Session (CTI)

Several EU policy initiatives aim to strengthen research, innovation and decision-making on access to medicines, including the European Health Data Space (EHDS), the EU HTA Regulation, and broader pharmaceutical, biotech and AI legislation. Together, these frameworks could improve availability and use of real-world data (RWD) and real-world evidence (RWE) in regulatory and HTA processes. However, it remains unclear whether these policy initiatives are sufficiently aligned, operationally mature, and responsive to payer and HTA needs to be able to inform access decisions in practice. Bhattacharjee (moderator) will open with reflections on the geopolitical environment, national and international RWD initiatives, Europe’s competitiveness in life sciences innovation, and the potential role of RWD and RWE in demonstrating value in European healthcare systems. Schutte will discuss implementation of the EHDS, including emerging guidelines and technical specifications formulated by Joint Action TEHDAS2, which facilitates access to health data and strengthen cross-border collaboration, outlining implications for HTA and payers. Hedberg will examine how RWE has featured in Joint Scientific Consultations and Joint Clinical Assessments under the HTA Regulation since January 2025, and how the role of RWE may evolve as implementation expands to additional therapeutic areas and high-risk medical devices. Natz will address opportunities arising from the EHDS, General Pharmaceutical Legislation, the Biotech and AI Acts for RWE development to inform Outcomes-Based Managed Entry Agreements, reflecting on increased healthcare digitalization but continued slow uptake of RWE in HTA and payer decision-making. After 10 minutes for each presentation, there will be 20 minutes for panel discussion. This session will be relevant to life sciences industry stakeholders, HTA bodies, payers, regulators, data custodians, patient organizations, and evidence-generation experts. Attendees will gain practical insight into how these policy frameworks may shape RWD availability, evidence expectations, stakeholder collaboration and use of RWE in access decisions across Europe.