Preliminary study on Chinese standards for defining rare diseases / 中国卫生政策研究

ABSTRACT

Objective:To suggest approaches for the establishment of Chinese standards for defining rare disea-ses and advance corresponding Chinese legislation. Methods:By comparing the standards for defining rare diseases in Europe, the United States, and other countries and studying key influencing factors of standards, this paper proposes suggestions for the establishment of proper Chinese standards for defining rare. Results and Conclusion:Social and e-conomic development levels, medical development levels and social security levels influence the establishment of standards. It is recommended that the national conditions should be taken into consideration and the number of pa-tients, severity of the diseases and economic indicators of orphan drugs be used to define rare diseases in China.