The BUAV, as Secretariat of the International Council on Animal Protection in Pharmaceutical Programs (ICAPPP), has welcomed news that the European Medicines Agency (EMA) has deleted its guideline requiring new drugs to be tested on two species of animals for acute toxicity. Following lobbying by ICAPPP, the EMA has withdrawn its 1987 guideline and replaced it with a Question and Answer paper that explains how pharmaceutical companies can avoid these short-term but severe animal tests.
Animals are subjected to a battery of tests before a new drug goes into a human clinical trial. One of these tests has traditionally been the ‘acute’ or ‘single-dose’ toxicity test, designed to see what happens when a very large dose of a drug is taken (as with accidental overdoses). It is a particularly inhumane test, involving force-feeding or injecting high levels of potentially harmful substances into rats, mice or other animals and observing them for signs of toxicity which could include diarrhoea, weight loss, convulsions, and ultimately death – without any pain relief. In a conservative estimate, since 2003, approximately 340,000 animals may have suffered and died in such tests in Europe alone.
Dr Katy Taylor of the BUAV, the secretariat of ICAPPP states:
“We are relieved to see the acute toxicity guideline finally removed from the EMA website. We estimate that approximately 340,000 animals have been used in exceptionally painful tests that have been completely redundant. Harmonisation of guidance and the acknowledgement that these tests are not required by regulatory agencies is an issue that ICAPPP has been lobbying on for some time so we are pleased that the EMA has now acted“.
ICAPPP is an international coalition of animal protection groups with a combined supporter base of over 30 million people throughout Europe, Asia and North America. Its aim is to ensure the widest possible integration of alternative methods (replacements, reductions and refinements) in regulatory frameworks for therapeutic products, in the interests of animal protection, public health and sound science.
Current member organisations are: