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Irish Examiner - 5th September 2012

A new method of testing Botox has been licensed here but the controversial animal poison test it will replace may not be phased out.
This is despite EU regulations which say an experiment shall not be performed on animals if a non-animal alternative “is reasonably and practically available”.
Pharmaceutical and medical device giant Allergan has been licensed by the Irish Medicines Board (IMB) for its new non-animal cellbased method for the testing of Botox. The test will replace the standard animal based LD50 method of test- ing botulinum neurotoxins.
The contentious LD50 test aims to determine the lethal dose of a toxin that kills exactly half of the animals used in an experiment.
It has been routinely criticised by animal welfare groups.
A subsection of the EC Cruelty to Animals Act, states that “an experiment shall not be performed if another scientifically satisfactory method of obtaining the result sought, not entailing the use of an animal, is reasonably and practically available”.
However, despite Allergan having developed such a non-animal alternative, James Reilly, the health minister, said his department would not be withdrawing the license to carry out the test from other companies as Allergan’s new method was confidential and the intellectual property of the company.
“The IMB advised us that the data submitted by the applicant is confidential and that if another company proposed a similar change, it would need to submit its own variation application with supporting data.
“As the new non-animal cell-based test method is not available to other companies, the issue of withdrawing current licences involving LD50 tests does not arise. We have informed other companies in this area, however, that such a test exists and en- couraged them to develop other similar models.”
For its part, Allergan said its new test was specific to its products and did not extend to other products by other manufacturers. It did not rule out the possibility of licensing the method.
In a statement, it said: “Allergan has communicated that we are willing to discuss licensing the technology to other companies that share our commitment to implementing non-animal alternative to the manufacture of botulinum toxin products.
“It’s worth noting that the manufacturers of other botulinum toxin products would need to conduct their own validity tests as the botulinum toxins are not interchangeable.”
Dr Dan Lyons, policy consultant with the Irish Anti-Vivisection Society, said the Government had to ensure the new non-animal alternative was shared across all companies in Ireland using what he called the “cruel and barbaric” LD50 test.
“In all likelihood, the new Allergan non-animal botox test is easily applicable to other companies similar products. The Government’s failure to ensure this technology is shared appears to breach European and Irish laws,” he said.

- Conall Ó Fátharta

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