The FASPM replaces the previous agreement which had been entered into in 2021 and which expired at the end of September 2025 (“the 2021 Agreement”). At the same time, a similar agreement covering the same time period has been published between the State and Medicines for Ireland, the representative body for generic, biosimilar, and value-added medicines.

The FASPM retains the core structure of the 2021 Agreement (see our briefing from that time  IPHA publishes new Framework Agreement on the supply and pricing of medicines). However, it does introduce a form of commitment to an 180-day new medicines assessment process, as well as material changes to pricing rules, realignment mechanisms, loss of exclusivity measures, rebates, governance and security of supply. There are also specific commitments relating to the legislative provisions enshrined in the Health (Pricing and Supply of Medical Goods) Act 2013 (“the 2013 Act”).

We look at some selected key points below.

Section 1: Interpretation

• The definition of “Supplier” is extended to include manufacturers, importers, or agents.
• Nominated States – Austria, Belgium, Denmark, Finland, France, Germany, Greece, Italy, Luxembourg, Netherlands, Portugal, Spain, Sweden remain, but the UK is included expressly only for the May 2026 realignment. We look at realignment dates further below.

Section 2: Scope and legal status

• The FASPM is expressly non-binding and does not create legal expectations, consistent with the 2021 Agreement.

Section 3: Term

• 1 January 2026 – 31 December 2029, after which date obligations will cease unless continued by mutual agreement.
• Successor negotiations are to begin at least 6 months before expiry.

Section 4 deals with general statutory obligations under Irish and EU law.

Section 5:  General pricing

Subject to any price increases which may be agreed, there are to be no price increases during the term.

There is expansion and recalibration of realignment rules:

• Downward only realignments for all on patent medicines reimbursed before 31 December 2025.
• Annual realignments on 1 March 2027, 2028, 2029 using Nominated States averages.
• May 2026 realignment includes the UK, but the UK is not included in subsequent realignments.
• New medicines receive their first realignment after 36 months on the Reimbursement List (or having been priced as a Hospital Medicine) based on the relevant price in the Nominated States on 1 March 2028.
• The FASPM includes specific guidance around the scenarios in which representations might be made by a Supplier to the Health Services Executive (“HSE”). It will be interesting to see how these play out in practice.

Section 6: Pricing of new medicines

• The Health Services Executive (“HSE”) assesses the proposed price under the 2013 Act. The Supplier will propose a price which is to be considered by the HSE “in accordance with the 2013 Act and, as applicable, the Assessment Principles.” (section 6.2 FASPM). The Assessment Principles are set out in Schedule 3 to the FASPM. In these, suppliers are asked to aim to submit applications and/or “meaningfully engage” with the HSE withing 6 months of the granting of a marketing authorisation. The HSE in turn, commits to make a decision within the timelines set out in Schedule 4 to the FASPM, provided that the application is complete and no further information is sought. Schedule 3 also expressly links to the Health Technology Assessment Regulation. It further states that each application’s status will be visible on the HSE’s online tracker. Rapid Review Assessment reports will be issued within 4 weeks of commissioning of the assessment and validation of the dossier received.
• Suppliers are to acknowledge that the HSE will have regard to the average currency adjusted prices in Nominated States where marketed on the date of application.
• All new medicines subject to annual price realignment and rebates.

Sections 7-9:  Loss of exclusivity pricing, biologics, biosimilars and hybrid medicines

• From 1 January 2026, the price of a Patent Expired Non Exclusive Medicine i.e. a generic, must be ≤40% of the original branded ex-factory price as of 1 October 2025. This is a maximum – medicines may be supplied for a lower price, provided the HSE is notified. For new applications (where no equivalent originator is available in the market), the price proposed by the Supplier shall once again be considered by the HSE in accordance with the 2013 Act and the Assessment Principles.
• There are new percentage thresholds, new reference dates, and a new biologics rebate set out in the remainder of these sections.

Section 10: Rebates

• A new rebate structure has a declining system for rebates paid by suppliers to the HSE, for newly listed medicines, set out by year of the agreement. The rebates begin at 9% for the year 2026 and end at 5% for medicines added to the list during the last year of the FASPM. There is a flat rate of 9% to medicines added prior to January 2026. This section also has specific provisions for Hospital Medicines.

Other key provisions

• There are new provisions to address potential issues around Exempt Medicinal Products, security of supply, shortages and continuation of supply.
• Strengthened horizon scanning: suppliers must notify new medicines 12–18 months in advance -called the “new medicines horizon scan” in the FASPM.
• Suppliers are to provide the HSE with a list in June of each year, of their current pipeline of biosimilar medicines including indicative dates of availability on the Irish market, where known.
• Schedule 2 contains a detailed operational framework for best-value biological medicines and best-value medicines processes not present in the 2021 Agreement.

Governance of agreement

• Schedule 1 sets out the process by which “the State negotiation team” and IPHA will work together to implement the FASPM. There is envisaged a structured system for periodic review and evaluation, with an oversight committee to meet bi-annually. A midterm review will take place in October 2027, with specific points for consideration agreed.

Programme of change for pricing and reimbursement

• Arguably the most significant aspect of the FASPM is to be found in the fourth and final Schedule. In this, the State commits to achieving a 180-day review of new medicines. Despite this timeframe being enshrined in the 2013 Act, Schedule 4 notes that this will require an “end to end, outcomes based review to be conducted in 2026.” Further, “robust and transparent mutually agreed stop clock procedures for all new applications submitted from 1^st January 2026” are to be applied. These will be captured on the online application tracker.
•  The KPIs to be tracked as part of Schedule 4 are not set out, save for the notable KPI that the 180-day period is anticipated to be reached by Q1 2029.

For more information, please contact our Life Sciences Group.