Abstract
There have been significant developments in the use of animals to test Botulinum toxin products in Europe in recent years. This paper summarises and discusses these from the perspective of the animal protection organisation. A cell-based assay has been validated by Allergan and is now being used for the replacement of the mouse bioassay for the batch testing of their Botulinum toxin A products. Two further companies (Merz and Ipsen) have recently validated similar cell-based assays to replace animals in their batch testing. However, the number of animals being used in batch tests across Europe remains at record levels; an estimated 400,000 animals per year, based on official statistics and non-technical summaries. There are concerns from animal protection organisations about the authorisation of animal testing for Botulinum toxin products that are to be used for aesthetic purposes. Furthermore, should testing for companies that have not yet implemented the alternative method continue to be permitted under the EU Directive 2010/63 on the use of animals for scientific purposes? Whilst we are on the cusp of an era where the mouse bioassay has been replaced for the potency testing of Botulinum toxin A for injection, it is important that Europe sees a reduction of animal testing in real terms.
Highlights
Botulinum toxin (Bt) via injection has been used therapeutically for a variety of medical and cosmetic purposes for approximately 30 years.The use of animals to test batches of Bt has been a concern to animal protection groups and others since the early 2000s when the use of Bt for aesthetic purposes began to dramatically increase worldwide
The tests are of concern for a number of reasons: a) the severity of the suffering experienced by the animals, b) the high numbers of animals used on an annual basis, c) the trivial purpose for which these products are often used, and d) the delay in implementing a complete replacement of the animal test for all Bt products
As we discuss here, the general public would describe the use of these products for aesthetic purposes as “cosmetic” and even the General Medical Council of the UK1 refer to the use of Bt for aesthetic purposes as a “cosmetic” procedure
Summary
Botulinum toxin (Bt) via injection has been used therapeutically for a variety of medical and cosmetic (hereafter “aesthetic”) purposes for approximately 30 years (see Bottril, 2003). The use of animals to test batches of Bt has been a concern to animal protection groups and others since the early 2000s when the use of Bt for aesthetic purposes began to dramatically increase worldwide. The European Coalition to End Animal Experiments (ECEAE) has had a long running campaign against animal testing for Bt products and has been in regular contact with the manufacturers and regulatory authorities. In this article we summarise the progress with the implementation of alternatives to the animal test for batch testing Bt products and highlight some of the ongoing issues. Our evidence is drawn from official statistical reports, company reports, non-technical summaries of animal experiments published by member states, investigation reports, legal cases, and correspondence with the manufacturers
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