GDI D2.3 Recommendations on the sustainability of the 1+MG Infrastructure

This deliverable presents a set of recommendations to support the long-term sustainability of the 1+ Million Genomes (1+MG) infrastructure and initiative. The focus is on establishing a resilient, federated genomic infrastructure capable of supporting precision medicine, genomic research, and health innovation across Europe. Particular emphasis is placed on governance, technical and operational integrity, data management, risk management, funding models, and value creation mechanisms that can reduce long-term dependency on public funding, maintain public trust, and comply with European regulatory frameworks. Our recommendations for sustainability are built upon these core ideas: 1+MG aims to unlock the full value of genomic and clinical data across Europe by creating a sustainable, federated infrastructure that makes high-quality data Findable, Accessible, Interoperable, and Reusable (FAIR) for healthcare, research, and innovation. A core mission is to break down data silos between healthcare, research, and institutions by harmonising, curating, and quality-controlling genomic data across data sources, and linking this data with valuable phenotypic, clinical, and other data to accelerate precision medicine. The platform is designed to be valuable for multiple user groups, including healthcare providers, researchers, innovators, and policy makers, enabling them to build specialised tools and services on top of a common, trusted data resource. Long-term success depends on strong governance, operational excellence, and robust risk management, ensuring compliance with data protection law, information security, operational transparency, and consistent service delivery across all participating countries and other participating organisations. The ultimate goal is transformative healthcare impact, supporting the shift from reactive to proactive healthcare, with data-driven prevention and precision care, while strengthening Europe’s research capabilities, innovation ecosystem, and healthcare efficiency and ultimately citizen health and patient outcomes. Engagement with the research community and existing research infrastructures is essential to success as they provide critical expertise in data harmonisation, quality assurance, federated analytics, and standards development in a constantly evolving field. By building on established capabilities and fostering close collaboration, we can accelerate implementation, support innovation, and ensure that both the healthcare and research communities benefit from a trusted genomic data ecosystem that can adapt to their evolving needs. The work accomplished for and presented in this deliverable includes the development of a business model canvas, a list of sustainability recommendations, and a portfolio of potential value propositions. The business model canvas builds upon extensive engagement across the GDI project and prior implementation experience, identifying vital components for the sustainable operation of the 1+MG infrastructure. The recommendations cover national governance and mandate, stakeholder engagement and market enablement, data policy and linkage, technical infrastructure and quality, risk management and compliance (see footnote for a definition of compliance and risk management)1, federated operations, legal and ethical readiness, and value, funding, and pricing principles. Finally, the value propositions identify how the 1+MG can generate sustainable value for different stakeholders. The last part of the analysis describes how the long-term sustainability of the 1+MG infrastructure depends on establishing clear value propositions supported by robust business and pricing models. To achieve long-term sustainability, the infrastructure should take a platform-based approach that leverages network effects, enables third-party innovation, and supports both generic and bespoke services built on shared federated resources. Core costs associated with core data stewardship, harmonisation, and storage should be covered by national and EU contributions, while marginal, use-based costs associated with secure processing and user-facing services should be covered by users. This approach aligns with European principles on public data stewardship and contributes to compliance and fairness across the federated network. Success will depend on building trust, data resources, and organisational capacity, maintaining equitable access across countries, and ensuring clear separation of responsibilities to support compliance, avoid conflicts of interest, and safeguard long-term operational integrity. Ultimately, the infrastructure has the potential to become a trusted European platform for genomic data sharing and analysis, delivering lasting value for healthcare, research, innovation, and public policy