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Inquiry opens on sodium valproate following two-year wait

By Reporter - 22nd Jul 2025

iStock.com/Aramyan

The Minister for Health Jennifer Carroll MacNeill has today welcomed the commencement of the non-statutory inquiry into the historical licensing and use of sodium valproate in women of childbearing potential.

The development comes two years after Government approval to establish the inquiry. In June last year, the then Minister Stephen Donnelly announced Ms Bríd O’Flaherty BL as the Chair of the inquiry and stated it would be established within weeks.

Background

Organisation Anticonvulsant Syndrome (OACS) Ireland and Epilepsy Ireland have strongly advocated for an inquiry to determine what State authorities knew about the teratogenic risks of sodium valproate, when this information was known, and why many women were not provided with this information.

The two organisations have also urged improvements in communication to women, stronger implementation of risk minimisation measures, and better supports for affected families.

Valproate-containing medicines have been approved nationally in the EU to treat epilepsy and bipolar disorder and in some countries for prevention of migraine.

While sodium valproate (Epilim) 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 are prescribed such medicines during pregnancy. Women and girls who have been prescribed sodium valproate should not stop taking their medicine without consulting their doctor.

Speaking today, Minister Carroll MacNeill said: “I welcome the commencement of the inquiry, which will give those directly affected by sodium valproate an opportunity to have their voices heard. I was grateful to meet with Organisation Anticonvulsant Syndromes Ireland (OACS Ireland) recently and I know this is an important day for them and the families they represent.

“I have every confidence that the Chair will conduct an independent and fair inquiry and finally get answers for those affected and their families.”

The inquiry will examine the historical and current context of sodium valproate use through three distinct strands:

Review Phase

The first strand will be the review phase, which will establish 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 will seek to document the evolution of sodium valproate regulation and the practices around the control of this product. The inquiry will have responsibility to request documentation and submissions from a range of stakeholders. The Chair will highlight and record difficulties encountered where such requests are refused as part of their reporting function.

Personal Statements

The second strand of the inquiry will enable oral statements from individuals diagnosed with foetal valproate spectrum disorder (FVSD), their mothers and other family members who may wish to participate. Other stakeholders may also be invited to provide oral statements in separate sessions. All sessions will be held in private.

Health Service Capacity

The third strand will focus on assessing the health service’s current capacity to respond to safety issues related to use of anti-seizure medications (ASMs) in women of childbearing potential. It will involve 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 childbearing potential; development of other recommendations regarding current control systems for sodium valproate and other ASMs, and the services and supports for those impacted by sodium valproate. The results of this assessment will inform future service development.

A communications campaign will be launched in the coming weeks to raise public awareness and support engagement with the inquiry.

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IHCA calls for healthcare litigation reforms in Programme for Government 

By Reporter - 13th Jan 2025

The IHCA is calling for the next Programme for Government to include the implementation of high-level recommendations on healthcare litigation reform.

A Department of Health expert group, chaired by Prof Rhona Mahony, recently recommended various approaches and mechanisms, including the introduction of pre-action protocols, with sanctions for any party who fails to adhere to them.

As outlined in the report, the primary driver of the rising cost of claims is the cost of care in a relatively small number of very serious injury claims. Over 50 per cent of healthcare litigation costs come from 2 per cent of claims, mainly involving severe cases like perinatal brain injury and cerebral palsy.

Pre-action protocols have resulted in reduced legal costs in other jurisdictions. It is anticipated that their introduction in Ireland would have a similar effect and lead to swifter resolution of claims.

According to the IHCA: “Implementing these reforms will be crucial to accelerating the resolution times of claims, reducing the cost of litigation, and sparing patients and families from prolonged and stressful legal processes.”

Upon the publication of the report, consultants welcomed the Government’s commitment to establish a working group to ensure the recommendations were “implemented without delay”. The IHCA stated it looked forward to supporting the next Minister for Health in “delivering on this commitment”.

IHCA President Prof Gabrielle Colleran said: “One of the first priorities of the next government should be the swift introduction of pre-action protocols to curtail the surging costs of litigation and to provide speedier resolution of claims for patients.

“The present litigation system in Ireland is excessively adversarial, with clinical negligence claims often taking several years to resolve. This is just adding to the distress faced by patients, their families and healthcare professionals.

“The current protracted claims processes are not fit for purpose and are resulting in increased legal costs that are among the highest in the world.

“Importantly, such costs represent a significant drain on public funds and draw resources away from the provision of healthcare. By working together to implement these reforms, we can not only control rising costs but also ensure better outcomes for patients, healthcare professionals, and the public. The IHCA is eager to engage with the next government to make this vision a reality.”

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