Foetal anticonvulsant syndrome is a condition that affects children born to women who were prescribed the anti-epileptic drug Epilim during pregnancy. Children exposed to this drug in the womb have a higher chance of genetic malformations compared to the general population. An additional 40% of children exposed to Epilim experience developmental delays and have a three to five times greater risk of developing autism and ADHD. In comments made at Epilepsy Ireland's national conference, a neurologist described the impact of Epilim as much worse than thalidomide and much more widespread. Indeed, we know following a statement from the then Minister for Health, Deputy Harris, in 2019 that between 153 and 341 children born in Ireland will have experienced a major genetic malformation due to unnecessary and avoidable exposure to Epilim. The HSE also estimates that 1,250 families have been impacted since the 1970s in Ireland.

Progress on identifying how this could have happened seemed to be taking place when, in November 2020, the Minister, Deputy Stephen Donnelly, issued a statement in which he committed to prioritising an independent inquiry. This followed a meeting with Epilepsy Ireland and the Organisation for Anticonvulsant Syndromes Ireland. However, it was only last week that the draft terms of reference were drawn up, with no indication as to whether the format of the inquiry will be non-statutory or statutory. If it is non-statutory, the parents of women and children want and deserve to know why, especially given the public interest and the potential recommendations which could be made to help to prevent an issue like this from happening again with future medications.

These families have already been through enough, and I think we can agree on that. They must see meaningful action taken from an inquiry, not just a report on a shelf. These families need to know what services are being put in place to help them. Can the Tánaiste outline exactly what services these families can avail of? Will he commit to doing everything possible to assist these families, who need urgent and immediate assistance beyond the promised inquiry and beyond a report on a shelf?

I thank the Deputy. I know this is a very important issue. It affects some of my constituents and some of the Deputy’s. I have read up on it but I have not had an up-to-date briefing for quite some time, so I am reluctant to answer the Deputy’s questions in full for fear of giving her misinformation. I will ensure that my office is in touch with the Minister, Deputy Stephen Donnelly, today to see if we can get her a more detailed reply in writing.

In terms of the format of the inquiry, there are advantages and disadvantages to the statutory and non-statutory approaches, as the Deputy knows. The Scally report, for example, was non-statutory but was done quickly and, I think, was done very well. A statutory one would take a lot longer but would have the advantages of particular powers of compellability and being able to make particular findings that could not be made by a non-statutory one. I am not sure what the Minister decided in that regard.

I also hear the question the Deputy has asked in regard to the services being made available to these patients. Again, I will be in touch with the Minister for Health about that and will make sure the Deputy gets a detailed note on it.

I thank the Tánaiste for his constructive response and his commitment to seek further information, which I am sure the families will appreciate. I want to point out that the Minister, Deputy Stephen Donnelly, did commit to convening a stakeholder group to see what can be done and, certainly, to stamp out the risks associated with Epilim. It is vital that the stakeholder group be established immediately because this is something that could run alongside an inquiry. In addition, back in 2018, the recruitment of four epilepsy nurses was committed to. That would also be very helpful, particularly for the purpose of the implementation of the pregnancy programme, so we need to have that recruitment also. These measures will go some way to ensuring that no family will be affected by Epilim in the future.

I also want to point out that it is very concerning that approximately 1,600 women take this drug in Ireland, yet an Epilepsy Ireland survey in 2020 found that one in six women are still unaware that the drug can in some cases cause serious birth defects and learning and developmental problems in children. This highlights an urgent need to get this matter moving and an urgent need also to support so many of those who are affected by this drug.

I thank the Deputy. We will all acknowledge that Epilim is a very effective medicine in controlling epilepsy but, of course, if anyone is pregnant, they need to be made aware of any risks when it comes to any medicine they may take and what risks may affect their child. It is always a difficulty when treating pregnant women that the medicine they often need to control their condition can potentially have a negative impact on the child they are carrying. That makes it a difficult call to make. It is really important that the decision is not just made by the doctor and that the patient is fully informed as to what the risks and benefits are in continuing the medicine and what the alternatives are, and that should happen if it is not happening.

I will come back to the Deputy on the issues around the recruitment of staff and the stakeholder group. Certainly, it is the case that we could have a stakeholder group at the same time as an inquiry, and it is not that one would prevent the other.