13 European countries have signed a declaration for delivering cross-border access to their genomic information. This is a game changer for European health research and clinical practice: sharing more genomic data will improve understanding and prevention of disease, allowing for more personalised treatments (and targeted drug prescription), in particular for rare diseases, cancer and brain related diseases.
The signatory Member States commit to collaborate on the secure and authorised access to national and regional banks of genetic data and other data relevant for health.
The declaration foresees in particular to:
- Bring together fragmented infrastructure and expertise supporting a shared and tangible goal: One million genomes accessible in the EU by 2022;
- Leverage and maximise the investments already made by Member States at national and EU level, particularly in sequencing, bio banking and data infrastructure;
- Reaching a larger cohort that will provide a sufficient scale for new clinically impactful research.
Welcoming the signature, Vice-President for the Digital Single Market Andrus Ansip and Commissioner for Digital Economy and Society Mariya Gabriel both said:
Health relies on digital innovation and cross-border interoperability. Secure access to genomic and other health data among Member States is essential for better health and care delivery to European citizens and to ensure that the EU will remain at the forefront of health research. The European Commission will facilitate this process and will continue to work with all Member States and interested parties on this matter.
The Commissioner for Health and Food Safety, Vytenis Andriukaitis also welcomed the signature:
I welcome this initiative connecting genomic and other health data across the EU. This initiative can boost the development of public health for the benefit of EU citizens. It adds to data capabilities of the European Reference Networks, who started clinical treatment and research of rare diseases towards the end of last year, and improves clinical trials. I congratulate Member States signing this declaration today and call upon other Member States to join this great initiative and to make the EU a beacon for global health research.
The Commission will support Member States in setting up a voluntary coordination mechanism of public authorities to link ongoing genomic medicine initiatives. The coordination mechanism will:
- Define a governance model of the cooperation, particularly concerning the terms and conditions for distributed access to genomic data across-borders, usage of the data and others;
- Support the development of technical specifications for secure access and cross-border exchange of genomic datasets within the internal market, and;
- Facilitate interoperability of relevant registries and databases to support personalised medicine research.
List of signatory countries of the Declaration: The Czech Republic, Cyprus, Estonia, Finland, Italy, Lithuania, Luxembourg, Malta, Portugal, Slovenia, Spain, Sweden, UK. Bulgaria, Croatia, Greece have also committed to sign the declaration. The other EU countries are welcome to join.
This initiative is in line with the European Commission's Digital Single Market mid-term review priorities, including the goal of "supporting the establishment of a secure health data infrastructure at EU level, to advance research and personalised medicine".
Furthermore, the declaration is pursuant to the intention of the European Commission to adopt a Communication including, inter alia, "supporting data infrastructure to advance research, diseases prevention and personalised health and care in key areas including rare, infectious and complex diseases".
Signatory Member States believe that citizens' needs are at the centre of data-driven healthcare innovation and that they should have an active role in their personalised treatment, in full respect of their right to the data privacy. In order to overcome data silos, lack of interoperability and fragmentation of initiatives across the European Union, enhanced cooperation between Member States is essential. This will also keep the EU at the forefront of genomic and personalised medicine globally, fostering its scientific output and industrial competitiveness.
Some research projects on eHealth supported by EU:
- MuG - encoding genomics data
- PredictND - support for patients with Dementia
- Sound of Vision - help for visually impared
- Transformation of Health and Care in the Digital Single Market
- European Commission's Digital Single Market mid-term review
- Council conclusions on "Health in the digital society – making progress in data-driven innovation in the field of health", adopted on 8 December 2017
- Council Conclusions on "Encouraging Member States driven Voluntary Cooperation between Health Systems”, adopted on 16 June 2017
- General Data Protection Regulation (GDPR)
Digibyte | 19 April 2018
Bulgaria has signed the declaration 'Towards access to at least 1 million sequenced genomes in the EU by 2022', becoming the 14th country to participate in the joint national and European effort to deliver cross-border access to genomic information.