Lisa Chambers (Mayo, Fianna Fail)
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313. To ask the Minister for Health the steps he and the Health Service Executive are taking regarding the issue of children affected by foetal anticonvulsant syndrome in circumstances in which children were exposed to sodium valproate medicines in the womb; his plans to conduct a review of the families and children affected by this issue; his further plans to set up a compensation scheme for the families affected in view of a compensation scheme set up in France; and if he will make a statement on the matter. [49891/17]

Simon Harris (Wicklow, Fine Gael)
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Medicines containing sodium valproate are approved nationally in Ireland, under the brand name Epilim, for the treatment of epilepsy and bipolar disorder. Valproate-containing medicines are authorised for these indications in all EU Member States, and in Norway and Iceland.

It has been well established that children exposed to valproate in the womb have an increased risk of congenital malformations and neurodevelopmental disorders, including autism. The product information for valproate-containing medicines clearly states that such medicines should not be used in female children, in female adolescents, in women of childbearing potential and pregnant women unless alternative treatments are ineffective or not tolerated. A warning label for the outer packaging of Epilim products was introduced in Ireland earlier this year; products carrying the new external warning label are now being supplied to retail pharmacies.

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 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.

When the EMA's current review of valproate is concluded, the HPRA will communicate the outcome and recommendations of the review to Irish patients, healthcare professionals and relevant stakeholders, including the HSE. The HSE National Clinical Programme for Epilepsy will also consider the outcome of the EMA review in finalising its protocol for the effective management of women with epilepsy.

In terms of supports and services for children with foetal anti-convulsant syndrome, the National Disability Strategy is based on a non-condition-specific approach to the delivery of public services. The current Programme for Partnership Government commits this Government to improving services and increasing supports for all people with disabilities, particularly for early assessment and intervention for children with special needs. This commitment is guided by two principles: equality of opportunity and improving the quality of life for people with disabilities. 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.

I am aware that France has a state-funded compensation scheme for medical accidents, and that this scheme is now considering claims from individuals affected by valproate. I am also aware that a patient representative group in France has filed a class action lawsuit against the manufacturer of a valproate-containing medicine. My Department will monitor developments in France and in other member states, and will give appropriate consideration to the findings and recommendations of the current EMA review of valproate when this review is completed.

Lisa Chambers (Mayo, Fianna Fail)
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314. To ask the Minister for Health the number of children and families diagnosed with foetal anticonvulsant syndrome; the wait time for a diagnosis of foetal anticonvulsant syndrome; the number of children on the waiting list for this diagnosis; the measures taken by the HPRA to ensure warnings are displayed on all sodium valproate medicines; his plans for an awareness campaign; and if he will make a statement on the matter. [49892/17]

Simon Harris (Wicklow, Fine Gael)
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The Deputy's questions regarding diagnosis of foetal anti-convulsant syndrome (FACS) are service matters for the HSE; therefore, these questions have been referred to the agency for attention and reply to the Deputy.

The Health Products Regulatory Authority (HPRA) has implemented a number of measures intended to ensure that all patients and healthcare professionals understand the risks and benefits of medicines containing sodium valproate. These measures include the introduction earlier this year of a warning label for the outer packaging of Epilim (sodium valproate) products; retail pharmacies are now being supplied with products carrying the new external warning label.

The product information supplied with this medicine also includes detailed warnings and recommendations for healthcare professionals and patients regarding the use of valproate, including the need for treatment to be initiated and supervised by a specialist experienced in the management of epilepsy or bipolar disorder. Within the last two weeks, the HPRA has been in contact with the pharmacy regulator, the Pharmaceutical Society of Ireland (PSI), to re-emphasise the importance of informing women of childbearing age of the potential risks of taking valproate-containing medicines. The PSI subsequently issued a circular to all registered pharmacists highlighting the need to include a patient leaflet and Alert Card with each supply of these medicines, and to provide additional labelling and counselling to patients as required.

Since March of this year, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency has been conducting a new review to examine the use of valproate-containing medicines in the treatment of women and girls who are pregnant or of childbearing age. When the PRAC's review is concluded, the HPRA will communicate the outcome and recommendations of the review to Irish patients, healthcare professionals and relevant stakeholders, including the HSE.