Simon Harris (Wicklow, Fine Gael) | Oireachtas source

I had an excellent meeting with FACS Forum Ireland and I heard directly from parents whose children have been impacted by foetal anticonvulsant syndrome. I believe parents have been let down. As the Deputy said, it is not just an issue in Ireland and this is why the European Medicines Agency, EMA, has looked at the matter.

There are three issues, which I discussed with the FACS Forum Ireland. The first issue is what we do going forward to address the concerns, as raised by Deputy Aylward, such as labelling, safety and awareness of the appropriateness of prescribing this drug or not prescribing it. As recently as yesterday the Health Products Regulatory Authority, HPRA, issued new guidelines to all stakeholders on the use of the drug. I am confident and satisfied that HPRA is implementing the recommendations of the European Medicines Agency. This is the body of work we need to keep a close eye on; that it is progressing well; and how to make sure that from this point on the correct information, correct labelling, correct warning and appropriate prescribing is dealt with.

The second issue is what to do for the children who have been born with malformations and disabilities as a result of this situation. When I met with FACS Forum Ireland I was concerned that these are children who must deal with lots of different doctors and various different conditions. No two affected children have the same set of conditions. I am a little concerned that they have been run around from Billy to Jack. I want them to have one single point of contact within the HSE that can give them all of the information. I wrote to the director general of the HSE on 17 April instructing him that all the clinical leads in the HSE and the Children's Hospital Group need to meet with the FACS Forum Ireland to discuss how we deal with these children's needs, just as we have done in other areas.

The third issue is around how we look at the past and how we check that in the past Ireland did everything it could to make sure that parents were aware and that appropriate guidance was followed. My colleagues in the UK and France have initiated some reviews in this regard and I have promised to consider that and revert to the FACS Forum Ireland within the next month.

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