Bridging medicine access gaps through cross-national market linkage in South Korea and Italy: a conceptual case
- 1Sahmyook University
Abstract
BackgroundMedicine shortages are monitored within national borders, but complementarity across national markets is poorly characterised.
ObjectiveTo characterise medicines supplied through South Koreas national access programme and to quantify this complementarity between South Korea and Italy.
MethodsIn this cross-sectional study, we linked shortage records from the Italian Medicines Agency and Korean Ministry of Food and Drug Safety, Korea Orphan and Essential Drug Center supply notices, and national reimbursement lists. The primary outcome was the proportion of shortage configurations with a reimbursed counterpart in the partner country, identified by normalised ingredient, pharmaceutical form, and route, and not recorded as withdrawn or in shortage. The primary analysis covered Jan 1-June 30, 2026, and the secondary analysis covered 2023-26.
ResultsAmong 341 formulations supplied through the Korean national access programme, 242 (71.0%) lacked domestic marketing authorisation at first observed supply or were supplied after market withdrawal. Of 338 Italian shortage configurations in the first half of 2026, 228 (67.5%) had an available reimbursed Korean counterpart; over 2023-26, 332 of 549 (60.5%) did. Conversely, 27 of 47 Korean configurations (57.4%) had such an Italian counterpart; over 2023- 26, 93 of 184 (50.5%) did. In both directions, ingredients on EU critical or Korean essential medicine lists more often had a cross-border match than unlisted ingredients.
ConclusionsAbout half of shortage or access-gap medicines had a potentially available reimbursed counterpart in the other country. Cross-national linkage of medicine data may help identify potential counterparts, although these require regulatory, clinical, and procurement review.
Research in contextO_ST_ABSWhat is already known about the topic?C_ST_ABSStudies have mainly compared shortage patterns or management across countries or described importation and information sharing as responses. A 2025 US analysis found that, for about two-thirds of generic sterile injectables in shortage with three or fewer US manufacturers, a version was approved in peer countries. We found no study that linked national shortage records to a partner countrys reimbursement market while accounting for withdrawals and concurrent shortages.
What does this study add to the literature?In the first half of 2026, about two-thirds of Italian and more than half of Korean shortage or access-gap configurations had an available reimbursed counterpart abroad, and critical or essential medicines more often had a cross-border match. Most medicines supplied through South Koreas national access programme lacked domestic marketing authorisation at first supply or were supplied after market withdrawal.
What are the policy implications?Linking national registers can identify candidate counterparts across borders, but each requires product-level regulatory and procurement review and an institution able to act on the resulting information. Wider application would require standardised reporting of ingredient, form, route, and shortage date.
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BibTeX
@misc{sohn2026bridging,
title = {{Bridging medicine access gaps through cross-national market linkage in South Korea and Italy: a conceptual case}},
author = {M. Sohn and U. M. Musazzi},
howpublished = {medRxiv},
year = {2026},
month = oct,
doi = {10.64898/2026.10.08.26365076},
url = {https://www.medrxiv.org/content/10.64898/2026.10.08.26365076v1},
note = {CC BY},
}
RIS
TY - UNPB
TI - Bridging medicine access gaps through cross-national market linkage in South Korea and Italy: a conceptual case
AU - M. Sohn
AU - U. M. Musazzi
PY - 2026
DA - 2026/10/08
PB - medRxiv
DO - 10.64898/2026.10.08.26365076
UR - https://www.medrxiv.org/content/10.64898/2026.10.08.26365076v1
AB - BackgroundMedicine shortages are monitored within national borders, but complementarity across national markets is poorly characterised. ObjectiveTo characterise medicines supplied through South Koreas national access programme and to quantify this complementarity between South Korea and Italy. MethodsIn this cross-sectional study, we linked shortage records from the Italian Medicines Agency and Korean Ministry of Food and Drug Safety, Korea Orphan and Essential Drug Center supply notices, and national reimbursement lists. The primary outcome was the proportion of shortage configurations with a reimbursed counterpart in the partner country, identified by normalised ingredient, pharmaceutical form, and route, and not recorded as withdrawn or in shortage. The primary analysis covered Jan 1-June 30, 2026, and the secondary analysis covered 2023-26. ResultsAmong 341 formulations supplied through the Korean national access programme, 242 (71.0%) lacked domestic marketing authorisation at first observed supply or were supplied after market withdrawal. Of 338 Italian shortage configurations in the first half of 2026, 228 (67.5%) had an available reimbursed Korean counterpart; over 2023-26, 332 of 549 (60.5%) did. Conversely, 27 of 47 Korean configurations (57.4%) had such an Italian counterpart; over 2023- 26, 93 of 184 (50.5%) did. In both directions, ingredients on EU critical or Korean essential medicine lists more often had a cross-border match than unlisted ingredients. ConclusionsAbout half of shortage or access-gap medicines had a potentially available reimbursed counterpart in the other country. Cross-national linkage of medicine data may help identify potential counterparts, although these require regulatory, clinical, and procurement review. Research in contextO_ST_ABSWhat is already known about the topic?C_ST_ABSStudies have mainly compared shortage patterns or management across countries or described importation and information sharing as responses. A 2025 US analysis found that, for about two-thirds of generic sterile injectables in shortage with three or fewer US manufacturers, a version was approved in peer countries. We found no study that linked national shortage records to a partner countrys reimbursement market while accounting for withdrawals and concurrent shortages. What does this study add to the literature?In the first half of 2026, about two-thirds of Italian and more than half of Korean shortage or access-gap configurations had an available reimbursed counterpart abroad, and critical or essential medicines more often had a cross-border match. Most medicines supplied through South Koreas national access programme lacked domestic marketing authorisation at first supply or were supplied after market withdrawal. What are the policy implications?Linking national registers can identify candidate counterparts across borders, but each requires product-level regulatory and procurement review and an institution able to act on the resulting information. Wider application would require standardised reporting of ingredient, form, route, and shortage date.
ER -