Dr. med. Horst Spielmann Professor for Regulatory Toxikologie FU Berlin & State Animal Welfare Officer Berlin 1. Der Ttierschutzbeaufragte

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1 Der Ttierschutzbeaufragte Information Tour at the Invitation of the Federal Foreign Office Animal Protection in Germany Visitors Program of the Federal Republic of Germany 11/23-27/2014 State Animal Welfare Officer Berlin & EU Animal Welfare legislation focusing on DIRECTIVE 2010/63 on the protection of animals used for scientific purposes. Dr. med. Horst Spielmann Professor for Regulatory Toxikologie FU Berlin & State Animal Welfare Officer Berlin 1

2 In Germany ZEBET is the National Centre for Documentation ans Evaluation of Alternatives to Animal Experiments at the BfR (Federal Institute for Risk Assessment) in Berlin 2

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4 State Animal Welfare Officer - Berlin this is a honorary office, which has been establsiehd only in a few states (Länder) of the Federal Republic of Germany Prof. Horst Spielmann was appointed state animal welfare officer Berlin on 19 December 2012 Tasks/mission of the State Animal Welfare Officer Berlin Providing expert advice on all aspects of animal welfare to the minister of justice and consumer protection in particular on - legal changes of the animal welfare policy of the State of Berlin and also of the Federal government - official contact point for citizens on all apects of animal welfare providing advisory opinion to local adminsitrations of the 12 districts of Berlin initiation and promotion of proposals to improve animal welfare in Berlin contact point for citizens, anmal welfare organizations, members of parliament and the media internet platform for animal wlelfare via 4

5 Animal Welfare Legislation in Europe David Anderson, EU DG Environment 5

6 Animal Numbers in Europe Farm animals 2,000 million chickens/hens 300 million cows, pigs, sheep Pet animals 120 million dogs & cats Zoo animals 0.5 million Animals used in Research 12 million David Anderson, EU DG Environment 6

7 Animal Welfare Definition ( ) means how an animal is coping with the conditions in which it lives. An animal is in a good state of welfare if (as indicated by scientific evidence) it is healthy, comfortable, well nourished, safe, able to express innate behaviour, and if it is not suffering from unpleasant states such as pain, fear, and distress. Good animal welfare requires disease prevention and veterinary treatment, appropriate shelter, management, nutrition, humane handling and humane slaughter/killing. Animal welfare refers to the state of the animal; the treatment that an animal receives is covered by other terms such as animal care, animal husbandry, and humane treatment.( ) (World Animal Health Organisation definition, adopted by 172 members, May 2008) David Anderson, EU DG Environment 7

8 Five Freedoms 1) Freedom from hunger and thirst 2) Freedom from discomfort 3) Freedom from pain, injury and disease 4) Freedom to express normal behaviour 5) Freedom from fear and distress David Anderson, EU DG Environment 8

9 Definition of animal welfare A state of wellbeing that occurs when all of an animal s needs are met water and suitable food comfortable and not in pain able to behave normally and exercise social animals are group housed not afraid or distressed Includes physical and mental wellbeing David Anderson, EU DG Environment 9

10 European Animal protection Legislation & Guidance European Union Council of Europe OIE - Office International des Epizooties Member State David Anderson, EU DG Environment 10

11 28 Member States Expert advice, public consultations Legislative acts Directive sets outcomes to be achieved Regulation binding requirement Legal obligations with enforcement and sanctions European Union David Anderson, EU DG Environment 11

12 Animal Welfare in the EU High priority for citizens, Member States and the European Parliament Strong animal welfare lobby Conflicting pressures increasing concern for environment, and human and animal health new knowledge, new technologies (e.g. endocrine disrupters, nano-materials) David Anderson, EU DG Environment 12

13 Animal Welfare in the EU No legal basis for EU to legislate Treaty of Amsterdam - Protocol on Animal Welfare Desiring to ensure improved protection and respect for the welfare of animals as sentient beings, in formulating and implementing the Community's agricultural, transport, internal market and research policies, the Community and the Member States shall pay full regard to the welfare requirements of animals, while respecting the legislative or administrative provisions and customs of the Member States relating in particular to religious rites, cultural traditions and regional heritage". David Anderson, EU DG Environment 13

14 Animal Welfare in the EU EU Legislation taking AW into account with compulsory measures and standards EU Recommendations, guidelines Co-operation and joint activities (e.g. in the fields of E&T, best practice sharing) David Anderson, EU DG Environment 14

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16 3 Rs CONCEPT of RUSSELL & BURCH (1959, 1992) The Principles of Humane Experimental Technique REFINE improve the quality of the experiment, e.g. to use humane and more appropriate endpoints REDUCE reduce suffering & animal numbers (biostatistics) but not the quality of the experiment REPLACE ultimate goal complete replacement of a specific animal experiment 16

17 DIRECTIVE 2010/63/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 22 September 2010 on the protection of animals used for scientific purposes Starting point Ultimate goal is to replace the use of animals Acknowledgment that animals, including nonhuman primates, are still needed today Animals have intrinsic value in themselves which must be respected The principle of the Three Rs is the key to more humane and better science Susanna Louhimies, EU DG Environment 17

18 DIRECTIVE 2010/63/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 22 September 2010 on the protection of animals used for scientific purposes Key elements Authorisation of establishments and projects Systematic project (ethical) evaluation Active promotion and implementation of the principle of the Three Rs Increased transparency and better enforcement Susanna Louhimies, EU DG Environment 18

19 DIRECTIVE 2010/63/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 22 September 2010 on the protection of animals used for scientific purposes Article 4 Principle of replacement, reduction and refinement 1. Member States shall ensure that, wherever possible, a scientifically satisfactory method or testing strategy, not entailing the use of live animals, shall be used instead of a procedure. 2. Member States shall ensure that the number of animals used in projects is reduced to a minimum without compromising the objectives of the project. 3. Member States shall ensure refinement of breeding, accommodation and care, and of methods used in procedures, eliminating or reducing to the minimum any possible pain, suffering, distress or lasting harm to the animals. 4. This Article shall, in the choice of methods, be implemented in accordance with Article 13 (Choice of methods). 19

20 DIRECTIVE 2010/63/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 22 September 2010 on the protection of animals used for scientific purposes Article 13 Choice of methods 1. Without prejudice to national legislation prohibiting certain types of methods, Member States shall ensure that a procedure is not carried out if another method or testing strategy for obtaining the result sought, not entailing the use of a live animal, is recognized under the legislation of the Union. 2. In choosing between procedures, those which to the greatest extent meet the following requirements shall be selected: (a) use the minimum number of animals; (b) involve animals with the lowest capacity to experience pain, suffering, distress or lasting harm; (c) cause the least pain, suffering, distress or lasting harm; and are most likely to provide satisfactory results. 3. Death as the end-point of a procedure shall be avoided as far as possible and replaced by early and humane end-points. Where death as the end-point is unavoidable, the procedure shall be designed so as to: (a) result in the deaths of as few animals as possible; and (b) reduce the duration and intensity of suffering to the animal to the minimum possible and, as far as possible, ensure a painless death. 20

21 DIRECTIVE 2010/63/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 22 September 2010 on the protection of animals used for scientific purposes Article 47 Alternative approaches 1. The Commission and the Member States shall contribute to the development and validation of alternative approaches which could provide the same or higher levels of information as those obtained in procedures using animals, but which do not involve the use of animals or use fewer animals or which entail less painful procedures, and they shall take such other steps as they consider appropriate to encourage research in this field. 4. Member States shall, at national level, ensure the promotion of alternative approaches and the dissemination of information thereon. 21

22 EUROPEAN & INTERNATIONAL CENTRES FOR ALTERNATIVES TO ANIMAL TESTING 1981 CAAT Hopkins 2005 JaCVAM Japan 1998 ICCVAM USA ZET 22

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24 In Germany ZEBET is the National Centre for Documentation ans Evaluation of Alternatives to Animal Experiments at the BfR (Federal Institute for Risk Assessment) in Berlin 24

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26 Experimental Animal Numbers in Germany ,5 3 2,5 2 1,5 1 0,5 0 26

27 Increase in numbers of transgenic animals used in Germany 27

28 : animal welfare was introduced into the Constitution of Germany ( 20a) and the animals 28

29 Animal welfare accepted into the German Constitution 2002 Article 20a The government is responsible for protecting the natural environment for future generations and the animals within the constitution by appropriate legislation. German Animal Protection law (Tierschutzgesetz) 1 According to this legislation, humans are responsible for animals as their companions whom they must respect and protect. Nobody is allowed to induce pain, suffering or damage to animals without sensible reason. 29

30 State Animal Welfare Officer - Berlin this is a honorary office, which has been establsiehd only in a few states (Länder) of the Federal Republic of Germany Prof. Horst Spielmann was appointed state animal welfare officer Berlin on 19 December 2012 Tasks/mission of the State Animal Welfare Officer Berlin Providing expert advice on all aspects of animal welfare to the minister of justice and consumer protection in particular on - legal changes of the animal welfare policy of the State of Berlin and also of the Federal government - official contact point for citizens on all apects of animal welfare providing advisory opinion to local adminsitrations of the 12 districts of Berlin initiation and promotion of proposals to improve animal welfare in Berlin contact point for citizens, anmal welfare organizations, members of parliament and the media internet platform for animal wlelfare via 30

31 Website of the State Animal Welfare Officer - Berlin 31

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38 Thank Thank you you for for you your your for attention your attention! 38