Human Genetic Resources Regulation and Compliance

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Human Genetic Resources Regulation and Compliance

The promulgation of the Administrative Regulations on Human Genetic Resources of the People’s Republic of China (the “HGR Regulation”) in July 2019 has signaled that China starts to impose strong supervision on human genetic resources (“HGR”) management. Compared with the regulatory system previously adopted, the HGR Regulation has strengthened the supervision of HGR, including the strict regulatory requirements and administrative applications/recordal requirements regarding the collection, preservation, utilization and outbound provision of China's HGR. At the same time, the HGR Regulation has greatly aggravated the penalties on HGR management violations and set out specific sanction measures, including heavy fines, confiscation of illegal gains, and temporary or even permanent debarment of both entities and individuals from engaging in HGR-related activities. In this regard, under the HGR Regulation, when companies (including foreign companies) are facing substantial changes in their rights and obligations as well as the substantially elevated legal risks, it is imperative to deal with HGR-related regulatory matters like HGR applications, compliance, regulatory responses.

Prior to the promulgation of the HGR Regulation, Tian Yuan Law Firm (“Tian Yuan”) has accumulated extensive experience in HGR-related matters, including but not limited to when the clients failed notify as required, assisting clients to notify the HGRAC or to self-report. After the promulgation of the HGR Regulation, Tian Yuan has been entrusted by clients to provide comprehensive HGR regulatory and compliance services, including (1) identifying the applying entities, advising onthe forms of applications, the necessity of applications and other application-related issues; (2) assisting clients in handling the matters like exportation of HGR information and design of intellectual property arrangement under international collaborative projects; (3) handling the application of international collaborative projects on behalf of clients; and (4) assisting clients in appropriately respond to administrative investigations of the projects failed to notify the HGRAC. Up to now, Tian Yuan HGR Management Team has accumulated comprehensive and rich hands-on experiences in this emerging sector and will continue to provide clients with high-quality and comprehensive HGR management legal services.

 Our Legal Services:

  • HGR Compliance Consultation -- Providing customized and operational compliance advices to our clients based on our high sensitivity to the government concerns and our deep understanding of the pharmaceutical industry;

  • Assessment of Legal Risks under the HGR Regulation -- Identifying legal issues in specific projects, analyzing our clients’ statutory obligations, and providing legal advices based on our comprehensive knowledge on the HGR Regulation and other related government regulations;

  • Assessment and Consultation of HGR Projects’ Applications -- Analyzing problems frequently encountered during HGR-related administrative applications / recordal procedures, such as international collaborative clinical trials, international collaborative scientific research, exportation of Chinese HGR materials, and providing Chinese HGR information aboard or making them publicly available, etc.;

  • Representing Clients to Apply/Report HGR Projects -- Assisting clients to complete HGR administrative applications and recordal procedures, including but not limited to the preparation work as well as the submission of relevant materials to the competent agencies (e.g. the HGRAC);

  • Responses to Government Regulatory Management -- Assisting clients to appropriately respond to the market surveys, administrative investigations, and industry inquiries launched by competent agencies(e.g. the HGRAC); and

  • Others.

 Our Work Highlights

Tian Yuan has accumulated considerable experience in this relatively new area and is especially specialized in dealing with regulatory matters under the HGR Regulation. Tian Yuan’s representative achievements in this area include:

  • Provided compliance advices to several pharmaceutical companies regarding the HGR management issues, varying from whether a company is subject to relevant obligations set out in the new regulations and whether the project is subject to the HGRAC’s approval, to how to make clinical trials stratify the requirement of recordal procedures , how to arrange the IPR between parties, and how to deal with projects failed to notify the HGRAC, etc.;

  • Engaged by a number of pharmaceutical companies to handle the application of international collaborative projects, such as the preparation work as well as the submission of application materials to the HGRAC;

  • Entrusted by a number of pharmaceutical companies to assist them in responding to the HGRAC investigations on their unnotified HGR projects;  

  • Represented clients to communicate with the HGRAC on certain ambiguous issues, such as whether a specific project is subject to the new regulations, and provide legal opinions accordingly;

  • Others.


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