The European Directorate for the Quality of Medicines & HealthCare (EDQM) has announced the suppression of a widely-used test in rabbits from the quality standards of the European Pharmacopoeia.
Since 1971, manufacturers of injectable medicines in Europe have used the test on rabbits to check if their medicines (for example, vaccines) contained contaminants that caused a fever ("pyrogens"). The medicine was injected into the rabbits and if they developed a fever, the contaminants were considered to be present. The same rabbits were used repeatedly for the test, causing suffering and, eventually, the death of the animal. The decision to stop using the test therefore marks a significant milestone for animal welfare, potentially influencing global practices for a test reported to consume approximately 25 000 rabbits in Europe and 400 000 rabbits worldwide annually.
This landmark decision aligns with the Council of Europe's European Convention for the Protection of Vertebrate Animals used for Experimental and other Scientific Purposes (ETS No. 123), reflecting the EDQM's strong commitment to reducing animal testing wherever possible in medicine quality control. It also promotes the adoption of more reliable and humane in vitro (laboratory-based) testing methods to replace this animal test.
See also:
- Ph. Eur. bids adieu to rabbit pyrogen test in its monographs
- The Council of Europe / EDQM and alternatives to animal testing
