On May 28, 2019, China’s State Council releases a new Regulation of Human Genetic Resources (the “Regulation”) which will become effective on July 1. For the life sciences industry and research organizations that utilize any human genetic resource from China, regulatory compliance with the newly released Regulation could make a difference between success and failure.
According to the Regulations, human genetic resources include human genetic materials such as organs, tissues, and cells that contain human genomes and genes, as well as human genetic information such as data derived from human genetic resource materials. Anyone who collects, preserves, utilizes or provides China’s human genetic resources should comply with the regulations.
A Chinese entity is allowed to collect, preserve and utilizes China’s human genetic resources (CHGR) for scientific research or clinical trials. Sales of human genetic resources are prohibited.
For scientific research activities utilizing CHGR, foreign organizations and individuals, as well as organizations directly controlled by them (“foreign entity”) shall collaborate with a Chinese entity and seek approval from the technical administrative departments of the State Council. Any patent generated from the results of a collaborated research will be co-owned by both parties and the ownership for other technical results can be agreed. The foreign entity has a use right of the data generated from a collaborated research.
For clinical trials that utilize CHGR and does not involve export of the same, a simplified registration is required.
Export of CHGR materials is subjected to approval by the State Council. Providing or opening use of CHGR information to a foreign entity or is subjected to recordation and a copy of the information shall be submitted.
Irregularities will cause a series of punishments including penalties and prohibition of the relevant activity. According to the Chinese patent law, any patent application utilizing genetic resources obtained in breach of the PRC laws will not be granted a patent right or if granted will be invalidated in China.