Ms Joan O?Donnell:

I thank the Chairman, Deputy Harty, and members of the committee for the invitation to present today. I am here as chair of the foetal anti-convulsant syndrome forum, FACS and I am joined today by my colleague Ms Karen Keely, chair of the Organisation for Anti-Convulsant Syndrome Ireland, OACS, and Mr. Peter Murphy, CEO of Epilepsy Ireland. Karen and I will give the opening statement during which Karen will give some insight into the lived experience of families. Peter and I will be available to answer questions that committee members may have.

Sodium valproate, or Epilim, is a drug licensed in Ireland for the treatment of epilepsy and bi-polar disorder. Foetal anti-convulsant [valproate] syndrome - or FACS - describes a syndrome that affects children born to women who were prescribed Epilim during pregnancy. Children exposed to this drug in the womb have an 11% chance of malformations at birth compared with a 2% to 3% in the general population. Malformations include neural tube defects, malformation of limbs, digits and organs, cleft palate among many, many more physical conditions. An additional 40% of children experience developmental delay and have a three to five times greater risk of developing autism, autistic spectrum disorder and ADHD. We estimate that approximately 400 children may be affected by FACS in Ireland, but just 43 have a diagnosis from the genetics department in Our Lady's Hospital for Sick Children, Crumlin.

In 2014, the European Medicines Agency, EMA, strengthened the warnings and restrictions on the use of valproate in women and girls. In 2017, the agency reviewed how these recommendations were being implemented due to concerns that EU member states, including Ireland, were not implementing the recommendations properly. In February of this year, the EMA issued additional instructions aimed at further tackling issues around reducing risk for women and girls of childbearing age.

The FACS forum asks that the Government deal with this issue on three fronts. The first is in the context of those who are already affected. We call on the Government to undertake a national study to identify how many children in Ireland are affected by this condition. An independent investigation into the historical use of valproate in Ireland is needed. A system of redress must also be established to meet the lifelong care needs of children and to address the impact of diagnosis on families. This will go a long way towards avoiding the need for legal solutions for already stressed families, some of whom are represented in the Public Gallery today and the many more who would have liked to be here and who are watching online.

The second front is the need to put in place services for families who are currently affected. Valproate-related disabilities are complex, wide-ranging and individual. Obtaining a diagnosis is difficult and lengthy and treatment often involves attending many unconnected and un-co-ordinated specialist services. Often, families have more than one child affected and full-time caring is required. It is, therefore, critical that we develop a streamlined diagnostic pathway, develop a national register of those affected and audit their needs. Most important, we must put in place the services and supports they so desperately need now.

The third front is the need to reduce the risk of children being born with FACS in the future. There is an urgent need to fully implement the recent decision of the European Medicines Agency ruling and recommendations that I mentioned earlier. We in the FACS forum have been greatly encouraged by the measures proposed, and the commitment shown by the Health Products Regulatory Authority, the HSE, and the Pharmaceutical Society of Ireland among other stakeholders. We want to see all of this progress impact on the actual numbers of children being born with FACS. Therefore, we need a systems-wide commitment that all new risk reduction initiatives will be fully monitored, fully implemented, independently evaluated and additional action taken if necessary.

Finally, we want a commitment from HSE that all women currently prescribed Epilim, especially those under GP-only care, be given priority referrals in 2018 to a specialist for an urgent treatment review. This is now required by the EMA ruling and we ask that this happens with immediate effect. I thank members for listening and I will now hand over to my colleague Ms Karen Keely.