Animal Research in the UK
The use of animals in research in the UK is controlled by the Animals (Scientific Procedures) Act 1986 (A(SP)A) .
This Act replaced the “Cruelty to Animals Act” which had been introduced in 1876. The Animals (Scientific Procedures) Act introduced numerous changes to the ways in which animal research was controlled and included the provisions of the 1986 EU Directive 86/609/EEC.
This Directive was revised in 2010 (2010/63/EU) and this required the Animals (Scientific Procedures) Act to be amended (enacted 2013) to comply with the new Directive.
The legislation is administered by the Animals in Science Regulation Unit (ASRU), within the UK Home Office .
How does A(SP)A function?
The long history of legislation reflects the concerns within our society to avoid harming animals, but also the recognition that animal experiments can lead to benefits for society.
A(SP)A permits the use of animals for scientific purposes provided their use can be justified by the benefits that will result. The law defines what types of use can be allowed, what benefits can be considered to justify animal use, and sets limits on the “harms” that animals can be subjected to for scientific purposes.
Objectives of the legislation
The legislation has 3 main objectives:
- To ensure that research that involves the use of experimental animals has been well justified by being of benefit to society;
- To ensure there are no alternatives to the use of animals to achieve these benefits;
- To ensure that no unnecessary pain, distress or suffering is caused to the animals undergoing scientific procedures.
The revisions to A(SP)A in 2013 make clear the adoption of the principles of Replacement, Reduction and Refinement (the “3Rs” of animal research) and require that these principles are adhered to by all those working under the control of this legislation.
Not all types of procedures on animals need to be controlled by A(SP)A, and not all animals are included in the scope of the legislation. Research work would be controlled by A(SP)A if the following three criteria apply:
- It must involve procedures that are carried out for experimental or other scientific purposes;
- The procedures must be conducted, on a protected animal;
- The procedures could cause pain, suffering, distress or lasting harm.
What purpose?
A(SP)A limits the purposes for which animals may be used to:
- basic research
- applied research
- to help avoid, prevent, diagnose or treat disease in man, animals or plants
- to investigate physiology in man, animals or plants
- to improve the welfare of animals including on farms
- development of medicines or foodstuffs
- protection of the natural environment including preserving species
- higher education or training for skills
- forensic inquiries.
Which animals?
The animals that are protected by A(SP)A include all living vertebrates (other than man), and following its amendment in 2012, all cephalopods. The stage of development (life stage) is also important to define when protection starts. It is thought that sufficiently immature forms probably cannot suffer since their nervous systems are insufficiently developed. Mammals are protected once they have developed beyond two-thirds of their gestation. Birds are protected after two-thirds of their incubation period in the egg. Fish and amphibians are protected once they can feed independently, and cephalopods after development beyond the larval and paralarval stages.
All such animals are considered to be protected if they are:
- Bred for use in regulated procedures
- Housed at an establishment with the expectation that they will be used in regulated procedures; or
- Undergoing regulated procedures
- Bred specifically so that their organs or tissues may be used for scientific purposes
If a procedure is carried out at an early stage of development, but which will result in harms to the animal after it reaches the stage at which it would be protected under A(SP)A, then such procedures would be regulated.
The source of animals intended to be used in research is also controlled by the Act. This is intended to provide the optimal quality of animals so that experiments will be more reliable, with less variability, than would otherwise be the case. In most instances, this can be best achieved by breeding specifically for scientific use, but it is not practicable for all species. Schedule 2 specifies those species that must normally be obtained from establishments (in the UK or abroad) breeding or supplying animals for scientific use unless a specific exemption from this requirement has been authorised on the project licence. Breeding and Supplying establishments in the UK are required to be licenced by the Home Office.
If animals are being obtained from outside the UK, your research facility will have specific measures in place to ensure both Home Office, other legislation and local arrangements are all complied with.
What procedures?
In addition to meeting the criteria listed above, procedures are regulated by A(SP)A if the level of pain, suffering, distress or lasting harm “is equivalent to, or higher than, that caused by inserting a hypodermic needle according to good veterinary practice”. This is the “threshold” for regulation. In this way, experiments which do not cause any of these, such as observation of behaviour in the home environment, do not require authorisation.
The Act also regulates genetic modifications in protected animals, if this modification could cause pain, suffering, distress or lasting harm. Although many genetic alterations have no apparent adverse effects, the tests needed to show that they fall below the threshold are quite stringent. Because of this, all genetic alterations in protected species are usually considered to require authorisation for breeding and maintenance under A(SP)A.
Some procedures which cause pain, suffering or distress are excluded from A(SP)A, in some cases because they are controlled under different regulations, and others, as they are specifically excluded within the A(SP)A regulations. This can cause confusion at times. If you are ever in any doubt, speak to your facility managers or directly to the Home Office. Non-regulated procedures include:
- Procedures carried out primarily to identify animals where they cause no more than momentary pain, suffering or distress e.g., ear punching, ear tagging, marking (even if the tissue removed by ear punching is used subsequently for genotyping).
- Clinical trials on animals for evaluation of a veterinary product under the terms of the Veterinary Medicine Regulations.
- Recognised veterinary, agricultural or husbandry procedures;
- Changes to methods of husbandry for scientific purposes which are expected to improve the well-being of the animals and so fall below the threshold for regulation
- Humane killing of an animal using specific methods that are listed in Schedule 1 of A(SP)A is not a regulated procedure, and so does not require a personal or project licence, but is regulated under A(SP)A.
Some procedures which fall below the threshold for regulation may not be considered regulated when carried out alone. However, a series or combination of these non-regulated procedures which could together cause an animal pain, suffering, distress or lasting harm may be regulated. For example, multiple or cumulative minor changes to the environment may stress the animal sufficiently to be regulated.
A(SP)A and Licensing
Central to the operation of A(SP)A is a determination of the harms and the likely benefits of all research projects that use living animals. The benefits will be able to be categorised according to the “permitted purposes” allowed in A(SP)A showing the type of benefit that will be produced. The harms that could be caused to the animals used in each of the (series of) regulated procedures are also set out in Project Licences (PPL). These licences also describe in detail the overall program of work, why it is required, and how it will be conducted. With this information, inspectors (and others) can weigh the likely benefits against the harms. A project licence will only be granted where the benefits clearly outweigh the harms.
The project licence is central to the operation of the Act, but two other licences are also required when using animals in research: Personal Licences (PIL), that permits individuals to carry out “regulated procedures” on “protected animals”, and an Establishment Licence (PEL), which gives authorisation to conduct research that involves the use of animals in specific areas within that Establishment.
The operation of A(SP)A is administered by the Home Office, and inspectors audit establishments to determine whether people are complying with the requirements. However, A(SP)A is written so that there is local responsibility for its implementation by all those involved with this legislation – project and personal licence holders, the establishment licence holders and other “named people” appointed by the Establishment licence holder.