Bridging medicine access gaps through cross-national market linkage in South Korea and Italy: a conceptual case
Sohn, M.; Musazzi, U. M.
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Background Medicine shortages are monitored within national borders, but complementarity across national markets is poorly characterised. Objective To characterise medicines supplied through South Korea's national access programme and to quantify this complementarity between South Korea and Italy. Methods In 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in the partner country, identified by normalised ingredient, pharmaceutical form, and route, and not recorded as withdrawn or in shortage.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 to June 30, 2026, and the secondary analysis covered 2023-26. Results Among 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. Conclusions About 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.
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