What will shape European life sciences and healthcare in 2026?

It is likely to be a pivotal year for the European life sciences and healthcare sector, underpinned by the proposals set out in the EU life sciences strategy and UK life sciences sector plan published last year. 

A suite of new legislative proposals and regulatory reforms across biotechnology, medical devices and medicines regulation and clinical trials is set to strengthen competitiveness and resilience. Adoption of AI is expected to mature significantly, shifting from pilots and use cases to embedded, cross-functional tools that transform drug discovery and development, even as regulatory scrutiny intensifies around data governance, transparency and compliance. 

Pharmaceuticals and biotechnology    

EU 

New EU health  package  

On 16 December 2025, the European Commission published its comprehensive Health Package, comprising measures to modernise Europe's health ecosystem while ensuring long-term resilience and competitiveness.

The package includes the first phase of the EU's proposed Biotech Act, targeted revisions to medical device and diagnostic rules, and a Safe Hearts Plan addressing cardiovascular diseases. 

Biotech Act

The proposed Act aims to "turn Europe into a biotech powerhouse", by supporting innovation through a series of policy measures including access to funding to scale biotech companies, harnessing the use of AI, data and digital solutions, and streamlining regulatory procedures. 

The first phase of the Biotech Act (Biotech Act I) predominantly focuses on health-related biotech, food and feed. It emphasises streamlining and accelerating clinical trial authorisation procedures through amendments to the clinical trials rules. The amendments also introduce provisions to facilitate clinical investigations of in vitro diagnostics and combined studies involving both medicinal products and medical devices or IVDs through coordinated assessment procedures. A notable, previously untrailed proposal is a 12‑month supplementary protection certificate (SPC) extension (subject to conditions) for medicinal products developed through biotechnological processes and advanced therapy medicinal products. Read more in Osborne Clarke's European patent litigation predictions for 2026.
 
Biotech Act I will proceed through the EU legislative procedure during the course of 2026, with adoption unlikely to take place until later in the year (at the earliest). The second phase of the Biotech Act is scheduled for publication in the third quarter of 2026 and will focus on areas of industrial policy for biotechnology. 

Targeted revision of medical device rules

Following a year-long public consultation and targeted evaluation, the Commission has published a draft regulation proposing targeted simplification of the Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) to enhance effectiveness while maintaining highest global safety standards. Read more in the Medical Devices and Diagnostics section below.  

Safe Hearts Plan

The plan sets out a series of targets to significantly reduce cardiovascular related conditions and deaths by 2035. The EU proposes a harmonised approach to reduce existing inequalities regarding prevention, detection, diagnosis and care across Member States and to accelerate research and innovation. EU-wide data collection through the European Health Data Space will provide up-to-date information to guide policies and actions in this space.

New gene editing regulation 

On 16 December 2025, the European Council and Parliament reached a compromise agreement on the Commission's proposal for a new regulation for gene-edited plants. The new regulation is expected to come into force this year, and become applicable two years later.

EU Pharma Package 

On 11 December 2025, the European Parliament and Council reached agreement on the Pharma Package, which aims to modernise the EU regulatory framework for medicinal products and strengthen medicine supply security and competitiveness.

Formal publication in the official journal of the European Union is expected in Q2 or Q3 2026, after which full details of the proposed reforms and the applicable transitional periods will become clearer. Proposals include a simplified regulatory environment including 180-day drug approvals, valid by default market authorisations, tighter rules around combination products, mandatory shortage prevention plans, tweaks to existing marketing and advertising standards, stronger provisions on antimicrobial resistance, and enhanced environmental standards.

The European Medicines Agency (EMA) will keep stakeholders informed and involved throughout implementation. A new dedicated web page will also serve as the central hub for all reform implementation information.

The reforms are also expected to affect regulatory exclusivities, potentially leading to generics and biosimilars being able to enter the market earlier. Read more in Osborne Clarke's European patent litigation predictions for 2026.

Strengthened medicine supply security  

Critical Medicines Act

The European Parliament's public health committee approved its proposals to bolster Europe's medicine supply security. On 20 January, the full Parliament adopted its position on the Critical Medicines Act, paving the way for negotiations with Member States. Companies may wish to monitor the EMA's Union list of critical medicines, which was updated for the first time in December 2025. 

Compulsory licensing regulation

A regulation on compulsory patent licensing for crisis management entered into force on 19 January 2026, establishing an EU-wide framework that addresses current fragmentation as well as treating such licensing as a last resort with no obligation on rightsholders to disclose trade secrets. Read more in Osborne Clarke's European patent litigation predictions for 2026.

Health Technology Assessment Coordination Group launch 2026 Work Programme  

On 28 November 2025, the EU Health Technology Assessment Coordination Group adopted its 2026 Work Programme outlining the key activities and strategic priorities for 2026. The programme will launch 50 first joint clinical assessments (JCAs) for medicinal products, including ongoing assessments for cancer medicines and advanced therapy medicinal products, including five JCAs for high-risk medical devices. It will also launch new guidance documents for JCAs of medical devices and in vitro devices and strengthened governance processes.

UK 

Regulation of rare disease therapies 

The Medicines and Healthcare products Regulatory Agency (MHRA) is planning to introduce a "bold new rulebook" for rare disease therapies in 2026, including proposals to overhaul the current regulatory framework. The new framework aims to accelerate patient access to innovative treatments while maintaining safety and evidence standards.

The MHRA will be consulting on the framework in early 2026, with a view to establishing a "refined and implementable" model in late 2026. It is collaborating with international peers to align appropriate regulatory pathways to ensure that similar approaches can be used for academia and industry and accelerate developments. Read the policy paper. 

UK-US pharmaceutical deal  

The UK-US pharmaceutical deal agreed on 1 December 2025 provided for, among other measures, 0% US import tariffs on UK pharmaceuticals for at least three years in exchange for increased UK investment in US drugs and innovative medical products via the NHS. However, it remains to be seen whether geopolitical developments could potentially affect the terms of this deal.

NICE changes to cost-effectiveness thresholds to promote new medicines  

The National Institute for Health and Care Excellence (NICE) will be increasing the cost-effectiveness thresholds it uses for evaluating new medicines from April 2026.  The standard threshold will increase to £25,000-£35,000, enabling NICE to recommend an additional three to five new medicines or indications annually. 

Growth of UK regional clusters 

The growth of UK regional clusters – from the Oxford-Cambridge corridor to Scotland and the North – will remain significant in 2026 as companies seek diverse trial sites, manufacturing locations, and skilled workforces. The first Regional Health Innovation Zones are expected to launch, providing real-world testing grounds for new commissioning models and care pathway improvements developed with industry partners. Read our Insight for more

Medical devices and diagnostics 

EU 

Targeted revision of EU medical device regulations 

The Commission's draft regulation, published as part of the EU Health Package, proposes targeted simplification of the MDR and IVDR. The proposal removes the five-year certificate validity cap, replacing fixed recertification cycles with continuous risk-based notified body surveillance and periodic reviews. Other key measures include reduced administrative burdens, more proportionate and targeted requirements for conformity assessment procedures, enhanced predictability and cost-efficiency of device certification, increased digitalisation for product documentation and improved coordination and cooperation and EU and international level. The draft introduces new obligations requiring manufacturers to report actively exploited vulnerabilities and severe cyber incidents affecting medical devices to cybersecurity stakeholders within 30 days, integrating device-specific vigilance with EU-wide cybersecurity incident coordination. Read our Insight for more.

The Commission is seeking feedback on its simplification proposal, with the feedback period running from 7 January to 4 March 2026.

Mandatory Eudamed use for diagnostics and medtech from May 2026 

The Commission has declared four of the six EU databases on medical devices (Eudamed) modules functional. Following a six-month transition period, key database systems for medical device and diagnostics businesses in the EU market will become mandatory from 28 May 2026. Read more in our Insight. 

UK 

Continued implementation of future regulatory framework 

The MHRA is expected to introduce new statutory instruments for medical devices in 2026 as part of its continued implementation of the future regulatory framework for medical devices. A pre-market statutory instrument for medical devices, including an International Reliance Framework, is due to be introduced to Parliament by autumn 2026, proposing changes to the regulatory requirements that must be met before a device is placed on the GB market.

The MHRA is also expected to launch a consultation in early 2026, seeking views on the indefinite recognition of CE-marked medical devices.

Clinical trials 

EU

Amendments to the EU Clinical Trials Regulation 

The proposed EU Biotech Act sets out amendments to the EU Clinical Trials Regulation to improve and accelerate clinical trials, including streamlining and accelerating authorisation procedures.

For multinational clinical trials, end-to-end authorisation timelines will shorten from 75 to 47 days without further information requests, and from 106 to 76 days with such requests. Assessment periods for substantial modifications will reduce from 64 to 33 days without additional information requests, and from 96 to 47 days with requests.

The amendments also clarify the interface with the European Health Data Space and introduce combined study procedures enabling coordinated assessment of trials involving various types of health technologies.

FAST-EU launch to accelerate multinational clinical trials

FAST-EU (Facilitating and Accelerating Strategic Trials) launches in January 2026 to accelerate multinational clinical trial evaluation and authorisation through coordinated, shortened review processes involving national agencies and ethics committees. It aims to enhance Europe's research attractiveness and biotech competitiveness.

UK

New regime from April 2026

The new UK clinical trials regime under The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025, effective from April 2026, will modernise approvals and reporting, with a stronger inclusion and diversity focus, making the UK more competitive for global and biotech-led trials. 

The latest international Good Clinical Practice (GCP) guidelines (ICH-GCP E6(R3)) will be implemented alongside the updated regulations, with all trials needing to adhere to GCP principles. Following draft guidance published by the MHRA and Health Research Authority in October 2025, the MHRA is planning to publish draft GCP guidance in January 2026 and updates to the Modification of an Important Detail process in March 2026. Sponsors and researchers should ensure policies, processes, procedures and systems are updated ahead of the April deadline.

The government has also committed to reducing commercial clinical trials times to set-up in the UK to less than 150 days by March 2026. 

AI, data and digital health 

EU

Modified timelines for AI Act compliance obligations

Most of the EU AI Act's core obligations, management, transparency and governance for high-risk AI systems are due to be fully applicable by 2 August 2026, imposing stringent requirements on companies using AI or developing AI-enabled products. Medical devices and IVDs incorporating AI would further benefit from a lex specialis treatment under the revised MDR and IVDR proposals, with conformity assessment integrated through sectoral procedures rather than duplicative AI Act certification.

However, following industry feedback regarding compliance preparations and implementation, the Commission's Digital Omnibus on AI proposal (published on 19 November 2025) extends compliance timelines for certain high-risk AI to allow companies more time to prepare. For AI systems in medical devices and IVDs specifically, the Digital Omnibus extends the ultimate compliance deadline to 2 August 2028, recognising the complexity of dual MDR/IVDR and AI Act conformity pathways. It is reported that policymakers aim to conclude negotiations on the Digital Omnibus before August 2026.

Increased product liability and class action risk

The new EU Product Liability Directive, effective from 9 December 2026, will introduce changes to the existing product liability regime including an expansion of the definition of "product" to encompass software and AI, new rebuttable presumptions of defect and causation in certain circumstances (including scientifically or technically complex cases) and EU-wide disclosure.

The directive extends liability to manufacturers, fulfilment service providers and online platforms, while requiring regulatory documentation to address reasonably foreseeable product misuse beyond reliance on warnings alone – changes that will materially affect both online distribution strategies and product risk management for pharmaceutical and medtech businesses alike. Coupled with the Representative Actions Directive, which facilitates cross-border collective actions, the new directive is expected to increase the risk of product liability group actions for life sciences companies in 2026 and beyond.  

UK

Regulation of AI in healthcare

The MHRA has launched a call for evidence on the regulation of AI in healthcare, seeking views on whether the UK's current framework is adequate, how it might be enhanced to ensure rapid access to safe and effective AI medical devices, appropriate methods for monitoring safety once devices are deployed, and how responsibility and liability should be allocated among the various parties involved in AI medical device implementation. The feedback will inform the future recommendations of the National Commission. Feedback is due by 2 February 2026.

Continuation of the MHRA AI Airlock programme

Several AI tools that have the potential to improve patient care will continue in the next phase of the MHRA's AI Airlock programme until March 2026. These insights will inform the MHRA's future work around AI regulation in life sciences and healthcare.

UK NHS and life sciences sector plan commitments   

The UK government's life sciences sector and NHS 10-year health plans set out a series of commitments in relation to AI, data and digital health, with several listed to be actioned in 2026. These include:

• New framework for medical devices and AI: this is expected to be published by the MHRA by summer 2026.
• Accelerating access to health data for research and other purposes: The government proposes to reform the Health Service (Control of Patient Information, COPI) Regulations 2002 by the end of 2026, providing clearer legal authority for health and care organisations to access, use and share de-identified information for secondary purposes, supporting the 10-year health plan and single patient record system.
• Surgical robot adoption: The government pledges to expand surgical adoption in line with NICE guidelines, beginning in early 2026.
• AI research screening platform: A new pioneering AI research screening platform backed by nearly £6m in government funding, and which will enable NHS trusts to join AI trials aiming to accelerate diagnosis, is to be launched by NICE by the end of 2026.
• Innovator Passports: The NHS is set to introduce an Innovator Passport by the end of 2026, enabling innovations assessed by one NHS organisation as suitable for use to be used by other NHS organisations without repeated assessments. 

New cybersecurity obligations 

EU

Cyber Resilience Act

Several provisions of the Cyber Resilience Act (CRA), which aims to strengthen the security of connected digital products placed on the EU market, will take effect in 2026, including compliance with mandatory reporting obligations by 11 September 2026.

While the CRA excludes medical devices covered by the MDR and IVDR, draft provisions in the revised regulations intend to address this gap. In addition, the CRA may apply to other products with digital elements used in the broader life sciences and healthcare ecosystem such as wearables, software and apps. 

UK

Cyber Security and Resilience (Network and Information Systems) Bill

The UK’s Cyber Security and Resilience (Network and Information Systems) Bill received its second reading in the Commons on 6 January 2026 and has now moved to committee stage. It proposes new laws to strengthen UK cyber defences and protect essential public services, including healthcare.

Companies providing cybersecurity services to such organisations, including the NHS, will be regulated and required to comply with strict security obligations, including prompt reporting of significant or potentially significant cyber incidents.

The bill proposes for regulators to be empowered to designate certain life sciences businesses as “critical suppliers”, such as diagnostic labs providing services to the NHS. This designation would mean that their goods or services are judged to be so critical that an incident affecting their network and information systems could cause significant disruption to the economy.

The bill will be subject to parliamentary scrutiny in the coming months, following a call for evidence launched by the House of Commons Public Bill Committee. For more, see Osborne Clarke's Regulatory Outlook.

Osborne Clarke comment 

It will be a defining year for life sciences and healthcare, with EU and UK reforms reshaping product development, approvals, market access and risk allocation across the sector. The maturing AI landscape alongside new product liability and cybersecurity regimes will further test governance, compliance and litigation strategies.

On the corporate front, a marked increase in high-value M&A and licensing activity is anticipated, driven by looming patent cliffs, evolving geopolitical dynamics and the impact of new pricing frameworks on portfolio strategy and dealmaking. These trends are explored in greater detail in Osborne Clarke's International Deals report.

Osborne Clarke's Life Sciences and Healthcare team combines deep regulatory, transactional and disputes expertise to help you navigate regulatory reform, structure partnerships and investments, and manage risk across the UK and Europe.