JPM2024: Impact of China’s HGR Rules on clinical trials and scientific studies involving China sites

HGR “materials” and HGR “information”: considerations for foreign parties

Life sciences companies conducting or considering clinical trials/scientific studies in China must consider the Human Genetic Resources (HGR) Administrative Regulations (HGR Regulations), the Implementing Rules on the HGR Regulations (Implementing Rules), as well as the Chinese Biosecurity Law (BSL), which echoes the HGR Regulations and Implementing Rules in many respects but imposes different legal liabilities. Collectively, these are generally referred to as the HGR Rules.

What are HGR? The HGR Rules distinguish between HGR “materials”, such as organs, tissues, and cells, and HGR “information”, such as data generated by HGR materials, including human genes and genome data, which however excludes clinical data, image data, protein data and metabolic data. It is important to distinguish these because HGR information is subject to less rigorous regulatory requirements in some aspects than HGR materials, including in the context of cross-border transfers.

What constitutes a “foreign party”? Foreign individuals and entities, and Chinese entities that are established or “actually controlled” by a foreign individual or entity (even companies formed under a variable interest entity (VIE) structure) are deemed a foreign party under the HGR Rules. The consequences of this determination are substantial. According to the HGR Rules, a foreign party is not allowed to collect, utilize, preserve, or export Chinese HGR materials and HGR information in China by itself, and instead must collaborate with a local Chinese partner for collection, preservation, and exportation requirements related to HGR.

Moreover, depending on the type of research activities to be carried out in China, the foreign party must either seek approval or record-filing in advance through the Chinese partner with the Chinese Ministry of Science and Technology (MOST). In the context of clinical trials, in some scenarios, advance MOST approval may be required while in other scenarios, prior record-filing would be sufficient. In short, different administrative formalities may be required and depending on the complexity of the research program, more than one application may be needed. Whether or not a project is subject to the HGR Rules will need to be analyzed on a case-by-case basis.

Additional guidance from the Implementing Rules

In June 2023, MOST released the Implementing Rules, which became effective on 1 July 2023. The Implementing Rules clarified a number of points as to the various administrative formalities that participating parties to clinical trials and scientific studies involving China sites should follow:

The regulatory scope of HGR collection activities

In certain circumstances, the collection of HGR is subject to approval from the MOST. Under existing MOST administrative guideline, approval is required for the collection of (i) HGR of important genetic families; (ii) HGR in specific regions; and (iii) HGR of populations with rare diseases, or significantly different physical or physiological characteristics, or HGR of over 500 cases.

However, the Implementing Rules exclude high blood pressure, diabetes, red-green color blindness and hemophilia from important genetic families, delete the approval requirement for subjects with rare diseases, or significantly different physical or physiological characteristics, and lift the threshold number from 500 to 3,000. More importantly, clinical trials for the purpose of marketing authorization (MA) are exempt from the requirement of HGR collection approval (except for HGR of important genetic families and HGR in specific regions).

More “friendly” scope of clinical trials for drug and medical device MA

The Implementing Rules expand the scope of international collaborative scientific research projects that can be carried out with only a record-filing, rather than an approval, by specifying that such benefit could apply to international clinical trials carried out for the purpose of obtaining the MA of relevant drugs/medical devices in China and not involving exportation of HGR materials, if (i) the collection, testing, analysis and residual sample processing of the HGR involved are performed within Chinese medical institutions; or (ii) the HGR involved are collected within Chinese medical institutions, with the detection, analysis. and residual sample disposal carried out within domestic lab(s) specified in the clinical trial protocol.

Implications on HGR information exportation and use

The Implementing Rules introduce a “prior-reporting” regime for the exportation and open use of HGR information. Compared with the previous record-filing procedure, it appears the new prior reporting regime will have lighter administrative formalities.

Delegation

One notable signal is that the MOST may delegate certain of its powers to provincial governments or even “other relevant organizations”. This may include the review of HGR-related administrative applications, HGR-related investigations, and even penalty decisions. The Implementing Rules also provide guidance on the supervision and inspection procedures of MOST and its local counterparts.

Next steps

The Implement Rules provide stakeholders with certain clarifications regarding the approval of HGR collection, but also signals that China is increasing its supervision of HGR-related activities by empowering more regulatory bodies to monitor relevant actions.

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Authored by Lu Zhou and Jessie Xie.