Rose Conway Walsh (Sinn Fein) | Oireachtas source

I thank the Minister of State for coming into the House to hear this Commencement matter on the impact of prescribing sodium valproate, or Epilim, which is a drug licensed in Ireland for the treatment of epilepsy and bipolar disorder. The teratogenic effects of valproate, as the Minister of State will be aware, were first reported in the 1980s and have been widely accepted since the mid-1990s. Last year, the French regulator said women taking valproate were four times more likely to give birth to babies with malformations. The types of birth defects attributed to the drug include spina bifida, autism and developmental problems as well as neural tube defects, malformation of limbs, digits and organs and cleft palate. Bipolar women taking the drug were twice as likely to give birth to children with major birth defects. The FACS Forum Ireland is the umbrella group of organisations that have come together to advocate for better services and supports for families and children affected by foetal anticonvulsant syndrome.

The crux of the matter is that parents were not informed of the risks or risk reduction measures that needed to be put in place. Therefore, they continued to be prescribed valproate during pregnancy. The European Medicines Agency introduced measures to strengthen the warnings and restrictions on the use of valproate in women and girls. In February of this year, following a further review, the agency issued additional instructions aimed at further reducing the risks of this drug. While there are no definitive Irish data on how many children may have been affected by exposure to valproate, the FACS Forum Ireland estimates that more than 400 children have been affected since 1983, and I know some of these children. Our Lady's Children's Hospital in Crumlin has indicated that 43 children have received a diagnosis of foetal anticonvulsant syndrome.

We urgently need an independent investigation into the historical prescribing of valproate to pregnant women. If the Minister of State or the Minister has decided that an independent investigation is not warranted, I want to know in detail why. We need an investigation to address whether and how existing cases of FACS could have been prevented; whether appropriate and timely information was provided to healthcare professionals and patients in line with knowledge at the time; whether appropriate decision-making processes were in place concerning the treatment of women taking valproate in line with knowledge at the time; whether appropriate regulatory steps have been taken over time to ensure patient safety; and how a system of redress should be established to meet the lifelong care needs of children and the impact of diagnosis on their families to avoid the need for legal solutions for already burdened families.

I believe the valproate project group has met many times, but we are still waiting for the Department of Health to sign off on funding for the group. Has this funding been signed off on? This is one of the main things I want to leave here knowing today. If the money has not been signed off on, why not?In November last year the French Government approved a €10 million fund to meet compensation, and it said that was just a starting point for what it needed to do. In February of this year the British Health Secretary, Jeremy Hunt, announced a review of how valproate concerns were handled in the past. A do-nothing approach is not acceptable in this State. Appropriate services must be put in place for these children and their families. Valproate-related disabilities are complex, wide-ranging and individual. Obtaining diagnosis in Ireland is difficult and lengthy. Treatment often involves attending a multitude of unconnected and uncoordinated speciality services. Families often have more than one child affected, and in many cases are caring full time for a number of children. It is critical that appropriate supports are put in place. I know families who are desperately in need of therapies and treatment which they cannot afford. Parents have to give up work to care for these children with disabilities that were avoidable at the time. They have no income, and they have no means of getting the support and services they need. That must be done.