The European Directorate for the Quality of Medicines & HealthCare (EDQM) has recently made a groundbreaking announcement regarding the suppression of a widely-used test in rabbits from the quality standards of the European Pharmacopoeia. This decision marks a significant milestone for animal welfare and has the potential to influence global practices in the pharmaceutical industry.
For nearly five decades, manufacturers of injectable medicines in Europe have relied on a test using rabbits to detect the presence of contaminants known as pyrogens in their products. Pyrogens are substances that can cause fever when introduced into the body, making them a critical concern for the safety and efficacy of injectable medications, such as vaccines. The test involved injecting the medicine into rabbits and monitoring their body temperature for signs of fever. If the rabbits developed a fever, it was an indication that the medicine contained pyrogens.
However, the use of rabbits in this test has long been a subject of ethical debate due to the suffering and eventual death inflicted on the animals. The same rabbits were often used repeatedly for the test, leading to unnecessary harm and distress. The decision to discontinue this test reflects a growing awareness of the importance of animal welfare in scientific research and a commitment to reducing the use of animals in testing procedures.
The EDQM’s decision is in line with the Council of Europe’s European Convention for the Protection of Vertebrate Animals used for Experimental and other Scientific Purposes (ETS No. 123), which emphasizes the need to minimize the use of animals in scientific experiments. By phasing out the rabbit pyrogen test, the EDQM is demonstrating its dedication to upholding these principles and promoting the adoption of more reliable and humane alternatives.
In addition to its ethical implications, the suppression of the rabbit pyrogen test also has practical implications for the pharmaceutical industry. With an estimated 25,000 rabbits used for this test in Europe and 400,000 rabbits used worldwide annually, the transition to alternative testing methods represents a significant shift in testing practices. The development of in vitro (laboratory-based) testing methods offers a more efficient and cost-effective approach to ensuring the quality and safety of injectable medicines, without the need for animal testing.
Overall, the EDQM’s decision to eliminate the rabbit pyrogen test from the European Pharmacopoeia is a positive step towards advancing animal welfare and promoting the use of more humane and effective testing methods in the pharmaceutical industry. This landmark decision sets a precedent for other regulatory bodies and pharmaceutical companies to prioritize animal welfare and embrace innovative alternatives to animal testing in medicine quality control.
