Renegotiation of the IPHA Framework Agreement Update

As the current IPHA Framework Agreement on Supply and Pricing of Medicines nears expiration, our Life Sciences team discusses key concerns for stakeholders around pricing and faster access to new medicines.

What you need to know

• The IPHA Agreement between the HSE and IPHA outlines the pricing, supply and reimbursement procedures for medicines that are on the HSE Reimbursement List.
• Reimbursement decisions by the HSE, while legally required within 180 days, often take significantly longer, impacting patient access to medicines.
• In its Position Paper on the 2025 Programme for Government Commitments, the IPHA reported an average reimbursement processing time of 617 days, with cancer medicines averaging 694 days.
• Talks have commenced for a new agreement and will likely focus on pricing, reimbursement application times and faster access to new medicines.

The current version of the Framework Agreement on the Supply and Pricing of Medicines (IPHA Agreement) was negotiated in 2021 by the Health Service Executive (HSE) and the Irish Pharmaceutical Healthcare Association (IPHA). It applies to IPHA members only and is a key part of regulating the pricing, supply and reimbursement of new medicines supplied by IPHA members to the Irish public health service.

The legislative framework for medicine and medical device pricing and reimbursement is governed by the Health (Pricing and Supply of Medical Goods) Act 2013 (as amended) (2013 Act). The 2013 Act requires the HSE to maintain a list of items for reimbursement by the State (Reimbursement List). To add a medicine or medical device to the Reimbursement List, a supplier must make a reimbursement application to the HSE. The HSE is responsible, under the 2013 Act, for processing reimbursement applications and setting prices for medicines and medical devices on the Reimbursement List.

The 2013 Act provides that, when considering the proposed relevant price of an item by a supplier, the HSE must take into account a range of criteria. These criteria include the terms of any agreements with representative bodies where these agreements relate, whether directly or indirectly, to the pricing of the item in question. One of these representative bodies is the IPHA. The IPHA represents pharmaceutical companies making and supplying new and innovative medicines to Ireland. The current Framework Agreement between the HSE and the IPHA is effective from 1 October 2021 until 30 September 2025 (2021 IPHA Agreement).

The terms of the 2021 IPHA Agreement include:

• Providing a framework for the negotiation of prices for new medicines by suppliers requesting addition to the Reimbursement List
• Managing the price of patent-protected medicines by ensuring downward realignment in prices over the period of the Agreement
• Dictating the value of rebates to be paid to the HSE for the purchase of listed medicines

Overall, the aim of the IPHA Agreement is to ensure timely access for patients in Ireland to innovative medicines at an affordable price for the HSE.

Time to access new medicines

A longstanding issue with the reimbursement process has been the time taken to process reimbursement applications and make medicines available for supply in Ireland. Under the 2013 Act, the HSE is obliged to make decisions on applications for reimbursement within 180 days.[1] However, this timeframe is rarely if ever met.

The IPHA published a Position Paper in February 2025 on the 2025 Programme for Government Commitments.[2] The Position Paper sets out IPHA’s research on timelines from application for reimbursement to patient access. In a press release accompanying the publication of the Position Paper, the IPHA stated that its research found that, of the 88 IPHA medicines reimbursed from 2022 to 2024:

• It took an average of 617 days from medicine application in the Irish system to patient access
• The average time for cancer medicines was 694 days to patient access
• The average time for orphan medicines was 655 days to patient access
• Of the medicines reimbursed during that three-year period from 2022 to 2024, 86% took more than the 180-day statutory timeline outlined in the 2013 Act[3]

The 2025 Programme for Government[4] signalled a commitment to ensuring that patients have access to new innovative medicines and treatments as quickly as possible. The IPHA in its Position Paper was heavily critical of the HSE’s current reimbursement system. It stated that the system is not designed, resourced or governed to enable the HSE to make decisions within the 180-day statutory time period, as required by the 2013 Act. The IPHA noted that the prolonged timelines experienced by its members as part of the reimbursement application process lead to a significant cost to patient health. The IPHA noted that, as a result, increased hospitalisations, lower standards of care, reduced quality of life for patients, and lost lives can be seen

Key principles for a new agreement

The 2021 IPHA Framework Agreement has been in place since December 2021 and is due to expire on 30 September 2025.

The IPHA’s Position Paper proposes Five Key Principles for a renewed Framework Agreement. These Principles were unanimously endorsed by IPHA members:

• Ensuring patients in Ireland have access to a steady stream of pharmaceutical therapeutic advances within clear policy-driven timing after marketing authorisation
• Predictability and stability in medicines expenditure
• Process transparency and communication.
• Financial measures linked to process efficiencies and accelerated patient access
• Regular dialogue scheduled between industry and the Agreement parties[5] 

Speaking at the IPHA Conference in February of this year, IPHA Chief Executive, Oliver O’Connor, stated that he believed these Principles “will improve patient care, allow for more productive partnerships, improve health system functioning and will fulfil the commitments in the Programme for Government for quicker access to new innovative medicines.”[6]

Announcement of talks for a new agreement

On 29 September 2025, the Department of Health announced that it will be entering into negotiations for a new agreement with the IPHA. Minister for Health Jennifer Carroll McNeill said that the State’s relationship with the IPHA “has been an important one, particularly for patients in Ireland, contributing towards sustainable supply of innovative medicines”[7]. The IPHA welcomed this announcement commenting that the commencement of talks was enabled by Minister's assurances that the State is committed to working with the IPHA “with the explicit aim of achieving the timelines set out in legislation”[8].

However, ambiguity remains as to whether IPHA and the State have agreed to extend the term of the 2021 IPHA Agreement. It appears, based on the announcement of renewed talks, that it may have been extended but this is not yet confirmed.

Conclusion

The agreements between the IPHA and the State are instrumental in setting the framework for medicine pricing, supply and reimbursement in Ireland. However, persistent delays in the reimbursement process—often far exceeding the 180-day statutory timeline under the 2013 Act - have raised significant concerns about patient access to new and innovative treatments. The IPHA’s recent Position Paper underscores the need for a more transparent and efficient process to ensure timely decision-making by the HSE. The Department of Health’s announcement of new negotiations with the IPHA presents an opportunity to enhance the current framework, address operational inefficiencies and strengthen collaboration between the State and the pharmaceutical industry. A renewed agreement which maintains the principles of timeliness, transparency and partnership will be essential to ensuring sustainable access to innovative medicines for patients in Ireland.

For more information, contact a member of our Life Sciences team.

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The content of this article is provided for information purposes only and does not constitute legal or other advice

[1] Section 18(2)

[2] https://www.ipha.ie/wp-content/uploads/2025/02/IPHA-Position-Paper-on-Fairer-and-Faster-Access-to-Medicine.pdf

[3] https://www.ipha.ie/new-research-finds-that-patients-in-ireland-could-get-access-to-medicines-one-year-earlier/#:~:text=Section%2018(2)%20of%20the,guidance'%20and%20'endeavours'.

[4] https://www.gov.ie/en/departme...

[5] Chapter 5, ‘The Way Forward’, IPHA Position Paper. Available from: https://www.ipha.ie/wp-content/uploads/2025/02/IPHA-Position-Paper-on-Fairer-and-Faster-Access-to-Medicine.pdf

[6] https://www.ipha.ie/new-resear...(2)%20of%20the,guidance'%20and%20'endeavours

[7] Minister for Health announces commencement of formal talks with the Irish Pharmaceutical Healthcare Association, Department of Health

[8] IPHA welcomes the confirmation today (Tuesday 29th September) from the Minister for Health, Jennifer Carroll MacNeill TD, that the State will enter into formal talks on a new Framework Agreement on Pricing and Supply of Medicines..