Mr. Shaun Flanagan:

Two committees are involved in the process. The drugs group is the standard committee which reviews all new medicines that are coming to the HSE for reimbursement. Then there is the rare diseases TRC, which was in effect a recommendation from the previous report of the Joint Committee on Health for more patient engagement. One of the challenges around the rare diseases TRC is that because of its special nature, you have to constitute new expert members each time a drug goes to it. Basically, you need the clinicians who are the experts in that area to populate that committee.

The drugs group is a more general committee. Usually, it is not possible to make a quorum in August but other than that it meets monthly. In an effort to try to make the process as efficient as possible, the drugs group looks at a medicine first. If it is an orphan drug and the drugs group is minded to say "Yes", it does not send the drug to the rare diseases TRC because the HSE will have said "Yes" already. If the drugs group has some concerns or is unable to say "Yes" on the basis of the assessment in front of it, it then engages with the rare diseases TRC to try to acquire additional information to enable the drug to get over the line. A judgment has been made that this the most efficient way to utilise the expertise of the rare diseases TRC. Rather than asking it to look at every orphan drug, we ask it to focus on the orphan drugs that we are having difficulties around. That is why it seems to meet infrequently. When it has a medicine in front of it, my understanding is that it meets frequently and works hard.