Managing Human Genetic Resources in China, a Global Effort

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In the previous blog post, we discussed some highlights of the Implementation Rules for Human Genetic Resources Management (draft for comment) (人类遗传资源管理条例实施细则(征求意见稿))(the “Rules preliminaries”). In this blog post, we will discuss a few other provisions of the draft rules related to international cooperation involving China’s human genetic resources.

Global requirements for international cooperation

Chapter 2 of the draft rules (General Requirements) sets out some high-level requirements on international cooperation as follows:

  • Execution of cooperation agreements. Article 14 provides that in international cooperation in scientific research involving the utilization of China’s human genetic resources, both parties shall, in accordance with the principles of equality and mutual benefit, honesty and solvency, joint participation and mutual sharing of results, execute cooperation agreements in accordance with law and reach a clear and precise agreement on related matters.

  • Data backup. Article 15 provides that, when implementing international cooperation in the field of scientific research involving the utilization of China’s human genetic resources, the parties shall ensure that the participating institutions in China and their researchers participate substantially and comprehensively in the entire cooperative process, all records and research process data information (the “Information”) are made fully available to participating institutions in China, and to provide a backup copy of the Information to participating institutions in China.

  • Joint Intellectual Property Application. Article 16 provides that, in the context of international scientific research cooperation involving the use of China’s human genetic resources, if the parties apply for patents for the results of research, the parties shall apply for such patents. jointly and jointly own these patent rights.

  • Intellectual property right. Article 17 provides that: with regard to works, Data, standards, processes and other scientific and technological results generated by international cooperation in scientific research involving the use of China’s human genetic resources (the “Results”), the right to use, transfer and attribution rights and interests therein, shall be agreed by the parties as part of the cooperation agreement; if the cooperation agreement does not contain such provisions, for example if these provisions are ambiguous, both parties will have the right to use the Results, but the transfer of the Results to a third party must be approved by both parties and the proceeds from this transfer will be shared by the parties in proportion to their contribution percentage (if this percentage cannot be determined, the parties will share this proceeds equally).

Administrative license and filing requirements

The draft rules confirmed that international cooperative scientific research conducted jointly by Chinese institutions and foreign institutions (“international cooperation”) will receive a certain administrative license and, in some cases, follow certain filing procedures. The draft rules set out the specific conditions that must be met in order to obtain such an administrative license and complete such filing.

Notably, Article 61 of the draft rules clarified that, if any of the following events occur in the context of international cooperation, the parties must request an amendment to the original administrative license at least 1 month from advance:

  1. any of the sponsors, group lead units, contract research organizations, third-party laboratories has changed;

  2. the purpose of the search has changed;

  3. the content of the search has changed;

  4. the duration of the cooperation or other important search terms have changed.

Article 62 of the draft rules clarified that, if any of the following events occur in the context of international cooperation, the parties do not need to request a modification of the original administrative license, but must explain and report these events to the Ministry of Science and Technology with the appropriate media:

  1. the research plan remains unchanged and the change relates to a number of cases that does not exceed 10% of the number of approved cases;

  2. any change in participating organizations (other than sponsors, group lead units, contract research organizations, third party laboratories), or any change in the name of any legal entity of the participating organization;

  3. any change in the research program that does not involve a change in the type, quantity, intended use of human genetic resources, or that would cause the research program to exceed the approved scope.

Copyright © 2022, Sheppard Mullin Richter & Hampton LLP.National Law Review, Volume XII, Number 119

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