China issued draft “Implementing Rules” for HGR in March of 2022. On June 1st, 2023, the draft implementing rules are no longer in draft and will become enforced on July 1st, 2023, according to China’s Ministry of Science and Technology. While there are a number of key points in these implementing rules for HGR, several of the main points are outlined below.
The implementing rules will narrow the scope of what is considered HGR. The draft “implementing rules” included – (1) genetic data coming from HGR materials and (2) things like medical images, clinical trials, etc. The implementing rules will only focus on (1) above and not (2) above. In addition, the implementing rules reduce the data sharing responsibilities and IP ownership more than the draft implementing rules. Now, while data and records derived from Chinese HGR need to be accessible to the Chinese partner, foreign companies are able to have full ownership of IP that is not patentable from China and foreign HGR research.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.