Simon Harris (Wicklow, Fine Gael) | Oireachtas source

I thank the Deputy for her question which she highlighted last Thursday on Leaders' Questions.

Sodium valproate is a medicine licensed for use in Ireland to treat epilepsy and bipolar disorder. It is now well established that children exposed to valproate in the womb have an increased risk of congenital malformations and developmental disorders. In 2014, the European Medicines Agency, EMA, conducted a review of valproate and issued advice placing additional restrictions on the use of valproate in women and girls.

In March 2017, the EMA's pharmacovigilance risk assessment committee initiated a new review of the use of valproate in the treatment of women and girls who are pregnant or of child-bearing age. It is expected this review will be concluded before the end of the year. When it is, the Health Products Regulatory Authority, HPRA, will communicate its outcome and recommendations to Irish patients, health care professionals and relevant stakeholders, including the HSE.

The HSE national clinical programme for epilepsy is developing a draft protocol for the effective management of women with epilepsy. It includes prescribing guidance and detailed advice on the management of clinical issues relating to epilepsy in pregnancy. This guide will be for consideration and approval by the HSE before the end of 2017. The national clinical programme for epilepsy will consider the outcome of the EMA review when finalising this protocol.

Patients taking valproate-containing medicines are advised not to stop taking these medicines. If they have any concerns about their specific drug treatment and management of their condition, they should discuss these with a health care professional.

Health-related therapy supports and interventions for children can be accessed through both the HSE's primary care services and its disability services. We have a duty to meet the health care needs of our people, regardless of the situation. At my request, officials from my Department are scheduled to meet representatives from the foetal anti-convulsant syndrome, FACS, forum, on 23 November. I hope they find the meeting useful in exchanging information, ideas and their concerns. It will be an opportunity to be updated on the Department's perspective.

We have several important developments in the next few weeks with the EMA and the national clinical guidelines.

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