Ms Vicky McGrath:

Randomised controlled trials are not really an option for rare diseases because there are not enough patients to generate that type of data. It is, therefore, a little unethical for that to be the bar these conditions are being held to. The EMA is well regarded. It is making assessments and recognising there are risks with these assessments, as not everything passes muster a year or two later. When the EMA approves something it puts its best foot forward. The patient community and clinicians are putting their best foot forward. It strikes me that there has to be a way to say we will make a product available even though we do not have the robust data and if it does not work, there could be some kind of comeback on what has been paid to industry, or something like that. It is not beyond the wit of man to work out this kind of stuff. The problem at the moment is that patients are waiting for many years post approval before they get access to these medicines.

Deputy Pádraig O'Sullivan mentioned the number of days for approval. They are the days for the medicines that have been approved. What about the tens of others that have been sitting in the system for well over 600 days? If we approved all of those today, tomorrow the average wait would be up to 1,000 or 1,200 days. That is the real impact. We are looking at the subset that makes it through, but it is about all of those that do not make it through and those that are not even being submitted for reimbursement in this country. We need to turn the system on its head and put the patient first.