Alan Kelly (Tipperary, Labour) | Oireachtas source

The witnesses are very welcome and I thank them for their contributions. The committee has written its report and several of us have argued and fought for various different organisations. I and Deputy Brassil and others have worked closely with the Alpha-1 foundation in its fight. In the last week or so, we secured a guarantee on the 19 remaining patients that were on clinical trials. I had a sad situation of my own where someone I knew well, Marion Kelly from Nenagh, who is no relation, unfortunately passed away after being taken off Respreeza. Her family had some satisfaction last week.

Responsibility in clinical trials is a real issue. There are issues around honouring commitments, whereby pharmaceutical companies sign up to these trials but then can withdraw from them. We need protocols around clinical trials in Ireland, but my question is how we do that. It is a very important area and I do not want to see something like this happen again. As far as I am concerned, two people lost their lives after coming off a trial because of how it would be administered. One of those people had been in my office only two weeks earlier.

I am trying not to overlap with the good questions Deputy Donnelly asked. I refer to reimbursement and the whole process surrounding it. There is an issue around jumping between the Department of Health, HSE and the National Contact Points, NCP. Unlike Britain, the NCP here is not aligned with the budget. Therefore, unlike other jurisdictions, those who decide on drugs do not have control over the budget, which is a real issue. How can we change this? We have seen so much jumping around on decision making. The committee found a farcical situation where there were letters going between the Department of Health, the HSE and the NCP; it was insane and it is infuriating. Will the officials give their views on how we can have budgets and decision-making in the one place?

Will the officials comment on the rare disease committee being decision makers and how that might work into the future? I can see that the witnesses are passionate about this but how do they anticipate it will happen?

How do the witnesses envisage they will form part of the team that makes decisions? I ask that because I do not want to see a situation where the witnesses are not part of the team.

Some of us here have had a lot of discussions on biosimilars. How can we move quickly in this area? We must move a lot quicker in this area because it will solve some of the issues. The witnesses referred to the issue, on which I have strong views.

My last question is on genetic services. It is a topical issue because of the revelation about a transcription error in Crumlin. I understand that Ireland is quite behind in terms of genetic services. The HSE has tried to recruit senior people with expertise in this area in order to upgrade services, which hinges on the fact that personalised drugs are the future of medicine. I do not think they can match until genetic services reach the required level from a quality and quantity analysis perspective. In other words, we need a service that is able to review many people pretty quickly. We are nowhere near that stage in Ireland. I would like the witnesses to give their thoughts on that matter.