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Book Chapter

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Article 23 of European Union (EU) Directive 86/609/EEC required that Member States promote the development and validation of alternative technologies and stated that the European Commission (EC) “shall report before the end of 1987 on the possibility of modifying tests and guidelines” (European Parliament, 1986, Article 23). This Directive was replaced by Directive 2010/63/EU on the protection of animals used for scientific purposes, which now requires that Member States develop and validate alternative approaches much more precisely and specifies that the ultimate objective is the “full replacement of procedures on live animals for scientific and educational purposes, as soon as it is scientifically possible to do so” (European Parliament, 2010, Recital 10). However, having followed the initiatives of Member States for more than 30 years, we see that developments to replace animal experiments occur more by accident than by design. Directive 2010/63/EU has not changed this either. This chapter explores the reasons why the development and approval of animal-free methods are not advancing more quickly, and why the numbers of animals used is not declining despite the development of new methods. Undoubtedly, there are complex, multifactorial reasons behind this. Our analysis leads us to the heart of the matter. There is no master plan and there are no responsible project managers who effectively pursue the objectives of Directive 2010/63/EU at a national or EU level.


open access book chapter