The State has entered into agreements with the pharmaceutical industry since the 1970s. These Agreements provide stability to the medicines reimbursement market for the State and for Industry, thus providing certainty and stability to the supply and pricing of medicines in Ireland.
Two new Framework Agreements on Supply and Pricing of Medicines (FASPM), one with the Irish Pharmaceutical Healthcare Association (IPHA), representing the innovator biopharmaceutical industry) and one with its generic/biosimilar industry equivalent, Medicines for Ireland (MFI), for the period 2026-2029 were signed on the 3rd of March.
These Agreements contain a range of measures to:
• Strengthen security of supply of medicines, address the risk of shortages and minimise their impact on patients;
• Encourage off-patent launches, enhancing access to medicines;
• Deliver faster access for patients including a commitment and a structured process towards achieving a 180-day timeline for reimbursement decisions by Q1 2029, accelerating patient access to new treatments;
• Build capacity to implement improvements across the pricing and reimbursement process; and
• Support the financial sustainability of health services in Ireland.
These Agreements send a strong message to patients and innovators that Ireland is an attractive market and conducive to timely access to new medicines.
The structured process towards achieving a 180-day timeline for reimbursement decisions by Q1 2029 will be implemented over the lifetime of the Agreement and will involve an end-to-end review of the pricing and reimbursement system, considering every stage of the process.
IPHA member companies will also aim to shorten the timeline to submit reimbursement applications in Ireland to within six months of formal authorisation of medicines by the European Commission (as recommended by the European Medicines Agency).
The State and the sector have also agreed to develop a future strategic partnership. This partnership will support the development of a piloted early access programme focussed on rare diseases in line with Programme for Government commitments.
In terms of HSE Drugs Group meetings and number of drugs reviewed including information on same between 2023 and 2025, this information is publicly available at https://healthservice.hse.ie/staff/information-healthcare-workers/pcrs/corporate-pharmaceutical-unit/
