EU Legislation on Animal Research in 2009
Research on great apes is prohibited, ethical evaluation is mandatory, and greater focus should be placed on alternatives to animal research. These are some of the changes in the Commission’s proposal for the European legislation on animal research in 2009.
Research on great apes such as chimpanzees, gorillas, and orangutans will be prohibited. This, however, will not have a major practical impact since great apes are not used in European research today. In Sweden, great apes have not been used in research for several decades.
No prohibition on monkeys in researchThe debate on monkeys in research has raised demands to determine a time schedule for completely prohibiting the use of monkeys in research, but this has not been included in the legislation currently proposed. According to the Commission, it is not possible to phase out the use of monkeys in research in the near future since they are necessary to study life-threatening infections such as HIV, malaria, hepatitis, and SARS.
Ethical evaluation mandatory throughout EUObligatory ethical evaluation of animal research in all EU Member States has been proposed. In this respect, Sweden is already on the forefront. We have had legislation on ethical evaluation of animal research since 1979.
Focus on alternative methodsThe Commission wants the new legislation to strengthen the effort of finding alternatives to animal research. This involves finding ways to replace, refine, and reduce animal research. The principle is referred to as the 3Rs.
“The new, proposed law reflects the perspective of the research community, where this principle is already a guiding star,” says Håkan Billig, Secretary General of the Scientific Council for Medicine at the Swedish Research Council.
Legislation delayedThe current regulations became effective in 1986. The Commission’s work on the new proposal has been a long, drawn-out process and has been delayed on several occasions.
“It is high time to review the European regulations on laboratory animals. This effort is important since it will affect research conditions for many years to come,” emphasises Håkan Billig.
Critical review expectedThe Swedish Research Council is one of the reviewers of the proposed directive in the Swedish remit process. The Swedish Research Council’s ethical review board for laboratory animal science, a national expert group on research involving laboratory animals, deals with these issues.
“The legislation is extensive, and we will conduct a critical review of the proposal to study its effects on Swedish research,” says Håkan Billig.
Based on co-decision It is uncertain how long it will take for the new legislation to become effective. The process will follow a co-decision approach, i.e. the type of legislative process where the Parliament has the greatest opportunity for influence. This means that the Parliament, the Council, and the Commission must be in agreement before the law can be passed. The proposed legislation is sent to all Member States for review and comment, and will be addressed in both the EU Parliament and the Council of Europe.
Generally, the process takes two to four years. In Sweden, the Swedish Board of Agriculture is responsible for the preparatory work on this issue. The proposed legislation has been sent out for review and comment to the various agencies and organisations that can be affected by the new regulations.
Text: Cecilia Johansson