Scientific Procedures on Living Animals

James Brokenshire Excerpts

Tuesday 16th July 2013 Written Statements

[The Parliamentary Under-Secretary of State for the Home Department (James Brokenshire)]

My hon. Friend the Minister for Criminal Information, Lord Taylor of Holbeach, has today made the following written ministerial statement:

The “Statistics of Scientific Procedures on Living Animals—Great Britain—2012” (HC 549), was laid before the House today. Copies will be available in the Vote Office.

This annual statistical report meets the requirement in the Animals (Scientific Procedures) Act 1986 (ASPA) to inform Parliament about the licensed use of animals for experimental or other scientific purposes. It also forms the basis for meeting periodic reporting requirements at EU level. The next report to the EU is required in November 2015, which will be our 2014 statistics.

The 2012 statistical report shows that there were 4.11 million scientific procedures, which represents an overall increase of 8% over 2011. This increase is largely attributable to an increase in the breeding of genetically altered mice. Excluding the breeding of these animals, the total number of procedures actually decreased by 2%. The number of animals likely to be used in any given year is dependent on many factors, including investment in research and development, strategic decisions by funding bodies, global economic trends and scientific innovation.

The Home Office, as regulatory authority under ASPA, ensures that its provisions are rigorously applied and only authorises work that is scientifically justified and minimises the numbers of animals used and the animal suffering that may be caused.

The statistical report and supplementary information can be found at: https://www.gov.uk/government/publications/statistics-of-scientific-procedures-on-living-animals-great-britain-2012.

I am pleased to inform the House that I have also today placed in the Library the annual report of the Home Office “Animals in Science Regulation Unit” (ASRU) for the year 2012. The annual report can be found at: https://www.gov.uk/research-and-testing-using-animals.

The report describes how we have delivered our responsibilities under ASPA to regulate the use of animals, work to support the delivery of the transposed directive and provides information about cases of non-compliance with ASPA and the outcomes of those cases.

All establishments that carry out procedures on animals are subject to scrutiny by Home Office inspectors who play a key role in the implementation of ASPA. Inspectors implement a risk-based approach to inspection. Based upon an overview of risk across all licensed establishments, the chief inspector annually proposes a programme of inspection, agreed with the Minister, which best utilises the resources available. The risk-based approach and programme for 2012 is described in the ASRU annual report.

The transposition of directive 2010/63/EU into UK legislation during 2012 was a major undertaking. From the 1 January 2013 we harmonised standards with other EU member states where required and, where appropriate, maintained our higher standards whilst avoiding unnecessary bureaucracy and cost burden.

The programme for Government provides a commitment to work to reduce the use of animals in scientific research, an ambitious but achievable goal. We recognise that the use of animals in scientific research is a small but essential function in improving our understanding of medical and physiological conditions, the research and development of new medicines and the development of leading-edge medical technologies and is necessary to ensure the safety of our environment. Scientific advances in knowledge and new technologies present significant opportunities to replace animal use, reduce the use of animals, and, where animal use is unavoidable, to refine the procedures involved so as to minimise suffering (3Rs). It is key that we take these opportunities to ensure that replacement, refinement and reduction in the use of animals is integral to conducting animal research recognising that this not about baseline numbers. The statistics published today are evidence of a significant reduction in the use of animals for shellfish toxin testing. In 2009 the number of mice used in this test totalled 7,670 whereas in 2012 this has been reduced to 42. This is a prime example of successfully implementing a non-animal alternative.

In 2012, my predecessor announced the science-led programme being taken forward by the National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs), which is primarily funded by the Department for Business, Innovation and Skills, and I am pleased to report a number of significant advances in this area. Over the past 12 months, the NC3Rs has secured new funding which has helped launch the first 3Rs evaluation framework; made the biggest single investment in 3Rs research to date with new grant awards of £5.1 million; supported new approaches to replace animal use with £750,000 for interdisciplinary awards between toxicologists and mathematicians; and awarded four fellowships for exceptional early-career scientists developing models and tools with reduced reliance on animal research and improved welfare. The wider programme encompasses collaborative work led by the Home Office and the Department for Business, Innovation and Skills, between Government Departments and agencies, the Home Office inspectorate, the research community in both academia and industry, and others with relevant animal welfare interests. Significant progress has been made in developing a cross-Government action plan and we intend to provide a statement in the autumn that details our agreed plan and describes progress to date on the coalition agreement.

As the Home Office Minister responsible for ASPA, I was extremely concerned to read the allegations of non-compliance at Imperial College London (ICL) published by the British Union for the Abolition of Vivisection (BUAV). The use of living animals in scientific procedures which may cause pain, suffering, distress or lasting harm is strictly regulated under ASPA and I am determined to ensure that animal research is carried out humanely and only when necessary. The provision of a licence to an individual not only entrusts them to uphold their legal obligations but also to behave in ways which ensure the highest standards of animal care and welfare at all times. I take any reports suggesting that individuals or establishments are falling short of the high standards required by the Act very seriously.

I have met with the ICL establishment licence holder and other relevant senior individuals to discuss the independent investigative report that ICL have commissioned and agreed to publish. They have provided strong assurances of a rigorous inquiry. I have also had a meeting with the BUAV to assure them of the seriousness with which we are considering their allegations.

Visits by inspectors to licensed establishments, many of which are unannounced, are an important aspect of determining compliance with ASPA. An additional important role of inspectors is to advise those working under ASPA and encourage best practice with respect to the 3Rs. Inspectors have a right of entry to licensed establishments at all reasonable times and ready access to all records and it is, therefore, right and proper that they should investigate allegations when they are made. Home Office inspectors have been investigating the allegations against ICL at pace and I intend to publish a report later this year.

It is an imperative that lessons learned and broader issues for the wider community are taken from this incident. I have therefore requested the Government’s independent expert advisory body, the Animals in Science Committee (ASC), to review both the inspectorate’s report and the ICL independent report, when both are available, and to provide me with advice. The ASC report will also be made public.

Central to our work on openness and transparency is the review we are undertaking of section 24 of ASPA. Section 24 of ASPA provides for the protection of confidential information provided in connection with our regulatory activities under ASPA. A breach of section 24 can result in criminal sanctions. The requirements of section 24 are now out of step with our policy on openness and transparency and with the approach taken in other legislation, such as the Freedom of Information Act 2000. The solution we develop must improve the overall transparency surrounding research using animals, to create an environment which fosters informed debate leading to greater public trust, and also must protect personal identities and intellectual property.

The first stage of the review; engaging the full diversity of stakeholders in developing options has now been completed. The next stage of the process is to present those options in a wider public consultation, the outcome of which will further inform the direction of our work. We envisage completing the review and selection of the preferred option by the end of this year to enable us to present any legislative changes to Parliament in the new year.