RARE DISEASE MANAGEMENT ACT
Act No. 13667, Dec. 29, 2015
Amended by Act No. 16410, Apr. 30, 2019
Act No. 19844, Dec. 26, 2023
Act No. 20328, Feb. 20, 2024
Act No. 20547, Dec. 3, 2024
CHAPTER I GENERAL PROVISIONS
The purpose of this Act is to reduce individual and social burden caused by rare diseases and to contribute to improving people's health and welfare by setting and implementing comprehensive policies on the prevention, treatment, research, etc. of rare diseases.
The terms used in this Act are defined as follows:
| 1. | The term "rare disease" means a disease with a patient population of 20,000 persons or fewer, or a disease whose prevalence is unknown due to diagnostic difficulty, which is designated in accordance with the procedures and criteria prescribed by Decree of the Ministry of Health and Welfare; |
| 2. | The term "rare disease management" means various activities with the objectives of prevention, diagnosis, treatment, etc. of rare diseases. |
| Article 3 (Responsibilities of the State) |
| (1) | The State and local governments shall endeavor to implement and support rare disease management projects so that adequate medical services are provided to rare disease patients. |
| (2) | Medical personnel and the heads of medical institutes under the Medical Service Act shall positively cooperate in projects for the management of rare disease implemented by the State and local governments. |
| Article 4 (Rare Disease Day) |
| (1) | In order to enhance understanding of rare diseases among the citizens and to encourage the will to prevent, treat, and manage rare diseases, the last day of February each year shall be designated as the Rare Disease Day. <Amended on Jun. 13, 2023> |
| (2) | The State and local governments shall implement education and publicity projects concerning rare disease management, such as ceremonies appropriate to the meaning of the Rare Disease Day, prevention and early detection of rare diseases, etc. |
| Article 5 (Relationship to other statutes) |
Unless otherwise specifically provided by other Acts concerning rare disease management and support for rare disease patients, this Act shall apply.
CHAPTER II RARE DISEASE MANAGEMENT
SECTION 1 Comprehensive Rare Disease Management Systems
| Article 6 (Comprehensive rare disease management plans) |
| (1) | In order to manage rare diseases, the Minister of Health and Welfare shall, every five years, formulate a comprehensive rare disease management plan (hereinafter referred to as "comprehensive plan"). |
| (2) | A comprehensive plan shall contain the following matters: |
| 1. | Objectives and basic direction of rare disease management; |
| 2. | Rare disease management systems and fund-raising; |
| 3. | Plans to promote rare disease management projects, such as research necessary for rare disease management, development of medical technologies, support therefor, etc.; |
| 4. | Other matters necessary for rare disease management. |
| (3) | Where the Minister of Health and Welfare deems needs exist for the formulation of comprehensive plans, he or she may request the heads of relevant agencies to submit data necessary for the formulation of comprehensive plans. |
| (4) | Those persons in receipt of a request for data pursuant to paragraph (3) shall comply with the request unless there is good cause. |
| Article 7 (Rare disease management committee) |
| (1) | In order to deliberate on the following matters, a rare disease management committee (hereinafter referred to as "committee") shall be established under the Minister of Health and Welfare: |
| 1. | Matters concerning the formulation and evaluation of comprehensive plans; |
| 2. | Essential matters concerning the registration of and support for rare diseases; |
| 3. | Essential matters concerning probe into and research on rare diseases; |
| 4. | Other matters the Minister of Health and Welfare submits for discussion. |
| (2) | The committee shall consist of not more than 15 members including a chairperson. |
| (3) | The chairperson and members of the committee shall be appointed or entrusted by the Minister of Health and Welfare from among persons with extensive knowledge and experience. |
| (4) | Other matters necessary for the composition, organization and operation of the committee shall be prescribed by Presidential Decree. |
| Article 8 (Operation of rare disease support center) |
| (1) | For an effective management of rare diseases, a rare disease support center shall be established in the Korea Disease Control and Prevention Agency. <Amended on Aug. 11, 2020> |
| (2) | The rare disease support center shall conduct the following programs: <Amended on Jun. 13, 2023> |
| 1. | Inspection of and research on the occurrence, prevention, treatment, etc. of rare diseases, and support therefor; |
| 2. | Collection, analysis and provision of information and statistics relating to rare diseases; |
| 3. | Development and dissemination of new technologies concerning the diagnosis, treatment, etc. of rare diseases, and support therefor; |
| 4. | Registration and management of rare disease patients, and support for the treatment of rare disease patients; |
| 5. | Education, training and publicity concerning rare diseases; |
| 6. | International and domestic cooperation relating to rare diseases and support for the cultivation of specialists; |
| 7. | Evaluation and management of specialized rare disease institutes under Article 14; |
| 8. | Support for genetic counseling for the prevention and appropriate management of rare diseases; |
| 9. | Other projects deemed to be necessary for rare disease management, as prescribed by Decree of the Health and Welfare. |
| (3) | Necessary matters, such as standards for and methods of operation, etc. of the rare disease support center shall be prescribed by Decree of the Ministry of Health and Welfare. |
SECTION 2 Rare Disease Management Projects
| Article 9 (Implementation of rare disease research projects) |
| (1) | The Commissioner of the Korea Disease Control and Prevention Agency shall implement a rare disease research and development project (hereinafter referred to as "research project") for the development of technologies for the prevention, diagnosis and treatment of rare diseases, for the development of drugs, etc. <Amended on Aug. 11, 2020> |
| (2) | In order to efficiently implement the duties of planning, management, evaluation, etc. concerning specific and detailed matters on research projects, the Commissioner of the Korea Disease Control and Prevention Agency may have the rare disease support center under Article 8 perform the following duties: <Amended on Aug. 11, 2020> |
| 1. | Planning of research projects; |
| 2. | Evaluation and utilization of research project outcomes; |
| 3. | Other matters necessary for the performance of research projects. |
| (3) | All other matters, such as procedures for performing the duties under paragraph (2), etc., shall be prescribed by Decree of the Ministry of Health and Welfare. |
| Article 10 (Projects for statistics on registration of rare diseases) |
| (1) | The Commissioner of the Korea Disease Control and Prevention Agency shall continuously and systematically collect and analyze data on the risk factors, occurrence, treatment, etc. of rare diseases, and implement a project of registration, management and inspection (hereinafter referred to as "registration statistics project") to produce statistics. In such case, the Statistics Act shall apply mutatis mutandis to the collection of statistical data, preparation of statistics, etc., and personal information processed for the production of statistics shall be deemed personal information to which the Personal Information Protection Act is not applicable pursuant to Article 58 (1) of that Act. <Amended on Aug. 11, 2020> |
| (2) | The Commissioner of the Korea Disease Control and Prevention Agency may request the following persons to submit data, to submit opinions, etc. necessary for registration statistics projects, as prescribed by Decree of the Ministry of Health and Welfare. In such case, the persons in receipt of a request to submit data shall comply therewith unless there is good cause: <Amended on Aug. 11, 2020; Dec. 26, 2023> |
| 1. | Medical personnel or medical institutes diagnosing and treating rare disease patients; |
| 2. | One person recommended by the president of the National Health Insurance Service (hereinafter referred to as the "NHIS") under the National Health Insurance Act and the Health Insurance Review and Assessment Service; |
| 3. | Corporations, institutes and organizations performing projects relating to rare diseases. |
| (3) | Other matters necessary for registration statistics projects shall be prescribed by Presidential Decree. |
| Article 11 (Fact-finding surveys) |
| (1) | Where the Commissioner of the Korea Disease Control and Prevention Agency deems needs exist for rare disease management, he or she may conduct a fact-finding survey. <Amended on Aug. 11, 2020> |
| (2) | Matters necessary for the methods, details, etc. of fact-finding surveys under paragraph (1) shall be prescribed by Presidential Decree. |
| Article 12 (Medical expense support project) |
| (1) | In consideration of the rare disease patients' economic capability to bear expenses, etc., the State and local governments may give financial support for expenses necessary for the prevention, diagnosis, and treatment of rare diseases, which derives from the budget or the National Health Promotion Fund under the National Health Promotion Act. <Amended on Jun. 13, 2023> |
| (2) | Matters necessary for who are eligible for medical expense support, standards for support, methods of support, etc. under paragraph (1) shall be prescribed by Presidential Decree. |
| Article 12-2 (Special cases concerning the National Health Insurance Act) |
| (1) | Where the State or a local government has provided rare disease patients with co-payments under Article 44 (1) of the National Health Insurance Act pursuant to Article 12 and the total annual amount of such co-payments exceeds the co-payment ceiling under the former part of Article 44 (2) of that Act (hereafter in this Article referred to as "co-payment ceiling"), the NHIS shall not restrict insurance benefits, notwithstanding Article 53 (2) of that Act. |
| (2) | Where the NHIS provides insurance benefits for an amount exceeding the co-payment ceiling under paragraph (1), notwithstanding the latter part of Article 44 (2) of the National Health Insurance Act, it shall notify the State or a local government that has provided co-payment under Article 12 of such excess amount and pay it. |
[This Article Added on Dec. 26, 2023]
| Article 13 (Provision of financial information) |
| (1) | A person who seeks medical expense support under Article 12 shall submit a document stating that he or she agrees to the provision of following data or information: |
| 1. | Average deposit balance from among the data or information on the details of financial assets and financial transactions under subparagraphs 2 and 3 of Article 2 of the Act on Real Name Financial Transactions and Confidentiality, and other data or information prescribed by Presidential Decree (hereinafter referred to as "financial information"); |
| 2. | Amount of liabilities from among the credit information under subparagraph 1 of Article 2 of the Credit Information Use and Protection Act, and other data or information prescribed by Presidential Decree; |
| 3. | Insurance premiums paid by him or her after he or she bought insurance under the subparagraphs of Article 4 (1) of the Insurance Business Act, and other data or information prescribed by Presidential Decree. |
| (2) | The Commissioner of the Korea Disease Control and Prevention Agency may request the heads of financial institutions, etc. (referring to the financial companies, etc. under subparagraph 1 of Article 2 of the Act on Real Name Financial Transactions and Confidentiality and to the credit information collection agencies under Article 25 of the Credit Information Use and Protection Act) to provide financial information, credit information or insurance information (hereinafter referred to as "financial information, etc.") in writing in an electronic format converted from the written agreement under paragraph (1), notwithstanding Article 4 (1) of the Act on Real Name Financial Transactions and Confidentiality and Article 32 (1) of the Credit Information Use and Protection Act. <Amended on Aug. 11, 2020> |
| (3) | The heads of financial institutions, etc. in receipt of a request for the provision of financial information, etc. under paragraph (2) shall provide financial information, etc. of title holders, notwithstanding Article 4 of the Act on Real Name Financial Transactions and Confidentiality and Article 32 of the Credit Information Use and Protection Act. |
| (4) | The heads of financial institutions, etc. who provide financial information, etc. pursuant to paragraph (3) shall notify title holders of the fact that financial information, etc. are provided to the Commissioner of the Korea Disease Control and Prevention Agency; provided, where title holders give consent, the heads of financial institutions, etc. may choose not to make notification, notwithstanding Article 4-2 (1) of the Act on Real Name Financial Transactions and Confidentiality and Article 35 of the Credit Information Use and Protection Act. |
| (5) | An information and communications network under Article 2 (1) 1 of the Act on Promotion of Information and Communications Network Utilization and Information Protection shall be used to make a request for the provision of financial information, etc. and to provide financial information, etc. under paragraphs (2) and (3); provided, where unavoidable reasons such as damage to the information and communications network, etc. exist, this shall not apply. |
| (6) | Persons who are or have been engaged in the duties under paragraphs (2) and (3) shall not use the financial information, etc. that they have learned in the course of duties for a purpose other than that under this Act, or provide or divulge such information to other persons or institutions. |
| (7) | Matters necessary for requesting the provision of financial information, for providing financial information, etc. under paragraphs (2), (3) and (5) shall be prescribed by Presidential Decree. |
| (8) | The Commissioner of the Korea Disease Control and Prevention Agency may link and utilize the social security information system under Article 37 (2) of the Framework Act on Social Security in order to request and provide financial information, etc. under paragraphs (2), (3), and (5). <Added on Aug. 11, 2020> |
| Article 13-2 (Application for designation of rare disease) |
| (1) | A person, who intends to obtain designation of a rare disease for a disease not designated as a rare disease under this Act, may file an application with the Commissioner of the Korea Disease Control and Prevention Agency for the designation thereof. In such cases, the Commissioner of the Korea Disease Control and Prevention Agency shall notify the applicant of the results thereof. |
| (2) | Matters necessary for the procedures and methods for filing applications, notification, etc. under paragraph (1) shall be prescribed by Decree of the Ministry of Health and Welfare. |
[This Article Added on Jun. 13, 2023]
SECTION 3 Specialized Rare Disease Institutes
| Article 14 (Designation of specialized rare disease institutes) |
| (1) | The Commissioner of the Korea Disease Control and Prevention Agency may designate medical institutes meeting the requirements prescribed by Presidential Decree, such as facilities, personnel, etc., as a specialized rare disease institute, from among the medical institutes under Article 3 (2) 1 (a) of the Medical Service Act and subparagraph 3 (a) and (e) of that paragraph: <Amended on Aug. 11, 2020> |
| 1. | Treatment of rare disease patients; |
| 2. | Research on rare disease management; |
| 3. | Registration statistics projects; |
| 4. | Other projects prescribed by Decree of the Ministry of Health and Welfare, which are needed for rare disease management. |
| (2) | Matters necessary for the standards for designation and for cancellation of designation of a specialized rare disease institute, procedures therefor, methods thereof, etc. shall be prescribed by Decree of the Ministry of Health and Welfare. |
| (3) | Where an institute designated as a specialized rare disease institute falls under any of the following, the Minister of Health and Welfare may cancel the designation after conducting a hearing: |
| 1. | Where it falls short of standards for designation; |
| 2. | Where it does not implement duties under this Act; |
| 3. | Where it violates this Act, or disposition or an order under this Act. |
| (4) | Any specialized rare disease institute whose designation has been canceled under paragraph (3) shall not be re-designated as a specialized rare disease institute within two years from the date of cancellation of such designation. <Added on Apr. 30, 2019> |
| Article 15 (Evaluation of specialized rare disease institutes) |
| (1) | In order to improve the quality of medical services relating to rare diseases, the Commissioner of the Korea Disease Control and Prevention Agency may evaluate the quality and level of facilities, personnel, equipment, etc. of specialized rare disease institutes, present situation of treatment of rare diseases, etc. <Amended on Aug. 11, 2020> |
| (2) | The Commissioner of the Korea Disease Control and Prevention Agency may disclose the results of evaluation under paragraph (1), as prescribed by Decree of the Ministry of Health and Welfare. <Amended on Aug. 11, 2020> |
| (3) | The Commissioner of the Korea Disease Control and Prevention Agency may entrust the business affairs of evaluation under paragraph (1) to relevant institutions and organizations, as prescribed by Presidential Decree. <Amended on Aug. 11, 2020> |
| Article 16 (Development and dissemination of treatment methods) |
| (1) | The Commissioner of the Korea Disease Control and Prevention Agency shall endeavor to develop and disseminate effective and appropriate methods, etc. of preventing and treating rare diseases. <Amended on Aug. 11, 2020> |
| (2) | The Commissioner of the Korea Disease Control and Prevention Agency shall arrange support measures to promote the utilization of new technologies concerning the methods, etc. of preventing and treating rare diseases that have been developed pursuant to paragraph (1). <Amended on Aug. 11, 2020> |
| Article 17 (Cultivation of specialists) |
| (1) | The State and local governments shall endeavor to cultivate specialists relating to rare diseases. |
| (2) | In order to improve the quality of specialists relating to rare disease management projects, the Commissioner of the Korea Disease Control and Prevention Agency may implement education as prescribed by Decree of the Ministry of Health and Welfare. <Amended on Aug. 11, 2020> |
SECTION 4 Support for Development of Drugs
| Article 18 (Support for production and sale of drugs) |
| (1) | The State and local governments may provide necessary administrative and financial support to persons who produce or sell drugs or medical devices for the diagnosis and treatment of rare diseases. <Amended on Dec. 3, 2024> |
| (2) | The State and local governments may provide necessary administrative and financial support to persons who produce or sell food for patients with rare diseases whose ability to ingest, digest, absorb, or metabolize food is impaired, or who require restriction or supplementation of specific nutrients. <Added on Dec. 3, 2024> |
| (3) | The State and local governments may provide tax support for drugs and medical devices deemed necessary for the diagnosis and treatment of rare diseases, as prescribed by the Act on Restriction on Special Cases concerning Taxation and other statutes related to taxation. <Amended on Dec. 3, 2024> |
| (4) | The Commissioner of the Korea Disease Control and Prevention Agency may, if necessary for identifying the details of administrative and financial support under paragraphs (1) and (2), request the heads of relevant central administrative agencies or the heads of local governments to provide data or otherwise cooperate. In such cases, the head of a central administrative agency or the head of a local government in receipt of such request shall comply therewith, unless there is a compelling reason not to do so. <Added on Dec. 3, 2024> |
| (5) | A consultative body in which relevant central administrative agencies and related organizations participate shall be organized and operated to determine necessary matters including the recipients, scope, and procedures of support under paragraphs (1) and (2), and matters regarding the organization and operation of the consultative body shall be prescribed by Presidential Decree. <Amended on Dec. 3, 2024> |
[Title Amended on Dec. 3, 2024]
| Article 19 (Exceptions to Pharmaceutical Affairs Act) |
The Minister of Food and Drug Safety may apply the following exceptions to medications used for the purpose of diagnosing or treating rare diseases under this Act, which are determined by the Minister of Food and Drug Safety (hereinafter referred to as "orphan drug"):
| 1. | With regard to an application for marketing approval for an orphan drug to be manufactured or imported under Article 31 (2) and 42 (1) of the Pharmaceutical Affairs Act, he or she may grant approval in preference to other applications; |
| 2. | Notwithstanding Article 31 (11) of the Pharmaceutical Affairs Act, data and criteria for approval, approval conditions, etc. for an orphan drug may be separately determined according to the nature of the rare disease; |
| 3. | Notwithstanding Article 31-5 of the Pharmaceutical Affairs Act, the validity of marketing approval for an orphan drug may be set for 10 years; |
| 4. | Deleted; <Feb. 20, 2024> |
| 5. | Where a clinical trial of an orphan drug under Article 34 of the Pharmaceutical Affairs Act is implemented, support may be given to the preparation of a clinical trial protocol, recruitment of human subjects for the clinical trial, and implementation of an international joint clinical trial; |
| 6. | Fees for an application for approval, preliminary examination, permission, etc. under Article 82 of the Pharmaceutical Affairs Act may be abated. |
CHAPTER III SUPPLEMENTARY PROVISIONS
| Article 20 (Expense support) |
The State and local governments may subsidize all or part of the following expenses required for the management of rare diseases: <Amended on Jun. 13, 2023; Dec. 3, 2024>
| 1. | Expenses incurred in conducting research projects, registration statistics projects, and fact-finding surveys for rare diseases; |
| 2. | Expenses incurred in preventing, diagnosing, and treating rare diseases; |
| 3. | Expenses incurred in conducting education and training of specialists related to rare diseases and international exchange; |
| 4. | Education and publicity on rare diseases; |
| 5. | Expenses incurred for the establishment, designation, and operation of the rare disease support center and the designation and operation of specialized rare disease institutes; |
| 6. | Expenses incurred for education and publicity projects of corporations and organizations that conduct rare disease management projects. |
| 7. | Expenses incurred by medical institutions in submitting statistical data on rare diseases for registration. |
| Article 21 (Guidance and supervision) |
| (1) | Where needs arise for rare disease management, the Minister of Health and Welfare or the Commissioner of the Korea Disease Control and Prevention Agency may guide and supervise persons in charge of rare disease management on their duties, order them to make a report or to submit documents, or have affiliated public officials make inquiries of such persons or inspect relevant documents. <Amended on Aug. 11, 2020> |
| (2) | Any public official who conducts an inspection shall carry identification verifying his or her authority and present it to relevant persons. |
| Article 22 (Delegation or entrustment) |
| (1) | Part of the authority or business affairs of the Minister of Health and Welfare under this Act may be delegated to the Commissioner of the Korea Disease Control and Prevention Agency, the head of an agency under his or her jurisdiction, the Special Metropolitan City Mayor, a Metropolitan City Mayor, a Special Self-Governing City Mayor, a Do Governor, a Special Self-Governing Province Governor, or the head of a Si/Gun/Gu, or may be entrusted to a relevant corporation or organization, as prescribed by Presidential Decree. |
| (1) | Part of the authority or business affairs of the Commissioner of the Korea Disease Control and Prevention Agency under this Act may be delegated the Special Metropolitan City Mayor, a Metropolitan City Mayor, a Special Self-Governing City Mayor, a Do Governor, a Special Self-Governing Province Governor, or the head of a Si/Gun/Gu, or may be entrusted to a relevant corporation or organization, as prescribed by Presidential Decree. |
[This Article Wholly Amended on Aug. 11, 2020]
| Article 23 (Confidentiality) |
Persons who are engaged or have been engaged in rare disease management projects pursuant to this Act shall not divulge classified information learned in the course of duties, or use it for other purposes.
| Article 24 (Penalty provisions) |
Any person who falls under any of the following shall be punished by imprisonment for not more than three years or a fine not exceeding 30 million won:
| 1. | A person who uses financial information, etc. for other purposes or divulges them to other persons or institutions in violation of Article 13 (6); |
| 2. | A person who divulges classified information or uses it for other purposes in violation of Article 23. |
ADDENDA <Act No. 13667, Dec. 29, 2015>
Article 1 (Enforcement date)
This Act shall enter into force one year after the date of its promulgation.
Article 2 (Transitional measures concerning medical expense support)
The chronic renal failure, Parkinson's disease and (exudative) senile macular degeneration that have been qualified for medical expense support with regard to intractable and rare disease patients at the time this Act enters into force shall be deemed qualified for medical expense support under Article 12.
ADDENDUM <Act No. 16410, Apr. 30, 2019>
This Act shall enter into force on the date of its promulgation.
ADDENDA <Act No. 17472, Aug. 11, 2020>
Article 1 (Enforcement date)
This Act shall enter into one month after the date of its promulgation; provided, ... the amended provisions of any Act, which is amended under Article 4 of the Addenda and promulgated before this Act enters into force but the enforcement date of which has yet to arrive, shall enter into force on the enforcement date of such Act.
Articles 2 through 5 Omitted.
ADDENDUM <Act No. 19467, Jun. 13, 2023>
This Act shall enter into force 6 months after the date of its promulgation.
ADDENDA <Act No. 19844, Dec. 26, 2023>
Article 1 (Enforcement date)
This Act shall enter into force on the date of its promulgation.
Article 2 (Special cases concerning the National Health Insurance Act)
The amended provisions of Article 12-2 shall begin to apply where the State or a local government provides co-payment under Article 44 (1) of the National Health Insurance Act after January 1, 2024.
ADDENDA <Act No. 20328, Feb. 20, 2024>
Article 1 (Enforcement date)
This Act shall enter into force one year after the date of its promulgation. (Proviso Omitted.)
Articles 2 through 5 Omitted.
ADDENDUM <Act No. 20547, Dec. 3, 2024>
This Act shall enter into force 6 months after the date of its promulgation.