Authorisation of Animal Studies: the Legal Situation in Germany
In Germany and many other countries, strict controls are in place to ensure that animal experiments are kept to a minimum. The German Animal Welfare Act (Tierschutzgesetz TSchG) – from an international perspective, one of the most stringent laws governing this sector – regulates animal research in Germany. Section 5 of the Act (§§ 7-10 TSchG) provides a precise definition of animal studies, as well as when and under which preconditions it may be carried out. In the case of experiments on mammals, researchers require authorisation from the relevant authority for each individual experiment planned.
The application for the authorisation of an animal study must be submitted in writing to the relevant authority. The detailed application must specify exactly why the research objective cannot be achieved without the use of laboratory animals. The authority is supported by an advisory commission (§ 15 TSchG) in its decisions to grant or reject an application for an animal study. The majority of the members of this commission must have the expert knowledge in the area of veterinary medicine, medicine or science necessary for the assessment of animal experiments. One third of the commission members is selected by the authority from lists proposed by animal welfare organisations.
The Animal Welfare Act also specifies that animal studies may only be carried out by persons who have the necessary training and can provide proof of this training. If an experiment involves pain or significant stress to the animal, normally a sufficient dose of painkiller or anaesthetic must be administered. In this way, the Act ensures that all animal studies are carried out in a way that provides optimum protection for the animal, and subjects it to the minimum possible level of stress.
Animal keeping and the implementation of the experiments are also subject to rigorous controls: the Animal Welfare Act requires that they be monitored by an independent veterinarian. Representatives of the authorising authorities carry out unannounced inspections of research facilities several times per year.