That the trans-Atlantic data relationship needs some healing and repair is well-understood. The highly innovative biotechnology sector delivers breakthrough innovations that transform health care, promote public health and cure once incurable diseases. Perhaps a remedy to the trans-Atlantic data relationship is not beyond the sector's reach as well.
Data flows between the United States and the European Union are critical for advancing biomedical research. Collaborations between researchers on both sides of the Atlantic resulted in COVID-19 vaccines, have revolutionized healthcare and advanced personalized medicine.
When the European Commission launched the European strategy for data in February 2020 — a document that seeks to enable a digital revolution in the EU and promote data-driven innovations across a number of sectors — the relatively unknown, emerging area of personalized medicine was the first illustration offered by the commission of a field poised to benefit from this digital revolution.
References to health care are found throughout the strategy for data, and it's of little surprise that as part of its rollout the European Commission promoted the development of a common European Health Data Space, currently in an open public consultation process through July 26.
The European Health Data Space — which, incidentally, has been prioritized over green technology, agriculture, energy and finance — aims to "promote better exchange and access to different types of health data (electronic health records, genomics data, data from patient registries, etc.)," to support health care delivery, enable cutting edge research and promote innovation. As part of this effort, clear reference is made to the use of digital tech, including AI, to drive innovation in the health care space. First and foremost, it recognizes the potential for improved quality of health care to European citizens followed by the goal to create a robust environment for entrepreneurship, economic development and small-to-medium enterprise creation.
But there is a dissonance between the ambitions of the health data space and the existing challenges around international data flows to enable biomedical research and discovery, particularly regarding the flow of data originating from the EU. Consider the data flow challenges arising from ambiguities in the EU General Data Protection Regulation and the variations throughout EU member states where provisions are being interpreted. How will the European Health Data Space achieve its goals of promoting innovation, scientific development, entrepreneurship and SME creation if data cannot be exchanged, and global collaborations are frustrated by existing regulatory frameworks?
The global biotech community could work together to promote a European Health Data Space that delivers the highest quality care to European citizens and supports groundbreaking innovation for the benefit of patients worldwide. And perhaps this collaboration may simultaneously unlock the huge potential for broader trans-Atlantic collaboration in the data sciences to heal and repair the trans-Atlantic data relationship.
International data flows and the digital revolution in the life sciences
Why are cross-border data flows so critical to biomedical R&D? What exactly do we mean by a digital revolution in the life sciences and the emergence of personalized medicine?
Biomedical research has always been highly data-driven. After all, generating, collecting and analyzing data to test and ultimately develop new scientific hypotheses captures the essence of the scientific method.
What is new is advances in data sciences enable the generation and analysis of vast amounts of data, allowing researchers to more rapidly understand disease pathways and potentially identify treatments to remedy or even prevent the onset of disease. This convergence of big data capabilities and powerful biotech tools drives a major paradigm shift in healthcare, from traditional one-size-fits-all medical care to the development of treatments tailored to patients' genomic, molecular and lifestyle characteristics.
Central to this remarkable innovative potential is our ability as researchers to access, use and transfer data. Biotech researchers operate in a highly collaborative and globalized world, where data and insights must be shared in an efficient and timely manner with partners to advance R&D projects.
However, restrictions on obtaining and using global data sets may frustrate and delay scientific advances in the biotech space. For example, limitations on the transfer of personal data for health research purposes affect early-stage R&D efforts, clinical trial development and execution, including patient recruitment, the delivery of treatment to patients, and the assessment and reporting of potential adverse events.
For the biomedical research community, chief among all international data transfers is between the U.S. and EU. A March 2021 ITIF report that surveyed the trans-Atlantic data relationship across a number of sectors found data transfers between the U.S. and the EU are critical for biomedical innovation. Francis Collins, the Director of the U.S. National Institutes for Health, shared how the GDPR affected NIH research in the fields of Alzheimer's and diabetes after it entered into force May 2018. A partnering Finnish institute stopped data sharing on a Type 2 diabetes project because the NIH could not guarantee it would satisfy the institute's interpretations of the GDPR requirements.
Recognizing the central role the EU plays in the global innovative biotech ecosystem, it is essential a legal and policy framework supporting global R&D is developed and supported by the proposed European Health Data Space framework.
The inconsistent approaches across Member States regarding international transfer of patient data affect global clinical studies. These challenges will also affect emerging biotech SMEs and researchers in the EU, undercutting their ability to participate meaningfully in global collaborations and drive cutting-edge life science research. For example, European SMEs will have significant expenditures and allocate resources to conduct assessments on transfers abroad on a case-by-case basis. Given how data-intensive our sector has become, this would amount to a significant logistical undertaking that puts European biotech SMEs at a competitive disadvantage globally. It would delay R&D efforts, add to an already expensive and complex scientific research program, and compromise cross-border collaborations that require timely and efficient data flows.
Creating challenges for biotech SMEs based in the EU to grow and partner globally on cutting-edge research is clearly incongruent with the European Commission's broader vision of establishing global leadership in the sciences and cultivating a thriving, innovative biotech ecosystem. The uncertainties and complexities with engaging in global R&D programs due to the restrictions on data flows could deter scientific investment in the EU and frustrate the EU's ambitions to lead in the life sciences.
Beyond the impacts of EU international data transfer policies on the field of biomedical research and biotech SME creation, a recent DigitalEurope study suggested EU restrictions on international data transfers may result in the EU missing out on around 2 trillion euros worth of growth by the end of 2030.
Ultimately, uncertainties around the ability to transfer data abroad to support biotech research do a disservice to science, which is increasingly globalized and interconnected. Global society depends on life science innovation — especially the critical collaborations between European scientists and international partners — to solve some of the most pressing concerns facing humanity. The current COVID-19 pandemic is evidence of this. Strengthening scientific cooperation between the EU and the global biotech community should be a priority. It can be incentivized appropriately without impinging on the legitimate protections of EU citizens' privacy rights.
Herein lies the potential for the European Health Data Space — to create a research and innovation-friendly European data policy framework that enables biotech innovation and strengthens scientific collaborations with researchers worldwide while recognizing and respecting the values of privacy, security, safety and ethics.
In accordance with Recital 4 of the GDPR, the processing of personal data should be designed to serve humankind. It is difficult to imagine a greater service to humanity than developing scientific capabilities to cure diseases and improve public health.
The European Health Data Space presents a clear opportunity to solidify the role the EU plays in global biomedical innovation by developing clear frameworks to enable global collaboration based on the international transfer of data. Not only would this be welcome news to the global biotech research community and patients around the world waiting for cures, but it may ultimately be an important step towards healing the transatlantic data relationship.
Photo by National Cancer Institute on Unsplash
