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Legal Matters, Guidelines & Figures

​​​Information on laws, regulations and guidelines, the 3R principle and laboratory animal statistics from the federal and state governments and Leipzig University Medicine.​

Legal Basis

​​In Germany, the Animal Welfare Act (Tierschutzgesetz - TierSchG) and the Laboratory Animal Welfare Ordinance​​ (Tierschutz-Versuchstierverordnung - TierSchVersV) form the legal framework for animal experiments. This legal framework stipulates that animal experiments may only be carried out if no non-anim​al alternatives are available to answer the specific scientific question (Section 7a (2) no. 2 TierSchG) and certain other requirements are met. Every animal experiment must first be applied for at the competent authority of the respective federal state and undergoes an extensive approval process; in Saxony, the competent authority is the State Directorate of Saxony (Landesdirektion Sachsen), Department 25.

Section 1 of the Animal Welfare Act expressly states the purpose of the law, which is to protect the life and well-being of animals based on the responsibility of humans as fellow creatures (Section 1 TierSchG). This means that no human being may inflict pain, suffering or harm on an animal without reasonable cause. Since 2002, animal protection (Article 20a of the Basic Law - Grundgesetz) - like the freedom of research and teaching (Article 5 of the Basic Law) before it - has also been enshrined in the Basic Law and thus has constitutional status.​

In order to do justice to this contradiction, laws and ordinances precisely regulate the work of university animal facilities. These include both national and European requirements, such as the.

  • Directive 2010/63/EU (EU Laboratory Animals Directive)
  • Animal Welfare Act (TierSchG)
  • Laboratory Animal Welfare Ordinance​ (TierSchVersV)
  • Laboratory Animal Reporting Ordinance (VersTierMeldV)
  • Veterinary Medicinal Products Act (Tierarzneimittelgesetz - ​TAMG)
  • Genetic Engineering Act (Gentechnikgesetz​ - GenTG)
  • Animal Welfare Transport Ordinance (Tierschutztransportverordnung - T​ierSchTrV)
  • Animal Welfare Livestock Farming Ordinance (Tierschutznutztierhaltungsverordnung - TierSchNutztV)

The legal regulations govern many areas of animal handling within narrow limits and must be observed by all persons who handle the animals. It goes without saying that the Central Animal Husbandry of the University M​​edical Center is officially approved (Section 11 TierSchG in conjunction with Section 11 TierSchVersV) and is regularly inspected by the supervisory authority, the State Directorate of Saxony.

Expertise and Requirements

In order to be allowed to carry out an animal experiment at all, scientists must first acquire the necessary expertise. The Central Animal Husbandry offers the relevant courses for this purpose. Even more extensive requirements apply to the management of animal experiments, which must have at least three years of experience in addition to expertise. The competent and experienced scientists must first submit an application for approval of their planned animal experiment project to the responsible authority, in our case the State Directorate of Saxony (Landesdirektion Sachsen), Department 25. They are advised and supported in all matters by the animal welfare officers, the members of the animal welfare committee and the veterinary staff to ensure that the experimental project is carried out with as little stress as possible for the animals. The so-called 3R principle is consistently applied.

Replacement - replacement of animal experiments

Before submitting an application for an experimental project, it must be checked whether the desired results can also be achieved without live animals. Replacement methods include, for example, cultures of cells or tissues or computer simulations. Leipzig University is actively researching such alternative methods and is committed to their application and promotion. Only if the results cannot be achieved using alternative methods, and only then, may an application be submitted to the approval authority.

Reduce - reduction in the number of animals used in animal experiments

Only as many animals may be used in an experimental project as are absolutely necessary to achieve the experimental objective. Through comprehensive experimental planning and a clever approach, also with the help of specialist literature, it is possible to reduce the number of animals used in animal experiments to the necessary level. Statistical programs help scientists to calculate how many animals are required for a statistically sound evaluation of the test results.

Refinement - improving the methods used

New findings on improved methods, e.g. in handling, husbandry conditions or treatments in the experiment, are consistently implemented. As a result, the necessary tests are carried out with the least possible stress for the animals. The comprehensive education and training of all those involved, as well as regular further training, also leads to more animal-friendly procedures.​

In this video you will find further explanations of the important 3R principle (in German, automatic captions​ available):

 


Applications to carry out an experimental project are sent to the approval authority for processing after being checked by the animal welfare officers. The subject specialists review the applications and submit all applicatio​ns to the Animal Welfare Commission for consultation in accordance with Section 15 TierSchG. Improvements or amendments are often suggested by the authority or the Animal Welfare Commission, which the applicant incorporates into the test application. Only when all ambiguities or suggestions for improv​ement have been integrated into t​he experimental application is the application approved by the licensing authority and the scientific working group may begin to carry out the experimental project.

An excellent overview of all the steps and requirements involved in the application process can be found on the website​ of "Tierversuche verstehen, eine Informationsinitiative der Wissenschaft" ("Understanding animal testing, a science information initiative", in German).​​​

Data and Figures

In Germany as a whole, 2.437.794​ laboratory animals were used in 2022 and 2.503.682 in 2021. You can always find the latest figures on the website of the German Federal Institute for Risk Assessment. A detailed overview of the numbers of laboratory animals used in 2022, also broken down by federal state, can be found in the Animal Experiments Compass 2024 ​​(Kompass Tierversuche 2024) of the "Understanding animal experiments" initiative (Initiative „Tierversuche verstehen“​). Corresponding publications for previous years can also be found on this website.

T
he charts provide an overview of the laboratory animals used at Leipzig University Medicine in the past year. The figures are always available as of March 31 for the previous year.

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Liebigstraße, various locations
04103 Leipzig
Email:
mb-mez@medizin.uni-leipzig.de
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