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:

In terms of answering that, I am not sure what the Deputy expects. It did not come through a reimbursement process. A standard reimbursement process involves, at the start, the EMA reviewing a medicine for a particular use to decide if the quality, safety and efficacy is appropriate to support market authorisation. After that, we have an assessment process regarding cost-----

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