China Issues Human Genetic Resources Management Regulations

19 November 2012 Personalized Medicine Bulletin Blog

Those seeking to conduct research involving human genetic material within the People’s Republic of China or to import into China such material should review China’s recently issued draft regulations (“Draft”) for the management of its human genetic resources. The regulations apply to the collection, preservation, research, development, immigration and other activities involving human genetic material.

The Draft provides provides that only legal entities established by law in China may engage in the collection and preservation of human genetic material. Foreign entities can conduct research with the cooperation of a Chinese entity. Such cooperation shall be subject to the approval of Ministry of Science and Technology of P.R.C (MOST). In addition, the foreign entity shall ensure that staff from the Chinese entity take part in the substantive research and development activity during the collaboration. Though the Draft does not provide that the Chinese party will retain title to any intellectual property developed from the collaboration, the Chinese entity is required to provide a report to MOST regarding the research and development activities within three months from the ending of the international cooperation. The Draft allows the ownership of intellectual property generated from the collaboration to be decided by agreement between the Chinese and foreign entities.  

The Draft also notes that the export of human genetic resource sourced from the territory of China shall be subject to the approval of MOST. Because the Draft prohibits trading of human genetic resources, the foreign receiving unit must be the foreign party to the international cooperation approved by MOST. Human genetic resource material imported into China shall be registered with MOST.  

Special thanks to Foley & Lardner’s Max Lin for summarizing the Draft regulations. Max is resident in Foley’s Shanghai office.

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