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China Adopts Biotechnology Regulation, Amid Authoritarianism Concerns
Photo: BillionPhotos.com/Adobe Stock
By Sevan Araz
China is gearing up to become a biotechnology powerhouse. Within the past five years the Chinese government is estimated to have invested over $100 billion in life sciences research and development. Further signaling its determination, Beijing is lavishing the sector with a host of fiscal incentives while state-backed entities dish out largesse to promising startups.
As biotechnologies rapidly proliferate, China—and other states—are rushing to develop regulatory and ethical frameworks. The COVID-19 pandemic has raised the urgency of such efforts. To set parameters for the evolving sector, Beijing has rolled out various initiatives.
In 2017, the Ministry of Science and Technology issued a series of regulatory measures to streamline the management of biotechnology research and development (R&D). Among the provisions was the establishment of the National Biotechnology Research and Development Safety Management Expert Committee. The advisory board draws from a broad swath of professionals: lawyers, economists, physicians, and biologists. The purview of the committee includes developing inspection practices, safety protocols and incident response guidelines.
Tepid efforts to rein in rogue biotechnology R&D were jolted by revelations of unethical gene-editing trials at the Shenzhen-based Southern University of Science and Technology. The affair, commonly referred to as the “CRISPR-baby scandal”, centered on the experimental endeavors of biophysicist He Jiankui. Applying the CRISPR–Cas9 gene-editing technique, He engineered mutations into human embryos in an attempt to confer resistance to HIV. The edited embryos were subsequently implanted into two recipients, resulting in several births. Following this disclosure in 2018, the scandal swept China and the globe, attracting public scrutiny and prompting a slew of ethical questions. Seeking to deter future bouts of frankensteining, Beijing set a firm precedent by indicting He for practicing illegal medicine. In 2019, a Chinese court condemned the infamous biophysicist with a three-year prison sentence, while two colleagues received lighter sentences. The long-awaited verdicts marked the end of the gripping saga. But the bioethical concerns kindled by the incident continue to reverberate.
He’s disregard for ethical principles for research involving human subjects spurred Chinese lawmakers to curb unfettered biomedical research. As part of the regulatory drive, the Chinese Ministries of Justice and Science and Technology released a revamped slate of codes for administering the use of human genetic resources—and associated data. The directives supersede earlier measures promulgated in 1998. The scope of the regulation package extends to the collection, preservation, utilization and export of Chinese human genetic resources. The rules, which came into effect in July 2019, also establish procedures for obtaining research approval. Compliance management is within the remit of provincial science and technical administrative departments, according to article four of the regulations.
While unveiling the genetic governance codes in March 2019, Justice Minister Fu Zhenghua and Science and Technology Minister Wang Zhigang touted the industrial advantages conferred by China’s demographic diversity. The cabinet members characterized vast, polyethnic gene pools as a critical asset in propelling Chinese life sciences ambitions. (Presently, Beijing is exploiting its genocide against Muslim minorities in Xinjiang to develop, field, and assess a bevy of novel, disturbing biotechnologies.)
In the course of the press conference, the ministers also revealed the government’s intention to establish genetic registries across select provinces, presaging the state-orchestrated gene harvesting campaigns roiling China, and Xinjiang in particular. The accumulated data is set to buoy Beijing’s bulging surveillance capabilities.
Later that March, the Ministry of Science and Technology rolled out fresh draft regulations for biotechnology R&D. The draft establishes a risk taxonomy—high, moderate or low risk—for assessing biotechnology activities. Compliance requirements are specified for each risk category. The document also proposes organizations adopt in-house governance measures. To this end, the draft lists a series of recommendations for institutions carrying out high-risk biotech R&D, including having a detailed outline of research plans and methods, instituting risk reduction measures, and creating emergency response strategies. Institutions are also instructed to set up biotechnology security commissions. These advisory committees are charged with supervising the implementation of the aforementioned policies. Intent to maintain tabs on its burgeoning biotechnology industry, Beijing required security commissions to register with local authorities.
Aiming to advance the ethical reckoning precipitated by the CRISPR-baby scandal, Beijing also launched the National Science and Technology Ethics Committee in July 2019. The committee is tasked with crafting uniform ethical standards for emerging technologies. To date, its primary focus areas are artificial intelligence and biomedicine.
The enduring COVID-19 crisis has also animated Chinese biosafety concerns—and resolve. While addressing a session of the powerful Central Comprehensive Deepening Reform Commission in February 2020, Chinese President Xi Jinping pushed for the rapid crafting of biosafety legislation and the establishment of biosecurity governance frameworks. Xi also harped on incorporating biosecurity tenets into China’s national security strategy.
Despite mounting a regulatory embrace, Beijing’s flagrant violation of bioethics casts doubt on its sincerity. As states navigate the fallout of the COVID-19 pandemic, global biotechnology norms are set to be the subject of greater discourse—and rivalry. Precedent suggests China may seek to set standards that are in its own national interest. Yet Beijing’s margin to influence emerging norms should be scrutinized and curtailed as a rebuke of its harrowing strand of biotech-driven authoritarianism.
China is gearing up to become a biotechnology powerhouse. Within the past five years the Chinese government is estimated to have invested over $100 billion in life sciences research and development. Further signaling its determination, Beijing is lavishing the sector with a host of fiscal incentives while state-backed entities dish out largesse to promising startups.
As biotechnologies rapidly proliferate, China—and other states—are rushing to develop regulatory and ethical frameworks. The COVID-19 pandemic has raised the urgency of such efforts. To set parameters for the evolving sector, Beijing has rolled out various initiatives.
In 2017, the Ministry of Science and Technology issued a series of regulatory measures to streamline the management of biotechnology research and development (R&D). Among the provisions was the establishment of the National Biotechnology Research and Development Safety Management Expert Committee. The advisory board draws from a broad swath of professionals: lawyers, economists, physicians, and biologists. The purview of the committee includes developing inspection practices, safety protocols and incident response guidelines.
Tepid efforts to rein in rogue biotechnology R&D were jolted by revelations of unethical gene-editing trials at the Shenzhen-based Southern University of Science and Technology. The affair, commonly referred to as the “CRISPR-baby scandal”, centered on the experimental endeavors of biophysicist He Jiankui. Applying the CRISPR–Cas9 gene-editing technique, He engineered mutations into human embryos in an attempt to confer resistance to HIV. The edited embryos were subsequently implanted into two recipients, resulting in several births. Following this disclosure in 2018, the scandal swept China and the globe, attracting public scrutiny and prompting a slew of ethical questions. Seeking to deter future bouts of frankensteining, Beijing set a firm precedent by indicting He for practicing illegal medicine. In 2019, a Chinese court condemned the infamous biophysicist with a three-year prison sentence, while two colleagues received lighter sentences. The long-awaited verdicts marked the end of the gripping saga. But the bioethical concerns kindled by the incident continue to reverberate.
He’s disregard for ethical principles for research involving human subjects spurred Chinese lawmakers to curb unfettered biomedical research. As part of the regulatory drive, the Chinese Ministries of Justice and Science and Technology released a revamped slate of codes for administering the use of human genetic resources—and associated data. The directives supersede earlier measures promulgated in 1998. The scope of the regulation package extends to the collection, preservation, utilization and export of Chinese human genetic resources. The rules, which came into effect in July 2019, also establish procedures for obtaining research approval. Compliance management is within the remit of provincial science and technical administrative departments, according to article four of the regulations.
While unveiling the genetic governance codes in March 2019, Justice Minister Fu Zhenghua and Science and Technology Minister Wang Zhigang touted the industrial advantages conferred by China’s demographic diversity. The cabinet members characterized vast, polyethnic gene pools as a critical asset in propelling Chinese life sciences ambitions. (Presently, Beijing is exploiting its genocide against Muslim minorities in Xinjiang to develop, field, and assess a bevy of novel, disturbing biotechnologies.)
In the course of the press conference, the ministers also revealed the government’s intention to establish genetic registries across select provinces, presaging the state-orchestrated gene harvesting campaigns roiling China, and Xinjiang in particular. The accumulated data is set to buoy Beijing’s bulging surveillance capabilities.
Later that March, the Ministry of Science and Technology rolled out fresh draft regulations for biotechnology R&D. The draft establishes a risk taxonomy—high, moderate or low risk—for assessing biotechnology activities. Compliance requirements are specified for each risk category. The document also proposes organizations adopt in-house governance measures. To this end, the draft lists a series of recommendations for institutions carrying out high-risk biotech R&D, including having a detailed outline of research plans and methods, instituting risk reduction measures, and creating emergency response strategies. Institutions are also instructed to set up biotechnology security commissions. These advisory committees are charged with supervising the implementation of the aforementioned policies. Intent to maintain tabs on its burgeoning biotechnology industry, Beijing required security commissions to register with local authorities.
Aiming to advance the ethical reckoning precipitated by the CRISPR-baby scandal, Beijing also launched the National Science and Technology Ethics Committee in July 2019. The committee is tasked with crafting uniform ethical standards for emerging technologies. To date, its primary focus areas are artificial intelligence and biomedicine.
The enduring COVID-19 crisis has also animated Chinese biosafety concerns—and resolve. While addressing a session of the powerful Central Comprehensive Deepening Reform Commission in February 2020, Chinese President Xi Jinping pushed for the rapid crafting of biosafety legislation and the establishment of biosecurity governance frameworks. Xi also harped on incorporating biosecurity tenets into China’s national security strategy.
Despite mounting a regulatory embrace, Beijing’s flagrant violation of bioethics casts doubt on its sincerity. As states navigate the fallout of the COVID-19 pandemic, global biotechnology norms are set to be the subject of greater discourse—and rivalry. Precedent suggests China may seek to set standards that are in its own national interest. Yet Beijing’s margin to influence emerging norms should be scrutinized and curtailed as a rebuke of its harrowing strand of biotech-driven authoritarianism.
Sevan Araz is a research intern with the Technology Policy Program at the Center for Strategic and International Studies in Washington, DC.
The Technology Policy Blog is produced by the Technology Policy Program at the Center for Strategic and International Studies (CSIS), a private, tax-exempt institution focusing on international public policy issues. Its research is nonpartisan and nonproprietary. CSIS does not take specific policy positions. Accordingly, all views, positions, and conclusions expressed in this publication should be understood to be solely those of the author(s).