In the previous blog post, we discussed a few highlights of the Implementing 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 “Draft Rules”). In this blog post, we will discuss a few other provisions of the Draft Rules that are related to international cooperation involving human genetic resources of China.
Overall Requirements on International Cooperation
Chapter 2 of the Draft Rules (Overall Requirements) sets forth a few high-level requirements on international cooperation as follows:
- Execution of Cooperation Agreements. Article 14 provides that, when carrying out international cooperation in scientific research involving the use of China’s human genetic resources, the two parties shall, in accordance with the principles of equality and mutual benefit, honesty and creditworthiness, joint participation and mutual sharing of results, execute cooperation agreements in accordance with law and reach clear and specific agreement on related matters.
- Data Backup. Article 15 provides that, when carrying out international cooperation in scientific research involving the use of China’s human genetic resources, the parties shall ensure that the participating institutions in China and their researchers substantively and completely participate in the whole process of the cooperation, all the records and data information of the research process (the “Information”) is completely made available to the participating institutions in China, and to provide a backup copy of the Information to the participating institutions in China.
- Joint Application for IP. Article 16 provides that, when carrying out international cooperation in scientific research involving the use of China’s human genetic resources, if the parties apply for patents for the research results, the parties shall apply for such patents jointly and own such patent rights jointly.
- IP Right. Article 17 provides that: regarding the 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 them, transfer them and the allocation of the rights and interests in them, shall be agreed by the parties through the cooperation agreement; if the cooperation agreement does not include such provisions, such if such provisions are ambiguous, both parties shall have the right to use the Results, but the transfer of the Results to a third party shall be approved by both parties and the proceeds of such transfer shall be shared by the parties pro rata to their percentage of contribution (if such percentage cannot be determined, the parties shall share such proceeds equally).
Administrative License and Filing Requirements
The Draft Rules have confirmed that international cooperative scientific research jointly carried out by Chinese institutions and foreign institutions (the “International Cooperation”) shall receive certain administrative license and in some cases complete certain filing procedures. The Draft Rules have set forth the specific conditions that should be met in order to obtain such administrative license and to complete such filing.
Notably, Article 61 of the Draft Rules have specified that, if any of the following events occurs with respect to an International Cooperation, the parties should apply for an amendment to the original administrative license at least 1 month in advance:
- any of the sponsors, group leader units, contract research organizations, third-party laboratories has changed;
- the purpose of the research has changed;
- the content of the research has changed;
- the duration of cooperation or other major terms of the research have changed.
Article 62 of the Draft Rules have specified that, if any of the following events occurs with respect to an International Cooperation, the parties do not need to apply for an amendment to the original administrative license, but should explain and report such events to the Ministry of Science and Technology with appropriate supporting materials:
- the research plan remains unchanged and the change involves a number of cases that does not exceed 10% of the approved number of cases;
- any change in participating organizations (other than sponsors, group leader units, contract research organizations, third-party laboratories), or any change in the name of any legal entity of the participating organization;
- any change in the research program that does not involve any change in the type, amount, intended use of human genetic resources, or that would render the research program to exceed the approved scope.