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Historical background
The use of animals went parallel with the use of medical science. Hippocrates already used animals, those days
there were no anesthesia available, everything was done on alive and awake animals.
Galenus mostly used pigs, dogs and monkeys and was able to show that urine was produced by the kidneys by
using animals.
After the rising of Christianity nearly no research was done during several centuries and very little animals were
used.
This changed in the 15th century, there was a new urge to increase knowledge and experiments on non-
anaesthetized animals were performed. Those days people thought about animals like a mechanic object that
lives because of physical and chemical laws, without conscience and not capable of feeling pain.
Andreas Vesalius was a famous medical doctor and was interested in human anatomy, but also in animals.
William Harvey believed that animals were an important source of information. He increased the knowledge of
blood circulation and valves by performing animal experiments.
In the second half of the 19th century there was an important increase in animal use, this was caused by the
discovery of anaesthetics and by several important scientific discoveries: Darwin for instance showed that there
were biological similarities between humans and animals, therefore he believed we could use animals as model
for humans.
Claude Bernard defends the use of animals in experimental work. He used animals to show the importance of
organs like the liver and pancreas.
Robert Koch believed that animals had to be infected in laboratory to show pathogenicity of micro-organism
while Louis Pasteur used animals in the production and testing of vaccines.
After WO I production of pharmaca and development of new disciplines (such as toxicology, immunology, …)
resulted in a strong increase in the number of laboratory animals.
There was a shift in type of animals that were used: until the end of the 19th century mostly dogs, cats, rabbits,
and pigs were used. Later on, more rodents were used, especially rats and mice.
Now there is a legal obligation to test compounds in animals before to use them in clinical studies.
The first legislation concerning the use of animals in research was put in place in England in 1876. This law was
called the law of “Cruelty to Animals Act”. Of course, there were also countermovements, originations that
were against experiments with animals. The First countermovements arosed in England (Animal Liberation
Movement and Animal Rights Movement).
Legislation
Numbers
– World wide: appr. 100 million
– VS: appr. 20 million
– EG: appr. 12 million
– Belgium (2013): 626.742
• 77% rodents and 8% rabbits
• 11% fish, amphibians and reptiles
• 4% birds
• 0,6% farm animals
• 0,09 % for dogs, 0,05% cats and 0,002% primates (lower numbers)
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,• use of laboratory animals is fluctuating
– development of alternatives, ethics,legislation, more responsible use and high costs decrease
– development of transgenic animals increase
Overview of the national and European legislation
The first European Convention for the protection of vertebrate animals dates from March 1986. This European
Convention was translated into Belgian law in August of 1986. There was an update of this law in November
1993.
In April 2010 there was a New Belgian Royal Decree with even stricter rules concerning the housing of
laboratory animals.
In September 2010 there was a new European Directive on the protection of animals used for scientific
purposes. The translation of this directive into National law is still pending.
De definition of Laboratory animal
= every free-living vertebrate animal, including free living and/or reproducing larval forms and excluding other
foetal or embryonic forms.
= all animals used or intended for laboratory experiments.
What will change with the new legislation?
Up until now laboratory animals were only vertebrate animals. Now also some invertebrate will be included
like squid and lobsters. Also, the embryonic forms must be protected from pain and suffering starting from the
last third of term on.
De defenition of animal experiment
= every use of a living vertebrate animal for experimental and other scientific purposes. This includes every
treatment that has the purpose or the consequence of the birth of an animal in such a condition. It does not
include the least painful way to kill or mark an animal nor any non- experimental treatments in agriculture and
veterinary practice.
The law states that an animal should not be used more than once in experiments that inflicts serious pain and
suffering. Pain, suffering, and discomfort were not defined in previous legislation, but now it is included in the
new European Directive, and it will also be defined in the new royal decree.
What is mild, moderate, or serious pain?
Not just pain has to be considered but also permanent injury: hole body irradiation for instance doesn’t hurt
but at least do serious damage of the bone marrow cells, amputation is not painful when good use of
anesthesia and painkillers, but it is a serious injury.
Mild pain
- The administration of anesthesia
- Non-invasive imaging
- Superficial procedures like ear and tial biopsies
Moderate pain
- Surgery under general anesthesia and appropriate analgesia associated with post-surgical pain
- Induction of tumors or spontaneous tumors
- Irradiation of chemotherapy with a sublethal dose
Serious pain
- Toxicity testing
- Vaccine potency testing
- Irradiation or chemotherapy with a lethal dose without reconstitution of the immune system
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, For what purpose can laboratory animals be used?
- Production and control of sera, vaccines, or diagnostics
- Toxicological and pharmacological research
- Diagnose of diseases
- Education
- Answer scientific questions
In practices this means for instance that animal use is not allowed to test cosmetic products.
Some numbers
- Fundamental research (33%)
- Development and quality control of products and material for human, veterinary and dental medicine (62%)
- Toxicological and other security studies (1,5%)
- Diganosics, teaching and education (3,5%)
Housing and taking care of laboratory animals
Housing conditions, environment, space to move, feed, water and care must meet the animals’ needs.
The law also states that the animal and its environment like the temperature and the relative humidity have to
be checked every day, including during the weekends and holidays.
The law gives a detailed overview concerning caretaking and housing of animals per species. Also, the animals
have to be checked regularly by the veterinarian for animals or by an animal expert for rodents and rabbits
(=small animals)
Source and identification of laboratory animals
- Lab animals have to be purpose bred.
- This should never be stray (verdwaald) pets, lost or abandoned animals.
- Large animals like pigs and sheep’s do not have to be purpose bred, they can be purchased from a farm.
- When you need animals that are not available purpose-bred like a special breed of dog for instance you can
apply for exemption with the government. However, you do need a strong motivation as to way you cannot
use other animals, the same goes when you need to take animals from the wild.
- All animals coming in and going out of the lab have to be registered.
- Dogs, cats and primates have to be marked individually and permanent immediately after weaning (spenen)
Statistical information
Every year statistical data concerning the use of laboratory animals have to be passed on to the government.
They want to know the numbers used per species and the number per type of experiment like fundamental
research, toxicology, education, ….
Responsible use of laboratory animals
It’s quite clear that animal experiments must be restricted to the absolute minimum. They may only be
performed if the purpose cannot be achieved by other methods. The choice of animal species must be seriously
considered and is preferably the animal with the lowest neurophysiologic degree.
Animals must never be subject to serious pain, great discomfort, or suffering. If there is pain or injury involved
experiments should be performed under anesthesia. If this is not possible analgesia or another fitting method
to decrease pain or suffering should be used.
The principles of Humane Experimental Technique
The three R’s
- Reduction:
• Choosing well the experimental design
• Standardizing the laboratory animal population and the experimental procedures
- Replacement:
• Replacing the animal experiments with another method or an invertebrate
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, - Refinement
• Less discomfort
• Gathering knowledge about biological needs of the animal
• Environmental enrichment
• Apply analgesia
What do you need before starting animal experiments?
Before one is allowed to perform animal experiments several approvals are necessary.
Governmental Laboratory license
The first approval is the Governmental Laboratory license. This license is issued by the Federal Public Service,
department of animal welfare. In the application form an overview of the rooms where the animals are housed
and where the experiments go on has to be given and also an overview of the kind of experiments that will be
performed plus a list of the species and their source and lastly an overview of the staff, responsible for the
projects and working with the animals.
The staff consists of:
- The laboratory director, who is the responsible manager
- An expert, who is responsible for the protection of the health and well-being of laboratory animals
- Project leader, who sets up the experiments and is responsible for the animal use
- Biotechnicians
- Animal caretakers
Permission of the Ethical Committee
You also need the approval of the Ethical Committee; it is obligatory in laboratories and institutions since 2001.
* Tasks:
- They have to evaluate the planned experiments
- They have to set up some ethical criteria concerning animal experiments
- They have to advise laboratories and the government
- They have to report to the government on a yearly basis
Composition:
- Laboratory director
- Project leader
- Biotechnician
- Veterinarian or expert
- At least two independent members
The members must have certain skills like knowledge of animal models, knowledge of statistics, alternative
methods and so on.
To apply for the permission of the Ethical Committee there is an appropriate form describing:
- The staff that will be responsible for this project
- The purpose and description of the project
- The number and species of animals, the degree and duration of pain, suffering and injury
- The anesthesia and analgesia that will be used and the post-operative recovery care
- The alternative methods
- The humane endpoints and euthanasia
Importing animals?
When you want to import animals from non-EU member states, you need to get an import license to get the
animals through customs and veterinary examinations.
All work involving viruses, viral vectors and micro-organisms need to be described in a bio-security dossier,
while work involving radioactivity requires special training.
What do you need before starting animal experiments?
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