Brussels, 11 December 2025

“Innovative biotech medicines for patients make progress in the GPL agreement”, says Dr Claire Skentelbery, Director General of EuropaBio. “It’s clear that governments recognise the need for increased market attractiveness, and there are positives in the GPL, but concerns remain that the scale of ambition does not reflect seismic global changes that are shaping the future for innovation and patients”.

EuropaBio is encouraged by measures seeking to support innovative health biotechnologies, such as the introduction of sandboxes for innovative therapies. However, it believes that protection for orphan medicinal products should be stronger, to signal the EU’s commitment to these complex and underserved patient populations and the frontier technologies needed to succeed.

Measures that curtail incentives if a product is not launched in a specific market following the request of a Member State are worrisome, and indicate that the complexity of the EU pharmaceutical market and barriers to market access may not be fully grasped.

As the GPL implementation phase begins, EuropaBio urges policymakers to adopt bold and progressive measures that strengthen the EU biotech ecosystem by de-risking investment in innovation, streamlining regulatory requirements and broadening access to patients. The EU Biotech Act is a critical catalyst to maximise GPL outcomes, and EuropaBio will champion an Act that is truly transformative for Europe.

The swift implementation of the GPL will be critical to deliver assurances to innovators and patients that Europe can strengthen its biotech ecosystem and industry.