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
The purpose of this Decree is to prescribe matters delegated by the Rare Disease Management Act and matters necessary for its enforcement.
Article 2 (Composition of Rare Disease Management Committee) |
(1) | The term of office of entrusted members of the rare disease management committee (hereinafter referred to as "committee") under Article 7 of the Rare Disease Management Act (hereinafter referred to as "Act") shall be three years, and they may be re-entrusted only one more time: Provided, That where a person is entrusted with the position of member of the committee after an entrustment agreement with an existing member is terminated, etc., his or her term of office shall be the remaining term of office of his or her predecessor. |
(2) | Where a committee member falls under any of the following, the Minister of Health and Welfare may dismiss him or her or terminate the entrustment agreement: |
1. | Where he or she is unable to perform duties due to mental disorder; |
2. | Where he or she has committed a violation with regard to duties; |
3. | Where he or she is deemed unfit for a member due to negligence, injury to dignity or other reasons; |
4. | Where he or she personally expresses his or her intent that fulfilling duties is difficult. |
Article 3 (Operation of Rare Disease Management Committee) |
(1) | The chairperson of the committee (hereafter referred to as "chairperson" in this Article) shall represent the committee and take charge of the business of the committee. |
(2) | Where the chairperson is unable to perform duties due to unavoidable reasons, a member designated by the chairperson shall perform the duties in place of the chairperson. |
(3) | A meeting of the committee shall be called by request of the Minister of Health and Welfare or not less than 1/3 of the members, or when the chairperson deems needs exist, and the chairperson shall chair the meeting. |
(4) | The committee shall begin its session with the attendance of a majority of members on the register and a resolution is passed by a majority vote of the attending members. |
(5) | The committee shall have an executive secretary to handle the duties of the committee, who shall be designated by the Minister of Health and Welfare from among public officials affiliated with the Ministry of Health and Welfare. |
(6) | Entrusted members who attend a meeting of the committee may be paid allowances, traveling expenses and other necessary expenses within budgetary limit. |
Article 4 (Specialized Committees) |
(1) | In order to expertly deliberate on matters of deliberation, the committee may have specialized committees by field of expertise, if necessary. |
(2) | A specialized committee by field of expertise shall consist of not more than 20 members including a chairperson. <Amended on Mar. 7, 2023> |
(3) | The chairpersons and members of specialized committees by field of expertise shall be appointed or entrusted by the Minister of Health and Welfare. |
Article 5 (Detailed Operational Rules) |
In addition to those prescribed by this Act, matters necessary for the composition, operation, etc. of the committee and specialized committees by field of expertise shall be determined by the Minister of Health and Welfare.
Article 6 (Projects for Statistics on Registration of Rare Diseases) |
(1) | For the efficient performance of projects for statistics on registration of rare diseases under the former part of Article 10 (1) of the Act (hereinafter referred to as "registration statistics project"), the Commissioner of the Korea Disease Control and Prevention Agency may construct and operate a comprehensive rare disease information management system as determined by the Commissioner of the Korea Disease Control and Prevention Agency. <Amended on Sep. 11, 2020> |
(2) | Where the Commissioner of the Korea Disease Control and Prevention Agency handles sensitive information or personally identifiable information pursuant to Article 23 of the Personal Information Protection Act with regard to the implementation of registration statistics projects, he or she shall take measures necessary for assuring the safety of personal information as determined by the Commissioner of the Korea Disease Control and Prevention Agency. <Amended on Sep. 11, 2020> |
(3) | Where the Commissioner of the Korea Disease Control and Prevention Agency deems needs exist for rare disease management, he or she may make public the outcomes of registration statistics projects as determined by the Commissioner of the Korea Disease Control and Prevention Agency. <Amended on Sep. 11, 2020> |
Article 7 (Details, Methods, etc. of Fact-Finding Surveys) |
(1) | Details of the fact-finding surveys under Article 11 (1) of the Act (hereinafter referred to as "fact-finding surveys") shall be as listed hereunder: <Amended on Sep. 11, 2020> |
1. | Matters concerning distribution, etc. of rare disease patients by age, sex and region; |
2. | Matters concerning clinical signs, developments, etc. in rare disease patients; |
3. | Matters concerning treatment information, such as diagnosis, examination, prescription, etc. of rare disease patients; |
4. | Matters concerning personnel, facilities, equipment, etc. related to treatment of and research into rare disease patients; |
5. | Matters concerning inspection of books, data, etc. on rare disease patients; |
6. | Other matters the Commissioner of the Korea Disease Control and Prevention Agency deems specifically necessary for rare disease management. |
(2) | The methods of fact-finding surveys shall be as follows: <Amended on Sep. 11, 2020> |
1. | Questionnaire surveys and specimen inspections of rare disease patients, household members, etc.; |
2. | Inspection of data on the medical charts, etc.; |
3. | Sample questionnaire surveys and specimen inspections of the public; |
4. | Other methods that the Commissioner of the Korea Disease Control and Prevention Agency determines to be specifically necessary for fact-finding surveys. |
(3) | Where the Commissioner of the Korea Disease Control and Prevention Agency deems needs exist for the efficient promotion of a fact-finding survey, he or she may request related research institutes, organizations or specialists to conduct a fact-finding survey. <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 Projects) |
(1) | The medical expense support projects under Article 12 of the Act (hereinafter referred to as "medical expense support project") shall be as listed hereunder: |
1. | Inspection of data on the property and income of persons to be given medical expense support; |
2. | Selection of persons to be given medical expense support and notification thereto; |
3. | Payment of medical expenses to persons to be given medical expense support; |
4. | Publicity relating to medical expense support; |
5. | Development and management of an information system for medical expense support. |
(2) | Persons whose income, property, etc. are below the standard determined and publicly notified each year by the Commissioner of the Korea Disease Control and Prevention Agency from among those under the following shall be eligible for medical expense support under Article 12 (1) of the Act: <Amended on Sep. 11, 2020> |
(3) | A person who intends to be given medical expense support pursuant to Article 12 (1) of the Act shall file an application for support with the head of a jurisdictional public health center as prescribed by Ministerial Decree of Health and Welfare. |
(4) | The head of a jurisdictional public health center in receipt of an application for medical expense support pursuant to paragraph (2) may request related central administrative agencies, local governments or public institutions under the Act on the Management of Public Institutions to submit data, to verify information, etc. where needs arise for the inspection or verification of personal information, family relations, income, property, etc. of the applicant. |
(5) | When the head of a jurisdictional public health center requests the submission of data, verification of information, etc. to others pursuant to paragraph (4), he or she may make a request 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 medical expense support projects, 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 shall mean the following data or information: |
1. | Demand deposit, such as ordinary deposit, savings deposit, free savings deposit, etc.: Average balance within the last three months; |
2. | Savings deposit, such as time deposit, time installment savings, time savings, etc.: Balance or total payments; |
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 occurring 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 shall mean 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 shall mean the following data or information: |
1. | Insurance policy: Refund to be received if an insurance policy is cancelled or the amount of premiums paid within the last one year; |
2. | Annuity insurance: Refund to be received if an insurance policy is cancelled or the amount to be received on a regular basis. |
Article 10 (Request for Financial Information, etc. and Provision thereof) |
(1) | Where the head of a public health center receives a written consent from persons seeking medical expense support pursuant to Article 13 (1) of the Act, he or she shall submit it to the Commissioner of the Korea Disease Control and Prevention Agency through a social security information system. <Amended on Sep. 11, 2020> |
(2) | Where, pursuant to Article 13 (2) of the Act, the Commissioner of the Korea Disease Control and Prevention Agency, who is in receipt of a written consent under paragraph (1), requests the heads of financial companies, 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 institutions, etc.") to provide financial information, credit information and insurance information (hereinafter referred to as "financial information, etc."), he or she shall make a request in writing (including electronic format) containing the following: <Amended on Aug. 4, 2020; Sep. 11, 2020> |
1. | Names and resident registration numbers of persons seeking medical expense support; |
2. | Scope of financial information, etc., base date for inquiry and inquiry period. |
(3) | Where the heads of financial institutions, etc. who are requested to provide financial information, etc. pursuant to paragraph (2) provide relevant financial information, etc. to the Commissioner of the Korea Disease Control and Prevention Agency, they shall provide the financial information, etc. in writing (including electronic format) containing the following: <Amended on Sep. 11, 2020> |
1. | Names and resident registration numbers of persons seeking medical expense support; |
2. | Names of financial institutions, etc. providing financial information, etc.; |
3. | Names and account numbers of financial products to be provided; |
4. | Details of financial information, etc. |
(4) | The Commissioner of the Korea Disease Control and Prevention Agency may request the heads of financial institutions, etc. to provide financial information, etc. through an information and communications network of an association, federation, national federation with which the financial institutions, etc. are affiliated. <Amended on Sep. 11, 2020> |
(5) | Where the Commissioner of the Korea Disease Control and Prevention Agency is provided with financial information, etc. pursuant to paragraph (3) or (4), he or she shall notify the financial information, etc. to the head of jurisdictional public health center through a 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 shall mean the following requirements: <Amended on Sep. 11, 2020> |
(a) | That it shall have at least one medical specialist for treating and researching a rare disease; |
(b) | That it shall have an office for the treatment of and research into a rare disease; |
(c) | That is shall have a track record of treatment of a rare disease for at least one year; |
(d) | That it shall have an online business processing system necessary for performing the duties under the subparagraphs of Article 14 (1) of the Act; |
(a) | That it shall have at least three staff members including at least one medical specialist for treating and researching a rare disease; |
(b) | That it shall have an office for the treatment of and research into a rare disease, and facilities determined and publicly notified by the Commissioner of the Korea Disease Control and Prevention Agency; |
(c) | That it shall have a department in charge of the duties under the subparagraphs of Article 14 (1) of the Act; |
(d) | That it shall meet the requirements under subparagraph 1 (c) 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 duties 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> |
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 duties. |
(2) | Where the Commissioner of the Korea Disease Control and Prevention Agency intends to entrust the duties of evaluating specialized rare disease institutes pursuant to Article 15 (3) of the Act to an institution or organization, he or she shall, beforehand, publicly announce matters concerning 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 duties of evaluating specialized rare disease institutes pursuant to Article 15 (3) of the Act to an institution or organization, he or she shall publicly notify matters concerning 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 duties of evaluating specialized rare disease institutes pursuant to 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 notification of details of entrustment, report on entrusted duties, etc. shall be determined and publicly notified by the Commissioner of the Korea Disease Control and Prevention Agency. <Amended on Sep. 11, 2020> |
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 pursuant to Article 22 (1) of the Act: <Amended on Jan. 16, 2024> |
1. | Composition of specialized committees by field of expertise, and appointment and commission of the chairpersons and members thereof under Article 4; |
2. | Establishment and management of detailed operational rules regarding the composition, operation, etc. of specialized committees by field of expertise 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 affairs 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 business affairs 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 (Handling of Sensitive Information and Personally Identifiable Information) |
(1) | Where an unavoidable situation arises when the following duties are performed, the Commissioner of the Korea Disease Control and Prevention Agency (including persons entrusted with the duties of the Commissioner of the Korea Disease Control and Prevention Agency pursuant to Articles 15 (3) and 22 (2) of the Act) may handle information on health under Article 23 of the Personal Information Protection Act (limited to cases in which duties 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 the same 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 regarding registration statistics projects under Article 10; |
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. |
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.