Question 1

What does the Health (Pricing and Supply of Medical Goods) (Amendment) Bill 2021 do?

Accepted Answer

Excludes fixed cost-effectiveness thresholds (ICER) from assessment of orphan drugs seeking HSE reimbursement listing, preventing standard financial value metrics from disadvantaging rare-disease treatments. Adds new orphan drug assessment criteria to Schedule 3 requiring HSE to consider qualitative patient/clinician data, unmet medical need, and EU availability alongside quantitative evidence. Defines 'orphan medicinal product' under EU Regulation 141/2000 and requires HSE to apply differentiated reimbursement decision-making process specific to orphan drugs.

Question 2

What stage is the Health (Pricing and Supply of Medical Goods) (Amendment) Bill 2021 at?

Accepted Answer

As of 28 May 2025, the Health (Pricing and Supply of Medical Goods) (Amendment) Bill 2021 is at Committee Stage in 33rd Dáil. Once a bill passes every stage in both Houses of the Oireachtas and is signed by the President, it becomes law.

Question 3

Who introduced the Health (Pricing and Supply of Medical Goods) (Amendment) Bill 2021?

Accepted Answer

The Health (Pricing and Supply of Medical Goods) (Amendment) Bill 2021 was sponsored by Pádraig O'Sullivan, and was introduced on 5 Oct 2021.

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

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