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Ankara, 12-13 November 2007
Workshop on Alternative Methods (3 R's) to Animal Tests
Faculteit der Diergeneeskunde
Report of an animal welfare officer
Fred Poelma, Ph.D.animal welfare officer
Faculty of Veterinary MedicineUtrecht University, The Netherlands
e-mail: [email protected]
Ankara, 12-13 November 2007
Workshop on Alternative Methods (3 R's) to Animal Tests
European regulations for the care and use of laboratory animals:
Directive 86\609\EEC for the protection of animals used for experimental and other scientific purposes.
Convention ETS 123 for the protection of animals used for experimental and other scientific purposes.
Ankara, 12-13 November 2007
Workshop on Alternative Methods (3 R's) to Animal Tests
The 45 member states of the Council of Europe
The Council of Europe was set up to achieve a greater unity between its Members for the purpose of safeguarding and realising ideals and principles.(Human rights, environmental protection, bio-ethics, animal protection, …)
Ankara, 12-13 November 2007
Workshop on Alternative Methods (3 R's) to Animal Tests
The 27 member states of the European Union
The aim of the EU is to eliminate disparities between laws, regulations or administrative provisions in the Member States… so as to avoid distortion of the competition or barriers to trade.
Ankara, 12-13 November 2007
Workshop on Alternative Methods (3 R's) to Animal Tests
Legislation in the Netherlands
• Experiments on Animals Act (1977/1996) ‘protect the laboratory animal’ Principle: “no, unless…”, 3 R’s Definitions: “what is an animal experiment?” Persons involved: authorized and competent Supervision: animal welfare officer (internal)
inspector (external, Ministry of Public Health, Welfare & Sport)
Licenses (license holder; conduct of animal experiments, breeding and supply of laboratory animals, etc.)
Animal Ethics Committee (AEC)
• Other Acts/regulations: health and welfare, housing, genetically modified organisms, etc.
Ankara, 12-13 November 2007
Workshop on Alternative Methods (3 R's) to Animal Tests
Some key figures in the Netherlands
• 16 million people • 81 license holders (institutions)• 35 animal welfare officers (FELASA D)• 25 Animal Ethics Committees• 603.741 animal experiments in 2006• 579.248 laboratory animals in 2006
523.956 (European registration, not included re-use and animals just killed)
Ankara, 12-13 November 2007
Workshop on Alternative Methods (3 R's) to Animal Tests
Purposes Animal Experiments in NL - 2006
• Science 275.017 45,6%• Drugs (medicines) 270.859 44,9% • Toxicity 33.038 5,5% • Education 15.504 2,5%• Diagnostics 9.287 1,5%• Other 36
Totally 603.741 100%
• Source: zo doende 2006 (www.vwa.nl)
Ankara, 12-13 November 2007
Workshop on Alternative Methods (3 R's) to Animal Tests
Laboratory animals used in NL in 2006
• Mice 47%• Rats 23%• Chickens 18%• Fish 3%
• Monkeys 0,1%
Ankara, 12-13 November 2007
Workshop on Alternative Methods (3 R's) to Animal Tests
Primary legal task of the animal welfare officer
• Supervision and monitoring the welfare of laboratory animals
(Directive 86/609/EEC, Article 19.2d:“In user establishments a veterinarian or other competent person
should be charged with advisory duties in relation to the well-being of the animals”)
• Institution: University of Utrecht (UU) University Medical Centre Utrecht (UMCU)
• 2 awo’s: Harry BlomFred Poelma
• embedded: Department of Animals, Science and SocietyDivision of Laboratory Animal ScienceFaculty of Veterinary MedicineUtrecht University
Ankara, 12-13 November 2007
Workshop on Alternative Methods (3 R's) to Animal Tests
Department Animals, Science & Society
• Ethology and Welfare [Prof.dr. B.M. Spruijt]
• Laboratory Animal Science [Prof.dr. F. Ohl, chair]
• Human – animal relationship[working group]
• Netherlands Centre Alternatives to animal use (NCA) [Prof.dr. C.F.M. Hendriksen]
Ankara, 12-13 November 2007
Workshop on Alternative Methods (3 R's) to Animal Tests
Key figures 2006 UU and UMCU
• 33.805 animal experiments• 2 license holders (UU and UMCU)• 3 AECs (different specialisations), monthly meeting• 700 AEC – protocols• 1200 detailed protocols (experimental design)• 280 animal caretakers, research technicians (FELASA
A,B)• 670 scientists (FELASA C)• Research: Education:
Brain and behaviour Veterinary medicine Infection and immunology Medicine Surgery, orthopedics Biology Endocrinology, cardiology, Pharmacology anaesthesia, imaging techniques
Ankara, 12-13 November 2007
Workshop on Alternative Methods (3 R's) to Animal Tests
Tasks of an animal welfare officer
• supervision and monitoring welfare of laboratory animals and quality of experiments
• promotion of 3 R’s• education, FELASA C course (2 wk), practical courses
students • advise scientists, AEC, license holders, animal
technicians/caretakers• administration and registration of animal experiments
and laboratory animals • registration of scientists and animal caretakers• public task: lectures at schools, tours in facilities, PR
Ankara, 12-13 November 2007
Workshop on Alternative Methods (3 R's) to Animal Tests
How does the awo perform his tasks at the UU/UMCU?
• Advise scientists increase quality of animal experiments (design,
statistics, housing (enrichment), monitoring welfare, adequate anaesthesia and analgesia, humane endpoint, etc.)
pre-screening AEC protocol, detailed protocol, etc.• Advise License holders
quarterly meeting, report, PR• Advise Animal Ethics Committee
monthly meeting of 3 AECs, frequent communication with secretary of AEC
• Site visits (14 sites in UU / UMCU) Monthly site visit of each site, report/feedback to
scientist and other responsable persons
Ankara, 12-13 November 2007
Workshop on Alternative Methods (3 R's) to Animal Tests
How does the awo perform his tasks at the UU/UMCU?
• Advise laboratory animal facility managers structurally monthly, informal weekly
• Education lectures on housing, monitoring welfare, humane
endpoint, AEC-procedure, etc, in FELASA C course coaching students in scientific practical courses
• Research on Refinement e.g. alternative bloodsampling techniques,
alternatives for tailcutting in mice (genotyping), improve analgesia and anesthesia
• Registration of experiments, animals and persons annual meetings with departments/divisions
Ankara, 12-13 November 2007
Workshop on Alternative Methods (3 R's) to Animal Tests
title personnel: applying scientist (FELASA cat. C) lab. animal technician (FELASA cat. B) animal caretaker (FELASA cat. A) others (students, medical specialist)
refereeing of scientific quality funding description of scientific problem aim of the study scientific relevance societal relevance
Protocol-conducting animal experiment1. Ethics committee application form
Part A (background information)
Ankara, 12-13 November 2007
Workshop on Alternative Methods (3 R's) to Animal Tests
1. Ethics committee application formPart B (animals)
species (strain)
number
housing conditions
(mandatory in EU:group / solitairycage enrichment)
choice of animal model
alternatives (arguments underpinning need for animal use / reduction / refinement)
arguments for number of animals required
development / import of genetically modified animals (potential discomfort)
Ankara, 12-13 November 2007
Workshop on Alternative Methods (3 R's) to Animal Tests
1. Ethics committee application formPart C (animal experiment)
concise protocol description experimental design estimation of level and description of discomfort per
treatment / procedure duration of discomfort description of anaesthesia / analgesia arguments for not using anaesthesia / analgesia humane endpoint and method of euthanasia
Ankara, 12-13 November 2007
Workshop on Alternative Methods (3 R's) to Animal Tests
Protocol- conducting animal experiment 2. Detailed (working) protocol
per experiment info on:
personnel involved animals (species,
number) housing conditions detailed protocol (data,
volumes, routes, etc.) and specification of expected effects
anaesthesia / analgesia description of
discomfort
description of agreements on: responsibilities (who
does what and when) communication lines humane endpoint method of killing carcas treatment and
post mortem investigation
Ankara, 12-13 November 2007
Workshop on Alternative Methods (3 R's) to Animal Tests
Protocol- conducting animal experiment 3. Welfare monitoring
daily records in direct neighbourhood of the animals specification of relevant welfare (discomfort) parameters
to be assessed (clinical signs, appearance, body weight, ..) specification of relevant assessment time points Assessment per group / individual
4. Make an evaluation after the experiment has been finished! legal registration: purpose, number of animals,
degree of discomfort, anaesthesia, analgesia, etc.
Ankara, 12-13 November 2007
Workshop on Alternative Methods (3 R's) to Animal Tests
Role of awo in education course FELASA Cat. C - scientist
Legal requirements to design and conduct an animal experiment:
• 500 study hours in biological disciplines (anatomy, physiology, etc.)
• Basic course of 80 h in laboratory animal science
• master in a biomedical discipline (e.g. Biology, Medicine, Pharmacology, Veterinary Medicine)
Ankara, 12-13 November 2007
Workshop on Alternative Methods (3 R's) to Animal Tests
Role of awo in education course FELASA Cat. C - scientist
Curriculum of 80 h course:
• biology and husbandry of laboratory animals• microbiology and disease• health hazards and safe practices in the animal facility• design and conduct of animal experiments• anaesthesia, analgesia and experimental procedures• alternatives to animal use• ethical aspects and legislation• analysis of scientific article (animal experiments)
Ankara, 12-13 November 2007
Workshop on Alternative Methods (3 R's) to Animal Tests
FELASA C courses at Utrecht University
Division of Laboratory Animal Science, Faculty of Veterinary Medicine organizes annually:
10 courses in Dutch language
• 4 courses in English • 2 courses for foreigners working in the Netherlands• 2 courses for foreigners just attending the course
(each course has 20-25 attendants)
Ankara, 12-13 November 2007
Workshop on Alternative Methods (3 R's) to Animal Tests
Offspin from international courses at Utrecht University
Assistance in organizing and teaching in LAS training programs in foreign countries:
Belgium proposals from:BrazilGreece SloveniaHungary ThailandLatvia TurkeyPortugalS-Africa
Ankara, 12-13 November 2007
Workshop on Alternative Methods (3 R's) to Animal Tests
Summary Guideline in advise and education
• Aim: Standardisation and 3 R’s
• Genetic quality/ definition (e.g. inbred)
• Microbiological (SPF)• Housing (standard
dimensions; enrichment; group/ individual)
• Care• Techniques
• Tools:
• QA-system (ISO:9001, GLP, AAALAC)
• QA book (description procedures)
• SOP’s (standard procedures)
• Experimental protocol• Daily welfare record• Evaluation welfare
record
Ankara, 12-13 November 2007
Workshop on Alternative Methods (3 R's) to Animal Tests
Summary Guideline in advise and education
• QC = Quality Control, 3 R’s
• Results of animal experiments should be Verifiable Reproducable
Increase quality of animal experiments Enhance welfare of animals
Ankara, 12-13 November 2007
Workshop on Alternative Methods (3 R's) to Animal Tests
Dilemma advisor < - > police officer
Relation with AEC Relation with License holder, PR Relation with (external) inspector Relation with scientists, animal caretakers,
etc.
Ankara, 12-13 November 2007
Workshop on Alternative Methods (3 R's) to Animal Tests
Current developments in NL
• Public accountability – politics• Improvement position of awo
independant, professional, transparant• Permanent education of awo
(symposia, professional association) professionalization handbook (guideline) awo accreditation (education, performance)
Ankara, 12-13 November 2007
Workshop on Alternative Methods (3 R's) to Animal Tests
How to improve functioning of the awo
• Describe tasks and responsibilities of awo • Describe training program for awo • Describe instructions and procedures for
persons involved in animal experiments (Quality system – handbook)
• Design and implement a central database (computerization)
• Diminish bureaucracy (;-)
Ankara, 12-13 November 2007
Workshop on Alternative Methods (3 R's) to Animal Tests
Tesekkurler!
Thanks for your attention!
Fred Poelma