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: f.g.j.poelma@uu.nl

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