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 case the Deputy misinterpreted what I was saying, I am pretty clear in my view that the only way we can provide guarantees to the population on quality, safety and efficacy is by following the processes that are set out. However, I can understand how, in extremisand in cases where it is thought that the State may have had a role in something, exceptions may be made. Historically, it has always been possible for clinicians to set out individual circumstances of patients under exempt medicinal products legislation, where drugs were not licensed. There are, in exceptional individual circumstances-----

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