Louise O'Reilly (Dublin Fingal, Sinn Fein)
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144. To ask the Minister for Health if a registry of the children affected by foetal anticonvulsant syndrome, also known as foetal valproate syndrome, during pregnancy will be established; and if he will make a statement on the matter. [47360/17]

Louise O'Reilly (Dublin Fingal, Sinn Fein)
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145. To ask the Minister for Health if a registry of the women affected by taking sodium valproate during pregnancy will be established; and if he will make a statement on the matter. [47361/17]

Louise O'Reilly (Dublin Fingal, Sinn Fein)
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146. To ask the Minister for Health if additional services for children affected by foetal anticonvulsant syndrome during pregnancy will be provided; and if he will make a statement on the matter. [47362/17]

Louise O'Reilly (Dublin Fingal, Sinn Fein)
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147. To ask the Minister for Health if a six-monthly screening process for a person exposed to sodium valproate during pregnancy will be provided in order that problems are recognised immediately and supports put in place; and if he will make a statement on the matter. [47363/17]

Simon Harris (Wicklow, Fine Gael)
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I propose to take Questions Nos. 144 to 147, inclusive, together.

The Irish Epilepsy and Pregnancy Register, based in Beaumont Hospital, was set up in 2001 for pregnant women with epilepsy in Ireland. The aim of this Register is to find out which type of epilepsy drugs women are taking while pregnant and to collect information on the health of their babies after delivery. Since 2007, the Irish Register has had a formal link to the United Kingdom Epilepsy and Pregnancy Register. Women with epilepsy who become pregnant, whether or not they are taking anti-epileptic drugs for their epilepsy, are eligible to register their pregnancy.

In March of this year, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) initiated a new review of the use of valproate-containing medicines in the treatment of women and girls who are pregnant or of childbearing age. This review is examining the available evidence and consulting with relevant stakeholder groups. The most recent component of the current review was a public hearing held at the London offices of the EMA on 26 September.

In its summary of the public hearing, the EMA noted that the PRAC would consider a number of proposals and ideas presented by participants, including registers of women who were receiving valproate and children who had been exposed to valproate during pregnancy.

It is anticipated that the PRAC’s current review of valproate will be concluded before the end of this year. As soon as the review is concluded, the Health Products Regulatory Authority (HPRA), which is the competent authority for the regulation of medicines in Ireland, will communicate the outcome and recommendations of the review to Irish patients, healthcare professionals and relevant stakeholders, including the HSE.

The HSE Clinical Strategy and Programmes Division has developed the National Clinical Programme for Epilepsy, to provide the best value, safe care for all people with epilepsy in the right place, at the right time, sharing the best information available. The model of care under the national clinical programme includes the development of a very detailed Standard Operating Procedure on the management of women with epilepsy. It will cover the pathways of care associated with all aspects of pregnancy, contraception and menopause, and includes detailed support for the obstetrics service in the management of seizures and guidance for ante-natal care, including specific information covering the known extra risks of epilepsy associated with pregnancy to both the mother and foetus.

It is anticipated that this Practice Guide for the Effective Management of Women with Epilepsy will be ready for approval by the HSE before the end of the year.

In relation to the provision of additional services, the overarching principle governing the planning and delivery of health services, and supports for adults and children with disabilities, is that they should be integrated, as much as possible, with services and supports for the rest of the population. The Government’s agenda with regard to disability is set out in the current National Disability Strategy, which is based on a non-condition-specific approach to the delivery of public services. The matter of the services available to these patients has been referred to the HSE for attention and direct reply to you. If you have not received a reply from the HSE within 10 working days, please contact my Private Office and they will follow up with the HSE.

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