European biotech stakeholders are pushing for changes as the EU Biotech Act advances through negotiations, aiming to strengthen global competitiveness and make pathways to market less fragmented. EuropaBio and other groups argued that the framework must harmonize regulatory pathways and reduce delays that have deterred multi-country clinical trials. Speakers at BIO-Europe Spring in Lisbon pointed to Europe’s uneven manufacturing investment, trial coordination burdens, and venture capital risk tolerance as persistent structural constraints. They also highlighted the historic pattern of European biotech IPOs listing outside Europe. Negotiators will now balance ambition and feasibility as they decide what regulatory simplification and trial-support measures can be implemented across member states without diluting safety requirements.