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Rabbit pyrogen test to be eliminated from EU medicines rule book

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Cell-based methods will completely replace the cruel rabbit test within next five years

Welcome moves to eliminate the rabbit pyrogen test from the European Union’s ‘rulebook’ for medicine safety – the European Pharmacopeia (Ph. Eur.) have recently been announced.

The cruel rabbit pyrogen test is one of ten animal experiments on our RAT (Replace Animal Tests) list which we have been highlighting as easily replaceable. We are working to encourage regulators to remove these ten tests – and save three quarters of a million animals every year in Europe alone.

The pyrogen rabbit test is used to check if batches of injectable medicines or medical devices are inadvertently contaminated, measured by whether a fever response is triggered. Rabbits are restrained in boxes with temperature probes inserted deep into their rectums for hours at a time as the substance is injected into a vein in the ear. Rabbits typically undergo repeated injections until their ears become too damaged to be used again, or they experience a reaction - in which case they are killed.

This test should not be happening.  There are cell-based methods such as the monocyte activation test (MAT), which can be used instead.

According to a recent press release by the European Directive for the Quality of Medicines and Healthcare (EDQM), the rabbit test continues to be conducted in the EU, despite multiple efforts to encourage developers to use the MAT, which was first published in the Ph. Eur. in 2009.  

New figures from the EU show that 30,453 rabbit pyrogen tests were indeed conducted in 2018, with 81% of use of rabbits for pyrogen testing taking place in France, Spain and Germany.

Over the next five years, the rabbit test will be deleted and replaced with cell-based methods in 59 texts of the Ph. Eur. covering a range of medical products including vaccines, blood products and antibiotics. It is hoped that this move will ultimately lead to the complete replacement and elimination of this cruel test in the EU.

Our Director of Science, Dr Katy Taylor said: “We are delighted that steps are being taken to eliminate the rabbit pyrogen test in the EU once and for all. It is unacceptable that tens of thousands of rabbits continue to suffer in these cruel and unnecessary tests when a non-animal alternative is available.