Beyond 1 Million Genomes Plus (European Digital Infrastructure Consortium, EDIC)

We are honored that the ICGD together with the UMF "Carol Davila" Bucharest and the Romanian Society of Medical Genetics, are organizing the first Beyond 1+ Million Genomes Plus (B1MGPlus) conference in Bucharest on 10-13 March 2025: https://www.b1mgplus-bucharest2025.com/

The Digital Decade Roadmap 2030 was launched in 2020 by European Commission President Ursula von der Leyen to promote the digital transformation in line with the values and strategic interests of the European Union. Decision 2022/2481 of the European Parliament and of the Council establishing the policy agenda for the Digital Decade Roadmap 2030 translates the vision of a digitally enabled society outlined in the Digital Compass into a concrete set of objectives aiming at bridging the digital capability gaps of the Union. Through its objectives, the Digital Decade Roadmap also sets out to establish a governance structure that will enhance collaboration between the European Union and its Member States to identify weaknesses and propose common solutions.

At the same time, through the EU Decision 2022/2481, and in the context of the acceleration of the digital transformation processes and beyond, the European Commission has proposed the launch of Multi-Country Projects, a series of large-scale projects that no Member State can develop alone, by 2030, in order to achieve its objectives. Multinational Projects are one of the cornerstones of this governance, providing a tool to drive collective efforts in areas of highest priority.
Multinational Projects (MCPs) will play a crucial role in achieving the Union's digital transformation and can be implemented through different instruments, including: European Research Infrastructure Consortia (ERICs), Major Projects of Common European Interest (IPCEIs), Member States' independent actions, European Digital Infrastructure Consortia (EDICs), etc.

aThe task of Genome EDIC is to create a genomic data infrastructure for research, innovation, healthcare, and policy development to accelerate the implementation of personalized medicine, enhance competitiveness, and deliver cross-border, data-driven health and care solutions for the benefit of Union citizens through the following activities:
(a) collecting, organising, and improving, including harmonizing, personal and non-personal genomic, demographic, and health-related data, as well as data related to health determinants, such as lifestyle data;
(b) transforming the data referred to in point (a) into easily discoverable data through appropriate data catalogues and tools that enable discovery of relevant records;
(c) enabling secure user access to the data referred to in point (a) for:
(i) research that contributes to a better understanding of health and disease and the development of prevention, diagnosis, and treatment strategies;
(ii) policy development aimed at improving public health;
(iii) reuse of data in healthcare to support patient prevention, diagnosis, and treatment; or,
(iv) healthcare management to enhance the quality of healthcare delivery;
(d) acting as an information intermediary between users and other stakeholders where necessary for the user to pursue lawful objectives;
(e) providing aggregated data and information relevant to genomic medicine based on user requests;
(f) informing individual users about opportunities to participate in biomedical research, including clinical trials;
(g) supporting the communication of clinically significant incidental findings to individuals, resulting from the reuse of data enabled by Genome EDIC;
Participation in Genome EDIC as a member is conditional on a financial contribution and the federated storage of genomic information within the system. Access to datasets will be secure, ethical, and in compliance with both European and national legislation.

Romania's participation in Genome EDIC will include, among others, the following benefits:

access to genomic data for personal and non-personal use, including demographic and other health-related data, which may be used for medical purposes, research, or participation in other European research initiatives;
access to standardized systematization protocols for genomic data, allowing their transfer to and from Romania with maximum efficiency;
exchange of information on national genetic/genomic characteristics and their integration into a pan-European system;
participation in specific European Genome EDIC projects;
increase the potential to participate in personalized medicine studies;
strengthening the national genomics infrastructure: Romania's involvement will contribute to the development and reinforcement of a robust genomics data infrastructure at the EU level, thereby facilitating cross-border research and healthcare services, in alignment with Romania's genomics objectives;
building trust in genomic data exchange: participation in Genome EDIC will help Romania create a secure and trusted environment for the cross-border exchange of genomic and clinical data between healthcare providers, research institutes, and public health agencies, promoting e-health;
the legal framework for data sharing: Romania will benefit from a legal structure that enables the lawful and ethical sharing of genomic data, ensuring compliance with the GDPR;
sustainable operations and procurement: the consortium will provide Romania with the necessary legal status for the long-term acquisition and operation of the advanced genomic data infrastructure;
diverse funding opportunities: Romania will be able to access multiple funding streams, both national and European, to support and expand its genomics initiatives;
inclusive governance: Romania will be part of a governance model that includes key stakeholders, such as the European Commission, ensuring that the country's interests and contributions are adequately represented;
strategic contributions to genomic medicine: Romania will have the opportunity to participate in shaping the development of the Genome EDIC, including the creation of new use cases, ethical guidelines, and data exchange protocols, thereby contributing to the advancement of genomic medicine at the European level.

The above benefits are conditional on strict compliance with European and national regulations on biomedical research ethics, human subject research ethics, fundamental human rights, patient rights, and data protection.

This action is foreseen in the National Action Plan for the Digital Decade for Romania.