Minister Announces New Framework Agreements on Supply and Pricing of Medicines

The Minister for Health, Jennifer Carroll MacNeill TD today announced the finalisation and signing of two new Framework Agreements on the Supply and Pricing of Medicines with Medicines for Ireland (MFI) and the Irish Pharmaceutical Health Association (IPHA). The Agreements have been achieved following collaborative efforts between the State and industry. This announcement follows the announcement of Agreements in Principle in January.

The Agreements will enable faster access to new innovative medicines for patients in Ireland. They also reflect the Government’s commitment to ensuring security of supply for essential medicines, reducing the risk of medicine shortages for patients while safeguarding the sustainability of the health services.

At this time of unprecedented uncertainty in international pharmaceutical policy, these Agreements will support greater certainty and consistency in respect of Ireland’s pharmaceutical and medicines supply. They were developed in close partnership between the Department of Health, the Department of Public Expenditure, Infrastructure, Public Service and Digitalisation, the Health Service Executive (HSE) and the pharmaceutical sector.

The Agreements benefit patients across Ireland by providing 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.

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 for rare diseases in line with Programme for Government commitments.

Minister Carroll MacNeill said:

“In January I announced that agreements in principle had been reached on two new Framework Agreements on the Supply and Pricing of Medicines. Since then, all parties have worked intensively to develop the detailed text and commitments, aimed at improving access to and supply of medicines.

“These Agreements reflect Ireland’s commitment to enhancing security of supply of medicines, rewarding innovation, and ensuring affordability, to enable our health services to provide the right care in the right place at the right time for patients across Ireland.

“The new Framework Agreement with MFI will strengthen the secure and stable supply of biosimilar and generic medicines, securing increased access to world class biosimilar medicines. It will also recognise opportunities to add value for the State through a pilot programme leveraging the unique advantages offered by Value-Added Medicines.

“The new Framework Agreement with IPHA represents a major step forward in improving access to innovative medicines and providing for improved certainty and predictability for patients in Ireland. It strikes a balance between investing in new medicines, fostering research and development while maintaining financial sustainability.

“Together, these Agreements support continued investment and innovation in medicines at a pivotal time for Ireland and the pharmaceutical sector. This year we have a record budget for medicines, increased by over €200 million with €30 million ringfenced to support access to the latest medicines.

“I appreciate the contributions and collaborative efforts of everyone involved in reaching these Agreements.”

These new Agreements will run to 31 December 2029 and final Agreement documents will be published in the coming days.