Written answers
Tuesday, 10 June 2025
Department of Health
Medicinal Products
Pádraig Rice (Cork South-Central, Social Democrats)
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1481. To ask the Minister for Health the reason for the delay in commencing the inquiry into the historical licensing and use of sodium valproate; the work carried out to date; the timeline for formal commencement; and if she will make a statement on the matter. [29835/25]
Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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Thank you, Deputy, for raising the important issue of the 'Non-Statutory Inquiry into the Historical Licensing and Use of Sodium Valproate in Women of Child-Bearing Potential in the State’.
Ms. Bríd O’Flaherty BL was appointed as the Chair of the ‘Non-Statutory Inquiry into the Historical Licensing and Use of Sodium Valproate in Women of Child-Bearing Potential in the State’ in June last year. Since then, significant work has been carried out to put in place the necessary arrangements to operationalise and establish the inquiry.
Prior to the formal commencement of the inquiry, it is necessary to have in place regulations made under the Data Protection Act 2018, to ensure that there is a robust legal basis supporting the work of the Inquiry and ensure that data protection obligations are being supported appropriately, given the sensitive nature of the data in question.
My Department, in collaboration with the Office of Parliamentary Counsel and the Data Protection Commission are drafting the necessary Statutory Instruments to provide this robust legal basis as a matter of priority. When these have been finalised, it is anticipated that the public facing elements of the inquiry will commence shortly thereafter.
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