165,000 signatures against botox animal testing
Meeting with the European Medicines Agency (EMA) in Amsterdam
Tens of thousands of mice are still being cruelly suffocated to death to test botulinum toxin products – better known under the brand name "Botox" – despite the existence of animal-free testing methods for over 12 years. The European Coalition to End Animal Experiments (ECEAE) is calling for the removal of the mouse test from the European Pharmacopoeia. Today in Amsterdam, the ECEAE handed over 164,770 signatures collected across Europe to the European Medicines Agency (EMA), after the responsible authority, the EDQM, had previously refused to accept them.
The neurotoxin botulinum toxin is best known for its cosmetic use, such as smoothing facial wrinkles. However, it is also used for medical purposes, for example to treat eyelid spasms or torticollis (twisted neck). Regardless of its intended use, each individual production batch must be tested before being released for sale. This is typically done using the so-called LD50 test on mice. Groups of mice are injected with various dilutions of the substance into their abdominal cavities to determine the dose at which 50% of them die (LD50 = lethal dose 50 percent). The toxin causes paralysis of the respiratory muscles, often leading to a prolonged and agonizing death by suffocation.
The test is mandated in the European Pharmacopoeia, but the guidelines also allow the use of animal-free testing methods. The three major manufacturers – Allergan, Merz, and Ipsen – have received regulatory approval for their own non-animal test methods since 2011 and now largely refrain from animal testing. Nevertheless, tens of thousands of mice still suffer and die each year in Europe alone for Botox products. In Germany, 22,440 mice were approved for Botox testing in 2021. In Ireland, which is a major center for Botox testing, more than 100,000 mice were used in 2020.
The European Coalition to End Animal Experiments (ECEAE), of which Doctors Against Animal Experiments (DAAE) is an active member, has been running a Europe-wide campaign against these cruel tests since 2009 and has achieved some successes in convincing major manufacturers to switch to animal-free methods. The ECEAE is calling for the LD50 test to be removed from the European Pharmacopoeia. However, the responsible authority – the European Directorate for the Quality of Medicines (EDQM) – refused to accept the collected signatures.
Today, a three-member ECEAE delegation met with representatives of the EMA in Amsterdam and handed over the nearly 165,000 statements of support. The EMA works closely with the EDQM and is expected to use its influence to push for the removal of the mouse test from the regulatory framework.
"The four-member EMA delegation was receptive to our concerns and announced that it would address the issue in a timely manner," summarized Dr Corina Gericke, Vice Chair of Doctors Against Animal Experiments.
From left: Emeline Gougeon (Pro Anima), Jenn Scannell (Irish Anti Vivisection Society) and Dr Corina Gericke (Doctors Against Animal Experiments) in front of the EMA in Amsterdam.