RARE DISEASE MANAGEMENT ACT

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 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 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 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.

RARE DISEASE MANAGEMENT ACT

Article 1(Purpose) #

Article 2(Definitions) #

Article 3(Responsibilities of the State) #

Article 4(Rare Disease Day) #

Article 5(Relationship to other statutes) #

Article 6(Comprehensive rare disease management plans) #

Article 7(Rare disease management committee) #

Article 8(Operation of rare disease support center) #

Article 9(Implementation of rare disease research projects) #

Article 10(Projects for statistics on registration of rare diseases) #

Article 11(Fact-finding surveys) #

Article 12(Medical expense support projects) #

Article 12-2(Special cases concerning the National Health Insurance Act) #

Article 13(Provision of financial information) #

Article 13-2(Application for designation of rare disease) #

Article 14(Designation of specialized rare disease institutes) #

Article 15(Evaluation of specialized rare disease institutes) #

Article 16(Development and dissemination of treatment methods) #

Article 17(Cultivation of specialists) #

Article 18(Support for production and sale of drugs) #

Article 19(Exceptions to Pharmaceutical Affairs Act) #

Article 20(Expense support) #

Article 21(Guidance and supervision) #

Article 22(Delegation or entrustment) #

Article 23(Confidentiality) #

Article 24(Penalty provisions) #