My Lords, I am also extremely grateful to my noble friend Lord Carter of Coles; to his predecessor as chairman of EU Sub-Committee D, my noble friend Lord Sewel; and to all the Clerks and members for the committee's very well balanced and perceptive report and for organising this debate. I am also grateful to all noble Lords who spoke, many of whom have a very detailed knowledge across this area. I mention, in particular, the noble Lord, Lord Soulsby, who seems to have been working in this field for some 60 years and has a remarkable depth of knowledge. Rather like the noble Lord, Lord Addington, I feel that I am dipping my toe into something that is a little tricky. I am no deep expert in this area, although I have a team who brief me very well. However, at least when the cephalopods were mentioned, I felt that I was getting a little closer to salt water and was a little more at home than I would otherwise have been.
On cephalopods, decapods and so on, the noble Lord, Lord Skelmersdale, asked me a specific question about pain and what research had been done. Perhaps I can get back to him in writing, as it might take a long time to answer him now.
Science and animal welfare have progressed significantly since 1986, as a number of speakers have mentioned, and no doubt a revision of the directive on the protection of laboratory animals is overdue. I share the view of the noble Lord, Lord Skelmersdale, that since 1876 we have led the world on issues of animal welfare. In this country, we have nothing to be ashamed of on that aspect. We have, quite rightly, put in a huge effort and that reflects what we expect.
Despite the progress on developing alternatives, animal use continues to be necessary to develop improvements in healthcare and in protecting man and the environment. The National Health Service could not function without treatments developed through research using animals. Almost every form of modern medical treatment has relied, in part, on animal use, as was so eloquently and clearly articulated by my noble friend Lord Winston.
It is vital that new European legislation is practical and proportionate and does not delay the scientific progress and benefits brought through animal research. As my noble friend Lord Sewel clearly pointed out, it is certainly required because the old directive was quite inadequate. It is essential that it does not undermine the success of UK researchers or our own high animal-welfare standards. At the same time, we have to develop proactively, validate and implement alternatives to animal use to deliver better welfare and better science.
The Commission's proposal is premised on three high-level objectives, all of which we support. The first is to rectify variations in the implementation of the current directive by member states-that has been seen by some member states, including the United Kingdom, as adopting stricter measures and providing a high level of protection for animals. Meanwhile, other member states provide for only the minimum requirements of the current directive. We fully support harmonisation, which is essential to create a level European playing field for researchers in industry and academia.
Secondly, the Commission sought to strengthen the protection of animals by making better provision for their welfare. Good animal welfare and good science are inseparable and it is right that the European Community should set high welfare standards. That is also essential if we are to maintain public support-as touched on by a number of speakers-for the important research that still requires animal use. Confidence in the regulatory framework is an important component of our strategy to eliminate animal rights extremism.
Thirdly, the Commission sought to promote the three Rs: the development, validation, acceptance and implementation of methods and strategies that replace, reduce and refine the use of animals. That was mentioned by a number of speakers, particularly the noble Lord, Lord Soulsby, and the noble Earl, Lord Arran. The UK plays a leading role in this area. I strongly support the desire of the noble Earl, Lord Caithness, that one day we will not have to use animals. I am sure that all of us would like that, but my noble friend Lord Winston gave us a blast of reality that one cannot see that at the moment. However, that does not mean that we should not aspire to it. The three-Rs framework was developed in the United Kingdom, is a key component of our current harm/benefit assessment, and is supported by our National Centre for the Replacement, Refinement and Reduction of Animals in Research, something which is not replicated across Europe, unfortunately.
Of the European Commission's proposal published in November 2008, a number of the provisions were acceptable in principle. Indeed, many were variations of current UK provisions. However, there were a number of concerns: for example, the inclusion of invertebrate species; poorly thought-through mandatory care and accommodation standards and humane killing methods; the absence of detail of severity classification, as mentioned by the noble Lord, Lord Carter; inadequate provision for the reuse of animals; and proposed restrictions on the use of non-human primates. Many detailed provisions would increase the administrative burden without benefiting science and, more importantly, animal welfare.
I can report that many concerns, including those identified in the committee's report, have been remedied by negotiation. Only the arrangements for delegating and implementing acts under the Lisbon treaty remain to be finalised. I shall mention some key changes in the revised text; many were covered either in correspondence with the noble Lord, Lord Roper, or in the Government's response to the committee's report.
As regards the use of non-human primates, the draft text now includes a definition of "debilitating clinical condition" which encompasses almost all current uses of non-human primates in the UK. This has allayed our earlier concerns that work to remedy unmet clinical needs might be prohibited. Borderline cases can be provisionally authorised by a member state and subject to final decision by the Commission via comitology. In addition, the Commission has given a commitment to convene an expert working group to provide guidance on the interpretation of restrictions on primate use.
We believe that the new definition, the safeguard clause and the promised guidance provide the clarity we require and a suitable mechanism to resolve any areas of uncertainty about the use of primates, such that well justified use can continue. Although not a current EU requirement, only captive-bred non-human primates are currently used in the UK. The revised directive will go further and make the use of non-human primates which are themselves the offspring of captive-bred animals-so-called F2 animals-the European norm. The revised text requires the Commission to conduct a feasibility study to ensure that the timetable for this move will be adjusted if it is found to be unrealistic. The draft also requires the Commission to conduct a further study to establish the feasibility of sourcing non-human primates exclusively from self-sustaining colonies. This is also welcome.
Details of a severity classification system are based on the work of an expert working group which met in July 2009, as mentioned by a couple of speakers. The draft directive also sets an upper limit to the severity of procedures that may be authorised by member states without reference to the Commission. To go above this threshold would be to permit animals to be used in procedures which would involve long-lasting, severe pain, suffering or distress. We are disappointed that the possibility to allow such procedures remains within the scope of the new directive. However, we cannot foresee any circumstance whatever where we would permit this to happen in the UK.
We and the Committee were concerned that the framework for the reuse of animals in the Commission's proposal would have increased the number of animals used and the suffering caused to the additional animals, a point raised by the noble Lord, Lord Addington. Changes made during the negotiations make better provision for the responsible reuse of animals, reducing the total suffering caused without causing unreasonable cumulative suffering to the animals used. That is consistent with the principles of reduction and refinement. It is with those principles in mind that the reuse requirements will be implemented in the UK.
The annexes setting out standards for the care and accommodation of animals and specifying humane killing methods have been substantially amended to correct the many faults in the original text. The deadline for implementation of the care and accommodation standards has been set at January 2017, allowing projects up to six years to adapt their facilities. Complying with these requirements will not compromise any of the UK's very high welfare standards.
It is now agreed that all projects will be ethically evaluated prior to authorisation, which is already standard practice in the UK. Proposals for "notification" and "tacit approval" of projects, which were of significant concern to the committee, have been dropped.
The requirement for data sharing has been removed, and my noble friend Lord Winston gave a clear exposition of why that is not particularly damaging. The requirement for national reference laboratories for the validation of alternative methods has also been dropped. Instead, much more practical requirements are placed on the Commission to consult member states in setting priorities for validation studies, and over the allocation of tasks to the laboratories nominated.
Not everything in the negotiation has gone as we would have wished. The revised text would allow the use of great apes in exceptional circumstances-something we do not permit. Again, we cannot foresee any circumstances when this would be permissible in the UK.
Surprisingly, as commented on by my noble friend Lord Sewel, many member states, but not the UK, saw the requirements for at least two inspections at each establishment each year as too ambitious. The revised text requires a risk-based approach to inspection, but it requires only a minimum of one-third of users to be inspected each year. That is significantly less than the current United Kingdom inspections regime.
The noble Lord, Lord Soulsby, and my noble friend Lord Sewel both spoke well about the value of our inspectorate and how important it is. In addition, the Commission will be under an obligation to carry out controls, but only where there is reason for concern. Notwithstanding the comments made by the noble Earl, Lord Caithness, we are pleased that the principle of regular, risk-based inspection has been established through the EU, which is something that we believe requires more than the specified minimum inspection frequency, and that the Commission is under an obligation to oversee and enforce this aspect of the directive. My honourable friend Meg Hillier pushed to the limit what the market would bear. The risk-based approach will require that we work above the minimum and that others do likewise to satisfy the Commission and to make sure that its responsibility is being properly discharged. The latter point is significant, and the committee rightly noted that weak enforcement by the Commission was one factor contributing to the ultimate weakness of the current directive. I cannot argue with that; that was one of our concerns.