By James Radke of Rare Disease Report

China is about to publish its first list of national rare diseases.
Given the population of China and the fact that 8-10% of people globally have a rare disease, the market for orphan drugs could be enormous. However, getting access to that market requires a proper definition of a rare disease and an orphan drug—2 things currently missing in the China Food and Drug Administration.
When the list of rare diseases is published, the size of the list may surprise some people. In a report by Reuters, they quoted Li Dingguo, chairman of the Shanghai Rare Disease Prevention and Treatment Fund, who said China’s draft list covers over 100 diseases. Given there are an estimated 7000 rare diseases, we hope the draft list is more accurate but as Li noted to Reuters,
“Here in China, the state has good intentions but there is no detailed regulation, no preferential policies and no tax breaks (for orphan drugs).”

At present, Chinese patients with rare diseases have very few options. According to Cheng and Xie (2017) who published a review of orphan drug policy in China, rare diseases are not well defined and under the current healthcare system in which patients pay 5% co-pays, most orphan drugs are unaffordable.
Further, even if a person can afford to buy the orphan drug, most of them are not available in China. Currently only 38% and 54% of orphan drugs approved in the United States and Japan, respectively, are available in China.  
Cheng and Xie noted that a ‘grey market’ exists for those orphan drugs not yet available in the China in which people pay cash for the drugs that are smuggled in from other countries and/or prescribed by a doctor off-label.
Cheng and Xie argued that while there is no current rare disease policy in China, they are hopeful that the country takes into account some (or all) of the suggestions that were listed in 2009 when the National People’s Congress (NPC) and Chinese People’s Political Consultative Conference (CPPCC) proposed that legislation on rare diseases in China include:

  1. establishing an authentic and scientific definition of rare diseases;
  2. constructing a reasonable drug reimbursement system;
  3. simplifying the registration process for imported orphan drugs;
  4. promoting research and development of orphan drugs through intensified policy support;
  5. building-up national health service institutes for rare disease patients.



Cheng A, Xie Z. Challenges in orphan drug development and regulatory policy in China. Orphanet J Rare Dis. 2017;12:13 DOI: 10.1186/s13023-017-0568-6

Image courtesy of the South China Morning Post

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