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As I have indicated, there is a long-standing acceptance in this country that the testing of animals is regrettably necessary to help advance our understanding and

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treatment of diseases, but also that it must be conducted in as humane a manner as we are able to achieve. Unless we have a common approach to protecting animals used for scientific procedures, there is a risk that the good practices espoused in this country may be undermined if research is simply transferred elsewhere in the EU to places with less stringent standards. The question that my noble friend Lord Caithness put into my mind, therefore, is: what would be our legal position if our arrangements in this area went further than the directive? Are we likely to be taken before the European Court? I cannot understand how harmonisation will be achieved without a central EU inspectorate. I hope that the Minister will tell us how the Government reached their conclusion.

The draft revised directive is a step forward from the original proposals, and I am heartened to see in the Government's response to the report of your Lordships' sub-committee that the positions espoused by the directive, held by the Government and advocated by the sub-committee are becoming aligned. Some of the more objectionable measures have been reined in. For example, the idea that projects that should be subject to prior authorisation might be permitted by,

has been dropped. I welcome that step. Ideally, when implementing the changes in the directive, administrative burdens should be kept to a minimum, and those that are imposed must be justified by a gain in animal welfare. This must be the right approach.

As we have heard this afternoon, the sub-committee and the Government both support the promotion of the three Rs-the replacement, reduction and refinement of the scientific use of animals-and so do we on these Benches. The updating of animal welfare legislation is necessary as scientific procedures and our understanding of the physiology of animals advance. It is my hope that, by taking into account such advances when we put these rules in place, we are increasingly able to reduce the need for animal experimentation. An example of this responsiveness can be seen in the inclusion of new categories of protected animals.

That said, I am curious to know why, in the list of protected animals, decapods are excluded but cyclostomes are to be included. Decapods include creatures such as lobsters and crabs, which I am well aware can meet an unfortunate, if sudden, end in restaurants, but is it proven that they feel less pain than cyclostomes? Indeed, do they feel any pain? Our researches all those years ago on the late Earl's Bill concluded that fish, including hagfish, did not feel pain That was accepted by the scientific community at the time, so what has changed since, or perhaps what scientific physiological progress have I missed in the intervening 30 years? I cannot be so certain that the absence of a sense of pain is true of cephalopods, such as the octopus, which are also included in the list. I may be incorrect in that assessment but it is an interesting distinction none the less, and I should be grateful if the Minister could enlighten me further.

My major concern with the directive, which the sub-committee has highlighted and which I do not think has been adequately dealt with in the government response, is how any future changes to the control

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regime in the directive will be made. If new scientific understanding emerges that necessitates protection being extended to other categories of animals, how will this be effected? The Government admit in their response to the sub-committee's report that comitology will not allow changes to an essential element of the directive, but that the Government will,

Can the Minister please elaborate on what the Government have done, or intend to do, to allow flexibility into the system where it would plainly be beneficial?

I was the Whip on the Bench in 1985 when my noble friend Lord Glenarthur introduced the Animals (Scientific Procedures) Bill to your Lordships' House. I was struck then, as I am reminded now, of a dictum of the RSPCA, which as long ago as 1980 observed in a written response to the late Lord Halsbury's Private Member's Bill that the aim of any new legislation should be to provide a comprehensive system of control which can easily be interpreted, is readily applied and is applicable to current animal usage. I believe that that is what we should be striving for in applying any changes to the directive, and I congratulate noble Lords on the sub-committee who have sought to untangle the provisions of the updated directive and officials who have evidently worked hard to make sure that the standards that are to be applied across Europe will rise to meet the high standards of animal welfare that we expect of our scientists here. I therefore concur with the sub-committee that this new directive should now be agreed and implemented effectively.

4.13 pm

The Parliamentary Under-Secretary of State, Home Office (Lord West of Spithead): My Lords, I am also extremely grateful to my noble friend Lord Carter of Coles; to his predecessor as chairman of EU Sub-Committee D, my noble friend Lord Sewel; and to all the Clerks and members for the committee's very well balanced and perceptive report and for organising this debate. I am also grateful to all noble Lords who spoke, many of whom have a very detailed knowledge across this area. I mention, in particular, the noble Lord, Lord Soulsby, who seems to have been working in this field for some 60 years and has a remarkable depth of knowledge. Rather like the noble Lord, Lord Addington, I feel that I am dipping my toe into something that is a little tricky. I am no deep expert in this area, although I have a team who brief me very well. However, at least when the cephalopods were mentioned, I felt that I was getting a little closer to salt water and was a little more at home than I would otherwise have been.

On cephalopods, decapods and so on, the noble Lord, Lord Skelmersdale, asked me a specific question about pain and what research had been done. Perhaps I can get back to him in writing, as it might take a long time to answer him now.

Science and animal welfare have progressed significantly since 1986, as a number of speakers have mentioned, and no doubt a revision of the directive on the protection of laboratory animals is overdue. I share the view of

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the noble Lord, Lord Skelmersdale, that since 1876 we have led the world on issues of animal welfare. In this country, we have nothing to be ashamed of on that aspect. We have, quite rightly, put in a huge effort and that reflects what we expect.

Despite the progress on developing alternatives, animal use continues to be necessary to develop improvements in healthcare and in protecting man and the environment. The National Health Service could not function without treatments developed through research using animals. Almost every form of modern medical treatment has relied, in part, on animal use, as was so eloquently and clearly articulated by my noble friend Lord Winston.

It is vital that new European legislation is practical and proportionate and does not delay the scientific progress and benefits brought through animal research. As my noble friend Lord Sewel clearly pointed out, it is certainly required because the old directive was quite inadequate. It is essential that it does not undermine the success of UK researchers or our own high animal-welfare standards. At the same time, we have to develop proactively, validate and implement alternatives to animal use to deliver better welfare and better science.

The Commission's proposal is premised on three high-level objectives, all of which we support. The first is to rectify variations in the implementation of the current directive by member states-that has been seen by some member states, including the United Kingdom, as adopting stricter measures and providing a high level of protection for animals. Meanwhile, other member states provide for only the minimum requirements of the current directive. We fully support harmonisation, which is essential to create a level European playing field for researchers in industry and academia.

Secondly, the Commission sought to strengthen the protection of animals by making better provision for their welfare. Good animal welfare and good science are inseparable and it is right that the European Community should set high welfare standards. That is also essential if we are to maintain public support-as touched on by a number of speakers-for the important research that still requires animal use. Confidence in the regulatory framework is an important component of our strategy to eliminate animal rights extremism.

Thirdly, the Commission sought to promote the three Rs: the development, validation, acceptance and implementation of methods and strategies that replace, reduce and refine the use of animals. That was mentioned by a number of speakers, particularly the noble Lord, Lord Soulsby, and the noble Earl, Lord Arran. The UK plays a leading role in this area. I strongly support the desire of the noble Earl, Lord Caithness, that one day we will not have to use animals. I am sure that all of us would like that, but my noble friend Lord Winston gave us a blast of reality that one cannot see that at the moment. However, that does not mean that we should not aspire to it. The three-Rs framework was developed in the United Kingdom, is a key component of our current harm/benefit assessment, and is supported by our National Centre for the Replacement, Refinement and Reduction of Animals in Research, something which is not replicated across Europe, unfortunately.

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Of the European Commission's proposal published in November 2008, a number of the provisions were acceptable in principle. Indeed, many were variations of current UK provisions. However, there were a number of concerns: for example, the inclusion of invertebrate species; poorly thought-through mandatory care and accommodation standards and humane killing methods; the absence of detail of severity classification, as mentioned by the noble Lord, Lord Carter; inadequate provision for the reuse of animals; and proposed restrictions on the use of non-human primates. Many detailed provisions would increase the administrative burden without benefiting science and, more importantly, animal welfare.

I can report that many concerns, including those identified in the committee's report, have been remedied by negotiation. Only the arrangements for delegating and implementing acts under the Lisbon treaty remain to be finalised. I shall mention some key changes in the revised text; many were covered either in correspondence with the noble Lord, Lord Roper, or in the Government's response to the committee's report.

As regards the use of non-human primates, the draft text now includes a definition of "debilitating clinical condition" which encompasses almost all current uses of non-human primates in the UK. This has allayed our earlier concerns that work to remedy unmet clinical needs might be prohibited. Borderline cases can be provisionally authorised by a member state and subject to final decision by the Commission via comitology. In addition, the Commission has given a commitment to convene an expert working group to provide guidance on the interpretation of restrictions on primate use.

We believe that the new definition, the safeguard clause and the promised guidance provide the clarity we require and a suitable mechanism to resolve any areas of uncertainty about the use of primates, such that well justified use can continue. Although not a current EU requirement, only captive-bred non-human primates are currently used in the UK. The revised directive will go further and make the use of non-human primates which are themselves the offspring of captive-bred animals-so-called F2 animals-the European norm. The revised text requires the Commission to conduct a feasibility study to ensure that the timetable for this move will be adjusted if it is found to be unrealistic. The draft also requires the Commission to conduct a further study to establish the feasibility of sourcing non-human primates exclusively from self-sustaining colonies. This is also welcome.

Details of a severity classification system are based on the work of an expert working group which met in July 2009, as mentioned by a couple of speakers. The draft directive also sets an upper limit to the severity of procedures that may be authorised by member states without reference to the Commission. To go above this threshold would be to permit animals to be used in procedures which would involve long-lasting, severe pain, suffering or distress. We are disappointed that the possibility to allow such procedures remains within the scope of the new directive. However, we cannot foresee any circumstance whatever where we would permit this to happen in the UK.

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We and the Committee were concerned that the framework for the reuse of animals in the Commission's proposal would have increased the number of animals used and the suffering caused to the additional animals, a point raised by the noble Lord, Lord Addington. Changes made during the negotiations make better provision for the responsible reuse of animals, reducing the total suffering caused without causing unreasonable cumulative suffering to the animals used. That is consistent with the principles of reduction and refinement. It is with those principles in mind that the reuse requirements will be implemented in the UK.

The annexes setting out standards for the care and accommodation of animals and specifying humane killing methods have been substantially amended to correct the many faults in the original text. The deadline for implementation of the care and accommodation standards has been set at January 2017, allowing projects up to six years to adapt their facilities. Complying with these requirements will not compromise any of the UK's very high welfare standards.

It is now agreed that all projects will be ethically evaluated prior to authorisation, which is already standard practice in the UK. Proposals for "notification" and "tacit approval" of projects, which were of significant concern to the committee, have been dropped.

The requirement for data sharing has been removed, and my noble friend Lord Winston gave a clear exposition of why that is not particularly damaging. The requirement for national reference laboratories for the validation of alternative methods has also been dropped. Instead, much more practical requirements are placed on the Commission to consult member states in setting priorities for validation studies, and over the allocation of tasks to the laboratories nominated.

Not everything in the negotiation has gone as we would have wished. The revised text would allow the use of great apes in exceptional circumstances-something we do not permit. Again, we cannot foresee any circumstances when this would be permissible in the UK.

Surprisingly, as commented on by my noble friend Lord Sewel, many member states, but not the UK, saw the requirements for at least two inspections at each establishment each year as too ambitious. The revised text requires a risk-based approach to inspection, but it requires only a minimum of one-third of users to be inspected each year. That is significantly less than the current United Kingdom inspections regime.

The noble Lord, Lord Soulsby, and my noble friend Lord Sewel both spoke well about the value of our inspectorate and how important it is. In addition, the Commission will be under an obligation to carry out controls, but only where there is reason for concern. Notwithstanding the comments made by the noble Earl, Lord Caithness, we are pleased that the principle of regular, risk-based inspection has been established through the EU, which is something that we believe requires more than the specified minimum inspection frequency, and that the Commission is under an obligation to oversee and enforce this aspect of the directive. My honourable friend Meg Hillier pushed to the limit what the market would bear. The risk-based approach will require that we work above the minimum and that others do likewise to satisfy the Commission and to

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make sure that its responsibility is being properly discharged. The latter point is significant, and the committee rightly noted that weak enforcement by the Commission was one factor contributing to the ultimate weakness of the current directive. I cannot argue with that; that was one of our concerns.

The Earl of Caithness: My Lords, could the noble Lord expand on this a bit? Why was what was agreed by the technical expert working group beforehand-so the Commission came up to the level in Article 33-resiled on when it was agreed by all the member states? The Minister has already given examples of where there are going to be differences in treatment in the UK compared to the rest of Europe. Why in this instance has there been such a resiling from the position of the expert working group?

Lord West of Spithead: My Lords, if I may, I will come back on the detail of that. As I understand it, we went as far as the market would bear. I do not think that it was a problem for us, but I will get back to the noble Earl about the details of the negotiation, as I cannot speak to them at the moment.

We have negotiated to develop practical, proportionate and enforceable legislation that makes proper provision for the welfare of laboratory animals and can adapt to further technical progress. My noble friend Lord Sewel asked whether we can guarantee unannounced inspections. The rigour of the current system and unannounced inspections will be maintained. We sought to avoid inflexible or disproportionate measures that would damage or undermine the competitiveness, sustainability and success of the UK and European research base or unnecessarily delay the healthcare benefits that animal research and testing continue to support.

Overall, we are satisfied that the revised text provides a sound and practical framework for the regulation of animal experimentation and testing in Europe. It is certainly better balanced, more flexible and less prescriptive than the Commission's proposal and will allow the United Kingdom to maintain its traditionally high standards of welfare and animal protection. The noble Lord, Lord Skelmersdale, asked whether we can maintain current standards, so I hope that that answers that. Article 2(a) of the text will permit that and it will be done.

We welcome the fact that the revised proposal will allow member states to retain existing, additional animal welfare measures that do not distort the internal market. My noble friend Lord Sewel asked whether all projects will still be ethically evaluated and authorised. Simpler applications may be subjected to a lesser bureaucracy, but I can assure my noble friend that animal welfare and the quality of decision-making will not be compromised. The revised proposals avoid unnecessary bureaucracy and offer opportunities to reduce the current UK regulatory burden without harming animal welfare.

I have a response from the Box to the question asked by the noble Earl, Lord Caithness. The response says exactly what I said already, which is that I will write and explain the matter in detail. The Box has nothing further to add; clearly it knows as much as I do.

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To summarise, we have a position in the UK to be proud of. I think that the negotiation has been successful. The European standard has been raised across the board. We can be proud of that negotiation. Could more be done? Probably, and we must keep doing it, but we have a good record in this country and it is important that we keep pressure on all these areas, because this matter is so important. Finally, I thank the committee again for its work and for bringing this report for debate.

4.29 pm

Lord Carter of Coles: My Lords, I thank all noble Lords who have taken part in today's debate, which was enriched by the highly authoritative and informative contribution from the noble Lord, Lord Soulsby of Swaffham Prior. He set out clearly what has been achieved in this country by a control regime of many years' standing. He talked at length about the three Rs-replacement, reduction and refinement-as have many other noble Lords. The committee took evidence from the UK's NC3Rs and we were clear that it offers a model for wider application throughout Europe.

The noble Lord, Lord Sewel, and the noble Earl, Lord Caithness, both made powerful points. The noble Lord, Lord Sewel, as my predecessor, gave a clear and compelling explanation of the risks and gaps that we see in the proposed requirements for inspection and monitoring-a recurring theme. The noble Earl, Lord Caithness, with his depth of understanding and recall of things past, highlighted some of the recurring issues that we will have to continue to tackle and keep an eye on.

I was pleased to hear the welcome that the noble Lord, Lord Winston, gave to the committee's report. The important part of his remarks related to the possibility of a reduction in the use of animals in scientific procedures. He gave several compelling examples of important research to which animals were essential. It is relevant to note that such research has been possible within the UK regime of controls. We should be concerned that a new directive will ensure that similar controls-this theme again-apply across the whole of the European Union. The noble Earl, Lord Arran, spoke eloquently about the importance of the NC3Rs, the UK's national centre, and, importantly, about the continued need to search for alternatives to the use of animals.

The issue of consistent implementation of the directive's requirements was raised by the noble Lords, Lord Addington and Lord Skelmersdale, and was addressed by the Minister, the noble Lord, Lord West, in setting out the Government's view. We were pleased to hear the points that the Minister made, but the whole issue of risk-based assessment and the need constantly to monitor how it is being applied will be a matter of great focus going forward.

In our debate today, we have again brought out the strength of arguments surrounding the use of animals in scientific procedures and the importance of agreeing a regulatory framework that strikes the right balance-a point that many have made-

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between animal welfare and the interests of scientific research. As our report makes clear, the proposed revision of the EU directive provides an opportunity to get that balance right across all member states. We urge all those involved not to waste this opportunity.

Motion agreed.

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Royal Assent

4.33 pm

The following Acts were given Royal Assent:

Terrorist Asset-Freezing (Temporary Provisions) Act,Fiscal Responsibility Act.

House adjourned at 4.34 pm.

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