Grundlagenforschung im Tierversuchsrecht

There are many endeavors to reduce or replace the number of animal experiments by developing new methods. Despite a significant downward trend, the number of laboratory animals used in the life sciences remains high, as many scientific questions cannot yet be answered with sufficient reliability using other research methods. While the necessity of animal experiments is gradually easier to explain in applied research, basic research in particular is typically under social pressure to justify itself. Current EU law realizes the cross-cutting task of animal welfare (Art. 13 TEU) in the entire regulatory area of substance-related product and authorization law (cosmetics, chemicals, medicinal products, veterinary medicinal products, medical devices) to the extent that this is either already or at least de lege ferenda aligned with the 3R principles (replacement, reduction, refinement). The European Commission supports this, but at the same time correctly assumes that non-animal tests currently do not fully fulfil the regulatory requirements, for example with regard to quantitative assessments of hazards and risks and therefore still cannot be replaced. Nevertheless, there is already a very tight regulatory corset for animal experiments in research in European Union law. The relevant Animal Experiments Directive 2010/63/ EU is one of the strictest animal welfare regimes in the world. Nevertheless, the German legislator and the state administrations enforcing animal welfare law in accordance with Article 83 of the German Constitution have succeeded in further tightening the animal welfare standards practiced in comparison to most other member states of the European Union. In its 2020 implementation report for Germany, the European Commission recently found that the permissible duration of approval procedures was exceeded in an impressive 79 per cent of cases. This not only affects research, but also the qualification of young scientists, who can only start their own research work with delays if it requires animal-experimental methods. The necessary efforts to progressively improve animal welfare in experimental animal research can certainly not be reduced to simple bureaucratic costs, because animal welfare as a legitimate material objective (Art. 13 TFEU; Art. 20a German Basic Law) is not in question. However, the same also applies to freedom of research (Art. 13 EU Charter of Fundamental Rights; Art. 5 para. 3 sentence 1 German Basic Law), which also requires a procedural rationality that is not designed to block and prevent from the outset. The licensing authority is bound by fundamental rights (Art. 1 para. 3 German Basic Law) and must observe the limits resulting from the freedom of science, which according to general principles requires a procedural design appropriate to science. Against this background, this article is dedicated to the legal processing of basic research within animal experimentation law. At the same time, some selected problems that are currently of particular concern to animal research will be addressed in a targeted and in-depth manner.