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

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 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 P

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

Article 1(Purpose) #

Article 2(Definitions) #

Article 3(Responsibilities of the State) #

Article 4(Relationship to Other Statutes) #

Article 5(Formulation and Implementation of Comprehensive Pathogen Resource Management Plans)

Article 6(Survey of Current Status of Domestic Pathogen Resources) #

Article 7(Pathogen Resource Deliberative Committee) #

Article 8(Establishment and Operation of National Culture Collection for Pathogens) #

Article 9(Designation and Operation of Specialized Pathogen Resource Banks) #

Article 10(Revocation of Designation) #

Article 11(Collection) #

Article 12(Deposits) #

Article 13(Analysis, Evaluation, and Registration) #

Article 14(Approval for Distribution and Other Relevant Matters) #

Article 14-2(Fees) #

Article 15(Revocation of Approval for Distribution) #

Article 16(Approval for Outbound Transfer) #

Article 17(Revocation of Approval for Outbound Transfer and Other Relevant Matters) #

Article 18(Acquisition of Pathogen Resources by Foreigners and Other Relevant Matters) #

Article 19(Safety Management of Pathogen Resources and Other Relevant Matters) #

Article 20(Support for Technological Development regarding Pathogen Resources, Promotion of Utilization, and Other Relevant Matters) #

Article 21(Establishment and Operation of Pathogen Resource Information System) #

Article 22(Fostering of Specialists) #

Article 23(Utilization of Pathogen Resources, Promotion of International Cooperation, and Other Relevant Matters) #

Article 24(Annual Reports) #

Article 25(Obligation to Maintain Confidentiality) #

Article 26(Reporting and Inspection) #

Article 27(Hearings) #

Article 28(Delegation and Entrustment) #

Article 29(Deemed Public Officials for Purposes of Penalty Provisions) #

Article 30(Penalty Provisions) #

Article 31(Penalty Provisions) #

Article 32(Joint Penalty Provisions) #

Article 33(Administrative Fines) #