Professor Michael Barry:

What the Deputy is referring to is what we call managed access programmes with specific starting and finishing criteria, or stopping criteria if the system is not working. I do not think there are IT barriers to it. For example, in the case of Nusinersen we are not talking about a lot of patients so it should be relatively easy to track patients and their outcomes. The focus on managed access programmes came on stream with the rare diseases technology review committee, the focus of which is not on cost effectiveness or money but clinical outcomes from the point of view of patients and patient representatives. It is a question of the system focusing on managed access programmes. I think they can be delivered but I take the Deputy's point that for the conditions in respect of which the patient numbers are larger there would be a challenge. For the conditions about which we are speaking, the patient numbers are not large and it should be eminently possible to do it. The idea of a managed access programme is that we know from the trials that, say, 50% of patients may not respond to the drug. I do not think anybody wants to be funding expensive drugs like Spinraza at a cost of €500,000 in the first year and €250,000 per patient in the second year. It is about trying to do the best we can and to ensure that people who respond to the drugs get them.