results in

“hundreds of millions of dollars…being wasted every year by drug companies using these [animal] models”,

according to Leaf 2004.

Other areas of valuable research that might help in understanding the impact of drugs in human beings suffer as a result of animal testing. Despite animal models forming a very minor part of research, they receive a large proportion of funding. Society does not need new research methods; it simply needs to fund the ones that we already have. The important point is that it is possible to test these clinical drugs on humans, so that we can have a better indication of how they will react pre and post-clinical trials.

Society needs to make a fundamental change from animal-based research to human-based research. If it is humans whom we are trying to help, then scientists must study disease and drug reactions in humans. New technologies, outlined by the Safer Medicines Trust, are based on monitoring human responses to new drugs in a variety of ways. Those range from combinations of tissues in “body-on-a-chip” devices to safe volunteer studies such as micro-dosing, where tiny amounts of a new drug are administered to human volunteers. Scientists, in turn, evaluate what the drug does to the body and what the body does to the drug. Micro-dosing in particular has shown to be highly predictive of results in the clinic. Astoundingly, these tests are already commercially available from a number of UK companies, and offer a much safer and less risky alternative to using animals in clinical trials.

More than 150 colleagues have signed a motion calling on the Government—it is Christmas and this is not too much to ask—to initiate a small, cheap comparative study to demonstrate whether these new technologies are indeed superior. Sadly, the Government are resisting such a study and insist that human biology-based tests are not better able to predict adverse drug reactions than animal tests, despite scientific evidence to the contrary.

Roger Williams (Brecon and Radnorshire) (LD): The hon. Gentleman makes a compelling argument. Indeed, no one doubts his sincerity. However, if these human-based tests were more effective and cheaper than the animal tests, why are the commercially sensitive companies not taking that route? Why do they persist with animal testing?

Mr Amess: I am not going to fall out with a tough farmer, because the hon. Gentleman and I have perhaps slightly different views about animals generally. I understand his point, but he will be pleasantly surprised to find that there are many companies that now want to go for this different option. I have taken a lot of advice on it and we just need a little more encouragement from the Home Office and its advisers.

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The attitude at the moment—I do not wish to be unkind to the Home Office—typifies the herd mentality that we are facing; a mentality that aims to promote quantity of opinion and that goes against the pioneering mentality of many breakthrough scientists. The comparison with human biology-based methods has attracted high-level support among scientists. Some 83% of GPs who were surveyed were in favour. Many colleagues have supported the early-day motion and I have received strong support for the Safety of Medicines Bill. All the scientists at the conferences of the Safer Medicines Trust in the House of Lords and the Royal Society were also in favour of my Bill.

The British Union for the Abolition of Vivisection is concerned that Britain is not one of the countries, such as Austria and Belgium, that has urged the European Commission to stand firm on an animal ban for cosmetics without exceptions, as was provisionally agreed by the European Union for 2013. That is not acceptable. Although I welcome the Government’s commitment to trying to encourage a reduction in animal experiments, there has so far been a lack of new initiatives to reverse what the evidence shows is a rising trend. I know that the Minister has received more than 20 proposals from the BUAV for policy changes. I very much hope that she will respond to those 20 points in correspondence.

Let me conclude with these thoughts. I am talking about negligible expenditure on a comparative study. The amount is quite small relatively, and—I say this to the hon. Member for Brecon and Radnorshire (Roger Williams)—pharmaceutical companies will willingly fund such a study, which would therefore not impose a cost on the public purse. Such a study could save the billions of pounds that are currently wasted on animal testing by reducing ADRs and boosting pharmaceutical company efficiency. Critically, the sheer scale of ADRs and the fact that they are increasing at twice the rate of prescriptions means that we have an ethical imperative to take action to address what is a serious public health problem, with reported deaths up by 155%, according to The Independent. The key question is this, and I hope that the Minister can answer it—if she cannot, I would appreciate it if she wrote to me: on what basis do the Government refute the evidence that a number of human biology-based tests have predicted ADRs that animal tests failed to predict?

As we move towards Christmas celebrations, we are drawn to the image of the nativity, with the infant baby Jesus and his parents surrounded by animals. The image and the link could not be clearer. I trust that the Government will reflect on what I have said today and ensure that the proposals in the Safety of Medicines Bill, which I introduced earlier this year through the ten-minute rule procedure, can be enshrined in legislation, as the final gift, after gold, frankincense and myrrh, to both kingdoms represented by the nativity.

5.17 pm

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.

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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.

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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

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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.

Paul Flynn: Will the Minister give way?

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.

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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.

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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

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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.

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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.

5.38 pm

House adjourned.