VALPROATE SCANDAL – By Rose Conway Walsh

July 13, 2020


It is now time for new Health Minister, Stephen Donnelly, to make good on his ‘100% commitment’ to hold an Independent Public Enquiry into the Valproate Scandal and to put in place a Redress Scheme for the 1,200 plus families impacted by the failure of the State to protect them.

This week sees a key moment in the long running battle to uncover the truth about why the anticonvulsant drug Sodium Valproate continued to be prescribed to pregnant women for decades when it was known that taking it increased the risk of children being born with serious malformations.

Packet of valporate epilim

The UK ‘First Do No Harm’ report of the Independent Medicines and Medical Devices Safety Review chaired by Baroness Julia Cumberlege is published. This report is the two-year accumulation of harrowing patient testimony and mounting evidence concerning three medical interventions: Primodos, Sodium Valproate (Epilim) and Pelvic Mesh.

Having worked with families in this state impacted by Sodium Valproate for the past number of years I think Baroness Cumberlege sums up the scandal when she states ‘I have conducted many reviews and inquiries over the years, but I have never encountered anything like this; the intensity of suffering experienced by so many families, and the fact that they have endured it for decades.’

‘I feel as though I am an unsuspecting, unwilling participant in a cruel experiment that has gone wrong’.

She goes on to say: ‘much of this suffering was entirely avoidable, caused and compounded by failings in the health system itself.’ Repeatedly the anguish of the mothers I meet is driven by the fact that they feel intense guilt at having taken medication that resulted in their child/children being harmed. One mother said, ‘I feel as though I am an unsuspecting, unwilling participant in a cruel experiment that has gone wrong’. The truth is it was never their fault. They were harmed because the State failed to protect them.

Baroness Cumberlege

Baroness Cumberlege speaking at Maternity Transformation Programme in 2016

The Valproate Scandal is not confined to Ireland but we have chosen to address how it differs from other countries.

Take France for instance, where Sanofi, the pharmaceutical company that manufactures sodium valproate, has been indicted. Two thousand families are taking a class-action against Sanofi. It is estimated that more than 50,000 people could have been affected over the years. France has accepted their responsibility in this affair and set up a multi-million euro ‘state compensation fund’ to compensate the victims and introduced a partial ban on sodium valproate.

Sodium valproate has been licensed for the treatment of epilepsy in Ireland since 1975 and for bipolar disorder since 2008. Discussions regarding possible teratogenicity can be traced back to the early seventies.

Over 3,100 children were potentially exposed, it is estimated that 341 have experienced a major congenital malformation due to the exposure to valproate in utero up to 2015. So, going on international data it is estimated that over 1,250 children will have experienced some form of neuro- developmental delay.

In 2018, the Oireachtas Health Committee recommended an independent investigation into the use of valproate (Oireachtas PDF report download) and that consideration should be given to a redress scheme.

Since then a number of measures have been introduced to support families impacted by FACS and patient information leaflets have been updated to warn of possible teratogenic effects. The development of a diagnostic pathway for children and adults who may have Foetal Anti-convulsant Syndrome (FACS) has proven to be deeply unsatisfactory for many parents.

Most concerning is the reluctance of the government to uncover the truth. I believe the as yet unpublished, HSE Valproate Response Report has been used to delay the commencement of a necessary inquiry. Sanofi or other state agencies must be accountable for this scandal. The harm imposed on these children was entirely avoidable. Why should children in France be any different from children in this state?

I want to acknowledge the unrelenting commitment of Karen Keeley, Chairperson of Organisation for Anti-Convulsant Syndrome (OACS) Ireland, Epilepsy Ireland and the wonderful mothers I have met in the pursuit of the truth.

Rose is a friend of Shared Ireland and has done a podcast with us previously which you can listen to here.

Rose Conway WalshRose Conway Walsh ( is a TD for the Mayo constituency. She was a Seanad Éireann member on the Agricultural Panel (2016-20). You can follow Rose on Twitter here and her Facebook here. You can follow her contributions in the Dail here.


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