Annex A
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1. The responsibilities of those with roles under the 1986 Act, together with how the 1986 Act is administered and enforced is set out in the Guidance on the Operation of the Animals (Scientific Procedures) Act 1986 (the Guidance). Relevant extracts from the Guidance are set out below.
Extracts:
2. A project licence specifies a programme of work. That is a combination of regulated procedures and endpoints designed to achieve the objectives specified in the licence (chapter 5.1).
3. A project licence issued under the 1986 Act defines the specific objectives of the research to be carried out; itemises the realistic likely benefits; outlines the plan of work; details the experimental or other scientific protocols to be followed; identifies the likely adverse effects, the means by which they will be avoided, recognised and alleviated; and sets the severity limit for individual protocols and the severity band of the project as a whole (chapter 5.4).
4. The Secretary of State is required to weigh the likely adverse effects on the animals used against the likely benefits to result from the programme of work when considering whether to grant a licence (cost/benefit assessment) (chapter 5.10).
5. The severity limit for a particular protocol is determined by the upper limit of the expected adverse effects on an animal, having taken account of the measures specified in the licence for avoiding and controlling adverse effects. It indicates the worst potential outcome for any animal used in the protocol, even if it may only be experienced by a small number of the animals used (chapter 5.40).
6. When assessing the severity limit of a protocol, account should be taken of all the procedures that are to be applied to each animal or group of animals; the nature and extent of the likely adverse effects; the action taken to mitigate those effects; and the humane endpoints to be applied (chapter 5.41).
7. There are four categories of severity limits: unclassified; mild; moderate; and substantial (chapter 5.42).
8. If it seems likely that the severity limit of a procedure has or may be exceeded, the licence holder must contact the Home Office. If the licence holder can show sufficient justification the Secretary of State may allow a temporary higher severity limit in order for the balance of the likely benefit and likely cost to be reviewed and for consideration of amendment to the licence (chapter 5.44).
9. The assessment of the severity band for a project as a whole reflects the number of animals used in each procedure and the actual suffering likely to be experienced by each animal and not just the single worst possible case. It takes account of the number of animals expected to reach the severity limit of the protocol and the duration of that exposure, the nature and intensity of the adverse effects, and the actions to be taken to relieve suffering (chapter 5.48).
10. Inspectors at the Animals (Scientific Procedures) Inspectorate (the Inspectorate) are the primary assessors of licence applications submitted to the Secretary of State. Project licence applications are assessed in detail and challenged where necessary to determine whether the benefits likely to result from the project outweigh the cost in suffering to the animals used, and whether there is scope for replacement, reduction or refinement alternatives. To make these judgments, inspectors must take a view on the significance, scientific quality and validity of the proposed work, the appropriateness of the animal use and the measures to be taken to minimise suffering (appendix G paragraph 12).
11. It is generally necessary for inspectors to discuss the proposals in detail with applicants (appendix G paragraph 13).
12. The number and nature of visits of inspection to each establishment made by the Inspectorate will be determined by the size and nature of the establishment, the types of work carried out, and the proportion of Inspectorate resources devoted to the visiting programme. The majority of visits are made without notice (appendix G paragraph 17).
13. The cost/benefit assessment requires more than establishing that the likely benefit exceeds the likely cost. The benefits must be maximised and the cost, in terms of animal use and suffering, must be minimised (appendix I paragraph 1).
14. The likely benefit is primarily derived from the utility of the data or product to result from the programme of work, rather than the importance of the general area of study. Thus, although the long-term objective may be to find new medical treatments, the benefit for the purposes of the cost/benefit assessment relates to the progress likely to result directly from the programme outlined in the application (appendix I paragraph 6).
15. Although the 1986 Act only requires that the Secretary of State weighs the costs and benefits before granting project licences, the cost/benefit assessment is not a single event exercised only at the beginning of a programme of work. It is a continuous process throughout the life of the licence. Every effort must be made to maximise benefit and minimise severity when work is being planned and whilst work is in progress. The emerging and actual costs and benefits must be evaluated and reviewed, to ensure that the original assumptions and assessment remain sound (appendix I paragraph 13).
