Health (Pricing and Supply of Medical Goods) (Amendment) Bill 2021

Public bill · Private Member · Introduced

The proposed law would change how the Health Service Executive decides whether to pay for rare-disease medicines, known as orphan medicinal products. It would give the HSE specific guidance for judging these medicines, so they are not treated the same as ordinary drugs when standard cost tests don’t reflect the small patient numbers and severe illnesses involved. It would also add new factors for the HSE to consider, including patient and doctor evidence, unmet medical need, whether the same treatment is available elsewhere in the EU, and whether risk-sharing deals with the manufacturer can reduce uncertainty.

Formal long title

Bill entitled an Act to amend the Health (Pricing and Supply of Medical Goods) Act 2013 to establish specific criteria applicable for orphan medicinal products for the purposes of the Health Service Executive making a relevant decision regarding adding an item to the Reimbursement List.

Last updated 28 May 2025