Mr. Shaun Flanagan:

The Senator asked specifically how many orphan drugs get conditional approval and how many do not. Deputy Burke suggested that there were 158. There have been 158 orphan drug approvals over the years but 45 of those are technically no longer orphan drugs because once the patent is lost it is no longer classified as such. As of 6 November there are 113 public assessment reports on the EMA website on orphan drugs. Technically there are 113 orphan drugs left in Europe. Of those, 98 have had approvals, 11 have been refused by the EMA, and four have had withdrawn market authorisations. Of the 98, 14 of those market authorisations were approved on a conditional basis, 72 had full market authorisations and 12 were approved on an exceptional basis. Seventy-six of the 98 orphan medicines have been approved on a conditional or exceptional basis by the EMA, but 72 of them have full market authorisation.