Remember me
The real test will be whether Ireland pairs its strong cost controls with stronger governance, clearer timelines and better resourcing for decision-making, writes Terence Cosgrave
Access to safe, effective and affordable medicines is one of the central tests of any modern health system. In Ireland, that access is shaped not only by clinical decisions, but by the commercial frameworks governing how medicines are priced, reimbursed and supplied. The current multi-annual Framework Agreements between the Irish Government and the pharmaceutical industry—through the Irish Pharmaceutical Healthcare Association (IPHA) and Medicines for Ireland (MFI)—have attracted debate. Critics argue that Ireland still lags behind other European countries in speed of access to new medicines. Supporters counter that the agreement provides sustainability, stability and a platform for improved patient access over time.
Terence Cosgrave and pup
In my humble opinion (IMHO) the current Irish deal represents a genuinely positive settlement for patients, particularly when viewed against Ireland’s previous agreement and comparable arrangements across Europe. Its core strength lies in combining cost control with predictability, freeing up resources for new treatments while avoiding the volatility that ultimately harms patients.
The current agreements were concluded in late 2021 and ran until 2025. One applies to originator and on-patent medicines (IPHA), while the other governs generics and biosimilars (MFI). Together, they establish the rules under which medicines are priced, reimbursed and supplied to the Irish health system.
The Government has stated that these agreements will deliver €600–€700 million in savings or cost efficiencies over their lifetime, relative to what the State would otherwise have paid. These efficiencies arise through a combination of mandatory price reductions, international reference pricing, and—crucially—increased rebates paid by manufacturers to the Health Service Executive (HSE). Under the new deal, rebates rise in steps over time, reaching around nine per cent, compared with approximately 5.5 per cent under the previous agreement.
From a patient perspective, this headline figure matters because medicines spending is not a theoretical exercise. Ireland spends over €3 billion per year on medicines. Without mechanisms to control that growth, health systems typically respond by delaying reimbursement decisions, restricting eligibility, or simply refusing to fund new therapies. The value of the deal, therefore, is not merely the cash saved, but the budgetary headroom and predictability it creates.
Why is the Deal Is Good for Patients
1. Sustainability Is a Precondition for Access
Patients ultimately benefit most from systems that can say ‘yes’ consistently, rather than ‘no’ sporadically. By locking in large, predictable efficiencies, the Irish agreement reduces the risk that high-cost innovative medicines crowd out other treatments or destabilise the system.
In practical terms, the Government explicitly linked the agreement to additional funding for new medicines. Between 2021 and 2025, Budgets allocated €158 million specifically for new medicines, and the Department of Health has stated that this supported the approval of 238 new medicines for Irish patients during that period. While not every approval can be attributed solely to the agreement, the connection between controlled costs and expanded access is clear.
2. A Rules-Based System Benefits Patients
The framework approach replaces repeated ad hoc negotiations with a clearer, rules-based structure. This matters to patients because unpredictability is the enemy of access. When manufacturers, clinicians and the health service all operate under defined commercial rules, decision-making becomes more consistent and less prone to sudden freezes or reversals.
Ireland has used such agreements for decades, but the current version strengthens this approach through higher rebates and tighter pricing mechanisms, particularly in off-patent markets. For patients dependent on long-term treatments, stability of supply and pricing is not an abstract benefit—it directly affects continuity of care.
3. Off-Patent Savings Fund Innovation
A particularly patient-friendly aspect of the deal is its emphasis on extracting greater value from generics and biosimilars through the MFI agreement. These medicines treat large patient populations and represent a major share of volume, even if they are cheaper per unit.
Every euro saved on an off-patent medicine is a euro that can be redeployed to fund innovative therapies for cancer, rare diseases or advanced chronic conditions. In this sense, the agreement supports a virtuous cycle: mature medicines are priced aggressively, while resources are redirected toward innovation.
4. Supply Stability in a Small Market
Ireland is a small market that relies heavily on imported medicines. Multi-annual agreements reduce uncertainty for suppliers and lower the risk that Ireland becomes unattractive or administratively burdensome relative to other countries. While global shortages are driven by many factors beyond national control, stability and predictability improve the likelihood that Ireland remains a reliable destination for supply.
From a patient perspective, the key improvement is not simply that the State pays less, but that the State has more confidence to approve new medicines without fear of uncontrolled cost escalation. The Government’s own narrative—that the agreement helped enable hundreds of new medicine approvals—would not have been credible under the looser fiscal environment of the earlier deal.
How Ireland Compares with Other European Countries
No European country has solved the medicines access challenge perfectly. The difference lies in how systems balance price control, speed of access, and budget impact.
United Kingdom: Strong Access Guarantees, Strong Industry Rebates
England’s system combines a national commercial deal (currently VPAG) with assessments by NICE. Once NICE recommends a medicine, the NHS is generally expected to fund it within a defined timeframe, typically around three months. This creates clarity for patients and clinicians.
However, this certainty is underpinned by substantial industry repayments when overall spend exceeds agreed growth rates. In effect, the UK secures access by shifting more financial risk onto manufacturers. Ireland’s approach is less prescriptive but arguably more cautious, reflecting a smaller system with less leverage.
Germany: Early Access, Later Negotiation
Germany’s AMNOG system allows medicines onto the market quickly, with prices negotiated later following assessment of added benefit. This delivers fast access, but it can expose the system to higher short-term costs if prices are not swiftly corrected.
Ireland has chosen a more conservative path: agreeing commercial rules upfront and reimbursing once value is established. This is slower, but it reduces the risk of paying high prices for marginal benefit—an outcome that ultimately harms patients if budgets are exhausted.
France and Italy: Value-Based Negotiation with Conditions
France and Italy rely heavily on central negotiation linked to assessments of therapeutic value, often combined with managed entry agreements or outcome tracking. These systems can expand access under uncertainty, but they also impose significant administrative complexity.
Ireland’s framework is simpler and less burdensome to administer, which can be an advantage in a smaller system with limited capacity.
The strongest criticism of the Irish model—and one that patients feel most acutely—is delay. Reimbursement decisions in Ireland frequently exceed statutory timelines, and access to some new medicines lags behind other European countries.
Importantly, this is not primarily a flaw of the commercial deal itself, but of the broader decision-making and resourcing environment around health technology assessment and reimbursement. A price framework can enable access, but it cannot, on its own, guarantee speed.
The real test of the next iteration of the agreement will be whether Ireland pairs its strong cost controls with stronger governance, clearer timelines and better resourcing for decision-making.
The Irish Government/IPHA/MFI medicines deal is best understood not as a magic solution, but as a necessary foundation. It secures hundreds of millions of euro in efficiencies, improves predictability, strengthens off-patent competition, and supports sustained funding for new medicines. Compared with Ireland’s previous agreement, it is more robust and more explicitly linked to patient access. Compared with other European systems, it prioritises sustainability and value over speed, reflecting Ireland’s size and fiscal constraints.
For patients, the deal is generally a good one because it makes access more sustainable over time, even if it does not yet make it as fast as patients would wish. The challenge now is not to dismantle this framework, but to build on it—ensuring that the financial stability it provides is translated into faster, fairer and more consistent access to medicines for everyone who needs them. 
Comments (0)