At a time when innovation is more critical than ever in oncology, ESMO is determined to ensure that regulatory developments support, rather than hinder, cancer research in Europe.
Two key initiatives – the In Vitro Diagnostic Regulation (IVDR) and the European Health Data Space (EHDS) – are shaping the research landscape in Europe, with significant implications for the development of new treatments and, ultimately, patient care.
The IVDR was introduced in May 2022 to enhance the quality and safety of in vitro diagnostic devices across Europe, yet its inconsistent implementation has created barriers to clinical research. A lack of infrastructure, guidance, and coordination has led to delays and disruptions, making Europe a less attractive environment for conducting oncology trials. If these challenges are not addressed, they could undermine Europe’s role in advancing cancer research, driving trials and investment away.
In view of this risk, ESMO has renewed its calls for regulatory reforms to ensure the implementation of the IVDR supports, rather than obstructs, high-quality cancer research and maintains Europe's competitive edge.
While regulatory challenges with IVDR persist, the EHDS presents a promising opportunity to transform cancer research by creating a harmonised, cross-border health-data ecosystem. Improved data sharing can accelerate discoveries, enhance treatment strategies, and enable stronger collaboration among researchers across Europe.
ESMO welcomes the publication of the EHDS regulation and continues to advocate for a harmonious framework – one that ensures scientific progress while safeguarding patient privacy and data security. If effectively implemented, the EHDS could significantly boost cancer research and improve patient outcomes.
Through its ongoing engagement with policymakers and stakeholders, ESMO remains committed to shaping a regulatory environment that fosters innovation and supports scientific progress. By advocating for improvements to the IVDR and supporting the development of the EHDS, the Society is working to ensure that Europe remains a strong and competitive hub for cancer research.