At the end of September, the European Medicines Agency in London held a public hearing on the epilepsy drug sodium valproate, better known in Ireland as Epilim. The purpose of the hearing was to consider whether the warning against taking the drug while pregnant was strong enough. It followed on from a review in 2014 based on which the European Medicines Agency took the decision to strengthen the restrictions on valproate containing medicines owing to the risk of malformations and developmental problems in children exposed to the drug in the womb. The agency's most recent summary guide for health care professionals on the risks associated with valproate for female patients issued in 2016 states: "Sodium valproate 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 because of its high teratogenic potential and risk of developmental disorders in infants exposed in utero to valproate". In its most recent valproate patient toolkit the HSE states: "If you take valproate when you are pregnant it can harm your unborn child". The leaflet goes on to state that for women who take valproate while pregnant around ten babies in every 100 will have a birth defect and that about 30 to 40 children in every 100 may suffer from developmental problems. Shockingly, it was only earlier this year that instructions were issued to include a warning label for the outer packaging of Epilim products that had been introduced in Ireland, but they still not being adhered to everywhere. Unfortunately, these measures have come too late for some. A number of women in Ireland, some of whom are in the Visitors Gallery, were not informed about the harmful repercussions for their unborn child when they were prescribed and took sodium valproate while pregnant. In 2013 Epilepsy Ireland estimated that the drug had affected at least 400 children. The syndrome which affects these children is known as foetal anticonvulsant syndrome or foetal valproate syndrome. It can give rise to spina bifida, heart defects, breathing difficulties, overlapping fingers and toes, club foot, hip dislocation and distinctive facial characteristics.

Last week, I met Karen, Wendy and Susan, all of whom had been prescribed sodium valproate while pregnant and all of whom have children with foetal valproate syndrome. They are not looking for much. Will the Government undertake an investigation into the current and historical use of the drug? Will it acknowledge that these women should be compensated for the impact of the drug on their families? Will it also commit to establishing a State-wide register for those who are on the medicine and those who will be prescribed it in the future, as well as a register for the children who have been affected by foetal anticonvulsant syndrome caused by exposure to sodium valproate? As a matter of urgency, will it put in place appropriate pathways for the diagnosis and treatment of foetal anticonvulsant syndrome, as well as providing additional services for children with the syndrome? Previous Governments did not exactly cover themselves in glory when it came to women's health issues. We have seen Taoisigh and Ministers for Health stand where the Tánaiste is and apologise to women. She has a chance to do this right. I ask her to take that chance.

The Deputy raises an issue about a drug that women have been prescribed during pregnancy. As she said, this is not the first time issues have arisen about drugs prescribed during pregnancy which potentially have extremely adverse effects. We have seen this happen in the case of thalidomide and numerous other drugs and women have had to fight quite hard to prove the consequences of the use of such drugs. I am not familiar with the details of the particular drug, but the Minister for Health is informed on issues such as this by the Chief Medical Officer, CMO and the Health Products Regulatory Authority, HPRA, which regulates the use of medicines and drugs. Obviously, there are always clinical decisions involved in the use of a particular drug or prescription. The Minister has heard what the Deputy said and I have no doubt that he will seek a report from the CMO and the HPRA on the particular drug and revert to the Deputy with the details of the information available at this point. The Deputy has said that up to 400 children have been impacted on. If there is information to that effect - I take the Deputy's word for it - clearly it is an issue that needs to be addressed. Further information must be obtained and the clinical position in terms of prescriptions and their impact and so on will have to be examined. I am not in a position to give the Deputy a detailed answer on the drug today, but the Minister will get the information and revert to the Deputy on it.

I thank the Tánaiste for her response. The families affected believe they have been ignored, sidelined and let down by the State. I am giving the Tánaiste an opportunity to make a statement on behalf of the Government to the effect that it will consider the issues of compensation, establishing a register for those who have taken or will take valproate and the putting in place of appropriate care pathways. The women concerned have had to fight for every single element of treatment for their children. They have had to fight and scrap hard and want to hear that the Tánaiste, the Government and the Dáil are on their side. They want to know that the Government is on their side and will not treat them in the same way it treated other women who fought for themselves and their families. There is a black mark on the history of the State in that regard, as the Tánaiste has acknowledged. We have an opportunity to do this the right way and I urge the Government to take it.

As the Deputy said, the European Medicines Agency has started a review of the approach to use of this drug. Very strict warnings are in place in prescribing it for women and girls. It is a drug that is prescribed across Europe. A review is under way and it is expected that a decision will be made by the end of the year by the European Medicines Agency on whether there should be further warnings about the drug being given to women who are pregnant or girls. This is a European as well as an Irish issue. I have no doubt that the Minister for Health will take the results of the review fully into account when making a decision on the management of this issue, as will the HPRA.