The EU’s proposed European Biotech Act (“Biotech Act I”) is intended to close Europe’s biotechnology innovation gap. Following publication of the legislative proposal in December 2025 (see our briefing) the European Commission has now released a detailed Staff Working Document (27 May 2026) setting out the evidential and analytical basis for the initiative. This analysis outlines how the EU plans to boost its biotech ecosystem through simpler regulation and stronger innovation support, balanced by strict safety, public health and data safeguards. With the starting gun having been fired on Biotech Act II, we also look at the focus of the second phase.