BioTalk Round Up - Autumn 2025

In this edition, you'll find the following updates on key topics:

• UK Regulatory Insights
• Digital Health & Medtech
• EU Pharmaceutical Law Reform
• Women In Tech Driving Innovation in Healthcare AI
• Patent Law Insights
• Employment Law Insights
• Bio & Beyond - Your new US Life Sciences Regulatory Newsletter

Please get in touch if you have any questions or would like further information on these topics, or visit our webpage for more information about Bird & Bird’s International Life Sciences & Healthcare Group.

UK Regulatory Insights

Fit for the Future: England’s 10-Year Health Plan and Implications for US Companies

England’s 10-Year Health Plan seeks to modernise the NHS through prevention, digital innovation, integrated care, and sustainability. For US companies, it opens doors in digital health, MedTech, pharma, workforce training, and green supply chains. Success hinges on navigating UK regulations, interoperability standards, and NHS procurement. Companies that align with NHS priorities and deliver clinical and societal value will be best positioned to shape the future of English healthcare.

For more information, please contact Sally Shorthose.

UK Launches World-First Framework for Decentralised Medicine Manufacturing

The UK has become the first country in the world to introduce a dedicated legal framework for the point of care (‘PoC’) and modular manufacture of medicines. The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 (the ‘Regulations’) seek to give patients access to pioneering treatments whose application has, so far, been potentially hamstrung by fundamental incompatibilities with conventional medicine manufacturing. The landmark legislation is backed by funding, with the UK Government allocating £520 million in grants to the expansion of domestic medicines manufacturing.

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For more information, please contact Sally Shorthouse, Pieter Erasmus or Charlotte Getz.

Digital Health & Medtech

Navigating the interplay of MDR and AIA: New MDCG Guidance on Medical Device AI Under the EU AI Act: EU and UK perspectives

Europe’s new guidance on AI in medical devices reshapes the regulatory landscape, merging the MDR/IVDR with the EU AI Act into a dual framework for safer, smarter innovation. For manufacturers, it’s a call to align AI risk, quality, and data governance within existing systems while preparing for new transparency, oversight, and change-control rules. Across the Channel, the UK’s MHRA is crafting its own AI-ready model focused on fairness, accountability, and Good Machine Learning Practice. Together, these moves set the stage for a new era of AI-enabled MedTech. Companies that master both EU and UK compliance will lead in delivering trustworthy, high-performance medical AI to global markets.

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For more information, please contact Pieter Erasmus, Maud van Haaren or Hester Borgers.

Navigating Digital Health: When Software Becomes a Medical Device – Critical Legal Considerations for Technology Suppliers in the Healthcare Sector

As digital health tools grow more complex, the line between ordinary software and regulated medical devices is increasingly blurred - bringing significant legal and compliance risks for tech suppliers. Recent EU guidance and enforcement trends highlight how even simple or AI-enabled software can qualify as a medical device, triggering strict MDR/IVDR obligations. Companies must proactively assess their products’ regulatory status to avoid costly surprises in this fast-evolving landscape.

Our team supports life sciences and digital health companies by assessing regulatory status, ensuring compliance with EU and UK requirements, and advising on risk management for AI-enabled and other digital tools. For additional insights, explore our BioTalk platform and OXYGY podcast series, where we discuss practical guidance for technology suppliers navigating these complex regulatory frameworks. 

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For more information, please contact Henri Kaikkonen.

EU Pharmaceutical Law Reform

EU Pharmaceutical Law Reform: New Framework for Combination Products

The EU is reforming its rules for combination products - where medicines meet devices, technologies, or AI. The goal is to replace today’s patchwork of regulations with clearer definitions and pathways, making it easier to bring innovative hybrid therapies to market while keeping patients safe. With broad support from the Council, companies should prepare for a more harmonised, though still strict, regulatory framework.

Our team advises companies on regulatory strategy, compliance, and product classification for combination therapies. For deeper insights, we provide webinars and articles through BioTalk, and explore topics like the European Health Data Space, secondary use of health data, and intellectual property protections in our EHDS webinar series.

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For more information, please contact Christian Lindenthal or Annelie Säurig.

EU Pharmaceutical Law Reform: Council advances paediatric medicine reform with more flexible investigation plan proposals

On 4 June 2025, the EU Council published its position on the "Pharma Package," updating paediatric medicine development. Key changes include earlier Paediatric Investigation Plan (PIP) deadlines, wider product exemptions, and clearer PIP waiver criteria, aiming to streamline regulation and promote innovation.

Following last month’s discussion of the Council’s negotiating mandate, this update highlights two reform areas: paediatric medicines and combination products. Both reflect the EU’s push to modernise pharmaceutical regulation - shortening timelines, simplifying processes, and encouraging innovation while ensuring patient safety.

If you need any assistance understanding the evolving EU Pharma Package or want guidance on adapting your paediatric or combination product strategies, our team is here to help - get in touch here.

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For more information, please contact Clarissa Junge-Gierse.

Council adopts its position on EU pharmaceutical law reform: focus on antimicrobials and transferable data exclusivity vouchers

The EU Council’s pharma package amendments target antimicrobial resistance, revising the transferable data exclusivity voucher system for priority antimicrobials. Key changes include stricter eligibility, capped voucher numbers, and rules on transfer and use. Trilogue negotiations will now shape the final framework, expected by early 2026.

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For more information, please contact Caroline Arrighi-Savoie, Nour Saab or Margot Pietri.

Women in Tech Driving Innovation in Healthcare AI

Episode 9: AI Transforming Healthcare Workflows

Dana Ghosn, AI Program Senior Lead at Doctolib and founder of Typeless, joins our Women in Tech series to share how AI is transforming healthcare. Typeless uses Natural Language Processing to reduce the hours clinicians spend on medical documentation, freeing up time for patient care. Dana highlights the role of interdisciplinary collaboration, supportive regulations, and Switzerland’s ecosystem in advancing healthcare innovation. This episode shows how technology and life sciences intersect to improve clinical workflows and patient outcomes.

Read our key takeaways from episode 9 with Dana Ghosn from Typeless here.

Episode 10: Supporting Innovation and Entrepreneurship in the Nordic Tech Scene

In episode 10, we are joined by Louise Lachmann, General Partner at Ugly Duckling Ventures, an early-stage venture capital firm helping Nordic startups scale rapidly in today's challenging investment landscape. Louise has also been appointed Chair of the Danish Foundation for Entrepreneurship, which seeks to promote entrepreneurship among young people. Interviewed by Martin von Haller Grønbæk, Commercial Of Counsel in our Copenhagen office, Louise shares her remarkable journey from the dotcom era to the current AI revolution, offering unique insights into the evolution of technology investment and entrepreneurship across the Nordic region.

Look out for episode 11, where our Intellectual Property Partner Melissa Murray, based in our Dubai office, chats to Lina Al Hashmi, Project Manager for Intellectual Property Acquisition at Advanced Technology Research Council and Ruxandra Cojocaru, Lead Researcher at the AI Digital Research Center within Technology Innovation Institute.

Read our key takeaways from episode 10 with Louise Lachmann from Ugly Duckling Ventures here.

Life Sciences Patent Law Insights

Patent Litigation in Practice Series: Spotlight on the Czech Republic – Preliminary Injunctions

Czech courts are increasingly significant for life sciences patent disputes, particularly when it comes to preliminary injunctions to block generic or biosimilar entry. Our Patent Litigation in Practice Series: Czech Republic explores this in detail. For broader European strategies, the Unified Patent Court (UPC) Webinar Series highlights key developments affecting pharma and biotech patent enforcement. Our Life Sciences & Healthcare Brochure outlines how our team helps companies navigate multijurisdictional patent disputes, prepare strong injunction applications, and protect market share in high-stakes litigation.

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For more information, please contact Vojtěch Chloupek and Jiří Malý.

Employment Law Insights

Horizon Scanning 2025/2026

Are you prepared for the emerging HR landscape of 2025 and beyond?

Our comprehensive report identifies 12 pivotal trends reshaping global employment – from advancing DEI initiatives and pay transparency requirements to innovative wellbeing strategies that attract top talent. We also examine critical challenges facing multinational employers including global restructuring, managing a multi-generational workforce, and responding effectively to workplace activism.

To view these insights, click on the links below:

• General
• Life Sciences

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For more information, please contact Nathalie Devernay, Thomas Hey, Emily Clark or Alison Dixon.

Bio & Beyond - Your Autumn Edition of US Life Sciences Regulatory Newsletter

Bio & Beyond

Welcome to the Autumn edition of our quarterly Life Sciences & Healthcare Regulatory Newsletter - Bio & Beyond - tailored specifically for our US colleagues and friends.

This newsletter provides an overview of key regulatory developments across the European Union, the United Kingdom and the Asia-Pacific region. We focus on changes that may influence strategic planning, product pathways, market access and ongoing compliance.

In this edition, we highlight notable international regulatory updates relevant to US businesses, accompanied by concise, practice-focused insights. Our aim is to help your organization understand where requirements are shifting and to stay ahead of the curve as global regulatory frameworks continue to evolve.

We would be pleased to discuss any of the updates featured, or any other regulatory considerations of interest. We look forward to staying connected. To view these insights, click on the links below:

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If you’d like to be the first to receive the next newsletter, please let us know here.