Ethics of Research involving animals
The A(SP)A: general operational aspects
13.4 The A(SP)A4 regulates the use of all vertebrate animals5 (mammals, reptiles, amphibians, birds and fish) and, by a subsequent order in Parliament, the common octopus in ‘any experimental or other scientific procedure...which may have the effect of causing that animal pain, suffering, distress or lasting harm’. These purposes are called ‘regulated procedures’ (see Box 13.1), and may only be undertaken if the Secretary of State has granted the necessary licences (see paragraphs 13.5–13.6).
13.5 The regulatory scheme imposed by the A(SP)A is complex. There are absolute rules that, if broken, will lead to criminal liability. For example, it is a criminal offence to carry out what would qualify as a regulated procedure without the required licences. Such breaches are potentially punishable with an unlimited fine and imprisonment for a maximum of two years.6 The Act also empowers the Secretary of State to make regulations (secondary legislation) to implement the principles embodied in the statute such as extending the categories of protected animals. Most crucially, the Act grants the Secretary of State extensive discretionary powers in relation to licensing research. This means that the Home Office necessarily develops, within limits, internal guidance and policy with regard to whether and on what terms requests for licences may be granted. The Act sets out the parameters within which discretion is exercised; and in practice they are applied on a case by case basis. So, for example, Section 5 (6) of the Act directs that ‘The Secretary of State shall not grant a project licence authorising the use of cats, dogs, primates and equidæ7 unless he is satisfied that animals of no other species are suitable for the purposes of the programme to be specified in the licence or that it is not practicable to obtain animals of any other species that are suitable for those purposes’. In more general terms, Section 5 (5) states that ‘The Secretary of State shall not grant a project licence unless he is satisfied (a) that the purpose of the programme to be specified in the licence cannot be achieved satisfactorily by any other reasonably practicable method not entailing the use of protected animals’.
| Box 13.1: Why does the A(SP)A use the term ‘procedure’ instead of ‘experiment’? The welfare of animals may not only be affected by the consequences of a particular scientific experiment but also by a range of other aspects of their lives. Since the A(SP)A seeks to regulate any activity that involves a protected animal and may cause pain, suffering, distress or lasting harm, the term ‘procedure’ was introduced to refer to the broad range of events that may affect animals. Thus, under the A(SP)A all aspects of the scientific experiment itself, as well as relatively minor interventions, such as the taking of a blood sample, are all termed regulated procedures and any research study will usually involve a number of these. Similarly, other scientific uses of animals, for example the testing of vaccines, or the use of animals for the production of biological products such as antibodies, are categorised as procedures, as well as the breeding of harmful mutants and GM animals (see paragraphs 13.14 and 13.25). |
13.6 Subject to the general directions set out in the A(SP)A, the Secretary of State enjoys considerable discretion in the exercise of the statutory powers, including the development of both policy and administrative procedures.8 For example, following an announcement by the Secretary of State before Parliament, the Home Office adopted a policy whereby licences for scientific procedures using animals to test cosmetics, or procedures that involve the great apes would not be issued.9 The Secretary of State has thereby used the administrative powers to effect a de facto ban. Similarly, by attaching a standard condition to all certificates of designation that every establishment shall have a local ERP, this provision has become a mandatory requirement (paragraph 13.21). 13.7 Sections 19 and 20 of the A(SP)A established the APC, which was first appointed in 1987. The APC provides independent advice to the Secretary of State on any matters related to the A(SP)A as it sees fit or as may be referred to it by the Secretary of State (see Box 13.2 and paragraph 13.16).
| Box 13.2: The Animal Procedures Committee The APC is composed of scientists, lawyers, veterinary surgeons, doctors, animal welfarists and philosophers. The Committee was established by the A(SP)A, which specifies that the Committee should comprise a chairman and at least 12 other members. At least two thirds of the members should have qualifications or experience in a relevant biological subject or have full registration as a medical practitioner or veterinary surgeon and at least one member should be a barrister, solicitor or advocate. The Act also states that the Secretary of State, responsible for appointments to the committee, should take into account the desirability of ensuring that the interests of animal welfare are represented. Usually one member of the Committee is an academic philosopher. The A(SP)A specifies that the APC should have regard to both the requirements of science and industry and the protection of animals against avoidable suffering and unnecessary use. The Committee has the dual function of advising on certain licence applications when asked and independently advising on policy and practice. Most licence applications are assessed by the Home Office Animals (Scientific Procedures) Inspectorate (see paragraph 13.20). However, there are certain categories of project applications that the APC also considers, including those that involve the use of wild-caught primates and primates in procedures of substantial severity. The APC advises the Home Secretary on these applications, but does not itself decide on the outcome. |
3 In 1983, the Government produced a White Paper entitled Scientific Procedures on Living Animals. This Paper led to extensive
consultation, and was followed by a supplementary White Paper with the same name, which appeared in 1985. The Bill that
became the A(SP)A was based on the two White Papers. It was introduced in the House of Lords, where it was debated
extensively and amended. The amended Bill then passed through the Commons with relatively little discussion.
4 Animal (Scientific Procedures) Act 1986 (A(SP)A), available at:
http://www.archive.official-documents.co.uk/document/hoc/321/321-xa.htm. Accessed on: 4 May 2005.
5 Animals at early stages of development are excluded from the Act, see A(SP)A Section 1 (2) which states that: ‘Any such
vertebrate in its foetal, larval or embryonic form is a protected animal only from the stage of its development when (a) in the
case of a mammal, bird or reptile, half the gestation or incubation period for the relevant species has elapsed; and (b) in any
other case, it becomes capable of independent feeding.’
6 See A(SP)A Schedule 3 and 22. To inflict pain or suffering on an animal in the course of an unlicensed experiment could also
involve criminal liability under the general law against cruelty to animals, contained in the Protection of Animals Act 1911,
the Wild Mammals (Protection) Act 1996 and the Protection of Animals (Scotland) Act 1912, although the maximum penalties
are lower.
7 The term ‘equidæ’ refers to the family that includes horses.