How to fix the GDPR's frustration of global biomedical research

• Published in: Science (American Association for the Advancement of Science) Vol. 370; no. 6512; pp. 40 - 42
• Main Authors: Bovenberg, Jasper, Peloquin, David, Bierer, Barbara, Barnes, Mark, Knoppers, Bartha Maria
• Format: Journal Article
• Language: English
• Published: United States The American Association for the Advancement of Science 02.10.2020
• Subjects: Beliefs; Biomedical Research - trends; Computer Security; Coronavirus Infections; Coronaviruses; COVID-19; COVID-19 vaccines; Ethics; Experimentation; Experiments; Frustration; Guidelines as Topic; Humans; Information Dissemination; Leadership; Pandemics; Pneumonia, Viral; Public health; Regulatory agencies; Review boards; Scientists; Vaccines; Viral diseases
• ISSN: 0036-8075; 1095-9203; 1095-9203
• DOI: 10.1126/science.abd2499

Sharing of data for research beyond the EU must improve Since the advent of the European Union (EU) General Data Protection Regulation (GDPR) in 2018, the biomedical research community has struggled to share data with colleagues and consortia outside the EU, as the GDPR limits international transfers of personal data. A July 2020 ruling of the Court of Justice of the European Union (CJEU) reinforced obstacles to sharing, and even data transfer to enable essential research into coronavirus disease 2019 (COVID-19) has been restricted in a recent Guidance of the European Data Protection Board (EDPB). We acknowledge the valid concerns that gave rise to the GDPR, but we are concerned that the GDPR's limitations on data transfers will hamper science globally in general and biomedical science in particular (see the text box) ( 1 )—even though one stated objective of the GDPR is that processing of personal data should serve humankind, and even though the GDPR explicitly acknowledges that the right to the protection of personal data is not absolute and must be considered in relation to its function in society and be balanced against other fundamental rights. We examine whether there is room under the GDPR for EU biomedical researchers to share data from the EU with the rest of the world to facilitate biomedical research. We then propose solutions for consideration by either the EU legislature, the EU Commission, or the EDPB in its planned Guidance on the processing of health data for scientific research. Finally, we urge the EDPB to revisit its recent Guidance on COVID-19 research.