The first legislation concerning animal experimentation in Europe was enacted in the United Kingdom in 1876 in the form of the Cruelty to Animals Act. This statute emerged as a result of a long debate between scientists and animal-rights activists. The U.K. was thus the first and, for many years, the only country with legislation protecting animals used for scientific purposes. However, concern for laboratory animals has since grown. In the 1980s, two important documents controlling the use of animals in experiments were issued in Europe. In 1985, after several years' discussion, the 26 countries of the Council of Europe (a political intergovernmental organization set up in 1949) in Strasbourg reached agreement on the Convention for the Protection of Vertebrate Animals used for Experimental and Other Scientific Purposes (ETS 123).1 A convention, however, is not a binding document and has no legislative force. Rather, a convention should be considered as soft law. A convention becomes effective when it is signed and ratified by a member state, i.e., when the parliament or government of a country has approved the instrument. Then, the member state becomes a party to that convention and is legally bound under international law to implement its provisions.

Convention ETS 123 contains the provision that parties should hold multilateral consultations to examine the progress of its implementation and the need for revision or extension of any of its provisions on the basis of new facts or developments. During the last decade, three multilateral consultations have been held. At these multilateral consultations, parties adopted the following resolutions:

Resolution on the interpretation of certain provisions and terms of the convention (1992): This resolution gives some precision on the scope of the convention with regards to animals carrying harmful genetic modifications, and a common interpretation of certain terms used in the statistical tables. Furthermore, it provides sample statistical tables used to facilitate communication of statistical information.

Resolution on education and training of persons working with animals (1993): This resolution presents guidelines for topics included in educational and training programs for four categories of persons working with laboratory animals (from animal caretaker to animal science-specialist).

Resolution on the acquisition and transport of laboratory animals (1997): This resolution states criteria for granting exemption for the acquisition of animals in supplying or breeding establishments that are not registered. It also contains principles of best practices in the packing and transport of laboratory animals, with particular emphasis on the necessary competence and responsibilities of the persons involved to ensure a proper transport with the shortest delays.

Resolution on the accommodation and care of laboratory animals (1997): This resolution contains guidelines, complementary to those of Appendix A of the convention, for the housing and care of laboratory animals, as defined in the light of scientific evidence and practical experience (e.g., environmental enrichment and group housing).

In 1986, the Directive for the Protection of Vertebrate Animals used for Experimental and Other Scientific Purposes (86/609/EEC)2 was adopted by the Council of Ministers of the European Economic Community. This document was based upon the convention, although its text is more concise and its requirements more stringent. The aim of this directive is to ensure that where animals are used for experimental or other scientific purposes, the provisions laid down by law, regulation, or administrative provisions in the member states for their protection are approximated so as to avoid affecting the establishment and functioning of the common market, in particular, by distortions of competitions or barriers to trade. All EEC member states are compelled to implement the provisions of the EEC directive through their national legislation. These provisions must be seen, however, as minimum requirements.

All laboratory-animal protection legislation is based on the premise that, under certain conditions, it is morally acceptable to use animals for experimental and other scientific purposes. Most laws, however, contain provisions ensuring that the number of animals used is kept to a minimum. In addition, most regulatory systems have the following general objectives:

♦ To define legitimate purposes for which laboratory animals may be used

♦ To ensure competence of all laboratory personnel and researchers

♦ To limit animal use where alternatives are practicably available

♦ To prevent unnecessary pain or distress to animals

♦ To provide for the inspection of facilities and procedures

♦ To ensure public accountability

In some regulatory systems, the principles of the 3Rs of Russell and Burch3 have been implemented explicitly.

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