1. Joint CAAT-Europe / ecopa workshop, Berlin, 31.01 – 02.02.2011 Implementation of the new EU Directive 2010/63/EU on the protection of animals used for scientific purposes: Opportunities for the 3Rs The Situation in Germany Roman Kolar ecopa board member Deputy Director Animal Welfare Academy German Animal Welfare Federation

2. The situation in Germany OUTLINE A) Major achievements re. 3Rs advancement: Funding The Centre for Documentation and Evaluation of Alternatives to Animal Experiments (ZEBET) Academic activities B) Transposition of Directive 2010/63/EU (Legal requirements) – (state-of-the-art) = needs German Animal Welfare Federation – Animal Welfare Academy

3. The situation in Germany Funding Federal Ministry of Education and Research (BMBF) Federal States Centre for Documentation and Evaluation of Alternatives to Animal Experiments (ZEBET) Foundation set Research awards German Animal Welfare Federation – Animal Welfare Academy

4. Federal Ministry of Education and Research (BMBF)  Since 1980/1981  Funding of projects of research and development in the field of „methods to replace animal experiments”  € 4 Mio. annually during the most recent years + € 1.7 Mio. for special grant applications.  2000 – 2009: € 41.5 Mio for 152 research projects.

5. German Animal Welfare Federation – Animal Welfare Academy Federal States Baden-Württemberg: About € 300.000 per year Rheinland-Pfalz: About € 80.000 per year

6. Approximately € 400.000 annually 2000-2010: 63 Projects funded to the amount of around € 4.000.000 German Animal Welfare Federation – Animal Welfare Academy ZEBET - Centre for Documentation and Evaluation of Alternatives to Animal Experiments within the Federal Institute of Risk Assessment (BfR)

7. German Animal Welfare Federation – Animal Welfare Academy set - Foundation for the Promotion of Alternatives to Animal Testing  established in March 1986  initial industry funding of € 500.000  interest on the Foundation’s capital  from 1993/94: industry donations of € 120.000 – 220.000 annually  from 2000: industry donations of € 120.000 annually  from 2010: industry donations of € 220.000 annually + € 100.000 provided by the German Federal Ministry of Food, Agriculture and Consumer Protection (BMELV) for the next 4 years, (amount to be matched by industry donors)  1986-2010 : 50 projects

8. Research Awards for 3R Methods German Animal Welfare Federation – Animal Welfare Academy Ministry of Consumer Protection: € 15.000 Baden Württemberg: Up to € 25.000 Hessen: € 15.000 Rheinland-Pfalz: € 20.000 every two years DFG: € 50.000 (from a private donation)

9. German Animal Welfare Federation – Animal Welfare Academy ZEBET - Centre for Documentation and Evaluation of Alternatives to Animal Experiments within the Federal Institute of Risk Assessment (BfR) Established in 1989: First governmental research institution in charge of alternatives to animal experiments worldwide Mission: Replacement of animal experiments by alternative test methods, particularly those experiments required by law, reduction of the number of test animals to the minimum absolutely necessary, and alleviation of pain and suffering of animals used in experiments.

10. German Animal Welfare Federation – Animal Welfare Academy ZEBET - Centre for Documentation and Evaluation of Alternatives to Animal Experiments within the Federal Institute of Risk Assessment (BfR) Responsible for: documenting alternatives to animal experimentation assessing and recommending them promoting their validation both nationally and internationally. Also: in-house research separate budget for external projects

11. German Animal Welfare Federation – Animal Welfare Academy ZEBET - Centre for Documentation and Evaluation of Alternatives to Animal Experiments within the Federal Institute of Risk Assessment (BfR) Information centre for alternative methods for CA in charge of enforcement of the legal requirements on animal experiments.  database AnimAlt-ZEBET (free of charge; in English).

12. Academic 3Rs activities German Animal Welfare Federation – Animal Welfare Academy Chair for Alternative Methods: University of Konstanz: University Projects and/or departments specifically addressing 3Rs issues: University of Erlangen University of Veterinary Medicine Hannover University of Berlin University of Giessen

13. The CA carrying out the project evaluation must consider expertise in 3Rs, animal husbandry etc. (Art. 38(3)) Situation in Germany:   members of local ethical committees may be competent in the required areas; no standards etc. exist; these committees are based on voluntary work   CA may request advice from ZEBET, but ZEBET’s capacity is clearly limited  national competence centre is needed that can cope with the to be expected workload and provides professional expertise in all relevant areas German Animal Welfare Federation – Animal Welfare Academy Transposition of Directive 2010/63/EU

14. MS can establish programmes for the sharing of organs and tissues of killed animals (Art. 18). Situation in Germany: no such programme exists  to be set up German Animal Welfare Federation – Animal Welfare Academy Transposition of Directive 2010/63/EU

15. MS shall contribute to the development and validation of 3Rs a) Establish 3Rs centres (Art. 47) including the provision of qualified labs for validation studies (Art 47(2)) and a single contact point to provide advice on suitability of methods proposed for validation (Art 47(5)) Situation in Germany: With ZEBET Germany already has such a centre  other areas of animal use need to be included (apart from toxicology) German Animal Welfare Federation – Animal Welfare Academy Transposition of Directive 2010/63/EU

16. MS shall contribute to the development and validation of 3Rs b) Specific funds for the development and validation of 3Rs methods / strategies. Situation in Germany: Germany already has funding provided by BMBF, ZEBET, set foundation, and 2 Federal States  increased and more strategic funding needed  being the major research community in Germany, the DFG must be involved to provide special funding for alternative methods German Animal Welfare Federation – Animal Welfare Academy Transposition of Directive 2010/63/EU

17. MS shall ensure the dissemination of info on the 3Rs (Art. 47 (4)) Situation in Germany: ZEBET runs a database on 3Rs of mainly toxicological animal tests.  other areas of animal use need to be included ZEBET holds courses on 3Rs; there are also some academic activities in that regard + those of the national LASA (GV-SOLAS)  establishment of specific education and training courses on 3Rs at universities and other institutions  comprehensive system needed for the regular distribution of relevant info on the 3Rs to, and education & training of, all those that are involved in animal research and the authorisation thereof German Animal Welfare Federation – Animal Welfare Academy Transposition of Directive 2010/63/EU

18. German Animal Welfare Federation – Animal Welfare Academy MS shall contribute to the development and validation of 3Rs + MS shall ensure the dissemination of info on the 3Rs (Art. 47 (4)) Situation in Germany: Scarce focussed academic activities in the field of the 3Rs; the only chair on alternative methods is based on a private donation  Promotion and funding of chairs/departments/institutes for animal- free research at German universities Transposition of Directive 2010/63/EU

19. MS shall ensure that each breeder, supplier and user sets up an animal- welfare-body (Art. 27) Situation in Germany: presently some of the tasks of the future animal-welfare-body are dealt with by the animal welfare officer. Not foreseen for breeders and suppliers. Not necessarily knowledgeable in 3Rs. The efficiency of the AWO strongly depends of personal motivation.  to be set-up also for breeders and suppliers; 3Rs experts needed; how to avoid conflicts of interest? German Animal Welfare Federation – Animal Welfare Academy Transposition of Directive 2010/63/EU

20. MS shall establish national committees for the protection of animals used for scientific purposes to advise CA and animal welfare bodies - also with a view to 3Rs issues (Art. 49) Situation in Germany: no national committee for this specific purpose exists; present national animal welfare committee not suited for this purpose  to be set-up; 3Rs experts needed German Animal Welfare Federation – Animal Welfare Academy Transposition of Directive 2010/63/EU

21. Joint CAAT-Europe / ecopa workshop, Berlin, 31.01 – 02.02.2011 Thank you for your attention! German Animal Welfare Federation – Animal Welfare Academy