Maureen O'Sullivan (Dublin Central, Independent)
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Question 822: To ask the Minister for Health if he amended or withdrew relevant licences to prohibit the animal LD50 assays for testing of botulinum neurotoxins, potency and stability determinations for which the new non-animal cell based test method has been approved by the Irish Medicines Board as a replacement; the date such prohibitions came into force, as required by Section 2 (2)(b) of S1555 (2002); and if he will make a statement on the matter. [26514/12]

James Reilly (Dublin North, Fine Gael)
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I take it that the Deputy is referring to Section 2(2)(b) of the Cruelty to Animals Act, 1876 which was inserted by Regulation 2(c) of the European Communities (Amendment of Cruelty to Animals Act 1876) Regulations 2002 (S.I. No. 566 of 2002). This sub-section 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 practicably available"

As you will be aware a new non-animal cell based test method has been approved by the Irish Medicines Board (IMB) for the testing of Botox. 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 encouraged them to develop other similar models.