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RARE DISEASE MANAGEMENT ACT

Act No. 13667, Dec. 29, 2015

CHAPTER I GENERAL PROVISIONS
 Article 1 (Purpose)
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.
 Article 2 (Definitions)
The terms used in this Act shall be defined as follows:
1. The term "rare disease" means a disease that affects fewer than 20,000 people, or whose number of carriers is unknown because diagnosis of the disease is difficult, which is determined according to the procedures and standards prescribed by Ordinance 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 (Obligations of State, etc.)
(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 with the State and local governments in the rare disease management projects implemented by the State and local governments.
 Article 4 (Rare Disease Day)
(1) In order to enhance understanding of rare diseases among the people and to encourage the will to prevent, treat and manage rare diseases, May 23 of each year shall be designated as the Rare Disease Day.
(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 with Other Acts)
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/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 any justifiable reason exists.
 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 abundant 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, etc. of Rare Disease Support Center)
(1) For efficient rare disease management, the Minister of Health and Welfare shall establish a rare disease support center in the Korea Centers for Diseases Control and Prevention.
(2) The rare disease support center shall perform the following projects:
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. Other matters deemed to be necessary for rare disease management, which are prescribed by Ordinance of the Ministry of 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 Ordinance of the Ministry of Health and Welfare.
Section 2 Rare Disease Management Projects
 Article 9 (Implementation, etc. of Rare Disease Research Projects)
(1) The Minister of Health and Welfare 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 medications, etc.
(2) In order to efficiently implement the duties of planning, management, evaluation, etc. concerning specific and detailed matters on research projects, the Minister of Health and Welfare may have the rare disease support center under Article 8 perform the following duties:
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 Ordinance of the Ministry of Health and Welfare.
 Article 10 (Projects, etc. for Statistics on Registration of Rare Diseases)
(1) The Minister of Health and Welfare 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 the same Act.
(2) The Minister of Health and Welfare may request the following persons to submit data, to submit opinions, etc. necessary for registration statistics projects, as prescribed by Ordinance of the Ministry of Health and Welfare. In such case, the persons in receipt of a request to submit data shall comply therewith unless any justifiable reasons exist:
1. Medical personnel or medical institutes diagnosing and treating rare disease patients;
2. The National Health Insurance Corporation and the Health Insurance Review and Assessment Service under the National Health Insurance Act;
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 Minister of Health and Welfare deems needs exist for rare disease management, he/she may conduct a fact-finding survey.
(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 Projects)
(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 diagnosis and treatment of rare diseases, which derives from the budget or the National Health Promotion Fund under the National Health Promotion Act.
(2) Necessary matters concerning who are eligible for medical expense support, standards for support, methods of support, etc. under paragraph (1) shall be prescribed by Presidential Decree.
 Article 13 (Provision of Financial Information, etc.)
(1) A person who seeks medical expense support under Article 12 shall submit a document stating that he/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/her after he/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 Minister of Health and Welfare 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.
(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 Minister of Health and Welfare: Provided, That 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, Etc. 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, That 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.
Section 3 Specialized Rare Disease Institutes
 Article 14 (Designation, etc. of Specialized Rare Disease Institutes)
(1) The Minister of Health and Welfare 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 the same paragraph:
1. Treatment of rare disease patients;
2. Research on rare disease management;
3. Registration statistics projects;
4. Other projects prescribed by Ordinance 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 Ordinance 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.
 Article 15 (Evaluation of Specialized Rare Disease Institutes)
(1) In order to improve the quality of medical services relating to rare diseases, the Minister of Health and Welfare may evaluate the quality and level of facilities, personnel, equipment, etc. of specialized rare disease institutes, present situation of treatment of rare diseases, etc.
(2) The Minister of Health and Welfare may make public the results of evaluation under paragraph (1) as prescribed by Ordinance of the Ministry of Health and Welfare.
(3) The Minister of Health and Welfare may entrust the evaluation duties under paragraph (1) to relevant agencies or organizations as prescribed by Presidential Decree.
 Article 16 (Development, Dissemination, etc. of Treatment Methods)
(1) The Minister of Health and Welfare shall endeavor to develop and disseminate effective and appropriate methods, etc. of preventing and treating rare diseases.
(2) The Minister of Health and Welfare 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).
 Article 17 (Cultivation, etc. 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 Minister of Health and Welfare may implement education as prescribed by Ordinance of the Ministry of Health and Welfare.
Section 4 Support for Medication Development, etc.
 Article 18 (Support for Production and Sale of Medications, etc.)
(1) The State and local governments may give administrative and financial support to persons who produce or sell medications for the diagnosis and treatment of rare diseases.
(2) The State and local governments may give tax support to medications deemed to be necessary for the diagnosis and treatment of rare diseases as prescribed by tax-related Acts such as Restrictions of Special Taxation Act, etc.
(3) Necessary matters concerning who are eligible for support under paragraph (1), scope thereof, procedures therefor, etc. shall be prescribed by Presidential Decree.
 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 Articles 31 (2) and 42 (1) of the Pharmaceutical Affairs Act, he/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 ten years;
4. In the case of an orphan drug, marketing approval may be reviewed again within three months from the date ten years pass from the date the marketing approval is obtained, notwithstanding Article 32 of the Pharmaceutical Affairs Act. In such case, where the safety and efficacy of an orphan drug in the pediatric population is included as an item to be reviewed again, one-year extension may be made;
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 support following expenses, in whole or in part, necessary for rare disease management:
1. Expenses necessary in performing research projects, registration statistics projects and fact-finding surveys relating to rare diseases;
2. Expenses needed for the diagnosis and treatment of rare diseases;
3. Expenses needed for the education and training of professionals relating to rare diseases and for international exchanges;
4. Education and publicity of rare diseases;
5. Expenses needed for the establishment and designation of rare disease support centers and for the establishment and designation of specialized rare disease institutes;
6. Expenses needed for education and publicity projects of the corporations and organizations performing rare disease management projects.
 Article 21 (Guidance, Supervision, etc.)
(1) Where needs arise for rare disease management, the Minister of Health and Welfare 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.
(2) Public officials making an inspection shall carry an identification card indicating authority and present it to interested parties.
 Article 22 (Delegation and Entrustment of Authority)
(1) The Minister of Health and Welfare may delegate part of their authority under this Act to the director of the Korea Centers for Diseases Control and Prevention, Special Metropolitan City Mayor, Metropolitan City Mayors, Special Self-Governing Province Mayor, Do Governs, Special Self-Governing Province Governor or heads of Sis, Guns or Gus, as prescribed by Presidential Decree.
(2) The Minister of Health and Welfare may entrust part of their duties under this Act to relevant corporations or organizations as prescribed by Presidential Decree.
 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 (Penal 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
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.