Oireachtas Joint and Select Committees

Wednesday, 8 November 2017

Joint Oireachtas Committee on Health

Evaluating Orphan Drugs: Discussion (Resumed)

9:00 am

Mr. Shaun Flanagan:

In talking about the FDA, all we are saying is it is an authoritative international body with a good strong reputation of assessment of medicines. It has come to a similar decision as the HSE. Did the HSE consider the FDA position in making its decision? Absolutely not. The HSE came to its own decision independently. Granted, when it is trying to defend a decision, the HSE will then point to decisions that other agencies have made. However, one is not using their decision process as a proxy for one's own.

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