Dáil debates

Wednesday, 15 November 2017

Other Questions

Medicinal Products Regulation

4:00 pm

Photo of Simon HarrisSimon Harris (Wicklow, Fine Gael) | Oireachtas source

That is a fair point. We must ensure that all appropriate information and advice is followed but the Deputy raises the legitimate issue of what to do in respect of affected children. The Health Products Regulatory Authority, HPRA, advice notes that up to 10% of children exposed in utero to valproate are at risk of a congenital malformation and it is further estimated that up to 30% to 40% of such children are at risk of serious developmental disorders. The European Facts Forum estimated that up to 400 children in this country could be affected. A paper published in 2016 indicates that the use of sodium valproate in pregnancy has declined between 2008 and 2013 and an analysis of HSE pharmacy claim data from January 2014 to August 2016 indicates a decline from roughly 2,000 to fewer than 1,700 women aged 16 to 44 who were dispensed sodium valproate medicines under the community drugs scheme in that period.

The service needs of these children should be the primary purpose of the meeting on 23 November. Health services are available regardless of diagnosis or condition but if there is a sense that there is not a proper understanding or realisation of the needs of these children I hope that can be teased out at the meeting.

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