{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,26]],"date-time":"2026-08-26T18:19:43Z","timestamp":1787768383700,"version":"build-2784847793"},"reference-count":36,"publisher":"Public Library of Science (PLoS)","issue":"8","license":[{"start":{"date-parts":[[2026,8,26]],"date-time":"2026-08-26T00:00:00Z","timestamp":1787702400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["www.plosglobalpublichealth.org"],"crossmark-restriction":false},"short-container-title":["PLOS Glob Public Health"],"abstract":"<jats:p>The COVID-19 pandemic exposed critical gaps in Japan\u2019s infectious disease governance, including fragmented structures and limited coordination between research and policy. In response, Japan established the Japan Institute for Health Security (JIHS) in April 2025 by merging the National Institute of Infectious Diseases and the National Center for Global Health and Medicine, yet no comprehensive assessment exists of the legal frameworks supporting this transformation. This descriptive qualitative study combined document review with semi-structured key informant interviews to examine JIHS governance structures, objectives, and legal reforms. We reviewed five pieces of legislation, two grey literature documents, and eight government publications, and interviewed eight purposively selected informants\u2014one national legislator, four senior Ministry of Health, Labour and Welfare officials, and three JIHS executive officers\u2014in Japanese between August and September 2025, analyzing transcripts with Braun and Clarke\u2019s thematic analysis framework. The JIHS Act and associated amendments established JIHS as a Special Public Corporation, creating mechanisms for vertical and horizontal coordination and embedding preparedness and research capacity as core elements of national health security. Consistent with Japanese enabling legislation, the Act sets a broad framework whose operational adequacy is calibrated through subordinate regulations and administrative practice. Document analysis and interviews revealed a tripartite governance model integrating political leadership, administrative coordination, and scientific expertise, and informants emphasized that inter-agency trust and cultural integration between the merged institutions are essential for effective implementation. JIHS thus internalizes scientific advice within the national public health framework while preserving institutional autonomy, offering context-dependent lessons that underscore the importance of tailoring reforms to national administrative traditions. Future evaluation will focus on the real-world operationalization of this enacted framework, assessing whether its specific design choices translate into improved pandemic preparedness and response.<\/jats:p>","DOI":"10.1371\/journal.pgph.0007088","type":"journal-article","created":{"date-parts":[[2026,8,26]],"date-time":"2026-08-26T17:39:01Z","timestamp":1787765941000},"page":"e0007088","update-policy":"https:\/\/doi.org\/10.1371\/journal.pgph.corrections_policy","source":"Crossref","is-referenced-by-count":0,"title":["Legal design for establishing a novel parastatal public health institute \u2013 Japan Institute for Health Security: A case study"],"prefix":"10.1371","volume":"6","author":[{"given":"Miyako","family":"Otsuka","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mio","family":"Kato","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takaji","family":"Wakita","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6250-4464","authenticated-orcid":true,"given":"Tomoya","family":"Saito","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"340","published-online":{"date-parts":[[2026,8,26]]},"reference":[{"key":"pgph.0007088.ref001","unstructured":"Mitsubishi Research Institute. 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GHSA; 2023 [cited 2026 May 25]. https:\/\/globalhealthsecurityagenda.org\/wp-content\/uploads\/2024\/08\/Final_May2023_Legal-Preparedness-Definition.pdf"},{"issue":"1","key":"pgph.0007088.ref011","doi-asserted-by":"crossref","first-page":"88","DOI":"10.4337\/jghl.2024.01.05","article-title":"Commentary: strengthening legal preparedness and response within the global health emergency framework: the role of the GHSA Legal Preparedness Action Package*","volume":"1","author":"S Negri","year":"2024","journal-title":"Journal of Global Health Law"},{"key":"pgph.0007088.ref012","volume-title":"Joint external evaluation tool: International Health Regulations (2005), third edition","author":"World Health Organization","year":"2022"},{"issue":"2","key":"pgph.0007088.ref013","doi-asserted-by":"crossref","first-page":"77","DOI":"10.1191\/1478088706qp063oa","article-title":"Using thematic analysis in psychology","volume":"3","author":"V Braun","year":"2006","journal-title":"Qual Res Psychol"},{"key":"pgph.0007088.ref014","doi-asserted-by":"crossref","DOI":"10.4135\/9781036232078.n9","volume-title":"Thematic Analysis: A Practical Guide","author":"V Braun","year":"2021"},{"key":"pgph.0007088.ref015","unstructured":"House of Representatives. The 201st session of the National Diet House of Representatives, Budget Committee meeting No. 12. 2020. https:\/\/kokkai.ndl.go.jp\/#\/detail?minId=120105261X01220200217\u00a4t=1"},{"key":"pgph.0007088.ref016","unstructured":"Expert Council on COVID-19 Response. Expert Council on COVID-19 Response. Mid- to long-term challenges for the next infectious disease crisis, based on past efforts against COVID-19. 2022 [cited 2025 Oct 19]. https:\/\/www.cas.go.jp\/jp\/seisaku\/coronavirus_yushiki\/pdf\/corona_kadai.pdf"},{"key":"pgph.0007088.ref017","unstructured":"Prime Minister\u2019s Office of Japan. 93rd Meeting of the Novel Coronavirus Response Headquarters. https:\/\/japan.kantei.go.jp\/101_kishida\/actions\/202206\/_00029.html. 2022. Accessed 2025 October 19."},{"key":"pgph.0007088.ref018","unstructured":"Social Security Council, Ministry of Health, Labour and Welfare. Specific measures to prepare for the next infectious disease crisis based on past efforts regarding COVID-19. 2022 [cited 2025 Oct 19]. https:\/\/www.mhlw.go.jp\/content\/12601000\/000985193.pdf"},{"key":"pgph.0007088.ref019","unstructured":"House of Councillors, The National Diet of Japan. Act on Japan Institute for Health Security. 2023. https:\/\/www.sangiin.go.jp\/japanese\/joho1\/kousei\/gian\/211\/meisai\/m211080211049.htm"},{"key":"pgph.0007088.ref020","unstructured":"House of Councillors, The National Diet of Japan. Law Concerning the Preparation of Related Laws in accordance with the Enforcement of the Act on Japan Institute for Health Security. 2023. https:\/\/www.sangiin.go.jp\/japanese\/joho1\/kousei\/gian\/211\/meisai\/m211080211050.htm"},{"key":"pgph.0007088.ref021","unstructured":"Ministry of Health, Labour and Welfare. 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