knowledge 17 November 2025 |

Charting Ireland’s Life Sciences Strategy: Scope and Policy Priorities

In a pivotal moment for a sector that employs around 100,000 people in Ireland and delivers close to €100 billion in exports annually, the Department of Enterprise, Tourism and Employment (DETE) has launched a public consultation on shaping Ireland’s planned new National Life Sciences Strategy. 

The consultation is the first step in delivering on the commitment in the Programme for Government 2025 – Securing Ireland’s Future to shape a national strategy for life sciences to bolster Ireland’s globally competitive position, grounded in its existing “strong competitive advantage” in the areas of pharma and medtech.

Focusing on Scope and Policy

The consultation focuses on scope and the policy context.  It should be considered by stakeholders against the backdrop of the Programme for Government’s commitments regarding access to innovative medicines and treatments, supporting intellectual property rights for medicines, reviewing reimbursement processes, more clinical trials, implementing the recommendations from the review on the end-to-end approval process for drugs, digitalisation of records, a national patient app, electronic prescriptions and a ‘Health in AI’ policy.  The Programme for Government also prioritised boosting IDA Ireland and Enterprise Ireland staffing levels to complement the Irish diplomatic presence in the US, coupled with a need to ensure specialist expertise in the life sciences and digital areas to maximise Ireland’s opportunities.

The Minister for Enterprise, Tourism and Employment has been clear that the strategy, when formalised next year, will be a roadmap for supporting the pharma, medtech and diagnostic industries, positioning them strongly on the global stage at a time when the life sciences sector is rapidly moving up the policy hierarchy.  The European Commission’s EU Life Sciences Strategy, published in July 2025, is evidence of the global importance attached to this sector – the Commission wants to position the EU as the world’s most attractive location for life sciences by 2030 (with the sector currently adding almost €1.5 trillion in value to the EU economy and supporting 29 million jobs across the EU). The DETE consultation looks for input on how the measures set out in the EU strategy could be applied in an Irish context. 

The DETE has also asked for feedback on how broad the scope of Ireland’s strategy should be, observing that life sciences spans “multiple sectors, including (bio)pharmaceuticals, medical technologies, agriculture, fisheries and food production”. 

It also looks for stakeholder input on framing the strategy’s key objectives (e.g. should these cover research and innovation (R&I), global competitiveness, patient outcomes, talent and skills, sustainability, or other areas?) and any key challenges and opportunities that the sector is likely to face over the next 10 years which could be addressed by the strategy. 

While the Government plans to deliver the strategy in 2026, the DETE signposted that further consultations may be necessary before then.

Life Sciences – EU Policy Shift

As mentioned above, the consultation is against the backdrop of an EU policy shift which is repositioning the life sciences sector more prominently on the EU policy and regulatory agendas.  The shift was signposted back in 2024 as part of Ursula von der Leyen’s Political Guidelines for the European Commission 2024-2029 (which highlighted plans for an EU Biotech Act) and was again highlighted in the European Commission’s Competitiveness Compass.

The EU’s Life Sciences Strategy, published in July 2025, continues the competitiveness focus and is grounded in a three-phase approach to repositioning the EU as the most attractive place for life sciences globally by 2030: optimising R&I, ensuring rapid market access for life sciences innovation, and boosting trust and uptake of those innovations.  

Global competition, issues with translating innovation into products and services, complex regulatory frameworks for innovators, and fragmented R&I ecosystems are challenges that the EU is determined to overcome through implementation of the strategy’s deliverables. 

Notable deliverables under the EU strategy include:

• The EU Biotech Act, which will aim to create an innovation-friendly framework in the biotech sector – this is a flagship action under the EU strategy.
• Other key legislative proposals such as the proposed Critical Medicines Act, the planned European Innovation Act, proposed reforms to pharmaceutical legislation, and planned regulatory simplification for medical devices and in vitro diagnostics. 
• Planned strategies in the areas of bioeconomy, medical countermeasures, AI in science, and data union. 
• A Life Sciences Coordination Group to drive innovation-friendly policies, funding and activities, and an interface to connect corporates and investors. 

Some of this has also translated into action points in the European Commission’s Work Programme 2026, which explicitly calls out medical devices as an area where simplification initiatives and omnibus packages would be relevant. Progress is planned for the proposed regulations relating to supplementary protection certificates and unitary supplementary certificates for medicinal products, the authorisation and supervision of medicinal products for human use, and the EU code on medicinal products for human use.  

2026 will be a key year for the sector

2026 will be a strategically important year of legal and regulatory developments for the life sciences sector.  Our Life Sciences Group will be engaging with our clients to deliver legal, regulatory and market intelligence, help navigate new frameworks, implement recent frameworks (EU AI Act, European Health Data Space (and the related Health Information Bill in Ireland), and the Health Technology Assessment Regulation) and scope the challenges and opportunities that will arise.  

Engaging with the DETE on the consultation

Those who wish to make a submission and provide input into Ireland’s first National Life Sciences Strategy should note that the closing date for receipt of submissions is 5pm on Friday 5 December 2025. Respondents have been asked to make their submissions by email marked ‘National Life Sciences Strategy Consultation’ to lifesciences@enterprise.gov.ie.

As Ireland prepares to take up the EU Council Presidency in July 2026, this consultation marks a unique opportunity for our clients to shape a forward-looking life sciences strategy nationally and across Europe. Your engagement can help advance policies that accelerate access to new therapies, support innovation in pharma, medtech, and digital health, and deliver better outcomes for patients and your business. Our Life Sciences Group is ready to help you maximise these opportunities - please contact us to discuss further.