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Orphan Drugs Bill

July 14th, 2021

Legislation to streamline the HSE decision-making process on orphan drugs

We are pleased to see that legislation is being brought forward to the Dáil that will seek to streamline the HSE decision-making process on orphan drugs. Orphan drugs are medicinal products intended for diagnosis, prevention or treatment of life-threatening or very serious conditions that are rare.

The bill will seek to amend the Health (Pricing and Supply of Medical Goods) Act 2013 (the Principal Act) by putting in place a structure for the HSE to appropriately assess orphan medicinal products when making a decision on adding an item to the Reimbursement List.

The bill is being brought forward by Fianna Fáil TD, Pádraig O’Sullivan, who commented, “Presently, the HSE does not differentiate an orphan medicinal product from other medicines in assessing the cost effectiveness of a medicine seeking reimbursement. The current process often results in roadblocks in approving these vital medicines for people with rare diseases. The Bill will provide clear guidance to the HSE over the appropriate usage of Health Technology Assessment Guidelines when assessing an orphan drug, as well as establish new criteria for the HSE to consider when making a relevant decision. This amendment will help ensure the timely delivery of critical medicines to patients with rare diseases.”

If you’d like to read about how medicines are assessed and reimbursed in Ireland, IPPOSI’s publication, A Charter for Patient Involvement – Medicines Assessment and Reimbursement in Ireland, explains everything that is involved. You can view it here. IPPOSI_Patient-Charter_A4_LO_FINAL.pdf

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