title: Comments on the sub-group reports of the EU Technical Expert Working Group on the revision of Directive 86/609/EEC on the protection of animals used for experimental and other scientific purposes.
abstract: A critical analysis is presented of the reports produced by four Technical Expert Working Group Sub-groups (SGs) on Ethical Review, Cost-Benefit, Authorisation and Scope, which were published on the EC website (http://ec.europa.eu/environment/chemicals/lab_animals/ia_info_en.htm), as part of the European Commission (EC)s review of EU Directive 86/609 EEC. This is in addition to our official response to the internet consultation questionnaire, submitted to the Commission on behalf of FRAME. Whilst the respective SG reports were extensive and detailed, we have identified several shortcomings, and in particular, a frequent lack of consensus among the SG members, resulting in a lack of clear guidance for the EC on what the revised Directive should contain, with reference to a number of crucial issues. Such indecisiveness could lead to wide discrepancies in the approaches of the EC, the European Parliament and the EU Member States concerning many issues of importance to animal welfare and the implementation of alternatives to animal experiments. These concerns range from logistical issues, such as requirements for named officers in authorised establishments, and the recording and publishing of statistics on animal use, to ethical and scientific problems, including the use of non-human primates, local ethical review, and education and training on the essential link between the Three Rs concept and best scientific practice. In each case, the basis for our concerns is explained, and suggestions for improvements to be incorporated into the revised Directive are made, in the hope that the harmonisation of approaches to laboratory animal experimentation and the use of alternative methods in the Member States can be maximised.
authors.affiliation: FRAME, Russell & Burch House, 96-98 North Sherwood Street, Nottingham, UK. bob@frame.org.uk
authors.forename: Robert
authors.initials: R
authors.lastname: Combes
authors.forename: Michael
authors.initials: M
authors.lastname: Balls
mesh_terms: D000822:Animal Husbandry / Q000941:ethics / Q000331:legislation & jurisprudence* / Q000592:standards; D000826:Animal Testing Alternatives / Q000941:ethics / Q000331:legislation & jurisprudence* / Q000592:standards; D000827:Animal Welfare; D000818:Animals; D000830:Animals, Laboratory; D005062:European Union; D006801:Humans; D015203:Reproducibility of Results