A PATIENT GROUP and opposition TDs have expressed disappointment at the delay in appointing a chairperson to lead the inquiry into the historical use of sodium valproate, prescribed as an anti-epilepsy drug to women while pregnant.
The inquiry into the historical licensing and use of the drug in Ireland was approved by Cabinet in July 2023, almost three years after Health Minister Stephen Donnelly committed to holding an inquiry into the drug.
Without a chairperson, however, the inquiry cannot begin.
“We want this inquiry, which was approved by cabinet over six months ago, to move ahead, but the Department [of Health] so far has not shown us any real direction regarding this,” the Organisation for Anticonvulsant Syndromes (OACS) Ireland patient group told The Journal.
The group has been invited to attend a meeting with Department officials. “It is our hope this meeting may change things and move things along quickly,” OACS Ireland chairperson Karen Keely said.
The Department of Health said that Stephen Donnelly is “committed” to making sure the inquiry happens and said the Department is working to find “an appropriate person” to head the inquiry.
Sodium valproate can cause serious birth defects and developmental disorders to an infant if taken during pregnancy and women have been advised against using it unless no other treatment is possible.
The drug was prescribed in Ireland and elsewhere for years after the danger was discovered and many countries are now investigating its use.
Today, the Health Products Regulatory Authority (HPRA) states that the drug can cause birth defects and problems with the development and learning of the child if their mother takes it during pregnancy.
Children exposed to the drug while in the womb are at a high risk of serious developmental disorders (in up to 30-40% of cases) and congenital malformations (in approximately 10% of cases).
Symptoms of fetal valproate syndrome (FVS) vary, but can include characteristic facial features, spina bifida, congenital heart defects, cleft lip and/or cleft palate, genital abnormalities, skeletal abnormalities and developmental delay.
The drug’s risk to infants has been made public in recent years, but campaigners in the UK found documents in the National Archives that indicated health regulators were aware of the risk as far back as 1973 but chose not to warn patients, saying it “could give rise to fruitless anxiety”.
A HSE report published in 2018 estimated that 1,250 children have been affected by valproate since 1975 in Ireland.
In 2021, an investigation by Noteworthy found that around 3,000 Irish children were potentially harmed by exposure to the drug in the womb.
Six months after the inquiry’s approval, a chairperson has still not been appointed to lead it.
In a statement to The Journal, the Department of Health said Minister for Health Stephen Donnelly has been “consistent” in his support for an inquiry into sodium valproate and “is committed to making that happen”.
“This inquiry will be designed to give a voice to patients and their families, while looking at the use of sodium valproate in Ireland since it was first licensed,” the statement read.
“The Department of Health is continuing work to establish the inquiry as soon as possible and is actively working to source an appropriate person to Chair the inquiry to lead a fair and independent process.”
In a statement, the Organisation for Anticonvulsant Syndromes (OACS) Ireland patient group said it has been engaging with officials in the Department for a significant period, but had not received any communications on the appointment of a chair since November.
The group said that at its last meeting with Department officials, “the number of candidates approached was at that time nearly exhausted, and suggestions were made that perhaps there was an option of running a public jobs campaign or a limited tender process”.
It also criticised the briefing document the Department had circulated to prospective chairs, saying it felt it presented an “overly sanitised view of the events which have led to the establishment of the inquiry”.
OACS Ireland told The Journal today that it has been invited to attend a meeting with Department officials.
“One of our objectives is to gain explicit reasons on why there has been such a delay on appointing a chairperson to the inquiry and get decisive information on what the department is doing to resolve it,” the group said.
“We want this inquiry, which was approved by cabinet over six months ago, to move ahead, but the department so far has not shown us any real direction regarding this. It is our hope this meeting may change things and move things along quickly, as promised by Minister Donnelly in July 2023.”
Sinn Féin TD Rose Conway-Walsh asked the Minister for Health Stephen Donnelly for an update regarding the appointment of an independent chair to the inquiry in a parliamentary question (PQ) last November.
At the time, Donnelly said work was “actively ongoing” to find an appropriate chair.
“The Chair is an essential role that needs careful consideration. The role requires and experienced person who will run a fair and independent process, and who can give the inquiry the time and attention it deserves,” he said.
Speaking to The Journal, Conway-Walsh said it is “wholly unacceptable and unexplainable” that a chair has not been appointed at this stage.
“The families continue to be let down over and over again. A chair must be appointed with immediate effect.”
Conway-Walsh said that while it would have been “preferable” to have a statutory inquiry into the use of the drug, the main priority is “that the truth is told”.
“We have to remember that this drug was licenced back in 1975. There’s a historical injustice here that’s happened to these families through absolutely no fault of their own, and it must be put right. The first step to putting that right is to get this inquiry up and running,” she said.
She noted proceedings that have been taken in other countries, such as France.
In 2022, a French court allowed families to join a class action against manufacturer Sanofi, who sold the drug in France under the brand name Depakine.
French health authorities estimate was responsible for deformities in between 2,150 and 4,100 children and neuro-developmental defects in up to 30,400 children.
Conway-Walsh added that the inquiry “absolutely has to be” up and running in the first quarter of this year.
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