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In chapter 2 of our report, we deal with a number of general issues, including the proposed extension of the scope of the directive. The proposal of November 2008 was that the directive should apply not only to vertebrate animals, but also to certain classes of invertebrates, including cephalopods, such as octopus and squid, and crustacean decapods, such as crabs, lobsters and shrimp. The arguments for extension of the scope turn on the issue of whether such creatures feel pain and can suffer; that is "sentience". We concluded that, on

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the basis of current scientific knowledge about sentience, cephalopods should be included in the directive, but decapods should not.

In the UK, under the 1986 Act, protection is provided to animals from half way through the gestation or incubation period for the relevant species. The November 2008 proposal for a revised directive foresaw extending its scope to embryonic forms of animals from the last third of their normal development; that is, at a later stage than half way. We saw no evidence to suggest that the UK's approach was unjustified, but in the interests of EU-wide consistency we supported the proposal.

The November 2008 proposal provided that scientific procedures should be classified according to the severity of pain experienced by animals, but it failed to include definitions of the four categories proposed: "up to mild", "moderate", "severe" and "non-recovery". We welcomed the steps which the Commission took to fill that gap. During the course of our inquiry, an EU expert working group made proposals for relevant definitions, which we endorsed. We also made the important point that, regarding the reuse of animals, the provisions needed to be carefully considered to avoid unintended consequences for animal welfare.

As your Lordships would expect, we received a good deal of often conflicting evidence on the issue of the care and accommodation standards proposed. The standards in the EU proposal presented as mandatory requirements had previously been formulated as non-mandatory guidelines by the Council of Europe, but much of the explanatory text accompanying the Council of Europe guidelines had not been included in the EU proposal. We were told that this meant that the resulting provisions of the proposal could be misleading, so we concluded that the some of the text had been "lost in translation" and needed to be restored.

In the face of evidence that the standards proposed for reduced stocking densities for rodents and rabbits would not necessarily offer any measurable benefit for the welfare of animals, we concluded that the timescale for introducing the revised densities should be extended, and in particular we recommended that the timescale for the academic sector to implement the range of new standards should be extended.

In chapter 3, we looked at the use of non-human primates in research. The primates in question are essentially macaque, marmoset or tamarin monkeys. The use of non-human primates accounts for less than 1 per cent of all procedures, but such is the particular concern of the general public that this is an important area. In the UK, the use of non-human primates is already more tightly controlled than the use of other animals. It is authorised by the Home Office only if there is sufficient justification, if there is no alternative, and if purpose-bred animals are used.

The Commission's proposal of November 2008 provided that all use of great apes-such as gorillas, orangutans, and chimpanzees-should be prohibited. This is already the case in the UK. However, going beyond that, it also proposed that the use of other non-human primates should be limited to research related to,



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Again, our witnesses were divided on the justification for that additional limitation. Representatives of the pharmaceutical industry said that, in stipulating that research could be justified only if it related to a specific disease, the additional limitation appeared to show a misunderstanding of the way in which research operated. Conversely, witnesses from animal protection organisations argued that special provisions were appropriate, and that progress needed to be made towards phasing out the use of non-human primates altogether.

Evidence from the European Commission suggested that, in practice, the proposed limitation could be applied less restrictively than was feared by the pharmaceutical industry-allowing the use of non-human primates for research into infertility, for example.

In the light of that evidence, we concluded that the proposed limitation struck the right balance between animal welfare and scientific research. We recognised that it could be helpful to clarify the wording of the limitation to make its range of application clearer, but we stood clearly by the desirability of placing tighter limits on the use of non-human primates than on other species.

The November 2008 proposal also contained provisions aimed at limiting the use of non-human primates to the offspring of animals bred in captivity-so-called F2 animals. The proposal specified deadlines, varying according to species, after which only F2 animals could be used.

Here again, as your Lordships would expect, there was a sharp division of views. Representatives of the RSPCA, for example, stressed the power of deadlines for bringing about changes in industry practice, citing experience with the cosmetics directive, which meant that from March 2009 no animal testing of cosmetics was allowed in the European Union. Conversely, witnesses from the pharmaceutical industry and the research community questioned the animal welfare benefits of the F2-only policy, and underlined the practical difficulties of moving to self-sustaining F2 colonies over a relatively short timescale. We supported the aspiration of restricting use of non-human primates to F2 animals, but we recommended that the feasibility of the time limits proposed for each species should be reviewed for practicability.

In chapter 4, we looked at some generic procedural aspects of the 2008 proposal. The first relates to sharing of data from the use of animals in scientific procedures. Two types of data were in the Commission's sights. The first was data from tests required under Community legislation. We agreed with many of our witnesses that mutual acceptance between member states of such data is highly desirable. The second was information generated by scientific procedures conducted more generally for both academic and commercial research. We heard the concerns of the pharmaceutical industry and the research community and, in the absence of cogent evidence of widespread duplication of procedures, we made it clear that we too had reservations about the proposal for sharing the second type of data.

However, most of chapter 4 relates to the authorisation of scientific procedures using animals. In broad terms, the November 2008 proposal provided that authorisation

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arrangements similar to those in place in the UK should apply across the EU. We were therefore interested to hear comments from our witnesses on the effectiveness of the UK control regime. We were not persuaded by the concern expressed by representatives of the pharmaceutical industry and research community that, although high standards of animal welfare in the UK had been achieved and should be maintained, the operation of the UK system of controls was slower and more complex than elsewhere. Not only the Home Office but other witnesses pointed to publicly available information that, for applications under the 1986 Act, the evidence did not chime with claims of tardiness. In fact, 85 per cent of project licence applications were awarded in 35 days, with an average of 18 days.

For us, however, the most important consideration is to ensure that the system of authorisation set out in the proposed revision of the directive should be effectively and consistently implemented across the EU. We were concerned to hear that negotiations on the proposal under the Swedish presidency might allow for the concept of tacit approval of certain procedures. In the UK, all procedures have to be authorised under the 1986 Act. Tacit approval, on the other hand, might allow procedures to go ahead without specific reference to the regulatory body concerned. We made it clear that we were opposed to any such change to the proposal, and we have been reassured to hear from the Government that the concept of tacit approval is not being taken forward.

Finally, I come to what we regard as the central issue: the measures proposed to ensure effective and consistent implementation. Member states will have primary responsibility for implementing the requirements for the authorisation of scientific procedures. They had that responsibility under the 1986 directive, but the significant differences in the way in which the 1986 directive has been implemented in practice make a prima facie case for increasing the pressure on member states to act fully on that responsibility.

The November 2008 proposal provided that member states should carry out two inspections of relevant sites each year, and that the Commission would monitor national inspection arrangements. When the European Parliament gave a First Reading to the proposal in May 2009, it agreed amendments to oblige the Commission to undertake controls of the infrastructure and operation of national inspections. In our report, we voiced firm support for all those provisions. We are deeply concerned that the tendency of negotiations on the proposal during the latter months of the Swedish presidency has been to weaken them by reducing the required frequency of national inspections, and by limiting the monitoring role of the Commission.

The committee supports the objectives which the Commission says that a new directive should serve: strengthened protection for animals in scientific procedures and, importantly, a level playing field across the EU. However, if the new directive does not contain effective safeguards to ensure consistent implementation, animal welfare standards will vary, and different member states will require those involved in the use of animals in research to expend different degrees of effort. We hope that this will not be the case, and we look to

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those involved in the current negotiations-in particular, the UK Government-to ensure that they take the opportunity of agreeing the new directive to secure high standards of animal welfare across the EU and, most importantly, at the same time place all concerned on an equal footing.

3.11 pm

Lord Soulsby of Swaffham Prior: My Lords, I join Her Majesty's Government in welcoming the House of Lords EU Select Committee report and its findings. In doing so, I declare several interests. I have a long-term interest in the protection of animals. I held a Home Office licence from 1950 until my retirement from the university. I have been a member of the Animal Procedures Committee of the Home Office and I am currently a patron of the Fund for the Replacement of Animals in Medical Experiments, otherwise known as FRAME.

Over the past 50 years or so, the United Kingdom has been in the lead in laboratory animal practice legislation, development and welfare. Many years ago, it was well recognised that good welfare for laboratory animals equated with good science, good research and reliable results that were important in understanding and treating diseases of man and animals. Some countries have been slow to adopt laboratory animal regulation believing that it would be prejudicial to biological research in general and to the development of biological research. An example is the United States of America where, until relatively recently, there was strong opposition to the regulation of laboratory animal work. It was only in the 1960s that federal regulations and financing projected laboratory animal welfare on a federal scale. In 1981, the Johns Hopkins Center for Alternatives to Animal Testing-CAAT-was established. It gave strong impetus to the production of federal regulations.

In the United Kingdom, there are three main stages governing laboratory animal work. First, an institution needs to have a certificate of designation; secondly, there is a project licence in which a research worker or group details the work to be done and which is approved by the Home Office inspectorate; and, thirdly there is a personal licence for the individual to undertake the research. Each institution must also have a named veterinary surgeon who advises on standards of animal health and welfare and on experimental technology and may assist in certain surgical procedures and the rest. In addition, each establishment is required to have a permanent, independent ethical review committee whose duty is to review proposals for a project licence and to promote the three Rs-reduction, refinement and replacement-which I shall come to later.

An important strength of the United Kingdom system is the inspectorate. It currently consists of 27 full-time professionals, of whom 25 are veterinarians and two are medically qualified. There are approximately 200 establishments in the United Kingdom where animal research is conducted, and the inspectorate undertakes about 2,000 visits a year. Apart from its inspectoral duties, it also plays an important advisory role, and many of its members are specialists in given fields and may be called upon to advise on issues of physiology, pathology and sentience, for example. It is important that the inspectorate be maintained as well as the professionalism of its members. The inspectorate

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has recently been audited under the Hampton principles of better regulation, and the auditors' report praises it for the strong advisory role it plays in supporting the science community while assuring high standards of animal welfare.

It is therefore disappointing that the proposed EU directive considerably reduces the role of a professional inspectorate, under pressure, I believe, from other member states that currently have no inspectorate, a much less focused inspectorate or a less professional inspectorate. The proposed directive does not require inspectors to be veterinarians or medically qualified persons. An indication that the United Kingdom takes this issue seriously is the fact that the Royal College of Veterinary Surgeons has recognised certificate and diploma qualifications in laboratory animal science that are required for appointment as a named veterinary surgeon in an institution. Furthermore, several veterinary faculties in this country have specific courses on laboratory animal welfare in preparation for those who might serve in various capacities up and down the country.

I have mentioned the promotion of the three Rs, the concept of which was introduced by Russell and Burch in 1959 in the seminal publication, Principles of Humane Experimental Techniques. This was a landmark publication, and the concept has spread globally. There has always been a need for research to advance the three Rs. Initially, any work to advance them was almost a secondary issue for the Home Office committee, although they were considered a better way to undertake research and investigation.

In 2003, the House of Lords committee that dealt with laboratory animals proposed a national centre for the three Rs, which was established; the noble Lord, Lord Turnberg, was its first chairman from 2004 to 2007. The important point about the centre was that specific provision was made for funds to be provided to advance the three Rs in all their aspects. This has made an important difference to the development of the three-R concept.

Another important issue in laboratory animal work is public confidence. The committee took evidence on animal welfare, on the care taken in research and on secrecy about what research was being done. Its report in 2003 indicated that research work should be published, at least in summary. This is now done and will, I hope, allay the fear that so much is done in secrecy. Of course a degree of confidentiality must be maintained by, for example, pharmaceutical companies, but it is necessary to assuage the charge of secrecy that is often levelled at the Home Office and the research establishment, and the numbers and the work that is undertaken by research workers are published regularly.

The advisory Animal Procedures Committee and the new centre for the three Rs will do much to determine the extent of the need to study the sentience of laboratory animals in more detail. Sentience issues for a number of species have been referred to already this afternoon, and this is where the three Rs will take particular effect. We have heard that cephalopods, such as the octopus, are now included as protected animals in United Kingdom legislation. It took several meetings of the Home Office advisory committee to

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reach this conclusion, and much evidence was given by physiologists and people connected with pain transmission and sentience before it did so.

Although other invertebrates are not included at this time, as physiological sciences advance in the coming years, other animals, such as decapods, might be added to the list of protected animals. I am informed that although cephalopods are now protected animals and can be used in experimental work, very few, if any, have been used so far. The animals whose sentience is also under question are the foetal forms of non-human vertebrates, which are now included and are protected species. Given the three-R situation and the fact that the committee is allocating funds, it is likely that we will go ahead and will have a much firmer basis for study.

In conclusion, I welcome the report and the directive should be implemented. I hope that it will be consistent across the member states and that laboratory animals are used across what is often called a level playing field.

3.24 pm

Lord Sewel: My Lords, I declare an interest in so far that my wife is employed by a university where research is conducted on animals, although she does not do that herself-except on me. I thank my noble friend Lord Carter of Coles for his generous comments. I should let him into the secret that you should make sure that you have enormously able Clerks and committee specialists behind you. In that, I was enormously fortunate. I have many happy memories of my time as chair of the sub-committee. Perhaps my most fond memory is of the refreshment-a Scottish term-that unfailingly appeared, thanks to the noble Earl, Lord Arran, when we went to Brussels. We had a wonderful refreshment to accompany our rather dry sandwiches.

The case for a new directive boils down to one simple argument; namely, that the old one failed. It failed because it was inconsistently applied across the EU. In judging the proposed new directive, the criterion must be whether it meets the test of being able to ensure consistent application across the EU. I wish to concentrate on two areas, authorisation and inspection.

Authorisation has two basic legs-ethical reviews and prior authorisation. Great emphasis rightly has been placed on ethical reviews, but ethical reviews in themselves cannot carry the whole burden of authorisation. There needs to be prior authorisation in order to get full and proper scrutiny of the details of the projects being considered. As my noble friend Lord Carter indicated, during the passage of the evidence that we took, we were particularly concerned that there was a weakening-a dilution-of prior authorisation, with the idea of tacit approval gaining currency. Fortunately, that has been rejected, but quite rightly.

However, it has been replaced by something which I understand is called simplified administrative processes. I have a concern when I read about such things in this context. Obviously, one wants the most simple administrative process available. But is it possible that we are opening the door to the very thing on which we tried to close it; namely, that by simplified administrative processes, inconsistent application will be allowed to

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rear its ugly head again? That is my concern. It is not necessary or inevitable, but we should be concerned about it and look at it. The test will be to ask when the simplified administrative process becomes an inconsistent application. We need to be alive to that issue.

As my noble friend has already indicated, the original text allowed or required two inspections at each establishment a year. It is quite worrying that that was viewed by many member states as being too onerous, too resource-intensive and too prescriptive. It is difficult to see how you can have an effective inspection regime unless there is a minimum requirement for the number of inspections that will be carried out and a number of inspections are carried out on an unannounced basis. That is fundamental and I am concerned that we seem to be moving away from it by introducing the concept of a risk-based approach. Again, that is something which needs a little more definition and a little more flexibility left in the hands of the domestic operators, if I may put it that way.

The most worrying thing of all is that the number of inspections, in terms of the proportion of unannounced inspections, is described as "appropriate". We all know that "appropriate" is one of the principal weasel words in the administrative lexicon. Can the Minister confirm that zero could be an appropriate proportion in some cases? If so, that is worrying. I am afraid that there is a need for a degree of specificity that the directive fails to deliver.

I turn now to the role of the Commission itself. It has a fundamental role to play in ensuring that although the enforcement processes and mechanisms are the responsibility of member states, to put it bluntly, the Commission ought to be making sure that they do the job by checking that there is an effective regime in place on the ground. During the latter part of the discussions under the Swedish presidency, that was significantly weakened. The amendment from the European Parliament quite rightly would have obliged rather than merely permitted the Commission to undertake control of the monitoring of national inspections throughout the member states, but it has not been adopted. Instead, the Commission will be under an obligation to carry out controls where there is reason for concern. Again, this is a slight weakening of the position. Given the fact that the Commission sees its role as one that ought to be resource neutral-so no more resources are going to be put into this activity-it is difficult to see how the Commission will play a stronger role now than it did in the past, yet in many ways it was the failure of the Commission to play an effective role that lay at the heart of the failure of the 1986 directive.

I make no apology for concentrating at some length on these two points because this is a fundamental issue that lies at the heart of whether the new directive will be as effective as we want. The rest of the detail set out in the draft directive is perfectly acceptable and commands general support but, in these two areas and particularly on inspection, there is a real concern that the very objective of trying to remove inconsistent application will actually bring it back into the system, and therefore the strength and justification for the directive will be fatally undermined.



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In closing, I should say that this is not important only to this particular draft directive. It has a more general application throughout the EU. That is because what undermines confidence in the EU among its citizens is when it becomes clear that directives are being implemented in wholly inconsistent ways across the Union. That leads to scepticism and cynicism which undermines the very Union itself. The answer must be for a greater role for the Commission. I understand that some member states may not welcome that, but in this context it is worrying that the Commission itself does not wish to seize the challenge.

3.35 pm

The Earl of Caithness: My Lords, I thank the noble Lord, Lord Sewel, who has said much of what I was going to say and has got right to the kernel of what the directive is about. I also thank him for the wonderful way in which he chaired the committee. Although we were considering a serious and interesting subject, we did, as he rightly said, have a little bit of fun as well which made the work all the more pleasurable. I also thank all those who helped us. I am grateful for what the noble Lord, Lord Carter of Coles, said, and I echo his thanks for the work of our special adviser and support team.


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