ENFORCEMENT DECREE OF THE RARE DISEASE MANAGEMENT ACT
Presidential Decree No. 27731, Dec. 30, 2016
Amended by Presidential Decree No. 30893, Aug. 4, 2020
Presidential Decree No. 31013, Sep. 11, 2020
Presidential Decree No. 33319, Mar. 7, 2023
Presidential Decree No. 34147, Jan. 16, 2024
Presidential Decree No. 35481, Apr. 29, 2025
Presidential Decree No. 35947, Dec. 30, 2025
The purpose of this Decree is to prescribe matters delegated by the Rare Disease Management Act and matters necessary for the enforcement thereof.
| Article 2 (Composition of Rare Disease Management Committee) |
| (1) | The term of office of commissioned members of the Rare Disease Management Committee under Article 7 of the Rare Disease Management Act (hereinafter referred to as the "Committee") shall be 3 years and may be renewed only once; provided, where a member is newly commissioned due to dismissal or other reasons, the term of office of the new member shall be the remaining term of his or her predecessor. |
| (2) | The Minister of Health and Welfare may dismiss or revoke the appointment of a member of the Committee if the member falls under any of the following subparagraphs: |
| 1. | Where he or she is unable to perform duties due to mental disorder; |
| 2. | Where he or she has committed misconduct in connection with his or her duties; |
| 3. | Where he or she is deemed unfit to serve on the Committee due to negligence of duty, impairment of dignity, or other reasons; |
| 4. | Where he or she voluntarily expresses that it is impracticable to perform his or her duties. |
| Article 3 (Operation of Rare Disease Management Committee) |
| (1) | The chairperson of the Committee (hereafter in this Article referred to as the "Chairperson") shall represent the Committee and have general supervision and control of its business affairs. |
| (2) | Where the Chairperson is unable to perform his or her duties due to unavoidable circumstances, a member designated by the Chairperson shall act on behalf of the Chairperson. |
| (3) | A meeting of the Committee shall be convened when requested by the Minister of Health and Welfare or by at least 1/3 of the members of the Committee, or when the Chairperson deems it necessary; and, the Chairperson shall preside over the meeting. |
| (4) | A majority of the members of the Committee shall constitute a quorum, and any resolution thereof shall require the concurring vote of a majority of those present. |
| (5) | The Committee shall have 1 executive secretary to handle its business affairs, who shall be designated by the Minister of Health and Welfare from among public officials of the Ministry of Health and Welfare. |
| (6) | Commissioned members who attend meetings of the Committee may be paid allowances, travel expenses, and other necessary expenses within the budget. |
| Article 4 (Specialized subcommittees) |
| (1) | The Committee may establish field-specific specialized subcommittees, if necessary, to conduct expert reviews of matters subject to deliberation by the Committee. |
| (2) | A field-specific specialized subcommittee shall be comprised of up to 20 members, including 1 chairperson. <Amended on Mar. 7, 2023> |
| (3) | The chairperson and members of a field-specific specialized subcommittee shall be appointed or commissioned by the Minister of Health and Welfare. |
| Article 5 (Detailed operational rules) |
Except as provided in this Decree, matters necessary for the organization and operation of the Committee and field-specific specialized subcommittees shall be determined by the Minister of Health and Welfare.
| Article 6 (Rare disease registration and statistics program) |
| (1) | The Commissioner of the Korea Disease Control and Prevention Agency may establish and operate an integrated information management system for rare diseases, as determined by the Commissioner, to efficiently implement the rare disease registration and statistics program (hereinafter referred to as the "registration and statistics program") under the former part of Article 10(1) of the Act. <Amended on Sep. 11, 2020> |
| (2) | Where the Commissioner of the Korea Disease Control and Prevention Agency processes sensitive information or personally identifiable information under Articles 23 and 24 of the Personal Information Protection Act in connection with the implementation of the registration and statistics program, the Commissioner shall take measures necessary to ensure the security of personal information, as determined by the Commissioner. <Amended on Sep. 11, 2020> |
| (3) | Where the Commissioner of the Korea Disease Control and Prevention Agency deems it necessary for the management of rare diseases, the Commissioner may publish the results of the registration and statistics program, as determined by the Commissioner. <Amended on Sep. 11, 2020> |
| Article 7 (Details and methods of fact-finding surveys) |
| (1) | The details of the fact-finding survey under Article 11(1) of the Act (hereinafter referred to as the "fact-finding survey") shall be as follows: <Amended on Sep. 11, 2020> |
| 1. | Matters regarding the distribution of rare disease patients by age, sex, region, etc.; |
| 2. | Matters regarding the clinical symptoms and progression of rare disease patients; |
| 3. | Matters regarding treatment information, such as diagnosis, examination, prescription, etc. of rare disease patients; |
| 4. | Matters regarding personnel, facilities, equipment, etc. related to treatment and research of rare disease patients; |
| 5. | Matters regarding the investigation of various literature and data related to rare diseases; |
| 6. | Other matters deemed particularly necessary by the Commissioner of the Korea Disease Control and Prevention Agency for the management of rare diseases. |
| (2) | The methods of fact-finding surveys shall be as follows: <Amended on Sep. 11, 2020> |
| 1. | Questionnaire surveys and specimen testing of rare disease patients, household members, etc.; |
| 2. | Investigation of data including medical records of medical institutions; |
| 3. | Sample questionnaire surveys and specimen testing of the general public; |
| 4. | Other methods deemed particularly necessary for the fact-finding survey, as determined by the Commissioner of the Korea Disease Control and Prevention Agency. |
| (3) | Where the Commissioner of the Korea Disease Control and Prevention Agency deems it necessary for the efficient implementation of the fact-finding survey, the Commissioner may entrust the survey to a relevant research institute, organization, or expert. <Amended on Sep. 11, 2020> |
| (4) | Except as provided in paragraphs (1) through (3), matters necessary for fact-finding surveys shall be determined by the Commissioner of the Korea Disease Control and Prevention Agency. <Amended on Sep. 11, 2020> |
| Article 8 (Medical expense support program) |
| (1) | The scope of the medical expense support program under Article 12 of the Act (hereinafter referred to as the "medical expense support program") shall be as follows: |
| 1. | Investigation of data on the property and income of persons eligible for medical expense support; |
| 2. | Selection of persons eligible for medical expense support and notification thereof; |
| 3. | Payment of medical expenses to persons eligible for medical expense support; |
| 4. | Publicity relating to medical expense support; |
| 5. | Development and management of an information system for medical expense support. |
| (2) | A person eligible for medical expense support under Article 12(1) of the Act shall be a person falling under any of the following subparagraphs whose income, property, etc. are below the standards determined publicly notified every year by the Commissioner of the Korea Disease Control and Prevention Agency: <Amended on Sep. 11, 2020> |
| 1. | Rare disease patients among the health insurance policyholders or dependents under Article 5 of the National Health Insurance Act; |
| 2. | Rare disease patients among the eligible recipients under Article 3 of the Medical Care Assistance Act. |
| (3) | A person who intends to receive medical expense support under Article 12(1) of the Act shall apply for such support to the director of the competent public health clinic, as prescribed by Decree of the Ministry of Health and Welfare. |
| (4) | Where an application for medical expense support is filed under paragraph (2), the director of the competent public health clinic may, if necessary for verifying the applicant's personal information, family relations, income, property, etc., request necessary cooperation from relevant central administrative agencies, local governments, or public institutions under the Act on the Management of Public Institutions, such as the submission of data or verification of information. |
| (5) | Where the director of the competent public health clinic makes a request for the submission of data or verification of information under paragraph (4), such request may be made through a social security information system under Article 37 of the Framework Act on Social Security (hereinafter referred to as "social security information system"). |
| (6) | Except as provided in paragraphs (1) through (5), detailed matters necessary for the scope of the medical expense support program, for medical expense support, etc. shall be determined and publicly notified by the Commissioner of the Korea Disease Control and Prevention Agency. <Amended on Sep. 11, 2020> |
| Article 9 (Scope of Financial Information, etc.) |
| (1) | "Other data or information prescribed by Presidential Decree" in Article 13(1)1 of the Act means the following data or information: |
| 1. | Demand deposit, such as ordinary deposit, savings deposit, free savings deposit, etc.: Average balance within the last 3 months; |
| 2. | Savings deposit, such as time deposit, time installment savings, time savings, etc.: Balance or total payments; |
| 3. | Stocks, beneficiary certificates, investments and investment shares: Final market value. In such cases, to the evaluation of unlisted stocks, Article 54(1) of the Enforcement Decree of the Inheritance Tax and Gift Tax Act shall apply mutatis mutandis; |
| 4. | Bonds, notes, checks, debt certificates and preemptive right certificates: Face value; |
| 5. | Annuity savings: Amounts paid regularly or final balance; |
| 6. | Interests, dividends, or discounts arising from the financial property under subparagraphs 1 through 5. |
| (2) | "Other data or information prescribed by Presidential Decree" in Article 13(1)2 of the Act means the following data or information: |
| 1. | Current state of loans and details of unpaid debts; |
| 2. | Amount of unpaid credit card debts. |
| (3) | "Other data or information prescribed by Presidential Decree" in Article 13(1)3 of the Act means the following data or information: |
| 1. | Insurance policies: Refunds receivable upon cancellation or insurance benefits paid within the past year; |
| 2. | Pension insurance: Surrender value to be received upon cancellation or amounts paid periodically. |
| Article 10 (Request for financial information, etc. and provision thereof) |
| (1) | Where the director of the competent public health clinic receives a written consent from a person who intends to receive medical expense support under Article 13(1) of the Act, the director shall submit it to the Commissioner of the Korea Disease Control and Prevention Agency through the social security information system. <Amended on Sep. 11, 2020> |
| (2) | Where the Commissioner of the Korea Disease Control and Prevention Agency in receipt of a written consent under paragraph (1) requests the head of a financial company, etc. under subparagraph 1 of Article 2 of the Act on Real Name Financial Transactions and Confidentiality or the head of the Committee for Centralized Management of Credit Information under Article 25(2)1 of the Credit Information Use and Protection Act (hereinafter referred to as "financial institution, etc.") to provide financial information, credit information, and insurance information referred to in Article 13(1)1 through 3 of the Act (hereinafter referred to as "financial information, etc.") under Article 13(2) of the Act, such request shall be made in writing (including electronic documents) containing the following: <Amended on Aug. 4, 2020; Sep. 11, 2020> |
| 1. | Name and resident registration number of the person subject to the request; |
| 2. | Scope of the requested financial information, etc., and the reference date and period for the inquiry. |
| (3) | Where the head of a financial institution, etc., upon receiving a request for submission of financial information, etc. under paragraph (2), provides such financial information, etc. to the Commissioner of the Korea Disease Control and Prevention Agency, such provision shall be made in writing (including electronic documents) containing the following: <Amended on Sep. 11, 2020> |
| 1. | Name and resident registration number of the person subject to the request; |
| 2. | Name of the financial institution, etc. providing financial information, etc.; |
| 3. | Name of the financial product and the account number subject to the provision of information; |
| 4. | Details of financial information, etc. |
| (4) | The Commissioner of the Korea Disease Control and Prevention Agency may request the head of a financial institution, etc. to provide financial information, etc. through an information and communications network operated by an association, federation, or central association to which the financial institution, etc. is affiliated. <Amended on Sep. 11, 2020> |
| (5) | Where the Commissioner of the Korea Disease Control and Prevention Agency receives financial information, etc. under paragraph (3) or (4), the Commissioner shall notify the director of the competent public health clinic thereof through the social security information system. <Amended on Sep. 11, 2020> |
| (6) | Except as provided in paragraphs (1) through (5), detailed matters necessary for making a request for the provision of financial information, etc. and for providing financial information, etc. shall be determined and publicly notified by the Commissioner of the Korea Disease Control and Prevention Agency. <Amended on Sep. 11, 2020> |
| Article 11 (Requirements for designation as specialized rare disease institutes) |
| (1) | "Requirements prescribed by Presidential Decree, such as facilities, personnel, etc." in the provisions, with the exception of the subparagraphs, of Article 14(1) of the Act means the following requirements: <Amended on Sep. 11, 2020> |
| 1. | A medical institution under Article 3(2)1a of the Medical Service Act: Following requirements: |
| a. | It shall have at least 1 medical specialist for treating and researching rare diseases; |
| b. | It shall have an office for the treatment of and research of rare diseases; |
| c. | It is shall have at least 1 year of clinical experience in treating rare diseases; |
| d. | It shall have an online business processing system necessary for performing the duties under the subparagraphs of Article 14(1) of the Act; |
| 2. | A medical institution under Article 3(2)3a and e of the Medical Service Act: Following requirements: |
| a. | It shall have at least 3 staff members including at least 1 medical specialist for treating and researching rare diseases; |
| b. | It shall have an office for the treatment and research of rare diseases, and facilities determined and publicly notified by the Commissioner of the Korea Disease Control and Prevention Agency; |
| c. | It shall have a department in charge of the duties under the subparagraphs of Article 14(1) of the Act; |
| d. | It shall meet the requirements under subparagraph 1c and d. |
| (2) | Detailed standards for requirements for designation under paragraph (1) shall be determined and publicly notified by the Commissioner of the Korea Disease Control and Prevention Agency. <Amended on Sep. 11, 2020> |
| Article 12 (Entrustment of evaluation of specialized rare disease institutes) |
| (1) | Pursuant to Article 15(3) of the Act, the Commissioner of the Korea Disease Control and Prevention Agency may entrust following institutions or organizations with the tasks of evaluation of specialized rare disease institutes under Article 14(1) of the Act (hereinafter referred to as "specialized rare disease institutes"): <Amended on Sep. 11, 2020> |
| 1. | Public institutions established with an establishment objective related to health and medical services from among the public institutions under Article 4 of the Act on the Management of Public Institutions; |
| 2. | Institutions or organizations determined and publicly notified by the Commissioner of the Korea Disease Control and Prevention Agency, which have structure, personnel, expertise, etc. necessary for performing entrusted tasks. |
| (2) | Where the Commissioner of the Korea Disease Control and Prevention Agency intends to entrust the tasks of evaluating specialized rare disease institutes under Article 15(3) of the Act to an institution or organization, he or she shall make a prior public announcement of matters regarding standards for entrustment, procedures therefor, methods thereof, etc. <Amended on Sep. 11, 2020> |
| (3) | Where the Commissioner of the Korea Disease Control and Prevention Agency intends to entrust the tasks of evaluating specialized rare disease institutes under Article 15(3) of the Act to an institution or organization, he or she shall publicly notify matters regarding the details of entrustment, trustees, etc. in the Official Gazette, and post them on the website of the Commissioner of the Korea Disease Control and Prevention Agency. <Amended on Sep. 11, 2020> |
| (4) | The institution or organization entrusted with the tasks of evaluating specialized rare disease institutes under Article 15(3) of the Act shall report the Commissioner of the Korea Disease Control and Prevention Agency on the project operational plan, current state of implementation of the project, fund operational plan, details of disbursed funds, etc., as determined by the Commissioner of the Korea Disease Control and Prevention Agency. <Amended on Sep. 11, 2020> |
| (5) | Detailed matters necessary for the public announcement of standards for entrustment, etc., public notice of details of entrustment, report on entrusted tasks, etc. under paragraph (2) through (4) shall be determined and publicly notified by the Commissioner of the Korea Disease Control and Prevention Agency. <Amended on Sep. 11, 2020> |
| Article 12-2 (Organization and operation of policy council for support of rare diseases) |
| (1) | The Commissioner of the Korea Disease Control and Prevention Agency shall organize and operate a policy council for support of rare diseases (hereinafter referred to as the "Council") to consult and coordinate the following matters under Article 18(5) of the Act: |
| 1. | Matters regarding the formulation and review of detailed plans for administrative and financial support under Article 18(1) and (2) of the Act; |
| 2. | Matters regarding the sharing and utilization of information among relevant agencies on the current status of support for rare diseases; |
| 3. | Other matters deemed necessary by the chairperson of the Council to determine the recipients, scope, and procedures of administrative and financial support for the diagnosis and treatment of rare diseases. |
| (2) | The Council shall be comprised of up to 10 members, including 1 chairperson, with consideration given to gender balance. |
| (3) | The chairperson of the Council shall be a public official of director-general level in charge of rare diseases at the Korea Disease Control and Prevention Agency, and the members of the Council shall be the following persons: <Amended on Dec. 30, 2025> |
| 1. | Public official of Grade IV or higher (including equivalent officials) belonging to the following central administrative agencies, as designated by the head of the respective agency: |
| a. | The Ministry of Finance and Economy; |
| b. | The Ministry of Agriculture, Food and Rural Affairs; |
| c. | The Ministry of Health and Welfare; |
| d. | The Ministry of Food and Drug Safety; |
| e. | Other relevant central administrative agencies deemed necessary by the Commissioner of the Korea Disease Control and Prevention Agency for consultation and coordination regarding support for rare disease patients; |
| 2. | A person commissioned by the Commissioner of the Korea Disease Control and Prevention Agency upon the recommendation of the head of an institution or organization related to rare diseases, from among its executive officers or employees, as deemed necessary by the Commissioner. |
| (4) | The term of office of a member commissioned under paragraph (3)2 shall be 2 years. |
| (5) | Except as provided in paragraphs (1) through (4), matters necessary for the organization and operation of the Council shall be determined by the Commissioner of the Korea Disease Control and Prevention Agency. |
[This Article Added on Apr. 29, 2025]
| Article 13 (Delegation of authority and entrustment of business affairs) |
| (1) | The Minister of Health and Welfare shall delegate the following authority to the Commissioner of the Korea Disease Control and Prevention Agency under Article 22(1) of the Act: <Amended on Jan. 16, 2024> |
| 1. | Composition of field-specific specialized subcommittees, and appointment and commissioning of the chairpersons and members thereof under Article 4; |
| 2. | Establishment and management of detailed operational rules regarding the composition, operation, etc. of field-specific specialized subcommittees under Article 5. |
| (2) | Pursuant to Article 22(2) of the Act, the Commissioner of the Korea Disease Control and Prevention Agency may entrust the following tasks to a public institution under Article 4 of the Act on the Management of Public Institutions, a non-profit corporation established under the Civil Act or other statutes, or any other corporation or organization specialized in tasks related to rare diseases. <Added on Jan. 16, 2024> |
| 1. | Collection, analysis, and provision of information and statistics relating to rare diseases under Article 8(2)2 of the Act; |
| 2. | Education, training, and publicity related to rare diseases under Article 8(2)5 of the Act. |
| (3) | Where the Commissioner of the Korea Disease Control and Prevention Agency intends to entrust business affairs under paragraph (2), he or she shall post matters regarding the details of entrustment, trustees, etc. on the website of the Commissioner of the Korea Disease Control and Prevention Agency. <Added on Jan. 16, 2024> |
[This Article Added on Mar. 7, 2023]
[Title Amended on Jan. 16, 2024]
| Article 14 (Processing of sensitive information and personally identifiable information) |
| (1) | Where an unavoidable situation arises when the following tasks are performed, the Commissioner of the Korea Disease Control and Prevention Agency (including persons entrusted with the tasks of the Commissioner of the Korea Disease Control and Prevention Agency under Articles 15(3) and 22(2) of the Act) may process information on health under Article 23 of the Personal Information Protection Act (limited to cases in which tasks under subparagraphs 1 through 4 are performed) or data containing resident registration numbers, driver's license numbers or foreigner registration numbers under subparagraph 1 or 4 of Article 19 of the Enforcement Decree of that Act: <Amended on Sep. 11, 2020; Jan. 16, 2024> |
| 1. | Business affairs under the subparagraphs of Article 8(2) of the Act; |
| 2. | Business affairs regarding rare disease research and development projects under Article 9; |
| 3. | Business affairs related to the registration and statistics program under Article 10 of the Act; |
| 4. | Business affairs regarding fact-finding surveys under Article 11; |
| 5. | Business affairs regarding designation and cancellation and designation as specialized rare disease institutes under Article 14; |
| 6. | Business affairs regarding evaluation of specialized rare disease institutes under Article 15. |
| (2) | Where it is unavoidable for performing business affairs related to the medical expense support for rare disease patients under Article 12 of the Act and Article 8 of this Decree, the director of the competent public health clinic may process data containing health information under Article 23 of the Personal Information Protection Act, and resident registration numbers or alien registration numbers under subparagraph 1 or 4 of Article 19 of the Enforcement Decree of that Act. |
| (3) | Where it is unavoidable for performing the programs under the subparagraphs of Article 8(2) of the Act, the head of the rare disease support center under Article 8(1) of the Act may process data containing health information under Article 23 of the Personal Information Protection Act, and resident registration numbers or alien registration numbers under subparagraph 1 or 4 of Article 19 of the Enforcement Decree of that Act. |
ADDENDUM <Presidential Decree No. 27731, Dec. 30, 2016>
This Decree shall enter into force on the date of its promulgation.
ADDENDA <Presidential Decree No. 30893, Aug. 4, 2020>
Article 1 (Enforcement date)
| (1) | This Decree shall enter into force on August 5, 2020. (Proviso Omitted.) |
Article 2 Omitted.
Article 3 Omitted.
Article 4 Omitted.
ADDENDA <Presidential Decree No. 31013, Sep. 11, 2020>
Article 1 (Enforcement date)
This Decree shall enter into force on September 12, 2020.
Article 2 Omitted.
Article 3 Omitted.
ADDENDUM <Presidential Decree No. 33319, Mar. 7, 2023>
This Decree shall enter into force on the date of its promulgation.
ADDENDUM <Presidential Decree No. 34147, Jan. 16, 2024>
This Decree shall enter into force on the date of its promulgation.
ADDENDUM <Presidential Decree No. 35481, Apr. 29, 2025>
This Decree shall enter into force on June 4, 2025.
ADDENDA <Presidential Decree No. 35947, Dec. 30, 2025>
Article 1 (Enforcement date)
This Decree shall enter into force on January 2, 2026; provided, the amendments to Presidential Decrees to be amended pursuant to Article 6 of the Addenda, which were promulgated before this Decree enters into force but the enforcement dates of which have yet to arrive, shall enter into force on the enforcement date of the relevant Presidential Decree.
Articles 2 through 5 Omitted.
Article 6 Omitted.