(2) how the Government defines moderate pain in relation to animal experimentation.
The Animals (Scientific Procedures) Act 1986 makes provision for the protection of animals used for experimental or other scientific purposes which may have the effect of causing pain, suffering, distress or lasting harm.
Projects licensed under the 1986 Act specify “protocols” which are the means by which the project will be carried out. Each protocol is assigned a severity limit in one of four categories, ‘unclassified’, ‘mild’, ‘moderate’ or “substantial”. The severity limit for each protocol is determined by the upper limit of the expected adverse effects that may be encountered by a protected animal, taking into account the measures specified in the licence for avoiding and controlling adverse effects. It represents the worst potential outcome for any animal subjected to the protocol, even if it may only be experienced by a small number of the animals to be used.
A detailed description of each category of severity limit is set out in paragraph 5.42 of the published Guidance on the Operation of the Animals (Scientific Procedures) Act 1986 (HC 321). In general terms, the “moderate” category is reserved for protocols in which suffering is effectively controlled or terminated before the animal shows more severe effects. In the case of animals experiencing pain in such protocols, effective analgesia is provided or the protocol is terminated before the animals show more severe effects.
Under standard project licence condition eight, set out in Appendix D to the Home Office Guidance, it is the responsibility of the project licence holder to ensure adherence to the severity limits and if these constraints appear to have been, or are likely to be, breached, the project licence holder must ensure that the Secretary of State is notified as soon as possible. Veterinary surgeons and animal care staff skilled in the recognition of the severity of signs of suffering or distress in animals are available at each establishment to advise the licensees on when an animal is experiencing or liable to experience more than moderate pain.
The Animals (Scientific Procedures) Inspectorate also visit designated establishments where animal experiments are being carried out to determine whether the conditions of licences are being complied with. Inspectors report to the Secretary of State any case in which any provision of the 1986 Act or any condition of a licence or certificate under the 1986 Act has not been or is not being complied with and advise on the action to be taken in any such case. Home Office records show that non-compliance with severity limits is rare.