Abstract Background Rare diseases affect over 300 million people worldwide but have historically lacked dedicated global governance within the World Health Organization (WHO). Efforts remained fragmented, with no unified framework or accountability mechanism. Objective This commentary analyses the significance, opportunities, and implementation challenges of the first-ever WHO resolution on rare diseases (WHA78.11), unanimously adopted on 27 May 2025 and co-sponsored by Egypt and Spain. Key Content of the Resolution The resolution designates rare diseases as a global health priority for equity and inclusion. It urges the development of a comprehensive 10-year Global Action Plan (GAP), integration of rare diseases into Universal Health Coverage (UHC), strengthened registries and coding systems, patient-centred care pathways, and meaningful involvement of patient organizations. It also establishes reporting mechanisms, with progress updates expected in 2026, 2028, and 2030. Critical Analysis While the resolution represents a historic milestone and provides a much-needed governance framework, significant challenges remain. These include insufficient sustainable financing (particularly in low- and middle-income countries), slow preparatory progress, heterogeneity across Member States, limited interoperable data systems, and the tension between innovation and affordability. Measurable success will depend on strong governance structures, innovative financing mechanisms, robust data management, and the development of clinical care pathways. Conclusions WHA78.11 marks the first lap in a long marathon toward equitable care for persons living with rare diseases. Its ultimate impact will be determined by the timely development and effective implementation of the Global Action Plan, with clear, time-bound targets and adequate resource allocation. The coming months, particularly the report to the 79th World Health Assembly in May 2026, will be critical.
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