This deliverable, the first in the EPND White Paper series prepared by Work Package 2 (Legal and Ethical Regulations), maps the legal, governance, and sustainability challenges that should be considered by EPND. It was prepared to inform the development of the EPND's access governance framework and long-term strategic roadmap.

The report covers three core themes. On data protection, it provides an in-depth analysis of the GDPR's scope and legal bases for data sharing, defines the roles of controllers and processors in multi-party research environments, and sets out compliance obligations for cohorts, the platform, and data users. On governance, it examines the fragmented European legal landscape governing retrospective biomedical research — spanning research ethics, biobanking, and data protection law — and identifies key barriers to cross-border sample and data sharing. It then outlines best-practice recommendations for defining access and use conditions, standardising agreements, streamlining access request processes, and establishing appropriate safeguards. On sustainability, it draws on early stakeholder research and a benchmarking review of comparable platforms to identify community needs and opportunities for EPND to offer a differentiated service.

The document concludes with actionable recommendations across all three themes to steer the consortium's priorities for years two to five of the project and beyond. These findings directly informed the development of the EPND's ELSI Support Desk and the access governance framework described in Deliverable D2.3.

For more information, find the full “White Paper V1” here.