Oireachtas Joint and Select Committees

Wednesday, 21 November 2018

Joint Oireachtas Committee on Health

Evaluating Orphan Drugs: Discussion (Resumed)

9:00 am

Mr. Shaun Flanagan:

The question the Deputy is asking about Spinraza is not one on which we can give a time limit or make any guarantee. Our responsibility while appearing before the committee is to give honest testimony. As context, the drugs group has reviewed Spinraza on five separate occasions to date and has not been able to accept it at the proposed cost, which is a commercially improved offer from that which was originally approved. I am not a member of the group but rather a secretary, and I am non-voting. As I am involved in the commercial negotiations, it is clear it is better to separate me from the vote. It is hard to put a time limit on it because the difference is that Translarna has gone past the drugs group and is under consideration by the senior leadership team. There is a step where the drugs group must make a deliberation, and that drugs group has a responsibility under the Act to give HSE advice but it has not yet given that advice and I cannot guarantee it will be positive, although I would not say it will be negative either. We cannot make a comment on it. The Deputy is asking us to make a guarantee on something that is in an ongoing process.