International Comparison and Enlightenment of Legislation on Rare Diseases&#x02014;&#x02014;Construction of Legal System Based on the Principles of Moderate Guarantee and Targeted Protection

doi:10.19546/j.issn.1674-3830.2023.9.001

China Health Insurance ›› 2023, Vol. 0 ›› Issue (9) : 5-17. DOI: 10.19546/j.issn.1674-3830.2023.9.001

International Comparison and Enlightenment of Legislation on Rare Diseases——Construction of Legal System Based on the Principles of Moderate Guarantee and Targeted Protection

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Abstract

Currently, China's measures for the prevention and treatment of rare diseases are scattered across various administrative normative documents, lacking systematic and coordinated mechanism. Legislation in other jurisdictions indicates that rare disease legislation should encompass four structural systems, i.e. rare disease and orphan drug identification, drug supply, cost fundraising, and medical services. Based on this foundation, it is crucial to improve the incentive mechanism for the supply of rare disease drugs, establish a multi-level medical security system for rare diseases, and enhance the level of medical services through collaborative diagnosis and treatment of rare diseases. Drawing from the experience of legislation abroad and considering China's actual conditions, future efforts should be made towards constructing a legal framework for the prevention and treatment of rare diseases, guided by the principles of moderate guarantee and targeted protection. In terms of disease identification, priority should be given to rare diseases with high prevalence. As for drug supply, preference should be given to pharmaceutical companies with research and development capabilities and willingness. Regarding cost fundraising and assurance levels, the principle of moderation should be upheld. Medical services should be targeted towards regions and populations lacking in medical resources.

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rare disease legislation / rare disease identification / drug supply / cost fundraising / medical services

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International Comparison and Enlightenment of Legislation on Rare Diseases——Construction of Legal System Based on the Principles of Moderate Guarantee and Targeted Protection[J]. China Health Insurance. 2023, 0(9): 5-17 https://doi.org/10.19546/j.issn.1674-3830.2023.9.001

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