EU regulatory shifts for Healthcare and Life Sciences in 2026

As 2026 approaches, the regulatory environment for healthcare and life sciences companies in the European Union is poised for significant change. Building on a busy 2025, the coming year will see several important legislative reforms and new initiatives that are expected to shape the sector's operations and strategic priorities. This article outlines the principal regulatory trends to monitor in 2026, highlighting the implications for industry stakeholders.

Pharma Package: a new chapter for EU pharmaceuticals

A major focus for 2026 will be the ongoing revision of the EU's pharmaceutical legislation, commonly referred to as the "pharma package". This comprehensive reform represents a long-awaited update to existing directives and regulations. At the time of the address, the third trilogue negotiation was imminent, with the Danish Presidency aiming to conclude inter-institutional discussions. The process will continue with the finalisation of the draft legislation, further expert review, and subsequent votes in the European Parliament and Council, followed by publication in the Official Journal.

Depending on the pace of these steps, adoption and publication could occur under the Cyprus or Irish Presidencies, potentially by the end of 2026. The central aim of the reform is to make medicines more available, accessible, and affordable, while simultaneously enhancing the competitiveness and attractiveness of the EU pharmaceutical industry and raising environmental standards. Key topics include recalibration of exclusivity incentives, stronger obligations to ensure medicine availability, and faster access to market to address shortages.

Critical Medicines Act: safeguarding Europe's vital medicines

In March 2025, the European Commission adopted a draft regulation known as the Critical Medicines Act, designed to strengthen EU resilience against shortages of vital medicines such as antibiotics, insulin, and painkillers. The Act introduces a Union list of critical medicines and mandates supply chain mapping and strategic projects to support domestic manufacturing of both essential ingredients and finished products.

With the Council having agreed its position, the next step is for the European Parliament to establish its stance, after which negotiations will proceed to finalise the text. The ultimate goal is to guarantee reliable access to essential medicines, with further developments expected in 2026.

Health Technology Assessment: streamlining innovation across Europe

From January 2025, the EU's Health Technology Assessment (HTA) framework, including the Joint Clinical Assessment, became applicable. Initial implementations have focused on oncology and advanced therapies. The new system aligns evidence requirements across Member States, streamlining access to innovative treatments and enabling earlier alignment on evidence packages, comparators, and launch sequencing.

Looking ahead, this joint approach is expected to expand to additional therapeutic areas, presenting new opportunities for companies to support clients through the evolving regulatory process.

Biotech Act Proposal: biotechnology on the brink

Further, the European Commission published its Proposal for a Biotech Act. It addresses a broad variety of aspects, including measures to:

• foster the use of AI in the medicinal product lifecycle;

• SMEs to obtain easier access to funding and regulatory advice;

• facilitate biotechnology projects in the EU;

• simplify the Clinical Trial Regulation and authorization process;

• provide easier access to funding for EU health biotechnology (€ 10 Billion for now);

• simplify the regulation of ATMPs, including the limitation for the need of Environmental Risk Assessments;

• extend the validity of SPC for ATMPs developed by biotechnology processes;

• screen, report and track suspicious biotechnology product transactions;

• simplify data protection requirements for clinical trials.

The Biotech Act is accompanied by a Proposal for a Directive to place genetically modified micro-organism (GMMO) on the market and on the processing of organs.

Digital Omnibus: navigating the digital regulatory maze

November 2025 saw the publication of the Digital Omnibus, a significant bundle of digital legislation affecting the sector. This includes pivotal laws such as the Data Act, the General Data Protection Regulation (GDPR), and the ePrivacy Directive. These measures are expected to have a substantial impact on digital compliance and data management within healthcare and life sciences. Specifically, if adopted in its current form, (IV)MD would be excluded from the AI Act's HRAIS requirements and no longer be subject to a dual conformity assessment procedure.

European Health Data Space: unlocking a shared future for health data

The European Health Data Space (EHDS) is now in force, with implementation scheduled to roll out in phases from 2029 to 2030. This initiative is of particular relevance to organisations managing health data, as it aims to facilitate secure and efficient data sharing across the EU.

AI Act: Artificial Intelligence moves to centre stage

The AI Act marks a transition from pilot projects to regulated deployments of artificial intelligence within the sector. For companies involved in the life cycle of medicinal products and medical devices, this introduces new regulatory requirements. For (in vitro) medical devices incorporating AI, the current framework entails dual conformity assessment procedures, increasing the regulatory burden.

Product Liability Directive (PLD) Revision

The forthcoming revision of the PLD, due to be adopted nationally by each Member State from 9 December 2026, will fundamentally alter the liability landscape for businesses operating in the EU. One of the most significant changes is the introduction of a presumption of causation in technically complex cases, which lowers the evidentiary burden for claimants and could lead to an increase in successful claims. Pharmaceutical products and medical devices (particularly where safety critical) will be a particular focus for claimants pursuing claims under the PLD.

The revised PLD also places greater emphasis on disclosure and transparency, requiring companies to provide evidence in an accessible manner and subjecting them to increased scrutiny regarding data sharing and disclosure, particularly in cross-border and multi-jurisdictional contexts.

Businesses will need to navigate overlapping and sometimes inconsistent requirements between the GPSR and the new PLD, making careful compliance planning essential. In line with the recent clarification of the GPSR's scope, the recent expansion of the GPSR's scope, the revised PLD also adopts a wider definition of 'product' and a broader scope of liable parties, expressly covering software (including updates and AI systems), digital manufacturing files (such as those used for 3D printing), and digital services that are necessary for a product's function or integration. This will have an impact on, for example, smart medical devices which use software to monitor, diagnose or prevent health conditions or symptoms; and personalised medicine where complex software and AI will be required.

Packaging and Packaging Waste Regulation (PPWR)

The EU's PPWR came into force on 11 February 2025 and its general application is scheduled to begin in August 2026, 18 months later, introducing a comprehensive set of requirements aimed at improving the sustainability and safety of packaging, including life sciences products. By 2030, all packaging placed on the EU market must be designed for recyclability, with strict criteria governing material separation, labelling, and the minimisation of hazardous substances such as PFAS (which can be present in certain life sciences materials including medical devices). Recyclability will become a condition for market access, and packaging that does not meet minimum performance grades will be prohibited. The regulation also mandates harmonised labelling to aid consumer recycling efforts and introduces eco-modulation of extended producer responsibility (EPR) fees, which will be adjusted based on recyclability and recycled content. These measures are designed to incentivise sustainable design and material choices across the supply chain.

Staying ahead in a transformative year

In summary, 2026 is set to be a pivotal year for regulatory change in the healthcare and life sciences sector. Companies should prepare for the implementation and impact of the pharma package reform, Critical Medicines Act, Health Technology Assessment expansion, forthcoming Biotech Act, Digital Omnibus legislation, the phased introduction of the European Health Data Space, and the evolving requirements of the AI Act. In parallel, businesses will need to navigate a new generation of product safety, liability, and sustainability rules, including the revised PLD and the PPWR. Staying informed and proactive will be essential for navigating the dynamic regulatory landscape in the year ahead.