Experience reference and China's path of legislation on orphan drugs and medical devices

XU Ying-ling; YANG Yue

doi:10.20251/j.cnki.1003-3734.2025.19.001

Abstract：Orphan drugs and medical devices are related to the forefront of science and technology,with high R&D difficulties,long cycles,and high costs.However,the market size is relatively small.It is difficult to effectively motivate enterprises to increase R&D investment through market mechanisms alone.How to improve product accessibility and help patients share the dividends of reform and development is an important issue during the process of Chinese modernization.The United States,the European Union,Japan,Taiwan province of China,and other countries and regions have formed useful experience in solving product supply problems through legislation,especially specialized legislation.With the improvement of economic strength,scientific and technological strength,and comprehensive national strength,it has become a consensus among all sectors of society to draw on the experience of comparative law to carry out specialized legislation at the national level.As the country's rare disease prevention,treatment and protection work enters a new stage of high-quality development,the Law on Promoting the Development of orphan drugs and medical devices should be formulated and promulgated as soon as possible.This law belongs to promotional legislation,with empowerment,incentive and support as the main approach of adjustment.On the basis of defining basic concepts,such as rare diseases,it concretizes existing incentive policies and localizes comparative legal experience.It creatively sets up incentive systems,such as product qualification recognition,market exclusivity,and tax reductions.On the track of the rule of law,institutional innovation and institutional synergy are used to enhance product accessibility and promote people's health and well-being.