Dáil Éireann Debate, Thursday - 26 February 2026
492. Deputy David Cullinane asked the Minister for Health if she will provide an update on the work of the non-statutory inquiry into the licensing and use of sodium valproate in women of child-bearing potential in the State; the details of the stages of the inquiry; the remaining timeline for the inquiry; and if she will make a statement on the matter. [15728/26]
Amharc ar fhreagraThe Non-Statutory Inquiry into the Historical Licensing and Use of Sodium Valproate in Women of Child- Bearing Potential in the State formally commenced its work on 22 July 2025.
In advance of commencement, and following the appointment of an independent Chair, Ms. Bríd O'Flaherty BL, significant preparatory work was undertaken to establish and operationalise the inquiry, including staffing the inquiry team, securing office accommodation, procuring a secure IT system and website, and establishing a multi-supplier framework agreement to support the engagement of documentary counsel.
With the assistance of the Department, the Chair oversaw the development and implementation of a nationwide public awareness campaign for the inquiry which ran for eight weeks from August to October 2025 and included newspaper, radio, and social media advertisements.
The Chair also put in place a range of supports for participants, including financial, counselling and legal supports, recognising the needs of affected individuals and families and acknowledging that participation in the inquiry may be a difficult experience for many.
The inquiry is structured into three strands:
The first strand is the review strand, which is establishing a timeline for the use of sodium valproate in the State in women of childbearing potential including information on regulation, prescribing, dispensing and safety information issued. The inquiry seeks to document the evolution of sodium valproate regulation and the practices around the control of this product. The inquiry has responsibility for requesting documentation and submissions from a range of stakeholders.
The second strand of the inquiry enables oral statements from individuals diagnosed with Fetal valproate spectrum disorder (FVSD), their mothers and other family members who may wish to participate in this inquiry. These statements will be considered in the third phase by the Chair in developing recommendations on supports for patients. Other stakeholders may also be invited to provide oral statements, in separate sessions.
The third strand focuses on assessing the health service’s current capacity to respond to safety issues related to use of anti-seizure medications in women of child-bearing potential. It involves an assessment of the current systems in place to respond, disseminate and implement measures that address safety issues relating to use of sodium valproate in women of child-bearing potential; development of other recommendations regarding current control systems for sodium valproate and other anti-seizure medications, and the services and supports for those impacted by valproate. The results of this assessment will inform future service development.
The terms of reference envisaged a 12 - 18 month timeframe for the inquiry, including the submission of an interim report within six months of commencement. The Chair submitted her interim report to me on 20 January 2026, and it is currently under consideration.
