Stephen Donnelly (Wicklow, Fianna Fail) | Oireachtas source

I thank the Deputy for raising the matter. I am very sympathetic to the patients and their families over what has happened. I met the patient groups involved in late 2020 and supported their call for a review into sodium valproate. I committed to making it happen. Since then, senior officials in my Department have been engaging closely with the patient groups and other stakeholders over the past year to finalise the terms of reference to get this review under way.

Critically, the review will be designed around giving a voice to patients and their families and looking at the use of sodium valproate in Ireland since it was first licensed. It was important that enough time and resources were invested in scoping out the work to be done and engaging with patient groups as opposed to simply designing something and telling them what it would be. Many factors needed to be considered and I wanted to ensure the terms of reference incorporated what people wanted to see.

Many different groups are involved here, including the manufacturer, prescribers of the drug, our medicines and pharmacy regulators, and most importantly the patients themselves and their families.

As a result, there has been a lot of preparatory work to get this together and to make sure all of the groups involved would come together for the review.

With regard to community-based care, as part of the valproate response project, the HSE has developed a diagnostic and community pathway to ensure patients are properly assessed and are referred to community services if they receive a diagnosis of foetal valproate syndrome, FVS. The first step in developing the pathway was establishing a dedicated diagnostic clinic in 2019. That was established in Children's Health Ireland in Crumlin and is headed by a specialist consultant geneticist. As of today, 36 patients have received a diagnosis. There is, critically, no waiting list at the moment for that diagnosis. I will, in my next response, continue on the rest of the community pathways.

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