Development of alternatives to animal testing of medicinal products containing Botulinum neurotoxin
Expert meeting on the development of alternative methods
Before medicinal products containing Botulinum neurotoxin (BoNT) can be marketed, animal experiments in mice are carried out to test the activity of the toxin. Given the high toxicity of the BoNT, this activity determination is required for all batches of the relevant medicinal products. These experiments serve the purpose of patient safety and are required by the pharmacopoeia. The animals die from respiratory paralysis in the course of the experiments.
On 12 May 2011, representatives of the Federal Ministry of Food, Agriculture and Consumer Protection (BMELV), the Federal Ministry of Education and Research (BMBF) and the Federal Ministry of Health (BMG) as well as experts of the Federal Institute for Risk Assessment (BfR), the Federal Institute for Drugs and Medical Devices (BfArM) and the Paul-Ehrlich-Institut – Federal Agency for Sera and Vaccines (PEI) met to develop a common strategy to replace this animal testing with alternative methods.
Uses of BoNT
Medicinal products containing Botulinum neurotoxin (BoNT) are, for instance, used for the symptomatic treatment of lid spasms, but also in the case of spasticity of the upper extremities following heart attacks in adults. In addition, the neurotoxin is also used for the purpose of smoothing out wrinkles in "aesthetic medicine".
It is the common aim of the federal ministries to replace this harmful testing with alternative methods without jeopardising the safety of patients. In this context, the Centre for Alternative Methods to Animal Experiments (ZEBET) within the Federal Institute for Risk Assessment (BfR) established an expert panel in 2009 to look into this matter from a scientific point of view. Further information can be found at http://www.bfr.bund.de.
The Federal Government is actively involved in various measures to both reduce and replace animal testing with alternative methods. Since 1980, the Federal Ministry of Education and Research has funded research projects in the field of "Alternative methods to replace experiments on animals" with more than 120 million €. The Animal Welfare Research Prize awarded by the Federal Ministry of Food, Agriculture and Consumer Protection (BMELV) and the ministry's financial support of the "Foundation for the support of research into alternative methods to animal experiments" are examples for further initiatives.