Mr. John Hennessy:

I will take that one, and I might ask Professor Barry to speak to Deputy Durkan's point again about European standards, the FDA and consistency across jurisdictions. Deputy O'Connell inquired as to who in the leadership makes the decision. Essentially, what happens there is that the HTA reports go to the drugs committee, which reports to the leadership team of the HSE. A number of those reports are on the agenda for the HSE leadership team each month. As an indicator of the significance of the decisions that are involved, we are talking about multimillion euro expenditure and investment decisions, particularly over the five-year lifespan of most drugs and products that are considered.

Those applications come to the leadership team. They are considered in the context of all the other demands on the health care resources, such as hospitals, mental health services, social care, etc. The decisions taken are published as part of the HSE directorate minutes each month. My experience is that it is very unusual for the decision of the leadership team to be contrary to what was recommended by the drugs committee. In fact, I cannot remember any occasion when that has happened.

The process is pretty clear and transparent. The decisions taken are published each month as part of the leadership team papers.