Home » Bulletin 2002
Animal research directive to be revised
On 28 November 2001, the European Commission announced its plans to revise Directive 86/609/EEC, which governs the "approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes". This would require every EU Member State to amend its national legislation regulating the use of animals in experiments.
The decision to revise the Directive is a consequence of the Council of Europe's revision of the Appendix to their Convention about animal experimentation. This revision, which is expected to be completed in the next two years, sets new standards for the housing and welfare of laboratory animals that will apply to all those countries which have adopted the Convention.
In 2000, the European Union itself adopted the Convention making it obliged to adopt the same changes into the Directive. However, it requires the approval of the European Parliament to amend any part of the Directive and it is extremely unlikely that the Parliament would agree to make only those changes required and not want to amend any other parts of the Directive. Animal experimentation is an issue that some MEPs have strong views about and they would be certain to propose a number of restrictive amendments. Since any changes to this Directive will have to be made under the co-decision procedure, the Commission cannot not ignore any amendments passed by the Parliament.
The Commission has proposed a two-step procedure: first, to amend the Directive to introduce the Regulatory Committee Procedure and second, to allow an opportunity for in-depth scientific/technical discussions, thus contributing to a fully-fledged revision of the Directive.
In the text, the Commission acknowledges that the welfare of laboratory animals is an increasingly politically sensitive issue, "especially in the light of the increase in the Commission's responsibilities towards animal protection imposed by the recent amendment of the Treaty on the European Union, which includes a Protocol requiring the European Union and Member States to pay full regard to the welfare of animals when drawing up agriculture, transport, single market and research policies."
The 1986 Convention and Directive
In 1986, the Council of Europe adopted a Convention ETS 123 on Animal Welfare, ratified by 14 Member States, plus the EU.
The EU Directive, adopted in the same year, is concerned with the protection of animals used for experimental and other scientific purposes, and is the implementing tool for the Convention. Directive 86/609/EEC strives to ensure that where animals are used for experimental or other scientific purposes, the provisions laid down in the Member States for their protection are largely similar so as to avoid affecting the functioning of the common market, in particular by distortions of competition or barriers to trade. It therefore gives general guidelines as regards experiments on animals (housing, use of anaesthesia, killing, competent authorities etc).
The Directive contains two Annexes (Annex 1 listing the species of animals covered by the Directive and Annex 2 containing the guidelines for the housing and care of laboratory animals). Annex 2 is equivalent to Appendix A which concerns housing and welfare standards of the Convention.
The appendices to the Convention are of a technical nature, and are heavily science-based. They need periodic adaptation to the latest scientific and technical developments. Appendix A has been under review since 1997 and will be finally amended in 2003 in order to improve welfare standards. Thus the Annexes to the Directive also require periodic adaptation.
To simplify the amendments of the Appendices, the Council of Europe has opened for signature a "Protocol of Amendment" to the Convention. The Directive should also provide for a simplified procedure as regards adaptation of the Appendices to technical progress. This simplified procedure is a Regulatory Committee Procedure, without which the Community's implementing legislation will be out of line with the Convention. The existing Regulatory Committees do not cover the area of the protection of animals used in experiments. Therefore it is necessary to establish a Regulatory Committee that has the appropriate competence.
Rapporteurs appointed... and manoeuvring begins
Caroline Jackson, a senior Conservative MEP from the UK, has been appointed rapporteur for the Environment Committee, which will be the lead Committee on this proposal. Ms Jackson will also be rapporteur on a related legislative text, the proposal on the Council of Europe Convention for the protection of vertebrate animals used for experimental and other scientific purposes (ETS 123), which deals with the fact that five Member states have not yet ratified the Convention. On this issue, the European Parliament is only consulted, which makes its views non-binding.
Although the full scale revision is not likely to start for two or more years, the political manoeuvring has already begun. Within days of the Commission publishing their proposal, the European Parliament Environment Committee announced that they would be preparing a report on the use of animals in experiments that would consider how effective the Directive had been to date. Jillian Evans, a Green MEP from the UK, will be the rapporteur for the Committee's report, which is due to be completed by December 2002. In a second step, the EU will also need to amend Directive 86/609/EEC together with the changes made to the Convention to improve welfare standards.
Areas currently outside the scope of the Directive but likely to be covered by the revision are:
- the use of animals in education, training and forensic inquiries
- routine production
- animals killed for tissue and organs
- commercial breeding of animals destined for experiments (housing and care)
- authorisation and inspection
- statistical requirements
- the use of animals in the production of monoclonal antibodies
- use of non-ruminants, cats and dogs
- ethical review and the application of the 3Rs
- specific provisions concerning the use of non-human primates, dogs and cats
- specific conditions relating to the use of transgenics and cloning, and to the areas of biotechnology and pharmaceuticals.