Strategy to Innovate the Korea Biobank to Effectively Respond to Infectious Diseases

Abstract

In the early stages of the COVID-19 outbreak, domestic in vitro diagnostic medical device companies developed diagnostic reagents and with the implementation of the “Emergency Use Authorization” by the government, were able to quickly use diagnostic kits. With the sustained growth of infectious disease diagnostic testing products related to COVID-19, in vitro diagnostic medical device companies experienced significant growth, and became the key drivers of the medical device industry. However, under the strengthened clinical trials mandated by the In Vitro Diagnostic Regulation (IVDR), securing clinical samples has become more important for in vitro diagnostic medical devices. The purpose of this study was to emphasize the significance of obtaining clinical samples for infectious disease research in response to strengthened regulations. Additionally, it highlights the crucial role of government support in providing information on clinical samples collection and offering clinical trial assistance to in vitro diagnostic medical device companies. To accomplish this, the study examined the types and grades of in vitro diagnostic medical devices in the medical device industry, domestically and internationally, and highlighted the challenges faced by companies in securing clinical samples through real-world examples. Starting with the terms and concepts of biobanking in various countries, the study investigated its operations, purposes, and institutional and legal advancements to understand the current status of domestic and international biobanks for problem-solving. Lastly, to maximize the utilization of infectious disease clinical samples, the study was concluded by deriving strategic plans for expanding and using domestic and international biobank networks. Through this research, a step-by-step strategy is proposed to activate domestic biobanks. First, we propose a legislative amendment by referencing the legal framework of countries with advanced healthcare systems. This amendment aims to facilitate the utilization of clinical samples and activate biobanks by changing the legislative purpose. Second, there is a need to create an environment that facilitates clinical samples information collection from procurement to use. Third, we aim to enhance global collaboration in the Korean Biobank Project by designating domestic partners for overseas clinical trials and other collaborative initiatives. Fourth, we recommend the expansion of specimen collection types within Korea Biobank Network Portal, comprehensive integration of information from all domestic biobanks, and globalization of Korean biobank network portal to enhance its international reach. Focusing on strengthening ongoing government–private sector collaboration and expanding the domestic biobank network, we propose a national-level strategy for expanding global partnerships with organizations enabling South Korea to successfully lead the future in vitro diagnostics market globally.