Animal Experimentation and Animal Welfare: Lessons from the European Union

Abstract

This article examines the regulatory framework governing the use of animals in scientific research in the European Union (EU) and analyses the extent to which this can limit animal use and promote animal welfare. The EU is chosen as a case study of a well-developed regulatory system, and the present analysis focuses on Directive 2010/63/EU and its amendment Delegated Directive (EU) 2024/1262. Drawing on a review of legal doctrine, binding regulations, official interpretative documents, and selected scientific
literature, this article identifies the gap between normative obligations and documented challenges in the implementation of the regulations. The main question is whether the EU has managed to turn the 3Rs into a binding and effectively enforceable norm through its coordination and monitoring instruments, or whether implementation gaps and institutional diversity at the level of the Member States have made this goal challenging. The findings of this analysis show that, despite the high level of EU legal obligations, factors such as heterogeneity in the implementation of laws across Member States, the variable quality and transparency of non-technical summaries (NTSs), challenges related to the validation and regulatory acceptance of alternative methods (New Approach Methodologies – NAMs), as well as institutional and financial constraints, prevent the full realization of the envisaged support objectives. Finally, by focusing on the structural assessment of the EU regulatory framework, this article shows how the experience of this legal system can provide an analytical and instructive model and a basis for designing or reforming regulatory systems for countries that lack a specific legal framework for the use of animals in scientific research or have fragmented and ineffective regulations. In this context, the EU legal framework can be used as an analytical reference point for the gradual development of legal and institutional standards in other countries.