, Legislation
Numbers
Use of laboratory animals is fluctuating:
• Decrease: development alternatives, ethics, more strict legislation, more responsible use, high costs
• Increase: development of transgenic (altered genes) animals
Legislation
First European Convention for protection of animals: March 1986 —> Belgian Law in the same year (update in 1993)
• In 2010
—> New Belgian Royal Decree with stricter rules concerning housing of laboratory animals (april)
—> New European Directive on protection of animals for scientific purposes
Laboratory animal
= every living vertebrate animal used or intended for laboratory experiments including larval forms and excluding foetal/embryonic forms
—> New legislation: inclusion of some invertebrae and mammalian embryonic forms (form last third of term)
Animal experiment
= every use of a living vertebrate animal for experimental and other scientific purposes
—> Can inflict pain, suffering, discomfort of permanent injury
—> Including every treatment that has purpose or consequence of the birth of an animal in such a condition
—> Exception of the least painful methods to kill or mark the animal (humane methods) and non-experimental treatments in agriculture and
veterinary practice
—> An animal should not be used more than once in experiments that inflict serious pain and suffering
Examples degrees of pain and suffering:
Purpose of laboratory animals:
• Production and control of sera, vaccines or diagnostics
• Toxicological and pharmacological research
• Diagnose of diseases
• Education
• Answer scientific questions
,Housing and taking care of laboratory animals:
• Housing conditions, environment, moving space, food, water and care should meet the animals’ needs
• Daily control of animals and environment (temperature, humidity…)
• Regular control by verterinarian (large animals) or expert (rodents and rabbits)
Source and identification of laboratory animals
• No stray pets, lost or abandoned animals
• Mice, rats, guinea pigs, hamsters, rabbits, primates, dogs, cats, quail (a bird), farm animals
—> Should be purpose-bred (not farm animals, purchased from farm) bij licensed breeding companies
—> If not available: apply for exemption with government (strong motivation needed)
—> Dogs cats and primates: marked individually and permanent (immediately after weaning)
—> Register must be kept of all animals coming in and leaving the laboratory
Statistical information
• Statistical data about the use of laboratory animals must be handed to the government every year: numbers used per species and
numbers per type of experiment
Responsible use
Animal experiments:
• Restricted to absolute minimum
• Only if the purpose cannot be achieved by other methods
• May only cause pain, suffering or injury if they cannot be avoided for the purpose
• May only be performed under anaesthesia unless the pain, suffering or injury is less than what is caused by the anaesthesia
—> If anaesthesia not possible: analgesics or another fitting method to decrease pain should be used
• Animals must never be subject to serious pain, great discomfort or suffering
• Choice of animals must be seriously considered (preferably animals with the lowest neurophysiologic degree)
The 3 R’s (Russell and Burch)
Reduction: choosing the experimental design well, standardising labo animal population and experimental procedures
Replacement: replacing the animal experiments with another method or invertebrate
Refinement: less discomfort, gathering knowledge about biological needs of the animal needs, environmental enrichment and apply analgesia
What do you need before starting animal experiments?
Laboratory licence
= governmental laboratory licence (Flemish Community, department Animal Welfare)
• Overview and map of the rooms (description and function)
• Overview of the kind of experiments that will be performed
• List of the species and their source
• Overview of the staff responsible for the projects and working with the animals
—> Laboratory director: responsible manager
—> Expert: responsible for the protection of the health and well being of the laboratory animals (vet for large, FELASA C training for small)
—> Project leader: sets up experiments, responsible for them, needs to keep a log
—> Biotechnicians: staff that conducts the experiments
—> Animal caretakers
, Permission of the Ethical Committee
• Obligatory since 2001
Tasks:
• Evaluation of the planned experiments
• Setting up ethical criteria concerning animal experiments
• Advising laboratories and government
• Reporting to the government (yearly)
Professional secrecy for the members
Composition: laboratory director, project leader, biotechnician, veterinarian or expert, at least 2 independent members
—> Governmental inspector (not a member) can attend ECD meeting at any time
What’s new?
• Competencies (ethics, alt methods, animal health…) are important, at least 7 members are present (and all the competencies) and no
conflict of interest allowed
• Apply in the appropriate form:
—> Staff responsible for the project, purpose and description of the project, number and species of the animals, degree and duration of pain,
anaesthesia and analgesia that will be used, post-op recovery care, alt methods, humane endpoints and euthanasia
What else in the new legislation:
• Retrospective assesment: assessment of # animals, pain and suffering, gain of the project
• Non-technical summary: to inform the public
Education
• Project leaders (80h course C), researchers and lab technicians (40h course B) and animal caretakers (25h course A)
• FELASA directives, BCLAS and continuous education
What else is there?
Animal Welfare Body
• Set up by every ‘user’
• Includes an animal caretaker, scientist and vet/expert
• Tasks: advise on animal welfare, review internal operational processes
• Ultimate goal: improve animal welfare (beter follow-up humane endpoints, improve protocols) and transparancy
Reporting all animals used in the creation of a new line
= more animals in the statistics
• Creation of GA line: genetic manipulation, recipient female and vasectomised males, birth of potention mutants…
• Project authorisation and reporting until ine is ‘established’
Genetically altered animals - harmful phenotype
• Every animal that has a likely harmful phenotype can suffer due to the genetic alterations
• Perform an AWA (animal welfare assessment): check breeding, anomalies, abnormal behaviour, try to decrease suffering
Other paperwork
• Import licence: importing animals from non EU states
• Bio-security dossier
• Radio-activity use in laboratory animals
Numbers
Use of laboratory animals is fluctuating:
• Decrease: development alternatives, ethics, more strict legislation, more responsible use, high costs
• Increase: development of transgenic (altered genes) animals
Legislation
First European Convention for protection of animals: March 1986 —> Belgian Law in the same year (update in 1993)
• In 2010
—> New Belgian Royal Decree with stricter rules concerning housing of laboratory animals (april)
—> New European Directive on protection of animals for scientific purposes
Laboratory animal
= every living vertebrate animal used or intended for laboratory experiments including larval forms and excluding foetal/embryonic forms
—> New legislation: inclusion of some invertebrae and mammalian embryonic forms (form last third of term)
Animal experiment
= every use of a living vertebrate animal for experimental and other scientific purposes
—> Can inflict pain, suffering, discomfort of permanent injury
—> Including every treatment that has purpose or consequence of the birth of an animal in such a condition
—> Exception of the least painful methods to kill or mark the animal (humane methods) and non-experimental treatments in agriculture and
veterinary practice
—> An animal should not be used more than once in experiments that inflict serious pain and suffering
Examples degrees of pain and suffering:
Purpose of laboratory animals:
• Production and control of sera, vaccines or diagnostics
• Toxicological and pharmacological research
• Diagnose of diseases
• Education
• Answer scientific questions
,Housing and taking care of laboratory animals:
• Housing conditions, environment, moving space, food, water and care should meet the animals’ needs
• Daily control of animals and environment (temperature, humidity…)
• Regular control by verterinarian (large animals) or expert (rodents and rabbits)
Source and identification of laboratory animals
• No stray pets, lost or abandoned animals
• Mice, rats, guinea pigs, hamsters, rabbits, primates, dogs, cats, quail (a bird), farm animals
—> Should be purpose-bred (not farm animals, purchased from farm) bij licensed breeding companies
—> If not available: apply for exemption with government (strong motivation needed)
—> Dogs cats and primates: marked individually and permanent (immediately after weaning)
—> Register must be kept of all animals coming in and leaving the laboratory
Statistical information
• Statistical data about the use of laboratory animals must be handed to the government every year: numbers used per species and
numbers per type of experiment
Responsible use
Animal experiments:
• Restricted to absolute minimum
• Only if the purpose cannot be achieved by other methods
• May only cause pain, suffering or injury if they cannot be avoided for the purpose
• May only be performed under anaesthesia unless the pain, suffering or injury is less than what is caused by the anaesthesia
—> If anaesthesia not possible: analgesics or another fitting method to decrease pain should be used
• Animals must never be subject to serious pain, great discomfort or suffering
• Choice of animals must be seriously considered (preferably animals with the lowest neurophysiologic degree)
The 3 R’s (Russell and Burch)
Reduction: choosing the experimental design well, standardising labo animal population and experimental procedures
Replacement: replacing the animal experiments with another method or invertebrate
Refinement: less discomfort, gathering knowledge about biological needs of the animal needs, environmental enrichment and apply analgesia
What do you need before starting animal experiments?
Laboratory licence
= governmental laboratory licence (Flemish Community, department Animal Welfare)
• Overview and map of the rooms (description and function)
• Overview of the kind of experiments that will be performed
• List of the species and their source
• Overview of the staff responsible for the projects and working with the animals
—> Laboratory director: responsible manager
—> Expert: responsible for the protection of the health and well being of the laboratory animals (vet for large, FELASA C training for small)
—> Project leader: sets up experiments, responsible for them, needs to keep a log
—> Biotechnicians: staff that conducts the experiments
—> Animal caretakers
, Permission of the Ethical Committee
• Obligatory since 2001
Tasks:
• Evaluation of the planned experiments
• Setting up ethical criteria concerning animal experiments
• Advising laboratories and government
• Reporting to the government (yearly)
Professional secrecy for the members
Composition: laboratory director, project leader, biotechnician, veterinarian or expert, at least 2 independent members
—> Governmental inspector (not a member) can attend ECD meeting at any time
What’s new?
• Competencies (ethics, alt methods, animal health…) are important, at least 7 members are present (and all the competencies) and no
conflict of interest allowed
• Apply in the appropriate form:
—> Staff responsible for the project, purpose and description of the project, number and species of the animals, degree and duration of pain,
anaesthesia and analgesia that will be used, post-op recovery care, alt methods, humane endpoints and euthanasia
What else in the new legislation:
• Retrospective assesment: assessment of # animals, pain and suffering, gain of the project
• Non-technical summary: to inform the public
Education
• Project leaders (80h course C), researchers and lab technicians (40h course B) and animal caretakers (25h course A)
• FELASA directives, BCLAS and continuous education
What else is there?
Animal Welfare Body
• Set up by every ‘user’
• Includes an animal caretaker, scientist and vet/expert
• Tasks: advise on animal welfare, review internal operational processes
• Ultimate goal: improve animal welfare (beter follow-up humane endpoints, improve protocols) and transparancy
Reporting all animals used in the creation of a new line
= more animals in the statistics
• Creation of GA line: genetic manipulation, recipient female and vasectomised males, birth of potention mutants…
• Project authorisation and reporting until ine is ‘established’
Genetically altered animals - harmful phenotype
• Every animal that has a likely harmful phenotype can suffer due to the genetic alterations
• Perform an AWA (animal welfare assessment): check breeding, anomalies, abnormal behaviour, try to decrease suffering
Other paperwork
• Import licence: importing animals from non EU states
• Bio-security dossier
• Radio-activity use in laboratory animals
