The European Union’s Approach to the Legal Regulation of Basic and Preclinical Animal Research

Directive 2010/63/EU on the protection of animals used for scientific purposes is the key piece of legislation in the European Union (EU) in the field of animal experimentation. It is based on three principles of working with laboratory animals (Replacement, Refinement, Reduction) that were developed by zoologists Russell and Burch in the middle of the last century. Today, however, the effectiveness of the Directive 2010/63/EU is being questioned. In September 2021, the European Parliament passed a resolution calling for an EU-wide action plan to the active phase-out the use of animals in research. The reason for this is that the EU has not achieved the objectives of the Directive on the reduction of laboratory animals and their replacement by alternative methods. Over the past 10 years, researchers have conducted a large number of studies analysing the provisions of the Directive 2010/63/EU, i.e., how exactly the welfare of laboratory animals is protected. However, the question remains as to exactly what measures have been taken by EU and its Member States to achieve the objectives of the Directive. As the problem lies in the failure to achieve the objectives of the Directive, it seems necessary to turn to the activities of the actors that carry obligations under its framework. In particular, the question arises to what extent the legal instruments comply with the bioethical rules: 3Rs principles and whether the research is sufficiently transparent. Compliance with bioethical standards will lead to a reduction in the number of laboratory animals. Nevertheless, simply listing the tools is not enough. When it comes to animal protection and the validity of scientific results, the content is important: how well they meet the standards for the proper treatment of laboratory animals. In this chapter, I would like to elaborate further on what legal instruments exist in the European Union concerning laboratory animals. For the analysis, it will be important to see how “legal” norms enshrine “bioethical” norms and whether the regulation as a whole is of an “ethical” nature. The interpretation and application of these norms is also important. In the second part I will analyse the practices of three Member States to illustrate how bioethical norms can be implemented in a particular context.