Committee StageStage in the legislative process — click for what it meansCurrentThe bill’s status — click for what it means33rd DáilThe House currently handling the bill122/2021Official bill number / year
Health (Pricing and Supply of Medical Goods) (Amendment) Bill 2021
- Sponsor
- Pádraig O'Sullivan · Fianna Fáil
- Introduced
- 5 Oct 2021
- Last updated
- 28 May 2025
What this bill doesAI · claude-haiku-4-5-20251001
- 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.
Stage timelineWhat do these stages mean?
- First Stage33rd Dáil5 Oct 2021
- Second Stage33rd Dáil5 Oct 2021
- Committee Stage33rd Dáil27 May 2025
Debates
Related bills
- Animal Health and Welfare (Ban on Hare Coursing) Bill 2020First Stage
- Public Health (Single-Use Vapes) Bill 2025Fifth Stage
- Public Health (Tobacco Products and Nicotine Inhaling Products) (Amendment) Bill 2026Second Stage
- Health (Amendment) (Home Support Providers) Bill 2025Fifth Stage
- Public Health (Alcohol) (Amendment) Bill 2025First Stage
- Mental Health Bill 2024Enacted