Why is animal testing still legal?

Animal experiments at the DRFZ

© © Jacqueline Hirscher

Take animal welfare into account

Research focus of the DRFZ
Around 10% of the population suffer from autoimmune diseases such as rheumatism, psoriasis, lupus erythematosus, intestinal inflammation or multiple sclerosis, to name just a few. Invalidity and pain become daily companions. Worse still, the likelihood increases that these patients will also develop cancer and die early.
The drugs currently available have to be taken for life and can at most alleviate these chronic diseases, but not cure them. Even the most effective drugs to date are only able to temporarily interrupt the mechanisms of inflammation, but not to eliminate its causes. In addition, many therapies are associated with considerable side effects, since they have to attack centrally due to the nature of the disease and thus strongly suppress the immune system. In the long term, this leads to intolerance or even therapy failure. That is why the scientists and doctors at the DRFZ are researching the causes of these diseases, although animal experiments are still indispensable.

Animal experiments, alternative methods and animal welfare

Many alternative methods for animal experiments are already in use, but cannot completely replace them.

According to the Animal Welfare Act, animal experiments may only be carried out if no animal-free methods are available (Animal Welfare Act, Section 7a, Paragraph 2, No. 2). You can still only find out in animal experiments what circumstances cause the immune system to react against your own body. It is not yet possible to simulate outside the body how the cells of the immune system communicate with each other and with the other cells of the body in complex organ structures. However, this knowledge is essential for the development of new, more potent therapies with fewer side effects or even healing options for these previously incurable autoimmune diseases. Likewise, effects and side effects of drugs on other organ systems and functions can only be tested in one living being, especially since the complex interactions between the various organ systems have so far been difficult or impossible to represent in vitro. For this reason, in addition to the fundamental ethical aspects, new therapeutic strategies must first be tested in an animal model. If successful, clinical studies are then carried out in the patient.
Less complex relationships can, however, be investigated with cell material from patients or healthy volunteers without animal experiments. Many groups of the DRFZ work completely without animal experiments. They are constantly developing new test systems to analyze cells of the immune system outside the body. However, animal experiments will remain indispensable for the foreseeable future, but at the same time help to develop possible alternative methods. However, these are already being used in addition to animal experiments in order to reduce the number of animals required.

Alternative methods

Every scientist is obliged to use alternative methods whenever possible. This animated film gives a clear overview of this topic.

(Source: https://www.tierversuche-verhaben.de/filme/)

The 3R principle

This animated film explains the 3R principle and describes how it is implemented in research.

(Source: https://www.tierversuche-verhaben.de/filme/)

The scientists are advised by the independent animal welfare officers, who also ensure and monitor the welfare of the animals and compliance with all guidelines and regulations. The animal welfare committee, which meets regularly, supports the animal welfare officers in their work and in monitoring animal welfare.

3R principles

The scientists at the DRFZ are very aware of their responsibility towards animals and use the 3R principle in their animal experiments in order to reduce the suffering of animals in animal experiments to an essential level. The 3Rs stand for "Replace, Reduce, Refine", in English "Avoid, Reduce, Improve".
In practical terms, this means: The researchers at the DRFZ try to carry out as many experiments as possible without the use of animals (“Reduce & Replace”), for example by using cell cultures. When carrying out animal experiments, care is taken to use a statistically calculated minimum group size of animals, but not more animals than necessary (“Reduce”). Today's highly developed technology now offers many non-invasive examination methods (“Refine”), which reduces the suffering of animals and a lot of data can be generated from a few animals (“Reduce”).

The animal welfare officer

Gudrun Wibbelt from the Leibniz Institute for Zoo and Wildlife Research and Boris Jerchow from the Max Delbrück Center on their work as animal welfare officers.

(Source: https://www.tierversuche-verhaben.de/filme/)

Animal species, animal husbandry and handling of laboratory animals

The type of animals used in animal experiments consists of weighing up two criteria: the use of the species that suffers least from the effects of the experiment, but is at the same time most relevant to the question at hand.

At the DRFZ we only work with mice. Among other things, the genetics, anatomy and physiology of mice are very similar in evolutionary terms to those of humans and thus offer an important basis for research into diseases. Most of the mice at the DRFZ are genetically modified through special breeding processes or genetic engineering. As a result, specific features of a human disease can be evoked and examined in a targeted manner. Some mouse strains develop disease processes that are very similar to those in humans and can therefore be used for preclinical testing of novel therapies. For many questions, however, the clinical picture of humans is not mapped 1: 1, since it is more productive to examine in isolation specific components that are responsible for the resulting clinical picture. By specifically switching off individual genes in so-called knock-out mice, their influence on inflammation can be tested, for example. This helps to better understand the molecular causes of autoimmune diseases and thus to develop new, highly specific therapies.

Keeping and handling laboratory animals at the DRFZ - animal welfare and good research go hand in hand.

The mice at the DRFZ are kept in groups, separated by sex. The cages are bedded out with bedding. A red plastic house serves as a shelter. Due to the special color vision of the mouse, it is dark inside because it cannot perceive light in the red area. Conversely, however, zoo keepers and scientists have the opportunity to inspect the animals undisturbed and thus to check their well-being without disturbing the rest of the cage. In addition, nesting material made of cellulose and chewing sticks are provided in each cage to nibble on. The animals receive complete feed consisting of pellets and water at their disposal.
Strict guidelines are adhered to in order to protect the animals from external influences such as pathogens that could affect the health of the animals and planned experiments as well as possible. For this purpose, the animals are kept in individually ventilated cages (IVCs, individually ventilated cage systems) under so-called SPF (specified pathogen-free) conditions. In addition, the animal husbandry is equipped with personal sluices in which the zookeepers and scientists have to dress with special protective clothing made of autoclaved overalls, special hairnets, masks, gloves, socks and shoes. All introduced materials are sterilized or disinfected beforehand by autoclaving. In addition, the health status of the mice in the facility is determined at regular intervals in order to detect potentially pathogenic microorganisms at an early stage.
The handling of laboratory animals is also strictly regulated at the DRFZ. The DRFZ offers a training program carried out by veterinarians to train scientists to deal with animals and their experimental activities in accordance with current legislation and taking animal protection into account. This includes a theoretical and a practical part. Successful participation is certified with a certificate. Only after passing such a training course is a scientist allowed to handle an animal. In addition, for all employees who work with animals, regular training courses and advanced training courses on the protection of laboratory animals and the 3R principle are initiated and carried out by the veterinarians.

Keeping laboratory animals and animal experiments

Employees of the Max Delbrück Center (MDC) in Berlin give an insight into the living and keeping conditions of laboratory animals.

(Source: https://www.tierversuche-verhaben.de/filme/)

Severity of the attempts

An animal experiment is only legally permitted if the expected pain, suffering or damage to the animals is ethically justifiable with regard to the purpose of the experiment.

Therefore, the indispensability of a planned animal experiment must be checked and weighed against the expected exposure for each individual animal. The following principle applies: the higher the expected stress on the animals, the greater the scientific benefit must be.

In animal experiments, the associated, expected exposure to the animal is assessed very precisely and its ethical justifiability is weighed. The load is not determined by the scientist. Rather, the scientist provides a personal exposure assessment that is critically reviewed by the animal welfare officer and then submitted to the licensing authority. This then determines the final exposure of the animals for each experiment.

On the basis of Directive 2010/63 / EU of the European Parliament and of the Council of September 22, 2010 for the protection of animals used for scientific purposes, a distinction is made between the levels of exposure "low", "medium", "severe" and "no restoration of vital function" .

Care is taken to keep the stress on the individual animal as low as possible. However, it applies here that the degree of exposure for the overall test is based on the highest exposure to be expected for the individual animal. This means that even if other groups of animals are not exposed to any stress in an experiment (e.g. control animals), the entire experiment is still considered severely stressed if a single animal can experience this stress.

Source BFR

Definition of terms for the degree of exposure
  • "No restoration of vital function": This term is used for procedures that are carried out entirely under general anesthesia, from which the animal no longer wakes up, or the killing of animals for scientific purposes for subsequent organ removal (without prior treatment, intervention or manipulation). The latter makes up by far the largest part of the animals killed for experimental purposes and, although it is not considered animal experiments according to the Animal Welfare Act, it is included in the annual test animal report as the degree of stress “no restoration of vital function”.
  • "Low": Procedures which cause brief pain, suffering or damage in animals or which do not cause any significant impairment of the welfare or general condition of the animals are classified as "low".
  • "Medium": Procedures that cause short-term moderate pain, moderate suffering or damage or long-lasting low pain in the animals, as well as experiments that cause moderate impairment of the welfare or general condition of the animals are classified as "medium".
  • "Severe": Procedures which cause severe pain, severe suffering or fear or long-lasting, moderate pain, moderate suffering or harm in the animals, as well as procedures which cause severe impairment of the welfare or general condition of the animals are classified as "severe" classified.

Numbers and Statistics

  • In Germany, a total of 2,902,348 vertebrates were used for experimental purposes in 2019.

    Thus, the number of laboratory animals in Germany increased slightly in 2018 compared to the previous year (2018: 2,825,066 animals). The figures include 2,202,592 animals used in animal experiments and 699,756 animals killed for scientific purposes without prior animal experimentation.

    Rodents, especially mice and rats, made up by far the largest proportion with around 75% of all test animals. The number of fish used increased compared to the previous year with a proportion of 16% (2018: 9%), while the proportion of Rabbits (4%), cats and dogs (0.12%) remained almost unchanged. The proportion of monkeys and lemurs was 0.12%; great apes were last used in Germany for scientific purposes in 1991.

  • A total of 185,265 test animals were used in Berlin in 2019, 16.7% fewer than in the previous year.
    Berlin has long been known as the “capital of animal experiments”. The high number of experimental animals can, however, be explained by the high density of research facilities.

Animal welfare at the DRFZ

Animal experiments are necessary to understand biological principles and to develop new therapeutic approaches for humans. However, the scientists are obliged to replace animal experiments with alternatives as far as possible and to work towards the development of further alternative methods.

  • In 2010 there was an amendment to the “Directive of the European Parliament and of the Council for the Protection of Animals Used for Scientific Purposes” (2010/63 / EU), with the aim of standardizing the sometimes widely divergent regulations of the individual EU member states.
  • Animal experiments are regulated in Germany by the Animal Welfare Act and the Animal Welfare Laboratory Animal Ordinance, whereby Germany has one of the strictest animal welfare laws in the world. In 2002, animal welfare was even included as a state goal in the Basic Law (Article 20a).
  • Every animal experiment must first be approved by the competent authority, and the scientific benefit must be justified.
  • In addition to extensive literature research, the application process also includes biometric, i.e. mathematical, planning of the number of animals to be used, so that this is limited.
  • Animal experiments may only be carried out by specially trained and trained persons. They are subject to constant control by the animal welfare officer and the competent authority.
  • Every animal experiment is recorded and the number of animals used is reported annually to the competent authority.

Talking about animal experiments

"What if there was no more animal testing?" They exist, the people who are open to the fact that there are good reasons for doing animal experiments. On November 5, 2019, they faced the public's questions in Berlin's Urania, thus objectifying what was sometimes an emotional debate.

Why are animal experiments still being carried out when there are so many alternative methods today? How are the animals? And to whom are such experiments actually useful? There is great public interest in these questions, but at the same time many myths about animal experiments are still circulating. In this situation, first-hand information is required, but also open discussion on an equal footing.

For this reason, the Berlin animal welfare officer organized a joint event for the first time as part of the Berlin Science Week together with major biomedical research institutions in the city. The invitation to the theme evening with the title “Animal experiments in conversation - absolutely necessary or long outdated?” At Urania Berlin was followed by around 250 interested parties, including schoolchildren and teachers.

Trustful audience
At the beginning of the evening, the moderator of the evening, the Berlin science journalist Lilo Berg, asked about attitudes towards animal experiments. Only a dozen guests pleaded for such attempts to be abolished altogether. About a third saw a benefit in principle, but said that there were too many animal experiments. Around two thirds raised their hands with the option "I trust the scientists that they only use animal experiments if there is no other way".

The next question and answer session also dealt with the popular topic of animal testing and cosmetics. In the public discussion there are always errors, as on this evening.Some were of the opinion that the permit for testing in animal experiments depends on the type of cosmetic product, or that cosmetics tested on animals abroad may be imported into the EU. Cosmetics that have been tested on animals have not been allowed to be sold in the EU for several years - even if they come from abroad.

Animal experiments in conversation - audience survey

© Jacqueline Hirscher

Interview with animal experiments - Prof. Anja Hauser

© Jacqueline Hirscher

Animal experiments in conversation - Lilo Berg and Dr. Fabienne Ferrara

© Jacqueline Hirscher

Animal experiments in conversation - panel discussion

© Jacqueline Hirscher

Animal experiments for veterinary medicine
Little is known in the public that animal training is considered an animal experiment, said Professor Christa Thöne-Reineke from the Free University of Berlin. The veterinarian specializing in laboratory animal science trains veterinary and animal care personnel there, among other things.

It is based on the internationally valid 3R principle for experiments on living animals. The three “Rs” stand for the development of experiments that are gentler on the animal (refinement), for the reduction of experiments (Reduction) and for the replacement of animal experiments (Replacement). Christa Thöne-Reineke is also involved in the graduate college of the Berlin-Brandenburg research platform BB3R, which is located at the Free University of Berlin - the first graduate college on alternatives in animal experimentation worldwide - and a cooperation partner in the network of Charité 3R, an initiative founded in 2018 to anchor the good idea of 3R in research and practice. The professor already uses a number of alternative methods in her courses, including online tutorials, models and simulators. Thöne-Reineke said: "As long as the legislature classifies animal training as animal experimentation, we cannot do without animal experiments in veterinary medicine training."

Research the basics - also on animals
Professor Anja Hauser, veterinarian and immunologist at the German Rheumatism Research Center and the Charité, explained why animal experiments are currently indispensable for basic research and clinical research. Thomas Kammertöns, immunologist at the Max Delbrück Center for Molecular Medicine and at the Charité.

Experiments in cell cultures or on organoids are suitable for gaining initial knowledge, said both researchers. The complex processes in the immune system, in which a large number of cell types in different organs interact, can only be observed in the whole organism. Anja Hauser described how research on mouse models has led to a new type of drug that helps some people with multiple sclerosis. And Thomas Kammertöns is currently using mouse experiments to develop a new type of cancer therapy that stimulates the body's immune system to fight tumor cells.

Faster to alternatives
Robert Landsiedel is developing alternative methods to replace animal experiments in the legally required “compulsory experiments”. The chemist and toxicologist works with his large team at the Ludwigshafen chemical company BASF.
Currently, it often takes up to ten years for an alternative method to be recognized by the authorities as a suitable replacement. "With the current approach, more than a hundred years will pass before all regulatory animal experiments for toxicological testing of chemicals can be replaced," said Landsiedel. He suggested simplifying the recognition of alternative methods and setting priorities for the future development of alternative methods.

The lively discussion focused on alternative methods to animal experiments and questions about keeping laboratory animals. When the audience asked "What happens when an animal experiment is approved - does fire-free then apply?", The experts on the podium described the strictly regulated and meticulously documented procedure in which precise records must be kept for each individual animal. “And what if no more animal experiments were allowed to be carried out overnight?” Asked another guest. Then there would be no more new drugs or chemical substances, it was said from the podium, because animal experiments are required by law and still make sense. After the official end of the event, the discussion continued over pretzels and beer - all about the well-attended information booths of the working group of the Berlin animal welfare officers.

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In many cases, animal experiments are still indispensable in basic research. Scientists use the experiments to study complex biological processes in animals in order to better understand the human organism and how it works. Animal experiments also play a decisive role in medicine, for example in the development of new drugs and therapeutic methods. Nonetheless, opponents of animal experimentation criticize that scientists should switch to existing alternative methods. They demand the abolition of experiments. Are animal experiments really necessary for research? And is it even allowed to let other animals suffer for their interests? In this debate, well-known experts who have to do with animal experiments in different contexts have their say. Because they use animal experiments in their research themselves, because they consider animal experiments too replaceable, or because they address the ethical dilemma that animal experiments pose to us. The debate is intended to contribute to a well-founded and objective discussion about animal experiments and to make the various arguments transparent.