Minister Must Honour Valproate Inquiry Commitment

The Valproate scandal of who knew what, when they knew it and why they did nothing to prevent harm to the unborn babies of pregnant women prescribed Epilim (Valproate) reaches a key point today when the UK Report ‘First Do No Harm’ is published.

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.

Over 3,100 children were potentially exposed to Valproate. Based on international data, it is estimated that 341 have experienced a major congenital malformation and over 1,250 children will have experienced some form of neuro-developmental delay.

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

“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 that 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.

Deputy David Cullinane, Sinn Féin Health Spokesperson has stated:

“In this state, the long running battle to uncover the truth about why Sodium Valproate continued to be prescribed to pregnant women for decades came before the Joint Oireachtas Health Committee in 2018 recommending an independent investigation into the use of valproate and consideration of a redress scheme.

“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 inflicted on these children was entirely avoidable.”

The response in dealing with the Valproate issue differs in 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. Why should children in this state be any different to children in France?

“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 that I have met in the pursuit of the truth and justice for their children.

Read the ‘First Do No Harm’ Report here.