The EU’s conclusion of the pharmaceutical package marks an important step for the sector, but it falls short of significantly boosting European competitiveness in innovative medicines. While the reforms include positive measures—such as reduced EMA timelines, a regulatory sandbox, electronic product information, and incentives for new antibiotics via transferable exclusivity vouchers—critical issues remain. Maintaining eight years of regulatory data protection and reducing market exclusivity for rare diseases, along with extending the Bolar exemption, may undermine investment and IP enforcement, limiting Europe’s ability to attract and retain global R&D.

EFPIA emphasizes that Europe has lost a substantial share of global investment and clinical trials over the past two decades. To remain competitive, Europe needs stronger support for innovation, faster patient access to new medicines, and reinforced IP protection. The sector hopes that future policies, including the Biotech Act, will address these challenges and prioritize healthcare innovation.