B1MG D1.4 Report of Stakeholders Forum 2022 including recommendations to the 1+MG Working Groups

The Beyond 1 Million Genomes (B1MG) project aims to facilitate the 1+MG initiative to provide access to genomics data and associated health data across borders and drive the development of personalised health strategies within Europe. The 1+MG/B1MG Stakeholder Forum 2022 held in October 2022, assembled for the third time a broad range of stakeholder experts, active in scientific and technical communities, international initiatives, projects, national healthcare systems, as well as industry to capture their input in the design of the infrastructure, the legal guidance and the best practices to realise the 1+MG infrastructure. 

Being the last Stakeholder Forum (SF) organised by the B1MG project, this meeting centred on identifying how stakeholders could contribute to the scale up and sustainability of the 1+MG/B1MG efforts. The day included key updates on the progress of 1+MG/B1MG, specifically on the 1+MG Trust Framework (focussed on the ELSI and technical recommendations and guidelines for privacy-preserving access to genomics data), and including the B1MG Maturity Level Model as a tool for countries to assess progress towards implementation of genomics-based personalised health strategies into healthcare. This was then followed by a session on the next steps towards scale-up and implementation of the genomics data-sharing landscape by speakers from the recently established (1+MG-associated and EC-funded) Genomic Data Infrastructure (GDI) project, TEHDAS/EHDS and GAIA-X. 

Acknowledging the role of industries in the scale-up and sustainability of these efforts, the day specifically included several ways to explore the role of companies as key stakeholders in realising cross-border genomic data sharing efforts and in developing a practice of genomics-based personalised health in 1+MG associated countries. A dedicated panel discussion included representatives from 1+MG WG7 (industry engagement), an umbrella industry organisation (EFPIA), an SME (Hyve - EHDEN project), as well as Australian Genomics, an initiative outside of Europe that has considered industry as part of their genomics activities. Clear recommendations were made to build a continuous exchange with industry to build mutual trust between public and private stakeholders. Further to this there was a proposal to explore the opportunity to establish a set of projects, such as under the framework of IHI. This clear output from the SF meeting should be explored further by the 1+MG initiative.

The second half of the day led into parallel workshops to consider scale up and sustainability in the context of rare diseases, cancer, common complex disease and infectious disease. The Trust Framework was regarded and the user communities addressed the question how stakeholders, including industry, could help realise these key components of the 1+MG infrastructure. It is clear that there are requirements specific to each disease community that are important to continuously review, discuss and understand in order to develop and sustain the 1+MG Trust Framework. The balance between how much research and care are entangled differs across use cases (rare diseases and cancer breakouts are already intertwined) and discussions stressed how the 1+MG infrastructure must be able to support primary and secondary use equally well.  

The annual Stakeholder Forum meetings run by the B1MG project have all been very successful. They have strengthened the alignment of the stakeholders with the 1+MG initiative, enabling the leads of various activities to take on board suggestions and ensuring the outcomes of the project fit with stakeholder needs, encouraging innovation and alignment across a broader landscape. To continue stakeholder engagement and ensure further impact, these events will be continued as part of the GDI project.