Draft Animals (Scientific Procedures) Act 1986 Amendment Regulations 2012
The Committee consisted of the following Members:
Lloyd Owen, Committee Clerk
† attended the Committee
The following also attended, pursuant to Standing Order No. 118(2):
Draft Animals (Scientific Procedures) Act 1986 Amendment Regulations 2012
It is a pleasure, Mr Streeter, to serve under your chairmanship. The draft regulations amend the Animals (Scientific Procedures) Act 1986 to transpose European directive 2010/63/EU on the protection of animals used for scientific purposes. They apply to the United Kingdom. The new directive was adopted in September 2010 and came into force on 9 November 2010. It replaces directive 86/609/EEC, which is transposed into current UK legislation by the 1986 Act. National legislation transposing the new directive must be implemented from 1 January 2013.
Directive 2010/63/EU has three main objectives, and I hope we will be talking in English from now on, rather than in European directives: to rectify wide variations in the implementation of the former directive by member states; to strengthen the protection of animals used in scientific procedures; and to promote the three R’s—strategies that “replace”, “reduce” and “refine” the use of animals in scientific procedures. It provides a practical framework for the regulation of animal research and testing in Europe and, indeed, sets a benchmark for the rest of the world.
Many of the provisions in the new directive are similar to current UK legislation and practice. For example, it places a strong emphasis on minimising the use of animals, and includes the promotion of the three R’s. Some of its provisions are new or go further than current UK legislation. For example, it extends protection to some invertebrate species, or cephalopods, including octopus, squid and cuttlefish, and to animals bred primarily so that their tissues and organs can be used in scientific research. The new directive also requires member states to apply mandatory minimum standards of care and accommodation, and there is a requirement for formal retrospective review of some types of project.
Other provisions are potentially less stringent than current UK requirements. For example, the 1986 Act, which we are amending, provides special protection for non-human primates, cats, dogs and horses, whereas the directive extends special protection only to non-human primates. Article 2 of the new directive allows member states to retain national provisions in force on 9 November 2010 that give more extensive protection to animals than those set out in the new directive, so long as they are not used to inhibit the free market. We are going to make full use of that provision, and I will explain a little more about that shortly.
A public consultation on the options for transposing the new directive was launched on 13 June 2011 and closed on 5 September that year. Responses were received from 98 organisations and more than 13,000 individuals. The majority of responses supported the retention of current UK animal welfare requirements where they are stricter than those set out in the directive. Many other responses suggested we should use transposition to streamline regulation where that would not harm animal welfare.
The Government’s response to the public consultation was published on 17 May this year. In it, we explained that we would retain most of our current stricter UK standards, including special protection for cats, dogs and horses; protection for immature forms of birds and reptiles; larger enclosure and cage sizes for dogs and a number of other species; and methods of killing animals that are more humane. The retention of those and other stricter standards in the regulations is necessary and justified on animal welfare grounds, and to maintain public confidence that animals used in experiments and testing will continue to be properly protected.
At the same time, we explained in the Government’s response that we would simplify our system of personal licences, which authorise individuals to apply procedures to animals. A system of personal licensing is essential to ensure that procedures causing pain and suffering are applied to animals only by individuals who are properly trained and competent. At the same time, we accept that the system must not be overly bureaucratic, so we have made some small but important changes through the regulations to allow us to simplify the detail required in personal licences and the way we process the applications.
Another important change we have transposed in the draft regulations is the requirement placed on member states to collect and publish statistical information on the actual severity of the procedures applied to animals. Publication of information about the actual experience of animals would be a major step forward in transparency and, combined with the mandatory requirement to publish non-technical summaries of authorised projects, will help to inform the debate on the use of animals in research and testing.
My final point concerns the severity of classification. Although the directive requires procedures to be classified by their severity, there is no requirement to ensure that those classifications are subsequently adhered to. Under current UK arrangements, licence holders are required to inform the Home Office if a severity limit is breached or is likely to be. We intend to continue that requirement by maintaining the existing condition on the project licence, which sets a clear obligation to adhere to the severity limit and to notify the Secretary of State if the limit appears to have been breached or is likely to be. I assure the Committee that we are not weakening the current requirement for project licence holders to ensure compliance with severity limits.
The transposition of the new directive has provided a valuable and timely opportunity to review and strengthen our legislation. We believe that the draft regulations provide a sound basis for the regulation of animal research and testing, and commend them to the Committee.
I thank the Minister for setting out clearly, in his usual way, the effect of these important draft regulations. I also offer my thanks to his officials in the Home Office, who kindly offered me a factual briefing earlier this year to allow me to understand fully the Government’s thinking and how they were likely to move on the regulations. It is also important to note the widespread consultation with many organisations, and we ought to pay tribute to the work of the Royal Society for the Prevention of Cruelty to Animals, the Fund for the Replacement of Animals in Medical Experiments, People for the Ethical Treatment of Animals, the UK Bioscience Sector Coalition, Understanding Animal Research and the Centre for Animals and Social Justice, among many others, which have contributed to the debate in a helpful way.
The draft regulations are important and the Opposition are pleased to have the opportunity to debate them. I have a series of questions for the Minister, some of which are detailed and technical, so I will understand if the Minister cannot give me a full answer today but will write to me with his response. I hope the Committee will forgive me if, given that this is a complex subject, I return to some of the issues the Minister raised so that we are clear about exactly how the Government are moving forward.
The number of animals used in experiments in Great Britain has been increasing steadily for a number of years, reaching 3,710,621 in 2011, which is more than at any time in the past 25 years. I also note that the coalition Government pledged in the coalition agreement to work to reduce the use of animals in scientific research. I was pleased that the Minister talked about the principle of the three R’s—to replace, reduce and refine the use of animals used for scientific purposes—and that the directive is clear in keeping those three R’s embedded in UK animal testing policy. I am glad that the directive will continue to prohibit animal experiments where an equivalent non-animal experiment can be used.
In October 2010, a revised EU directive controlling animal experiments was published, as the Minister said. As I understand it, that was after eight years of discussion and debate throughout the whole of Europe. The intention was to improve EU standards, which are nearly 25 years old and out of date in many cases, and to harmonise the controls throughout the member states.
to come into force in January 2013. Given that this issue has been around for many years, why we are dealing with it in December 2012—after the November deadline? Secondly, does he think there is sufficient time to allow for the regulations to be brought into force by the beginning of next month?
As the Minister said, we know the UK already has good animal protection law under the 1986 Act, which many recognise as probably the best in the world. It is important to note that the key to how the regulations will work is in the detail of the codes of practice, which
Will the Minister comment on the fact that there may be differences in the guidance provided by different member states, thereby introducing the strong possibility of variation in practice among member states? Ultimately, that could frustrate the directive’s aim to bring harmony in that area.
Overall, the Opposition welcome the directive, but we seek further assurances from the Minister that welfare standards will not drop as a result of the directive’s enactment in the United Kingdom. Much of the new directive is an improvement on the original, as he said, and much of it is modelled on our own legislation. If implemented properly, the directive will result in better provision for animals in labs in many European countries, which I am sure we all welcome. The directive should reduce the risk of animal experiments going abroad, and taking well paid bioscience jobs with them. That shows what can be done to support key UK industries when we work with EU allies.
In the UK, standards have been higher for some time, and there is concern about how the directive will be transposed into UK law and the effect that will have on animal welfare, science and public confidence in the UK’s controls. I note what the Minister said about wanting to make full use of the provisions to allow the higher animal welfare standards to be kept in place, but will he assure the Committee that, wherever possible, UK standards will be retained where they are higher than the directive’s standards?
Following calls from both sides of the debate—animal welfare groups, including the RSPCA and the British Union for the Abolition of Vivisection, and the UK Bioscience Sector Coalition—for clear, robust and unambiguous guidance documents and codes of practice, what are the Government going to do to ensure that that will be achieved? Who is involved in the preparation of the codes of practice, and what is the time scale for agreeing them? Will Parliament have an opportunity to consider the codes of practice?
On the specifics of the directive and the draft regulations, will the Minister commit to ensuring that personal licences will be retained as part of the three-tier UK licensing system? At the moment—for the person, the place and the project—three licences are granted. That is important in preventing the possibility of people being pressed into undertaking procedures they are not fully competent to perform.
Secondly, is the Minister aware of any cases in which penalties under the current practices for contravention have not been enforced? If he is, does he intend to revise the penalties? Thirdly, what assessment has he made of the current guidance and training, as set out in proposed new section 5C(2) of the 1986 Act? Does he believe that guidance and training requires updating? If so, will he commit to doing so? Will he also comment on what thought has been given to standardised Europe-wide training requirements in the sector?
The directive states that the place of work must be specified in the licence, which is set out in proposed new section 5(2), but proposed new section 5(3) allows for a
Another critical issue that has been flagged up is the reduction in Home Office inspectorate funding and the move to decentralise controls, transferring more responsibility from the Home Office to local establishments. Some believe that, taken together, those factors could constitute a serious attack on the standard of regulation of animal experiments. The inspectorate has an extremely important role in advising on licence applications and best practice, participating in expert working groups and conferences, and inspecting establishments for compliance, and that was recognised by all stakeholders in the 2010 Hampton implementation review. The Royal Society for the Prevention of Cruelty to Animals has raised concerns that the directive, together with the Home Office budget cuts, may result in a lower frequency of inspections. Will the Minister reassure the Committee that there will be no reduction in establishment visits as part of the inspection regime?
On the reduction in local controls, all currently licensed UK establishments must have a local ethical review process, with defined aims, functions and membership, as set out by the Home Office. The ERP has been in existence for more than 10 years, in which time it has been shown to raise standards of welfare, science and ethical review, while improving the local culture of care. The directive, on the other hand, only requires an animal welfare body to be set up, with a more limited remit than the UK’s ERP, and a reduced membership. The Home Office has stated that establishments will be able to choose to maintain their ERPs, but that will not be mandatory. Will the Minister take steps to ensure that the local ERPs are retained, because there is a view that removing them would damage animal welfare and, most importantly, that the public could lose confidence in the legislation?
The Minister touched on high levels of animal suffering in his opening remarks, and many animal welfare groups have raised concerns about the new directive allowing higher levels of suffering than are currently permitted in the UK. There are already considerable public concerns about the amount of pain inflicted during procedures under the existing law. Will the Minister confirm that experiments will continue to be graded on the scale of “mild”, “moderate” or “substantial/severe”? Will he confirm that the three thresholds will remain the same? Will he confirm that the Home Secretary will continue to maintain the current maximum threshold of severity? Is he able to confirm that no experiment that is currently prohibited on the basis of the severity of pain could be permitted once the regulations are introduced? Will he confirm whether the Animal Procedures Committee will continue to evaluate all projects involving the application of severe procedures to non-human primates?
On inhumane killing methods, one annex to the directive sets out approved methods of killing animals, and many believe that it is badly thought through and includes techniques that will cause avoidable suffering and cause the public concern. For example, very young puppies and kittens could be killed by a blow to the
On the use of primates, as the Minister said, the current proposals contain little special provision for primates, except that additional justification is required for the use of cats, dogs, primates and equines. There is, however, a long-standing Home Office voluntary policy ban on the use of great apes; no countries in Europe use them, and there is a general feeling worldwide that their use is unacceptable. Will the Minister confirm that the current Home Office policy ban on the use of primates will continue under the directive? Will he confirm whether his Department has a policy ban on the breeding and/or keeping of great apes and, if so, whether it intends to maintain it? Will he confirm whether any great apes are being kept in the UK that have previously been experimented on?
Can the Minister confirm the position in relation to stray animals? A lot of animal charities are concerned that dogs and cats that are lost on the streets might be picked up and used in animal experimentation, so it would be helpful if the Minister could confirm that that will not happen.
Can the Minister reassure the Committee, animal welfare groups and the public that there are no plans to remove existing departmental policy bans on animal experiments, and that the reality of removing such bans is complex and would not occur without thorough consultation with all key stakeholders?
I want to ask the Minister again about the lower standards of accommodation and care in the directive. An annex to the directive sets out mandatory minimum standards for animal accommodation and care, which is a hard fought-for advance for much of Europe, but some of the revised cage or pen sizes are lower than current UK standards. For example, for dogs, space is reduced from 4.5 to 4 square metres per dog, and the cage height for rats is reduced from 20 cm to 18 cm. A further problem is that the essential text that puts the tables in context and gives information on how to provide a good environment for animals has not been included in the annex. Can the Minister confirm whether UK standards will be retained where they are higher than those in the directive?
I also ask the Minister’s view of the paragraph on page 6 on the impact assessment about article 10, which sets out the future ability to supply laboratory animals from throughout Europe. That paragraph expresses concerns about the long distances that animals might have to travel, the impact on their welfare and the supply being made more vulnerable to disruption. Can the Minister comment on that particular aspect of the directive?
I ask the Minister about ensuring transparency for all types of animal use. The revised directive requires projects to include a non-technical lay summary for publication in the public domain. A retrospective assessment must also be carried out of the actual numbers of animals used, the levels of suffering and whether the objectives of the project were achieved. Both aspects are important, will increase transparency and are welcome but, unfortunately, serious limitations seem to be apparent in their implementation. Member states may waive the requirement for a lay summary for some regulatory
Has the Minister considered going further in the implementation of article 38 which calls for a transparent process of project evaluations? At present, information about animal experiments is largely exempted from the Freedom of Information Act by section 24 of the Animals (Scientific Procedures) Act 1986. There may be good reasons for keeping some information out of the public domain, but the lack of open access can fuel conspiracy theories and concerns about what is happening inside scientific bodies.
There is also the possibility of strengthening the scrutiny of animal experiments by allowing the wider scientific community greater information. Scientific research is premised upon peer review, and more could be done to further that principle with regard to ensuring that no unnecessary animal experiments are conducted. I do not want to denigrate the record of the Home Office in scrutinising applications—l am sure it does that well—but I am also sure we all agree that that process could be aided by greater open debate, particularly within the bioscience community. I hope the Minister will commit himself to ensuring that there is a proper review of the issue. When can he give the fuller response that the Government have talked about making?
I will briefly raise three other issues. Will the Minister please clearly define what is to be accepted as “multiple generic projects” in proposed new section 5(4) of the 1986 Act? On resources, having looked carefully at the impact assessment and waded through many pages, I have concluded that the overall transitional costs of the implementation are £21.2 million. Has additional funding been made available to the Home Office to enable that, or will the money have to come out of its departmental budget? Finally, according to the impact assessment, there will be a review of the legislation in 2017. Has the Minister thought about having one before then, because that is many years away? If things do not work well, surely we should address that sooner rather than later.
I congratulate all the people involved, because the directive and its transposition has been a huge, long piece of work. I particularly congratulate the former Minister, my hon. Friend the Member for Hornsey and Wood Green (Lynne Featherstone), who put a huge amount of work into considering the details. Her dedication was very impressive; she is now trying to do that for the rest of the world in her new role at the Department for International Development.
I thank the people who have provided me with extra information on the issue, particularly Professor Max Headley, and Michelle Brook from the Physiological Society. Although I used to be a scientist, I always
It is worth highlighting that the basic principle, with which I hope everyone agrees, is that we want good animal welfare for experimental animals. I hope that we all also want the UK to maintain its international lead in biosciences. The debate is really about trying to balance those two issues.
It is important to highlight why such experiments are done. They are often described as being simply for one purpose—testing—and the dialogue often relates to that. However, they are done for several reasons, such as fundamental biological research and for trials for treatments and medicines. Critically, trials are not only for humans but for animals, which raises the key issue that, although humans are the best model for humans, a new cat medicine is probably best studied and tested in cats, which is why animals are used. Experiments are also done for fundamental veterinary research into animal diseases, which must also be considered, and for fundamental issues of ecosystem research. We do not do experiments for cosmetic research, which will continue to be banned under the directive and its implementation. Such research is illegal in the UK, and should continue to be so. There is a shared focus between our aims of reducing the number of animals used, of replacing them wherever possible and of refining experiments.
The hon. Lady spoke about the number of animals used in experiments, but I hope she recognises that in talking about that, we must be careful not to mislead people about their purpose. A huge proportion of the experiments or procedures involve breeding and giving birth, which are relatively natural activities that animals generally do happily, without human intervention. Some 44% of procedures annually simply involve the birth of a mouse, which is clearly less worrying to many of us than what one sees on anti-vivisectionist posters.
The key to getting the three R’s—reduction, replacement and refinement—is to look, wherever possible, for alternatives. Interesting work is being done on human tissue. One of the first debates I took part in in this House considered how to make it easier to get consent for the use of spare human tissue—for example, from surgery. That could be used far more to reduce the numbers covered by the transposition of the directive, in that an aspect of human tissue could be used to test drugs. The Government should continue to work with the Department of Health to enable access to better consent procedures, an issue which was debated in Westminster Hall in early 2010.
Good work is being done on “humans on a chip”. Can we do more work on very small human cells, which can be grown in various ways? We could then test for toxicity and do modelling work that should not affect any sort of animal, as it would be merely chip-based. There is also the type of work I used to do, on in silico experimentation—computational simulations of what would happen. Far more could be done in that regard, which would help with the aims of this work.
One point is clear: I have had it put to me that some in the pharmaceutical industry are keen to have animal experimentation, but generally speaking, people would be keen not to have animal experimentation if they could get the results they require in another way.
Roger Williams (Brecon and Radnorshire) (LD): I thank my hon. Friend for making that important point. Experimentation with live animals is extraordinarily expensive, and if people can find other ways of getting the results they require, they would rather do so without using live animals.
Dr Huppert: I will indeed. The costs involved are significant and they are affected by the regulations. The 2,663,000 mice that we used last year cost between £10 and £20 each, and the figure was significantly more for other animals.
That brings me nicely on to the legislation’s implementation. As cost is an issue, I urge that the legislation be supported as it stands, but how it is implemented is important. Excessive bureaucracy in introducing it would stifle research, not only by increasing costs but by eating into the time of the people doing such work, who would have to comply with the paperwork requirements. Bureaucracy in and of itself does not increase welfare. The directive had to balance advancing the welfare agenda with minimising the part of bureaucracy that does not benefit welfare. The UK is going further than the initial EU legislation in interpreting the directive in a particular way. In some ways, that is helpful. Where welfare is helped, we would all support the legislation, but I urge the Home Office not to implement it in a way that increases red tape.
If the legislation is implemented badly, we would see more major pharmaceutical companies moving animal work abroad, where there is generally less welfare protection, as Pfizer and others have done. Many academics do a huge amount of their animal work abroad, not because they want to escape the welfare controls—they care very much about those—but because they want to have lower costs and lower infringement when the bureaucracy hits them. There are suggestions—we will have to see how the provisions are implemented—regarding very narrow relative humidity tolerances for keeping lab animals. Such tolerances would never be applied in a hospital environment. We have to keep such things in perspective. It is noteworthy that, although a mouse or rat held in a cage for the purposes of experimentation is covered, the same mouse or rat running across the floor of the lab just outside it is not. It is treated in the same way as a domestic mouse or rat, which raises some interesting moral and ethical issues.
We lead Europe in the quality of our science and animal welfare, and we should continue to do so. Following this transposition, it will remain illegal both to use an animal if there is a suitable non-animal alternative, and to use an animal to test cosmetics. Using great apes will also remain illegal. Special protections for dogs, cats, non-human primates and equids will continue. There will be improvements in animal accommodation and there will still be full licensing. I hope the Committee will support the regulations.
As chairman of the all-party group on the three R’s—the reduction, replacement and refinement of the use of animals in experimentation—I want to thank the Minister and his predecessor, the hon. Member for Hornsey and Wood Green, for their strong work in engaging with the scientific community and animal welfare groups. Officials have also worked hard in that process, which has not been easy. This is a complex piece of legislation being transposed into UK law. Many concerns remain, but Ministers and officials have managed the process in such a way that they have the confidence of all parties at this point. They should be congratulated on that, because it is no mean feat.
However, as always with such things, the proof of the pudding is in the eating; I look forward to scrutinising the guidance and the code of practice. My hon. Friend the Member for Kingston upon Hull North made a series of important points and asked important questions, which I am sure the Minister will respond to. As the guidance and code of practice are developed, the strong principles of engagement with animal welfare groups that have got us successfully to this point need to be driven forward to ensure that we have legislation that truly allows us to remain at the forefront of animal welfare in animal experimentation.
My hon. Friend pinpointed a number of issues, but there are four that I want to highlight and ask the Minister to clarify. The Government have made the ban on the use of great apes clear, but this is an opportunity for them to make it absolutely clear. The same applies to the use of stray animals. Is the size of the spaces that animals live in likely to be reduced, or will we be able to maintain the UK’s higher standards? Finally, I echo my hon. Friend’s concerns about the Home Office inspection regime, which has been a strength of the UK’s position. It would be helpful if the Minister assured us that that will be in no way weakened inadvertently through this process.
I welcome where we have got to so far in this complex transposition of legislation, and I thank the officials and Ministers involved. I look for a commitment that the working together—the engagement—that has got us thus far will continue into the future with the code of practice and the guidance.
Fiona Bruce (Congleton) (Con): I welcome the revised measures for the improvement of animal welfare legislation that the EU directive requires, but I want to highlight a number of concerns regarding human and animal admixed embryos.
First, on ethical scrutiny, what will the regulations mean for the ethical oversight of research on human-animal chimeric and hybrid embryos? Regulation 20 will abolish the Animal Procedures Committee, which advises the Secretary of State on matters relating to the 1986 Act and covers both animal welfare and broader ethical issues. The regulations will replace it with the committee for the protection of animals used for scientific purposes, which will be concerned with animal welfare only.
“applications of any kind raising novel or contentious issues, or giving rise to serious societal concerns, (for example, any application involving the genetic modification of non-human primates or embryo-aggregation chimaeras involving dissimilar species)”.
I am advised that there does not appear to be a similar statutory requirement in the regulations, which narrow the range of advisory functions the new committee would have to animal welfare issues. What safeguards, therefore, has the Home Office put in place to direct project applications raising novel or contentious issues or giving rise to serious societal concerns, such as embryo-aggregation chimeras involving human and animal cells, to an appropriate body which would advise the Secretary of State on licensing decisions? Which committee would such applications be directed to, and who would decide which project applications should be directed to the committee?
Secondly, may I raise concerns about the clarification of the interface between the human fertilisation and embryology legislation and the 1986 Act? The regulations require the creation of new bodies called animal welfare and ethical review bodies, but their remit appears to be related, whether directly or indirectly, to animal welfare, and does not seem to extend to broader ethical issues, such as human-animal chimeric and hybrid embryos. The newly formed National Committee for the Protection of Animals used for Scientific Purposes is to provide advice to the Secretary of State and the new animal welfare and ethical review bodies, but it is unclear what degree of ethical scrutiny and oversight there will be, other than that relating to animal welfare. For example, might the animal welfare bodies replace the local ethical review process currently established in the UK, which has a greater degree of independence, and which includes critical appraisal of applications for project licences before submission to the Home Office? I would welcome the Minister’s comments on that. Will the Minister please confirm whether the regulations have put in place more stringent requirements on animal welfare bodies than those in the EU directive? If so, what are they, or are the regulations the minimum requirement set out in the directive?
Will the Minister clarify whether the remits of the National Committee for the Protection of Animals used for Scientific Purposes and the animal ethical review bodies are solely concerned with animal welfare issues, or whether they include broader ethical issues, such as advising on the moral status of certain human-animal chimeras and hybrids and on the desirability, or otherwise, of permitting research involving them? If they do not, will he explain what official ethical oversight will be set in place to assess their moral status, whether such research should be licensed, and how such oversight will differ from that currently in place?
A further concern relates to the independence of the animal welfare and ethical review body, because it is the section 2 licence holder that must establish and maintain it. Does the Minister think that that might cause a conflict of interest? How could that be avoided
I turn now to the concerning issue of the interface between human legislation and animal legislation, and the creation of human-animal chimeras or hybrids that have ambiguous moral status, particularly where they may be considered substantially human, although they do not quite fall under the regulation of the HFEA. Could there be less scrutiny than previously of individual cases of human-animal chimeras and hybrids, and less assessment of their moral status and the desirability, or otherwise, of their creation and implantation into an animal?
The 1986 Act regulates research using animals, including animal embryos. It also regulates human-animal chimeric and hybrid embryos that are not considered predominantly human, which may be implanted in an animal under the Act, and which would be allowed to go to a much later stage of development than the 14-day limit allowed by the HFEA—potentially to birth and beyond, if my understanding is correct. That potentially includes embryos that would be considered only marginally more animal than human. In its guidelines, the Animal Procedures Committee highlights the Academy of Medical Sciences’s recommendations on the regulatory scrutiny of experiments considered ethically controversial. Those are divided into categories 1, 2 and 3. I will not go into all of them, but according to the committee, the Home Office, the HFEA and the Department of Health have all accepted the recommendations. Should they be appended at least to the guidelines, even if the draft regulations cannot be amended at this stage?
The Scottish Council on Human Bioethics has recommended additional provisions, which should also be incorporated, if not into the regulations, at least as an annex to the guidelines. Does the Minister agree that minimum ethical guidelines should clearly be put in place? Is it possible for the recommendations of the Academy of Medical Science concerning regulatory scrutiny and restriction of the more ethically controversial experiments involving animals containing human material to be appended to the guidelines, if they cannot be incorporated into the regulations, along with clarification of which categories of human-animal interspecies embryos should be regulated under the Human Fertilisation and Embryology Act 2008, as described by the then Health Minister, Lord Darzi, when the Act was before the Lords, so that the remit of those animals used for scientific purposes, and regulated under these regulations, is clarified?
The Committee will already have realised that my scientific knowledge extends to a scraped biology O-level 30 years ago, so I apologise if my reading appears to be laborious, but obviously these are important points to many people concerned about such issues.
I have a number of questions on tetraploid complementation. Will the Minister ensure that it is communicated to the HFEA, the Department of Health, the Home Office, the Animal Procedures Committee and any relevant new bodies under the draft regulations that human-animal chimeric embryos made by tetraploid complementation would require a licence from the HFEA, as stated by Lord Darzi during the debate to which I have previously referred? Will the Minister ensure that, where the Animal Procedures Committee has produced
Will the Minister consider whether the Animal Procedures Committee’s guidelines for researchers should include clear instructions that any embryo that might ultimately, even for a short time, be predominantly human would require a licence from the HFEA; that any embryo whose cells might develop, whether fully or partially, a human brain would also require an HFEA licence, even though the human cells are less than 50% of the entity; and that any other embryo that might develop a predominantly human function would also require an HFEA licence?
The Committee will be relieved to hear that I am coming to the end of my remarks, but I have two further points. First, will the Minister clarify whether “relevant species” in section 1(2)(a) of the 1986 Act applies to the foetus itself or to the animal carrying the foetus? Which species would be the “relevant species” in the case of a human-animal chimeric foetus? What would be the status of a human-animal chimeric foetus when more than two thirds of the gestation period has elapsed, given that section 1(1) of the 1986 Act excludes “man” from the definition of a protected animal?
Finally, on the principle of replacement, could the regulations result inadvertently in preferring or requiring research on human or human admixed embryos over research on animal embryos? Will the Minister clarify whether there are any circumstances under which the principle of replacement, which requires alternative approaches to the use of protected animals, might take precedence over the conditions for granting licences under the Human Fertilisation and Embryology Acts, where licences to carry out research on human or human admixed embryos will not be granted unless the research is deemed necessary or desirable?
I may have to be a little selective in my replies so that I can try to respond to at least some of the questions raised by each of the hon. Members. If I start with the questions of the hon. Member for Kingston upon Hull North, I might run out of time for the others, so I hope she will forgive me. I will answer some of her questions, and I will then spread my answers around other colleagues before returning to some of her other questions.
If we get to the end of the sitting and you unfairly cut me off in my prime, Mr Streeter, I will write to you and copy in members of the Committee and anyone who is here who is not a member of the Committee. If people desperately want to be included in an answer, they should tell the Clerk they were here so that we include them. We will ensure that everyone is informed in that way.
Picking up some of the points made by the hon. Member for Kingston upon Hull North, the first was on process issues to do with the timing of the transposition of the directive into regulation. As has been mentioned, the area is complex and comprehensive. We were keen to ensure that the draft regulations were properly scrutinised and they have been, carefully, by the Secondary Legislation Scrutiny Committee and the Joint Committee on Statutory Instruments. We were keen to permit consultation on the draft regulations themselves, using the summer for that purpose, which meant that we did not quite hit the 10 November target date.
The hon. Lady asked a sensible question about how all those affected by the legislation will cope. In the meantime, we have issued guidance to current licence holders and begun work on the necessary transitional changes, so I am confident that those involved will be clear about the legislation. It is worth remembering that the new directive was largely built on the work that we already do, so for most people involved in animal research in the United Kingdom it is not a dramatic shift to a new regime.
Guidance on the implementation of the amended legislation is being prepared. It will be published for consultation before the amended legislation comes into force. The guidance will be subject to the negative resolution procedure, which will repeal the current statutory guidance. The new guidance will provide an overview of the amended legislation and guidance for holders of the three types of licence—personal, project and establishment—and the final version will be published during 2013.
It is worth mentioning the two Government commitments in the coalition agreement, because they were raised by the hon. Lady and the hon. Member for Cambridge. One was to work to reduce the use of animals in scientific research, under the three R’s process referred to by the hon. Lady and the hon. Member for Scunthorpe, who chairs the all-party group, as well as by the hon. Member for Cambridge. The National Centre for the Replacement, Refinement and Reduction of Animals in Research project closely involves a number of Departments—not only the Home Office—the research community and those involved with animal welfare interests. The hon. Lady was right to pay tribute to all those who responded to the consultation, both individuals and organisations, because the broader the consultation the more confidence we have that we got things right.
The other area was to end the testing of household products on animals. That work is under way, defining a definition of “household product” and ensuring that the work is done sensibly. It is worth remembering that no testing of household products on animals was recorded in the annual statistics for 2011. That work is well under way.
Dr Huppert: While the Minister is making his excellent point, in particular on the coalition commitment to reduce the numbers involved, does he agree that it would be helpful if the presentation of the numbers separated out breeding from other experiments, because people have different views? Both numbers could be presented, somewhat like immigration statistics with students separated out.
The hon. Member for Kingston upon Hull North referred to the codes of practice and what the Government were going to do to ensure that they were acceptable. We have already consulted once on the codes, and we will consult on a further draft before publication and before we lay them before Parliament, so they will be available to Members.
The hon. Lady also made a point about personal licensing. In my opening remarks, I said that we were keeping the system of personal licensing. Indeed, we believe it essential to ensure that any procedures causing pain and suffering are only applied to animals by individuals who are properly trained and competent.
The hon. Members for Kingston upon Hull North and for Scunthorpe asked about inspection. We are committed to maintaining a strong and properly resourced inspectorate and full risk-based programme of inspections. The relationship between inspectors, licence holders and animal care staff is crucial to implementing the regulatory framework, and we do not want to do anything to jeopardise it. The Secretary of State will be able to give a direction, under new subsection (2A) to section 18, that requires that a suitable number of visits are performed during the course of a year and that a suitable proportion of the visits are carried out without notice to the breeder, supplier or user concerned. The Secretary of State can meet her obligations under the directive, which sets out that there have to be regular inspections and that an appropriate proportion are carried out without prior warning. We think that requirement is met.
On animal welfare and ethical review bodies, our consultation, to which there was a good response, showed strong support for the view that animal welfare bodies should work in a similar manner to our current ethical review processes. We will publish revised guidance on the membership and functions of animal welfare ethical review bodies, based largely on the current ethical review processes. Until that guidance is published, existing local ethical review processes will operate as animal welfare and ethical review bodies. They must continue to include as participants at least those individuals required by article 6 of the animals directive, and must carry out all the tasks set out in article 27 of that directive.
The hon. Lady also referred, in both general and specific terms, to departmental policy bans. Where there are policy bans, they will be retained. She mentioned specifically the prohibition on the use of great apes. We currently operate a policy ban and we will continue to prohibit their use. We have put an absolute ban on the face of the legislation and have made no provisions for exceptions to that ban.
The hon. Lady and the hon. Member for Scunthorpe talked about stray and feral animals. Earlier this year, concern was expressed that the changes might be intended to allow the use of stray animals. That was never the
In general, where we have stricter standards in the United Kingdom, as I said, we have the ability to retain those and we plan to do so. To pick up a point made by the hon. Member for Scunthorpe, that includes enclosure and cage sizes for dogs and a number of other species.
The hon. Lady brought up severity classification. As I mentioned in my opening remarks, I can confirm that there are no changes in the severity regime. We are not weakening it. We will ensure that the severity classifications are adhered to, even though the directive is not explicit on that—again, this is an area where we have gone further than the directive—and we will do so through the authorisation process. We are also retaining existing project licence condition 8, which requires that those limits are adhered to. Within personal licences, there is also licence condition 13, which sets a clear line of responsibility for notifying the Secretary of State. There will be no change to the current application of severity or the highest acceptable thresholds. Again, I hope that reassures the hon. Lady.
The hon. Lady also referred to humane killing. There has been broad agreement across sectors that some methods of killing prescribed in annex 4 to the directive could impose a high welfare cost. In the public consultation, a clear majority supported retention of the current methods, set out where appropriate. We have revised schedule 1 to implement annex 4, but have retained current UK methods where they are more humane. That is along the lines of our standard approach.
The hon. Lady also talked about transparency and the non-technical summaries. We will require that non-technical summaries take place for all projects. The need for retrospective reviews will be determined on a case-by-case basis. I think that meets the requirements.
On section 24, to which the hon. Lady referred, the consultation response did not reveal a clear consensus about whether the provision should be replaced or repealed. Therefore the Government are giving further thought to that. We intend to do that next year. We do not need to take immediate action in relation to the transposition of the directive in that area. Once any changes to section 24 have been agreed, they can be implemented through domestic legislation.
The hon. Lady also talked about multiple generic projects. As far as the definition is concerned, again, we have gone further than the directive. A project in this context is a subset of a programme of work: a type of experiment, study or production process. “Multiple” means that a programme of work may include more than one study of the same type. “Generic” is best exemplified by reference to the breeding of genetically altered mice, the production of antibodies, or the conduct of a safety evaluation test, within each of which the particular experiment study or production process is
The hon. Lady said that she had studied the impact assessment with great care in terms of how the Department is affected. The assessment made it clear that the impact on the public sector is cost-neutral, so we do not envisage any further resources being required for the Home Office to carry out its inspection function.
On penalties and compliance, there are criminal sanctions specified for breaches of the regulations. Some additional penalties have been included. The matter goes to the point made by the hon. Member for Cambridge: those involved in animal research are committed to high standards of animal welfare. There is a high level of compliance with the regulations, and the need to consider criminal penalties is rare. We have a regime that is stronger than many others but is well complied with. That is worth remembering, because the hon. Gentleman drew attention to the risk that if we drove such research away from the United Kingdom, we would have regimes that were both less tough and less complied with. Having the research carried out in the United Kingdom, with a tough regime that is well complied with, is good for the UK, research, our economy and the welfare of animals.
I think I have answered many of the questions raised by the hon. Member for Kingston upon Hull North. Let me deal with those raised by others. If I have missed any of the ones that she asked me, I will ensure that I write to her, but I think I have answered pretty much all of them.
Although the hon. Member for Cambridge edged towards the boundaries of staying in order—nudged slightly back by you, Mr Streeter—he did a valuable task, because he set out clearly the reasons why animal research is necessary. He also set out some avenues on which the three Rs could be pursued, which is important to his constituency’s interests and to his previous life before he entered this place. That was helpful.
The hon. Gentleman referred specifically to red tape and not making the regime too difficult to comply with for those involved. I think I have made it clear that we will use the transposition to get rid of unnecessary bureaucracy where we can. For example, I mentioned that we are simplifying the detail of personal licences in the process. We will continue to look at that. If there are specific areas, it will be helpful to have those drawn to our attention. The good thing is that the new regulations are largely building, as did the directive, on our existing regime, which I think works well, is well complied with and delivers a good regime not just in theory but in practice; that is not always the case with everything done by the Government.
The hon. Member for Scunthorpe, who chairs the all-party group on the replacement of animals in medical experimentation—I did not know that, but I do now—mentioned the engagement of animal welfare and science organisations in the consultation. On behalf of the Ministers involved in the previous and the present Governments—which does not include me—and of officials, I will accept his congratulations on the way they have conducted themselves. I am sure that they will hear what he has said. The area is a difficult one.
I have dealt with the hon. Gentleman’s point about great apes. I have dealt with the accommodation and spaces for animals, including stray and feral animals. He is right to mention those, because it is important that there is clarity in that regard. I have also dealt with inspection regimes.
My hon. Friend the Member for Congleton took us down an important avenue, although she not only passed her own level of scientific understanding, by her own admission, but rocketed past mine, as well. I will answer some of her questions now, but I hope that she forgives me, particularly with regard to the important ones where we are looking at the intersection of the science and moral questions. If she would like a fuller response, I will write to her and ensure that Committee members receive a copy of the letter.
My hon. Friend mentioned the advisory committee, as did the hon. Member for Kingston upon Hull North. The new advisory committee that is being set up will be comparable with the existing one. Effectively, although there is change, it broadly continues a similar level of policy. Any novel or contentious project applications will continue to be submitted to the new committee for independent advice on ethical issues, which my hon. Friend asked about.
My hon. Friend the Member for Congleton asked about research using a combination of human and animal hybrid, or chimeric, embryos. She knows that research using human embryos is separately regulated under the Human Fertilisation and Embryology Act 1990, as amended. Some research using human-animal hybrid embryos and similar entities may require licensing under that Act and these regulations. Applications have to undergo detailed scrutiny and have to be considered case by case. If applications are novel and raise wider questions, they will be referred to the national committee for advice. Those may be considered under both regulatory regimes and permission to carry out work may be refused by either one or both regimes. I am afraid that I will have to write to my hon. Friend about some of her more detailed questions on the moral status of some of the chimeric embryos.
My hon. Friend asked specifically whether the regulations were supported by the Department of Health and another Department, the name of which I have forgotten. The regulations are supported by all Departments and agreed collectively in the usual way.
My hon. Friend mentioned conflicts of interest. The existing processes have proven successful and, as far as we are aware, are not affected by conflicts of interest. We have seen no evidence to suggest that the new procedures would be any different. If she has any evidence that she wishes to draw to my attention, I should be happy to take the matter up. However, we think that the current processes work well, and the new ones are analogous to those.
My hon. Friend asked whether the guidelines on the use of animals containing human material will be reflected in the guidance. Yes, we can ensure that that happens. A comprehensive guidance note has been prepared by the Home Office, the Human Fertilisation and Embryology Authority and the Human Tissue Authority, on regulation of the use of animals containing human material. We will ensure that that note is widely available to all those whom it might affect.
On my hon. Friend’s final question, the Home Office is working closely with the HFEA to ensure that any embryo that is predominantly human is licensed under the relevant regime, to ensure that the appropriate higher level of ethical consideration is given. The animal carrying the foetus will be also protected under the animal regulations. The foetus will only become protected under the regulations if allowed to develop beyond two thirds of gestation, which is not currently permitted. I hope