On September 22, 2010, the European Union (EU) adopted a new set of requirements for the protection of animals in scientific procedures including those for research, education, and training. Directive 2010/63/EU was adopted by the European Parliament and the Council of the European Union after extensive negotiations and a lengthy approval process. It will go into effect on January 1, 2013.
Directive 2010/63 will have the greatest impact on scientists working in EU member nations, but it may also affect U.S. scientists in EU-based pharmaceutical companies if they make global changes in procedure for reasons of comparability and consistency. In addition, the new Directive may affect scientists who collaborate with EU researchers or who want to publish their research in certain EU-based journals.
Directive 2010/63 replaces the 24-year-old Directive 86/609. Many improvements to laboratory animal welfare occurred since Directive 86/609 went into effect, and while some EU members had revised their national animal welfare laws during the interim, others had not. A new Directive was deemed necessary to eliminate these disparities.
The new Directive contains 60 substantive articles and 8 annexes along with a preamble consisting of 56 paragraphs. Some sections of the preamble embody different points of view on the necessity for and desirability of research with animals. However, as noted by the UK advocacy group Understanding Animal Research, “The main legally-binding parts of the text are the ‘articles’ and ‘annexes’” while the preamble is “intended to explain and justify the rest of the Directive.” The significance of this distinction may become more apparent as the Directive is incorporated into the laws, regulations, and/or administrative provisions of each member state. The process of incorporating the Directive into the laws of member states is called “transposition” and is supposed to be completed by November 10, 2012 so that the provisions of new Directive will enter into force in all member nations as of January 1, 2013.
Most animal welfare standards in the new Directive are similar to those prevailing in the U.S. However, methods for assuring compliance differ, and a few provisions exceed US requirements. For example, the Directive covers cephalopods, whereas in the US, research with invertebrates is not subject to government oversight. The use of wild-caught animals and stray or feral domestic animals is prohibited unless there is a scientific rationale why purpose-bred animals of the same species cannot be substituted. Translational or applied research with nonhuman primates is restricted to that intended prevent, diagnose, treat, or cure a health condition in humans. This restriction does not apply to basic research. Research with great apes such as chimpanzees is prohibited, except for research aimed at the preservation of the species. An exemption may be sought if there is an outbreak of a life-threatening disease for which no other research model would suffice. In addition, the Directive mandates the publication of a nontechnical summary of all animal research projects minus any trade secrets or information that could identify researchers or institutions. Evaluation of a research project to determine whether it is justified may integrate the opinion of independent parties.
A group of European scientists who met in Basel, Switzerland in November 2010 called upon their colleagues to rise to the challenges contained in the new Directive. (See related article on the Basel declaration calling for more trust, transparency and communication on animal research.)