Ms Clair Kelly:

I will go back to Deputy Brassill's question, which we did not answer. The NCPE process was probably one of the most transparent elements as it was published. There is a 90-day timeline, albeit with a stop-the-clock element as well.

They have that period within which they have to report back. The problem arises for us when the recommendation leaves the NCPE. There are then no timeframes and there is very little transparency. There is also no direct communication with the HSE. That is the stage at which we come up against most of the problems. In the case of the NCPE, we do not know what actual studies were reviewed. While the NICE in the United Kingdom has a list of every document it has received, the NCPE does not. There is no record of an entire study and it is the same with Respreeza. We do not know where the study went or if and when it was assessed.

As regards the children and clinical trials, we did not have a clinical trial site in Ireland for this treatment. The children have been at a double disadvantage in that they have not had an opportunity to take part in a clinical trial and, when trials do come through, they have to waiting longer. It is 22 months since the beginning of the NCPE process and three years since the EMA approved the drug. That is a long time in anybody's life but particularly so in the case of a five year-old child.