Ms Joan O'Donnell:

I will deal with the questions regarding State responsibility, services and costed services and then hand over to Mr. Murphy.

We must consider the issue of the State's responsibility. We recently met the Minister for Health, Deputy Harris, and clearly informed him that, as we understand it, the State bears the responsibility to ensure that women and children who have been affected by this drug get answers in terms of accountability. The Minister has committed to get back to us by the end of May and consider the issue of compensation. My colleague, Mr. Murphy, will be able to tell us more about what is happening in other jurisdictions on this issue. France and the United Kingdom are very much moving in the direction of compensation. There is a mismatch between when the dangers of the drug were known and when patient information leaflets were changed. There is a huge culpability and liability since 2014, when the EMA had made a ruling but that was not being implemented by a state. There is clear accountability since that ruling. This was the first time the PRAC revisited a drug on which it had made recommendations in order to ensure that those recommendations were being properly implemented.

Yesterday, we heard of a woman in Cork who collected her medication in a plastic bag without a label. It is a similar situation to that earlier referred to by Deputy O'Reilly. There must be an investigation into this matter. We must understand who is responsible. The families and parents affected are under enormous stress. As we explained, they are going from Billy to Jack in terms of getting services for their children. There is no co-ordination of services. It is extremely difficult to get a diagnosis and many people are leaving work in order to care for children. The costs are both unbearable and unmanageable. It is not for us to quantify them. We are an unresourced body trying to advocate on behalf of women and do not have the resources to carry out that sort of cost analysis. There is financial cost but also a cost in terms of lives, quality of life and lost and damaged relationships. The costs to people's lives are immense. We must establish accountability and make some retribution or redress on that basis. We hope that there will be a cost analysis on the Cumberlege report, which has just been issued in the UK, because it has been resourced.

As far as I am aware, there has been no resource put into this here. I will hand over at this point to Mr. Murphy.