In December, the European Commission proposed a new EU Biotech Act: a broad regulatory framework designed to make Europe a more competitive place to build, scale, and commercialise biotechnology. It comes off the back of years of steady European decline in a sector now dominated by the US and China. This, despite the quality talent pool European firms still have to draw from. The act aims to correct this imbalance, and its implications are not just limited to those still within the EU…

At its core, the act aims to:
• Simplify and speed up regulation, especially for clinical trials and advanced therapies
• Harmonise rules across member states, reducing fragmentation
• Unlock capital and scale-up funding via EU and EIB-backed initiatives
• Support AI, data sharing, and biomanufacturing, while strengthening biosecurity

The goal is clear: keep European science in Europe, close the gap with the US and Asia, and turn world-class research into world-class companies. For the EU, this could be a step-change: faster time to market, deeper pools of capital, and a more coherent innovation ecosystem across 27countries. For the UK, the implications are more nuanced.

There are clear opportunities. Europe remains Britain's largest trading partner and a major technological collaborator. A stronger biotech sector on the continent could translate to deeper EU-UK collaboration on trials, data and manufacturing. For UK companies already operating within the EU or looking to expand there, the new harmonised rules should make it simpler to align with their regulatory requirements. And, crucially, it should apply a healthy dose of pressure on the United Kingdom to streamline and modernise its own regulatory framework.

But that’s where we arrive at the risk: the UK does nothing and is left behind.  Let’s be clear, this legislation is designed to benefit European companies, not their neighbours. An attractive EU market could absorb international investment, dragging it away from UK firms. It could also drag key talent away, as they look across the channel for better paid and better funded opportunities. Benefits may still “trickledown” by virtue of our close trading ties, but they’re a far cry from the benefits of having your own thriving domestic biotech sector.

The EU Biotech Act signals intent: biotech is now a strategic priority. The question for the UK is whether it keeps pace, diverges boldly, or finds smart ways to align.