Oireachtas Joint and Select Committees

Wednesday, 12 July 2017

Joint Oireachtas Committee on Health

Evaluating Orphan Drugs: Discussion

9:00 am

Mr. John Hennessy:

We will try our best to answer the questions and I will refer certain aspects to colleagues. We are very conscious of this and have huge sympathy for the patients caught in the middle of a dreadful situation. These patients and their families are desperate for solutions.

At the same time we have to strike a balance in that we must comply with legislation which obliges us to proceed or pursue a particular process. Unfortunately, that process takes time. There are some extremely difficult tests to be passed to determine clinical effectiveness and affordability, which is a hard reality. The legislation sets out the rules we must follow.

We have to follow it. The majority of applications get through and get approval, but we have to have regard to the resourcing and the availability of funding. Some previous speakers mentioned drug approvals this year. Six or seven new drugs have been approved already this year and are in reimbursement schemes. Approximately nine from the first half of the year will require additional resourcing to bring them into a reimbursement scheme.