The law The law that covers all animal use in experiments and testing in the UK is the Animals (Scientific Procedures) Act 1986 (ASPA) which was revised in 2012 to include the new regulations as specified by the European Directive 2010/63/EU on the protection of animals used for scientific purposes. The revised legislation came into force on 1 January 2013 and is now known as the “Animals (Scientific Procedures) Act 1986 Amendment Regulations 2012 (ASPA 2012)”. It is important to define some phrases that are used frequently throughout ASPA so that we can better understand the Law. A “protected animal” is any living vertebrate other than man and any living cephalopod. Only ‘protected animals’ are safeguarded under ASPA, other animals are not afforded any legal protection under ASPA. A “regulated procedure” is any procedure applied to a ‘protected animal’ which may have the effect of causing the animal a level of pain, suffering, distress or lasting harm equivalent to, or higher than, that caused by the introduction of a needle in accordance with good veterinary practice. The use of animals in scientific research in England, Scotland and Wales is regulated by the Home Office. Within the Home Office is the Animals in Science Regulatory Unit (ASRU) which is the department responsible for regulating and enforcing the law related to animal use. ASPA 2012 has now enshrined the principles of the 3Rs into UK Law. As defined in Section 2A of ASPA 2012: 2A Principles of replacement, reduction and refinement (1) The Secretary of State must exercise his or her functions under this Act with a view to ensuring compliance with the principles of replacement, reduction and refinement. (2) For the purposes of this Act— (a) the principle of replacement is the principle that, wherever possible, a scientifically satisfactory method or testing strategy not entailing the use of protected animals must be used instead of a regulated procedure; (b) the principle of reduction is the principle that whenever a programme of work involving the use of protected animals is carried out the number of protected animals used must be reduced to a minimum without compromising the objectives of the programme; (c) the principle of refinement is the principle that the breeding, accommodation and care of protected animals and the methods used in regulated procedures applied to such animals must be refined so as to eliminate or reduce to the minimum any possible pain, suffering, distress or lasting harm to those animals. What this means is that when a scientist applies for a licence to conduct animal experiments, they must prove to ASRU that there is no scientifically satisfactory non-animal based procedure that can be used instead of an animal experiment. This has raised the barrier to obtaining an ASPA licence somewhat. As stated by the Home Office in their official guidance: “Our regulations ensure that animals are used in scientific procedures only when there’s no validated alternative and when the potential benefits outweigh the harms. We are committed to: using non-animal alternatives wherever possible; reducing the number of animals used to the minimum needed; refining procedures as much as possible to minimise suffering.” (https://www.gov.uk/government/policies/animal-research-and-testing). Before any animal experiments can take place, three licences are required. This is a legal requirement stated in the ASPA regulations. The three licences are: A ‘personal licence’ for each person carrying out any procedures on animals. This is to ensure that the person conducting the experiments is suitably qualified to do so and has the necessary and appropriate training. A ‘project licence’ for the programme of work. A project licence covers all the experimental procedures that will take place as part of the whole project. An ‘establishment licence’ for the place at which the work is carried out. This ensures that the place where the animal experiments will be conducted has suitable facilities for keeping, breeding and maintaining the animals as well as the correct facilities required to conduct the experiments. Without any one of these licences no animal experimentation can legally take place. Development of ‘Alternatives’. ASPA 2012 has also enshrined the concept of the development of alternatives as a legal requirement. The wording in ASPA 2012 reads: 20B Alternative strategies (1) The Secretary of State must support the development and validation of alternative strategies. (2) In particular, the Secretary of State must— (a) assist the European Commission in identifying and nominating suitable laboratories to carry out validation studies on alternative strategies; (b) nominate a person the Commission may contact for advice on the regulatory relevance and suitability of alternative strategies proposed by the Commission for validation; (c) take such other steps as the Secretary of State considers appropriate to encourage research into alternative strategies; (d) ensure the promotion of, and dissemination of information about, alternative strategies. (3) The Secretary of State may make grants to any person concerned with the development, promotion or validation of alternative strategies. (4) “Alternative strategies” means scientific methods and testing strategies which do not use protected animals, or which (compared to existing scientific methods and testing strategies) use fewer protected animals or reduce the pain, suffering, distress or lasting harm caused to protected animals. With the exception of clause (4), the aim of these regulations is the development and promotion of alternatives at a Governmental level, not just at a scientific level. The Law requires the Government to do what it can to ensure that scientific methods and testing strategies which do not use protected animals are used and developed over similar methods that continue to use protected animals.