The Impact of China's Human Genetic Resources Regime on Biopharma MNCs
May 14, 2021 | BY
Vincent ChowChina's HGR regime has been significantly bolstered in the last two years, delaying the research and development activities of biopharma MNCs in the country
Nikita G. Sidorov/iStockphoto.com
Multinational pharmaceutical companies are reducing research and development activity in China as the government tightens access to human genetic resources (HGR) and imposes ownership control on intellectual property. Now China is taking these restrictions one step further by incorporating the HGR regime into a national statute, the PRC Biosecurity Law (中华人民共和国生物安全法), for the first time, with significantly ramped up penalties for HGR-related violations.
China's HGR regime is not unfamiliar to pharmaceutical MNCs, dating back to the 1998 Tentative Measures for the Administration of Human Genetic Resources (人类遗传资源管理暂行办法). In 2019, these ministry-level tentative measures were replaced with a significantly expanded and more detailed set of regulations following the promulgation of the Regulations for the Administration of Human Genetic Resources (人类遗传资源管理条例).
This premium content is reserved for
China Law & Practice Subscribers.
A Premium Subscription Provides:
- A database of over 3,000 essential documents including key PRC legislation translated into English
- A choice of newsletters to alert you to changes affecting your business including sector specific updates
- Premium access to the mobile optimized site for timely analysis that guides you through China's ever-changing business environment
Already a subscriber? Log In Now