Rose Conway Walsh (Sinn Fein) | Oireachtas source

I second what the Senator said about the fisheries legislation. We need extensive consultation with the inshore fishermen before the Bill comes before us as otherwise, it will be rejected. We must listen to the inshore fishermen and their families.

Today, I want to talk about sodium valproate or Epilim, which is a medication used to treat epilepsy and bipolar disorder. The European Medicines Agency has restricted its use in women due to the increased risk of disabilities in children exposed to valproate in the womb. These disabilities are collectively known as foetal valproate syndrome and can include serious developmental disorders in between 30% and 40% of cases and congenital malformations in approximately 10% of cases. Data suggest that up to 1,250 children may have been born with valproate-related disabilities since the medication was licensed in Ireland in 1975.

Last year, the Oireachtas Joint Committee on Health produced a report on foetal valproate syndrome and the HSE established the valproate response project group to address a range of issues such as prevention, risk minimisation, establishing incidence, diagnosis and supports for the families affected. On 22 March, a major conference on the consequences of sodium valproate or Epilim 50 years on will be held in Trinity College. I encourage all Senators and the media to attend because there is something to see here and something to hear.

The Minister for Health told me at a meeting of the joint committee that he would consider the need for an inquiry into foetal valproate syndrome as soon as the HSE's valproate response team completed its work. Therefore, we need to know when its work will be completed and when he expects to further consider the matter.

A redress scheme has been set up in France to compensate the families and individuals who have been affected by foetal valproate syndrome. It is urgent that we take a similar initiative here. The Minister must meet the foetal anticonvulsant syndrome, FACS, forum, to discuss accountability issues, as well as redress and I ask him to outline the following. How long has his Department known about the risks associated with the use of valproate in pregnancy? What actions were taken by the State to minimise these risks, in particular prior to 2014 when the European Medicines Agency implemented its first review of risk reduction measures? What is his response to the recent study published in the British Medical Journalthat concluded there was clear evidence as far back as 1990 that there were risks of congenital malformations in women exposed to valproate, and that the risks were beyond all doubt from 2005? Will he explain what is known about the prevalence of foetal valproate syndrome within the Irish population? What clinical trials were conducted on Epilim or sodium valproate in Ireland prior to its licensing in 1975? If no trials were conducted in the State, what clinical trial data were used as a basis for its approval?

Many questions remain to be answered about valproate and they must be answered. I ask the Leader to arrange for the Minister for Health to come into the House to discuss this matter. We have waited long enough for the report. In the meantime, I encourage everybody to attend the conference. I commend the mothers, some of whom will be in here this evening, who have campaigned long and hard about this matter. We have families where two or three children were born with disabilities because their mothers were allowed to take valproate when they were pregnant.