Drug trials on rabbits banned
In the future, certain drug safety tests will no longer require the use of rabbits. There are now enough animal-free alternatives, it is said. However, rabbits can still be used as test animals for other purposes.
Certain drug safety tests will no longer be conducted on rabbits, but rather through animal-free alternatives. The rabbit tests for detecting fever-inducing substances will be largely removed from the European guidelines for drug testing by July 1, 2025, according to the Paul-Ehrlich-Institut (PEI), the federal institute for vaccines and biomedicines. These are known as rabbit pyrogen tests. Pyrogens are factors that cause fever, mainly bacteria, but also viruses, parasites, or chemicals. Because such fever can sometimes be life-threatening, tests for pyrogens are prescribed in the European Pharmacopoeia. Traditionally, the substance to be tested is injected into the blood vessels of rabbits to observe if they develop a higher body temperature. This allowed impurities in medicines to be detected early.
In recent years, tens of thousands of these tests were performed on rabbits across the EU annually. As other testing methods became available, the number of test rabbits decreased. "In fact, the rabbit pyrogen test has been virtually abolished," the PEI explained for Germany. However, rabbits are still used as test animals in other areas, such as antibody production or cancer research.
Animal-free tests developed
An EU database recorded over 65,000 rabbit tests in Germany in 2022. Initially, a test based on the blood of horseshoe crabs was developed as a replacement for the rabbit pyrogen tests. More recent tests, however, function without animals or materials of animal origin, the PEI explained. In one of these tests, the monocytic activation test, the drug to be tested is mixed with human blood. The so-called recombinant factor C test, on the other hand, uses an enzyme derived from horseshoe crabs, which is now produced in the laboratory.
The European Pharmacopoeia for the quality of medicines is published in Strasbourg. It contains the rules for the quality, testing, storage, dispensing, and labeling of medicines, as well as which substances may be used in their production. Responsible for this is the Pharmacopoeia Commission, in which the PEI and the Federal Institute for Drugs and Medical Devices are also represented.
Although rabbit pyrogen tests for drug safety will be largely phased out by 2025, animal testing in other areas, such as antibody production and cancer research, continues to be necessary. With the development of animal-free alternatives, the number of rabbits used for pyrogen tests has significantly decreased, with tests like the monocytic activation test and the recombinant factor C test now replacing the traditional rabbit pyrogen tests.
