I propose to take Questions Nos. 321 and 335 together.
I have been aware of the issues surrounding sodium valproate use in pregnancy since early 2017, when the European Medicines Agency (EMA) initiated its most recent review of the use of valproate-containing medicines in the treatment of women who are pregnant or of childbearing age. The risk reduction measures recommended by the EMA on foot of its previous review in 2014 were fully implemented in Ireland; prior to this, there were no specific restrictions over and above those listed in the Summary of Product Characteristics (SmPC) leaflet for healthcare professionals and the patient information leaflet. As with any medicine, these documents were regularly updated as new data emerged about the medicine and its potential side effects.
The HSE's Valproate Response Project is expected to be completed within the coming weeks, and a final report will be submitted to my Department upon completion of the project. Once that report is received and reviewed in the Department, I will give further consideration as to whether an inquiry is appropriate.