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INTERNATIONAL ANIMAL RESEARCH REGULATIONS
History of European Animal Welfare Legislation
Historically, animal research regulations across Europe have been fragmented. In the early 1800s, the first animal welfare legislation was introduced in Great Britain, followed by Saxony and Germany; however, these laws were not specific to laboratory use of animals. The first law specifically governing the use of animals in laboratories was not enacted until the late 1800s in Great Britain.
In the twentieth century, significant differences remained in animal welfare awareness and legal protection across Europe. Many countries enacted laboratory animal welfare legislation during the mid- to late 1980s. In 1986, Europe, as a political union (then the European Economic Community), approved Directive 86/609, which very specifically governed the use of laboratory animals (European Communities and Office for Official Publications, 1986). Blumer noted that this legislation set minimum standards across member states while allowing for stricter national-level legislation. However, in 2000, national animal welfare legislation still varied widely across the European Union.
Given the significant advances in biomedical technology, the addition of new member states whose animal welfare legislation was rudimentary or nonexistent, and increased public sensitivities, stakeholders concluded that revisions to EU Directive 86/609 were needed. One of the criticisms of EU Directive 86/609 was that it did not include strong guidance on housing and care, or provisions for genetic modifications of animals. Revision of the law began in 2002, and in 2010, EU Directive 2010/63 was adopted, updating and replacing Directive 86/609 (European Union, 2010). The deadline for adoption and transposition of the directive is January 2013.
EU Directive 2010/63
The new directive is a complex document, Blumer said, structured as an introduction with 56 “recitals” explaining the rationale and objectives of the law, followed by 6 chapters defining provisions, procedures, and authorizations, and 8 annexes providing additional detail (Box 2-1).
The main areas of focus are
• harmonization among EU member states;
• expansion of the legislative scope (e.g., more species, earlier stages);
• a push for the implementation of the 3Rs (replacement, refinement, and reduction);
• authorization of projects;
• limits on individual animal exposure (including upper pain limits and limitations on the reuse of animals);
• highly specific regulations for certain species including Great Apes and non-human primates;
• increased transparency within institutions and to the public; and