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Implementation Rules for the Regulations on the Management of Human Genetic Resources

Promulgation Date: 2023-5-26
Title: Implementation Rules for the Regulations on the Management of Human Genetic Resources
Document Number:科学技术部令第21号
Expiration date: 
Promulgating Entities: Ministry of Science and Technology
Source of text: https://www.most.gov.cn/xxgk/xinxifenlei/fdzdgknr/fgzc/bmgz/202306/t20230601_186416.html

Chapter I: General Provisions

Article 1: These Implementation Rules are drafted on the basis of laws and administrative regulations such as the PRC Bio-Security Law and the PRC Regulations on the Management of Human Genetic Resources (hereinafter “the Regulations”), so as to effectively protect and reasonably utilize our nation's human genetic resources, and to preserve public health, national security, and the societal public interest.

Article 2: These Implementation Rules shall be complied with in the collection, preservation, and overseas provision of our nation's human genetic resources.

Information on Human Genetic Resources as used in Article 2 of the Regulations includes information materials such as data on human genes and genomes produced using human genetic materials.

The Information on Human Genetic Resources referred to in the preceding paragraph does not include clinical data, imaging data, protein data, and metabolic data.

Article 3: The Ministry of Science and Technology (Hereinafter MST) is responsible for the nation's management work involving human genetic resources such as investigation, administrative permitting, oversight inspections, and administrative punishments.

As needed, MST is to lawfully retain relevant organizations to carry out form review and technical evaluation of applications for administrative permits involving human genetic resources, as well as efforts such as filings, advance reporting, oversight inspections, and administrative punishments involving human genetic resources.

Article 4: The science and technology departments (commissions or bureaus) of provinces, autonomous regions and directly-governed municipalities, as well as the Science and Technology Bureau of Xinjiang Production and Construction Corps (hereinafter collectively “provincial-level administrative departments for science and technology”) , are responsible for the following efforts on the management of human genetic resources within the corresponding administrative regions:

(1) Oversight inspections and routine management of human genetic resources;

(2) Investigation and handling of cases of lawbreaking involving human genetic resources within the scope of their authority;

(3) Carrying out work as entrusted by MST, such as surveys of human genetic resources in the corresponding region, administrative permitting on human genetic resources, and the investigation and handling of cases of lawbreaking involving human genetic resources.

Article 5: The MST and provincial-level administrative departments for science and technology shall strengthen the degree of oversight of human genetic resources, allocate administrative law enforcement personnel, and, carry out oversight inspections of human genetic resource activities and other work in accordance with their duties, and perform duties to oversee and manage human genetic resources in accordance with law.

Article 6: The MST is to appoint experts in the life sciences, technology, pharmaceuticals, health, ethics, law, and other areas to form an expert consultation committee on human genetic resource management, to provide consultation in decision-making and technical support in efforts on the management of human genetic resources for the whole nation.

Article 7: The Ministry of Science and Technology is to support the use of human genetic resources to carry out scientific research, to develop the biopharmaceuticals industry, and to improve technology for diagnostics and care; strengthening management and oversight of human genetic resources, optimizing review and approval mechanisms, increasing the efficiency of reviews, and advancing the regulation of reviews and disclosure of information, to raise the level of management and services.

 

Chapter II: General Requirements

Article 8: The collection, preservation, use, or provision overseas of our nation's human genetic resources shall comply with ethical principles and pass ethics reviews by the ethics (review) committee filed with the relevant management departments. Ethics review shall be conducted in compliance with laws, administrative regulations, and relevant state provisions.

Article 9: The collection, preservation, use, or provision abroad of our nation's human genetic resources shall respect and protect the rights and interests of those providing human genetic resources, such as their rights to privacy and in personal information, and informed consent is to be acquired in writing as provided, to ensure that the lawful rights and interests of those providing human genetic resources are not infringed.

Article 10: The collection, preservation, use, or provision abroad of our nation's human genetic resources shall comply with relevant requirements and technical specifications for scientific and technological activities, including but not limited to standards, specifications, and rules.

Article 11: The collection and preservation of our nation's human genetic resources, or their provision abroad, must be carried out by a research institution, school of higher learning, medical establishment, or enterprise from our nation (hereinafter the “Chinese Unit”). Domestically invested and controlled institutions that are established in Hong Kong or Macao are considered Chinese Units.

Foreign organizations and institutions established or actually controlled by foreign organizations or individuals (hereinafter Foreign Units), as well as foreign individuals, must not collect or preserve human genetic resources within our nation's mainland territory, and must not provide our nation's human genetic resources abroad.

Article 12: Institutions established or actually controlled by foreign organizations or individuals as used in Article 11 of these Implementation Rules includes the following situations:

(1) Overseas organizations or individuals possess or indirectly possess more than 50% of the shares, equity, voting rights, property shares, or other such rights and interests;

(2) Overseas organizations or individuals hold or indirectly hold less than 50% of the shares, equities, voting rights, property shares, or other such rights and interests, but enjoy sufficient voting rights or other rights and interests to dominate or have a major impact on the institution’s conduct such as resolutions, decision-making, or internal management.

(3) Overseas organizations or individuals use investment relationships, agreements, or other arrangements to dominate or exert a major impact on major matters such as the institution's decision-making or management;

(4) Other situations provided by laws, administrative regulations, and rules.

Article 13: Units that collect, preserve, or use our nation's human genetic resources, or provide them abroad, shall strengthen the establishment of management systems, and conduct reviews of matters such as the purpose and research plan for carrying out scientific research involving human genetic resources, to ensure that human genetic resources are used in accordance with law.

Article 14: The use of our nation's human genetic resources to carry out international scientific research collaboration shall ensure that the Chinese-side units and their researchers participate substantively in the entire course of research, and lawfully share in the relevant interests. In cooperative international scientific research, all records, data, and information produced using our nation’s human genetic resources shall be entirely open to the Chinese unit, and a backup copy is to be provided to the Chinese unit.

Article 15: The MST is to strengthen the IT establishment of management systems for human genetic resources, establishing open and uniform information system platforms for human genetic resources administrative permitting, filing, and security review work, to facilitate the use of the internet in handling administrative permits, filings, and other such matters, and advancing real-time dynamic management, to make it so that information on the management of human genetic resources is traceable and available for inquiries.

Article 16: In conjunction with the relevant State Council departments and provincial-level administrative departments for science and technology, the MST is to promote our nation’s scientific research institutions, schools of higher learning, medical establishments, and enterprises carrying out of efforts to preserve human genetic resources in accordance with laws and regulations, and promote the establishment of a standardized and regulated basic platform and big data for human genetic resource preservation, and open them to related scientific research institutions, schools of higher learning, medical establishments, and enterprises in accordance with relevant state provisions.

Article 17: MST is to establish a rapid mechanism for review and approval aimed at public health incidents and other emergencies and shall accelerate the handling of human genetic resource administrative permit applications involved in emergency response.

In carrying out rapid review of human genetic resources administrative permit applications, the MST is to accelerate the organization and carrying out of efforts such as on the acceptance, assessment, and review of human genetic resources administrative permit applications in accordance with the principles of unified command, high efficiency and speed, and scientific review. The MST is to separately provide for matters such as the circumstances, procedures, time limits, and requirements of rapid review.

Article 18: MST is to draft and promptly publish service guides and template examples such as for administrative permitting and filings for collecting, preserving, using, or externally providing our nation's human genetic resources; in order to facilitate and provide expert guidance and services to applicants handling administrative permits, filings, and other such matters for human genetic resources.

Article 19: MST is to periodically conduct training for researchers and managers at relevant departments that engage in activities such as the collection, preservation, use, or provision abroad of human genetic resources; enhancing awareness of laws and responsibilities, and increasing management service capacity.

Article 20: MST and provincial-level administrative departments for science and technology shall establish and continuously improve corruption-risk control measures, complete mechanisms for oversight and restraint, and strengthen oversight of important steps in the management of human genetic resources and key positions in the corresponding unit.

 

Chapter 3: Survey and Register

Article 21: MST is responsible for organizing and carrying out efforts to survey the nation’s human genetic resources. Provincial-level administrative departments for science and technology are responsible for carrying out efforts to survey the human genetic resources in the corresponding region as entrusted by MST.

Article 22: National human genetic resource surveys are to be carried out once every five years but may be carried out when necessary based on actual needs.

Article 23: The Ministry of Science and Technology is to organize experts in relevant fields to formulate a work plan for national human genetic resources surveys. After provincial-level administrative departments for science and technology complete efforts to survey the human genetic resources in the corresponding region, they shall promptly aggregate the collected survey data and information and report it to MST.

Article 24: On the foundation of efforts such as the national survey of human genetic resources, the Ministry of Science and Technology is to organize and carry out research on important genetic families and human genetic resources in specified regions, and gradually establish lists and catalogs of our nations’ human genetic resources and those in specified regions, which are to be revised and improved at appropriate times.

Article 25: The Ministry of Science and Technology is responsible for efforts to register important genetic families and human genetic resources in specified regions, is to draft measures on the management of declarations and registrations, and establish an information service platform for the management of declarations and registrations.

Article 26: Our nation's research institutions, schools of higher learning, medical establishments, and enterprises that discover information on important genetic families and the human genetic resources in specified regions, shall promptly conduct registration through the information platform for the management of declarations.

 

Chapter 4: Administrative permits and filings

Section 1: Administrative Permitting for Collection and Preservation

Article 27: Administrative permits for the collection of human genetic resources apply to the following activities planned to be carried out in our country:

(1) Activities collecting human genetic resources from important genetic families. Important genetic families refers to kinship groups that have hereditary illnesses or that possess special hereditary physical or physiological traits and that have had 3 or more generations exhibiting the illness or traits; but common illnesses such as high blood pressure, diabetes, red-green colorblindness, and hemophilia are not within this. A declaration shall be made in accordance with article 26 of these Implementation Rules when an inportant gene family is discovered for the first time.

(2) Human genetic resources of specified regions. Human genetic resources of specified areas refers to the human genetic resources of groups who have lived in isolated or special environments for a long time and have adaptive characteristics in terms of physical or physiological traits. The demarcation of the specified regions is not to be based on whether they are inhabited by ethnic minorities.

(3) Collection activities for large-scale research in which the human genetic resources of more than 3000 people are collected. Large-scale population research includes, but is not limited to cohort studies, cross-section studies, clinical research, and physiological research. Activities collecting human genetic resources that are related to clinical experiments involved in obtaining permits to put medicines or medical instruments on the market in our nation are not included in this list.

Article 28: Administrative permits for the preservation of human genetic resources apply to activities carried out in our nation's mainland territory that preserve human genetic resources and provide a foundation platform for scientific research.

"Preservation activities" refers to the saving of lawfully acquired human genetic resources in a suitable environment to ensure their quality and security for use in future scientific research, but does not include temporary storage for teaching purposes, as required by laws or regulations following laboratory testing, or as agreed to in clinical research plans.

Article 29: Where activities preserving human genetic resources that are required to apply for administrative permits concurrently involve the collection of human genetic resources, the applicants only need to apply for administrative permits for the preservation of human genetic resources and do not need to separately apply for administrative permits for the collection of human genetic resources.

Article 30: Units preserving human genetic resources shall submit an annual report to MST before January 1st each year on their preservation of human genetic resources in the preceding year, based on article 15 of the Regulations. Annual reports shall indicate the following content:

(1) The circumstances of preserved human genetic resources;

(2) Information on the source and use of human genetic resources;

(3) The implementation of management systems for the preservation of human genetic resources;

(4) The preservation or changes in the venues, facilities, and equipment used by the unit in preserving human genetic resources;

(5) Changes in the primary management staff responsible for the preservation of human genetic resources in the unit.

Units preserving human genetic resources shall strengthen management to ensure the legality of the sources of human genetic resources. MST is to organize each provincial-level administrative department for science and technology to conduct spot checks of activities preserving human genetic resources in the corresponding regions.

 

Section 2: Administrative Permitting and Filings for International Cooperation

Article 31: Applications for administrative permits for international collaborative research using our nation's human genetic resource for cooperative international scientific research shall pass ethics reviews by the countries (regions) of each side. Where the foreign unit is truly unable to provide materials showing an ethics review from its country (region), materials showing that the foreign unit accepts the opinions of the Chinese unit’s ethics review may be submitted.

Article 32: Approvals are not required for the use of our nation's human genetic resources by medical health institutions to carry out collaborative international clinical experiments, so as to obtain approvals for obtaining permits for the sale of drugs and medical instruments in our nation where it does not involve sending human genetic resource materials overseas; but one of the following circumstances shall apply, and before the clinical experiment is carried out, the types and amounts of human resources to be used, as well as their usages, shall be sent for filing to the MST:

(1) The collection, testing, analysis, and disposal of remaining human genetic resources are conducted in a clinical medical institution;

(2) The human genetic resources are collected in a clinical medical institution and the testing and analysis, and the disposal of remaining human genetic resources, are conducted by a domestic unit designated in the clinical experiment plan for drug or medical device marketing licenses;

Clinical medical institutions as used in the preceding preceding paragraph refers to medical establishments, disease control institutions, and so forth that have filed with our nation’s relevant departments and carry out clinical experiments in accordance with law.

An administrative permit for international scientific research collaboration permits shall be applied for for exploratory research carried out as part of clinical trials to obtain permits to market drugs or medical devices.

Article 33: Administrative permits for international scientific research collaboration and filings for international collaborative clinical trial plans shall be jointly applied for by the Chinese and foreign units. All parties in the collaboration shall make pledges on the truth, accuracy, and completeness of the information in the application materials.

Where international scientific research collaboration or international collaborative clinical trials on human genetic resources involve clinical research at multiple centers, the application for administrative permits or filings must not be made after dividing them.

Article 34: Where clinical research is carried out at multiple centers, after the leading unit passes the ethics review, either the applicant or leading unit may apply for the administrative permits or file.

After the applicant or leading unit obtains administrative permits or completes filings, the medical health institutions participating in the clinical research are to submit that unit’s ethics review approvals or materials showing acceptance of the ethics review approval materials provided by the leading unit, as well as a pledge issued by that unit, to the MST, before they can carry out international clinical research collaboration.

Article 35: Both collaborative parties to administrative permits obtained for international scientific research collaboration or international collaborative clinical trial plans for which filings have been completed shall jointly submit collaborative research reports to the MST within 6 months of the completion of the period for which the administrative permit or filings are valid. Collaborative research reports shall indicate the following content:

(1) Circumstances of changes to matters such as the purpose or content of research;

(2) The circumstances of the implementation of the research plan;

(3) The situation of completing research content;

(4) Circumstances of the usage and disposition of our nation's human genetic resources;

(5) All records from the course of the research as well as the circumstances of recording, preserving, and using data information;

(6) The Chinese side and its research staff’s substantive participation in the full course of the research, as well as the foreign unit’s participation in the research;

(7) The output, ownership, and rights and interests in the research results;

(8) Circumstances of the ethics reviews in which the research is involved.

 

Section 3: Advance reports for overseas provision or open use

Article 36: Where human genetic resources are transferred to foreign [non-mainland] organizations, individuals or bodies that they have established or are the actual controllers of, the owners of the Chinese side information shall make an advance report to the MST and submit a backup copy of the information. Advance reports to the MST shall report the following matters and information:

(1) The goals and uses of providing or opening the use of our nation’s human genetic resource information to foreign organizations or individuals and institutions that they have established or are the actual controllers of;

(2) The sources of human genetic resources and the circumstances of information backups in providing or opening the use of our nation’s human genetic resource information to foreign organizations or individuals and institutions that they have established or are the actual controllers of;

(3) The basic circumstances of the foreign organizations or individuals and institutions that they have established or are the actual controllers of, which are receiving human genetic resources;

(4) The assessment of latent risks to the protection of our nation’s human genetic resources in providing or opening the use of our nation’s human genetic resource information to foreign organizations or individuals and institutions that they have established or are the actual controllers of;

During the course of International scientific collaboration that has already received an administrative permit or international clinical trials that have already been filed, where the Chinese unit provides information on human genetic resources that was produced in the collaboration, if the international collaboration agreement already provides it is to be used by both sides, it is not necessary to independently make an advance report and submit back-up information.

Article 37: Where the provision or making human genetic resources available for use to overseas organizations and individuals, or entities they have established or are in actual control of, might impact public health, national security, and the societal public interest, it shall go through a security review organized by the Ministry of Science and Technology.

Circumstances for which security reviews shall be conducted include:

(1) Human genetic resource information on important genetic families

(2) Human genetic resource information of specified regions;

(3) Exome and genome sequencing of information resources for groups of more than 500 people;

(4) Other circumstances that might impact our nation's public health, national security, and societal public interests.

Article 38: In conjunction with relevant departments, the MST is to formulate rules for security reviews, organize experts from relevant fields to conduct security assessments, and make review decisions based on the security assessment opinions:

In the export of human genetic resources, if related items involve export controls, our nation’s export control laws and regulations must be obeyed.

Section 4: The administrative permitting, filing, and advance reporting process

Article 39: Where an applicant’s application materials are complete and in a compliant format, the MST shall accept them and issue a hard-copy or electronic receipt that is stamped with an official seal and has the date indicated.

Where the application materials are not complete or not in the format prescribed by law, within 5 days of receiving the application materials, the MST shall inform the applicant one time that they need to supplement and correct all of the content.

Article 40: As needed for technical reviews and security review work, MST is to organize a pool of experts and establish an expert management system.

The MST is to select reviewing experts by random selection from the pool of experts to conduct technical reviews of applications for human genetic resources administrative permitting matters, and to conduct security assessments for the foreign provision or open usage of human genetic resources for which a security review must be conducted. Techinical review and security assessment opinions are to be a reference basis for making administrative permitting decisions or security review decisions.

Expert participation in technical and security reviews is normally to be done online, and when nescessary methods such as meetings or site inspections may be employed.

Article 41: The MST shall make the administrative permitting decision on applications for human genetic resources administrative permits within 20 working days of accepting the application. Where an administrative permitting decision cannot be made within 20 working days, with the permission of the responsible person for the MST, the period may be extended by 10 working days, and the reason for the extension is to be notified to the applying work unit.

Article 42: Where the MST needs hearings, inspections, testing, quarantine, evaluations, or technical reviews in making administrative permitting decisions, the time needed is not to be calculated into the time limits provided in article 41 of these Implementation Rules, but the applicant shall be notified in writing of the time needed.

Article 43: After MST makes an administrative permitting decision, it shall notify the applicant of the administrative permit decision document, and send a copy to the provincial-level administrative department for science and technology at the applicant’s location.

Where a decision is made to grant an administrative permit in accordance with law, it shall be publicly disclosed on the MST website. Where a decision is made to not grant an administrative permit in accordance with law, the reasons shall be explained, and the applicant is to be informed that they enjoy the right to apply for an administrative reconsideration or to initiate administrative litigation in accordance with law.

Article 44: After an administrative permit for the collection of human genetic resources is obtained, where there are changes in major matters such as the units participating in the collection activities, the purpose of the collection, the collection plan, or the content of the collection, the permitted persons shall submit an application for a modification to the MST.

Article 45: After an administrative permit for the preservation of human genetic resources is obtained, where there are changes in major matters such as the purpose of the preservation, the preservation plan, or the content of the preservation, the permitted persons shall submit an application for a modification to the MST.

Article 46: After an administrative permit for collaborative international scientific research on human genetic resources is obtained, where there are changes during the course of the collaborative research such as to the purpose or content of the research, or where there is a change to major matters such as the applicant, leading unit, contract research organizations, third-party laboratories, etc, the permitted persons shall submit an application for a modification to the MST.

Article 47: Where any of the following situations occurs after an administrative permit for collaborative international scientific research on human genetic resources is obtained, the permitted persons do not need to submit an application for modification but shall submit a written explanation of the modified matters and related materials to the MST.

(1) The content and research plan are unchanged, and only changes of less than 10% of the total amount are involved;

(2) Where there are changes to participating units other than those listed in article 46 of these Implementation Rules;

(3) The name of a legal person collaborator changes;

(4) The research content or plan has changed, but the change to the type, amounts, and use of human genetic resources, or the modified content, are not outside the range already approved.

Article 48: Where the permitted persons submit applications for modifications of the matters listed in article 44-46 of these Implementation Rules, the MST shall review them and make a decision on whether to grant the modification. Where the legally-prescribed requirements or standards are met, MST shall grant the modification.

Procedures for the acceptance, review, handling times, decisions, and notifications for modification applications are to be enforced with reference to the provisions in articles 39 through 43 of these Implementation Rules regarding applications for administrative permitting applications.

Article 49: Where the applicant applies to withdraw before administrative permitting decisions are made, the MST is to terminate the review of the administrative permitting application.

Article 50: In any of the following situations, based on stakeholders’ demand or on the basis of their authority, MST may revoke human genetic resource administrative permits:

(1) Where administrative permitting decisions were granted through abuse of authority or dereliction of duty;

(2) Where administrative permitting decisions were made beyond the scope of legally-prescribed authority;

(3) Where administrative permitting decisions were made in violation of the legally-prescribed procedures;

(4) Where applicants who do not possess qualifications to apply or do not meet the legally-prescribed requirements are granted administrative permits;

(5) Other situations where an administrative permit may be revoked in accordance with law.

Where the permitted person obtained administrative permits through improper methods such as fraud or bribery, the MST shall revoke it.

Where the revocation of administrative permits in accordance with the preceding two paragraphs might cause major harm to the public interest, do not revoke.

Article 51: In applying to file for international collaborative clinical trials, clinical trial approvals, notification documents or filing and registration materials shall first be obtained from the drug regulatory departments.

Article 52: Applications for international collaborative clinical trial filings shall submit the following materials;

(1) The basic situations of all parties in the collaboration;

(2) The types, quantities, and uses of human genetic resources involved in the research;

(3) The research plan;

(4) The leading unit’s ethics review approval documents;

(5) Other supporting materials.

Article 53: After filing for collaborative international clinical trials, where there is a change in the type, quantity, or use of the human genetic resources involved, or there is a change in major matters such as the collaborative parties, research plan, research content, or research purposes, the person filing shall promptly handle the modification.

Where changes to the research plan or content does not involve the type, amounts, and use of human genetic resources, it is not necessary to handle a modification of the filings, but a written explanation of the changed matters and related materials shall be submitted to the MST before the modification activities begin.

Article 54: Where after an advance report is made to the MST for the provision or opening for use of human genetic resources to foreign organizations, individuals or bodies that they have established or are the actual controllers of, there is a change to matters such as the usage or recipient, a modification report shall be submitted to the MST before the changed matters take effect.

Article 55: Where the permitted persons needs to extend the validity period for the administrative permit, they shall submit an application to the MST 30 working days before the validity period of the administrative permit is completed. Based on the application of the permitted person, the MST is to make a decision on whether or not to approve the extension before the validity period of the administrative permit is completed, and where a decision is not made in time, it is to be viewed as an approval.of the extension.

Where the persons who made filings need to extend the filings’ validity period, they shall submit an application to the MST 30 working days before the validity period of the filings is completed. MST shall complete handling of the extension before the validity period for the corresponding filings is complete; and where they do not complete them in time, it is to be viewed as having completed the extension.

 

Chapter V: Oversight and Inspections

Article 56: MST is responsible for oversight inspections on human genetic resources throughout the nation, and each provincial-level administrative department for science and technology is responsible for oversight inspections on human genetic resources in the corresponding administrative region. Oversight inspections primarily include the following matters:

(1) The implementation of responsibility by relevant units that are collecting, preserving, using, or providing human genetic resources overseas, and the establishment, improvement, and enforcement of related rules systems;

(2) The collection, preservation, and use of human genetic resources by units approved for human genetic resource projects, and the export, provision overseas, or opening for use of materials or data, as well as their use abroad.

(3) Disposition of remaining materials from the use of human genetic resources, sharing of intellectual property rights and interests, and so fort;

(4) Circumstances such as the veracity of matters in the human genetic resources filing;

(5) Other matters that the MST or provincial-level administrative departments for science and technology need to oversee and inspect.

Article 57: the MST and provincial-level administrative departments for science and technology shall compile annual oversight inspection plans and carry out risk management for human genetic resources.

The annual oversight inspection plans shall include content such as the matters for inspection, the inspection methods, inspection frequencies, and the type of sampling program, and the sampling ration,

Article 58: the MST and the provincial-level administrative departments for science and technology shall increase the frequency of oversight inspections for units that have received administrative punishment within the last 3 years for illegal conduct involving human genetic resources, that have risks in the management of human genetic resources that are not promptly corrected, as well as units that have been entered in lists of punishments for untrustworthiness, and include them in the annual oversight inspection plan and carry out oversight inspections. Units that have noticeably improved management systems and specifications and have not had further illegal conduct may have the frequency of oversight inspections reduced.

Article 59: MST and the provincial-level administrative departments for science and technology may randomly determine the matters for oversight inspections in the human genetic resource activities of units other than those provided for in article 58 of these Implementation Rules, and randomly assign personnel oversight inspection personnel in carrying out oversight inspections.

Article 60: In the event of serious illegal conduct or short-term emergency tasks, as well as issues discovered through means such as complaints, transfers, or data monitoring, the MST and provincial-level administrative departments for science and technology may make arrangements for carrying out special oversight inspections.

Article 61: MST and provincial-level administrative departments for science and technology shall promptly record and aggregate information on routing oversight inspections for human genetic resources activities, to improve routine oversight inspection measures.

Article 62: When it is discovered that the subjects of oversight inspections might have risks that violate relevant provisions of the “Regulations”, MST or provincial-level administrative departments for science and technology may have administrative meetings with their legal representatives or principal responsible persons.

Article 63: Where it is discovered that the subjects of oversight inspections might have conduct that violates provisions of the “Regulations”, MST or provincial-level administrative departments for science and technology shall conduct inspections, and when necessary may employ the following measures:

(1) Employ measures such as recording, reproducing, photographing, or videorecording in accordance with law;

(2) Employ administrative compulsory measures such as sealing or seizure in accordance with law;

(3) Conduct testing, examinations, quarantine, or evaluations of related items in accordance with law.

Article 64: MST and provincial-level administrative departments for science and technology shall enforce administrative compulsory measures in accordance with the procedures provided for in the PRC Administrative Compulsion Law.

Article 65: MST or provincial-level administrative departments for science and technology shall get the approval of the responsible person for the corresponding unit to employ or lift administrative compulsory measures.

Where administrative compulsory measures of sealing or seizure are carried out in accordance with law, a written decision to seal or seize and an inventory shall be drafted and given to the parties at the scene. Where the situation is urgent and not promptly sealing or seizing might impact the handling of the case, or where there are risks that might cause the human genetic resources to be destroyed or lost, the sealing or seizure may be carried out first with the sealing or seizure decision sent to the parties within 24 hours.

 

Chapter VI: Administrative Punishments

Article 66: MST or provincial-level administrative departments for science and technology shall regulate discretion in exercising administrative punishments in human genetic resources, comprehensively considering the facts, nature, circumstances, and harm to society from the illegal acts, to determine a punishment that meets the crime within the types and ranges provided by the Regulations, and preventing abnormally light or heavy punishments.

The norms for discretion in administrative punishments for human genetic resources are to be seperately draft and publicly disclosed by the MST.

Article 67: In cases where giving an administrative punishment is planned, the MST or provincial-level administrative departments for science and technology shall inform the parties of the content, facts, reasoning, and basis of the proposed administrative punishment and notify the parties of the rights they enjoy in accordance with law such as to make statements and defenses before they make an administrative punishment decision. Where the planned administrative punishment is within the scope for hearings, they shall also inform the parties that they have the right to request a hearing.

Where the parties exercise their rights to make statements or justifications or request a hearing, they shall raise this within 5 working days of the written notice being served on them, and where they have not done so in this time, it is to be viewed as waiving the rights above.

MST or provincial-level administrative departments for science and technology must not impose heavier punishments due to the parties’ statements, justificiations, or requests for a hearing.

Article 68: Where MST or provincial-level administrative departments for science and technology plan to make the following administrative punishment decisions, and the parties do request a hearing, the administrative organs shall organize the hearing, a hearing shall be organized:

(1) Where fines of 1,00,000 or more are given to legal persons or other organizations, or fines of 100,000 or more are given to citizens;

(2) Where 3,000,000 or more RMB in unlawful gains is confiscated from legal persons or other organizations, or 300,000 or more RMB in unlawful gains is confiscated from citizens;

(3) Where a prohibition of 1 year or more is given on engaging in activities collecting, preserving, using, or providing of our nation's human genetic resources overseas;

(4) Where their applications for human genetic resources administrative permits will not be accepted for two years or more;

(5) Where human genetic resources administrative permits that have already been obtained are revoked;

(6) Other situations where laws or administrative regulations provide a hearing shall be organized.

Article 69: Before the MST or provincial-level administrative departments for science and technology make a decision on human genetic resources administrative punishments, the case-handling body of that department shall send the planned administrative punishment decision as well as the case materials to the working body of the department that is responsible for legal review to conduct a review. Decisions must not made where they have not gone through or did not pass legality review.

Where the planned administrative punishment decision only involves warnings, it is not necessary to conduct a legality review.

Article 70: After the written administrative punishment decision is made, the MST or provincial-level administrative departments for science and technology shall follow relevant legal provisions to serve the written administrative punishment decisions on the parties or other legally-prescribed recipients within 7 working days.

Article 71: The administrative punishment decision shall be made within 90 days of filing an administrative punishment case. Where it is not possible to make an administrative punishment decision within 90 days for reasons such as the case being complex, an extension of 90 days may be given upon approval from the responsible person for that organ. Where the case is especially complex and an administrative punishment decision still cannot be made after an extension, the responsible person for the organ is to decide whether to continue the extensions through collective deliberation. Where they decide on an extension, they shall concurrently determine a reasonable time limit for the extension, but it must not exceed 60 days.

The time for hearings, notifications, testing, examinations, quarantine, evaluations, accounting, adjournments, and so forth in the course of handling a case is not calculated in the time periods for case-handling provided for in the first paragraph of this article.

Article 72: The unlawful gains provided for in articles 36, 38, 41, 42, and 43 of the Regulations are to be calculated by deducting appropriate reasonable expenses from the entire income obtained through the illegal conduct; and where it is difficult to calculate, the unlawful gains are to be calculated from the value of the human genetic resources involved in the illegal conduct or the amount of funds invested in the human genetic resources.

Article 73: Where, in the course of human genetic resources oversight inspections or the investigation of illegal activity, it is discovered that citizens or legal persons do not possess the requirements for the preservation of human genetic resources, the MST or provincial-level administrative departments for science and technology shall organize the transfer of the human genetic resources that have been preserved to a unit that posses the capacity for preserving human genetic resources for preservation.

Article 74: Where provincial-level departments for science and technology make human genetic resources administrative punishment decisions in accordance with law, they shall report the case handling situation and a copy of the administrative punishment decision to the MST within 15 working days of making the administrative punishment decision.

Article 75: The MST has the authority to conduct oversight of human genetic resources administrative punishments carried out by provincial-level administrative departments of science and technology, and to order corrections of related illegal or improper conduct in accordance with law.

 

Chapter VII: Supplementary Provisions

Article 76: Provisions in these Implementation Regulations involving time limits that indicate working days do not include legally-prescribed rest days; where it does not indicate working days, this means calendar days.

Article 77: “Above“ and “not exceeding“ as used in these Implementation Measures all include the name number, “more than” or “less than” do not include the named number.

Article 78: These Implementing Rules will take effect on July 1, 2023.

 

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