Written Answers - Medicinal Products

Tuesday, 3 July 2012

Dáil Éireann Debate
Vol. 771 No. 1

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 604.  Deputy Maureen O’Sullivan Information on Maureen O'Sullivan Zoom on Maureen O'Sullivan  asked the Minister for Health Information on James Reilly Zoom on James Reilly  if he will publish all of the Irish Medicines Board's advice to him regarding the replacement non-animal cell-based test for botulinum neurotoxins; and if he will make a statement on the matter. [31895/12]

 605.  Deputy Maureen O’Sullivan Information on Maureen O'Sullivan Zoom on Maureen O'Sullivan  asked the Minister for Health Information on James Reilly Zoom on James Reilly  if and when Allergan’s authorities will carry out animal-based LD50 assays for testing botulinum neurotoxins were amended and withdrawn following confirmation that this represented an alternative to the LD50 assays; and if he will make a statement on the matter. [31896/12]

 606.  Deputy Maureen O’Sullivan Information on Maureen O'Sullivan Zoom on Maureen O'Sullivan  asked the Minister for Health Information on James Reilly Zoom on James Reilly  the proportion of animal-based LD50 assays for testing of botulinum neurotoxin in Ireland that have ceased as a result of Allergan’s switch to a non-animal replacement; and if there were any withdrawal of authorities; and if he will make a statement on the matter. [31897/12]

 607. Deputy Maureen O’Sullivan Information on Maureen O'Sullivan Zoom on Maureen O'Sullivan  asked the Minister for Health Information on James Reilly Zoom on James Reilly  if he has explored the possibility of Allergan making their non-animal botulinum neurotoxin test available to companies who continue to perform the animal-based test in Ireland, through licensing of the technology, for example; and the response he has received from other companies still carrying out animal botulinum neurotoxin LD50 tests to his Department’s encouragement to develop similar models; and if he will make a statement on the matter. [31898/12]

Minister for Health (Deputy James Reilly): Information on James Reilly Zoom on James Reilly I propose to take Questions Nos. 604 to 607, inclusive, together.

A new non-animal cell based test method has been approved by the Irish Medicines Board (IMB) for the testing of Botox. As the Deputy will be aware, this new marketing variation sought by Allergan will enable that company to replace the existing animal based test method with a non-animal method. I welcome this development.

The Deputy also asks if and when Allergan’s authorities to carry out animal-based LD50 assays for testing botulinum neurotoxins were amended and withdrawn following confirmation that the non-animal test represented an alternative to the LD50 assays. In this regard, I should point out that the company involved is not a establishment registered under the existing legislation for the performance of scientific experiments on animals. I have no doubt, however, that Allergan will look to have this new non-animal test method with regard to botox testing widely used given the considerable investment involved in the development of the test.

A reduction of LD50 animal testing assay should initially become evident on the publication of the 2012 statistics. It should be noted that 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. On the matter as to whether Allergan could make their non-animal botulinum neurotoxin test available to companies who continue to perform the animal-based test in Ireland, the IMB has advised my Department 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 documentation. It is open to companies in this area to approach Allergan in this regard but I do not consider that it would appropriate for me, as Minister for Health, to intervene in this matter. We have informed other companies in this area, however, that such a test exists and encouraged them to develop other similar models.


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