Ireland’s Presidency Health Agenda will aim at positioning health and competitiveness as mutually reinforcing priorities. We will promote population health and wellbeing as a vital foundation for European security and competitiveness and highlight how innovation in health systems delivers better health outcomes for European citizens. We will advance the EU Life Sciences agenda and promote innovative and proactive healthcare that focusses on prevention and the roll out of digital health across the EU.
Ireland's Presidency will drive progress on critical EU legislation that advances our health agenda.
Following over two years of intense negotiations, the EU Pharmaceutical Package is currently being finalised. Ireland welcomes the finalisation of this important file, as it gives certainty and stability to the regulatory landscape for pharmaceutical manufacturing across Europe. This is the first revision of the legislation in 20 years. Following formal approval of the text, work will commence to analyse the implications of the text, to allow for transposition and implementation, in collaboration with relevant stakeholders., political agreement on both the Regulation and the Directive of the Pharmaceutical Package was reached in December 2025. Ireland welcomes the finalisation of this important file, as it gives certainty and stability to the regulatory landscape for pharmaceutical manufacturing across Europe. This is the first revision of the legislation in 20 years. Following formal approval of the text, work will commence to analyse the implications of the text, to allow for transposition and implementation, in collaboration with relevant stakeholders.
One of the elements of the file is in relation to combatting antimicrobial resistance. The pharma package introduces a new transferrable exclusivity voucher incentivising pharmaceutical companies to help combat antimicrobial resistance by developing priority antibiotics. This voucher will grant companies one additional year of market protection for a pharmaceutical product of their choice.
The Biotech Act I (published in December 2025) is a strategic priority for EU competitiveness and sovereignty. The Act streamlines regulations across clinical trials, advanced therapy medicinal products, and biomanufacturing. It mobilises €10 billion in investment funding (2026–27) via the Biotech EU initiative with the European Investment Bank. Key measures include simplified clinical trial procedures, innovation support mechanisms, and biosecurity safeguards. This flagship legislation will dominate health policy discussions during our Presidency.
The Medical Devices Regulation & In Vitro Diagnostics Regulation (amendments published in December 2025) will simplify and modernise device approval while maintaining patient safety. Expected outcomes include €3–5 billion in annual cost savings for manufacturers, faster patient access to innovative devices, and reduced shortages of critical medical equipment.
The EU Safe Heart Plan aims to reduce premature cardiovascular deaths by 25% by 2035 through improved prevention, screening, and treatment across all Member States. The plan emphasises shifting from treatment to prevention, and among other things calls for stronger action against tobacco and smoking.
Other ongoing files expected to progress during our Presidency include the Critical Medicines Act, the WHO Pandemic Agreement Annex on Pathogen Access and Benefit-Sharing, and the EU Civil Protection Mechanism reform, if not completed during the Cyprus Presidency.
