The use of animals for scientific purposes is highly regulated. This page gives an overview of laws and regulations (this is a work in progress!).
This is the most general legal framework for animal experimentation in Europe. It does not address primate research in particular. There is a strong emphasis on replacement, that is, not to use animals when alternative methods exist.
This directive updates and replaces Directive 86/609/EEC, it took full effect on January 1st, 2013. The purpose of the Directive is to “strengthen legislation, and improve the welfare of those animals still needed to be used, as well as to firmly anchor the principle of the Three Rs, to Replace, Reduce and Refine the use of animals, in EU legislation” (EC).
The use of non-human primates is directly addressed in the directive. Paragraph 17 of the Preamble states:
Having regard to the present state of scientific knowledge, the use of non-human primates in scientific procedures is still necessary in biomedical research. Due to their genetic proximity to human beings and to their highly developed social skills, the use of non human primates in scientific procedures raises specific ethical and practical problems in terms of meeting their behavioural, environmental and social needs in a laboratory environment. Furthermore, the use of non-human primates is of the greatest concern to the public. Therefore the use of non-human primates should be permitted only in those biomedical areas essential for the benefit of human beings, for which no other alternative replacement methods are yet available. Their use should be permitted only for basic research, the preservation of the respective non-human primate species or when the work, including xenotransplantation, is carried out in relation to potentially life- threatening conditions in humans or in relation to cases having a substantial impact on a person’s day-to-day functioning, i.e. debilitating conditions.
The legal issues in this paragraph are set out in Art. 8 of the Directive.
Laws and Regulations
Verordnung zum Schutz von zu Versuchszwecken oder zu anderen wissenschaftlichen Zwecken verwendeten Tieren (TierSchVersV)
The Bremen Case
Decision of the Verwaltungsgericht Bremen 28.05.2010 (in German).
Decision of the Oberverwaltungsgericht Bremen 11.12.2012 (in German).
Decision of the Bundesverwaltungsgericht 20.01.2014 (in German).
Laws and Regulations
Tierversuchsgesetz 2012 (TVG 2012)
Laws and Regulations
Kantonales Tierschutzgesetz (Kanton Zürich) (LS 554.1)
The Zürich Case
Decision of the Bundesgericht 7.10.2009 (in German)
Interview with Kevan Martin and Daniel Kiper: “Tierversuchskommission agierte willkürlich” Neue Zürcher Zeitung, 1.12.2009.
Guidance: Research and Testing Using Animals. Details of the law on scientific research and testing involving animals, and guidance on applying for licenses.
Act on Animal Experimentation (Dyreforsøgsloven) [Danish]
Act on Animal Welfare (55/2013) [Icelandic]. The act came into force on January 1st, 2014.
Regulation on Animal Experiments (279/2002) [Icelandic]
The Icelandic Food Safety Authority (Matvælastofnun) is responsible for licensing and surveillance of animal research.
Act on Animal Welfare (Lov om dyrevelferd, LOV-2009-06-19-97) [Norwegian]
Regulation Regarding the Use of Animals for Research (Forskrift om forsøk med dyr, FOR-1996-01-15-23) [Norwegian]. New regulation on animal research, incorporating the EU Directive 2010/63/EU, is in preparation and may come into force in late 2014 or early 2015 (Mattilsynet, the Norwegian Food Safety Authority).
The Animal Welfare Act (Djurskyddslag 1988:534) [Swedish]
The Animal Welfare Ordinance (Djurskyddsförordning 1988:539) [Swedish]
The Animal Welfare Act and the Animal Welfare Ordinance [English] (Published 2009, later amendments therefore not included).
Information about Laws and Regulations at CODEX.
Information about Animal Experimentation in Sweden: www.djurförsök.se
The Canadian Council on Animal Care (CCAC) is an independent organization responsible for overseeing the use of animals in science in Canada and setting policy and standards for animal care. Its website provides a wealth of information on the use of animals in science in Canada and elsewhere.
Animal research is regulated at the provincial level, although the federal government has some power over animal welfare issues through the Criminal Code, the Health of Animals Act and the government spending power (i.e., through conditions set on research funding from national research institutes).
Alberta: Animal Protection Act, Animal Protection Regulation (Alberta Regulation 203/2005).
United States of America
Animal Welfare Act of 1966 (latest amendment 2008). The act remarkably applies only to “warm-blooded animals”, excluding mice, rats and birds.
The Animal Welfare Act and Animal Welfare Regulations are published together in the Blue Book [PDF].
The Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals [PDF] is administered by the Office of Laboratory Animal Welfare (OLAW) of the National Institutes of Health (NIH) and applies to all biomedical and behavioral research on vertebrate animals funded by the NIH or national research institutes.
U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training. The Principles are also found in the PHS Policy on Humane Care and Use of Laboratory Animals.
The Guide for the Care and Use of Laboratory Animals [PDF] is the single most important document about the use and care of animals in research in the U.S.
The Animal Information Center website of the US Department of Agriculture (USDA) links to US laws and regulations as well as other important information about the care and use of animals.
The NIH Office of Laboratory Animal Welfare (OLAW) provides links to laws, regulations, policies, guides and information relevant to animal research.
There is no national legislation on the use of animals for scientific purposes or even animal welfare generally, the states and territories are responsible for such legislation in their jurisdiction (for an overview of animal welfare legislation by state and territory see here).
The Australian code for the care and use of animals for scientific purposes (the Code). [PDF]
The Principles and guidelines for the care and use of non-human primates for scientific purposes (the Guidelines) “provide principles and best practice guidance for the care and use of non-human primates for scientific purposes”. [PDF]
The Australian National Health and Medical Research Council (NHMRC) maintains useful websites about the use of non-human primates for scientific purposes and more generally about animal research ethics.
Act on Welfare and Management of Animals (Act No. 105 of October 1, 1973) [PDF].
Guidelines for Proper Conduct of Animal Experiments [PDF].
Literature on Laws and Regulations
Regina Binder. “Laboratory Animal Law: An Introduction to Its History and Principles” in Erika Jensen-Jarolim (ed.), Comparative Medicine: Anatomy and Physiology, Vienna: Springer 2014, pp. 267-280.
Guillen, Javier (ed.). Laboratory Animals: Regulations and Recommendations for Global Collaborative Research. San Diego, CA: Academic Press 2014.
General Resources on Laws and Regulations
Association for the Assessment and Accreditation of Laboratory Animal Care International (AAALAC): Resources