ENFORCEMENT DECREE OF THE INFECTIOUS DISEASE CONTROL AND PREVENTION ACT
Wholly Amended by Presidential Decree No. 22564, Dec. 29, 2010
Amended by Presidential Decree No. 23356, Dec. 8, 2011
Presidential Decree No. 24454, Mar. 23, 2013
Presidential Decree No. 25448, Jul. 7, 2014
Presidential Decree No. 25532, Aug. 6, 2014
Presidential Decree No. 26024, Jan. 6, 2015
Presidential Decree No. 26865, Jan. 6, 2016
Presidential Decree No. 26916, Jan. 19, 2016
Presidential Decree No. 27277, jun. 28, 2016
Presidential Decree No. 27445, Aug. 11, 2016
Presidential Decree No. 27971, Mar. 29, 2017
Presidential Decree No. 28070, May 29, 2017
Presidential Decree No. 28962, jun. 12, 2018
Presidential Decree No. 29180, Sep. 18, 2018
Presidential Decree No. 29950, Jul. 2, 2019
Presidential Decree No. 29961, Jul. 9, 2019
Presidential Decree No. 30596, Apr. 2, 2020
Presidential Decree No. 30743, jun. 2, 2020
| Article 1-2 (Establishment and Operation of Organizations Supporting Infectious Disease Control Projects) |
| (1) | Under Article 8 (1) of the Infectious Disease Control and Prevention Act (hereinafter referred to as the "Act"), the Central Organization Supporting Infectious Disease Control Projects shall be established in the Ministry of Health and Welfare; and City/Do organizations supporting infectious disease projects in the Special Metropolitan City, Metropolitan Cities, Dos, and Special Self-Governing Province (hereinafter referred to as "City/Do"), as prescribed by the Minister of Health and Welfare. |
| (2) | Members of the Central Organization Supporting Infectious Disease Control Projects shall be commissioned by the Minister of Health and Welfare, from among the following: |
| 3. | A person with considerable knowledge and experience in the prevention and control of infectious diseases; |
| 4. | A person with considerable knowledge and experience in the areas of epidemiological investigation, disease control, etc.; |
| 5. | A person the Minister of Health and Welfare deems necessary for supporting infectious disease control projects. |
| (3) | If necessary for conducting its duties, the Central Organization Supporting Infectious Disease Control Projects may request the relevant institutions, organizations, experts, etc. to submit materials, opinions, etc. |
| (4) | The Central Organization Supporting Infectious Disease Control Projects shall report the status of its activities, etc. to the Minister of Health and Welfare as prescribed by the Minister of Health and Welfare every half year. |
| (5) | The Minister of Health and Welfare may provide the Central Organization Supporting Infectious Disease Control Projects with subsidies to cover the following costs within budgetary limits: |
| 1. | Costs incurred in the collection of materials, investigation, analysis, consulting, etc.; |
| 2. | Travel expenses, allowances, etc. incurred in the promotion of domestic and international cooperative projects; |
| 3. | Other expenses the Minister of Health and Welfare deems particularly necessary for conducting duties. |
| (6) | Except as provided in paragraphs (2) through (5), details necessary for establishing, operating, subsidizing etc. the Central Organization Supporting Infectious Disease Control Projects shall be determined by the Minister of Health and Welfare. |
| (7) | Paragraphs (2) through (6) shall apply mutatis mutandis to commissioning of members, requests for submission of materials, reporting on the status of activities, subsidization, etc. of City/Do organizations supporting infectious disease control projects. In such cases, "Minister of Health and Welfare" and "Central Organization Supporting Infectious Disease Control Projects" shall be construed as "Special Metropolitan City Mayor, Metropolitan City Mayor, Do Governor, or Special Self-Governing Province Governor (hereinafter referred to as "Mayor/Do Governor") and "City/Do organization supporting infectious disease control projects," respectively. |
[This Article Newly Inserted on Jun. 28, 2016]
| Article 1-3 (Designation of Infectious Disease Specialty Hospitals) |
| (1) | A medical institution (referring to a medical institution prescribed in Article 3 of the Medical Service Act; hereinafter referred to as "medical institution") eligible to be designated as an infectious disease speciality hospital prescribed in Article 8-2 (1) of the Act (hereinafter referred to as the "Central Infectious Disease Hospital") shall be a medical institution the Minister of Health and Welfare determines and publicly notifies, among general hospitals or superior general hospitals prescribed in Article 3-3 or 3-4 of the Medical Service Act. |
| (2) | The standards for designation of the Central Infectious Disease Hospital are as specified in attached Table 1. |
| (3) | Where the Minister of Health and Welfare designates the Central Infectious Disease Hospital, he/she may apply conditions to the standards for designation, conduct of duties, etc. thereof. |
| (4) | Where the Minister of Health and Welfare has designated the Central Infectious Disease Hospital, he/she shall deliver a certificate of designation and post the details of such designation on the website of the Ministry of Health and Welfare. |
| (5) | The Central Infectious Disease Hospital shall report the status of performance of duties, etc. to the Minister of Health and Welfare each quarter, as prescribed by the Minister of Health and Welfare. |
| (6) | The Minister of Health and Welfare may subsidize the Central Infectious Disease Hospital for building costs, operating costs, installation costs, etc., in consultation with the Minister of Economy and Finance under Article 8-2 (3) of the Act. |
| (7) | Except as provided in paragraphs (3) through (6), details necessary for procedures for designation, subsidies for expenses, etc. of the Central Infectious Disease Hospital shall be determined and publicly notified by the Minister of Health and Welfare. |
[This Article Newly Inserted on Jun. 28, 2016]
| Article 1-4 (Designation of Regional Infectious Disease Speciality Hospitals) |
| (1) | A medical institution eligible to be designated as a regional infectious disease specialty hospital under Article 8-2 (2) of the Act (hereinafter referred to as a "regional infectious disease hospital"), shall be a medical institution the Minister of Health and Welfare determines and publicly announces, among general hospitals or superior general hospitals prescribed in Article 3-3 or 3-4 of the Medical Service Act. |
| (2) | The standards for designating regional infectious disease hospitals are as prescribed in attached Table 1-2. |
| (3) | Where the Minister of Health and Welfare designates a regional infectious disease hospital under Article 8-2 (2) of the Act, he/she shall consider the following matters comprehensively: |
| 1. | The level of distribution of medical service resources in the relevant region; |
| 2. | The population and the range of habitat of the relevant region; |
| 3. | The frequency of outbreak and the level of control of infectious diseases in the relevant region; |
| 4. | The vicinity to harbors, airports, etc. in the relevant region; |
| 5. | Other matters the Minister of Health and Welfare deems particularly necessary in connection with the control of infectious diseases by region. |
| (4) | If necessary to designate a regional infectious disease hospital, the Minister of Health and Welfare may listen to the opinions of the heads of local governments, of the relevant public institutions or organizations, etc. or request the same to submit materials. |
| (5) | Article 1-3 (3) through (7) shall apply mutatis mutandis to the public announcement of detailed matters necessary for the addition of conditions of designation, delivery of certificates of designation, public announcement of designation, reporting on the status of performance of duties, subsidies for costs, procedures for designation, etc. of regional infectious disease hospitals. |
[This Article Newly Inserted on Jun. 28, 2016]
| Article 1-5 (Formulation of Measures for Controlling Resistant Bacteria) |
| (1) | Where the Minister of Health and Welfare intends to change important matters the Minister of Health and Welfare determines among the matters included in the measures for controlling resistant bacteria prescribed in Article 8-3 (1) of the Act (hereinafter referred to as "measures for controlling resistant bacteria"), he/she shall submit such changes for deliberation by the Infectious Disease Control Committee prescribed in Article 9 (1) of the Act. |
| (2) | Where the Minister of Health and Welfare formulates or changes measures for controlling resistant bacteria, he/she shall post such measures on the website of the Ministry of Health and Welfare and inform the heads of the relevant central administrative agencies, the President of the Health Insurance Review and Assessment Service under the National Health Insurance Act and the heads of other resistant bacteria-related institutions, corporations and organizations of the details thereof. |
| (3) | Except as provided in paragraphs (1) and (2), detailed matters necessary for the formulation and change of measures for controlling resistant bacteria shall be determined by the Minister of Health and Welfare. |
[This Article Wholly Amended on May 29, 2017]
| Article 1-6 (Establishment and Operation of Emergency Operations Center) |
| (1) | The Emergency Operations Center established pursuant to Article 8-5 of the Act (hereinafter referred to as "Emergency Operations Center”) shall meet all the following requirements for establishment and operation: |
| 1. | Establishing an information and communications system for promptly collecting and disseminating information on infectious diseases, comprehensively managing emergency conditions related to infectious diseases, etc.; |
| 2. | Securing facilities and equipment for effectively responding to emergency conditions related to infectious diseases and a system for operating and managing such facilities and equipment; |
| 3. | Securing dedicated personnel necessary to operate the Emergency Operations Center around the clock; |
| 4. | Preparing operational regulations and work manuals to facilitate the operation of the Emergency Operations Center. |
| (2) | Detailed matters related to establishing and operating the Emergency Operations Center shall be determined by the Director of the Korea Centers for Disease Control and Prevention. |
[This Article Newly Inserted on Jun. 12, 2018]
| Article 2 (Duties, and Terms of Office, of Members of Infectious Disease Control Committee) |
| (1) | The Chairperson of the Infectious Disease Control Committee (hereinafter referred to as the “Committee”) established under Article 9 (1) of the Act, shall represent the Committee and exercise general control over the administrative affairs thereof. <Amended on Jun. 28, 2016> |
| (2) | The vice-chairperson of the Committee shall assist the Chairperson and act on the Chairperson's behalf if the Chairperson is unable to perform any of his/her duties due to an extenuating circumstance. |
| (3) | The term of office of any commissioned member of the Committee shall be two years. |
| (4) | If a vacancy occurs in the office of Committee member, the term of office of a member filling the vacancy shall be the remainder of his/her predecessor’s term of office. |
| (1) | Committee meetings shall be convened upon request by the Minister of Health and Welfare, by a majority of the members thereof, or by the Chairperson when he/she deems necessary. |
| (2) | A majority of the members of the Committee shall constitute a quorum at Committee meetings and resolutions shall be passed with the concurrent vote of a majority of members present. |
| (3) | The Chairperson of the Committee shall report the resolutions adopted by the Committee to the Minister of Health and Welfare. |
| (4) | If deemed necessary for conducting its affairs, the Committee may request relevant public officials or experts to appear before the Committee to state their opinions. |
| Article 4 (Executive Secretary) |
The Committee shall have one executive secretary to administer the clerical work thereof, who shall be appointed by the Chairperson, from among public officials of the Ministry of Health and Welfare.
| Article 5 (Payment of Allowances) |
A member who attends a Committee meeting may be paid allowances and reimbursed for travel expenses, within budgetary limits: Provided, That this shall not apply where a member who is a public official attends a Committee meeting directly in connection with any of his/her official duties.
| Article 6 (Detailed Operating Rules) |
Except as otherwise expressly provided for in this Decree, matters necessary for operating the Committee shall be determined by the Chairperson, following a resolution by the Committee.
| Article 7 (Composition of Advisory Committees) |
| (1) | Pursuant to Article 10 (3) of the Act, the Committee shall establish the following advisory committees for each field: <Amended on Jan. 6, 2015; May 29, 2017; Apr. 2, 2020> |
| 1. | The advisory committee on vaccination; |
| 2. | The advisory committee on vaccination injury compensation; |
| 3. | The advisory committee on acquired immunodeficiency syndrome; |
| 4. | The advisory committee on tuberculosis; |
| 5. | The advisory committee on epidemiological investigation; |
| 6. | The advisory committee on zoonoses; |
| 7. | The advisory committee on infectious disease crisis control; |
| 8. | The advisory committee on infectious disease research and planning; |
| 9. | The advisory committee on antibiotic resistance; |
| 10. | The advisory committee on quarantine. |
| (2) | Each advisory committee shall be comprised of not exceeding 25 members, including one chairperson. <Amended on Apr. 2, 2020> |
| (3) | The chairperson of each advisory committee shall be appointed by the Chairperson of the Committee, from among Committee members. |
| (4) | Members of each advisory committee shall be appointed by the Chairperson of the Committee, from among Committee members, or commissioned by the Chairperson of the Committee, from among those recommended by the relevant academic society or organization or by Committee members. |
| Article 8 (Meetings and Operation of Advisory Committees) |
| (1) | Meetings of an advisory committee shall be convened upon request by the Chairperson of the Committee, by a majority of the members of the advisory committee, or by the chairperson of the advisory committee when he/she deems necessary. |
| (2) | A majority of the members of an advisory committee shall constitute a quorum at committee meetings and resolutions shall be passed with the concurrent vote of a majority of members present. |
| (3) | The chairperson of an advisory committee shall report the resolutions deliberated on and adopted by the advisory committee to the Chairperson of the Committee. <Amended on Jan. 6, 2015> |
| (4) | Except as provided in this Decree, matters necessary for operating each advisory committee shall be determined by the chairperson of the advisory committee, following a resolution by the advisory committee. |
| Article 9 (Other Zoonoses) |
| Article 10 (Public Institutions) |
“Public institutions prescribed by Presidential Decree” in the former part of Article 16 (7) of the Act means the Health Insurance Review and Assessment Service and the National Health Insurance Service established under the National Health Insurance Act. <Amended on Jan. 6, 2016>
| Article 11 (Information to Be Provided) |
| 1. | The name, resident registration number, gender, address, telephone number, occupation, name of infectious disease, date of onset of symptoms, and date of diagnosis of a patient of an infectious disease, a probable patient of an infectious disease, or a pathogen carrier (hereinafter referred to as “patient of an infectious disease, etc.”); |
| 2. | The name, location, and telephone number of the medical institution that diagnosed the case of a patient of an infectious disease, etc. and the name of the physician who made such diagnosis. |
| Article 12 (Details of Epidemiological Investigations) |
| 1. | The personal information of patients of an infectious disease, etc.; |
| 2. | The date and place where a patient, etc. was infected with an infectious disease; |
| 3. | The cause and route of infection for an infectious disease; |
| 4. | The medical record of a patient of an infectious disease, etc.; |
| 5. | Other matters necessary to reveal the cause of an infectious disease. |
| (2) | Matters to be identified through epidemiological investigations under Article 29 of the Act shall be as follows: |
| 1. | The personal information of persons showing adverse reactions to vaccinations; |
| 2. | The vaccination service institution, date of vaccination, and details of vaccination; |
| 3. | The record of medical treatment for adverse reactions to vaccinations; |
| 4. | The details of vaccines; |
| 5. | Other matters necessary to reveal the causes of adverse reactions to vaccinations. |
| Article 13 (Timing of Epidemiological Investigations) |
Epidemiological investigations specified in Articles 18 (1) and 29 of the Act shall be conducted, upon occurrence of the relevant ground classified as follows: <Amended on Jun. 28, 2016> | 1. | Where the Director of the Korea Centers for Disease Control and Prevention is required to conduct an epidemiological investigation: |
| (a) | Where the epidemiological investigation is to be conducted simultaneously in at least two Cities/Dos; |
| (b) | Where an urgent investigation is necessary, as to the outbreak or prevalence of an infectious disease or adverse reactions to vaccinations; |
| (c) | Where an epidemiological investigation conducted by a Mayor/Do Governor is deemed insufficient or it is deemed impracticable for a Mayor/Do Governor to conduct an epidemiological investigation; |
| 2. | Where a Mayor/Do Governor or the head of a Si/Gun/Gu (referring to an autonomous Gu; hereinafter the same shall apply) is required to conduct an epidemiological investigation: |
| (a) | Where an infectious disease is likely to occur and prevail within his/her jurisdiction; |
| (b) | Where an infectious disease is likely to occur and prevail outside his/her jurisdiction, but suspected to have an epidemiological link within his/her jurisdiction; |
| (c) | Where a case of an adverse reaction to a vaccination is found within his/her jurisdiction, thus making it necessary to conduct an investigation to identify the cause. |
| Article 14 (Methods of Epidemiological Investigation) |
The methods of conducting epidemiological investigations under Articles 18 (1) and 29 of the Act shall be as set forth in attached Table 1-3. <Amended on Jun. 28, 2016>
| Article 15 (Composition of Epidemiological Investigation Teams) |
| (1) | To conduct an epidemiological investigation under Articles 18 (1) and 29 of the Act, a central epidemiological investigation team shall be established in the Korea Centers for Disease Control and Prevention; a City/Do epidemiological investigation team in a City/Do; and a Si/Gun/Gu epidemiological investigation team in a Si/Gun/Gu (referring to an autonomous Gu; hereinafter the same shall apply). |
| (2) | The central epidemiological investigation team shall be comprised of at least 30 members; City/Do epidemiological investigation teams and Si/Gun/Gu epidemiological investigation teams, respectively, shall be comprised of not exceeding 20 members; and a disease control officer appointed under Article 60 of the Act or an epidemiological investigation officer appointed under Article 60-2 of the Act shall serve as the chief of each epidemiological investigation team. <Amended on Jan. 6, 2016> |
| (3) | Members of each epidemiological investigation team shall be appointed or commissioned by the Director of the Korea Centers for Disease Control and Prevention, a Mayor/Do Governor, or the head of a Si/Gun/Gu, respectively, from among the following: <Amended on Jan. 6, 2016> |
| 1. | Public officials who take charge of disease control, epidemiological investigations, or vaccination services; |
| 3. | Public health doctors employed under the Act on Special Measures for Health and Medical Services in Agricultural and Fishing Villages; |
| 5. | Other experts in the field of infectious diseases or similar. |
| (4) | Each epidemiological investigation team shall be divided into two sections covering the area of infectious diseases and the area of adverse reactions to vaccinations, and matters necessary to operate those sections shall be determined by the Director of the Korea Centers for Disease Control and Prevention. |
| Article 16 (Functions of Epidemiological Investigation Teams) |
| (1) | The functions of each epidemiological investigation team shall be as follows: |
| 1. | The central epidemiological investigation team: |
| (a) | Formulating, implementing, and evaluating an epidemiological investigation plan; |
| (b) | Developing the standards and methods for conducting epidemiological investigations; |
| (c) | Providing education and training for City/Do epidemiological investigation teams and Si/Gun/Gu epidemiological investigation teams; |
| (d) | Conducting epidemiological research on infectious diseases; |
| (e) | Collecting, analyzing, and providing for both the cases of outbreak and prevalence of infectious diseases and the cases of adverse reactions to vaccinations; |
| (f) | Providing technical guidance for and evaluation of City/Do epidemiological investigation teams; |
| 2. | City/Do epidemiological investigation teams: |
| (a) | Formulating, implementing, and evaluating an epidemiological investigation plan for each jurisdiction; |
| (b) | Developing detailed standards and methods for conducting epidemiological investigations in each jurisdiction; |
| (c) | Reporting the findings of epidemiological investigations in each jurisdiction, to the central epidemiological investigation team; |
| (d) | Collecting, analyzing, and providing for both the cases of outbreak and prevalence of infectious diseases, and for the cases of adverse reactions to vaccinations in each jurisdiction; |
| (e) | Providing technical guidance for and evaluation of Si/Gun/Gu epidemiological investigation teams; |
| 3. | Si/Gun/Gu epidemiological investigation teams: |
| (a) | Formulating and implementing an epidemiological investigation plan for each jurisdiction; |
| (b) | Reporting the findings of epidemiological investigations in each jurisdiction, to the relevant City/Do epidemiological investigation team; |
| (c) | Collecting, analyzing, and providing for both the cases of outbreak and prevalence of infectious diseases and the cases of adverse reactions to vaccinations in each jurisdiction. |
| (2) | Each epidemiological investigation team member who conducts an epidemiological investigation shall carry a certificate of epidemiological investigator prescribed by Ordinance of the Ministry of Health and Welfare, and produce it to interested parties. |
| (3) | The Director of the Korea Centers for Disease Control and Prevention, a Mayor/Do Governor, or the head of a Si/Gun/Gu may pay allowances and reimburse travel expenses incurred in epidemiological investigative activities, within budgetary limits, to epidemiological investigation team members. |
| Article 16-2 (Institutions or Organizations Required to Present Materials) |
“Institution or organization, etc. prescribed by Presidential Decree” in Article 18-4 (1) of the Act means the following: <Amended on Jun. 28, 2016> | 1. | A medical institution; |
[This Article Newly Inserted on Jan. 6, 2016]
| Article 16-3 (Extent of Request for Assistance) |
The Minister of Health and Welfare may request the head of a relevant central administrative agency to dispatch its personnel and provide goods necessary for conducting epidemiological investigations, to manage persons and institutions subject to epidemiological investigations, to conduct examinations and analyze information for identifying the source and route of infection, and provide other necessary assistance, pursuant to Article 18-4 (2) of the Act. [This Article Newly Inserted on Jan. 6, 2016]
| Article 17 Deleted. <Jun. 2, 2020> |
| Article 18 (Matters to Be Reported in Changing Permit for Introducing High-Risk Pathogens) |
“Minor matters prescribed by Presidential Decree” in the proviso of Article 22 (2) of the Act means the following: <Amended on Jun. 2, 2020> | 1. | The name, address and contact information of the person (limited to natural persons) permitted to introduce high-risk pathogens; |
| 2. | The name, address and contact information of the person (limited to legal persons) permitted to introduce high-risk pathogens and the name and contact address of the representative thereof; |
| 3. | The name, position and contact information of the manager who takes exclusive charge of high-risk pathogens. |
| Article 19 (Designation of Place to Acquire High-Risk Pathogens) |
A person who intends to acquire and transfer high-risk pathogens under Article 22 (3) of the Act, shall designate the place of acquisition from among those determined by the Minister of Health and Welfare.
| Article 19-2 (Permission for and Report on Establishment and Operation of High-Risk Pathogen Handling Facilities) |
| (1) | The classification of safety control grades of high-risk pathogen handling facilities under Article 23 (1) of the Act (hereinafter referred to as "high-risk pathogen handling facilities") as well as high-risk pathogen handling facilities subject to permission or reporting shall be as specified in attached Table 1-4. <Amended on Jun. 2, 2020> |
| (2) | The Minister of Health and Welfare shall determine and publicly notify the standards for permitting or accepting reports on the establishment and operation of high-risk pathogen handling facilities with regard to each of the following by safety control grade of high-risk pathogen handling facilities: <Amended on Jun. 2, 2020> |
| 1. | The types of high-risk pathogen handling facilities; |
| 2. | The equipment, personnel, and safety control necessary to inspect, possess, manage and transport high-risk pathogens; |
| 3. | The equipment, personnel, and safety control for facilities that can prevent harm to the human body during the process of inspecting, possessing, managing or transporting high-risk pathogens (hereinafter referred to as "facilities for preventing health harm"). |
| (3) | Any person who intends to establish and operate a high-risk pathogen handling facility subject to permission prescribed in Article 23 (2) of the Act and attached Table 1-4 shall submit an application for permission prescribed by Ordinance of the Ministry of Health and Welfare, along with the following documents, to the Minister of Health and Welfare: |
| 1. | Drawings and specifications of the high-risk pathogen handling facility or a copy thereof; |
| 2. | Documents certifying the scope of the high-risk pathogen handling facility, and the ownership or use rights thereto; |
| 3. | Basic drawings and specifications of a facility for preventing health harm, or a copy thereof; |
| 4. | Documents certifying compliance with the standards for permission prescribed in paragraph (2). |
| (4) | The Minister of Health and Welfare shall notify the applicant of whether permission is to be granted within 60 days from the date of receiving the application for permission referred to in paragraph (3). In such cases, when granting permission, the Minister of Health and Welfare shall issue a permit to establish and operate the high-risk pathogen handling facility prescribed by Ordinance of the Ministry of Health and Welfare. |
| (5) | Any person who intends to establish and operate a high-risk pathogen handling facility subject to reporting prescribed in Article 23 (2) of the Act and attached Table 1-4 shall submit a report prescribed by Ordinance of the Ministry of Health and Welfare, along with the following documents, to the Minister of Health and Welfare: |
| 1. | Documents certifying compliance with the standards for accepting reports prescribed in paragraph (2); |
| 2. | Documents prescribed in paragraph (3) 1 through 3. |
| (6) | The Minister of Health and Welfare shall notify the applicant of whether his/her report is to be accepted within 60 days from the date of receiving the report referred to in paragraph (5). In such cases, when accepting the report, the Minister of Health and Welfare shall issue a certificate of the report on establishing and operating the high-risk pathogen handling facility prescribed by Ordinance of the Ministry of Health and Welfare. |
[This Article Newly Inserted on Jun. 12, 2018]
| Article 19-3 (Permission for Changes to High-Risk Pathogens Handling Facilities) |
| (1) | Any person who intends to obtain permission for changes pursuant to the main sentence of Article 23 (3) of the Act shall submit an application for permission for changes prescribed by Ordinance of the Ministry of Health and Welfare, along with documents certifying the grounds and details of the relevant changes of permitted matters, to the Minister of Health and Welfare. |
| (2) | The Minister of Health and Welfare shall notify the applicant of whether permission for changes is to be granted within 60 days from the date of receiving the application for permission for changes referred to in paragraph (1). In such cases, when granting permission for changes, the Minister of Health and Welfare shall issue a permit for changes prescribed by Ordinance of the Ministry of Health and Welfare. |
| (3) | “Minor matters prescribed by Presidential Decree" in the proviso of Article 23 (3) of the Act means any of the following: |
| 1. | The name, address and contact information of a person who establishes and operates the high-risk pathogen handling facility (limited to natural persons); |
| 2. | The name, address and contact information of a person who establishes and operates the high-risk pathogen handling facility (limited to corporations), and the name and contact information of the representative thereof; |
| 3. | The name and address of a person responsible for establishing and operating the high-risk pathogen handling facility referred to in Article 19-6 (1) 1, a manager in the exclusive charge of high-risk pathogens, and a person responsible for biological safety control. |
| (4) | Any person who intends to report changes pursuant to the proviso of Article 23 (3) of the Act shall submit a report on changes of permitted matters prescribed by Ordinance of the Ministry of Health and Welfare to the Minister of Health and Welfare. |
| (5) | Upon receipt of a report on changes in permitted matters referred to in paragraph (4), the Minister of Health and Welfare shall issue a certificate of the report on changes prescribed by Ordinance of the Ministry of Health and Welfare. |
[This Article Newly Inserted on Jun. 12, 2018]
| Article 19-4 (Report on Changes to High-Risk Pathogen Handling Facilities) |
| (1) | Any person who intends to report changes pursuant to Article 23 (4) of the Act shall submit a report on changes prescribed by Ordinance of the Ministry of Health and Welfare to the Minister of Health and Welfare. |
| (2) | Upon receipt of a report on changes referred to in paragraph (1), the Minister of Health and Welfare shall issue a certificate of the report on changes prescribed by Ordinance of the Ministry of Health and Welfare. <Amended on Jun. 2, 2020> |
[This Article Newly Inserted on Jun. 12, 2018]
| Article 19-5 (Report on Closure of High-Risk Pathogen Handling Facilities) |
| (1) | Any person who intends to report the closure of a high-risk pathogen handling facility pursuant to Article 23 (5) of the Act shall submit a closure report prescribed by Ordinance of the Ministry of Health and Welfare, along with documents certifying the disposal of high-risk pathogens, to the Minister of Health and Welfare. |
| (2) | The Minister of Health and Welfare shall notify the reporter of whether his/her report is to be accepted within 10 days from the date of receiving the closure report referred to in paragraph (1). In such cases, when accepting the report, the Minister of Health and Welfare shall issue a certificate of the closure report prescribed by Ordinance of the Ministry of Health and Welfare. |
| (3) | Where the high-risk pathogen handling facility is closed pursuant to Article 23 (5) of the Act, the Minister of Health and Welfare shall determine and publicly notify the methods, procedures, etc. for closing the high-risk pathogen handling facility, such as disinfecting high-risk pathogen handling facilities and disposing of high-risk pathogens. |
[This Article Newly Inserted on Jun. 12, 2018]
| Article 19-6 (Safety Control Guidelines regarding Establishment and Operation of High-Risk Pathogen Handling Facilities) |
| (1) | “Safety control guidelines prescribed by Presidential Decree" in Article 23 (7) of the Act means the following: <Amended on Apr. 2, 2020; Jun. 2, 2020> |
| 1. | There shall be a person responsible for establishing and operating a high-risk pathogen handling facility, a manager in the exclusive charge of high-risk pathogens, and a person responsible for biological safety control; |
| 2. | He/she shall establish and operate a deliberative body composed of external experts, persons responsible for biological safety control, etc. at a high-risk pathogen handling facility in order to deliberate on matters related to safety control concerning the inspection, possession, management, and transport of high-risk pathogens; |
| 3. | Any high-risk pathogen shall be stored in a storage unit container indicating the relevant information, such as the name of high-risk pathogen, identification number including control number, and the date of manufacture, which shall be kept in a separate storage box or storage equipment with a locking device; |
| 4. | He/she shall operate a security system to control access to any area for handling or storing high-risk pathogens and to check the handling of high-risk pathogens; |
| 5. | Where he/she intends to use any high-risk pathogen after inactivating it (referring to treatment that permanently prevents its survival without disposing of it), he/she shall undergo deliberation by the deliberative body referred to in subparagraph 2; |
| 6. | He/she shall comply with the standards for granting permission and accepting reports prescribed in Article 19-2 (2). |
| (2) | Except as provided in paragraph (1), the details of safety control and matters pertaining to the composition, operation, etc. of the deliberative body referred to in paragraph (1) 2 shall be determined and publicly notified by the Minister of Health and Welfare. |
[This Article Newly Inserted on Jun. 12, 2018]
| Article 19-7 (Supplement of Documents Submitted for Permission for or Report on High-Risk Pathogen Handling Facilities) |
Where the Minister of Health and Welfare deems it necessary to supplement documents submitted for the purpose of obtaining permission for or reporting the establishment and operation of a high-risk pathogen handling facility pursuant to Article 19-2; obtaining permission for or reporting any change in permitted matters regarding the establishment and operation of a high-risk pathogen handling facility pursuant to Article 19-3; reporting any change of a high-risk pathogen handling facility pursuant to Article 19-4; or reporting the closure of a high-risk pathogen handling facility pursuant to Article 19-5, the Minister of Health and Welfare may require the submission of necessary documents for a specified period of not exceeding 30 days. In such cases, the period for submitting additional documents shall not be counted in determining the period prescribed in Article 19-2 (4) or (6), 19-3 (2), or 19-5 (2). [This Article Newly Inserted on Jun. 12, 2018]
| Article 19-8 (Matters Requiring Follow-Up Permission for Possessing Infectious Pathogens Spread through Bioterrorism) |
"Unavoidable cause prescribed by Presidential Decree" in the proviso of Article 23-3 (1) of the Act means any of the following cases where there is no intention to separate infectious pathogens spread through bioterrorism (hereinafter referred to as "infectious pathogens spread through bioterrorism") referred to in the main clause of the same paragraph: | 1. | Where the infectious pathogens spread through bioterrorism are separated in the process of diagnosing diseases of patients of an infectious disease, etc. and is possessed; |
| 2. | Where the infectious pathogens spread through bioterrorism are separated in the process of diagnosing diseases of animals or plants and is possessed; |
| 3. | Where the infectious pathogens spread through bioterrorism are separated from environmental specimens such as food or soil and is possessed. |
[This Article Newly Inserted on Jun. 2, 2020]
| Article 19-9 (Matters to Be Reported regarding Changes in Permission for Possessing Infectious Pathogens Spread through Bioterrorism) |
| 1. | The name, address and contact information of a person (limited to natural persons) who obtains permission for possessing pathogens of infectious disease spread through bioterrorism; |
| 2. | The name, address and contact information of a person (limited to legal persons) who obtains permission for possessing pathogens of infectious disease spread through bioterrorism and the name and contact information of the representative thereof; |
| 3. | The name, position and contact information of the manager who takes exclusive charge of high-risk pathogens. |
[This Article Newly Inserted on Jun. 2, 2020]
| Article 20 (Entrustment of Vaccination Services) |
| (1) | A Special Self-Governing Province Governor or the head of a Si/Gun/Gu may entrust vaccination services beyond the capability of public health centers or for residents, etc. having difficulty visiting public health centers, under Articles 24 (2) and 25 (2) of the Act, to medical institutions designated by the Special Self-Governing Province Governor or the head of the Si/Gun/Gu, from among general hospitals, hospitals, convalescent hospitals (limited to those in which medical services are rendered by physicians), and medical clinics specified in Article 3 of the Medical Service Act. In such cases, the Special Self-Governing Province Governor or the head of the Si/Gun/Gu shall publicly announce the institutions so entrusted. |
| (2) | When entrusting vaccination services under paragraph (1), the Special Self-Governing Province Governor or the head of the Si/Gun/Gu shall prepare an entrustment contract providing for each of the following: <Newly Inserted on Jan. 6, 2015> |
| 1. | The scope of the vaccination services entrusted; |
| 2. | The period for the entrustment contract; |
| 3. | The terms and conditions of the entrustment contract; |
| 4. | The cancellation of the entrustment contract. |
| (3) | Matters necessary for the procedures, etc. for calculating and refunding vaccination expenses incurred in relation to vaccination services entrusted under paragraph (1), shall be determined and publicly announced by the Minister of Health and Welfare. <Amended on Jan. 6, 2015> |
| Article 20-2 (Pre-Checking of Vaccination Records) |
The director of each public health center that provides vaccination services under Articles 24 (1) and 25 (1) of the Act and the head of each medical institution entrusted with vaccination services under Article 24 (2) (including where the said Article applies mutatis mutandis in Article 25 (2) of the Act) of the Act (hereinafter referred to as the "director of each public health center, etc.") shall obtain written consent from those who intend to be vaccinated or from their legal representatives on the following matters under the main clause of Article 26-2 (1) of the Act: | 1. | The fact that they have confirmed the details of the vaccination; |
| 2. | The method of confirming the details of the vaccination. |
[This Article Newly Inserted on Jun. 28, 2016]
| Article 21 (Organization of Vaccination Injury Investigation Teams) |
| (1) | A vaccination injury investigation team prescribed under Article 30 (2) of the Act (hereinafter referred to as “injury investigation team”) shall be comprised of not exceeding 10 members. |
| (2) | Members of the injury investigation team shall be appointed or commissioned by the Director of the Korea Centers for Disease Control and Prevention, from among public officials under his/her control or from among the following: |
| 1. | Experts in the field of vaccination and adverse reactions to vaccinations; |
| (3) | The injury investigation team shall investigate the following matters and report the findings therefrom to the advisory committee on vaccination injury compensation: |
| 1. | The evaluation and supplementation of the findings of a basic investigation submitted by a Mayor/Do Governor under Article 31 (2); |
| 3. | Other matters determined by the advisory committee on vaccination injury compensation in relation to vaccination injury compensation. |
| (4) | An injury investigation team member who conducts an injury investigation under paragraph (3), shall carry a certificate of vaccination injury investigator prescribed by Ordinance of the Ministry of Health and Welfare, and produce it to interested parties. |
| (5) | The Director of the Korea Centers for Disease Control and Prevention may pay allowances and reimburse travel expenses incurred in conducting injury investigations, within budgetary limits, to injury investigation team members. |
| (6) | Detailed matters for operating the injury investigation team shall be determined by the Director of the Korea Centers for Disease Control and Prevention, following a resolution by the advisory committee on vaccination injury compensation. |
| Article 21-2 (Personal Information of Persons Eligible for Vaccination) |
| (1) | The personal information details of those eligible for vaccination which the Minister of Health and Welfare may request from the relevant institutions and organizations under Article 33-4 (2) 1 of the Act, are as follows: <Amended on Jun. 12, 2018; Jun. 2, 2020> |
| 1. | Where a person eligible for vaccination is a national: The following materials: |
| (a) | The name, resident registration number and address of a person eligible for vaccination; |
| (b) | The following details on to which a person eligible for vaccination belongs: |
| (c) | The following details of a person eligible for vaccination: |
| (iii) | Whether a person eligible for vaccination is a recipient prescribed in subparagraph 2 of Article 2 of the National Basic Living Security Act (including persons of the second lowest income bracket prescribed in subparagraph 10 of the same Article) or a child of such recipient; |
| 2. | Where a person eligible for vaccination is a foreigner or a foreign nationality Korean: The following materials: |
| 3. | Other information on the personal information of those eligible for vaccination, which the Minister of Health and Welfare publicly announces in recognition that such information is particularly necessary in connection with conducting vaccination. |
| (2) | Materials the Minister of Health and Welfare may request from the relevant institutions and organizations as materials necessary for vaccination under Article 33-4 (2) 3 of the Act are as follows: <Amended on Jun. 2, 2020> |
| 2. | The details of a request for compensation for damage caused by vaccination; |
| 3. | Information on the control, etc. of diseases or illness, or infectious diseases for which vaccination is impracticable. |
[This Article Newly Inserted on Jun. 28, 2016]
| Article 21-3 (Input of Vaccination Information) |
Where the director of a public health center, etc. provides a vaccination service, he/she shall, without delay, input the following information into the Integrated Vaccination Management System prescribed in Article 33-4 (1) of the Act (hereinafter referred to as the "integrated management system") pursuant to Article 33-4 (3) of the Act: <Amended on Jun. 2, 2020> | 1. | The following information on persons vaccinated: |
| (b) | Resident registration number: Provided, That where the person vaccinated is a foreigner or a foreign nationality Korean, it refers to the foreigner registration number or the domestic residence report number; |
| 2. | The following information on the details of vaccination: |
| (b) | Number of vaccination; |
| (c) | Date/month/year of vaccination; |
| (d) | Name of the vaccine used in vaccination; |
| (e) | Names of the physician who made a preliminary diagnosis and the physician who vaccinated. |
[This Article Newly Inserted on Jun. 28, 2016]
| Article 21-4 (Provision of Details of Vaccination) |
| (1) | Where the Minister of Health and Welfare provides the parents of children eligible for vaccination with the details of the vaccination under the former part of Article 33-4 (4) of the Act, he/she shall do so by the method of reading by utilizing the integrated management system: Provided, That where the Minister of Health and Welfare deems it necessary, such details may be provided by text message, electronic mail, telephone, mail or other methods equivalent thereto. <Amended on Jun. 2, 2020> |
| (2) | Where the Minister of Health and Welfare issues a certificate of vaccination under the former part of Article 33-4 (4) of the Act, he/she may issue such certificate directly from the integrated management system as prescribed by the Minister of Health and Welfare or issue such certificate through an electronic civil petition window prescribed in Article 9 (3) of the Electronic Government Act. <Amended on Jun. 2, 2020> |
[This Article Newly Inserted on Jun. 28, 2016]
| Article 22 (Procedures for Formulating Crisis Control Measures against Infectious Diseases) |
| (2) | The Minister of Health and Welfare shall notify the heads of the relevant central administrative agencies of the crisis control measures against infectious diseases formulated under Article 34 (1) of the Act. |
| Article 23 (Methods and Procedures for Treatment and Quarantine) |
[Title of This Article Amended on Jun. 2, 2020]
| Article 23-2 (Providing Subsidies for Costs for Paid Leave) |
| (1) | Subsidies for paid leave provided to employers under Article 41-2 (3) of the Act shall be in the amount calculated by multiplying the amount the Minister of Health and Welfare publicly notifies in consultation with the Minister of Economy and Finance by the period during which an employee is hospitalized, quarantined, or isolated under the Act. |
| (2) | An employer who intends to be subsidized under Article 41-2 (3) of the Act shall file a written application (including written applications in electronic documents) prescribed by Ordinance of the Ministry of Health and Welfare with the Minister of Health and Welfare along with the following documents (including electronic documents): |
| 1. | Documents verifying the fact that an employee is hospitalized, quarantined, or isolated and the period of such hospitalization, quarantine, or isolation; |
| 2. | Documents evidencing that an employee continues to hold office, such as proof of employment; |
| 3. | Documents evidencing that the employer has given a paid leave to the relevant employee, such as a pay slip; |
| 4. | Other documents deemed particularly necessary by the Minister of Health and Welfare to provide subsidies for paid leave. |
| (3) | Where the Minister of Health and Welfare receives a written application prescribed in paragraph (2), he/she shall verify the certificate of business registration through administrative data matching prescribed in Article 36 (1) of the Electronic Government Act: Provided, That where the relevant employer disagrees therewith, he/she shall require the relevant employer to attach such certificate to the written application. |
| (4) | Where the Minister of Health and Welfare receives a written application prescribed in paragraph (2), he/she shall determine whether to grant subsidies for paid leave and the amount of subsidies and inform the relevant employer thereof in writing. |
| (5) | Except as provided in paragraphs (2) through (4), matters necessary for procedures for applying for subsidies for paid leave, notification of the results thereof, etc. shall be prescribed by Ordinance of the Ministry of Health and Welfare. |
[This Article Newly Inserted on Jun. 28, 2016]
| Article 23-3 (Designation of Infectious Disease Control Institutions for Quarantine or Isolation of Patients of Infectious Diseases) |
| (1) | An institution eligible to be designated as an infectious disease control institution to take charge of the investigation, diagnosis, quarantine or isolation, treatment, etc. of patients of infectious diseases, etc. under Article 42 (4) and (7) of the Act shall be an infectious disease control institution having single-occupancy hospital rooms (referring to hospital rooms with anterooms and negative pressure facilities) for patients of infectious diseases, etc., from among infectious disease control institutions designated under Article 36 (1) and (2) of the Act (hereinafter referred to as "infectious disease control institution"). <Amended on Apr. 2, 2020; Jun. 2, 2020> |
| (2) | Where the Minister of Health and Welfare, a Mayor/Do Governor, or the head of a Si/Gun/Gu designates an infectious disease control institution for conducting examination, medical diagnosis, quarantine or isolation, and treatment under Article 42 (11) of the Act, he/she shall consider the findings of evaluation of infectious disease control facilities prescribed in Article 39-2 of the Act. <Amended on Apr. 2, 2020> |
| (3) | Where the Minister of Health and Welfare, a Mayor/Do Governor, or the head of a Si/Gun/Gu designates an infectious disease control institution for conducting examination, medical diagnosis, quarantine or isolation, and treatment under Article 42 (11) of the Act, he/she shall issue a certificate of designation, as prescribed by the Minister of Health and Welfare. <Amended on Apr. 2, 2020> |
[This Article Newly Inserted on Jun. 28, 2016]
| Article 24 (Facilities Requiring Disinfection) |
Facilities that require disinfection necessary for preventing infectious diseases under Article 51 (3) of the Act, shall be as follows: <Amended on Dec. 8, 2011; Jul. 7, 2014; Jan. 6, 2015; Jan. 19, 2016; Jun. 28, 2016; Aug. 11, 2016; Mar. 29, 2017; Jun. 2, 2020> | 6. | Meal service facilities (limited to those capable of providing meals continuously for at least 100 persons simultaneously) specified in subparagraph 12 of Article 2 of the Food Sanitation Act; |
| 8. | Performance halls (limited to those with a seating capacity of at least 300) specified in the Public Performance Act; |
| 11. | Office buildings and multiple-purpose buildings with a total floor area of at least 2,000 square meters; |
[Title of This Article Amended on Jun. 2, 2020]
| Article 25 (Eligibility to Become Disease Control Officers and Duties) |
| (1) | Disease control officers specified in Article 60 (1) of the Act shall be appointed from among public officials of at least Grade IV with substantial experience in a field related to infectious diseases: Provided, That disease control officers of each Si/Gun/Gu may be appointed, from among public officials of at least Grade V with substantial experience in a field related to infectious diseases. <Amended on Jan. 6, 2016> |
| (2) | In addition to the authority to take measures specified in Article 60 (3) of the Act, each disease control officer shall have the authority to take the following measures in the outbreak area of an infectious disease: <Amended on Jan. 6, 2016; Jun. 2, 2020> |
| 1. | Hospitalizing or quarantining persons suspected of contracting an infectious disease for a certain period at an appropriate place; |
| 2. | Disinfecting places or buildings contaminated by the infectious pathogens, or taking other necessary measures; |
| 3. | Issuing orders to prohibit laundering at certain places or to handle wastes at designated places; |
| 4. | Taking measures to prevent zoonoses, against persons who have involved in slaughter or persons, etc. exposed to zoonoses. |
| (3) | Deleted. <Jan. 6, 2016> |
| Article 26 (Qualifications for and Duties of Epidemiological Investigation Officers) |
| (1) | Deleted. <Jan. 6, 2016> |
| (2) | Each epidemiological investigation officer shall perform the following duties: |
| 1. | Formulating epidemiological investigation plans; |
| 2. | Conducting, and analyzing the findings of, epidemiological investigations; |
| 3. | Developing the criteria and methods for conducting epidemiological investigations; |
| 4. | Providing technical guidance on epidemiological investigations; |
| 5. | Providing education and training on epidemiological investigations; |
| 6. | Conducting epidemiological research on infectious diseases. |
| (3) | Deleted. <Jan. 6, 2016> |
| (4) | The Minister of Health and Welfare and Mayors/Do Governors may pay research expenses and reimburse travel expenses to epidemiological investigation officers, within budgetary limits. |
| Article 26-2 (Ordering Medical Personnel to Perform Disease Control Duties) |
| (1) | Where the Minister of Health and Welfare or a Mayor/Do Governor issues an order to perform disease control duties under Article 60-3 (1) of the Act, he/she shall issue a certificate of order to perform disease control duties. In such cases, the relevant certificate of order shall include the institution to perform disease control duties, period of performing disease control duties, disease control duties to be performed, etc. |
| (2) | The period of performing disease control duties prescribed in Article 60-3 (1) of the Act shall not exceed 30 days: Provided, That where the person in question agrees in writing in advance, such period may be determined otherwise. |
| (3) | Where the Minister of Health and Welfare or a Mayor/Do Governor extends the period of performing disease control duties prescribed in paragraph (2), he/she shall obtain written consent from the person in question before the relevant period of performing disease control duties expires. In such cases, the period to be extended shall not exceed 30 days, on condition that where the person in question agrees, the period to be extended may be determined otherwise. |
| (4) | Where the Minister of Health and Welfare or a Mayor/Do Governor extends the period of performing disease control duties under paragraph (3), he/she shall issue a new certificate of order to perform disease control duties. |
[This Article Newly Inserted on Jun. 28, 2016]
| Article 26-3 (Appointment of Disease Control Officers) |
| (1) | Where the Minister of Health and Welfare appoints a disease control officer under Article 60-3 (2) of the Act, he/she shall issue a certificate of appointment. In such cases, the relevant certificate of appointment shall include the period for conducting duties. <Amended on Jun. 2, 2020> |
| (2) | Where the Minister of Health and Welfare, a Mayor/Do Governor or the head of a Si/Gun/Gu appoints an epidemiological investigation officer under Article 60-3 (3) of the Act, he/she shall issue a certificate of appointment. In such cases, the relevant certificate of appointment shall include the period for conducting duties. <Newly Inserted on Jun. 2, 2020> |
| (3) | Article 26-2 (2) through (4) shall apply mutatis mutandis to periods for conducting duties, extension of periods for conducting duties, issuance of certificates of appointment following the extension of periods for conducting duties, etc. of disease control officers and epidemiological investigation officers. <Newly Inserted on Jun. 2, 2020> |
[This Article Newly Inserted on Jun. 28, 2016]
| Article 27 (Ratio of Subsidy on Part of Cities/Dos) |
The amount of expenses subsidized by a City/Do (excluding a Special Self-Governing Province) under Article 66 of the Act shall be 2/3 of the amount to be borne by Sis/Guns/Gus.
| Article 28 (Objects and Scope of Compensation for Loss) |
| (1) | Objects and scope of compensation for loss prescribed in Article 70 (1) of the Act are as prescribed in attached Table 2-2. |
| (2) | If necessary to calculate the amount of compensation for loss under Article 70 (1) of the Act, the Compensation Deliberation Committee prescribed in Article 70-2 (1) of the Act (hereinafter referred to as the "Deliberation Committee") may have specialized institutions or experts in the relevant areas appraise, evaluate, investigate, etc. the subject-matter of the loss. |
| (3) | Where the Deliberation Committee calculates compensation for the loss in Article 70 (1) 1 through 3 of the Act, it shall consider the annual average revenue, business profits, etc. of the relevant medical institution. |
[This Article Wholly Amended on Jun. 28, 2016]
| Article 28-2 (Exclusion from Payment and Standards for Reducing Compensation for Loss) |
| (1) | The types of misconduct for which compensation for the loss shall not be paid or curtailed on the ground of violating the duty to take measures prescribed by this Act or by the relevant statutes or regulations, under Article 70 (3) of the Act, are as follows: |
| 1. | Neglecting or interfering with reporting prescribed in Article 11 of the Act or making such report falsely; |
| 2. | Neglecting the obligation to report prescribed in Article 12 of the Act or interference with reporting of persons obligated to report prescribed in the subparagraphs of paragraph (1) of the same Article; |
| 7. | Violating the duties to make measures the Minister of Health and Welfare publicly announces in recognition that such duties are particularly important among statutory duties to take measures. |
| (2) | Where compensation for loss is not paid or curtailed under Article 70 (3) of the Act, such non-payment or curtailed amount shall be based on whether the misconduct in the subparagraphs of paragraph (1) is directly related to the occurrence or expansion of the loss and whether such misconduct is a major cause of the loss. |
| (3) | Where the Deliberation Committee recognizes the existence of the causal relationship between the misconduct in the subparagraphs of paragraph (1) and the occurrence or expansion of loss under paragraph (2), it shall consider the motives for, details, nature, type, etc. of, the relevant misconduct comprehensively. |
| (4) | The Minister of Health and Welfare shall determine and publicly announce detailed matters necessary for exclusion from payment, standards for payment in reduced amounts, etc. of compensation for loss prescribed in paragraphs (2) and (3). |
[This Article Newly Inserted on Jun. 28, 2016]
| Article 28-3 (Composition and Operation of the Compensation Deliberation Committee) |
| (1) | Members of the Deliberation Committee established in the Ministry of Health and Welfare shall be appointed or commissioned by the Minister of Health and Welfare, from among the following persons duly considering gender: |
| 1. | Persons recommended by medical personnel organizations and medical institution organizations established under the Medical Service Act, and by the Korean Pharmaceutical Association and the Association of Korean Oriental Pharmacy established under the Pharmaceutical Affairs Act; |
| 3. | Persons recommended by the President of the National Health Insurance Service or by the President of the Health Insurance Review and Assessment Service under the National Health Insurance Act; |
| 4. | Persons holding office or have held office in the position of at least associate professor or in a position equivalent thereto at health and medical services-related departments of universities prescribed in the Higher Education Act; |
| 5. | Persons with considerable knowledge and experience in the prevention and control of infectious diseases; |
| 6. | Persons with considerable knowledge and experience in compensation for loss; |
| 7. | Members of the Senior Executive Service in charge of policies for health and medical services. |
| (2) | The term of office of commissioned members prescribed in paragraph (1) 1 through 6 shall be three years: Provided, That the term of office of members newly commissioned resulting from the dismissal, etc. of another member shall be their predecessor’s remaining term of office. |
| (3) | Where a commissioned member of the Deliberation Committee under paragraph (1) falls under any of the following cases, the Minister of Health and Welfare may dismiss the relevant commissioned member: |
| 1. | Where a commissioned member of the Deliberation Committee becomes unable to perform his/her duties due to mental or physical disability; |
| 2. | Where a commissioned member of the Deliberation Committee engages in any misconduct in connection with his/her duties; |
| 3. | Where a commissioned member of the Deliberation Committee is deemed unsuitable as a member due to neglect of a duty, loss of dignity, or any other reason; |
| 4. | Where a commissioned member of the Deliberation Committee voluntarily expresses that he/she has difficulties in performing his/her duties. |
| (4) | The Chairperson of the Deliberation Committee prescribed in paragraph (1) shall represent the Deliberation Committee and exercise general supervision over its affairs. |
| (5) | Meetings of the Deliberation Committee prescribed in paragraph (1) shall be convened at the request of a majority of members registered or when the Chairperson of the Deliberation Committee deems necessary, and the Chairperson of the Deliberation Committee shall preside over such meetings. |
| (6) | A majority of the members of the Deliberation Committee prescribed in paragraph (1) shall constitute a quorum at all its meetings, and any decision thereof shall require the concurring vote of at least a majority of those present. |
| (7) | To efficiently conduct affairs, the Deliberation Committee prescribed in paragraph (1) may have advisory committees organized by experts of the relevant areas. |
| (8) | Except as provided in paragraphs (1) through (7), matters necessary for the composition, operation, etc. of the Deliberation Committee prescribed in paragraph (1) and advisory committees shall be determined by the Chairperson of the Deliberation Committee through resolutions by the Deliberation Committee. |
| (9) | Paragraphs (1) through (8) shall apply mutatis mutandis to the composition, operation, etc. of Deliberation Committees established in Cities/Dos under Article 70-2 (1) of the Act. In such cases, "Minister of Health and Welfare" shall be construed as "Mayor/Do Governor.” |
[This Article Newly Inserted on Jun. 28, 2016]
| Article 28-4 (Subsidization to Medical Personnel or Founders of Medical Institutions) |
| (1) | The Minister of Health and Welfare, a Mayor/Do Governor, or the head of a Si/Gun/Gu may subsidize expenses, such as allowances and travel expenses, to the medical personnel or founders of medical institutions which have rendered assistance for the surveillance, prevention, control, or epidemiological investigation of infectious diseases under Article 70-3 (1) of the Act. |
| (2) | Any person who intends to receive subsidization prescribed in paragraph (1) shall file an application therefor with the Minister of Health and Welfare, the competent Mayor/Do Governor, or the head of the competent Si/Gun/Gu along with materials evidencing that he/she has rendered assistance for the surveillance, prevention, control, or epidemiological investigation of infectious diseases. |
| (3) | Upon receipt of an application for subsidization prescribed in paragraph (2), the Minister of Health and Welfare, the competent Mayor/Do Governor, or the head of the competent Si/Gun/Gu shall determine whether to grant subsidization, items of subsidization, amount of subsidization, etc. and inform the applicant thereof. |
[This Article Newly Inserted on Jun. 28, 2016]
| Article 28-5 (Livelihood Assistance for Patients of Infectious Diseases) |
The Minister of Health and Welfare, a Mayor/Do Governor, or the head of a Si/Gun/Gu may provide the following subsidies under Article 70-4 (1) of the Act: Provided, That no subsidies prescribed in subparagraph 2 shall be provided where paid leave is granted under Article 41-2 (1) of the Act: | 1. | Medical costs and hospitalization costs: The medical costs and hospitalization costs to be borne by the person in question: Provided, That costs prescribed by the Minister of Health and Welfare, such as costs excluded from costs eligible to be covered by medical care benefits prescribed by the National Health Insurance Act, shall be excluded; |
| 2. | Costs for supporting livelihood: The amount publicly notified by the Minister of Health and Welfare after consulting with the Minister of Economy and Finance. |
[This Article Newly Inserted on Jun. 28, 2016]
| Article 29 (Compensation Standards for Injuries Caused by Vaccination) |
Standards for paying compensation and deadline for application under Article 71 (1) of the Act shall be as follows: <Amended on Jan. 6, 2015; May 29, 2017; Sep. 18, 2018; Jul. 9, 2019; Jun. 2, 2020> | (a) | Standards for payment: The balance of the medical expenses for a disease contracted by an injury resulting from vaccination, less the amount borne or paid by an insurer under the National Health Insurance Act, or less the amount borne by the medical care fund under the Medical Care Assistance Act: Provided, That when the lump-sum compensation is paid under subparagraph 3, no medical expenses shall be paid; |
| (b) | Deadline for application: within five years from the day the injury resulting from vaccination occurs; |
| 2. | Nursing expenses: 50,000 won per day only for inpatient treatment; |
| 3. | Lump-sum compensation for those who become disabled: |
| (a) | Standards for payment: |
| (b) | Deadline for application: Within five years from the day of disability diagnosis; |
| 4. | Lump-sum compensation for a person who died: |
| (a) | Standards for payment: An amount equivalent to the monthly minimum wage prescribed under the Minimum Wage Act as at the time of death, multiplied by 240; |
| (b) | Deadline for application: Within five years from the day of death; |
| 5. | Funeral expenses: 300,000 won. |
| Article 30 (Persons Eligible for Compensation for Injuries Caused by Vaccination) |
| (2) | “Bereaved family members prescribed by Presidential Decree” in Article 71 (1) 3 of the Act means the spouse (including a person in a de facto marital relationship), children, parents, grandsons and granddaughters, grandparents, and siblings. |
| (3) | The priority order of bereaved family members shall coincide with the order listed in paragraph (2), excluding those to whom the compensation cannot be provided due to missing, etc.; and if at least two bereaved family members are in the same order of priority, the lump-sum compensation for death shall be apportioned equally among them. |
| Article 31 (Compensation Procedures for Injuries Caused by Vaccination) |
| (1) | Any person who intends to receive compensation under Article 71 (1) of the Act shall submit a written claim for compensation to the competent Special Self-Governing Province Governor or head of Si/Gun/Gu, along with a document evidencing his/her injury, as prescribed by Ordinance of the Ministry of Health and Welfare. |
| (2) | The head of a Si/Gun/Gu shall submit documents received under paragraph (1) (hereinafter referred to as “claim documents for injury compensation”) to the competent Mayor/Do Governor, and the Mayor/Do Governor in receipt of the claim documents for injury compensation or the Special Self-Governing Province Governor in receipt of the claim documents for injury compensation under paragraph (1), shall forward the claim documents for injury compensation without delay to the Minister of Health and Welfare, along with the findings of basic investigation conducted by him/her regarding the injury that has resulted from vaccination and the statement of his/her views thereon. |
| (3) | The Minister of Health and Welfare shall determine whether to provide compensation after gather consensus from the advisory committee on vaccination injury compensation and notify the relevant Mayor/Do Governor of the determination, and the Mayor/Do Governor (excluding a Special Self-Governing Province Governor) shall notify the head of the relevant Si/Gun/Gu thereof. In such cases, the Special Self-Governing Province Governor or the head of the Si/Gun/Gu so notified shall notify the relevant claimant for compensation under paragraph (1) of the details of the determination. <Amended on Jan. 6, 2015> |
| (4) | The Minister of Health and Welfare shall pay a person determined eligible for compensation under paragraph (3) the amount of compensation under the compensation standards under Article 29. |
| (5) | Except as provided in this Decree, matters necessary for the procedures and methods for deliberation on compensation for injuries caused by vaccination shall be determined by the Minister of Health and Welfare. |
| Article 32 (Delegation of Authority and Entrustment of Duties) |
| (1) | The Minister of Health and Welfare shall delegate the following authority to the Director of the Korea Centers for Disease Control and Prevention, pursuant to Article 76 (1) of the Act: <Amended on Jan. 6, 2015; Jan. 6, 2016; Jun. 28, 2016; Jun. 12, 2018; Jun. 2, 2020> |
| 1. | The following affairs concerning the organization for supporting infectious disease control projects established in the Ministry of Health and Welfare under Article 8 (1) of the Act: |
| (a) | Affairs concerning commissioning members prescribed in Article 1-2 (2); |
| (b) | Affairs concerning reporting prescribed in Article 1-2 (4); |
| (c) | Affairs concerning providing subsidies prescribed in Article 1-2 (5); |
| 3. | Affairs concerning reporting by a Special Self-Governing Province Governor or the head of a Si/Gun/Gu under Article 13 of the Act; |
| 4. | Affairs concerning the sentinel surveillance, etc. of infectious diseases conducted under Article 16 of the Act; |
| 4-2. | Affairs concerning the evaluation and management of the laboratory testing capability of institutions for confirming infectious pathogens prescribed in Article 16-2 of the Act; |
| 5-4. | Affairs concerning submitting materials necessary for epidemiological investigation and affairs concerning requests for providing assistance, such as dispatching personnel for conducting epidemiological investigation, which are prescribed in Article 18-4 (1) and (2) of the Act; |
| 5-5. | Affairs concerning funerals for the dead bodies of patients of infectious diseases, etc. prescribed in Article 20-2 of the Act; |
| 6. | Affairs concerning extraction, sale, transfer and reporting on transfer of high-risk pathogens under Article 21 of the Act; |
| 8. | Affairs concerning permission for or reports on the establishment and operation of high-risk pathogen handling facilities, permission for changes, reports on changes, reports on closure, and safety control prescribed in Article 23 of the Act; |
| 8-2. | Affairs concerning revocation of permission for high-risk pathogen handling facilities prescribed in Article 23-2 of the Act, an order for closure, and an order for suspension of operation; |
| 8-3. | Affairs concerning permission for possessing infectious pathogens spread through bioterrorism, permission for modification and reporting on modification prescribed in Article 23-3 of the Act; |
| 11. | Affairs concerning Vaccination Week, standards for conducting vaccinations, etc. specified under Article 32 of the Act; |
| 12. | Affairs concerning the planned production of vaccines, provision of subsidies, and reimbursement of expenses under Article 33 of the Act; |
| 12-2. | Affairs concerning the preemptive measures of stockpiling vaccines used for the mandatory vaccination services referred to in Article 24 of the Act and the special vaccination services referred to in Article 25 of the Act(hereinafter referred to as “mandatory vaccines, etc.”) and concluding a contract for purchases thereof pursuant to Article 33-2 of the Act; |
| 12-3. | Affairs concerning reporting on plans for producing or importing mandatory vaccines, etc. under Article 33-3 of the Act; |
| 12-4. | Affairs concerning establishing and operating the integrated management system; collecting, managing and keeping materials; requesting submission of materials; providing details of vaccination; issuing certificates of vaccination; and requesting for materials from the head of the National Court Administration, which are prescribed in Article 33-4 (1), (2) and (4) of the Act; |
| 12-5. | Affairs concerning the disclosure of information, filing objections, and necessary measures at the time of an infectious disease emergency under Article 34-2 of the Act; |
| 13. | Affairs concerning designating, subsidizing, etc. infectious disease control institutions under Article 36 of the Act and establishing, etc. infectious disease control institutions as at the time of infectious disease emergencies under Article 37 of the Act; |
| 14. | Affairs concerning the stockpiling of, conclusion of contracts for, requirement for production of, and epidemiological investigations into, medicines and equipment for infectious diseases, etc. spread by biological terrorism under Article 40 of the Act; |
| 14-2. | Affairs concerning the distribution standards including priorities in supplying medicines stockpiled and produced in preparation for a pandemic of infectious diseases and other necessary matters prescribed in Article 40-2 of the Act; |
| 16. | Affairs concerning making compulsory dispositions with respect to infectious diseases under Article 42 of the Act; |
| 17-2. | Affairs concerning measures to conduct medical examinations, vaccinations, etc. under Article 46 of the Act; |
| 17-3. | Affairs concerning measures to prevent the prevalence or spread of an infectious disease upon the outbreak of the infectious disease under Article 47 of the Act; |
| 18-2. | Affairs concerning orders for conducting disease control duties, and appointment and management of disease control officers and epidemiological investigation officers prescribed in Article 60-3 (1) through (3) of the Act; |
| 19-2. | Administrative affairs concerning medical costs, livelihood assistance and providing subsidies prescribed in Article 70-4 (1) of the Act; |
| 20. | Affairs concerning compensation by the State for injuries caused by vaccinations, etc. under Article 71 of the Act; |
| 20-2. | Affairs concerning requests for location information; providing information collected; and information and notification of destruction of information provided by persons provided with such information prescribed in Article 76-2 (2) through (4), (6), and (7) of the Act; |
| 20-3. | Affairs concerning designation of place to acquire under Article 19; |
| 20-4. | Affairs concerning public notification of the standards for permitting or accepting reports on the establishment and operation of high-risk pathogen handling facilities under Article 19-2 (2); |
| 20-5. | Affairs concerning public notification of procedures, etc. for calculating and refunding vaccination expenses in cases where vaccination services are entrusted under Article 20 (3); |
| 20-6. | Affairs concerning public notification of lump-sum compensation under subparagraph 3 (a) (iii) of Article 29. |
| (2) | The Minister of Health and Welfare may entrust the duties provided for in Article 4 (2) 4 through 9, 14 through 17, and Article 70 of the Act to any of the following entities, pursuant to Article 76 (2) of the Act: <Newly Inserted on Jan. 6, 2015; Jan. 6, 2016; Jun. 2, 2020> |
| 3. | Non-profit corporations established under the Civil Act or other Acts to conduct affairs concerning the prevention and control of infectious diseases; |
| 4. | Other institutions or organizations deemed by the Minister of Health and Welfare to have expertise in the prevention and control of infectious diseases. |
| (3) | Where the Minister of Health and Welfare entrusts duties pursuant to paragraph (2), he/she shall publicly announce the entities and details of duties entrusted. <Newly Inserted on Jan. 6, 2015> |
[Title Amended on Jan. 6, 2015]
| Article 32-2 (Information Requestable to be Provided) |
[This Article Newly Inserted on Jan. 6, 2016]
[Previous Article 32-2 Moved to Article 32-3 <Jan. 6, 2016>]
| Article 32-3 (Processing Sensitive Information and Personally Identifiable Information) |
| 1. | Affairs concerning the medical treatment and protection of patients of infectious diseases, etc. under Article 4 (2) 2 of the Act; |
| 3. | Affairs concerning international cooperation for the exchange, etc. of infectious disease control information under Article 4 (2) 9 of the Act. |
| (2) | The Minister of Health and Welfare, the Director of the Korea Centers for Disease Control and Prevention, the Mayors/Do Governors, the heads of Sis/Guns/Gus (including any medical institution entrusted with vaccination services by the head of a Si/Gun/Gu under Article 20), the directors of public health centers, or the institutions of sentinel surveillance of infectious diseases designated under Article 16 (1) of the Act may process data containing personal information prescribed in paragraph (1), with the exception of its subparagraphs, if essential to conduct the following: <Amended on Jun. 28, 2016; Jun. 2, 2020> |
| 2. | Affairs concerning the sentinel surveillance, etc. of infectious diseases under Article 16 of the Act; |
| 9. | Affairs concerning the designation of infectious disease control institutions and the establishment and operation of infectious disease control facilities, isolation wards, sanatoriums, and clinics under Articles 36 and 37 of the Act; |
[This Article Newly Inserted on Aug. 6, 2014]
[Moved from Article 32-2 <Jan. 6, 2016>]
| Article 33 (Imposition of Administrative Fines) |
[This Article Wholly Amended on Jan. 6, 2016]
ADDENDA <Presidential Decree No. 22564, Dec. 29, 2010>
Article 1 (Enforcement Date)
This Decree shall enter into force on December 30, 2010: Provided, That Article 7 (11) of the Addenda shall enter into force on January 1, 2011. Article 2 (Applicability to Standards for Compensating Nursing Expenses)
The amended provisions of subparagraph 2 of Article 29 shall begin to apply from the first nursing expenses reimbursed after this Decree enters into force. Article 3 (Transitional Measures concerning Institutions Entrusted with Vaccination Services)
Any institution entrusted with vaccination services under the former Enforcement Decree of the Prevention of Contagious Diseases Act as at the time this Decree enters into force, shall be deemed an institution entrusted with vaccination services under the amended provisions of Article 20 (1). Article 4 (Transitional Measures concerning Official Title of Disease Control Officer)
Disease control officials and disease control officers appointed under the former Enforcement Decree of the Prevention of Contagious Diseases Act as at the time this Decree enters into force, shall be deemed disease control officers appointed under the amended provisions of Article 25. Article 5 (Transitional Measures concerning Eligibility for Epidemiological Investigative Officers)
Any epidemiological investigative officer appointed under the former Enforcement Decree of the Prevention of Contagious Diseases Act as at the time this Decree enters into force, shall be deemed qualified as an epidemiological investigative officer under the amended provisions of Article 26 (1). Article 6 (Transitional Measures concerning Administrative Fines)
| (1) | The imposition of an administrative fine for any offense committed before this Decree enters into force, shall be subject to standards for imposing administrative fines for the first offense under the amended provisions of attached Table 3. |
| (2) | No disposition to impose an administrative fine taken against any offense before this Decree enters into force, shall be included in calculating the frequency of offenses committed under the amended provisions of attached Table 3. |
Article 7 Omitted.
Article 8 (Relationship to Other Statutes or Regulations)
Any citation of the former Enforcement Decree of the Prevention of Contagious Diseases Act or of any provision thereof, in any other statute or regulations, as at the time this Decree enters into force, shall be deemed a citation of this Decree or of the relevant provision hereof, if such provision corresponding thereto exists in this Decree, in lieu of the former provisions.
ADDENDA <Presidential Decree No. 23356, Dec. 8, 2011>
Article 1 (Enforcement Date)
This Decree shall enter into force on December 8, 2011. (Proviso Omitted.)
Article 2 Omitted.
ADDENDA <Presidential Decree No. 24454, Mar. 23, 2013>
Article 1 (Enforcement Date)
This Decree shall enter into force on the date of its promulgation. (Proviso Omitted.)
Articles 2 through 4 Omitted.
ADDENDA <Presidential Decree No. 25448, Jul. 7, 2014>
Article 1 (Enforcement Date)
This Decree shall enter into force on July 8, 2014.
Articles 2 through 4 Omitted.
ADDENDUM <Presidential Decree No. 25532, Aug. 6, 2014>
This Decree shall enter into force on August 7, 2014.
ADDENDUM <Presidential Decree No. 26024, Jan. 6, 2015>
This Decree shall enter into force six months after the date of its promulgation.
ADDENDUM <Presidential Decree No. 26865, Jan. 6, 2016>
This Decree shall enter into force on January 7, 2016.
ADDENDA <Presidential Decree No. 26916, Jan. 19, 2016>
Article 1 (Enforcement Date)
This Decree shall enter into force on January 21, 2016. (Proviso Omitted.)
Articles 2 through 4 Omitted.
ADDENDUM <Presidential Decree No. 27277, Jun. 28, 2016>
This Decree shall enter into force on June 30, 2016.
ADDENDA <Presidential Decree No. 27445, Aug. 11, 2016>
Article 1 (Enforcement Date)
This Decree shall enter into force on August 12, 2016.
Articles 2 through 22 Omitted.
ADDENDA <Presidential Decree No. 27971, Mar. 29, 2017>
Article 1 (Enforcement Date)
This Decree shall enter into force on March 30, 2017. (Proviso Omitted.)
Articles 2 through 11 Omitted.
ADDENDA <Presidential Decree No. 28070, May 29, 2017>
Article 1 (Enforcement Date)
This Decree shall enter into force on June 3, 2017: Provided, That the amended provisions of subparagraph 3 of Article 29 shall enter into force on January 1, 2018. Article 2 (Applicability to Compensation for Damage Caused by Vaccination)
ADDENDUM <Presidential Decree No. 28962, Jun. 12, 2018>
This Decree shall enter into force on June 13, 2018: Provided, That the amended provisions of Articles 1-6, 21-2, and 33 shall enter into force on the date of its promulgation, and the amended provisions of attached Table 2-2 shall enter into force on September 28, 2018.
ADDENDA <Presidential Decree No. 29180, Sep. 18, 2018>
Article 1 (Enforcement Date)
This Decree shall enter into force on September 21, 2018.
Articles 2 through 19 Omitted.
ADDENDUM <Presidential Decree No. 29950, Jul. 2, 2019>
This Decree shall enter into force on the date of its promulgation. (Proviso Omitted.)
ADDENDA <Presidential Decree No. 29961, Jul. 9, 2019>
Article 1 (Enforcement Date)
This Decree shall enter into force on the date of its promulgation.
Article 2 (Applicability to Criteria for Compensation for Injuries Caused by Vaccinations)
The amended provisions of subparagraph 3 (a) of Article 29 shall begin to apply where the Minister of Health and Welfare determines whether to provide compensation under Article 31 (3) after this Decree enters into force.
ADDENDUM <Presidential Decree No. 30596, Apr. 2, 2020>
This Decree shall enter into force on the date of its promulgation.
ADDENDA <Act No. 30743, Jun. 2, 2020>
This Decree shall enter into force on June 4, 2020: Provided, That any of the following matters shall enter into force on the specified date therefor:
| 1. | Amended provisions of Article 21-2 through 21-4, Article 23, Article 25, Article 26-3, Article 32 (1) 1-2 through 1-4, 12-2, 12-4, 12-5, 13-3, 15-2 and 20-2, Article 32 (2), Article 32-3, and attached Table 2: Date of promulgation; |