PURPOSE: to strengthen the protection of animals still used in scientific procedures in line with the European Union's Protocol on Animal Welfare.
PROPOSED ACT: Directive of the European Parliament and of the Council.
CONTENT: Directive 86/609/EEC on the protection of animals used for experimental and other scientific purposes was adopted to harmonise practices in the area of animal experimentation in the EU. However, due to a variety of weaknesses in that Directive, a number of Member States have established considerably more far-reaching measures in their national implementation whereas others apply only minimum rules. This uneven situation needs to be rectified to ensure that the objectives of the internal market are re-established. The proposal aims at ensuring a level playing field, throughout the EU, for industry and the research community, at the same time strengthening the protection of animals still used in scientific procedures in line with the EC Treaty's Protocol on Animal Welfare.
Many provisions of the current directive are open to interpretation. The latter does not include ethical reviews or requirements to obtain authorisations for experiments. The directive does not explicitly address the internationally recognised Three R concept of Replacement, Reduction and Refinement to minimise the use of experimental animals. Replacement refers to replacing procedures which involve live animals with alternatives not using sentient animals. Reduction refers to reducing to a minimum the use of animals in procedures without compromising the quality of results. Refinement refers to using methods that avoid pain, suffering or distress or lasting harm to a bare minimum. This last 'R' also includes improving the care, treatment and living conditions of animals. Revising the directive will strengthen legislation in the area of animal experiments in the EU, reduce the use of experimental animals and ensure that those that are still used in experiments receive appropriate care and humane treatment.
The main points of the proposal are as follows :
- the new directive will make it compulsory to carry out ethical reviews and require that experiments where animals are used be subject to authorisation;
- it will widen the scope of the directive to include specific invertebrate species and foetuses in their last trimester of development and also larvae and other animals used in basic research, education and training;
- it will also set minimum housing and care requirements;
- only animals of second or older generations should be used, subject to transitional periods, to avoid taking animals from the wild and exhausting wild populations;
- alternatives to testing on animals must be used when available and the number of animals used in projects be reduced to a minimum. Member States will be required to improve the breeding, accommodation and care measures and methods used in procedures so as to eliminate or reduce to a minimum any possible pain, suffering, distress or lasting harm caused to animals. These measures are based on the three R principle of replacing, reducing and refining the use of animals in experiments;
- the proposal provides for tightening of national inspections, not only to ensure compliance, but as a means to promote the exchange of best practices and implementation of the principles of the Three Rs.
Scope: the proposed directive covers all live non-human vertebrate animals intended for experiments plus certain other species likely to experience pain. It also includes animals specifically bred so that their organs or tissue can be used in scientific procedures. It does not cover behavioural studies carried out on animals kept in zoos or those used in military experiments, or non-experimental, agricultural or clinical veterinary practices and trials. It also does not cover animals used in husbandry or practices for marking an animal.
Non-human primates: specific provisions have been incorporated to reduce the use of non-human primates to an absolute minimum. A strict case-by-case scrutiny is imposed in cases where non-human primates are still the only suitable species. The proposal limits the use of non-human primates by prohibiting the use of Great Apes and restricting the use of other species of nonhuman primate to only specific fields of application. Furthermore, there are ambitious requirements on the origins of the animals and specific monitoring mechanisms are foreseen to ensure the effectiveness of the proposed measures, ultimately facilitating the move towards abolishing the use of non-human primates in scientific procedures. It is recognised, however, that current scientific knowledge will not allow us to achieve this goal in the near future.