The BUAV has welcomed an announcement by the European Medicines Agency (EMA) of its ‘work plan on the application of the 3Rs (replacement, reduction and refinement) in regulatory testing of medicinal products.’
The Agency has recently created an expert group to look into ways to reduce redundant animal tests and do more to promote alternative approaches - part of its role in “eliminating repetitious and unnecessary animal testing in the European Economic Area.” The move comes after years of campaigning by the BUAV for the agency to be more active in trying to reduce the animal testing of medicines.
The BUAV has especially welcomed that, as a priority, the Agency will look at potentially redundant requirements to routinely test injectable drugs on rabbits and/or mice. A BUAV investigation at Wickham Laboratories found that rabbit pyrogen and mouse abnormal toxicity tests were still being conducted for drugs that international regulations no longer required. The rabbit test involves restraining rabbits in ‘stocks’ by their necks, injecting the substance in their ear vein and taking their temperature over several hours via a probe inserted deep into their rectums. It has largely been replaced by an alternative test not involving live animals.
As a consequence of the investigation, the BUAV has called on regulatory authorities to take action to remove redundant requirements from their authorisation for medicines. The UK’s Veterinary Medicine’s Directorate was the first to respond and in July 2011 announced that authorisations for 26 products needed to be updated to remove the redundant animal tests, thereby saving an estimated 38,000 animals. The BUAV is hopeful that the EMA review, scheduled to be completed by the end of 2012, will be equally successful.
The BUAV’s Senior Science Advisor, Dr Katy Taylor states; “We are pleased that the European Medicines Agency is finally taking action on animal testing. Regulatory bodies play a critical role in providing guidance on testing to industry. We are, therefore, delighted that many of the recommendations made by the BUAV to tackle this important issue have been accepted. We look forward to seeing results that we hope will have a positive impact on animals in laboratories.”