Neil Smith, Schneider Electric’s Global Consumer Packaged Goods (CPG) President, explains the significance of the new legal framework.
As the UK implements a comprehensive legal framework for decentralised and point-of-care (POC) manufacture of medicines, we are entering a new era of personalised healthcare.
This landmark legislation positions the UK not only as a pioneer in patient-specific therapies — but also as a regulatory leader across Europe.
By enabling hospitals, clinics and even ambulances to produce patient-specific treatments in real-time, the UK is setting a precedent that could reshape how medicines are developed, delivered, and regulated globally.
This leadership is likely to attract significant international investment in biotech and advanced manufacturing, reinforcing the UK’s position as a hub for innovation in life sciences.
Personalised treatments, such as CAR-T cell therapies, are already demonstrating curative potential for 30–35% of patients who previously had no viable options.
Yet these therapies are often viable for just 24 hours post-production, making decentralised, near-patient manufacturing not just beneficial, but essential.
This is a prime example of how micro factories—compact, modular, and digitally integrated production environments—are key to unlocking this future. But with hundreds of decentralised production points, ensuring consistent quality, traceability, and regulatory compliance becomes exponentially more complex.
That’s where open, software-defined automation (SDA) can help.
By enabling real-time monitoring of critical parameters, automated documentation and adaptive manufacturing, SDA ensures that each batch— no matter how small or personalised — meets the highest standards of safety and efficacy.
It also allows for orchestration across distributed sites, ensuring that production, storage, and delivery are tightly controlled and compliant with Good Manufacturing Practice (GMP).
This aligns closely with the UK Government’s newly published Life Sciences Sector Plan, part of the broader UK Industrial Strategy that provides the macroeconomic and policy environment to modernise UK industry, improve resilience and accelerate innovation, supporting localised production and cutting-edge technologies.
The Life Sciences Sector Plan positions digital technologies, particularly the adoption of AI, as fundamental to reshaping the life sciences sector across research, diagnostics, treatment and manufacturing.
The convergence of this policy vision with the new POC legislation underscores the UK’s commitment to building a digitally enabled, patient-centric healthcare ecosystem.
At Schneider Electric, we believe the future of manufacturing, including life sciences, will be defined by flexibility, modularity and openness.
Our technologies are already helping manufacturers pilot, scale and orchestrate decentralised and flexible strategies that are cybersecure, compliant and future-ready.
The UK’s leadership in this space is not only a win for patients—it’s a blueprint for how industrial innovation can drive better outcomes, faster time to market, and more resilient supply chains.