Volume 1

The revision of the EU Directive on the protection of animals used for scientific purposes / House of Lords. European Union Committee.

  • Great Britain. Parliament. House of Lords. European Union Committee
Date:
2009
Catalogue details

Licence: Open Government Licence

Credit: The revision of the EU Directive on the protection of animals used for scientific purposes / House of Lords. European Union Committee. Source: Wellcome Collection.

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    a aS EE SnSES EEE Complexity of authorisation process 131. The complexity of the levels of authorisation and review currently proposed illustrated in the diagram below. PERSONNEL Performance of procedures Performance of humane killing Every 5 years Supervision and design of projects based on evidence of training and competence Supervision of animal care staff (Appropriate training Annex VI) Authorisation of Personnel (Art.20) Annual statistics (Art.49) ESTABLISHMENT Authorisation and registration (Art.21) Person responsible for animal care and welfare (Art.24) Designated Vet (Art.24) National animal welfare & ethics committee (Art.47) Inspection (Art.33) Amendment to project (Art.42) Ethical Evaluation of projects (Art.37) ETHICAL REVIEW COMMITTEE (art.25) Person responsible for » =} - - B animal care and welfare Vet, Scientist (Art 26 outlines responsibilities) Application for project NON Art.36, Annex VI!) ; aes Authorisation TECHNICAL of projects PROJECT (Art.35, Art.41) SUMMARY Ls fobs’ (Art.36, Art.40) eview o PROJECT Projects (Art.26) 4 ypars Maximum (Art.41) End of project ).--” ADVICE Retrospective assessment of projects (Art.38) 132. Before commencement of a project, six levels of authorisation must be obtained from the competent authority (authorisation of the establishment; personnel performing procedures; humane killing; supervising and designing projects; supervising animal care staff; authorisation of project (Articles 20, 21, 35 & 41)). The project is then potentially subject to a further five reviews during or at the end of its four-year lifespan (three annual reviews by the local ethical review committee, Article 26 plus retrospective assessment of project by the competent authority, Article 38; plus reporting of actual severity of procedures, Article 49). All this is carried out on a background of biannual inspection of the establishment to ensure compliance with the Directive (Article 33). 133. It is inappropriate that these multiple tiers of regulation apply comprehensively to procedures where there is no or minimal welfare impact (eg humane killing) as to those where the impact is severe. Parliamentary amendments would, for many projects, ameliorate some of the steps (eg annual review), but still leave much of the bureaucracy, for instance with all remaining categories of authorisation still required for humane killing. 134. The Commission claims that “positive impacts would occur at the level of authorisation bodies in the member states due to more flexible and efficient handling of the procedures. Industry and academia would benefit from deadlines for authorisation decisions.’*4 Our conclusion is quite the opposite. 135. An example of how the proposed authorisation process might work is given here: 1. The applicant must submit details to a competent authority for ethical evaluation, on which apparently no time limit is placed. The ethical evaluation must involve extremely detailed assessment as set out in Article 37, with no less than 15 areas of information to submit. The results of the ethical evaluation are presumably returned to the applicant for revision. 2. The establishment must keep records of the ethical evaluation (from the competent authority), to submit back to the competent authority on request. 4 Commission draft proposal (page 9)