Kate O'Connell (Dublin Bay South, Fine Gael) | Oireachtas source

I welcome the sharing of clinical information and joint clinical assessment, leading to efficiency. In the case of a recent drug, Orkambi, as far as I know it did not get through the normal approval process and there was an intervention after the assessment. I believe the approval of the drug was a combination of the process along with Ireland's unique relationship with the cystic fibrosis condition. In the case of another condition or illness that might be specific to a certain group or population, is there a facility for those groups within the combined model? Where countries have high scale manufacturing of drugs, is it built into the system that such countries would not favour their products over other countries' products?

My understanding is that the entire budget is together. Last week or the week before that this committee asked about the total drugs spend. Although the drugs spend is still very high, despite reference pricing and the arrival of generics, it appears that the savings on regular drugs have been taken up with the spend on high tech and orphan drugs. Would there be any benefit in separating these budgets, so it is clear where we are making savings and where is the spend? I am not sure if having a budget ceiling on spending on orphan drugs is the way to go. There is almost a target or limit for what can be spent. What happens if the money is all spent and an orphan drug emerges that we really want to approve? How will we deal with that? I take on board Dr. Lesley Tilson's comment that the research has to be in English as the first language. It is of no use if one cannot interpret it.

We are under time pressure so I will conclude with that.