Sodium Valproate Inquiry Enters Phase Two as Families of Affected Children Give Oral Testimony
Ireland's non-statutory inquiry into the historical licensing and use of the epilepsy drug sodium valproate has entered its second phase, with families of children diagnosed with Foetal Valproate Spectrum Disorder now giving oral testimony to the inquiry panel. The inquiry, chaired by Bríd O'Flaherty and established in July 2025, is expected to deliver its final report in April 2027, while advocacy groups including OACS Ireland have called for immediate support measures — including medical cards and formal care pathways — for affected individuals who cannot wait two more years for recommendations.
Background
Sodium valproate, prescribed under brand names including Epilim, is an effective treatment for epilepsy and bipolar disorder that has been in widespread use since the 1970s. However, research accumulated over several decades has established that the drug carries significant risks when taken during pregnancy: up to 40% of children exposed to valproate in utero may experience neurodevelopmental disorders, and approximately 10% are at risk of major congenital malformations. The condition resulting from this exposure — Foetal Valproate Spectrum Disorder — can include physical malformations, distinctive facial features, and lifelong developmental challenges including autism spectrum disorder, intellectual disability, and attention deficit hyperactivity disorder.
The scandal surrounding sodium valproate is not unique to Ireland. In the United Kingdom, a public inquiry chaired by Baroness Cumberlege found in 2020 that the drug had been prescribed to pregnant women for decades despite evidence of its risks, and that the medical establishment had failed to listen to the concerns of affected families. The UK government subsequently established a compensation scheme for affected individuals, a step that Irish advocacy groups have been pressing the Irish government to replicate.
In Ireland, the non-statutory inquiry was established following years of campaigning by OACS Ireland and Epilepsy Ireland. Its terms of reference cover the regulation, prescribing, and safety information associated with sodium valproate in Ireland, with a particular focus on the period from the drug's introduction in the 1970s to the implementation of the current Pregnancy Prevention Programme in 2018.
Key Developments
Phase one of the inquiry, which focused on establishing a timeline of the drug's regulation and prescribing in Ireland, was completed in June 2026. Phase two — now under way — involves gathering oral statements from individuals diagnosed with Foetal Valproate Spectrum Disorder and from their families. This phase is expected to be the most emotionally demanding part of the inquiry process, as families describe the impact of the drug on their children's lives and on their own experience of seeking diagnosis, support, and accountability.
An interim report was submitted to the Minister for Health in January 2026 but will not be published until the final report is completed in April 2027, a decision that the Department of Health has justified on the grounds of maintaining the integrity of the ongoing inquiry process. Advocacy groups have criticised this approach, arguing that the interim report may contain recommendations that could be implemented immediately to improve the lives of affected individuals.
OACS Ireland has called for the government to act without waiting for the final report, specifically requesting the provision of medical cards for all individuals with Foetal Valproate Spectrum Disorder, the establishment of formal care pathways within the HSE, and the creation of a dedicated support fund. The Department of Health has indicated that it is considering these requests but has not made any commitments.
Why It Matters
The sodium valproate issue is one of the most significant medical harm scandals in Irish history, comparable in its scope and its implications for institutional accountability to the symphysiotomy scandal and the contaminated blood products scandal of the 1990s. The common thread running through all of these cases is the failure of medical and regulatory institutions to listen to patients — predominantly women — who were raising concerns about the harm being done to them and their children.
The inquiry's findings, when they are published, will have implications not only for the individuals directly affected by sodium valproate but for the broader question of how Ireland's health regulatory system responds to emerging evidence of drug-related harm. The Health Products Regulatory Authority's current Pregnancy Prevention Programme represents a significant improvement on the previous approach, but the inquiry is expected to examine whether the HPRA acted quickly enough when evidence of valproate's risks first emerged.
Local Impact
Families affected by sodium valproate are spread across Ireland, with significant concentrations in Dublin, Cork, and Galway — the cities where the largest acute hospitals are located and where the drug was most widely prescribed. Many of these families have been waiting for years for the inquiry to deliver its findings, and the prospect of a further two-year wait until April 2027 is a source of real frustration. The HSE's six health regions have been asked to identify the number of individuals with Foetal Valproate Spectrum Disorder within their areas, but a comprehensive national register has not yet been established.
What's Next
Phase two of the inquiry is expected to continue through the autumn and winter of 2026, with phase three — which will evaluate the health service's capacity to address safety concerns regarding anti-seizure medications for women of childbearing age — beginning in early 2027. The final report is due in April 2027. The Department of Health has indicated that it will respond to the report's recommendations within three months of publication. OACS Ireland has announced that it will maintain its campaign for immediate support measures throughout the inquiry process.
