September 7, 2022, Brussels - EuropaBio, EuropaBio's SME Platform represents Europe’s biotechnology SME community, in close partnership with EuropaBio's National Associations Council, and advocates for innovative biotechnology delivered through SMEs. In May, the SME BioForum organised its inaugural event and invited SME Executives to discuss the business environment for Advanced Therapy Medicinal Products (ATMPs) in Europe.

Please find event conclusions and recommendations HERE.

’’SMEs are key drivers of innovation in Europe. They represent the pipeline through which Europe’s excellence in research is translated and matured, both for patient and economic benefit to Europe. SMEs in the ATMP field face unique challenges related to investment and speed to patients and market. We need to enable these champions of science through a legislative framework that balances competitiveness with delivery to patients, fostering innovation, investment and excellence in Europe. ‘’, said Claire Skentelbery, Director General of EuropaBio.’’

Regulatory pathways
The ATMP development field is fast-evolving. While technology progresses rapidly, national and EU regulators must learn and adapt quickly to support the development and approval of new cell and gene therapies.

Our recommendations:

• Reinforce EMA and national regulatory agency resources to allow for faster approval times
Promote EMA/Member States centres of excellence
• Foster early engagement with national regulatory Authorities
• Simplify GMO requirements for ATMP clinical trials

Market fragmentation
Healthcare systems are very different across Europe. Member States have distinct regulatory practices and experiences that condition how each country and region perceives and assesses value. It is essential to ensure that decision-makers regard ATMP costs as investments in patients, sustainable healthcare systems and society.

Our recommendations:

• Harmonise national requirements for the development of ATMPs
• Greater dialogue on the value and importance of ATMPs
• Adapt Health Technology assessments and consider innovative payment models

Other bottlenecks for growth
ATMP development advances alone do not deliver products to patients. The development pathway requires diverse skills to enable SMEs to succeed in delivering treatment solutions.

Our recommendations:

• Promote ATMP academic and professional development
• Foster partnerships with larger companies and strategic sectors


Next steps
EuropaBio is pleased to invite you to the event presenting policy recommendations and conclusions of both 2022 SME BioForum events (May and October editions) in the field of healthcare and industrial biotechnology on December 13, 11:00-12:15 CET. SAVE THE DATE! For more information about opportunities of participation please contact José Peres, NAC & SME Coordinator.