Minister for Health has announced new Framework Agreements in principle with IPHA and MFI on the supply and pricing of medicines
The Minister for Health Jennifer Carroll MacNeill TD recently announced the successful conclusion of two new
Framework Agreements in principle with the Irish Pharmaceutical Healthcare Association (IPHA) and Medicines for Ireland (MFI) on the pricing and supply of medicines. The Government said the agreements reflect its commitment to ensuring timely access to innovative medicines for patients and supporting security of supply of medicines.
At a time of uncertainty in international pharmaceutical policy, these Agreements, developed in close partnership between the Department of Health, the Department of Public Expenditure, Infrastructure, Public Service and Digitalisation, Health Service Executive (HSE) and the pharmaceutical sector, will support greater predictability and stability in respect of Ireland’s pharmaceutical and medicines supply, said the signatories.
The Department of Health said the Agreements provide a range of measures to:
- Deliver faster access for patients, including a commitment and a structured process towards achieving a 180-day timeline for reimbursement decisions;
- Strengthen security of supply of medicines and reduce the risk of shortages of medicines to patients;
- Encourage off-patent launches, streamlining access to medicines; and
- Support financial sustainability.
These new Agreements will run to 31 December 2029. Following reaching these Agreements in Principle, the parties will work to finalise the text of the new Agreements during the coming month. The final Agreement documents will be published thereafter.
During the previous Agreements period (2021–2025), 244 new medicines were introduced, including 101 for cancer treatment and 67 for rare diseases.
‘Strong message’
Minister Carroll MacNeill said: “[This] announcement sends a strong message to patients and innovators that Ireland is a positive environment for industry that rewards innovation, affordability, and the stable supply of generic and biosimilar medicines for the benefit of Irish patients. “The Agreement in Principle with
IPHA represents a major step forward in improving access to medicines for patients in Ireland. It strikes a balance between fostering innovation and maintaining financial sustainability, as well as providing for improved certainty and predictability.
“The Agreement in Principle with MFI will help to strengthen the secure and stable supply of medicines, securing increased access to state-of-the-art biosimilar medicines and recognising opportunities to add value for the State through a pilot programme for Value- Added Medicines.
“Together, they provide a platform for continued investment and innovation at a pivotal time for Ireland and the pharmaceutical sector. This year, our budget for medicines is increasing by over €200 million, with €30 million ring-fenced to support access to the latest medicines.
“My sincere thanks to all involved for their collaborative efforts in reaching this agreement.”
Key highlights of IPHA Agreement in Principle
The pricing and reimbursement process for new medicines will be enhanced across all stages of the assessment process, including for Health Technology Assessment, with a new framework of reforms to drive improvement over the course of the Agreement.
Faster access for patients
The agreement provides a commitment and a structured process towards achieving a 180-day timeline for completing health technology assessments (HTAs) and reimbursement decisions, accelerating patient access to new treatments. An implementation plan, process improvement and investment in enhanced capacity will support delivery of this ambitious commitment. Starting in 2026, the capacity of the HSE Drugs Group will be enhanced to facilitate a greater capacity to process applications, including those currently under consideration. A monitoring framework within the Pricing and Reimbursement system will support oversight of progress during the lifetime of the Agreement.
Financial sustainability
Measures include predictable pricing structures, lifecycle management of medicines, and mechanisms to manage financial risk. These steps aim to balance innovation with affordability, ensuring the health service operates within budgetary constraints.
Transparency and oversight
A joint oversight committee will monitor delivery of commitments, including timelines to reimbursement, access to new medicines, and agreed financial sustainability measures. Further, recognising the continued value in strengthening partnerships between the State and pharmaceutical representative body, the Agreement creates structures for enhanced and more frequent engagement throughout the life of the Agreement.
The IPHA member companies will 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 (EMA)).
Key highlights of MFI Agreement in Principle Strengthen security of supply of medicines and reduce the risk of shortages of medicines to patients:
A suite of measures is designed to ensure the supply of essential medicines and position Ireland as a competitive market, securing greater diversity of supply in areas where patient access may be at risk of disruption. These measures are critical to reducing the risk of medicine shortages that could negatively impact patients.
Encourage off-patent launches, streamlining access to medicines: Through the mechanism of tiered- pricing, review of current processes and rewarding of incremental technological improvements in the context of value- added medicines, companies will be further encouraged to launch generic and biosimilar products as quickly as possible into the Irish market upon lapse of a patent. This will support the maintenance of a diverse, stable supply of medicines for patients in Ireland.
Maintain financial sustainability of medicines for the State: Following engagement with MFI, the
The IPHA member companies will aim to shorten the timeline to submit reimbursement applications
State will review the current Best-Value Biologics (BVB) process and adapt it to ensure that best-value medicines, such as biosimilars, are introduced as early as possible.
Value-Added Medicines, for the purpose of this Agreement in Principle, are hybrid medicines where the modification at hand is a patented new technology which offers the potential for an added benefit for patients or for the health service generally. Specific criteria will apply.
Diversity
To enhance security of supply of medicines, the Agreement encourages MFI companies to apply for licensing and reimbursement in Ireland to reduce the use of high-cost Exempt Medicinal Products (EMPs). This should secure greater diversity of supply in markets where patient access is at risk of disruption by decreasing the dependency of our healthcare service on EMPs.
Speaking following the announcement, Paul Neill, Chair of MFI, said: “[This] Agreement in Principle marks an important milestone for Ireland’s medicines supply framework. The measures outlined… including supporting earlier off-patent launches, to reducing reliance on exempt medicinal products and enabling faster adoption of best- value biologics, are precisely the types of system improvements MFI has championed for years.
“These reforms will help reduce the risk of shortages, enhance suppliers’ predictability, and ensure the health service benefits from the value generated by our sector, which can be reinvested in the health system.”
