EuropaBio published policy recommendations for the healthcare and industrial biotechnology sectors

Brussels, 25 April 2022- EuropaBio today published the National Associations Council Summit 2022 Event Report ''Biotechnology: Delivering Europe’s industrial strategy across the sectors''. The report includes key policy recommendations for healthcare and industrial biotechnology sectors at national and the EU level which could serve the policymakers to get a better understanding of the sector’s potential and regulatory challenges in operating on the national and EU level.

EuropaBio recommendations for the Healthcare Biotechnology
We are entering a time of significant legislative change for many aspects of healthcare which will impact Europe on multiple levels. The revision of the pharmaceutical legislation, the Orphan and Paediatric regulations, the establishment of a new European Health Data Space and the latest progress on Advanced Therapy Medicinal Products (ATMPs) will significantly shape Europe’s innovative landscape. These developments will influence the translation of science into therapies, the ability of small companies to start and grow, and long-term investment decisions for large companies and countries within Europe.

Therefore, EuropaBio recommends:

• Create regulatory frameworks suited to accelerating novel technologies to market
• Improve timelines and procedural transparency for patients to access advanced novel therapies and healthcare across Europe
• Enhance national cooperation for alignment of data to enable greater international benefit
• Align the information required for regulatory and HTA frameworks
• Review instruments such as state aid to enhance European competitiveness globally for higher risk investment,
• Promote industry engagement to strengthen the ability of ERNs within research and innovation

EuropaBio recommendations for the Industrial Biotechnology
Industrial biotechnology is a key enabling technology for European competitiveness. It supports the transition toward a circular bioeconomy, transforming manufacturing processes as part of a global shift and contributing toward European Green Deal objectives, reducing production energy, water, and waste.

Therefore, EuropaBio recommends:

• Promote an evidence based pathway for environmental, economic and employment benefits in Europe
• Ensure sustainable innovation scale-up and facilitate market access
• Make sustainable choices the most accessible for consumers
• Adopt a product-centric regulatory approach, where requirements are predictable and proportionate to risk
• Modernize and accelerate regulatory frameworks for advanced innovation

The EuropaBio National Associations Council Summit now looks ahead to future Presidencies of the Council of the EU, with the next Summit planned with Member AseBio for the Spanish Presidency in 2023.

Please download the Report here