Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

The new Directive 2010/63/EU and its implementation in the European Economic Area (EEA): an Overview

Guido Bockler (Abschlußjahr: 2013)

Summary

Some external factors like changes in the EEC, a general change in the perception of the animal as sentient being and new knowledge and evidence in animal experimenting made a comprehensive revision of Directive 86/609/EEC unavoidable.

The Council Directive 86/609/EEC came into force on 24 November 1986 with a minimum of requirements for housing and training of the responsible for animal care and monitoring of the experiments. At this time animal welfare legislation was addressed to the member states.

The Treaty of Lisbon (ETS No.170) amending the Treaty on European Union establishing the European Community entered into force on 1 December 2009. As a consequence, as from that date, any reference to the European Communities shall be read as the European Union.

By this Convention the EU was "to draft international legislation setting out the conditions under which, and the scientific grounds on which, experiments on live animals may be authorised" (European Convention for the Protection of Vertebrate Animals used for Experimental and Other Scientific Purposes -Explanatory Report).

Directive 86/609/EEC is replaced by Directive 2010/63/EU on the protection of animals used for scientific purposes with effect from 1 January 2013 with the exception of Article 13, which shall be repealed with effect from 10 May 2013. The new Directive introduced for the first time legal provisions in the EU to harmonize national provisions covering the welfare of animals used for experimental and scientific purposes.

New key elements have been introduced under the new legislation based on the ethical principles of 3Rs namely Replacement, Refinement and Reduction (The 3Rs principles were first introduced in Russell and Burch's 1959 book 'The principles of humane ex-perimental technique').

The master thesis at hand provides an overview about the objectives and goals of the Directive 2010/63/EU. Furthermore, the aim was to investigate the approach of the European Commission to realize their own policy objectives and to comprehend and compare the adoption by three member states.

Pages: 49