Legal

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!).

Europe

European Convention for the Protection of Vertebrate Animals used for Experimental and Other Scientific Purposes (ETS 123), Strasbourg, 18.III.1986.

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.

Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes

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.

 

Germany

Laws and Regulations

Tierschutzgesetz (TierSchG)

Verordnung zum Schutz von zu Versuchszwecken oder zu anderen wissenschaftlichen Zwecken verwendeten Tieren (TierSchVersV)

Legal Decisions

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).

 

 Austria

Laws and Regulations

Tierversuchsgesetz 2012 (TVG 2012)

 

Switzerland

Laws and Regulations

Tierschutzgesetz (TSchG)

Tierschutzverordnung (TSchV)

Kantonales Tierschutzgesetz (Kanton Zürich) (LS 554.1)

Legal Decisions

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.

 

United Kingdom

Animals (Scientific Procedures) Act 1986, revised 2014 (consolidated version is here: PDF)

Guidance: Research and Testing Using Animals. Details of the law on scientific research and testing involving animals, and guidance on applying for licenses.

 

Denmark

Act on Animal Experimentation (Dyreforsøgsloven) [Danish]

Ministerial Order on Animal Experimentation (Bekendtgørelse om dyreforsøg) [Danish]

The Animal Experiments Inspectorate

 

Finland

Act on the Protection of Animals Used for Scientific Purposes or Education (28.06.2013) [Finnish] [Swedish]

 

Iceland

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.

 

Norway

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).

 

Sweden

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

 

North America

Canada

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.

CCAC Guide to the Care and Use of Experimental Animals (vols. 1 & 2).

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.

Other resources:

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.

 

AUSTRALIA

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]

Other resources:

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.

 

ASIA

Japan

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

Animal Law Resource Center

Association for the Assessment and Accreditation of Laboratory Animal Care International (AAALAC): Resources

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