In 1986 the Council adopted Directive 86/609/EEC on the protection of animals used for experimental and other scientific purposes. The Directive improves the controls on the use of laboratory animals, sets minimum standards for housing and care as well as for the training of personnel handling animals and supervising the experiments. It also aims at reducing the numbers of animals used for experiments by requiring that animal experiments should not be performed when an alternative method exists, and by encouraging the development and validation of alternative methods to replace animal methods. The latter served as the basis for the Commission to set up ECVAM, the European Centre for the Validation of Alternative Methods, in 1991.
The wording of the Directive follows international Conventions. Therefore, a significant number of its provisions are open to interpretation, and the style of some provisions is more political than regulatory in nature. The Directive also does not include ethical review processes or compulsory authorisation of experiments. Furthermore, the Directive does not explicitly mention the concept of the 3Rs – Replacement, Reduction and Refinement, which is a generally recognised approach to the use of laboratory animals. It became apparent that the Directive needed a revision in order to promote improvements in the welfare of laboratory animals and to further foster the development of alternative methods.
In 2008 the Commission presented a proposal to revise Directive 86/609/EEC. The proposal has followed the co-decision procedure and a text was agreed upon by the European Parliament and the Council in April 2010. This agreement was confirmed on 8 September when the European Parliament adopted the Council Common Position concluding 18 months of negotiations. See adopted text here.
Although the draft directive text was modified during the inter-institutional negotiations, all the key elements from the Commission's original proposal remain. In particular, the concept of the 'Three Rs' (Replacement, Reduction and Refinement of animal use) which will be firmly entrenched in the new legislation; projects using animals will be subject to authorisation and a systematic, compulsory project (ethical) evaluation. The scope of the directive is wider and now also includes specific invertebrate species (cephalopods), mammalian foetuses from the last trimester of their development, as well as animals used for the purposes of basic research, education and training. It will also set housing and care standards, tighter rules for the use and care of non-human primates and introduce a ban on the use of great apes in scientific procedures.
In 2002, as part of the preparatory work for the revision, DG Environment requested the opinion of the Scientific Committee on Animal Health and Animal Welfare (SCAHAW) on the welfare of non-human primates used in experiments. The Opinion was adopted by SCAHAW on 17 December 2002.
During the same period, the European Parliament drafted an own initiative report (A5-0387/2002), with Jillian Evans as the rapporteur, calling for the Commission to come forward with a proposal to revise Directive 86/609/EEC. The report was adopted on 13 November 2002.
In 2003, DG Environment organised a Technical Expert Working Group (TEWG) to collect scientific and technical background information for the revision of the Directive. The experts from Member States, acceding countries (which are now Member States), industry, science and academia as well as from animal welfare organisations worked through a set of questions prepared by DG Environment. The results of the TEWG provided an important input for the revision of the Directive.
In 2004, the Animal Health and Animal Welfare Panel (AHAW) of European Food Safety Authority was mandated to give a scientific opinion on further four questions in relation to the revision; whether the scope should include some invertebrate species and foetal/embryonic forms, which animals should be purpose bred and identifying humane methods of euthanasia. The Opinion was adopted on 14 November 2005.
In 2006 and 2007 the Commission performed an Impact Assessment. The objective of the impact assessment was to analyse, critically review and assess policy options, their impacts, test the conclusions and provide justifiable and quantitative (where possible) indications as to the related benefits and costs. The results of a Commission TEWG (Technical Expert Working Group) as well as the scientific Opinion by the AHAW (Animal Health and Animal Welfare) Panel were examined in more detail during the impact assessment. Using the results of the TEWG as well as the AHAW Panel Opinion and the preliminary results of the impact assessment as the basis, the Commission organised a public stakeholder consultation on the different options for a revision (16 June - 18 August 2006). When analysing the results, particular attention was paid to Member State and stakeholder expert inputs, especially the effects on industry competitiveness and research in the EU, administrative compliance cost and socio-economics on the one hand, and improvement in science and welfare of animals, the animal lives and individual animal suffering/distress on the other. The preliminary findings of the impact assessment were either confirmed or corrected as per the expert input of which the majority came from users of animals in the public and private sector.
The consultation also provided an opportunity to citizens and experts to bring forward their views/arguments including those of a political nature. The responses together with all other relevant background information have been taken into consideration during the preparation of the Commission proposal.
On 5 November 2008 the Commission adopted a proposal to revise Directive 86/609/EEC, and the co-decision procedure was launched.
On 5 May 2009, with Neil Parish MEP as rapporteur, the European Parliament adopted its First Reading of the document.
On 9 and 10 July the Commission convened an Expert Working Group (EWG), consisting of relevant stakeholders from various NGOs and experts from Member States, to produce a report outlining proposed criteria for the categories of severity to be assigned to procedures performed on animals. The criteria for the categories non-recovery, up-to-mild, moderate and severe were developed on the basis of the current existing schemes in the EU, and consideration was given to all available information and best practice including that existing outside the EU. The criteria will form part of the proposal to revise Directive 86/609/EEC.
After the Parliamentary elections of 2009 Elisabeth Jeggle MEP (EPP/ED) took over the dossier as rapporteur. Work in the Council (AGRI Committee) was pushed forward energetically by the Swedish Presidency with the aim of reaching an early second reading agreement by the end of the year, a goal which was shared by the rapporteur. A political agreement on substance was reached on 7 December 2009, and on 7 April 2010 an early second reading political agreement was reached on the compromise proposal concerning implementation issues.