Managing human genetic resources in China is a global effort

In the previous blog post, we discussed some of the highlights of the implementation of the Rules for the Management of Human Genetic Resources (Draft for Comment) (人类 遗传 资源 管理 实施 征求意见稿 (征求意见稿)) (“Draft Rules”). In this blog post, we will discuss some other provisions of the draft rules regarding international cooperation involving human genetic resources in China.

General 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 states that when carrying out international cooperation in scientific research involving the use of human genetic resources in China, the two parties shall, in accordance with the principles of equality, mutual benefit, honesty, creditworthiness, mutual participation and mutual sharing of results, implement cooperation agreements in accordance with the law and reach a clear and specific agreement on Related matters.

  • Data backup. Article 15 states that when carrying out international cooperation in scientific research involving the use of human genetic resources in China, the parties shall ensure that the participating institutions and researchers in China participate substantively and fully in the entire cooperation process, and all records. The search process data information (“Information”) is fully available to participating enterprises in China, and to provide a backup copy of the information to participating enterprises in China.

  • joint application for intellectual property. Article 16 states that, when carrying out international cooperation in scientific research involving the use of human genetic resources in China, if the two parties apply for patents for the research results, the two parties shall jointly apply for such patents and jointly own these patent rights subscriber.

  • intellectual property right. Article 17 states: In relation to business, dataStandards, processes and other scientific and technological results resulting from international cooperation in scientific research involving the use of China’s human genetic resources (“Outcomes”), the right to use and transfer and assign rights and interests therein, shall be agreed upon by the Parties through the Cooperation Agreement; If the cooperation agreement does not include such provisions, for example, if these provisions are ambiguous, the parties will have the right to use the results, but the transfer of the results to a third party must be agreed upon by the parties and the proceeds of such transfer must be shared by the parties in proportion to a percentage of their contribution (if this percentage cannot be determined, the parties must share this proceeds equally).

Administrative license and application requirements

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

Notably, Article 61 of the Draft Rules specifies that if any of the following events occur in connection with international cooperation, the parties must apply to amend the original administrative license at least one month in advance:

  1. any of the sponsors, group leader units, contract research organizations, or third party laboratories have changed;

  2. The purpose of the research has changed;

  3. change of search content;

  4. The duration of the collaboration or other key terms of the research have been changed.

Article 62 of the draft rules specified that if any of the following events occur in connection with international cooperation, the parties do not have to apply to modify the original administrative license, but must explain and report these events to the Ministry. Science and technology with appropriate supporting materials:

  1. The research plan remains unchanged and the change includes a number of cases not exceeding 10% of the approved number of cases;

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

  3. Any change in the research program does not include any change in the type, quantity or purpose of use of human genetic resources, or would cause the research program to exceed the approved scope.

Copyright © 2022, Sheppard Mullin Richter & Hampton LLP.National Law Review, Volume XII, No. 119