ACT ON THE PROMOTION OF COLLECTION, MANAGEMENT, AND UTILIZATION OF PATHOGEN RESOURCES
Act No. 13992, Feb. 3, 2016
Amended by Act No. 14513, Dec. 27, 2016
Act No. 14839, Jul. 26, 2017
Act No. 17472, Aug. 11, 2020
Act No. 18614, Dec. 21, 2021
CHAPTER I GENERAL PROVISIONS
The purpose of this Act is to enhance public health and to contribute to the development of the healthcare industry and the national economy by promoting the collection, management, and utilization of pathogen resources.
The term "pathogen resources" provided for in this Act means any of the following resources having actual or potential value for healthcare study or the healthcare industry:
| 1. | Pathogenic organisms, such as bacteria, fungi, viruses, and protozoa, that can cause infectious diseases in humans, and related information; |
| 2. | Pathogen-derived materials, such as cytological materials, antigens, and antibodies, that derive from pathogens and exist naturally, and related information. |
| Article 3 (Responsibilities of the State) |
| (1) | The State and each local government shall formulate and implement policy measures necessary for the collection, management, and utilization of pathogen resources. |
| (2) | In order to implement international norms, the State and each local government shall endeavor to fairly and equitably share the outcomes of collection, utilization, research and development of pathogen resources and the profits generated from the commercial use of such outcomes. |
| Article 4 (Relationship to Other Statutes) |
Except as otherwise provided in other statutes, this Act shall apply to the collection, management, and utilization of pathogen resources.
CHAPTER II FORMULATION AND IMPLEMENTATION OF COMPREHENSIVE PATHOGEN RESOURCE MANAGEMENT PLANS
| Article 5 (Formulation and Implementation of Comprehensive Pathogen Resource Management Plans) |
| (1) | In order to promote the collection, management, and utilization of pathogen resources, the Commissioner of Korea Disease Control and Prevention Agency shall formulate and implement a comprehensive plan for pathogen resource management (hereinafter referred to as "comprehensive plan") every five years, after deliberation by a pathogen resources deliberative committee established under Article 7. <Amended on Aug. 11, 2020> |
| (2) | Each comprehensive plan shall include the following matters: |
| 1. | Basic direction-setting for policy measures for the collection, management, and utilization of pathogen resources; |
| 2. | Collection, analysis, and evaluation of pathogen resources; |
| 3. | Research and development, using pathogen resources; |
| 4. | Establishment and operation of infrastructure for pathogen resources; |
| 5. | Establishment and operation of a pathogen resource information circulation system; |
| 6. | Other matters necessary for the collection, analysis, and evaluation of pathogen resources. |
| (3) | When the Commissioner of Korea Disease Control and Prevention Agency formulates a comprehensive plan, he or she shall have a prior consultation with the heads of the relevant central administrative agencies. <Amended on Aug. 11, 2020> |
| (4) | The Commissioner of Korea Disease Control and Prevention Agency shall formulate and implement an annual implementation plan (hereinafter referred to as "implementation plan") according to the comprehensive plan. <Amended on Aug. 11, 2020> |
| (5) | Matters necessary for the formulation and implementation of comprehensive plans and implementation plans shall be prescribed by Presidential Decree. |
| Article 6 (Survey of Current Status of Domestic Pathogen Resources) |
| (1) | In order to identify the current status of domestic pathogen resources and to formulate a comprehensive plan, the Commissioner of Korea Disease Control and Prevention Agency shall survey the current status, actual conditions, etc. of the collection, management, and utilization of pathogen resources every five years, and prepare the list of pathogen resources. <Amended on Aug. 11, 2020> |
| (2) | If the Commissioner of Korea Disease Control and Prevention Agency deems that it is necessary to identify the current status, etc. of pathogen resources, he or she may conduct other necessary surveys, in addition to the survey conducted under paragraph (1). <Amended on Aug. 11, 2020> |
| (3) | If deemed necessary for conducting a survey of the current status pursuant to paragraphs (1) and (2), the Commissioner of Korea Disease Control and Prevention Agency may request the relevant Ministries and institutions handling pathogen resources to provide cooperation regarding necessary data, etc. In such cases, the Ministries and institutions in receipt of such request shall comply therewith in the absence of good cause. <Amended on Aug. 11, 2020> |
| (4) | The scope of and methods for surveying the status of pathogen resources pursuant to paragraphs (1) and (2) and other necessary matters shall be prescribed by Presidential Decree. |
| Article 7 (Pathogen Resource Deliberative Committee) |
| (1) | In order to deliberate on the collection, management, and utilization of pathogen resources, the Pathogen Resource Deliberative Committee (hereinafter referred to as "Committee") shall be established under the jurisdiction of the Commissioner of Korea Disease Control and Prevention Agency. <Amended on Aug. 11, 2020> |
| (2) | The Committee shall deliberate on the following matters: |
| 1. | Formulation and implementation of comprehensive plans; |
| 2. | Surveys on status of pathogen resources; |
| 3. | Registration in the Register for Preservation and Management of Pathogen Resources; |
| 4. | Assistance to promote collection, management, and utilization of pathogen resources; |
| 5. | Other matters concerning the collection, management, and utilization of pathogen resources, tabled before the Committee by the Chairperson. |
| (3) | The Committee shall have up to 15 members, including one chairperson and one vice chairperson. |
| (4) | The Vice Commissioner of Korea Disease Control and Prevention Agency shall serve as the chairperson of the Committee; a vice chairperson shall be nominated by the chairperson from among the committee members; and the members shall be appointed or commissioned by the chairperson from among any of the following persons, in consultation with the heads of the relevant central administrative agencies: <Amended on Jul. 26, 2017; Aug. 11, 2020> |
| 1. | Public officials appointed to the Senior Executive Service within the relevant central administrative agencies; |
| 2. | Persons with abundant expertise and experience in the collection, management, and utilization of pathogen resources. In such cases, at least two specialists in the field of bioscience recommended by the Minister of Science and ICT shall be included therein. |
| (5) | In order to efficiently perform the business affairs of the Committee, the Committee may establish specialized committees by field of specialization, consisting of committee members and outside specialists. |
| (6) | Other matters necessary for the composition, operation, etc., of the Committee and specialized committees shall be prescribed by Presidential Decree. |
| Article 8 (Establishment and Operation of National Culture Collection for Pathogens) |
| (1) | In order to efficiently perform the collection, management, and utilization of pathogen resources, the Commissioner of Korea Disease Control and Prevention Agency may establish and operate the National Culture Collection for Pathogens. In such cases, the National Culture Collection for Pathogens shall be deemed a biological resource center established under Article 8 of the Act on the Acquisition, Management, and Utilization of Biological Research Resources or a competent authority designated under Article 10 of that Act. <Amended on Aug. 11, 2020> |
| (2) | The National Culture Collection for Pathogens shall perform the following duties: |
| 1. | Collection, receipt of deposits, analysis, and evaluation of pathogen resources; |
| 2. | Management, utilization, and distribution of pathogen resources; |
| 3. | Assistance for operation of specialized pathogen resource banks designated under Article 9; |
| 4. | Construction and operation of a cooperation network of domestic institutions and foreign institutions related to pathogen resources; |
| 5. | Establishment and operation of a pathogen resource information system pursuant to Article 21; |
| 6. | Other matters prescribed by Presidential Decree with regard to collection, management, utilization, etc., of pathogen resources. |
| (3) | Matters necessary for the establishment, operation, etc., of the National Culture Collection for Pathogens shall be prescribed by Presidential Decree. |
| Article 9 (Designation and Operation of Specialized Pathogen Resource Banks) |
| (1) | In order to efficiently collect, manage, and utilize pathogen resources in each field, the Commissioner of Korea Disease Control and Prevention Agency may designate an entity having the facilities, equipment, personnel, etc. prescribed by Presidential Decree, as a specialized pathogen resource bank in each field (hereinafter referred to as "specialized bank"). In such cases, the designated specialized bank shall be deemed a biological resource center established under Article 8 of the Act on the Acquisition, Management, and Utilization of Biological Research Resources. <Amended on Aug. 11, 2020> |
| (2) | A specialized bank shall perform the following duties: |
| 1. | Collection, receipt of deposits, analysis, and evaluation, of specialized pathogen resources; |
| 2. | Management, utilization, and distribution of specialized pathogen resources; |
| 3. | Operation in conjunction with the information system under the Ministry’s jurisdiction and a pathogen resource information system established under Article 21; |
| 4. | Cooperation with the National Culture Collection for Pathogens and other specialized banks; |
| 5. | Other matters necessary for the collection, management, utilization, etc., of specialized pathogen resources. |
| (3) | In order to be designated as a specialized bank, any of the following entities shall have facilities and personnel necessary for the collection, management, and utilization of pathogen resources and file an application with the Commissioner of Korea Disease Control and Prevention Agency, as prescribed by Presidential Decree: <Amended on Aug. 11, 2020> |
| 1. | State agencies and agencies under their jurisdiction; |
| 2. | National or public educational or research institutions; |
| 4. | Private educational or research institutions; juristic persons or organizations (limited to those incorporated or established for a non-commercial purpose). |
| (4) | The Commissioner of Korea Disease Control and Prevention Agency may fully or partially subsidize specialized banks designated pursuant to paragraph (1) for expenses incurred in conducting their duties, within the budget. <Amended on Aug. 11, 2020> |
| (5) | Matters necessary for designation procedures, operation, support, etc., for specialized banks shall be prescribed by Presidential Decree. |
| Article 10 (Revocation of Designation) |
| (1) | Where a specialized bank falls under any of the following subparagraphs, the Commissioner of Korea Disease Control and Prevention Agency may revoke its designation or issue an corrective order: Provided, That in cases falling under subparagraph 1, the Commissioner shall revoke the designation of the specialized bank, and in cases falling under subparagraph 2 or 3, the Commissioner shall revoke the designation if the specialized bank fails to comply with a corrective order without good cause within 60 days from the date of receiving the corrective order: <Amended on Aug. 11, 2020> |
| 1. | Where the specialized bank obtains its designation by fraud or other improper means; |
| 2. | Where the specialized bank fails to meet any of the requirements for designation referred to in Article 9 (1); |
| 3. | Where the specialized bank fails to perform the duties provided for in the subparagraphs of Article 9 (2) without good cause. |
| (2) | Matters necessary for detailed standards, procedures, etc., for the revocation of designation and corrective orders issued under paragraph (1) shall be prescribed by Presidential Decree. |
CHAPTER III COLLECTION, MANAGEMENT, AND UTILIZATION OF PATHOGEN RESOURCES
| (1) | In order to systematically manage and utilize pathogen resources, the Commissioner of Korea Disease Control and Prevention Agency shall collect pathogen resources. <Amended on Aug. 11, 2020> |
| (2) | The scope of and methods for collection pursuant to paragraph (1), and other necessary matters shall be prescribed by Ordinance of the Ministry of Health and Welfare. |
| (1) | A person who has pathogen resources may deposit such pathogen resources in the National Culture Collection for Pathogens or a specialized bank. |
| (2) | A person who implements a national research and development project relating to pathogen resources shall deposit the pathogen resources produced as the results of the project in the National Culture Collection for Pathogens, a specialized bank, or a biological resource center established under Article 8 of the Act on the Acquisition, Management, and Utilization of Biological Research Resources: Provided, That the same shall not apply to causes prescribed by Presidential Decree that are deemed by the head of the relevant central administrative agency, such as where other statutes prescribe that special protection is required. |
| (3) | The Commissioner of Korea Disease Control and Prevention Agency shall reflect the depositing and registration records of pathogen resources under paragraph (2) in the evaluation, etc. of the relevant projects. <Amended on Aug. 11, 2020> |
| (4) | Matters necessary for standards, methods and procedures for deposits provided for in paragraph (1), and for methods, procedures, etc., for deposits required under paragraph (2) shall be prescribed by Presidential Decree. |
| Article 13 (Analysis, Evaluation, and Registration) |
| (1) | The Commissioner of Korea Disease Control and Prevention Agency shall analyze and evaluate the characteristics, etc. of pathogen resources collected pursuant to Article 11 (1) or deposited in the National Culture Collection for Pathogens and specialized banks pursuant to Article 12 (1) and (2). <Amended on Aug. 11, 2020> |
| (2) | On the basis of the results of analysis and evaluation conducted under paragraph (1), the Commissioner of Korea Disease Control and Prevention Agency shall register pathogen resources worthy of preservation in the Register for Preservation and Management of Pathogen Resources, and systematically manage them. <Amended on Aug. 11, 2020> |
| (3) | The Commissioner of Korea Disease Control and Prevention Agency shall fully or partially disclose the results of analysis and evaluation conducted under paragraph (1) and the contents registered under paragraph (2) in accordance with the Official Information Disclosure Act. <Amended on Aug. 11, 2020> |
| (4) | Other matters necessary for the analysis and evaluation of pathogen resources and registration in the Register for Preservation and Management of Pathogen Resources shall be prescribed by Ordinance of the Ministry of Health and Welfare. |
| Article 14 (Approval for Distribution and Other Relevant Matters) |
| (1) | A person who intends to obtain a distribution of pathogen resources registered in the Register for Preservation and Management of Pathogen Resources shall determine their purpose of use and obtain approval therefor from the Commissioner of Korea Disease Control and Prevention Agency. <Amended on Aug. 11, 2020> |
| (2) | The Commissioner of Korea Disease Control and Prevention Agency need not approve the distribution in any of the following cases: <Amended on Aug. 11, 2020> |
| 1. | Where the volume of registered and managed pathogen resources in stock is insufficient; |
| 2. | Where distribution is prohibited by other statutes and regulations; |
| 3. | Where a person who has applied for approval for distribution fails to maintain facilities and equipment meeting the standards for safety management of pathogen resources referred to in Article 19. |
| (3) | Where a person who has obtained approval pursuant to paragraph (1) intends to modify any approved matter, such as the purpose of use, he or she shall obtain approval for modification of distribution from the Commissioner of Korea Disease Control and Prevention Agency: Provided, That where he or she intends to modify any of the minor matters prescribed by Presidential Decree, such as research period, he or she shall report thereon to the Commissioner of Korea Disease Control and Prevention Agency. <Amended on Aug. 11, 2020> |
| (4) | Matters necessary for approval for distribution required under paragraph (1), and standards, procedures, etc., for approval for modification of distribution and for reporting on modified matters pursuant to paragraph (3) shall be prescribed by Presidential Decree. |
The Commissioner of Korea Disease Control and Prevention Agency may collect fees for parts of expenses incurred in collection, preservation, and management of pathogen resources from a person who obtains a distribution of pathogen resources after obtaining approval therefor pursuant to Article 14 (1), as prescribed by Ordinance of the Ministry of Health and Welfare. [This Article Newly Inserted on Dec. 21, 2021]
| Article 15 (Revocation of Approval for Distribution) |
| (1) | In any of the following cases, the Commissioner of Korea Disease Control and Prevention Agency may revoke approval for distribution under Article 14 (1) or approval for modification of distribution under the main clause of Article 14 (3), and may issue an order to dispose of the pathogen resources which were approved for distribution: Provided, That in cases falling under subparagraph 1, he or she shall revoke the approval and issue an order to dispose of the distributed pathogen resources: <Amended on Aug. 11, 2020> |
| 1. | Where approval for distribution or approval for modification of distribution is obtained by fraud or other improper means; |
| 2. | Where a person modifies any approved matter without obtaining approval for modification of distribution, in violation of the main clause of Article 14 (3); |
| 3. | Where any of the standards for approval for distribution referred to in Article 14 (4) are violated. |
| (2) | Matters necessary for the revocation of approval for distribution, revocation of approval for modification of distribution, and an order to dispose of pathogen resources under paragraph (1) shall be prescribed by Presidential Decree. |
| Article 16 (Approval for Outbound Transfer) |
| (1) | A person who intends to transfer the following pathogen resources that are included in the list of pathogen resources subject to approval for outbound transfer (excluding cases where only information thereon exists in the list), which is prepared by the Commissioner of Korea Disease Control and Prevention Agency, from the Republic of Korea, shall obtain approval from the Commissioner of Korea Disease Control and Prevention Agency, specifying the purpose of use: Provided, That the same shall not apply to pathogen resources incapable of causing infectious diseases in humans, which are approved for outbound transfer pursuant to Article 18 of the Act on the Conservation, Management, and Use of Agricultural Bio-Resources or Article 22 of the Act on Securing, Management and Use of Marine and Fisheries Bio-Resources: <Amended on Dec. 27, 2016; Aug. 11, 2020> |
| 1. | Pathogen resources collected in the Republic of Korea; |
| 2. | Pathogen resources held by national agencies. |
| (2) | A person who intends to transfer pathogen resources that are not included in the list of pathogen resources subject to approval for outbound transfer, from the Republic of Korea, shall report thereon to the Commissioner of Korea Disease Control and Prevention Agency: Provided, That the same shall not apply to transfer for academic purposes or other relevant cases prescribed by Presidential Decree. <Amended on Aug. 11, 2020> |
| (3) | The Commissioner of Korea Disease Control and Prevention Agency need not grant approval for outbound transfer requested under paragraph (1) in any of the following cases: <Amended on Aug. 11, 2020> |
| 1. | Where such outbound transfer is prohibited in accordance with another statute or regulation; |
| 2. | Where a person who applied for approval for outbound transfer, fails to maintain facilities, equipment, etc., meeting the safety management standards for pathogen resources required under Article 19; |
| 3. | Where such outbound transfer is deemed likely to cause damage to the Republic of Korea. |
| (4) | Where a person who obtains approval pursuant to paragraph (1) intends to modify any approved matter, such as the purpose of use, he or she shall obtain approval for modification of outbound transfer from the Commissioner of Korea Disease Control and Prevention Agency: Provided, That if he or she intends to modify any minor matters prescribed by Presidential Decree, such as research period, he or she shall report thereon to the Commissioner of Korea Disease Control and Prevention Agency. <Amended on Aug. 11, 2020> |
| (5) | Where the Commissioner of Korea Disease Control and Prevention Agency prepares a list of pathogen resources subject to approval for outbound transfer under paragraph (1), he or she shall designate such pathogen resources after a prior consultation with the heads of the relevant central administrative agencies, and publicly notify such list. <Amended on Aug. 11, 2020> |
| (6) | Matters necessary for approval for outbound transfer under paragraph (1), reporting on outbound transfer under paragraph (2), standards and procedures for obtaining or reporting on approval for modification of outbound transfer under paragraph (4), etc. shall be prescribed by Presidential Decree. |
| Article 17 (Revocation of Approval for Outbound Transfer and Other Relevant Matters) |
| (1) | If a person falls under any of the following cases, the Commissioner of Korea Disease Control and Prevention Agency may revoke the approval for outbound transfer given under Article 16 (1) or approval for modification of outbound transfer under the main clause of Article 16 (4), and may issue an order to dispose of the pathogen resources that were approved for outbound transfer: Provided, That in cases falling under subparagraph 1, the Commissioner shall revoke such approval and issue an order to dispose of the pathogen resources that were approved for outbound transfer: <Amended on Aug. 11, 2020> |
| 1. | Where a person obtains approval for outbound transfer or approval for modification of outbound transfer, by fraud or other improper means; |
| 2. | Where a person modifies any approved matter without obtaining approval for modification of outbound transfer, in violation of the main clause of Article 16 (4); |
| 3. | Where a person violates the standards for approval for outbound transfer provided for in Article 16 (6). |
| (2) | Matters necessary for the revocation of approval for outbound transfer, revocation of approval for modification of outbound transfer, and issuance of an order to dispose of pathogen resources, pursuant to paragraph (1), shall be prescribed by Presidential Decree. |
| Article 18 (Acquisition of Pathogen Resources by Foreigners and Other Relevant Matters) |
| (1) | Where a foreigner (referring to a person who has foreign nationality, a foreign corporation established under foreign law, or the government of a foreign country; hereinafter the same shall apply) or an international organization (hereinafter referred to as "foreigner, etc.") intends to acquire pathogen resources in the Republic of Korea for purposes of research, development, production, commercial use, etc., it shall obtain permission from the Commissioner of Korea Disease Control and Prevention Agency, as prescribed by Presidential Decree: Provided, That the same shall not apply where it has obtained permission therefor or an agreement has been reached pursuant to other statutes or a treaty with the Government of the Republic of Korea. <Amended on Aug. 11, 2020> |
| (2) | A foreigner, etc., obtained permission pursuant to paragraph (1) shall implement the following obligations: |
| 1. | Submission of the outcomes of inspection of acquired pathogen resources and of data; |
| 2. | Provision of records analyzing the outcomes of inspection of acquired pathogen resources and data thereof; |
| 3. | Support for analysis of the outcomes of inspection and data. |
| Article 19 (Safety Management of Pathogen Resources and Other Relevant Matters) |
| (1) | For the safety management of pathogen resources, a person who handles pathogen resources pursuant to this Act shall comply with the safety management standards prescribed by Presidential Decree with regard to facilities, equipment, etc., for pathogen resources. |
| (2) | The Commissioner of Korea Disease Control and Prevention Agency may examine whether a person who handles pathogen resources under this Act complies with the safety management standards referred to in paragraph (1) and other relevant matters. <Amended on Aug. 11, 2020> |
| (3) | If a person ordered to dispose of pathogen resources pursuant to Article 15 (1) or 17 (1) fails to comply with the order, or in cases of emergency for public health, the Commissioner of Korea Disease Control and Prevention Agency may order relevant public officials to dispose of such pathogen resources or to impose other necessary dispositions. <Amended on Aug. 11, 2020> |
| (4) | Matters necessary for the safety management of pathogen resources other than those provided for in paragraphs (1) and (2) shall be prescribed by Presidential Decree. |
CHAPTER IV ESTABLISHMENT OF INFRASTRUCTURE FOR PATHOGEN RESOURCES
| Article 20 (Support for Technological Development regarding Pathogen Resources, Promotion of Utilization, and Other Relevant Matters) |
| (1) | In order to develop technologies necessary for the collection, management, and utilization of pathogen resources and to promote research and development, commercialization, etc., with regard to pathogen resources, the State may support the academic circles, research institutions, enterprises, etc. that participate in the projects, relating to policy measures on the following matters: |
| 1. | Technological development necessary for the collection, management, and utilization of pathogen resources; |
| 2. | Establishment of a cooperative system among academic circles, research institutions, and enterprises, for conducting research and development with regard to pathogen resources and promoting joint research; |
| 3. | Support for research, development, and inspection, utilizing pathogen resources; |
| 4. | Establishment and utilization of a pathogen resource information system; |
| 5. | Publicity and education for the efficient utilization of pathogen resources; |
| 6. | Other matters prescribed by Presidential Decree bas they are needed for technological development and promotion of utilization with regard to pathogen resources. |
| (2) | Matters necessary for conditions, methods, etc. with regard to support provided for in paragraph (1) shall be prescribed by Presidential Decree. |
| Article 21 (Establishment and Operation of Pathogen Resource Information System) |
| (1) | For the efficient formulation and implementation of policy measures on pathogen resources, the Commissioner of Korea Disease Control and Prevention Agency shall establish and operate a pathogen resource information system which enables the standardization of information on pathogen resources and the systematic management of information dispersed among the institutions. In such cases, if the Korean Bioinformation Center is designated pursuant to Article 11 of the Act on the Acquisition, Management, and Utilization of Biological Research Resources, the Commissioner shall manage the pathogen resource information system in conjunction with the Korean Bioinformation Center. <Amended on Aug. 11, 2020> |
| (2) | The Commissioner of Korea Disease Control and Prevention Agency may request relevant institutions and organizations handling pathogen resources to submit data necessary for the establishment and operation of a pathogen resource information system. In such cases, the agency or organization in receipt of such request shall comply therewith in the absence of good cause. <Amended on Aug. 11, 2020> |
| (3) | The Commissioner of Korea Disease Control and Prevention Agency shall take technological, managerial, and physical measures necessary to ensure information security so as to prevent any information loss, theft, leakage, fabrication, alteration, or damage. <Amended on Aug. 11, 2020> |
| (4) | Other matters necessary for the establishment and operation of a pathogen resource information system pursuant to paragraph (1) shall be prescribed by Presidential Decree. |
| Article 22 (Fostering of Specialists) |
| (1) | In order to systematically foster specialists necessary for the collection, management, and utilization of pathogen resources, the Commissioner of Korea Disease Control and Prevention Agency shall conduct fostering, education, and training of specialists on a mid- to long-term basis. <Amended on Aug. 11, 2020> |
| (2) | Matters necessary for fostering, educating, and training specialists pursuant to paragraph (1) shall be prescribed by Presidential Decree. |
| Article 23 (Utilization of Pathogen Resources, Promotion of International Cooperation, and Other Relevant Matters) |
| (1) | The State shall prepare policy measures to raise awareness of pathogen resources and to promote voluntary cooperation between relevant institutions and organizations handling pathogen resources. |
| (2) | The State may support institutions, organizations, etc., performing the research, development, utilization, etc., of pathogen resources. |
| (3) | In order to collect overseas pathogen resources and to promote the research and development of pathogen resources and international cooperation, the State shall formulate policy measures for international cooperation, such as information exchanges; joint inspection and research; and technological exchanges, with foreign countries, international organizations, etc. |
| Article 24 (Annual Reports) |
| (1) | The Commissioner of Korea Disease Control and Prevention Agency shall prepare a report on the collection, management, and utilization of pathogen resources and submit it to the competent Standing Committee of the National Assembly before the ordinary session of the National Assembly begins. <Amended on Aug. 11, 2020> |
| (2) | Each report prepared under paragraph (1) shall contain the following: |
| 1. | Formulation and management of an annual implementation plan pursuant to the relevant comprehensive plan; |
| 2. | Actual condition of promotion of collection, management, and utilization of pathogen resources and results of evaluation; |
| 3. | Status of collection, management, and utilization of pathogen resources at home and abroad. |
| (3) | Matters necessary for the preparation, submission, etc. of a report pursuant to paragraph (1) shall be prescribed by Presidential Decree. |
| Article 25 (Obligation to Maintain Confidentiality) |
No person currently and formerly engaged in the collection, management, utilization, etc., of pathogen resources in the National Culture Collection for Pathogens or in a specialized bank shall divulge or misappropriate any information he or she has become aware of in the course of preforming his or her duties.
CHAPTER V SUPPLEMENTARY PROVISIONS
| Article 26 (Reporting and Inspection) |
| (1) | The Commissioner of Korea Disease Control and Prevention Agency may require the heads of specialized banks to report on their business or duties, or order them to submit documents thereon. <Amended on Aug. 11, 2020> |
| (2) | The Commissioner of Korea Disease Control and Prevention Agency may require public officials under its jurisdiction to inspect books and documents of specialized banks and other matters necessary for the operation of their business. <Amended on Aug. 11, 2020> |
| (3) | Public officials conducting an inspection pursuant to paragraph (2) shall carry with him or her a certificate indicating his or her authority and present it to interested persons. |
The Commissioner of Korea Disease Control and Prevention Agency shall hold a hearing when he or she intends to impose any of the following dispositions: <Amended on Aug. 11, 2020>
| 1. | Revocation of designation pursuant to Article 10 (1); |
| 2. | Revocation of approval for distribution, revocation of approval for modification of distribution, and issuance of an order to dispose of pathogen resources pursuant to paragraph 15 (1); |
| 3. | Revocation of approval for outbound transfer, revocation of approval for modification of outbound transfer, and issuance of an order to dispose of pathogen resources pursuant to paragraph 17 (1). |
| Article 28 (Delegation and Entrustment) |
| (1) | The Commissioner of Korea Disease Control and Prevention Agency may delegate part of the authority under this Act to the head of an affiliated agency, as prescribed by Presidential Decree. <Amended on Aug. 11, 2020> |
| (2) | The Commissioner of Korea Disease Control and Prevention Agency may entrust part of the duties under this Act to relevant institutions and organizations, as prescribed by Presidential Decree. <Amended on Aug. 11, 2020> |
| Article 29 (Deemed Public Officials for Purposes of Penalty Provisions) |
A person engaged in the collection, management, utilization, etc., of pathogen resources in the National Culture Collection for Pathogens or in a specialized bank, who is not a public official, shall be deemed a public official for the purposes of Articles 129 through 132.
CHAPTER VI?PENALTY PROVISIONS
| Article 30 (Penalty Provisions) |
| (1) | Any of the following persons shall be punished by imprisonment with labor for not more than three years or by a fine not exceeding 30 million won: <Amended on Aug. 11, 2020> |
| 1. | A person who transfers any pathogen resources from the Republic of Korea without obtaining approval for outbound transfer, in violation of Article 16 (1); |
| 2. | A person who obtains approval for outbound transfer required under Article 16 (1), by fraud or other improper means; |
| 3. | A person who modifies any approved matter, such as the purpose of use, without obtaining approval for modification of outbound transfer, in violation of the main clause of Article 16 (4); |
| 4. | A person who acquires any pathogen resource in Republic of Korea without obtaining permission, in violation of Article 18 (1). |
| (2) | Pathogen resources transferred by a person who commits any violation provided for in paragraph (1) shall be confiscated; if confiscation is impossible, the value thereof shall be additionally collected. |
| Article 31 (Penalty Provisions) |
| (1) | Any of the following persons shall be punished by imprisonment with labor for not more than two years or by a fine not exceeding 20 million won: <Amended on Aug. 11, 2020> |
| 1. | A person who distributes or is distributed any pathogen resources without obtaining approval for distribution from the Commissioner of Korea Disease Control and Prevention Agency, in violation of Article 14 (1); |
| 2. | A person who obtains approval for distribution required under Article 14 (1), by fraud or other improper means; |
| 3. | A person who modifies any approved matter, such as purpose of use, without obtaining approval for modification of distribution, in violation of the main clause of Article 14 (3); |
| 4. | A person who fails to comply with safety management standards, in violation of Article 19 (1); |
| 5. | A person who divulges or misappropriates any information he or she has become aware of in the course of performing duties, in violation of Article 25. |
| (2) | Pathogen resources distributed or obtained by a person who has committed any violation listed under paragraph (1) 1, 2, and 3 shall be confiscated; if confiscation is impossible, the value thereof shall be additionally collected. |
| Article 32 (Joint Penalty Provisions) |
Where the representative of a juristic person or an agent, servant, or employee of a juristic person or an individual violates Article 30 or 31 in conducting the business affairs of the juristic person or the individual, a fine provided for in the relevant provision shall be imposed on the juristic person or individual in addition to the punishment of the violator: Provided, That this shall not apply where the juristic person or the individual has not been negligent in exercising due care and supervision with regard to the relevant duties in order to prevent such violation.
| Article 33 (Administrative Fines) |
| (1) | Any of the following persons shall be subject to an administrative fine not exceeding 10 million won: |
| 1. | A person who fails to comply with any order to dispose of pathogen resources issued under Article 15 (1) or 17 (1); |
| 2. | A person who fails to implement an obligation listed under Article 18 (2). |
| (2) | Any of the following persons shall be subject to an administrative fine not exceeding three million won: |
| 1. | A person who fails to report any modification of a minor matter regarding approved distribution, in violation of the proviso of Article 14 (3); |
| 2. | A person who removes any pathogen resource from the Republic of Korea without reporting required under Article 16 (2); |
| 3. | A person who fails to report on any modification of a minor matter regarding outbound transfer, in violation of the proviso of Article 16 (4). |
| (3) | Administrative fines provided for in paragraphs (1) and (2) shall be imposed and collected by the Commissioner of Korea Disease Control and Prevention Agency, as prescribed by Presidential Decree. <Amended on Aug. 11, 2020> |
ADDENDUM <Act No. 13992, Feb. 3, 2016>
This Act shall enter into force one year after the date of its promulgation.
ADDENDA <Act No. 14513, Dec. 27, 2016>
Article 1 (Enforcement Date)
This Act shall enter into force six months after the date of its promulgation.
Articles 2 through 10 Omitted.
ADDENDA <Act No. 14839, Jul. 26, 2017>
Article 1 (Enforcement Date)
This Act shall enter into force on the date of its promulgation: Provided, That the amendments to the Acts, which were promulgated before this Act enters into force but whose enforcement dates have yet to arrive, among the Acts amended under Article 5 of the Addenda, shall enter into force on their respective enforcement dates. Articles 2 through 6 Omitted.
ADDENDA <Act No. 17472, Aug. 11, 2020>
Article 1 (Enforcement Date)
This Act shall enter into force one month after the date of its promulgation: Provided, That ... <omitted> ..., the amendments to the Acts, which were promulgated before this Act enters into force but the enforcement dates of which have not yet arrived, among the Acts amended pursuant to Article 4 of the Addenda, shall enter into force on the enforcement dates of the respective Acts. Articles 2 through 5 Omitted.
ADDENDUM <Act No. 18614, Dec. 21, 2021>
This Act shall enter into force three months after the date of its promulgation.