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Legal Framework for Animal Experimentation in Research

In many European countries, animal welfare is an important topic in society. EU Directive 2010/63/EU (Directive on the Protection of Animals Used for Scientific Purposes) was issued in recognition of this. In Germany, the legal framework relating to animal experimentation is influenced by the Animal Welfare Act (TierSchG) and the Animal Welfare Laboratory Animal Regulations (TierSchVerV). In the field of animal experimentation, Germany aligned with European law in August 2013 with an amendment to the Animal Welfare Act. A high level of animal welfare is therefore ensured in Germany.

The specific prerequisites for the approval and execution of animal experiments are standardised in the Animal Welfare Act. For example, it describes the prerequisites under which animal experiments may take place at all and the prerequisites under which animal experiments require approval or registration. In addition, the Animal Welfare Act lists the conditions to be ensured for laboratory animals as well as the personnel-related prerequisites for people involved with experiments. What is more, institutions working in the area of animal experimentation are obliged to name a person responsible for animal welfare, who has the appropriate expert qualifications and authority. The institutions in which animal experiments are performed are monitored by the competent authorities.

Also significant is the European Convention for the Protection of Vertebrate Animals Used for Experimental and Other Scientific Purposes (ETS No. 123), to which Germany is bound by public international law. Appendix A of ETS 123 contains specific provisions for the accommodation and care of animals intended for use in experiments. ETS 123 was implemented in an ordinance of the German Federal Ministry of Food, Agriculture and Consumer Protection. Although the convention only contains guidelines and recommendations, these are drawn on by Germany’s state authorities responsible for animal welfare when it comes to interpreting the Animal Welfare Act for approval and monitoring purposes.

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