Oireachtas Joint and Select Committees

Wednesday, 21 November 2018

Joint Oireachtas Committee on Health

Evaluating Orphan Drugs: Discussion (Resumed)

9:00 am

Mr. John Hennessy:

To continue with Deputy Durkan's questions, his point about access schemes and participation in clinical trials was a good one.

I reinforce the point that steps have been taken to ensure patients are not vulnerable when they participate in such schemes. These steps include putting in place very transparent consent arrangements and very transparent and clear aftercare arrangements at the outset so that it is clear what happens when these access schemes and trials conclude. We have been in formal contact with our respective hospitals and hospital groups over the course of this year.

I was asked about Orkambi and the variance in cost. The Irish deal is regarded as the probably the best around or certainly one of them. Mr. Flanagan might be able to comment on that. Professor Barry may be able to help on the efficacy and evidence questions arising.

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