1. The work of ethical review committees in Germany and the United Kingdom - from the point of view of animal welfare Ursula G. Sauer, Germany For: Royal Society for the Prevention of Cruelty to Animals, United Kingdom

2. The work of ethical review committees in Germany & the UK from the point of view of animal welfare Why perform ethical review? - How? Legal basis for the performance of animal experiments – and thus ethical review EU Directive 86/609/EEC on the protection of laboratory animals Implementation in Member States German Animal Welfare Act UK Animals (Scientific Procedures) Act Comments from the point of view of animal welfare EU Workshop Alternatives, November 2007, Ankara, Turkey Ursula G. Sauer for:

3. Legal basis for ethical review committees EU Directive 86/609/EEC on the protection of laboratory animals Revision impending, but so far no official draft What is an Animal Experiment? Definition (Article 1(d)) Any use of an animal for scientific purposes, “which may cause it pain, suffering, distress or lasting harm.” By definition, animal experiments cause suffering Ethical principle not to cause suffering to creatures Animal experiments pose ethical dilemma EU Workshop Alternatives, November 2007, Ankara, Turkey Ursula G. Sauer for:

4. EU Directive 86/609/EEC on the protection of laboratory animals Restrictions reg. animal experiments (Article 7(2 - 4)) Experiment shall not be performed if non-animal method available If animal experiment: - use minimum number of animals - involve animals with the lowest degree of neuro- physiological sensitivity - cause the least possible suffering or harm 3Rs principle – Replace – Reduce - Refine EU Workshop Alternatives, November 2007, Ankara, Turkey Ursula G. Sauer for:

5. The work of ethical review committees in Germany & the UK from the point of view of animal welfare Why ethical review of animal experiments? Addresses ethical concerns reg. animal experiments Fulfillment of 3Rs obligation - replace, reduce, refine The 3Rs are legally required The 3Rs, good animal welfare and good science are intimately linked The most humane science is always the best science! EU Workshop Alternatives, November 2007, Ankara, Turkey Ursula G. Sauer for:

6. EU Directive 86/609/EEC on the protection of laboratory animals Ethical review? Authorisation procedure in 86/609? No, but (Article 12): Member States shall establish procedures whereby experiments shall be notified in advance to the authority. Experiments, in which animals are expected to experience severe pain which is likely to be prolonged, must be specifically declared & justified to, or specifically authorized by, the authority. The authority shall take appropriate action if it is not satisfied that the experiment is sufficiently important for meeting essential needs of man or animal. EU Workshop Alternatives, November 2007, Ankara, Turkey Ursula G. Sauer for:

7. EU Directive 86/609/EEC on the protection of laboratory animals No specific provisions on authorisation / notification procedure BUT: request to MS to install such a system No specific provisions on ethical review process BUT: “severe prolonged pain“ is only acceptable if experiment is “of sufficient importance for meeting the essential needs of man or animal” Balancing of “cost” (i.e. harm to the animals) and “benefit” of the experiment This is basis for ethical review EU Workshop Alternatives, November 2007, Ankara, Turkey Ursula G. Sauer for:

8. Implementation of Directive 86/609 and of Ethical Review Process in EU Member States 21 of the 25 EU Member States (EU as of Dec. 31, 2006) Have implemented some form of authorisation procedure for animal experiments Have included some form of ethical review process Examples: Germany & United Kingdom EU Workshop Alternatives, November 2007, Ankara, Turkey Ursula G. Sauer for:

9. German Animal Welfare Act Two categories of animal experiments 1. Not-legally required experiments (Such as fundamental biomedical research) Require authorisation by the authority 2. Legally required experiments (Such as toxicity tests for regulatory purposes, Chemicals Act, Medical Products Act, etc.) Require notification to the authority Less comprehensive since indispensability assumed (Is it?) EU Workshop Alternatives, November 2007, Ankara, Turkey Ursula G. Sauer for:

10. German Animal Welfare Act Regardless of whether experiment is subject to notification or authorisation: Article 7 (3): Animal experiments may only be performed if the expected suffering of animals appears ethically acceptable in regard to the scientific goals Ethical balancing (harm-benefit analysis) explicitly required EU Workshop Alternatives, November 2007, Ankara, Turkey Ursula G. Sauer for:

11. German Animal Welfare Act Authorisation procedure (I) Scientist writes application for authorisation Scientific goal Indispensability (state-of-science & available 3Rs) Specification of animal species, animal numbers Justification for wild-caught animals, if applicable Detailed project description (covering each animal) Classification of severity of procedures Justification for ethical acceptability Indication of what happens to animals after exp. Qualifications of persons involved EU Workshop Alternatives, November 2007, Ankara, Turkey Ursula G. Sauer for:

12. German Animal Welfare Act Authorisation procedure (II) Scientist submits application to authority Statement of Institutional Animal Welfare Officer Authority checks application If incomplete / inconsistent, goes back to scientist Forwards pre-checked application to “Advisory Committee in accordance with §15 of the German Animal Welfare Act” Ethical review by: Scientist, Institutional Animal Welfare Officer, Authority & Committee EU Workshop Alternatives, November 2007, Ankara, Turkey Ursula G. Sauer for:

13. German Animal Welfare Act Authorisation procedure (II) Committee gives advice to authority Advice within 4 weeks, extension possible if justified Authority can take into account Committee’s advice Authority approves / disapproves application within 3 (2) months of receipt of complete application If period elapses: “fictitious license”! Period is interrupted when questions to scientist Limitation of license to 3 years EU Workshop Alternatives, November 2007, Ankara, Turkey Ursula G. Sauer for:

14. German Animal Welfare Act Advisory Committees acc. to §15 Animal Welfare Act Licensing authorities are regional due to Germany’s de-centralised Federal structure Each authority nominates Committee to assist in authorisation of experiments As a rule, Committee consists of 6 members Appointed for 3 years, work on voluntary basis Majority must have “expertise necessary for evaluating animal experiments” 1/3 of the members must have been nominated by animal welfare organisations EU Workshop Alternatives, November 2007, Ankara, Turkey Ursula G. Sauer for:

15. German Animal Welfare Act §15 Committees give advice on Indispensability? - Replacement Species and animal numbers? - Reduction Suffering not more than indispensable? - Refinement Severe distress: are expected results of “outstanding relevance for essential needs of mankind or animals”? Expected distress appears ethically acceptable in regard to scientific goal? EU Workshop Alternatives, November 2007, Ankara, Turkey Ursula G. Sauer for:

16. Ethical Review Process in United Kingdom Animals (Scientific Procedures) Act 1986 3 licenses: establishment, research project & individual personnel One central licensing authority: The Home Office In addition, all establishments which use, breed and/or supply animals must have local ethical review process EU Workshop Alternatives, November 2007, Ankara, Turkey Ursula G. Sauer for:

17. UK Animals (Scientific Procedures) Act 1986 Ethical review process (ERP) Acts as adjunct to Home Office & advises the establishment’s Certificate Holder Members: scientists, veterinary & animal care staff May include independent lay member / animal welfare expert EU Workshop Alternatives, November 2007, Ankara, Turkey Ursula G. Sauer for:

18. United Kingdom ERP provides local framework to 1.Promote the 3Rs 2.Review harms and benefits of projects 3.Provide forum for discussion of issues relating to animal use 4.Undertake retrospective reviews of projects 5.Consider standards of care and accommodation and humane killing 6.Review managerial systems 7.Advise on staff training Key point is that it addresses issues at a local (establishment) level EU Workshop Alternatives, November 2007, Ankara, Turkey Ursula G. Sauer for:

19. Comments on ethical review from the point of view of animal welfare Germany: §15-Committees since 1987 UK: Ethical Review Process since 1999 In general, they have improved overall ‘culture of care’ regarding the animals Efficient Ethical Review Process improves animal welfare, science, legal compliance, ethical considerations & (UK) transparency of research The most humane science is always the best science! EU Workshop Alternatives, November 2007, Ankara, Turkey Ursula G. Sauer for:

20. Comments on German authorisation & ethical review system Points of criticism Huge differences in efficiencies of committees Sufficient time for preparation? (sometimes 20 applications every 2 weeks - honorary members!) No even parity – animal welfare can be ignored Authority can ignore Committee advice Discussion on ethical acceptability welcome? Notifiable animal experiments – always ethically acceptable? EU Workshop Alternatives, November 2007, Ankara, Turkey Ursula G. Sauer for:

21. Comments on ethical review system General, over-arching problems irrespective of Member State How to determine indispensability? Access to all relevant information Efficiency of information retrieval How to determine distress? Consider all causes for harm Controversy regarding severity No official classification system How to determine benefit? EU Workshop Alternatives, November 2007, Ankara, Turkey Ursula G. Sauer for:

22. How do animal welfare organisations contribute to ethical review process? In the UK, the RSPCA Believes including wide range of perspectives is key to effective and efficient ethical review Staff sit as animal welfare experts on ERPs Produces resources to help lay members and others participate effectively Works with other organisations such as Lab. Animals Science Association, Home Office EU Workshop Alternatives, November 2007, Ankara, Turkey Ursula G. Sauer for:

23. www.rspca.org.uk/ethicalreview RSPCA resources