The Government strongly support the development and use of non-animal alternatives where possible, use of animals in scientific procedures will not be licensed if alternative non-animal techniques are available. The National Centre for Replacement, Refinement and Reduction of Animals in Research (NC3Rs), which the Home Office part-funds, was established in May 2004 and acts as a focal point for research into the 3Rs. We have ongoing discussions with the NC3Rs.
The Government also continue to support the European Centre for the Validation of Alternative Methods (ECVAM), with a member of Home Office staff serving on the ESAC Scientific Advisory Committee, and through contributions to the European Union. It is ECVAM's task to monitor and co-ordinate research into alternatives and to develop the processes of validation—that is, the assessment of alternative methods to see whether they are reliable and whether they produce a level of information similar to the animal based tests they are to replace.
In addition the Home Office has established an inter-departmental group on the 3Rs to ensure other UK regulatory bodies take account of the progress with the 3Rs in their policies and practices. Home Office staff made a range of presentations on humane experimental technique at the 6th World Congress on Alternatives to Animal research in 2007. Reference is made to other relevant Home Office presentations in the 2007 Annual Report of the Animals (Scientific Procedures) Inspectorate.
The impact of progress on the uptake of suitable reduction and replacement alternatives can be seen in a number of classes of animal use reported in the Annual Statistical report series: for example reductions in numbers of rabbits used for pyrogen testing, the numbers of guinea pigs used for skin sensitisation testing, and the number of animals used for skin irritation studies.
The assessment of whether the threshold of moderate pain in animal experimentation is being adhered to is mainly through the Animals (Scientific Procedures) Inspectorate’s inspection programme and a selection of reports and published work.
The severity limits of protocols are defined in Section 5.42 of the Guidance on the Operation of the Animals (Scientific Procedures) Act 1986. Moderate protocols are defined as:
“Protocols regarded as moderate include toxicity tests (which do not involve lethal endpoints) and many surgical procedures (provided that suffering is controlled and minimised by effective post-operative analgesia and care).
Protocols that have the potential to cause greater suffering but include controls which minimise severity, or terminate the protocol before the animal shows more than moderate adverse effects, may also be classed within the moderate severity limit”.
We have received no formal representations on this issue since January 2008. Judicial Review proceedings in July 2007 considered four issues relating to the implementation of the 1986 Act one of which was on the severity limits for protocols. It was argued that in certain projects the severity limits should have been set at substantial rather than moderate. In its judgment issued on 23 April 2008, the Court of Appeal overturned the High Court’s earlier finding that the former Chief Inspector had erred in law in assessing severity limits in the relevant project licence. On this point, the Court found that neither the former Chief Inspector nor the Secretary of State had adopted an erroneous approach to the published Guidance on the Operation of the 1986 Act regarding the assessment of severity limits.
Furthermore, the Court of Appeal, in upholding our appeal, agreed that the severity limit is determined by the degree of suffering experienced by the animal prior to the point at which it is humanely killed.
Many factors influence trends in the use of animals under the Animals (Scientific Procedures) Act 1986, including the economic climate, global trends in scientific endeavour and strategic decisions by funding bodies. The increase in the use of genetically altered strains seen over recent years has also had an impact as advances in genetics open up new and promising avenues of medical research.
The licensing system under the 1986 Act is demand-led and we have no control over the number of project licence applications we receive. The Act limits such animal use to where there is a clear benefit to people, animals or the environment when there is no means of obtaining these benefits without animal use, or at a lesser animal welfare cost. All scientists and researchers undertaking animal research in the UK are required to take into account the ‘3Rs’ (measures to replace, reduce, and refine animal use) when devising their programmes of research proposals.
In 2004 the Government established the National Centre for the 3Rs to provide a focal point and resources for such activities. The NC3Rs, which is part funded by the Home Office, drives advances in the 3Rs by taking a robust scientific approach, and bringing together expertise from a diverse range of areas, including academia, industry, Government and regulatory bodies.
There have been no recent formal representations about this issue.
During the past 12 months we have issued no statutory instruments, departmental circulars or other documents consequential on the provisions of the Animals (Scientific Purposes) Act 1986 and currently have no plans to issue any in the next 12 months.
During 2008 we have issued a total of 10 PCD circulars and ASPD newsletters to stakeholders on a range of topical issues and these are also published on our website.