Michael Harty (Clare, Independent)
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227. To ask the Minister for Health his plans to examine the issue of accountability, compensation and the provision of medical services in relation to children affected by foetal anti-convulsant syndrome; and if he will make a statement on the matter. [14473/18]

Simon Harris (Wicklow, Fine Gael)
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Medicines containing sodium valproate are approved in Ireland, and the rest of the EU, for the treatment of epilepsy and bipolar disorder. 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.

In 2014, following a European Medicines Agency (EMA) review of valproate, the Health Products Regulatory Authority (HPRA) circulated recommendations to further restrict the use of valproate in women and girls. The HPRA also recommended that the use of valproate be restricted to doctors experienced in managing epilepsy or bipolar disorder in female patients, and provided advice for situations where it was considered that valproate treatment needed to be continued during the pregnancy.

In March 2017, the Pharmacovigilance Risk Assessment Committee (PRAC) of the 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 has now been completed, and the committee’s recommendations were published by the EMA in February. The key measures recommended by the PRAC are as follows:

- Valproate must not be used in pregnancy for the treatment of migraine or bipolar disorder.

- Valproate should not be used in pregnancy for the treatment of epilepsy. However it is recognised that for some women with epilepsy it may not be possible to stop valproate and they may have to continue treatment (with appropriate specialist care) in pregnancy.

- Valproate must not be used in female patients from the time they become able to have children – unless the conditions of a new pregnancy prevention programme (PPP) are met.

- The PRAC has also recommended that the outer packaging of all valproate medicines must include a visual warning about the risks in pregnancy. In addition to boxed text, this may include a symbol/pictogram, with the details to be adapted at national level.

- A patient reminder card will also be attached to the outer package for pharmacists to discuss with the patient each time the medicine is dispensed.

- Companies that market valproate should also provide updated educational materials in the form of guides for healthcare professionals and patients.

The PRAC’s position on sodium valproate has since been endorsed by an EMA regulatory committee, the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), and the recommendations will now be sent to the European Commission for a legally binding decision on all member states. Officials in my department are already working with other stakeholders, including the HPRA, HSE, and the Pharmaceutical Society of Ireland, to determine how these recommendations should be implemented in Ireland.

At my request, officials from my department met with representatives from FACS (Foetal Anti-Convulsant Syndrome) Forum Ireland in November. I have been briefed by officials as to the issues raised, and I am scheduled to hold a further meeting with this group today, 28 March.