My Lords, I am pleased that the House has the chance to consider the proposal to revise the EU directive on the protection of animals used for scientific purposes, particularly at a time when discussions are still under way in the European institutions.
The most recent statistical report by the European Commission shows that just over 12 million animals were used in scientific procedures in the 25 member states that made up the European Union in 2005. France, Germany and the United Kingdom were the member states with the highest numbers of animals used, accounting for half of the 12 million. This is not a new state of affairs. In 1986, the European Community adopted the first directive on the protection of animals used for experimental and other scientific purposes. Also in 1986, in the United Kingdom, the Animals (Scientific Procedures) Act was enacted, which put in place the current system of controls in this country regulating scientific work on living animals, as well as implementing the 1986 directive.
In carrying out our inquiry, it was made clear to us that since 1986 the UK has maintained controls which have promoted good standards of animal care and use. However, we were left in no doubt that the 1986 directive has not been implemented consistently across all member states and that the standards achieved in the UK are not replicated in all parts of the EU.
When the European Commission published the proposal in November 2008, it highlighted the following objectives: to strengthen the protection of animals used in scientific procedures; to promote the replacement, reduction and refinement of the scientific use of animals, the so-called three Rs; and to put right the wide variations in the implementation of the 1986 directive, to ensure a level playing field across the EU.
As a committee, we supported those objectives, and we agreed on the need to revise the 1986 directive. Since 1986, there have been developments in science and in the understanding of animal welfare which, after 24 years, should be taken into account in new legislation. The process of revision provides an opportunity to put in place some really effective safeguards, to ensure that the new directive will be implemented consistently across all member states.
We are grateful to all those organisations which sent us evidence or appeared in person and made some very powerful arguments. I should also record our thanks to our special adviser, Dr Jane Smith, who enabled us better to understand a subject of some complexity. I also acknowledge the work of my colleagues on the committee, who ensured that the inquiry into this challenging subject was carried out with vigour and insight. It is right for me to pay tribute to my predecessor, the noble Lord, Lord Sewel, who I see in his place, for whom this inquiry was his swansong as chairman, after guiding the committee through many perceptive and influential inquiries.
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 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,
"life-threatening or debilitating conditions in human beings".
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 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 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.