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ACT ON THE PROMOTION OF COLLECTION, MANAGEMENT, AND UTILIZATION OF PATHOGEN RESOURCES

Act No. 13992, Feb. 3, 2016

CHAPTER I GENERAL PROVISIONS
 Article 1 (Purpose)
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.
 Article 2 (Definitions)
The term "pathogen resource" 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 State, etc.)
(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 with Other Acts)
Except as otherwise expressly provided for in other Acts, this Act shall apply to the collection, management, and utilization of pathogen resources.
CHAPTER II FORMULATION, IMPLEMENTATION, ETC. OF COMPREHENSIVE PATHOGEN RESOURCE MANAGEMENT PLANS
 Article 5 (Formulation, Implementation, etc. of Comprehensive Pathogen Resource Management Plans)
(1) In order to promote the collection, management, and utilization of pathogen resources, every five years, the Minister of Health and Welfare shall formulate and implement a comprehensive pathogen resource management plan (hereinafter referred to as '"comprehensive plan") after deliberation by a pathogen resource deliberative committee established under Article 7.
(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 Minister of Health and Welfare formulates a comprehensive plan, he/she shall have consultation with the heads of relevant central administrative agencies.
(4) The Minister shall formulate and implement an annual implementation plan (hereinafter referred to as "implementation plan") according to a comprehensive plan.
(5) Matters necessary for the formulation and implementation of comprehensive plans and implementation plans shall be prescribed by Presidential Decree.
 Article 6 (Survey on Status of Domestic Pathogen Resources)
(1) In order to ascertain the status of domestic pathogen resources and to formulate a comprehensive plan, the Minister of Health and Welfare shall survey the current status and actual condition of the collection, management, and utilization of pathogen resources, every five years.
(2) If the Minister of Health and Welfare deems it is necessary to ascertain the status, etc. of pathogen resources, he/she may conduct surveys as necessary, in addition to the survey conducted under paragraph (1).
(3) In order to conduct a survey on status pursuant to paragraphs (1) and (2), if deemed necessary, the Minister of Health and Welfare may request relevant Ministries and institutions handling pathogen resources to provide necessary data, etc. In such cases, the Ministries and institutions in receipt of such request shall comply therewith unless just cause exists.
(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 Minister of Health and Welfare shall establish the Pathogen Resource Deliberative Committee (hereinafter referred to as "Committee") under his/her jurisdiction.
(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 a chairperson and a vice chairperson.
(4) The Vice Minister of Health and Welfare shall be the Chairperson of the Committee; a vice chairperson shall be designated by the Chairperson from among committee members; and such members shall be appointed or commissioned by the Chairperson from among the following persons, in consultation with the heads of relevant central administrative agencies:
1. Public officials appointed to the Senior Civil Service Corps within the relevant central administrative agencies;
2. Persons with abundant expertise and experience in the collection, management, and/or utilization of pathogen resources. In such cases, at least two specialists in the field of bioscience recommended by the Minister of Science, ICT and Future Planning shall be included therein.
(5) In order to efficiently perform 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, Operation, etc., of National Culture Collection for Pathogens)
(1) In order to efficiently perform the collection, management, and utilization of pathogen resources, the Minister of Health and Welfare may establish and operate a National Culture Collection for Pathogens. In this regard, 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 the same Act.
(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, Operation, etc., of Specialized Pathogen Resource Banks)
(1) In order to efficiently collect, manage, and utilize specialized pathogen resources, the Minister of Health and Welfare may designate an entity having facilities, equipment, personnel, etc., prescribed by Presidential Decree as a specialized pathogen resource bank (hereinafter referred to as "specialized bank"). In such cases, the designated 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.
(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) Where any of the following entities intends to be designated as a specialized bank, it shall have facilities and personnel necessary for the collection, management, and utilization of pathogen resources and file an application with the Minister of Health and Welfare, as prescribed by Presidential Decree:
1. State agencies and agencies under their jurisdiction;
2. National or public educational or research institutions;
3. Public institutions established under Article 4 of the Act on the Management of Public Institutions;
4. Private educational or research institutions; juristic persons or organizations (limited to those incorporated or established for a non-commercial purpose).
(4) The Minister of Health and Welfare may fully or partially subsidize specialized banks designated pursuant to paragraph (1), for expenses incurred in conducting their duties, within budgetary limits.
(5) Matters necessary for designation procedures, operation, support, etc., for specialized banks shall be prescribed by Presidential Decree.
 Article 10 (Revocation, etc. of Designation)
(1) Where a specialized bank falls under any of the following, the Minister of Health and Welfare may revoke its designation or issue an order to correct violation: Provided, That where subparagraph 1 applies, he/she shall revoke its designation; where subparagraphs 2 or 3 applies, he/she shall revoke its designation if the specialized bank fails to comply with a corrective order, without just cause, within 60 days from the date the specialized banks receives the corrective order:
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 just 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, UTILIZATION, ETC., OF PATHOGEN RESOURCES
 Article 11 (Collection)
(1) In order to systematically manage and utilize pathogen resources, the Minister of Health and Welfare shall collect pathogen resources.
(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.
 Article 12 (Deposits)
(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 outcomes 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 foregoing shall not apply where special protection is required by another Act or any other cause prescribed by Presidential Decree, which is recognized by the head of a relevant central administrative agency.
(3) The Minister of Health and Welfare shall reflect the depositing of pathogen resources required under paragraph (2) and registration of pathogen resources, as outcomes, in a repository in the evaluation, etc. of the relevant project.
(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 Minister of Health and Welfare shall analyze and evaluate the characteristics, etc., of pathogen resources collected pursuant to Article 11 (1) and deposited in the National Culture Collection for Pathogens and specialized banks pursuant to Article 12 (1) and (2).
(2) On the basis of the results of analysis and evaluation conducted under paragraph (1), the Minister of Health and Welfare shall register pathogen resources worthy of preservation in the Register for Preservation and Management Pathogen Resources, and systematically manage them.
(3) The Minister of Health and Welfare shall fully or partially disclose the findings from analysis and evaluation conducted under paragraph (1) and the contents registered under paragraph (2) in accordance with the Official Information Disclosure Act.
(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 designate their use and obtain approval from the Minister of Health and Welfare.
(2) Where any of the following applies, the Minister of Health and Welfare need not approve such distribution:
1. Where the volume of registered and managed pathogen resources in stock is insufficient;
2. Where distribution is prohibited by other statutes;
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 purpose of use, he/she shall obtain modified approval for distribution from the Minister of Health and Welfare: Provided, That where he/she intends to modify any of the minor matters prescribed by Presidential Decree, such as research period, he/she shall report thereon to the Minister of Health and Welfare.
(4) Matters necessary for approval for distribution required under paragraph (1), and standards, procedures, etc., for modified approval for distribution and for reporting on modified matters pursuant to paragraph (3) shall be prescribed by Presidential Decree.
 Article 15 (Revocation, etc., of Approval for Distribution, etc.)
(1) Where any of the following applies, the Minister of Health and Welfare may revoke approval for distribution under Article 14 (1) or approval for change of approved distribution under the main sentence of Article 14 (3), and order the relevant person to dispose of the pathogen resources of which distribution is approved: Provided, That where subparagraph 1 applies, he/she shall revoke the approval and order the relevant person to dispose of the distributed pathogen resources:
1. Where approval for distribution or approval to modify approved distribution is obtained by fraud or other improper means;
2. Where a person who obtains approval under Article 14 (1), modifies any approved matter without obtaining approval to modify approved distribution, in violation of the main sentence 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 change of approved distribution and order to dispose of pathogen resources under paragraph (1) shall be prescribed by Presidential Decree.
 Article 16 (Approval, etc. for Outbound Transfer and Other Relevant Matters)
(1) Among the following pathogen resources, a person, who intends to remove any pathogen resource included in the list of pathogen resources subject to approval for outbound transfer (excluding where only information thereon exists in the list), prepared by the Minister of Health and Welfare, from the Republic of Korea, shall obtain approval from the Minister of Health and Welfare, specifying their use: Provided, That the foregoing shall not apply to pathogen resources incapable of causing infectious diseases in humans and for which approval for outbound transfer is obtained pursuant to Article 18 of the Act on the Preservation, Management, and Use of Agro-Fishery Bioresources or Article 22 of the Act on Securing, Management, Use, etc. of Marine Bio-Resources:
1. Pathogen resources collected in the Republic of Korea;
2. Pathogen resources held by national agencies.
(2) A person who intends to remove pathogen resources, not included in the list of pathogen resources subject to approval for outbound transfer, from the Republic of Korea, shall report thereon to the Minister of Health and Welfare: Provided, That the foregoing shall not apply to removal for academic purposes or other relevant cases prescribed by Presidential Decree.
(3) Where any of the following applies, the Minister of Health and Welfare need not grant approval for outbound transfer requested in accordance with paragraph (1):
1. Where such outbound transfer is prohibited in accordance with another statute;
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 obtains approval pursuant to paragraph (1) intends to modify any approved matter, such as purpose of use, he/she shall obtain modified approval for outbound transfer from the Minister of Health and Welfare: Provided, That where he/she intends to modify any of the minor matters prescribed by Presidential Decree, such as research period, he/she shall report thereon to the Minister of Health and Welfare.
(5) Where the Minister of Health and Welfare intends to prepare a list of pathogen resources subject to approval for outbound transfer pursuant to paragraph (1), he/she shall designate such pathogen resources in prior consultation with the heads of relevant central administrative agencies, and publicly notify such list.
(6) Matters necessary for approval for outbound transfer provided for in paragraph (1); reporting on outbound transfer provided for in paragraph (2); standards and procedures for obtaining modified approval for outbound transfer or for reporting on modified approval for outbound transfer provided for in paragraph (4); etc. shall be prescribed by Presidential Decree.
 Article 17 (Revocation of Approval for Outbound Transfer and Other Relevant Matters)
(1) Where any of the following applies, the Minister of Health and Welfare may revoke approval for outbound transfer given under Article 16 (1) or modified approval for outbound transfer given under the main sentence of Article 16 (4) and may order the relevant person to dispose of the pathogen resources of which the outbound transfer is approved: Provided, That where subparagraph 1 applies, the Minister shall revoke such approval and order the relevant person to dispose of the pathogen resources of which the outbound transfer is approved:
1. Where a person obtains approval for outbound transfer or modified approval for outbound transfer, by fraud or other improper means;
2. Where a person modifies any approved matter without obtaining modified approval for outbound transfer, in violation of the main sentence 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 modified approval for outbound transfer, and issuance of 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 juristic person under foreign law, or the government of a foreign country; hereinafter the same shall apply) or a foreign 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 Minister of Health and Welfare, as prescribed by Presidential Decree: Provided, That the foregoing shall not apply where it obtains permission therefor according to another Act, or a treaty entered into or an agreement reached by the Government of the Republic of Korea.
(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 Minister of Health and Welfare may examine whether a person who handles pathogen resources pursuant to this Act complies with the safety management standards referred to in paragraph (1) and other relevant matters.
(3) Where a person ordered to dispose of pathogen resources pursuant to Article 15 (1) or 17 (1) fails to implement such order or in cases of emergency for public health, the Minister of Health and Welfare shall order relevant public officials to dispose of such pathogen resources or impose another necessary disposition.
(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 formulation and implementation of efficient policy measures with regard to pathogen resources, the Minister of Health and Welfare shall establish and operate a pathogen resource information system that standardizes information on pathogen resources and manages information dispersed among institutions. In this regard, if a National Information Center of Biological Research Resources is designated pursuant to Article 11 of the Act on the Acquisition, Management, and Utilization of Biological Research Resources, he/she shall manage the information system in conjunction with and the National Information Center of Biological Research Resource.
(2) The Minister of Health and Welfare may request relevant agencies 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 just cause.
(3) To prevent any information on pathogen resources from being lost, stolen, divulged, forged, altered, or damaged, the Minister of Health and Welfare shall take technological, managerial and physical measures necessary to ensure the security of such information.
(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 Minister of Health and Welfare shall provide fostering, education, and training of specialists on a mid- to long-term basis.
(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 Minister of Health and Welfare 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.
(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/she has become aware of in the course of preforming his/her duties.
CHAPTER V SUPPLEMENTARY PROVISIONS
 Article 26 (Reporting, Inspection, etc.)
(1) The Minister of Health and Welfare may require the heads of specialized banks to report on their projects or duties, or order them to submit documents thereon.
(2) The Minister of Health and Welfare may require public officials under his/her jurisdiction to inspect books and documents of specialized banks and other matters necessary for the operation of their projects.
(3) Public officials conducting an inspection pursuant to paragraph (2) shall carry with him/her a certificate indicating his/her authority and present it to interested persons.
 Article 27 (Hearings)
Where the Minister of Health and Welfare intends to impose any of the following dispositions, he/she shall hold a hearing:
1. Revocation of designation pursuant to Article 10 (1);
2. Revocation of approval for distribution, revocation of modified approval for distribution and order to dispose of pathogen resources pursuant to paragraph 15 (1);
3. Revocation of approval for outbound transfer, revocation of modified approval for outbound transfer, and issuance of an order to dispose of pathogen resources, pursuant to paragraph 17 (1).
 Article 28 (Delegation and Entrustment)
(1) The Minister of Health and Welfare may partially delegate the authority vested under this Act to the Director of the Korea Centers for Disease Control and Prevention as prescribed by Presidential Decree.
(2) The Minister of Health and Welfare may partially entrust the duties imposed under this Act to relevant institutions and organizations as prescribed by Presidential Decree.
 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 thirty million won:
1. A person who removes any pathogen resource 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 purpose of use, without obtaining modified approval for outbound transfer, in violation of the main sentence 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 twenty million won:
1. A person who distributes or is distributed any pathogen resource or without obtaining approval for distribution from the Minister of Health and Welfare, 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 modified approval for distribution, in violation of the main sentence 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/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 punished by a fine not exceeding ten 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 punished by a 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 to 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 to Article 16 (4).
(3) Administrative fines provided for in paragraphs (1) and (2) shall be imposed and collected by the Minister of Health and Welfare, as prescribed by Presidential Decree.
ADDENDUM
This Act shall enter into force one year after the date of its promulgation.