Mr. John Hennessy:

I will make a start on that group of questions. Again, I will be relying on colleagues to come in on aspects of the questions.

In response to Senator Dolan, my sense is that it is not necessarily the case that more rare diseases or rare conditions are being diagnosed but that perhaps more products are being developed to deal with rare conditions than would have been the case in the past. Obviously, that is good news and something we are all delighted about. The less attractive element of it is the extremely high prices that tend to accompany those products. The fact that new products are being developed for conditions that might not have been treated in the past is positive. My colleagues may have something more to say about that.

On the issue of delays, I repeat that the investment outlay required in respect of some of these conditions is quite considerable. It is for precisely this reason that the strict assessment criteria that are now in place were introduced. Professor Barry outlined earlier that we hope to refine this process as much as possible. He alluded to the arrangements for cancer care where some very high-priced products and drugs are coming on stream. That refinement aims to capture, in a more comprehensive way, the input of patients and the clinicians dealing directly with those patients, bring it into the heart of the process and ensure that these perspectives are taken into account when the product comes to the drugs committee and the leadership team. That approach has benefited cancer care here and, hopefully, we will see a similar benefit for rare diseases with which we are dealing this morning.

Deputy Durkan mentioned a few concerns that I will address. I will also rely on colleagues. The concern that we are paying too much is always there. It is for this reason that the 2013 legislation, controls and structures were introduced. Is there duplication? I suspect there is duplication across the EU on this. It does stand out as a really attractive opportunity to rationalise that. Colleagues may have views on this but I suspect the reason it has not happened up to now is because larger jurisdictions may be able to secure better discounts on behalf of their populations and may be less interested in doing this than smaller jurisdictions. The Deputy is right. The Minister has been pursuing this matter with colleagues from smaller states. It does look like an opportunity. I suspect that the HSE cannot proceed with that unilaterally in so far as it would need the agreement of health services across the EU to secure it. Again, it would be difficult for one small health service to determine that but I know the Minister is working on that approach and I hope it will progress.

I absolutely concur with Deputy Murphy O'Mahony that there are real patients and real families involved in every element of this and they are at the centre of it. With regard to the Respreeza clinical trials, I am pretty sure the hospitalisation dimension, or the avoidance of hospitalisation, was factored into the assessment, but I will ask Professor Barry to comment on this.