The harm-benefit analysis : an overview of project evaluation in terms of the EU directive on the protection of animals used for scientific purposes

Abstract

Directive 2010/63/EU was introduced in 2010 following a widescale dissatisfaction with Directive 86/609/EEC, with the intention of ensuring the efficient functioning of the EU internal market and enhancing competitiveness and innovation of the EU research industry by means of the creation of a level playing field, ensuring high standards of welfare for animals still bred and used for scientific purposes and to improve transparency to the general public on the use of live animals for scientific purposes within the EU. Amongst its many innovations, potentially the largest and most important was the introduction of the requirement of project evaluation and authorisation, by means of which the Directive is able to implement its objectives. The focus of this study is to provide an overview of project evaluation under Article 38 of Directive 2010/63/EU. This dissertation further outlines the objectives of this Directive, with particular reference to that of the preservation of the Three Rs Principle. This dissertation also contains an in-depth analysis of the project evaluation process under Directive 2010/63/EU and the manner in which the Harm-Benefit Analysis (HBA) is to be carried out. Using Malta as a case-study, this dissertation also discusses the implementation of the HBA within a domestic context and contains a critical analysis of the Maltese legal framework. This study contains a critical analysis of the HBA as a method for project evaluation, highlighting its many shortcoming and provides proposals by means of which project evaluation under Directive 2010/63/EU may be better suited for achieving its objectives.