NEW YORK — The Spanish government plans to invest €25 million ($29.5 million) into precision medicine, genomic medicine, and data science over the next three years under a new project called Precision Medicine Infrastructure Associated with Science and Technology (IMPACT). The effort will result in the creation of a national cohort for research, as well as an integrated clinical and genomic data infrastructure at the national level.
The Carlos III Institute of Health (ISCIII), based in Madrid, will manage IMPACT, which will operate according to a grant model, where various proposals are funded to achieve the objectives set out in the project. Overall, the effort is aimed at improving data integration across Spain's 17 autonomous regions as well as supporting its involvement in European research efforts, such as the 1+ Million Genomes Initiative and the Beyond 1 Million Genomes project.
According to Gonzalo Arévalo, deputy general director for international research programs and institutional relations at ISCIII, IMPACT is part of a more ambitious personalized medicine strategy that has been under discussion over the last years within the Spanish government.
It became a renewed priority under the current government, which came to power in June 2018. "That was an element that made this move forward, by becoming part of the science and innovation plan launched in July 2020, and that includes a total amount of €77.3 million for a larger set of actions," he said.
ISCIII is supported by Spain's Ministry of Science and Innovation and the Ministry of Health. It carries out its own research programs but also acts as the main funding agency for biomedical research in the country as part of the National Research Plan. IMPACT includes three pillars: precision medicine, data science, and genomic medicine. The first pillar, precision medicine, will result in the development of a national multipurpose cohort, including individuals' clinical, epidemiological, and biological data, that is representative of the Spanish population as a whole.
"This will be a multipurpose cohort that will allow us to build predictive models of disease," Arévalo said. He added that the resource will integrate clinical and biological data at the individual level and should represent the country's ethnic and geographical diversity. In addition to developing predictive disease models, the cohort, the size of which has not been determined yet, should serve to inform future healthcare decision-making, identify health inequalities, and to assess policies.
The second pillar, data science, is perhaps the most ambitious, as it aims to create and maintain a system for the collection, integration, and analysis of clinical and molecular data to improve the health of each patient from the national health system. This might entail a system for the collection and integrated analysis of data across all of Spain's regions, many of which have major differences when it comes to electronic health records, and even between hospitals within the same region. "This will not be easy," said Arévalo. "This is a reality that we and other big countries in Europe are facing."
One of the aims of the data science pillar is to streamline the management and application of data collected via the Spanish healthcare system, as well as to create bioinformatic tools for genomic data management, in addition to clinical informatics tools.
The third pillar, genomic medicine, aims to ensure Spain has the necessary infrastructure and protocols to carry out genomic analysis, as well as analysis of other omic data, information that can then be rendered to its national health system. This will be achieved by making access to genomic medicine available across the country, supporting larger Spanish research centers that already have implemented next-generation sequencing technology, and making these resources available to patients depending on their genetic diagnostic needs, with special attention to the molecular diagnosis of rare diseases.
The final breakdown of the funding for IMPACT among the three pillars is undetermined, and it will depend on the grant proposals, Arévalo noted. Each pillar will have its own coordinator, and there will be a global coordination board for the three pillars.
A 'dramatic change'
Spain's new investment in the research and innovation field is taking place across a backdrop of similar initiatives elsewhere in Europe. Neighboring France, for instance, has invested €670 million in Plan France Médecine Génomique 2025, its personalized and genomic medicine initiative, that also includes funding from France's health ministry.
At the regional level, plans are underway to build international data sharing infrastructure to make over a million genomes accessible to European researchers by 2022 as part of the 1+ Million Genomes initiative. Earlier this year, the European Commission awarded €4 million to a project called Beyond 1 Million Genomes to develop the infrastructure, standards, and protocols, to make the initiative a reality.
As such, Spain's decision to invest in precision and genomic medicine and data science is timely.
Ivo Gut, director of the National Center for Genomic Analysis (CNAG) in Barcelona, said the €25 million made available via IMPACT will "change Spain dramatically" as it will ensure continuity between all 17 regions when it comes to precision medicine, data science, and genomic medicine. He said that the levels of services available, and the kinds of informatics tools in place, currently vary from region to region.
"Different autonomies provide different levels of support to their people, and you cannot say there are good regions or bad regions; the support is just different," said Gut. "There are more advanced regions, such as Catalonia or Madrid, and others that are not as far along, so it is uneven," he said. Because of these discrepancies, he said IMPACT will "up the game for the entire country" and make the new infrastructure "equitable for everyone."
One reason that Spain has developed along its current trajectory is that healthcare is organized at the level of the autonomous regions, Gut noted. "The autonomous regions have the responsibility for delivering healthcare, and the National Ministry of Health sets the framework requirements."
One of the most significant achievements to come out of IMPACT, according to Gut, might be the standardization and integration of electronic health records. "The idea here is to raise the level of how we deal with patients, and to create a framework where one can work with records across the autonomies," he said, acknowledging that accomplishing this will be a challenge.
"In my opinion, this will be the most difficult thing to do," said Gut. Systems vary between hospitals, he added, and some in Spain still use paper records. "Yet if there is no funding, no one will ever do it," he said.
Gut noted that CNAG has already prepared some proposals for IMPACT funding but declined to further elaborate. He noted that Spain's participation in the 1+ Million Genomics initiative, of which it was an early signatory, as well as other international genomics projects, helped catalyze the vision for IMPACT.
"Spain was very influential in setting up the 1+ Million Genomes member state initiative," said Gut. By participating in such initiatives, he said, the country also learns how to invest in and restructure its own resources. "In some aspects, I think Spain still has a lot to learn," Gut said. "Yet in others, I think that Spain has a lot to offer."