- End of drug safety trials in rabbits
Certain specific safety tests for medications will no longer be permitted to be conducted on rabbits in the future, but will instead be carried out using animal-free alternatives. The rabbit tests used to detect fever-inducing substances will largely be removed from European drug testing regulations by July 1, 2025, according to the Paul-Ehrlich-Institut (PEI), the Federal Institute for Vaccines and Biomedical Drugs.
These are known as rabbit pyrogent tests. Pyrogens are fever-inducing factors - 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.
Until a few years ago, tens of thousands of these tests were carried out on rabbits across the EU each year. As other testing methods became more prevalent, the number of rabbits used for these tests decreased. "In fact, the rabbit pyrogent test has been almost abolished for some time," the PEI explained for Germany. However, rabbits are still used as test animals in other areas, such as antibody production or cancer research. 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 pyrogent tests. However, newer tests now function without animals or materials of animal origin, the PEI explained. One such test, the monocyte activation test, involves mixing the drug to be tested with human blood. Another, the recombinant factor C test, uses an enzyme derived from horseshoe crabs, which is now produced in the lab.
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 can be used in their production. The Pharmacopoeia Commission, which includes the PEI and the Federal Institute for Drugs and Medical Devices (BfArM), is responsible for this.
Communication from the PEI Understanding animal experiments: History of the pyrogent test EDQM statement on the end of tests, English Bf3R: Current animal experiment numbers EU directive "Protection of experimental animals" EU database on animal experiments
The shift towards animal-free alternatives is also pertinent in the realm of [Health and safety], as the use of animal-free tests for detecting pyrogens will become more common. The [European Pharmacopoeia], published in Strasbourg, will likely incorporate these new testing methods to maintain the quality and safety of medicines.
