Reforms set to generate up to €1.4 billion in value for reinvestment in the Irish healthcare system

Medicines for Ireland (MFI), the representative body for Ireland’s generic, biosimilar and value added medicines sector, today welcomed the conclusion of the new Framework Agreement on the Pricing and Supply of Medicines, marking a major step forward in strengthening Ireland’s medicines ecosystem.

The Agreement, developed in partnership with the Department of Health, the Department of Public Expenditure, and the HSE, sets out a comprehensive suite of measures designed to improve security of supply, enhance affordability, and create a more predictable and competitive market environment through to 31 December 2029. 

The new Agreement introduces significant reforms across generics, biosimilars, hybrids and value added medicines, including:

• Accelerated access to generic and biosimilar medicines, supported by smoother reimbursement pathways, clearer assessment timelines, and tiered pricing models designed to encourage earlier launches in Ireland. 
• Stronger protections against shortages, with new mechanisms for urgent price uplifts, structured supply obligations, earlier notifications, and a 1.5% annual price increase for essential medicines. 
• The first dedicated reimbursement pathway for Value Added Medicines, to be piloted from 2028, recognising the innovative contributions of reformulated or repurposed medicines that improve patient experience and system efficiency. 
• A strengthened Best Value Biologic (BVB) framework, with predictable timelines to support the earlier introduction and uptake of biosimilars. 

Taken together, the measures have the potential to generate up to €1.4 billion in value, which can be reinvested to support other innovation and frontline patient services. 

Speaking following the finalisation of the Agreement, Paul Neill, Chair of the Medicines for Ireland Negotiations Team, said: “This Framework Agreement represents a transformative step for Ireland’s medicines system. For years, MFI has championed reforms that create a more sustainable, competitive, and secure market. These reforms are aimed at protecting patients from shortages, encourage earlier access to generics and biosimilars, and support long-term affordability for the State. Today’s Agreement delivers precisely that”.

Donagh O’Leary, Chair of Medicines for Ireland, also added that the agreement: “introduces predictability for suppliers, strengthens supply resilience, and finally establishes a pathway for value added medicines that can bring meaningful improvements for patients. This is an important milestone, achieved through genuine partnership with the State, and we look forward to working collaboratively to ensure its successful implementation.” 

In addition, the agreement also embeds a new governance framework, including structured review points in 2026, 2027 and 2028, to assess impact, monitor supply resilience, and ensure that mechanisms such as tiered pricing, value maintenance realignments, and BVB processes are delivering as intended. It also provides flexibility to respond to future developments, including EU legislation such as the Urban Wastewater Treatment Directive that, if implemented as currently agreed, will have a detrimental impact on the supply of medicines.