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.
