knowledge 25 February 2026 |

Life Sciences: Update on National Strategy; Framework Agreements on Pricing and Supply of Medicines

Planned National Life Sciences Strategy: next steps

October 2025’s consultation by the Department of Enterprise, Tourism and Employment (DETE) on shaping Ireland’s planned new National Life Sciences Strategy was the first step in delivering on the commitment in the 2025 Programme for Government to shape a national strategy for life sciences.

In terms of timing for the roll-out of the Strategy, the Minister for Enterprise, Tourism and Employment confirmed to the Oireachtas last week that:

• A high-level inter-departmental steering group has been established to lead on the development and implementation of the Strategy.
• A dedicated working group has been established to draft the Strategy.
• Responses to the public consultation are being analysed.
• The DETE will host a series of consultative forums with stakeholders to further inform the Strategy. One forum has taken place already (focused on innovation and investment) and others will follow shortly on patient access, regulation, talent, and skills.

Ireland is preparing to take up the EU Council Presidency in July 2026.  Publication of the Strategy by the end of June 2026 would strategically align Ireland with the repositioning of the life sciences sector more prominently on the EU’s policy and regulatory agenda and continue to attract investment into Ireland’s life sciences sector. 

More information: McCann FitzGerald: Charting Ireland’s Life Sciences Strategy: Scope and Policy Priorities.

Pricing and Supply of Medicines: new Framework Agreements announced

Agreement in principle on new Framework Agreements with the Irish Pharmaceutical Healthcare Association (IPHA) and Medicines for Ireland (MFI) was announced by the Minister for Health on 20 January 2026. Once both agreements are finalised, they will apply until 31 December 2029, replacing the existing (2021-2025) framework agreements. 

The announcement is grounded in key policy objectives including security of supply, faster access for patients, streamlining access to medicines through off-patent product launches and maintaining financial sustainability.  Those objectives stem from long-standing challenges in the Irish market, including delays in reimbursement decisions and recurring supply pressures for certain medicines. Under the new IPHA framework, a joint oversight committee will monitor delivery against commitments.

The Minister also confirmed that the Government’s budget for medicines is increasing by > €200 million this year with €30 million ringfenced to support access to the latest medicines.

IPHA Framework Agreement: accelerating access

Commitment to the 180‑day reimbursement timeline 

Perhaps the most significant development is a clear policy commitment to meet the statutory 180‑day timeline for reimbursement decisions by the HSE under the Health (Pricing and Supply of Medical Goods) Act 2013. Issues with meeting the statutory timeline had been highlighted by the IPHA as part of its examination of Ireland’s pricing and reimbursement system in its Position Paper on the 2025 Programme for Government Commitments.

Underpinning this commitment will be a structured process which will include an implementation plan, a monitoring framework, and enhanced capacity within the HSE Drugs Group to process applications.

IPHA member companies will also look to shorten the timeline for submitting reimbursement applications in Ireland once a medicine has been authorised by the European Commission – the aim will be to submit those applications within 6 months of Commission authorisation.

This indicates a move towards a more predictable and transparent reimbursement pathway, which will benefit product launch planning and strategies for market access for pharma companies operating in the Irish market.

Pricing predictability and lifecycle management 

The new IPHA Framework Agreement will also look to provide greater predictability around pricing, and improved lifecycle management of medicines, alongside mechanisms to manage financial risk for the State. Importantly, it will establish a formal structure for ongoing engagement between industry and Government throughout the life of the Agreement.

MFI Framework Agreement: strengthening supply

The renegotiated MFI Framework Agreement will focus primarily on security of supply, and aim to enable earlier access to generic, biosimilar and value-added medicines.

Addressing supply shortages and encouraging off-patent launches

Reflecting increasing concern across Europe about supply disruptions, the new MFI Framework Agreement will include measures designed to reduce the risk of shortages. In particular, the role of generic and biosimilar manufacturers in maintaining stable supply is emphasised - process reviews, tiered pricing, and rewards for incremental technology improvements will be used to encourage launches of generic and biosimilar products once patent protection has lapsed.

Best-value medicines

The existing process for best-value biologics will be reviewed and amended to ensure that best-value medicines can be launched as early as possible. 

Steps will also be taken to facilitate the introduction of value-added medicines (hybrid medicines where the modification is a patented new technology with added benefits for patients or the health service).

MFI members will also be encouraged to apply to have products licenced in Ireland for launch, rather than depending on exempt medicinal products. 

For generic and biosimilar manufacturers, this will create opportunities to bring products to the Irish market more efficiently, while also supporting innovation beyond traditional price‑based competition.

Early Access Schemes

Again in line with commitments in the Programme for Government 2025, the Government also agreed with the pharma sector to develop a future strategic partnership on a sandboxed early access programme for rare diseases proof of concept.

How we can help

Our market-leading Life Sciences Group advises pharmaceutical, biotech and medical device companies on the full range of regulatory, pricing, reimbursement and supply‑chain issues arising in the Irish market. We are closely monitoring developments as the final Framework Agreements are settled and would be delighted to discuss what they mean for your business.