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Home Office

Answer

Mrs. Calton: To ask the Secretary of State for the Home Department what official Home Office classification was approved for experiments on primates by Imutran Ltd. [166357] Caroline Flint: The Imutran Limited research licensed by the Home Office under the Animals (Scientific Procedures) Act 1986 involving pig to non-human primate xenotransplantation studies was carried out between 1994 and 2000 under three project licences all of which were allocated an overall severity band of `moderate'. In addition, of the 28 separate protocols of regulated procedures authorised under these licences, two were allocated substantial severity limits, 16 were classified as moderate, seven were classified as mild, and three were unclassified. The administrative system under the Animals (Scientific Procedures) Act 1986 distinguishes between the `severity limit` of a protocol and the `severity band' of a project. The severity limit of a protocol is determined by the upper limit of the expected adverse effects that may be encountered by the animal involved, taking into account the measures specified in the licence for avoiding and controlling adverse effects. It represents the worse potential outcome for any animal subjected to the series of regulated procedures in the protocol, even if it may only be experienced by a small number of the animals to be used. Severity limits are categorised as unclassified, mild, moderate and substantial. Definitions of these categories are provided in paragraph 5.42 of the published Guidance on the Operation of the Animals (Scientific Procedures) Act 1986 (HC321). The allocation of a severity band to a project reflects the number of animals used on each protocol and the actual suffering likely to be caused as a result. It is based on the overall level of cumulative suffering to be experienced by each animal, not just the worst possible case. It takes into account the proportion of animals expected to reach the severity limit of the protocol and the duration of the exposure to that severity limit, the nature and intensity of the adverse effects, and the actions to be taken to relieve the suffering.

Secondary information

Type

Written question

Reference

420 c931-2W; 166357

Session

2003-04

Subjects

Animals Animal experiments Primates Research Imutran

Link

View this Written question on www.publications.parliament.uk