The Chairman: Does the member of the European Scrutiny Committee wish to make a brief explanatory statement about the decision to refer the relevant document to the Committee?

Mr. David S. Borrow (South Ribble) (Lab): It is a great pleasure to report to the Committee the reasons for referring European Union document No. 15546/08, and addenda 1 and 2, which relate to the protection of animals used for scientific purposes.

Existing legislation was set up by a European Union directive from 1986, which is 23 years ago. It set minimum standards for animal welfare and the way in which animals should be used for scientific purposes across the European Union. Since then, various member states have improved the standards beyond the minimum set down by that directive.

The European Commission has been thinking about bringing in a new directive to set a new minimum standard. The position given by the Minister when the draft directive was sent to the European Scrutiny Committee referred to a general agreement that the situation needed to be looked at again. A paragraph from the letter to the Committee states:

The view of the European Scrutiny Committee is that the subject is important to hon. Members, and that it is important for the Government to place and explain their position before further negotiations on the directive start within the European Union.

The Parliamentary Under-Secretary of State for the Home Department (Meg Hillier): It is a pleasure to serve under your Chairmanship, Mr. Martlew. We are discussing an important issue, and it might help if I outline the timetable. We have been waiting for a draft directive since 2002, and this one appeared in November last year. I welcome the European Scrutiny Committee’s view that it is good to have a debate about it at this stage, because it still has some way to go through the European Parliament, with the likely interruption of the European elections, unless there is swift progress in Europe between now and June. I am grateful to my hon. Friend the Member for South Ribble for his introductory remarks, outlining the European Scrutiny Committee’s views.

The use of animals in science in the European Union is currently regulated by directive 86/609/EEC, and in the UK by the Animals (Scientific Procedures) Act 1986, which incorporates much of that directive into UK law. The UK Government and the European Commission believe that animal experimentation continues to be a vital tool in developing improvements in health care, and protecting humankind and the environment.

The draft directive sets out revised measures for the protection of animals used for scientific purposes which are intended to achieve three high-level objectives. I shall outline those to the Committee and then explain some of the concerns that the UK Government have about them. I will be interested to hear hon. Members’ comments on them and will take questions.

First, the draft directive aims to rectify wide variations in the implementation of directive 86/609 by member states. This has seen some member states—including the UK—adopt stricter measures that provide a higher level of protection for animals used in scientific procedures, reflecting scientific progress and improved understanding of animal welfare. Other member states apply, at best, only the minimum requirements of the current directive.

Secondly, the draft directive is intended to strengthen the protection of animals used in scientific procedures—for example, by making special provision for non-human primates, and the ethical evaluation of proposed animal use a mandatory requirement. Thirdly, the draft directive seeks to promote the three Rs: the development, validation, acceptance and implementation of methods and strategies that replace, reduce and refine the scientific use of animals. The UK Government have funded that work through the National Centre for the Replacement, Refinement and Reduction of Animals in Research—NC3Rs—in the UK.

The UK Government support those high-level objectives. The harmonisation is essential if we are to create a level playing field in Europe for the research community in industry and the academic sector. We also agree that the European Community should set high welfare standards for laboratory animals. The UK, I believe, has a very good record in this area.

In my view, and that of the Government, good animal welfare and good science are inextricably linked. High standards of animal welfare are essential if we are to maintain public support for the vital research that still requires animal use. There can be no excuse for unnecessary or unjustified animal suffering. It is also timely and important to promote the development and use of alternatives more effectively. As I mentioned, the UK currently funds the NC3Rs to the tune of £250,000 a year. That was an element of the 1986 Act.

As I have hinted, the individual provisions of the Commission proposal, while accepted in principle, provide variations on elements of the current UK system. Our initial analysis suggests that the proposal as currently drafted—there is, of course, time, and a lot of work is going on to amend the draft—is unlikely to deliver the full benefits of harmonisation and the improved animal welfare that it sets out to achieve. There are ambiguities and inconsistencies in the text, elements where the specific provisions would frustrate the stated objectives or cause unnecessary harm to the European Union science base, and other components where a lack of flexibility would make it difficult to adapt regulation to continuing technical progress.

In addition, the Commission’s impact assessment is not robust and the draft directive does not reflect the Commission’s wider better regulation agenda. I am responsible for better regulation issues in the Home Office, and we are very alert to that in the animal science field, to ensure that while we maintain animal welfare and good science in the UK, we do not overburden business and academia with unnecessary regulation that has no positive impact on animal welfare or scientific outcomes.

One of our particular concerns with the directive as framed is the provisions relating to the acquisition and use of non-human primates. The proposed restriction of non-human primate use to research into life-threatening or debilitating clinical conditions in human beings may rule out a number of important areas of work, including unmet clinical needs, such as vision research and research into infertility.

To give more of an example of this, one of the tests would be justifying any work done on the grounds that it is debilitating or life-threatening. It would be difficult to get that definition right in such areas as infertility or vision research. How do we define effectively what is debilitating or life-threatening, to ensure that we are covering the right areas? Another area might be the neuroscience work on cognition, which has impacts on attention-deficit disorder. It is important to get such things right, and we need to get the wording clearly worked through, so that we do not limit work already being done and reduce scientific opportunity unnecessarily.

The provisions limiting the use of non-human primates to the offspring of animals bred in captivity also risk driving important areas of research out of Europe to countries with lower welfare standards. If overseas producers are unable or unwilling to adapt, the provisions would seriously damage the UK and EU science base and produce no animal welfare benefits. It is worth explaining to the Committee how that would work in practice.

The proposal is to move towards using only F2 offspring—offspring of captive-bred non-human primates—but there are not enough available at the moment to do that. Since 1997, we in the UK have not been accepting wild captured animals, only using captive bred ones—that is F1—and some F2. However, to do this we would end up discarding a lot of animals. In terms of animal welfare, the benefits would be reduced.

For example, because we need more females to carry out a breeding programme, in order to get to the F2 offspring stage, the discarded males would either have to be shipped thousands of miles to other parts of the world where they could still be used, or euthanased—killed, basically. They could be released back into the wild in certain circumstances, but if they were, many of the countries from which they originated would kill them as pests. Every year, thousands of males would be killed or shipped thousands of miles. The remaining females would be kept in captivity and used for breeding. They would produce around one offspring per year, and those offspring would be reserved and split up, and most of the males would be discarded. One male non-human primate is required for 12 or 15 females, so a lot of males would be discarded at that point. The F1 females would be kept for breeding, and some of the F2 females produced from that breeding round would be kept for the breeding colony, while others would go for experiments. At that point, we would begin to have mammals that could be used for experimentation.

The costs of doing that would increase. Currently, experimentation on a non-human primate costs between £2,500 to £4,000. To have an F2 mammal would cost about £26,000, and we believe that there are cost, time and welfare disbenefits to that route. My question to the Committee and the European Union is: where is the benefit to animal welfare in taking that approach?

Another concern is that the framework provided in the draft directive for the re-use of animals could increase the number of animals used in the UK, and the suffering caused to them. I have touched on the administrative burden, but we are concerned that a number of the provisions would add significantly to those burdens and costs without benefiting animal welfare. That could damage the success, sustainability and competitiveness of the EU research base. Hon. Members do not need reminding that in the current climate it is important for us not to add any unnecessary barriers.

Setting inflexible mandatory minimum standards for care and accommodation far above those found in other economic regions would add significantly to the cost of biomedical research and regulatory testing in the EU, without guaranteeing best provision for the animals. The UK has already been responsive to that issue. Scientific and welfare benefits are in place as the European Union requires, and we are in regular dialogue with industry and academia. We are keen to introduce better regulation without reducing welfare standards, but the proposal could mean that we introduce higher regulation and reduce welfare standards. In co-operation with stakeholders, we are developing a simpler IT system to reduce duplicate reporting and simplify the process of application. We are already working on an online process for those conducting experiments. My worry is that the EU directive might lead to an unnecessary increase in regulation.

Another important aspect in this economic climate is competition between the EU and the USA and China, which is intense. There are currently in the region of 50,000 toxicology graduates in China per annum. It is a growing marketplace, and if we in Europe do not get our approach right, we risk losing important work and scientific development to those areas.

The Government’s approach is clear. We are in no doubt that much needs to be done to ensure that a new directive delivers the intended benefits. We are looking carefully at how to improve the details of the proposal. I look forward to the debate and hope that it will help me and Ministers at the Department for Environment, Food and Rural Affairs, who will lead on this for the UK Government, together with support from Home Office officials and Ministers. We believe that if we can meet the stated objectives, it is vital that the new legislation does not delay or prevent the scientific progress and benefits that responsible animal use continues to bring.

Our key priority in negotiating a revised directive will be to develop practical, proportionate and enforceable legislation that makes proper provision for the welfare of laboratory animals, facilitates their responsible use, and can adapt to further technical progress. We will also work hard to ensure that in its desire to provide leadership in this area, Europe does not damage its competitiveness, and that the UK and European research base is maintained and developed, rather than hampered by adopting inflexible measures that add disproportionate or unjustified regulatory burdens.

The Chairman: We have until 5.30 pm for questions to the Minister. I remind members of the Committee that they should be brief. Hon. Members may ask related supplementary questions subject to my discretion.

Andrew Rosindell (Romford) (Con): It is a pleasure to serve under your chairmanship, Mr. Martlew, particularly knowing your own commitment to the welfare of animals in this country. I thank the Minister for her statement. I have a few questions that I would like to put to her.

I shall begin by addressing one of the most fundamental underlying provisions in the directive. In laying out the scope of this revision, article 2 makes reference to the animals to which the directive will apply. Article 2(a) makes specific reference to

First, I draw the Minister’s attention to the inclusion of the word, “embryonic”. The purpose of the directive is to enforce provisions to reduce suffering and distress to an absolute minimum. The proposal in article 2(a) would extend the protection afforded by the directive to animal forms which are non-sentient and therefore cannot suffer. However, this provision is not only pointless, but extremely bureaucratic. Some fish and amphibian species produce vast—