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I look forward to the day-I cannot see it in the foreseeable future but I hope it will come-when we do not have to carry out experiments on animals. In the mean time, while that work is necessary, we owe it to animals to keep them in the best conditions and to inflict on them the least possible suffering and stress. The committee set out on its inspection of the directive with the high hope that this would be the result of what the Commission proposed.

The noble Lord, Lord Soulsby of Swaffham Prior, gave a detailed account of the UK procedures. We are wonderfully blessed in this House that we have experts such as the noble Lord. He will recall the Select Committee on Animals in Scientific Procedures, on which he sat in 2001-02. I should like to draw the Minister's attention to some of the matters contained in that Select Committee's report, and I would like him to contrast, as I have, what the noble Lord, Lord Soulsby, said about the UK procedures and what is happening overseas.

Not much has changed since the report was published on 16 July 2002. I draw the Minister's attention to the evidence that the committee took in France. On page 61, the report states:

"Not all inspectors were trained in laboratory animal science, and those that were had only taken the same 15 day course as potential personal licence holders".

That is a marked difference to what happens in the UK. On page 14, in paragraph 1.27-again this relates to France-the report states:

"We were told that this makes the enforcement of care and welfare standards difficult. The Veterinary Inspectors considered that the system was essentially based on trust".

As the noble Lord, Lord Sewel, said, the directive was proposed because the 1986 directive failed.

In arriving at its proposals the Commission took a great deal of evidence. I refer the Minister to the evidence that our committee took from Susanna Louhimies, who is policy officer at the Directorate-General

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Environment, European Commission, on Wednesday, 3 June last year. I draw his attention in particular to question 10, which was asked by the noble Lord, Lord Sewel, and concerned the need to have a sufficiently rigorous and robust inspection regime. Ms Louhimies replied:

"The Commission is ambitious but we have to say that we based our proposal exactly on the results of the Technical Expert Working Group, which was agreed with the Member States".

She went on to say:

"The recommendation from that working group was to have two-yearly inspections covering not only the user establishment but, also, breeding and supplying establishments, and have one of those inspections unannounced. That, it was felt, would give enough security and assurance".

With that evidence, why has the UK changed its position? What is the Home Office up to? The proposed directive will not be worth the paper that it is written on. The only country to implement it will be the UK. The Home Office has not gold-plated this directive as it did the 1986 directive, and there is clear evidence that it is being less bureaucratic, for which I am grateful, but there is no doubt that the continuing stress and suffering of animals will be at varying levels throughout Europe. That cannot be seriously challenged. Why did Meg Hillier, the Parliamentary Under-Secretary of State, permit the UK to resile from the original text of Article 33 and go to a risk-based approach? That is a severe backward step which compromises the whole directive.

There are many good things in the directive-of course the law needs updating, and there needs to be flexibility for the future, as the noble Lord, Lord Soulsby, said-but if the Minister takes away nothing else from today's debate, he must take away the certainty that this directive will fail if the UK does not take a much stronger view and support the Commission. I do not expect the UK Government to support the European Parliament in its amendment, as I would, but they should at least go back to the original text of Article 33, because without that, this is all just a load of rubbish.

3.42 pm

Lord Winston: My Lords, I declare an interest in that I have held an animal-operating licence in various guises since 1970. I have about 40 years' experience of being an animal researcher in various university circumstances, in the United Kingdom, to some extent in Europe-where I worked in Belgium-and, most recently, in California in the United States, where I still conduct animal research.

Having read the report last night-I offer my congratulations to the committee and its chairman on the common sense in it and on how it has been laid out-I decided to go through my own curriculum vitae and look at the number of my publications which were purely animal-based concerns in peer-review journals. There are more than 100 publications of research which I believe could not have been done without the use of animals. While we support reduction and refinement, one has to say that reduction is only reduction. Perhaps unlike the noble Earl, Lord Caithness, who expressed worthy thoughts, I do not believe that

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we will ever find it very easy to abolish animal research completely. Those are great sentiments, but it is not the case in practice.

It has been interesting to make a list of the research that I have been involved with. For example, the research that we did on foetal lung development in premature infants, using a rat model, was crucial to understanding lung development; it could not have been done in humans. Some of the work done in contraception was benign work in rabbits. Fertility and IVF were largely animal research-based projects which could not have been done with a human egg. Work on ovarian function and the infections caused by chlamydia, which I have done in the United States, and refinements of pelvic surgery could not be done in human subjects; it had to be done in animals first. Ageing and the genes which affect it are much easier to study in the mouse model, but very difficult to study in the human. The same goes for gene expression in human development. Screening for fatal genetic diseases to prevent children dying of them essentially had to be done in animal models first of all. Xenotransplantation may offer great hope for transplantation in the future-it is worth bearing in mind that, every 15 minutes, somebody is put on a waiting list for an organ transplant. The idea of being able to use animals of human size for transplantation must be a humane endeavour.

One reason why I mention this is because the report points out that the breeding and killing of animals for their organs should not be part of a licence. I agree with that completely. It seems to me that it is essentially no different ethically from eating animals for dietary purposes, and if one is to use animals at all for farming one might be better off using them for their organs to save human lives.

Finally, I mention the work that Carol Readhead and I have done on humanised organs, which might make it easier to develop drugs that are not going to fatally attack the human immune system, as happened in Northwick Park hospital two or three years ago.

On reduction, which the report refers to, one should point out that there is likely to be, and perhaps there should be, a continued rise in the number of animals used, particularly of the mouse model. There is no question that if one looked at all the biological developments in the past 30 or 40 years, at least in my view, the human genome sequencing is really quite trivial compared with understanding how genes work. That was made possible only by the use of mouse transgenic models, whereby we can either remove or replace genes or make their expression inactive in various mouse models. That has been perhaps the most colossal development in biology in the whole of my lifetime as a medic, researcher and scientist. It seems inevitable that this work will continue to be important. It is worth bearing in mind that human children's lives have been saved from leukaemia and that cancer victims are saved as a result of using transgenic models. It is likely in future that more and more drugs will be needed to try to prevent different types of cancer and prolong lives in cancer victims. Some 40 per cent of us will eventually develop cancer and it is possible in future that we may live longer and almost normal lives with cancer, like diabetics. But

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that is likely to be possible only if we can continue to use the mouse model and similar models to develop those drugs. This is something that we have to bear in mind when we talk about reduction, as we do in this report.

The report also focuses on the use of primates. While all of us agree that there are massive ethical problems in dealing with non-human primates in research, there is no doubt that the continuing use of non-human primates in specific experiments is very desirable indeed. There are two examples that I would give. First, in the field of neuroscience, many of these things are quite benign, and the witnesses who sometimes spoke against the use of primates in the report did not quite do justice to the full scope of experimental procedures-particularly single-neuron recording, which cannot be done easily in the human but provides very useful evidence in animal models and is likely to be of extreme in the use of the rhesus macaque, which is a common non-human primate source.

Secondly, recently I made a visit to Singapore, which is rather different in its use of primates from most other developed countries, where there are quite large primate colonies, some of which are bred using F2 animals and some of which are brought in from other Asian countries. One of the most interesting and important aspects of the research in Singapore is the development not of genetics but the new field of epigenetics-how gene expression and gene working is changed by early developmental and environmental changes. That will be a very important area for human medicine in the next 10 or 20 years. If that sort of work were abandoned and we could not observe primates having a regulated diet or other environmental influences during early development, it would be a serious drawback to the pursuit of good human medicine.

The human genome on its own is useless, unless we understand the function of the genes within the genone, which will require huge investment in epigenetics. That is something that cannot just be done in humans because we cannot regulate the environment in a controlled way, as we can in a rhesus monkey. There is no question that the work in Singapore means that the Singaporean people, along with many interested people from Canada, America and New Zealand as well as British workers, because of those colonies, will lead in that field. It does not matter who leads in the field-I am not suggesting being in competition here-but it is important to understand that this work has a fundamental importance in pursuing the best human health under all circumstances, particularly for our children in future.

I want briefly to draw attention to data sharing. Dr Mark Walport told the committee that, in his view, data sharing would not reduce the suffering of animals, nor would it increase transparency-and Mark Walport, who is an absolutely honourable and honest scientist, is right to say that. It is worth bearing in mind that science is not black and white. We often think of science as portraying the truth, yet it is possible to do two experiments with diametrically opposing results but for both experiments in those cases to have valid results, which we can learn from. It would be ludicrous to suggest that we start taking action as a result of one or two experiments. Experiments always need to be

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replicated if we are to make sure that we get the best and safest information, particularly when it comes to human health.

Another issue that was briefly referred to is that of changing an experiment and its protocols during its course, because new data have come up. That has been a particularly difficult issue for human researchers and I hope that, with the Home Office, we can find ways to make sure that it is possible to modify an experiment more easily during its progress. Otherwise, I fear that the use of animals will become more prolific rather than less.

Finally, I mentioned that some of my work has been done-and is still being done-in the United States. Here, we are of course looking at a European directive, but it is very interesting to look at the animal research at, for example, the California Institute of Technology in Pasadena. It is interesting that it is actually much easier to get a licence or an authorisation to do work there. Certainly, my impression is that, if anything, animals are treated with absolute humanity in that establishment. It is highly effective, and what is also impressive about American institutions is the quality of the environment in which animals are kept and in which research is done. We could do well not merely to look in the rest of Europe, but to consider particularly what is happening across the Atlantic in the United States.

3.52 pm

The Earl of Arran: My Lords, I, too, congratulate the noble Lord, Lord Sewel, on chairing our committee so very ably, and I thank him for his generous remarks about me as a barman in Brussels. It is always a great privilege to serve on one of your Lordships' Select Committees, since our discussions frequently touch upon issues in which the public have a very considerable interest. Today is no exception.

Opinion polls suggest that a majority of people in Britain are conditional accepters of animal experimentation for medical purposes-that is, they can accept at least some forms of animal research, provided that there is no unnecessary suffering and/or that no alternative will do. It is very clear that people place importance on avoiding the use of animals where possible, with a majority of those polled-70 per cent in the most recent survey-also agreeing that there needs to be more research into alternatives. Clearly, it would be wrong to carry out an animal experiment if another method, not using animals, could achieve the goal. That ethical imperative is recognised in both the UK and EU laws, which prohibit the use of laboratory animals if another method is available. Yet what if another method has not yet been identified or developed? How can we enhance progress in finding substitutes for the use of animals?

One key aim in revising the EU directive on the use of animals for scientific purposes is to promote,

Those methods span all the three Rs, namely: the reduction, refinement and replacement of animal use. The Commission has shown ambition in asserting that,

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but is also realistic in its view that,

As witnesses called to our inquiry emphasised, future progress will need to capitalise on new technologies such as tissue engineering, advances in computer technology, non-invasive imaging techniques and understanding of gene function, to name but a few. Identifying, adapting and bringing new approaches on stream will in large part depend on the proactive efforts of researchers themselves. The scientific challenges should not be underestimated. Further progress will require lateral thinking, bringing a wide range of expertise to bear.

For this reason we took the view that the Commission's initial proposal that each member state should set up a national reference laboratory for the validation of alternatives would not provide the required impetus towards reducing the use of laboratory animals across the EU. It is unlikely that a single centralised laboratory can provide the breadth of scientific experience upon which any further progress will depend. More fundamentally, a focus on validation ignores the need to develop new methods in the first place. Instead, we were persuaded that a system of national centres across the EU would be a better approach, each working as a forum, aiming, like the UK national centre 3Rs, to bring together a wide range of experts and other interests to explore the potential of new technologies to reduce the use of animals; to think creatively about potential new approaches; and to serve as a source of inspiration and information about alternatives.

Since our report was published, the requirement for national reference laboratories has been removed from the draft directive. In the current draft, Commission and member states will be required to contribute to the development and validation of alternative approaches, the Commission to consult member states in setting priorities for validation studies, and member states to assist the Commission in placing validation studies in suitable laboratories. There will also be a Community reference laboratory covering all 3Rs.

It is my hope that these provisions will lay the foundation for an overarching strategic approach to the development of non-animal methods across the EU, which ultimately will help further to reduce the need to use animals in scientific research and testing. I noted very carefully the wise and experienced words of the noble Lord, Lord Winston, but I hope and think he will agree that it is most important that science and society continue to concentrate on this highly sensitive issue.

3.58 pm

Lord Addington: My Lords, when it fell to me to respond to this debate from these Benches, I felt that I was once again dipping my toe into traditionally choppy waters in which I had never thrashed before. However, I was rather relieved when I started to prepare for the debate, because the basic principle that research on animals should be kept to a minimum and carried out as humanely as possible seemed to run through the report and the responses to it. The concepts that you should not do anything more often than you need to

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and should avoid duplicating experiments ran through the report and reassured me as I read it. I think that theme has been reiterated by everybody who has spoken. Having said that, the noble Lord, Lord Winston, rightly asked what the minimum standard would be and how much of this you have to do at any one time. We do not know. As regards scientific research, sometimes we do not know what we do not know. We have to carry on working. Because something has worked once, it may work better next time. The need for expertise and a revaluation of evidence was at the centre of what the noble Lord said. However, I still felt that data sharing may well cut this over time. The idea of looking at that to make sure that we can reduce testing over time, as the number of models and the base of knowledge are increased, can be taken on.

I considered the interesting definition under which certain types of seafood are included or not included, and my attitude to crustaceans and octopuses. We went through the report discussing the various types of procedure. I can understand how people would find distressing the acceptance of the various types of suffering that an animal must undergo in certain types of experiment. I should be reassured if the Minister stated the Government's attitude towards reuse and said that they would give as much support as they could to the idea that an animal should not have to suffer at any level more than once. That would make me feel a little more comfortable about what is said in the report about continuing experimentation.

There is not too much that we disagree with on care and accommodation standards. Whether the use of non-human primates, which is more distressing, is logical or not, I do not know. I would enhance the position that work on primates should be looked at very closely. As the noble Earl, Lord Arran, has said, the idea of what is acceptable to society must go hand in glove with scientific evidence.

However, I find myself in total agreement with the noble Lord, Lord Sewel, on authorisation and enforcement. Unless you are going to be rigorous about the directive and enforce it, there is no point in having directives. Unless the Community is prepared, at whatever level of direction you do it from, to be slightly irritating to people or very intrusive, there is no point in having these directives. Unless we have some standards across the Community, there is not much point in having the Community. Unless we are prepared to interfere and occasionally cause trouble, there is no point in being there. This is a bit like health and safety-everyone thinks that there is too much of it until it is their son on the scaffolding. Unless we try to ensure that these standards can be enforced and the Government give their full weight behind making sure that they are enforced, and that inspection takes place at realistic intervals to make sure that those undertaking experimentation have a realistic idea that there will be control and punishment if they do not conform to a standard, there is no point in having the standards.

I should be very interested in what the Minister says on that for the simple reason that, unless there is enforcement, it does not really matter what we put down in any form of legislation. We have to be prepared to annoy people sometimes.

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4.03 pm

Lord Skelmersdale: My Lords, I congratulate the noble Lord, Lord Carter of Coles, on securing this debate so promptly after the report was issued. Unlike the noble Lord, Lord Addington, I should perhaps declare an interest in this subject. When I was comparatively green in your Lordships' House, I sat on the Select Committee on the late Lord Halsbury's second Private Member's Bill, entitled the Laboratory Animals Protection Bill. I should also perhaps declare a non-interest in that my daughter is a junior lecturer at Sheffield University, working in the cancer lab. It will perhaps be instructive for this debate if I say that, as she had neither training in laboratory animals nor, unlike my noble friend Lord Soulsby and the noble Lord, Lord Winston, a licence from the Home Office, she had to get someone else to pursue her PhD research.

At first blush, it may seem a surprise that responsibility for consideration of the subject, and therefore of the report, falls to the Home Office. However, I quickly reminded myself that the Animals (Scientific Procedures) Act 1986 was a Home Office creature, as was its predecessor by 110 years, the Cruelty to Animals Act 1876-the first law passed anywhere in the world aimed at regulating animal testing. This country should be proud of that. However, given the subsequent changes in ministerial responsibilities, it remains surprising that the Home Office is still the sponsoring department.

Leaving that aside, it is legitimate to reflect that the United Kingdom has led the world in legislation that promotes and protects animal welfare. I tell my noble friend Lord Arran that we spent a lot of time investigating mathematical techniques, with a view to the ultimate abolition of animal testing. We came to the conclusion that we could not envisage such a thing happening. That may please certain noble and scientific Lords who have spoken this afternoon.

The 1986 Act was designed to implement an EC directive that harmonised measures to regulate any experimental or scientific procedure applied to a "protected animal". As the noble Lords, Lord Carter and Lord Sewel, told us, the harmonisation has not been realised. It was intended to set a common minimum standard across the Community, and it is arguable-indeed, I do argue, and I hope that noble Lords will agree-that our 1986 Act went further than was strictly required by the Commission.

We are now confronted with proposals to update the 1986 rules. I congratulate your Lordships' European Union Sub-Committee D on giving such close scrutiny to the European Commission's proposed revision of the 1986 directive. I agree that the changes in scientific methods and understanding in the past 20 years mean that the rules on animal experimentation are due for an overhaul. I also agree that the exercise should be a levelling-up, as the noble Lord, Lord Winston, reminded us, rather than a search for the lowest common denominator, and that the high standards achieved and observed in the UK should not be diluted. Therefore, I have no objection to a process that seeks to raise standards across the EU to create a level playing field.

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