Dáil Éireann Debate, Tuesday - 18 April 2023
1623. Deputy Richard Bruton asked the Minister for Health if he has had representations from an organisation (details supplied) regarding an inquiry into the situation of families affected by a medication sodium valproate; and if he will make a statement on the matter. [17518/23]
View answerWhen I met with the patient groups involved with this issue, I supported their call for an inquiry into sodium valproate and I am committed to making that happen. I understand that the delay in establishing this inquiry is frustrating for those impacted and I share their frustration.
During 2022 the Terms of Reference were agreed after close consultation with patient groups. However, after further cross Departmental engagement these needed to be re-drafted to ensure the inquiry could be delivered in a meaningful way within a reasonable timeframe. I am aware that amended Terms of Reference have been prepared, again with input from patient representatives. My Department is taking steps to complete the policy documentation required to support this inquiry and to bring a memo to government seeking approval for the inquiry to commence.
This inquiry will be designed to provide a voice to persons with a diagnosis of foetal valproate spectrum disorder (FVSD) and their families. It will seek to document the regulation of sodium valproate and the control practices in place around prescribing and dispensing.
There are various stakeholders involved in addition to the advocate groups, including prescribers of the drug, and our medicines and pharmacy regulators. As a result, there is a lot of preparatory work involved in laying the groundwork for this inquiry. It is important that enough time and resources are invested in completing this work, as there are many factors to consider. I want to ensure that the inquiry delivers and allows those impacted to tell their story. My officials are working to ensure that this will be facilitated.
Completion of this work is important to me and I am determined that an inquiry will commence as soon as it is appropriate.
OACS Ireland are an important stakeholder in this process and my officials continue to engage with this group.
I would like to inform you that in parallel to the work on the inquiry a Valproate Stakeholder Group has been established by the Department to assess current systems in place around valproate use in women of childbearing potential. The Sodium Valproate Stakeholder Group had its second meeting recently and a representative from OACS Ireland is included in the meeting group. I look forward to monitoring the outcome of the work of this group.
