The '1+ Million Genomes' (1+MG) initiative aims to enable secure access to genomics and the corresponding clinical data across Europe for better research, personalised healthcare and health policy making. Since the Digital Day 2018, 25 EU countries, the UK and Norway signed Member States’ declaration on stepping up efforts towards creating a European data infrastructure for genomic data and implementing common national rules enabling federated data access. The initiative forms part of the EU’s agenda for the Digital Transformation of Health and Care and is aligned with the goals of the European Health Data Space.
What is the benefit for EU citizens?
Genomics has the potential to revolutionise healthcare in many ways. It could lead to the development of more targeted personalised medicines, therapies and interventions. It could also enable better diagnostics, boost prevention and make more efficient use of scarce resources. From cancer to rare diseases to neurodiseases and prevention, genomics can greatly improve health conditions of EU citizens.
Equally important, genomics has the potential to improve the effectiveness, accessibility, sustainability and resilience of health systems in the European Union.
What are the Signatories trying to achieve?
The Signatory countries have various objectives. Among these, are:
- ensuring that appropriate technical infrastructure is available across the EU, allowing for secure, federated access to genomic data;
- making sure that ethical and legal implications of genomics are clear and taken into account;
- ensuring that the general public and policy makers in Member States and signatory countries are well informed about genomics, in order to ensure its uptake by healthcare systems and integration into personalised healthcare.
The EU as a global player in genomics
Genomics has become increasingly important globally. The European Union makes it a priority for genomic collaboration and research to be citizen-focused and patient-friendly. Therefore, it commits to ensure that the highest standards are applied for the usage, access and storage of genomic data. The EU’s 1+MG is one of world’s biggest projects of this kind and contributes chiefly to setting global standards in this domain. The connection to the European Health Data Space will provide an additional boost to the information potential benefitting researchers, healthcare professionals and all citizens, eventually.
Implementation of the Declaration
Creating a complex data infrastructure for genomic and clinical data is a collaborative task, which will involve a variety of stakeholders. These include health professionals, specialists, researchers, decision-makers, patient organisations and more.
The signatory countries of the 1+MG initiative had their kick-off meeting on 21 September 2018 in Brussels. Since then, country representatives meet regularly and in 12 specialised working groups to define specifications and formulate guidelines for implementing genomics across Europe in line with the 1+MG Declaration.
In late 2020, the Commission created a special expert group, the 1+MG Group, with a view to formalising and facilitating the cooperation and coordination at the level of national representatives of the signatory countries. The group is co-chaired by the Commission and an EU country representative (currently Finland).
The 1+MG roadmap
To meet the objectives of the 1+MG Declaration, the signatories realised the 1+ Million Genomes initiative along a two-staged roadmap detailing their activities across four dimensions: governance, trust framework, infrastructure and data.
In the first phase, the Horizon 2020 project 'Beyond 1 Million Genomes' (B1MG) supported and coordinated on the operational level the implementation of the Roadmap, by leading up to an agreement on the infrastructure set-up, legal and technical guidance, data standards, and requirements, and best practices to enable data access (see Main outcomes and deliverables section below). It also looked beyond the initiative towards the development of a sustainable data sharing infrastructure. This infrastructure will support clinicians to pursue personalised medicine, benefit patients, activate efficiencies in healthcare systems, help scientists to form a better understanding of diseases, and innovators to contribute to and boost the European economy.
In November 2022, the project Genomic Data Infrastructure (GDI), co-funded under the Digital Europe programme (€20 million co-funding), was launched marking the start of the scale-up and sustainability phase of the 1+MG initiative. GDI is in the process of establishing It will establish a federated data infrastructure for genomic and clinical data across Europe enabling distributed learning for various use cases, provide a data access governance and a sustainable coordination mechanism, and contribute to improving the interoperability of genomic and clinical data made available for access. The project is also designing and implementing a comprehensive communication strategy aiming to inform citizens and ensure their trust, which is a key pre-requisite of success for this endeavour.
On 14 November 2023, the 1+MG Group endorsed a roadmap (.pdf) for the second phase of the initiative (Scale-up and sustainability phase). The Roadmap 2023-2027 specifies the activities for the implementation of common recommendations and guidance, establishing the technical infrastructure, initial infrastructure operation with research pilots in clinical use-cases, generation of additional quality data, national coordination mechanisms, and connection of the infrastructure to EHDS and other relevant EU initiatives.
This important step is bringing Europe closer to reaching the goal of enabling secure access to genomic data across borders to advance research and personalised care in Europe. By 2024, at least six EU countries will have implemented common specifications and will be able to manage genomic data access. By 2026, 15 countries will have an operational infrastructure in place.
Genome of Europe
The Genome of Europe is a multi-country project bringing together European countries to build a high-quality European network of national genomic reference cohorts, representative of the European population. It contributes to the objectives of the 1+MG Declaration and works closely with the EU-funded projects implementing it.
All countries involved will generate via whole genome sequencing a national genomic reference dataset based on their own national population, all according to jointly established ‘1+MG-proof’ guidelines. Each country’s dataset will form a unique national reference collection in its own right.
Collectively, cross-linked via the 1+MG initiative, the national collections will establish a world-class European reference data resource (The Genome of Europe) for research and innovation of healthcare. The collection will benefit national personalised healthcare and prevention strategies. This joint effort may be partly funded by the Digital Europe programme.
The 1+MG Framework
Furthermore, the 1+MG Initiative also launched the 1+MG Framework website, bringing together the recommendations, guidelines and best practices of European Union experts to realise the Initiative’s ambition for secure access to genomics and health data across Europe.
Main outcomes and deliverables
- Secure cross-border data access roadmap (iterative document)
- Proof-of-concept for the rare diseases’ use case (video)
Legal, ethical and governance aspects:
- Scope of 1+MG
- Incidental findings policy
- Communication of general research results to data subjects (recommendations)
- Special (vulnerable) subjects and groups (recommendations)
Data integration and quality:
- Quality metrics for sequencing (iterative document)
- Documented best practices in sharing and linking phenotypic and genetic data (iterative document)