As the European Union advances its Biotech Act, the U.S. Chamber of Commerce sees a critical opportunity to strengthen transatlantic collaboration in life sciences, a vital sector that underpins security, economic resilience, and technological leadership.
The U.S. biotech ecosystem, anchored by strong IP protections, deep capital markets, and agile regulatory pathways, remains the global benchmark. The EU’s ambition to accelerate innovation through the Biotech Act is welcome. Yet persistent structural challenges, including fragmented regulatory frameworks, slow clinical trial approvals, and inadequate market access continue to limit Europe’s competitiveness. As a result, Europe’s share of global pharmaceutical R&D has fallen from 37% to 31% over the past two decades and could fall to just 21% by 2040 if no corrective action is taken.
Three priorities can unlock shared success in the Biotech Act:
1. Regulatory Convergence and Speed:
Europe must accelerate timelines for clinical trials and market access. Today, European patients wait an average of 578 days for new medicines post-approval, far longer than in the U.S. Harmonized, risk-based oversight, expanded mutual recognition agreements (including GMP inspections), and adaptive pathways for advanced therapies would strengthen Europe’s position and benefit global innovation.
2. Investment and Scale-Up:
U.S. experience shows that deep, liquid markets are critical for biotech growth. Europe must overcome a big financing gap to boost biotech growth. Expanding InvestEU, mobilizing pension capital, and creating pan-European co-investment mechanisms will foster resilient supply chains and help prevent talent and technology leakage.
3. Intellectual Property and Data Protection:
Strong, enforceable IP rights and predictable regulatory data protection are critical to incentivize high-risk, high-capital R&D investments. The EU’s digital and data strategies must safeguard proprietary datasets while enabling responsible sharing under the European Health Data Space. AI-driven innovation depends on trust and clarity, regulatory sandboxes, and interoperable data frameworks to ensure both sides lead responsibly.
The U.S. Chamber urges EU policymakers to seize the Biotech Act to advance regulatory alignment, joint investment frameworks, and expanded trade. Greater U.S.-EU biotech cooperation would send a powerful signal that democratic economies can lead in innovation while upholding safety, privacy, and sustainability obligations. A transatlantic biotech alliance, built on trust, innovation, and shared standards, will not only advance patient access but also reinforce U.S. and EU global leadership in the bioeconomy.
About the author
Zach Helzer
Zach Helzer serves as Senior Director in the Europe Program and Head of the U.S.-U.K. Business Council at the U.S. Chamber of Commerce.
