Louise O'Reilly (Dublin Fingal, Sinn Fein) | Oireachtas source

I thank the witnesses for being here. We respect and appreciate the job the witnesses do and we acknowledge that very often they are portrayed as the bad guys but sometimes they do not help their own cause. Patients come to us because they want to know the status of their approvals. They should not have to contact their local public representatives to get that information. It should be readily available to them but clearly it is not because if it was patients would not be making representations to us. Patients are awaiting the approval of drugs that they believe will be effective for them but are unable to find out the status of the approval of those drugs.

What I am hearing from the Department of Health is that it is out of the loop with regard to the process. I understand there are various meetings and so on. Is it possible to bring transparency to this while respecting commercial sensitivity? I fully appreciate that the Department must uphold commercial sensitivity. Is it possible to put in place a system that keeps the families informed? Everyone seems to be waiting. The clock is ticking and people are told another meeting will take place. Yet, the Department does not know if the matter will get onto the agenda of the meeting. If it does, the Department does not know what is to happen at the next meeting. It seems that no matter who I talk to, that person is never the person who is responsible. It seems it is always a matter for another person.

I found it curious for Mr. Judge to say that the Department was out of the loop with regard to the process. I would have thought the Department would have been central to or involved more in the process. Do the officials have any suggestions on how we might be able to improve transparency?

I will bank the questions. It will be easier in terms of time and I know others wish to come in. Has the rare disease technology review group published a work programme? If so, I have not seen it. If there is a work programme, perhaps it can be shared with us. If there is none I would be a little concerned.

The question of reviews and expected timelines is relevant. We know that we are not dealing with things that necessarily move in a straight line but the possibility of expected timelines and sharing that information is important.

The patient and clinical engagement system in Scotland is a relevant model. Scotland has a similar population size, profile and so on in terms of health. It seems there are far fewer problems in Scotland and the system it has appears to work. Has consideration been given to replicating the best aspects of what they are doing in Scotland? It appears to be working. Central to the system there is the involvement of the patients. That is important.

Will the officials give us an update on or idea of what progress, if any, has been made on the BeNeLuxA group? I apologise if the question was already asked - I may have missed it.

There are problems at the moment relating to clinician and patient input into any new assessment programme. Will this take place before or after the health technology assessment will be completed? I am referring to the opportunity for clinicians and patients to have input. I am trying to understand how it works with the various committees. The officials will know this better than I do but the problem with the HTA and orphan drugs is the low level of information available. Often families say to us that they cannot satisfy the necessary numbers – they simply do not have them. Some assessments may set the bar higher in terms of numbers but if they are not there, they are simply not there. Often that leads people to believe they are excluded from the process and it seems to them as if they are not being listened to. That is why they come back through their local representatives.

Both clinicians and patients are involved in the health technology assessment. Is there an opportunity at that point for patients to have an input and influence over the process so that they will be there and will be able to discuss their experience? Often we are not dealing with big groups and we do not have a large population from which to gather the information. It seems sometimes that the information is not gathered from the people who are there because there are not enough of them.