China to Promulgate More Rules to Expedite Approvals for Genetic Resources Administration

by Morgan Lewis
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The right to privacy in China is generally recognized in the Constitution of the People’s Republic of China and Tort Liability Law. Over the past years, the Chinese government has continued to actively legislate into law a myriad of new regulations related to data privacy. With China’s Cybersecurity Law (CSL) and General Principles of Civil Law taking effect in 2017—which stipulate more stringent requirements for data governance and a private right of action against infringement of privacy, among others—the Chinese government has also made top-level policy statements to reaffirm its commitment to strengthening cybersecurity and the protection of data privacy.[1], [2] These policy directives are driven by increasing prevalence of data breach incidents as well as mounting economic value of “big data” analytics derived from population health information, genetic and clinical research data, biometrics, and other sensitive personal information. In recent months, several headline cases have further propelled the Chinese government’s legislative and enforcement priorities in this area to the forefront of the public discourse.

Case in Point: Administrative Penalties for Unlawful Cross-Border Transfer of Genetic Information

The Ministry of Science and Technology (MOST) publicly announced its penalty decision on October 24, 2018, against Shenzhen Huada Gene Technology Service Co., Ltd. (Hua Da Technology),[3] which was actually decided on September 7, 2015 (2015 Decision). This case is the first in which penalties were issued for the unlawful cross-border transfer of genetic information. According to an investigation conducted by China Administration of Human Genetic Resources (CAHGR), Huashan Hospital and Huada Technology improperly conducted a study on human genetic resources in China in collaboration with the University of Oxford. During the study, Huashan Hospital and Huada Technology transmitted human genetic information outside of China’s borders in violation of Articles 4, 11, and 16 of the Interim Measures for Management of Human Genetic Resources (Interim Measures). After the investigation in 2015, MOST demanded that Huada Technology cease their research immediately, destroy all relevant genetic material and related research data, and suspend all international cooperation between Huashan Hospital and Huada Technology. Huada Technology halted 12 projects as a result. And the stock price of Huada Gene, which is the parent company of Huada Technology, fell after the recent publication of the MOST penalty decision.[4]

The 2015 Decision is one of the six representative cases published by MOST in 2018. The publication of this decision from 2015 in October 2018 signifies that China will vigorously enforce laws regarding the cross-border transfer of human genetic resources and health information, as the government has long considered protection of Chinese genetic resources and related biosecurity a matter of national security. And these published decisions, viewed together, highlight China’s strict regulations on the use and transfer of genetic materials and information, the importance of conducting scientific researches within the scope of prior approval by regulatory agencies, and the prohibition on cross-border transfer of genetic information without regulatory approval.

Case in Point: Prohibition on Unauthorized Use of Human Genetic Resources in Research

Shortly after MOST announced the aforementioned enforcement cases, on November 25, 2018, MIT Technology Review published a story regarding the reported birth of the world’s first genetically modified human babies.[5] A Chinese scientist affiliated with Southern University of Science and Technology in Shenzhen reportedly modified the babies’ DNA in order to give them enhanced resistance to HIV using CRISPR/Cas9, a genome-editing technology. While CRISPR/Cas9 has previously been used in many applications in plants and animals, the reported birth of the twins would mark the first time that the technology was used to create genetically modified human DNA for reproductive purposes.

The revelation of this controversial research drew immediate public outcry and criticism from scientists around the world, many of whom expressed concern that such research has transgressed established ethical boundaries of biomedical research. The Chinese government announced shortly after the news broke that it has commenced a formal investigation into the incident.[6] On November 29, Xinhua News Agency, a government-affiliated news outlet, interviewed officials of the China National Health Commission, Ministry of Science and Technology, and the China Association for Science and Technology, who described the incident as extremely regrettable and stated that research activities of all involved personnel had been suspended.[7] The Chinese Academy of Medical Sciences also denounced genomic editing of human embryos for reproductive purposes in the absence of a scientific assessment, for such research constitutes a violation of laws, regulations, and ethical norms.[8] While the government’s investigation into the controversy continues, regulatory scrutiny on similar genetic researches and international collaborations is expected to intensify.

Expediting Regulatory Approvals for Cross-Border Transfer of Genetic Resources to Promote International Collaboration

Although the Chinese government’s renewed focus and reinforced regulations on genetic resources have caused the life sciences community to question whether increased regulations could create hurdles and delays in scientific exchanges and international collaborations on the R&D of new drugs, the Chinese government has avowed its support for international collaboration on biomedical research in State Council’s 2015 Action Outline for Promoting Big Data[9] and is addressing these concerns by implementing other measures to expedite the related approval processes.

For example, MOST, in response to the Opinions on Deepening the Reform of the Evaluation and Approval Systems and Encouraging Innovation on Drugs and Medical Devices issued by the General Office of the State Council of China, has further refined the licensing process for human genetic resources in international clinical trials for the purpose of obtaining drugs and medical equipment, which has taken effect since December 1, 2017. The new approval process, for example, has eliminated the requirement of obtaining the approvals from the State Council and the provincial-level MOST office; and the principal investigator(s) of a multi-site international clinical trial no longer needs to submit multiple applications for CAHGR’s approval. Instead, the principal institution’s ethics review can be adopted by other collaborating institutions to avoid repetitive approval of the same by CAHGR, thereby making the process more streamlined and efficient. Additionally, MOST and China Customs made a joint announcement on November 1, 2018, that the two agencies are working together to expedite the customs inspection of genetic resources that have been approved for export.[10] The electronic data of the “Certificate for Export and Cross-Border Transfer of Human Genetic Resources” is now shared directly in real time between MOST and China Customs to facilitate customs clearance of such materials for export.

Notably, the enforcement cases published by MOST, along with the recent headline cases, highlight the key features in the current legal framework for handling genetic resources – that each step in the collection, storage, use, and transfer of genetic resources, whether domestically or cross-border, and its application in international biomedical research or clinical trials require the government’s prior approval, even if the data is strictly used in China and even if the processed or analyzed data is published in world-renowned scientific journals.[11]

Furthermore, all foreign entities, wholly foreign-owned enterprises, or joint ventures in China that participate in or come in contact with human genomic specimens or samples, or handle data processing or management in connection with clinical researches need to obtain the approval from CAHGR before engaging in the aforementioned activities.[12] Institutions and businesses that conduct research using human genetic information in China are advised to establish a robust and effective information management system to ensure that the genetic information is collected with proper authorization and informed consent and stored within the country.[13] When transferring genetic information abroad, strict compliance with the CSL and related data privacy laws and regulations, particularly with respect to specific provisions on human genetic information and public health data, is also required.[14] In summary, the recent headline cases, as discussed above, are likely to engender a much stronger social and political will to impose regulatory scrutiny on commercial or academic activities involving genetic resources and invigorate the government’s agenda to legislate and enforce the laws in this area.



[1] Cyberspace Administration of China, National Cyber Security Strategy (Dec. 27, 2016), last visited Dec. 23, 2018.

[2] People’s Republic of China Ministry of Foreign Affairs, International Strategy of Cooperation on Cyberspace (Mar 1, 2017), last visited Dec. 23, 2018.

[3] MOST v. Hua Da Technology (Guokefa [2015] No. 2), last visited Dec. 23, 2018.

[6] Wang Zhu et al., Ministry of Science and Technology: “The Making of Genetically-edited Babies” Is Banned Under Established Law (Nov. 28, 2018).

[9] State Council of People’s Republic of China, Action Outline for Promoting Big Data (Guofa [2015] No. 5) (Aug. 31, 2015), last visited Dec. 24, 2018.

[12] Ministry of Science and Technology of the People’s Republic of China, MOST Host Forum with Pharmaceutical Company in Beijing (June 30, 2017).

[14] People’s Republic of China Administrative Licensing Law (effective July 1, 2004)(cross-border transfer of genetic resources requires the administrative license issued by CAHGR, and the agency reserves broad discretion to revoke approved licenses); Cyberspace Administration of China, Measures for Security Assessment for the Export of Personal Information and Important Data (draft for comments)(April 11, 2017); National Information Security Standardization Technical Committee (NISSTC), Information Security Technology – Personal Information Security Specification (effective May 1, 2018); NISSTC, Information Security Technology – Guidelines for Data Cross-Border Transfer Security Assessment (draft for comments)(Aug. 25, 2017); National Health Commission, Management Measures of Standards, Safety and Service of National Health and Medical Big Data (Trial) (effective July 12, 2018); Ministry of Public Security, Regulations on the Tiered Protection for Cybersecurity (draft for comments)(June 27, 2018).

 

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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