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Regulations

You will find hereunder a presentation of the French, the European and the international regulations. This information is given on an indicative basis. For more detailed information, please consult the referenced texts.

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NATIONAL REGULATIONS

The regulation in France (articles R214-87 to R214-137 of the French rural code) has been updated by the 2013-118 decree and five orders from february 1st 2013, published on february 7th, according to the 2010/63 directive from the EU. This regulation is under the responsibility of the French Ministry of Agriculture. It established the following rules.

Concerned animal species – the regulation protects vertebrate animals, including larva or developed foetus and cephalopods. This means it applies for example to fish, birds and mammals but not to insects. Using primates (such as macaques) is restrained. Using large monkeys (such as chimps) is forbidden and could be authorized only in a case of extreme sanitary necessity. It's important to note that for years now large monkeys have not been used in Europe.

Animal origin – the animals must originate from a breeding centre or an authorized supplier. Eventually, primates will only originate from breeding centres, with no use of exterior suppliers. Stray domestic animals can't be used unless there's a particular sanitary reason and derogation.

Lawfulness – tests on animals are aloud only if they're necessary and irreplaceable, and if they fall in the field of human or animal health, environment protection, higher education, professional or medico-legal investigations. The principles of replacement (by a method that doesn't resort to animals), of reduction (by decreasing the number of animals to a minimum) and refinement (by choosing the most gentle method) must be respected.

Pain – painful tests must be done under anaesthesia unless a documented derogation has been given. Death as part of the observation process should be avoided as much as possible.

Establishment authorizations – all breeding centres, suppliers and users must have authorizations (conformity of the buildings and of the employees' expertise). Authorizations are given for a period of 6 years. A veterinary and a structure allowing the well-being for the animals are necessary. Regular inspections are made.

National commission – a national commission on animal testing composed of 20 members (ministries, public and private research, associations for the protection of animals, research professionals) gives advice and makes propositions.

National committee  - a national committee reflects on the ethics of animal research, does the annual report on the activity of ethics committees and makes suggestions. It regroups 14 members (ministries, professionals, doctors, veterinaries, philosophers, jurists, sociologists, associations for the protection of animals).

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EUROPEAN REGULATIONS

The 2010/63 regulation defines the conditions under which animal testing can be allowed in the European Union.

Animal species – the directive concerns vertebrate animals, larva or developed embryos and cephalopods, whether they're destined for in vivo (using live animals) or in vitro (using organs or tissue) studies.

3R – the 3Rs principle (replacement, reduction, refinement) must be applied.

Lawfulness – the allowed scientific fields are fundamental research, human, animal and plant health, agronomic research, environment protection, specie preservation, higher or technical education, medico-legal investigations.

Seriousness – procedures must be ranked on a scale of gravity (annex VIII).

Registration – research institutes and breeding centres must be registered and have an authorization (conformity of the installations cf. annex III, conformity of the employees' education cf. annex V, existing structure for the animal's well-being).

Evaluations and authorizations – each project must receive a positive evaluation (scientific or educational interest, conformity to the 3Rs, evaluation of seriousness, ethic considerations, need of a retrospective evaluation) and a preliminary authorization.

Non-technical summary – a non-technical summary of authorized projects must be published.

Alternative methods – the members of the EU must encourage alternative methods (replacement, reduction, refinement).

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INTERNATIONAL REGULATIONS

Each country practicing biomedical research has regulations concerning animal protection in laboratories. They all refer to the same principles: limiting the scientific and medical use of animals, controlling the employees, structures, projects, educations and ethics evaluations. However practices can differ.

The United Kingdom published in 1876 the first law on the protection of research animals. In 1986, the Animals’ (Scientific Procedures) Act built a legislation recognized as the most protective in the world for lab animals: the establishments, projects and people in charge of the study must be declared and approved, and the project authorizations require an evaluation of the medical and scientific benefits ratio compared to the constraints endured by the animals. The administrative setup of this law created for researchers and administration a very important bureaucratic load. Today, the United Kingdom must revise its regulations to fit them to the 2010/63 European directive. They wish to take this opportunity to unload the bureaucratic weight while maintaining the high level of required animal protection.

Canada created in 1968 the Canadian council of animal protection (CCPA) to supervise ethical use of animals in research. Research institutes and ministries with scientific stakes fund the CCPA. The CCPA enacts politics, plans of action and norms for animal research. It publishes an annual report on the activity and number of animals used. It sets 4 complementary programs: plans of action, education and training, evaluation and certification and the 3Rs. Canada is the only country that has regrouped all these activities under the responsibility of one organism.

In the US the core federal text is the Animal Welfare Act (AWA) dating back from 1966, on animal protection in research, shows and education. The Health Research Extension Act of 1985 is the other essential federal law, and concerns only animals in research. To these fundamental texts we can add five good practice guides (such as the NIH Guide for the care and use of laboratory animals), dedicated scientific organizations (such as the Institute for Laboratory Animal Research – Ilar), programs for specialized training (such as the American college of Laboratory Animal Medicine) and accelerated accreditation programs (such as the Association for the Assessment and Accreditation of Laboratory Animal Care), all created long ago by the scientific community and largely used or copied outside of the US. It's important to note that the US doesn't have any inventory of used rodents for research.

China uses today on its own more animals for research then the whole of Europe. The fast development of the country's economy and of international exchanges with Europe and America enabled the progress of research conditions – formed employees and modern equipment. Legislation dates back to 1983. The Ministry of Science and Technologies (MOST) is responsible for its application with the help of the provinces' administration. In 2006, the MOST published a first series of recommendations on lab animals' well being (transport, accommodation, experimental methods). It works on fitting these recommendations to those existing in Europe.

Others countries participating in world biomedical research publish regulations on the basis or reflecting of the ones existing in Europe or in the US. The Ilar (Institute for Laboratory Animal Research) helps build these regulations.

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