<![CDATA[Most people living with a rare disease reside in countries with limited health system resources, yet these conditions have received little priority in national health policy in such settings. This scoping review examined how medication labeling, health literacy, equitable access, and patient empowerment intersected for rare disease patients in low- and middle-income countries. Literature published between 2018 and 2026 was searched through Europe PMC, supplemented by targeted retrieval of official policy documents. Every candidate source was verified in two stages: bibliographic details were confirmed independently against an external registry, and content was then confirmed from retrieved text. Twenty-five sources satisfied verification and eligibility criteria, while seven bibliographically confirmed records were withheld because their content could not be confirmed. Four themes were identified, comprising information asymmetry in rare disease care, medication labeling and comprehension, health literacy measurement capability, and equitable access as a condition of empowerment. No verified study evaluated medication labeling or leaflet comprehension among rare disease patients in a low- or middle-income setting. The contributing domains were found to be individually well developed but rarely joined. This absence constituted the principal finding, and validated instruments and trial designs already existed that appeared capable of addressing it.]]>
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