Legal Framework for Animal Experimentation in Research
Animal welfare is an important issue in many European countries. In Germany, the level of animal protection is very good. The main law governing the legal framework relating to animal experimentation is the Animal Welfare Act (TierSchG) and the ordinances passed on the basis of this act. In some areas, the German Animal Welfare Act is overruled by European regulations, in particular the Directive 86/609/EEC. However, the regulations contained in this Directive do not apply directly, but need to be implemented in national law. This implementation took place in Germany in particular by appropriate amendment of the Animal Welfare Act.
Another important law is the European Convention for the Protection of Vertebrate Animals used for Experimental and other Scientific Purposes (ETS 123), to which Germany is bound under international law. Especially relevant is the recently revised Appendix A of this convention, which lays down standards for the accommodation and care of laboratory animals used in animal research. Appendix A was implemented in national law in the ordinance passed by the Federal Ministry of Food, Agriculture and Consumer Protection (BMELV). Although these standards are merely guidelines and recommendations, it is safe to assume that the relevant state authorities will base their interpretation of the very general regulations contained in the Animal Welfare Act on the principles contained in Appendix A for the approval and inspection procedures.
The specific requirements for the approval and execution of animal experiments are governed by the Animal Welfare Act. For example, it stipulates the conditions under which animal experiments are permitted to take place at all (Art. 7 Sect. 2 TierSchG), the conditions under which animal experiments require approval or only need to be reported (Art. 8, Art. 8a TierSchG) as well as the conditions that have to be met for the animals (Art. 2 TierSchG) and the staffing requirements for the research staff performing the experiments (Art. 9 TierSchG). Institutions at which animal experiments are conducted are also required to appoint an animal welfare officer, who is required to have the appropriate qualifications and authority (Art. 8b TierSchG). Institutions at which animal experiments are conducted are subject to inspection by the relevant authorities (Art. 16 Sect. 1 TierSchG).
