Bríd O’Flaherty BL

While sodium valproate is an effective and essential treatment for some patients, valproate-containing medicines can cause birth defects, neuro-developmental disorders and autism in children whose mothers take such medicines during pregnancy.

The inquiry will document the evolution of sodium valproate regulation in Ireland, the practices and controls in relation to prescribing and dispensing, and the timeline of developments in scientific knowledge about the potential impact of the drug on foetal development.

It will assess the adequacy of services and supports currently in place for foetal valproate spectrum disorder (FVSD) patients and their caregivers, and consider the health service’s capacity to address safety issues relating to the use of sodium valproate in some groups of women.

Health minister Stephen Donnelly said: “Today marks a significant step for those who have for years spoken out as a voice for their loved ones, for those who cannot use their own voices as a result of FVSD.”

The minister met “advocates, patients and their families” on Wednesday ahead of the announcement.

“I’m delighted to be able to honour the commitment I made to them when we first met, beginning with the appointment of the chair of the inquiry,” he said.

“I know Brid O’Flaherty will lead an independent and balanced process that rigorously examines the use of sodium valproate in Ireland, providing us with valuable information and insights to inform our next steps, and putting patients and families at the core of her consideration.”

He added: “It’s important to note that sodium valproate is an effective medication and continues to be an essential part of the treatment plan for some patients. It is therefore vital that people currently taking sodium valproate do not make changes to their treatment without first discussing their concerns with their doctor.”

Once the inquiry is established, the chair will publicise information about how people can take part, including via an accessible website with clear routes of contact.

Lawyers acting for affected families have previously criticised the decision not to establish the inquiry on a statutory basis.