EU Directive on Animal Experimentation
Nicholas Dakin (Scunthorpe, Labour)
It is a pleasure to serve under your chairmanship, Mr Walker.
The transposition of the European Union directive on animal experimentation into United Kingdom law provides an opportunity to celebrate and protect the UK’s proud record of pursuing the best standards of animal welfare. It was initially thought that the new directive would have little effect on the operation of the seminal Animals (Scientific Procedures) Act 1986. However, the process has turned out to be much more comprehensive and complicated than expected.
In response to a call for comments issued in 2011, the Home Office received more than 10,000 responses from individuals and almost 100 from organisations, illustrating the high level of interest in this issue.
In October 2011, the Home Office said that a report on the outcome of the consultation would be published early in 2012, as would a draft code of practice and draft guidance on the application of the revised UK legislation, and that these documents would be accompanied by an indication of the Government’s intentions in making the transposition of the requirements of the directive into UK law. It later became clear that Parliament would have to consider the Government’s proposals in yes/no votes, without the opportunity to make amendments, before the summer recess in July 2012. It is now expected that regulations to transpose the provisions of the directive will be published in May, giving little time for meaningful, effective consultation.
It must be recognised that there was a need to harmonise protection of laboratory animals within the EU member states. The new directive has a number of positive, welcome provisions. For example, it requires that upper limits of pain and distress should be laid down and should not be surpassed; that the weighing of likely benefit and likely suffering should be conducted before any project work begins; that there should be retrospective assessments to evaluate whether the stated objectives were achieved and what harm was afflicted on the animals used; that there should be personal records from birth for individual cats, dogs and non-human primates; and that all personnel involved should be adequately educated and trained.
The Government have attempted to reassure interested parties that high standards of laboratory animal protection, which have operated in the UK for many years, will not be relaxed. However, there is concern that the UK legislation might be watered down to harmonise with an EU minimum. This concern is not only expressed by animal welfare groups. Comments published in February’s edition of the British Medical Journal indicated that organisations representing some of the main users of laboratory animals, including the UK Bioscience Coalition, the Association of Medical Research Charities and the Institute of Animal Technology, are also apprehensive.
The fear expressed in the BMJ article was that the Government will not take advantage of article 2 of the directive, which permits member states to maintain higher standards than those required by the directive, but will merely copy out those standards word for word into UK law. Recent experience indicates these concerns may be justified.
The use of great apes as laboratory animals in the UK has been banned since 1997, but it is not in UK law. I wrote to the Minister earlier this year, on behalf of the all-party parliamentary group for the replacement of animals in medical experimentation, which I chair, suggesting that there were compelling ethical, scientific, logistical and economic reasons for making the ban a legal stipulation in the UK. Unfortunately, the reply was disappointing, saying the intention was indeed to copy out the paragraphs in the directive that allow member states to apply to permit the use of great apes in certain circumstances.
The case against using chimpanzees is unanswerable, since, even if their use were ethically acceptable, scientifically justifiable and affordable, where would animals be obtained from in the necessary numbers, if an unforeseen threat to humans arose that could not be dealt with in any other way? Surely the Government should seize the opportunity to put protections into this legislation.
The Fund for the Replacement of Animals in Medical Experiments, which provides the secretariat to the all-party group, and the British Union for the Abolition of Vivisection presented a joint submission to the Minister, which spelled out the case for making the ban on using great apes in the UK permanent and legally binding. The answer they received again repeated the Government’s view that they did not envisage any circumstances in which the UK would claim that there was a compelling need to use great apes. So why not make it clear in this legislation?
Unfortunately, the Government’s approach to great apes fuels concerns about their overall approach to the transposition, giving credence to concerns expressed by bodies such as FRAME, the BUAV, Animal Defenders International and the Royal Society for the Prevention of Cruelty to Animals, as well as those listed in the BMJ article, which I mentioned earlier.
The Minister knows that there is particular public concern about the use of any primates, highlighted by the recent Bateson report, showing that at least 9% of experiments, and probably more, have no discernible potential benefit for humans. In transposing article 8, will the Government clarify the meaning of “debilitating clinical condition” to make it clear that the use of primates can only be considered where a serious human disease is involved, not simply a mild or temporary deterioration, such as baldness or the common cold?
I am particularly concerned that we take the opportunity to put animal experiments on a more transparent footing. I welcome the Government’s acknowledgement that section 24 of the Animals (Scientific Procedures) Act needs to be reconsidered to meet the transparency requirement of the directive. The simplest way to do that would be just to remove it, while leaving in place the protection of personal data, safety and commercial confidentiality provided for in the Freedom of Information Act 2000. In fact, if the Government published anonymised project licences centrally, together with the findings, whether positive or negative, that would remove any remaining risk of individual researchers being harassed, while allowing a mature public discussion of the costs and societal and scientific benefits of experiments, as well as enabling researchers to check that they are not duplicating previous research. Will the Minister confirm that university research will still be open to freedom of information requests, within the existing FOIA safeguards?
Of grave concern is the possibility that the current financial situation could be used to reduce the effort put into the administration of the UK legislation, including the licensing system and the work of the Home Office inspectorate. The system of licensing, consultation between licensees and inspectors, unannounced visits and regional administration has worked well for many years and is strongly supported by the scientific community. However, there are fears the number of inspectors will be allowed to dwindle, that inspectors will interact less with licensees, as advisers and unannounced visitors, and that the whole system will be run electronically from one site, probably at the Home Office in London.
Such changes could undoubtedly be made to fit with the requirements of the directive, but they would have a serious, deleterious effect on the standard of protection of laboratory animals in the UK, which, we are regularly informed, is currently the highest in the world and is something that we in the UK can rightly be proud of.
Given the high regard in which it is held and the key function it plays in ensuring compliance with the law, the implementation of the three R’s—replacement, reduction, refinement—and the maintenance of best possible practice, the Home Office inspectorate should be maintained at its current capacity and its advisory role should be kept intact.
Furthermore, there are concerns that UK housing and husbandry standards might be reduced to the lower EU standards, including for the floor area of cages for dogs or the height of cages for rats, which are greater in the UK than would be required under the directive. Many in the scientific community would find that undesirable. In order to maintain good public relations and perceptions of research and to ensure the continuation of the UK’s established reputation for high standards of animal welfare, lower standards should be avoided, by recourse to article 2 if necessary.
In addition to possibly lowering technical standards, the transposition could weaken the current, successful ethical review process, by substituting it with the “animal-welfare body” stipulated in the directive. Although the Home Office indicated in the consultation that the two were similar, there are important differences in function and emphasis. For instance, it is important to retain the “ethical” aspect of the name, as that more accurately reflects what the role of the body should be. A great deal of effort has been invested in improving the effectiveness of the process, and the general consensus is that it is useful and desirable, and that, where there are problems, they are about effective implementation, rather than with the process per se. There are strong arguments, therefore, for retaining function 2 of the process, namely project evaluation, which would be lost in purely animal welfare considerations. That is particularly important in considering local factors that impact on projects, and in facilitating communication and dissemination of information to the various people involved.
In summary, the recent media coverage concerning the unwillingness of internal transport companies to carry laboratory animals shows that animal experimentation remains high on the public and scientific agenda. Therefore, very great care should be taken to ensure the transposition of the directive does not in any way weaken the UK’s hard-fought reputation for maintaining highest standards in preserving the essential fine balance between science and animal welfare. In a joint response, the British
Veterinary Association and the Laboratory Animals Veterinary Association emphasised that the responsible use of animals in research has improved human and animal welfare through the advancement of scientific knowledge and the development of safer and more effective medicines. They went on to say:
“animals should only be used in research when no alternative is available and the work is justified through independent ethical scrutiny, and we continue to support the traditional principles of the ‘Three Rs’. We strongly believe that higher standards should be retained under Article 2 of the Directive even without clear evidence of benefit to animal welfare, unless there is evidence to show that no reduction in welfare will result.”
That is a clear message from the professional bodies. They conclude:
“The high level of public confidence in the robust regulation of scientific procedures using animals in the UK should not be compromised by the reduction of requirements without this evidence.”
I will be grateful if the Minister could clarify a number of issues in his response. How will he ensure sufficient parliamentary time to scrutinise the proposals when they are brought forward? Will he take the opportunity to put the protection of great apes in legislation? Will he clarify the meaning of “debilitating clinical condition”? Will he clarify how the transparency of access to information will work, so that researchers do not duplicate their research? Will he give reassurances that the current successful approach to licensing and inspection will not be weakened? Finally, will he commit to retaining a robust ethical review process?
Damian Green (Minister of State (Immigration), Home Office; Ashford, Conservative)
I congratulate Nic Dakin on securing the debate and on his energetic chairmanship of the all-party group. I may not be able to give him as much detail as he might like because, as he will appreciate, I am standing in—no doubt inadequately—for the Minister for Equalities, my hon. Friend Lynne Featherstone, and because she and the Home Office more widely are still looking at the details of the transposition, but I will try to answer as many of his detailed questions as I can.
I assure the hon. Gentleman that the Government recognise that the regulation of animal experiments is of significant public interest. We are strongly committed to ensuring the best possible standards of animal welfare and protection for animals used for scientific purposes.
Neil Parish (Tiverton and Honiton, Conservative)
My last report in the European Parliament, before I retired from it, took the directive through to First Reading. One of the problems in getting the agreement of 27 countries is that the regulations often have to be reduced in order to get them agreed by all member states. I would like to put it on record that I believe that we have some of the best research, done under the best welfare requirements in the world, and I do not want to see that watered down. In many cases I like to see the reduction of regulation, but on this occasion it is essential to keep our strong rules in place, because we are dealing with animal welfare and the quality of the science. I want that reassurance from the Government.
Damian Green (Minister of State (Immigration), Home Office; Ashford, Conservative)
By the time I sit down, I hope that I will have provided my hon. Friend with that reassurance. He, too, deserves congratulations, on taking legislation to that stage in the European Parliament, which I suspect is more complex and difficult than anything we try to do in this Parliament.
The Government are strongly committed to ensuring the best possible standards of animal welfare. Current legislation, as was rightly acknowledged by the hon. Member for Scunthorpe, provides that high level of protection: 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. That approach reflects closely what the public want. At the same time, animal experimentation continues to be a vital tool in developing health care improvements and in protecting man and the environment. The potential health and economic benefits from new and innovative treatments are dependent on providing the right framework for the UK’s life sciences sector and university research base, which are vital national assets and critical to our long-term economic growth, so we are determined to provide the right framework.
The transposition of the new European directive for the protection of animals used for scientific purposes provides us with a valuable and timely opportunity to review our own legislation governing experiments on animals. As has been pointed out, many requirements of the directive are similar to current UK legislation and practice. For example, it places a strong emphasis on minimising the use of animals and the promotion of alternatives. Some requirements go further than current UK legislation, most notably the introduction of mandatory minimum standards of care and accommodation for animals. Other requirements are potentially less stringent; the directive does not, as UK legislation does, provide special protection for cats, dogs and horses. Article 2 of the directive allows us to retain current stricter UK provisions as long as they do not inhibit the free market. The directive thus provides us with an opportunity to confirm the best aspects of current UK regulation and to make improvements where we can do better.
During 2011 we held a public consultation on options for transposition. I have slightly different figures from the hon. Gentleman, so I hope they are accurate. More than 13,000 individuals and 100 organisations responded, which clearly confirms a very strong interest in the topic. We are currently completing our analysis of the responses and will announce our decisions shortly—I hope shortly enough to leave proper time for parliamentary scrutiny, which the hon. Gentleman reasonably mentioned.
The directive clearly offers some opportunities, such as helping the work that we are already doing to promote the development of alternatives. The programme for government includes commitments to end the testing of household products on animals, and to work to reduce the use of animals in scientific research. The new directive assists with those objectives by strengthening the protection of animals used in scientific procedures, and promoting the three R’s: the development, validation, acceptance and implementation of methods and strategies that “replace, reduce and refine” the scientific use of animals.
The directive will also allow us to remove unnecessary bureaucracy where it still exists, and to build on the significant improvements we have already made in our
day-to-day implementation of current legislation. We are planning to focus on simplifying the details of personal licences, and making further improvements to the project licence application process and to the format of the project licence. The directive requires member states to inspect animal research laboratories and breeders, but the minimum frequency of inspection is less than we currently practise. Many of the responses to our consultation commented on the strengths of our current inspection system, and clearly that is an issue of great interest to the hon. Gentleman.
We are committed to maintaining a strong and properly resourced inspectorate, and a full, risk-based programme of inspections. The relationship between inspectors, licence holders and animal care staff is crucial to the effective implementation of the regulatory framework, and we will not jeopardise that relationship. The hon. Gentleman referred to the current move to centralise the operation of the administrative part of the legislation in London. That does not apply to inspectors. Indeed, it has been confirmed that inspectors will continue to be located close to those they inspect. I hope that that provides the hon. Gentleman with some reassurance.
We are aware of the concerns that have been expressed that transposition will lead to a lowering of welfare standards for laboratory animals in the UK. That is not our intention, and we are determined not to weaken UK standards, but that does not mean retaining stricter UK standards when there is no clear evidence that they translate into better welfare, nor does it mean that we must put everything into the legislation if we can achieve the right outcomes by encouraging good practice. What we are looking for is the right balance. We must ensure that we can maintain and further enhance our high standards, but at the same time we must avoid putting UK research at a competitive disadvantage compared with our counterparts in other member states. For the Government, both are objectives for the transposition of the new directive.
I shall give some specific examples of our approach to transposition. We intend to retain higher UK standards when there is strong and broadly-based support or good evidence for their retention. I mentioned some of those earlier, but it is important to put them on the record, not least to reassure the hon. Gentleman. One example is that we propose to continue to provide special protection for cats, dogs and horses, as well as non-human primates, and will allow their use only when no other species is suitable or available. That was widely supported in our public consultation.
I turn to the specific subject of great apes. We will continue to prohibit the use of great apes. There has been concern—the hon. Gentleman expressed it earlier— that the directive weakens the protection of those animals by providing a derogation allowing their use in exceptional circumstances. I can assure him and the House that we foresee no circumstances in which we would use that derogation, and we will put the ban in the legislation, as he asked. That is a full assurance such as he sought.
We propose to retain protection for foetal and embryonic forms of birds and reptiles during the last third of their development. That is not a requirement of the directive, but we received persuasive evidence from the public consultation of the welfare benefits of giving the same protection to those species as will be given to mammals during their development stages. I hope that that will
also be welcome. We were persuaded that the burden of providing that additional protection is proportionate to the benefit. That is the test we are operating. We also propose to retain a system of personal licences as a means of monitoring and ensuring the competence of those working with research animals.
The directive lists methods of humane killing that may be used without project authorisation. Our current UK legislation takes a similar approach as the directive in this area, but there are significant differences between the UK list of methods and that in the directive. Some methods listed in the directive are not currently permitted in the UK without specific authorisation. The differences have caused widespread concern, and we are minded to maintain the best of our current approach to humane killing. To take that forward, we have recently published a revised list of humane killing methods for consultation, and will incorporate only the best methods in our updated legislation. Again, I hope that that provides reassurance to the many people who are particularly concerned about this part of the directive.
Another issue of particular concern to many people is animal care and accommodation standards, specifically those examples in which current UK cage and enclosure sizes are greater than those required under the directive. For some, when there is good supportive evidence, we are minded to continue to mandate the UK dimensions. For others, the difference in dimensions may be so small as to make little difference to the welfare of the animals, but sufficient to add significantly to the costs for the life sciences community if they were retained, which would risk making the UK less competitive than other countries in Europe and beyond. Instead, we are considering ways of using the revision of our current UK code of practice on care and accommodation to encourage voluntary improvements in standards of housing.
The UK has a long tradition of housing animals in conditions that are better than those mandated in regulations—for example, the housing of non-human primates in the UK has significantly exceeded the minimum requirements for many years. Our approach has been driven by sound evidence from our welfare scientists, together with a willingness on the part of both the academic sector and industry to provide the best environment for our animals. We want to support that approach by encouraging the work of welfare scientists and the research community. As scientific evidence for higher standards emerges, we will expect our research community to respond.
On freedom of information, which the hon. Gentleman brought up at the start of the debate, most responders to the consultation recognise that section 24 in its current form is not compatible with the directive’s commitment to transparency, and many also recognise that it may be a barrier to the sharing of best practice and information on the three R’s. At the same time, personal details, intellectual property and commercial information will continue to require protection. We will consider how best to provide that protect under the new legislation, at the same time as meeting the aspiration to greater transparency.
The hon. Gentleman also brought up the issue of weighing pain against benefit. UK legislation already requires the Secretary of State to weigh the likely pain against the expected benefit, and in that regard the directive confirms current UK practice.
The hon. Gentleman referred to transport disruption. We have been working actively with the life sciences community and the transport sector to broker a commercial solution to provide a sustainable and resilient supply chain. That will be important to the future of the life sciences industry.
The hon. Gentleman asked about the use of non-human primates, and particularly the definition of a debilitating condition. We do not intend to define further what a debilitating condition is because we believe that that should be done on a case-by-case basis for each project licence application received. Using the current UK code of practice in that way to encourage voluntary improvements, particularly for housing, will lead to better standards. Overall, in addressing these sensitive issues, we believe that good welfare is fundamental to good science.
Animal experimentation is an area in which Government policy must recognise a wide range of opinions. Our current policy is based on the belief that there are real benefits to man, animals and the environment that can, at present, be achieved only with the use of animals, but it reflects the need for all animal use to be fully justified, and for animal suffering to be minimised. Any suffering must be carefully weighed against the potential benefits. Those are the foundations of our current legislation, and the directive provides us with the opportunity to build on them.
As I have said, my hon. Friend the Minister for Equalities and others will consider carefully—