Oireachtas Joint and Select Committees

Wednesday, 22 June 2022

Joint Oireachtas Committee on Health

Rare Diseases: Discussion (Resumed)

Mr. Shaun Flanagan:

Orphan drugs are defined in the European regulations. I do not want to put a number on it because I am not in the drugs space day to day anymore, but my memory is one in 50,000 people. I would have to double-check that. It is defined, and there is an orphanet. There is an EU reporting mechanism around how a drug is designated an orphan drug. I believe it is a prevalence rate of less than one in 50,000, but I would have to double-check that. There are other aspects around the rules in that companies can make commercial decisions to de-designate an orphan drug for whatever commercial reason a company might have. It is not so simple.

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