Bríd O’Flaherty BL has been appointed as Chair of the Inquiry into the historical licensing and use of sodium valproate in women of child-bearing potential in the State.
The Department of Health said that while sodium valproate was an effective and essential treatment for some patients, valproate-containing medicines could cause birth defects, neuro-developmental disorders and autism in children whose mothers took such medicines during pregnancy.
A qualified Barrister and Mediator, Bríd O’Flaherty has extensive medical negligence practice and is a versatile advocate in dispute resolution and mediation proceedings across a diverse range of practice areas, possessing strong research and analysis expertise relating to complex legal issues. Throughout her career she has worked with marginalised and vulnerable groups and people with disabilities.
The non-statutory 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 has been set up to give a voice to those affected by a diagnosis of foetal valproate spectrum disorder (FVSD) and will assess the adequacy of services and supports currently in place for patients and their caregivers. The inquiry will also consider the health service’s capacity to address safety issues relating to the use of sodium valproate in some groups of women and will make recommendations as deemed necessary”.
Minister 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 purpose of this Inquiry is to:
- Provide a voice to persons with a diagnosis of foetal valproate spectrum disorder (FVSD), or progressing through the diagnostic pathway, their mothers and other family members.
- Document the regulation of sodium valproate in the State from initial licensing to the present day and the corresponding practices and controls in place relating to the prescribing and dispensing of this product to women of child-bearing potential throughout this time.
- Develop a timeline of significant developments in the scientific knowledge relating to the teratogenicity (the ability of a substance to cause an abnormality following foetal exposure during pregnancy) of sodium valproate.
- Assess the Irish health service’s current capacity to respond, disseminate and implement measures that address safety issues relating to use of sodium valproate in women of child-bearing potential, and provide recommendations regarding same, with consideration of relevance to other anti-seizure medications (ASMs).
- Assess the adequacy of services and supports currently provided to those diagnosed with FVSD and their caregivers and provide recommendations regarding same if identified.
- Make recommendations as appropriate to the Minister for Health.
