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As Million European Genomes Initiative Advances, Alliance Promotes New Personalized Medicine Project


NEW YORK (GenomeWeb) – The European Alliance for Personalized Medicine has launched a new project to complement the 1+ Million Genomes Member State Initiative, a year-old effort the Brussels-based nonprofit helped to foment.

The initiative, initially referred to as MEGA, which has pledged to make a million genomes accessible to researchers by 2022,is a step toward developing the infrastructure to support genomic data sharing across Europe. However, other projects are necessary to realize personalized medicine in Europe, according to Denis Horgan, executive director of EAPM.

To achieve this, EAPM has proposed a new initiative called MEGA+ that will extend the process of genomic data sharing to all medical data, including electronic health records and imaging files. The term MEGA+ comes from the Million European Genomes Alliance that EAPM advocated.

Established in 2012, EAPM represents various stakeholders, including healthcare experts and patient advocates, who wish to encourage the adoption of personalized medicine.

The MEGA+ effort will focus on supporting regional pilot projects for data sharing and will seek financial support from sources such as the Innovative Medicines Initiative, the European Union's Horizon 2020 program, and regional development funds, Horgan said. Such projects will be undertaken with the "highest level of ethics and patient consent," he added.

According to Horgan, Europe's regions, "with their plethora of excellent universities and research bodies," are key to the process of achieving personalized medicine.

"Healthcare is still a national competence in Europe," he said. "The question is how to implement personalized medicine in practice. What will allow different regions to collaborate? How could, say, the Basque Country cooperate with Andalusia [in Spain], and then with regions in France?"

These kinds of pilot projects will help to create networks around the continent, setting standards and guidelines for data formatting and sharing that will raise Europe's profile for innovative healthcare. Horgan said that MEGA+ will look to work with networks that are already in place and determine ways of enhancing them.

"All the necessary pieces of the jigsaw need to be put in place to facilitate healthcare data sharing," said Horgan. "What is certainly required is a common vision and purpose to tackle the topics such as data governance and access rights, as well as the vital issue of interoperability."

MEGA+ projects could also prompt various European countries to invest more in their healthcare infrastructure to achieve these aims.

"A problem with Europe is that different member states are at different speeds," noted Horgan. "We need to leapfrog countries to what, say, Estonia has in terms of sequencing and e-health."

These projects will also demonstrate on a more local level the value of personalized medicine to patients, for whom larger-scale data sharing projects, such as the 1+ Million Genomes Member State Initiative, might be more difficult to grasp.

"It is well and good that we can sequence to scale, but how can people make use of this data if they can't understand it?" said Horgan.

EAPM for years advocated to make a million genomes available to European researchers for clinical research purposes. The EU responded last year with a declaration on linking genomic databases across borders by 2022.

This month, Norway became the latest country to sign the declaration. Austria, Bulgaria, Croatia, the Czech Republic, Cyprus, Estonia, Finland, Greece, Hungary, Italy, Lithuania, Latvia, Luxembourg, Malta, the Netherlands, Portugal, Slovenia, Spain, Sweden, and the UK have also signed the declaration.

France and Germany, the two largest countries in Europe, are official observers on the project but have not yet signed the declaration. The initiative is part of the EU's agenda for its Digital Transformation of Health and Care, outlined last year, which falls under its Digital Single Market strategy.

Signatories have agreed to build a federated framework that will allow secure and authorized cross-border access to genomic and other health data across the EU, supporting research, healthcare and prevention. They also aim to enable users to search and access the data through a user-friendly and effective data governance structure building on existing national and European initiatives.

Malin Eklund, a senior research officer at the Swedish Research Council in Stockholm, is leading one of the initiative's working groups that have been formed to address different aspects of the effort. Eklund's working group is focused on governance.

"The aim of the declaration is to build a framework linking genomic databases across borders and connect science and healthcare, which is the competence of the member states," Eklund said.

Since its initial meeting last September, representatives of the signatory member states have met on a regular basis, according to an EU statement issued in April. Since that time, the group has mapped and analyzed genomic initiatives across Europe and has focused on addressing questions of governance, including good genomic practices, data security issues, legal and ethical aspects, and standards for sharing sequencing data.

A roadmap for the initiative is expected by the end of the year, the EU said in its statement.

Regarding EAPM's proposed MEGA+ initiative, Eklund commented that it is "essential that national, European, and global initiatives join forces and that we build on ongoing initiatives." She said that EAPM is one actor that can contribute via pilot projects.

Eklund noted that EAPM is just one player in a larger ecosystem of European initiatives contributing to personalized medicine, including ELIXIR, the European infrastructure for life science data; the Biobanking and Biomolecular Resources Research Infrastructure (BBMRI); the European Open Science Cloud; as well as broader efforts, such as the Global Alliance for Genomics and Health.

The goal of these efforts is to keep the EU at the forefront of personalized medicine, an endeavor that is in line with EAPM's objectives in MEGA+.

"The next five years are 'make or break' for Europe in healthcare," said Horgan. "If Europe cannot get the guidelines and systems in place for data sharing, investments will go elsewhere."