Michael Harty (Clare, Independent)
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At a previous hearing, a recommendation or suggestion was made that orphan drugs need to be dealt with differently to standard drugs but the legislation does not allow for a distinction between a standard or common drug and an orphan drug. A recommendation was made that the legislation would be reviewed to see whether amendments to the legislation were necessary to allow a different process to be undertaken for orphan drugs. Do the witnesses believe that the legislation in its present form can accommodate orphan drugs or does it need to be amended?