ROUNDTABLE Hospital Exemption: Can we Attain Consensus in the EU? (part I)
Wednesday, May 31, 2023 08:00 AM - 09:00 AM
Room 251
Regulation & Reimbursement
Roundtable
How do we ensure Hospital Exemption serves the interest of individual patients without impeding product development for the broader patient population?
Moderator
Laertis Ikonomou, PhD, Associate Professor, The State University of New York at Buffalo, USA
Panelists
Christopher Bravery, PhD, Director , Advanced Biologicals Ltd, UK
Miguel Forte, MD, PhD, President-Elect ISCT; CEO Kiji Tx; EiR AdBio - Kiji Tx/AdBio Partners, Belgium
Stefaan Van der Spiegel, MD, Head of Sector, Health Innovation and Substances of Human Origin (DG SANTE)European Commission, Belgium
Session Description
Hospital exemption (HE) is a provision that allows the use of advanced therapy medicinal products (ATMPs) within individual member states of the European Union (EU) under rules set by each national medicine agency. In some EU countries, HE is granted for ATMPs with no demonstrated safety and efficacy; therefore, they are equivalent to unlicensed medicines. In other countries, HE is granted for ATMPs with demonstrated quality, safety, and efficacy.
This session provides a platform to discuss the value of HE in providing access to novel ATMPs for patients while addressing risks that this poses for the European ATMP market.
The session will also address whether an EMA pilot program targeting academic and non-for-profit developers offers an opportunity to overcome limitations of HE by incentivizing these organizations to work through the central EU regulatory framework.
Learning Objectives
Moderator
Laertis Ikonomou, PhD, Associate Professor, The State University of New York at Buffalo, USA
Panelists
Christopher Bravery, PhD, Director , Advanced Biologicals Ltd, UK
Miguel Forte, MD, PhD, President-Elect ISCT; CEO Kiji Tx; EiR AdBio - Kiji Tx/AdBio Partners, Belgium
Stefaan Van der Spiegel, MD, Head of Sector, Health Innovation and Substances of Human Origin (DG SANTE)European Commission, Belgium
Session Description
Hospital exemption (HE) is a provision that allows the use of advanced therapy medicinal products (ATMPs) within individual member states of the European Union (EU) under rules set by each national medicine agency. In some EU countries, HE is granted for ATMPs with no demonstrated safety and efficacy; therefore, they are equivalent to unlicensed medicines. In other countries, HE is granted for ATMPs with demonstrated quality, safety, and efficacy.
This session provides a platform to discuss the value of HE in providing access to novel ATMPs for patients while addressing risks that this poses for the European ATMP market.
The session will also address whether an EMA pilot program targeting academic and non-for-profit developers offers an opportunity to overcome limitations of HE by incentivizing these organizations to work through the central EU regulatory framework.
Learning Objectives
- Provide overview of Hospital Exemption and discuss implications of Member States allowing for ATMPs, with different degrees of evidence, to be used under a local and limited license versus centralized licenses. Discuss the implications for patient access and internal and external competitiveness of the sector
- Discuss whether the EMA pilot program to provide enhanced regulatory support for academic and non-profit organizations developing ATMPs addresses limitations with HE (integrates ATMPs within central regulatory framework while maintaining lower development costs) . In this context discuss the impending legislation changes proposed by the EU Commission
Stefaan Van der Spiegel MD
Head of Sector, Health Innovation and Substances of Human Origin (DG SANTE)
European Commission
Panelist
Head of Sector, Health Innovation and Substances of Human Origin (DG SANTE)
European Commission
Panelist