Authorisation of Animal Studies: the Legal Situation in Germany

In Germany, stringent monitoring ensures that animal research is limited to a minimum. Together with the Animal Welfare Laboratory Animal Ordinance (Tierschutz-Versuchstierverordnung, TierSchVersV), the German Animal Welfare Act (Tierschutzgesetz, TierSchG) regulates the treatment of laboratory animals and implements the provisions of the EU Directive on the protection of animals used for scientific purposes (2010/63/EU) in national law. Section 5 of this act (§§ 7-10 TierSchG) defines precisely what research with an animal is, and when and under which strict conditions such research may be carried out. For research on vertebrates, the scientists must obtain authorization of each planned procedure from the competent authority.

Scientists must submit their application for the authorization of a planned research procedure to the competent authority in writing. The detailed application must explain why the research objective cannot be achieved without the use of laboratory animals. The authority is supported in its decisions to grant or refuse authorization for animal research by an advisory committee (§ 15 TierSchG). At least two-thirds of the members of such committees are selected by the authority from lists proposed by animal welfare organizations.

In addition, the Animal Welfare Act also states that only persons who can demonstrate that they have the appropriate training are authorized to carry out research with animals. If research involves pain or considerable or suffering for the animal, the animal must be treated with pain-killing drugs or be anaesthetized. In this way, the Act ensures that all experimental research with animals is carried out in a way that provides maximum protection for the animals and causes them as little pain and suffering as possible.

The keeping of animals and implementation of research is also strictly controlled: the Act requires that this be monitored by an independent veterinarian. Representatives of the regulatory authorities pay unannounced visits to the research facilities several times per year.