Dr. Kathleen MacLellan:

I will start with Deputy O'Reilly's question about the confidence the Department would have in the quality of assessment and whether the assessments would be of sufficient standard. The Department's view of standardisation is that it is critical that those standards are met. What is proposed is building on the current work and our current work across the various EU HTA networks. The regulation proposes the use of common tools and common standards, which we would welcome. We were very clear when the Commission visited the Department in December that this was a red line for us, and that it would be problematic if standards are seen to be diminished around HTA assessment. There are articles within the regulation which require standardisation, so as the regulation is further developed we will have to engage with, track and monitor that to ensure we are satisfied that the requirements in the regulation will continue to allow us to have the confidence in the standards that would be expected around HTAs across the member states.

I will briefly comment on Deputy Durkan's reference to subsidiarity. I am responding on the issues to which I can respond before handing over to my colleagues. With regard to the subsidiarity principle, we have been considering this as the proposed regulation offers potential benefits and efficiencies to a small country such as this. It is probably small countries that will benefit most from this type of collaboration. We are already engaged in collaboration on a voluntary basis. The regulation is proposing to put a regulatory and legal framework behind that. At this stage and as it is developing we see many positive benefits for us. It gives us the opportunity to leverage the clinical assessments that are being carried out internationally and to prevent duplication. We believe that will be useful.

It will be important that we can continue to manage the aspects that are sensitive to our own national public interests and matters relating to economic, ethical and organisational elements. From that point of view, we hope that, as a country, we can contribute quite strongly to a stronger European health technology assessment, HTA, function. We are very confident that we have two bodies here that have exceptional expertise in HTA and that is already recognised at EU level. We can see by the fact that Dr. Máirín Ryan is actually chairperson of EUnetHTA that this is recognised and that this regulation will provide us with the opportunity to lead on and participate in HTAs. We are confident on that aspect. I might ask my colleagues to address other aspects raised. Mr. Finian Judge might want to take the question on the Department's role then we might potentially move to the Health Information and Quality Authority, HIQA, and National Centre for Pharmacoeconomics, NCPE.