Animal experiments in the Member States of the European Union are controlled by European Directive 2010/63/EU , which replaced the previous regulation in September 2010. The Directive lays down rules on
- the Three Rs (replacement, reduction and refinement)
- the origin, breeding, marking, care and accommodation, and killing of animals
- the operations of breeders, suppliers and users
- the evaluation and authorisation of projects
Each Member State of the European Union had to revise or introduce new legislation in order to comply with this Directive. However in the UK some of the rules were stricter than the European ones and where this was the case the UK kept its stricter controls.
The Three Rs are now an integral part of the Directive so Member States have to ensure:
wherever possible, a scientifically satisfactory method or testing strategy, not using live animals, should be used instead of an animal procedure.
the number of animals used in projects is reduced to a minimum without compromising the objectives of the project.
refinement of breeding, accommodation and care, and of methods used in procedures, eliminating or reducing to the minimum any possible pain, suffering, distress or lasting harm to the animals.
Cosmetics and their ingredients which have been tested on animals are not allowed to be sold or advertised within the European Union, under the Cosmetics Directive 76/768/EEC .
The testing of chemicals in Europe is controlled by the REACH legislation. REACH is a regulation of the European Union, adopted to improve the protection of human health and the environment from the risks that can be posed by chemicals, while enhancing the competitiveness of the EU chemicals industry. It also promotes alternative methods for the hazard assessment of substances in order to reduce the number of tests on animals. See here for more information
The first legislation anywhere in the world specifically to detail restrictions on the use of animals for experiments was The Cruelty to Animals Act 1876 in the UK. The Act made it an offence to perform on a living animal any experiment calculated to give pain, unless it was carried out with a view to advancing physiological knowledge, saving or prolonging life or alleviating suffering. This led to the creation of a regulatory system involving registration of premises where experiments were conducted and licensing of people who conducted the work, enforced by the newly establish Home Office Inspectorate.
More than a century after the 1876 Act came in to force, pressure again mounting on the Government in the UK and the promotion of alternatives to the use of animals in research resulted in the passing of the Animals (Scientific Procedures) Act 1986 (ASPA).
In January 2013 ASPA was amended to implement the requirements of the updated European regulations on animal experiments, European Directive 2010/63/EU (See above). In March 2014, after public consultation and discussions with interested parties the UK Government released a revised Guidance on the Operation of the Animals (Scientific Procedures) Act 1986 . This gives detailed guidance on how ASPA is administered and enforced.
ASPA controls animal experimentation through a three tier licence system. In order for animal experiments to be allowed the PLACE they are done in must have a license, the PERSON doing the experiment must have a license and the PROJECT that the experiments are being done for must be licensed.
The Three Rs have always been an integral part of ASPA but the amendment makes it much more explicit than the previous version of the legislation.
ASPA is implemented by the Home Office in England, Scotland and Wales and by the Department for Health, Social Security and Public Safety in Northern Ireland. Within the Home Office it is the Animals in Science Regulation Unit (ASRU) and its inspectorate the make sure the guidance is being followed and the regulations are not being broken.
In the US it is the Animal Welfare Act which sets the minimum standards of care and treatment for animals used in research. This was first enacted in to public law in 1966 and was then known as the Laboratory Animal Welfare Act. An amendment in 1970 changed the name to the current one and broadened the scope of the regulation to include animals used in exhibition or the wholesale pet trade. It has been strengthened and broadened several times by further amendments since then. The US Department of Agriculture (USDA) enforces the Animal Welfare Act through the Animal Care Programme of the Animal and Plant Health Inspection Service (APHIS).
As with European law the Act lays down;
- minimum standards of veterinary care and animal husbandry
- requirements for licensing of research facilities but not for individuals
- requirements for the provision of anaesthesia or pain relieving medication
- requirements for facilities to provide dogs with the opportunity to exercise
- requirements to promote the psychological well-being of primates
- forbiddance of unnecessary duplication of a specific experiment
- requirements for the establishment of an institutional animal care and use committee (IACUC) to oversee the use of animals in experiments.
However, the US situation is much less restrictive and there are some important differences. The starkest of these is the exclusion of birds, rats (of the genus Rattus), mice (of the genus Mus), fish, and amphibians and reptiles from the definition of ‘animal’ and as such they are not protected by the Act. According to the Humane Society of the United States (HSUS) this means that approximately 95% of the animals used for research in the US aren’t afforded even the minimal protections of the Animal Welfare Act.11 A second difference is that the IACUC (Institutional Animal Care and Use Committee) is the body responsible for ensuring compliance with AWA and for providing documentation of all areas of that compliance to APHIS, so compliance is measured internally.
Information on laws that govern laboratory animal use in other countries will appear here in the future.