Joint CAAT-Europe / ecopa workshop, Berlin, 31.01 – 02.02.2011 Implementation of the new EU...

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 GermanyRoman Kolar

ecopa board member

Deputy DirectorAnimal Welfare Academy

German Animal Welfare Federation

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

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



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.


Federal States

Baden-Württemberg: About € 300.000 per year

Rheinland-Pfalz: About € 80.000 per year

Approximately € 400.000 annually 2000-2010:

63 Projects funded to the amount of around € 4.000.000


ZEBET - Centre for Documentation and Evaluationof Alternatives to Animal Experiments within the Federal Institute of Risk Assessment (BfR)


set - Foundation for the Promotion ofAlternatives 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 annuallyfrom 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

Research Awards for 3R Methods


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)



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.



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



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).

Academic 3Rs activities


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

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


Transposition of Directive 2010/63/EUTransposition of Directive 2010/63/EU

MS can establish programmes for the sharing of organs and tissues of killed animals (Art. 18).


no such programme exists

to be set up



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))


With ZEBET Germany already has such a centre

other areas of animal use need to be included (apart from toxicology)




b) Specific funds for the development and validation of 3Rs methods / strategies.


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



MS shall ensure the dissemination of info on the 3Rs (Art. 47 (4))


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





+MS shall ensure the dissemination of info on the 3Rs (Art. 47 (4))


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


MS shall ensure that each breeder, supplier and user sets up an animal-welfare-body (Art. 27)


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?



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)


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



Joint CAAT-Europe / ecopa workshop, Berlin, 31.01 – 02.02.2011

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Joint CAAT-Europe / ecopa workshop, Berlin, 31.01 – 02.02.2011 Implementation of the new EU...

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