Masterstudiengang "Drug Regulatory Affairs"
Master-Thesis
The process of implementing Directive 2010/63/EU into German law
Dr. Uta Wrackmeyer (Abschlußjahr: 2014)
Summary
Every year animals are used for scientific purpose. This ranges from animal experiments in basic research to procedures for the development of new drugs that are obligatory by law. Since Directive 86/609/EC on the protection of animals used for experimental and other scientific purposes from 1986, scientific knowledge about animals and their capacity to percept stress and suffering has progressed. In parallel alternative methods for animal experiments were developed so that a revision of Directive 86/609/EC became indispensable. The Directive 2010/63/EU on the protection of animals used for scientific purpose was adopted 22nd of September 2010 by the European Council. It aimed to raise the minimum standards of animal welfare based on the new scientific knowledge and to achieve harmonization within the European Union. For all EU member states the Directive brought several novelties affecting the breeding, supply and use of animals for scientific purpose.
This thesis addresses the implementation of Directive 2010/63/EU into German law. It highlights the innovation and differences of the Directive in comparison to the existing German animal welfare act (latest version of 2010) and summarises the different opinions towards the implementation and interpretation of the Directive. The deepest disagreement was between animal welfare organizations that demanded stringent animal welfare standards and researching institutions underlining the importance of the freedom of research. Animal welfare and the freedom of research are national objectives as defined in the German Basic Constitutional Law. This thesis investigates if a balanced implementation of Directive 2010/63/EU into German law - considering equally both objectives - has been achieved by analysing the new German animal welfare regulations. In addition experts from researching institutions and representing organization as well as from the competent authority have been interviewed to elucidate the practical impact of the new regulations four to five month after the approval of the novelized animal welfare act and its enactment.