Rose Conway Walsh (Sinn Fein) | Oireachtas source

It would be wholly unacceptable if it was deemed to be cost-effective in Britain and was not deemed cost-effective here. I need the right decision to be made as quickly as possible.

I will ask about the valproate response project and the rapid assessment report. I was disappointed that the Minister, or a representative of his, was not at the recent conference with the HSE and the Organisation for Anti-Convulsant Syndrome Ireland, OACS. It was a very good conference. I will go back to the point I made to the Minister some time ago about the need for a judge-led public inquiry into this. We have had 40 years of this and we really need to know who knew what and when and on what basis Epilim was approved for the treatment of epilepsy and bipolar disorder. That was approved for pregnant women.

Does the Minister agree that there are issues of accountability here as to who knew what and when, particularly prior to 2014? That was when the European Medicines Agency, EMA, implemented the first series of risk reductions. The time path can be followed all the way along as the effects of Epilim in pregnant women became more certain. There are now between 43 and 95 children with major congenital malformations and another 1,200 children who have been impacted. It is very important that we have an inquiry into that as soon as possible and all of the documentation is made available. OACS Ireland, through Karen Keely, has obtained a lot of documentation. In the international context, there are hundreds of cases being brought before the French Government for consideration. There is also an investigation ongoing in the UK as to how this drug was prescribed. Will the Minister comment on the need for an inquiry into valproate?