罕见病立法倡议已久，加快进程有哪些阻力？

Core Viewpoint - There is a consensus on the urgency of legislation for rare diseases, but significant disagreements remain regarding the specific content of such legislation [1][2]. Group 1: Current Status of Rare Disease Legislation - The call for legislation on rare diseases has increased, with over 20 million patients in China facing challenges such as difficult diagnosis, medication access, and heavy financial burdens [1]. - Currently, there is no official definition of "rare diseases" in China, and the existing catalog includes only 207 diseases, which is limited compared to over 10,000 rare diseases globally [2][3]. - The existing mechanism for updating the rare disease catalog is deemed inadequate, necessitating legislative clarity on the definition of rare diseases and related medications [2]. Group 2: Challenges in Defining Rare Diseases - There is ongoing debate among various departments and experts regarding how to define rare diseases and rare disease medications, which is a major barrier to legislative progress [2][3]. - The need for a specialized legislative approach versus integrating rare disease provisions into existing laws is still under exploration [3]. Group 3: Local Initiatives and Legislative Efforts - Local governments, such as Shanghai and Jiangsu, have begun to incorporate provisions for rare diseases into their medical insurance regulations, which may be more readily accepted than standalone legislation [4]. - The Shanghai Medical Insurance Regulations encourage medical institutions to provide services for rare diseases and ensure coverage for medications listed in the national insurance catalog [4]. Group 4: Societal Perceptions and Economic Considerations - There is a lack of comprehensive understanding of rare diseases among the public, with some comparing the costs of treating rare diseases unfavorably to treating more common conditions [4][5]. - Some local governments exhibit a budgetary mindset, focusing on the costs associated with rare disease treatment rather than the potential economic benefits of developing a rare disease industry [5][6].