Ms Vicky McGrath:

The biggest delay is probably the fact that we are conducting assessments in Ireland when assessments have already been conducted at a European stage. It is a little bit like us saying we will throw EMA out the window and we are all going to do our own assessments of whether a drug is safe and effective. We are in that stage now with the newborn screening, where we just do not collaborate more across Europe and say, "Here is a European decision; let us implement it here." There is definitely lab work that has to be done locally, on the ground in Ireland. We cannot deny that, but it is the precursor to initiating that lab work. It could help if we could initiate the lab work at the same time as the NSAC is doing its reviews. There is reluctance to do that, however, because NSAC could potentially say "No", but it seems incredibly unlikely. All the clinicians are requesting this happen. We are not doing anything unusual. There is nothing particularly unique about the Irish system.