Life Sciences

EU pharmaceutical package

The long-awaited revision of the EU pharmaceutical legislation has reached a significant milestone: agreement was secured on 11 December 2025 at the trilogue stage between the European Commission, the European Parliament and the Council of the European Union. This marks the conclusion of interinstitutional negotiations on the comprehensive legislative proposals, which take the form of a new Directive and Regulation, and which are the first major overhaul of EU medicines law in over 20 years.

Agreement has been reached at a time when companies are already under pressure to adapt to shifting global trade and supply chain dynamics.

Companies should prepare for fundamental changes to regulatory data protection, market exclusivity, and supply/shortage notification obligations. Strategic planning for product development and lifecycle management will be essential to navigate the new framework effectively. The new texts will enter into force after publication in the Official Journal, which is not expected to take place until later in 2026. An as yet unspecified transition period will then apply which is likely to be between 18 and 36 months.

For more information read our briefings: EU pharma package: agreement reached and EU pharma package: trilogue negotiations commence.

Health Package & Food and Feed Package adopted by European Commission

In a suite of items labelled the “Health Package,” the following were announced on 16 December 2025:

• A Biotech Act;
• Revised rules for medical devices;
• A “Safe Hearts” plan which takes the form of a Communication on an EU cardiovascular health plan.

The measures comprise a mixture of simplification and new initiatives.

On the medical devices front, a revision of the Medical Devices Regulation and the In Vitro Diagnostic Medical Devices Regulation, was announced by the European Commission. These had been enacted in 2017 with delayed implementation dates of 2021 (MDR) and 2022 (IVDR). It is fair to say they have been subject to quite a lot of criticism from across the spectrum, in terms of their implementation and so this proposal to revise will be welcomed. The proposals are far from settled text as they will need to go through the legislative process.

The proposed Biotech Act will also need to go through the interinstitutional legislative process. The Safe Hearts plan will require work with Member States - one of the aims is to cut premature deaths from cardiovascular disease by 25% by 2035.

A Food and Feed Safety Omnibus proposal was also announced at the same time, with a particular focus on biopesticides.

For more information read our briefing: Green light – Health Package & Food and Feed Package adopted by European Commission.

Geopolitical considerations

The alignment of the above legislative processes with broader geopolitical and trade developments is prompting companies to think more strategically about regulatory certainty, supply chain restructuring, investment planning, and long-term market access.

Irish pharmaceutical and medtech companies are closely monitoring the evolving U.S. tariff environment. Notwithstanding the ongoing Section 232 investigations, under national security grounds, the position has stabilised somewhat since the summer.

The EU/US deal reached in Scotland has been confirmed as all inclusive in terms of EU pharma exports and pharma will be capped at a ceiling of 15% following the outcome of the s232 investigation. The position on medtech is still under negotiation.

Life Sciences Strategies & presidency of the Council of the European Union

An EU strategy for life sciences was published in July 2025, and a national strategy is expected to be published in 2026.

The EU strategy is called: Choose Europe for Life Sciences – a Strategy to Position the EU as the world’s most attractive place for Life Sciences by 2030. The Irish decision to have a domestic strategy for life sciences was announced in the Programme for Government in 2025. In September 2025, the Irish government published an Action Plan for Competitiveness & Productivity which indicated that the national strategy will be published in 2026. The Department of Enterprise, Tourism and Employment held a public consultation on the domestic strategy, which closed in early December 2025.

Ireland will assume the Presidency of the Council of the European Union in the second half of 2026. The focus of the Presidency has yet to be announced but it is widely anticipated that life sciences will feature.

For more information read our briefing, Towards 2030: The EU’s vision for life sciences and food innovation.

For a comprehensive overview of the sector please see our Life Sciences Outlook 2025, our Life Sciences Group publication with expert insights into the legal and regulatory developments shaping the life sciences sector.