Professor Michael Barry:

There were a number of points there. With regard to the submission of applications and why we are lagging behind on applications, the reality is that for up to 40% of our rare disease drugs, there is no application for pricing and reimbursement. That has to come down to, in large part, finance. Companies will launch and apply for reimbursement in larger countries - Germany with 80 million, France with almost 70 million, Italy with 60 million and Spain with 50 million in population. It is about money, to be fair about it. It is not all of it but it is a large part of it.

The Deputy mentioned early access. That is an interesting one. We have, through the office of the chief clinical officer, started to look at and are in discussions with regard to early access. I agree that there is a role for early access. It is a question of the devil being in the detail with regard to a lot of this. What drugs would go into an early access scheme? Essentially, we are looking at cancer initially. Who pays? How would you identify the drugs and who would identify them? The devil is in the detail, as I said, but I agree with the Deputy. Early access definitely needs to be looked at. It is a fair point and we are looking at it.

Regarding clinical trials, we have had problems with clinical trials over many years. The Deputy will know himself. We tried to do clinical trials in the past and they proved difficult to do. It is getting better but it is a very important area of access.

On givinostat, the drug for Duchenne muscular dystrophy, we were asked to review that initially. It received a marketing authorisation on 6 June. We were asked to look at it in August. We completed our initial review in nine days. We have met with the company since and we await its assessment of the full dossier. We will make sure that is done quickly.