In-Depth: Biotechnology Faces Boom Period, China's Genetic Resource Regulation Seeks Change (AI Translation)

【周刊提前读】深度：生物科技面临爆发期 中国遗传资源监管求变

The Chinese government is set to ease restrictions on human genetic resources, marking a significant regulatory shift. This change emerged during the 2023 National People's Congress when it was announced that the "Office of Human Genetic Resources Management" and the China National Center for Biotechnology Development would move from the Ministry of Science and Technology to the National Health Commission. By March 2024, the National Health Commission formally took over human genetic resource management, indicating a policy shift toward health-focused regulation [para. 1][para. 2][para. 3].

Human genetic resources encompass genetic materials containing human genomes, genes, and related data. They require approval for collection, preservation, and utilization, significantly impacting China's scientific research and biopharmaceutical industry. The new regulation aims to streamline administrative procedures, enhance supervision efficiency, and stimulate biopharmaceutical research [para. 4][para. 5][para. 6].

Historical management of human genetic resources in China began in the 1990s. Due to initial regulatory gaps, bypassing approval procedures was common, leading to a need for systematic regulation. In 2015, new regulations began constructing a comprehensive management system. The "Regulation on the Administration of Human Genetic Resources," the "Biosafety Law," and the "Implementation Rules" established a complete legal framework by 2023 [para. 7].

The "strict regulation" period soon led to industry criticisms over inefficiency and unnecessary bureaucratic hurdles. Stringent restrictions hinder the biopharmaceutical industry, prolonging clinical trial approvals and complicating international collaborations. This overregulation prompted calls for deregulation to foster academia-industry cooperation and attract foreign investment [para. 8][para. 9].

Scrutiny over approval authority highlighted misuse of power. In December 2020, Sun Yanrong, a former deputy director responsible for genetic resource regulation, was investigated for serious violations, exposing corruption issues. This led to personnel changes and calls for administrative streamlining to balance protection and development of human genetic resources [para. 10][para. 11][para. 12].

Recent reforms emphasize optimizing the "Implementation Rules" to raise administrative approval thresholds, redefine "foreign entities," and reduce burdens on enterprises and research institutions. For example, the sample collection threshold will increase from 3,000 to 10,000 cases, and firms with less than 50% foreign ownership will not be classified as foreign entities [para. 13][para. 14][para. 15].

Despite these changes, challenges persist. Barriers at the grassroots level and public skepticism hinder research involving human genetic resources. Experts stress the need to improve the management system to avoid overreach in regulation and promote scientific development [para. 16][para. 17][para. 18].

International perspectives show a move toward greater openness in managing genetic resources. U.S. regulations now restrict the sale of sensitive data to specific countries, including China. European and American models emphasize individual consent and data privacy while encouraging research freedom and data openness [para. 19][para. 20].

In closing, leveraging human genetic resources efficiently while ensuring protection poses a significant challenge. Balancing regulation with development, China aims to enhance its biopharmaceutical and genetic research industries. Learning from international practices, the focus is on creating a practical, balanced regulatory environment to support technological advancement and ensure national security [para. 21][para. 22][para. 23].