ORGANS TRANSPLANT ACT

영문법령 불러오는 중…

ORGANS TRANSPLANT ACT — 법갈피

Article 13(Organ Transplant Registration Organizations) #

(1) An entity that intends to engage in activities relating to registration of donors of organs, etc., potential organ or tissue donors, and potential recipients of organs, etc. shall acquire facilities and human resources prescribed by Presidential Decree and shall obtain designation as an organ transplant registration organization (hereinafter referred to as "registration organization") from the Minister of Health and Welfare. In such case, the Minister of Health and Welfare may designate the types of organs, etc. such registration organization may register, as prescribed by Presidential Decree.

(2) Any of the following entities may be designated as a registration organization:

1. The State or a local government;

2. The Korean Red Cross established under the Organization of the Republic of Korea National Red Cross Act;

3. Medical institutions prescribed in Article 3 of the Medical Service Act (hereinafter referred to as "medical institution");

4. Non-profit corporations established mainly for the business concerning the donation and transplantation of organs, etc.;

5. Public institutions designated under Article 4 of the Act on the Management of Public Institutions (hereinafter referred to as "public institution").

(3) Duties of a registration organization shall be as follows: Provided, That duties concerning the registration of potential recipients of organs, etc. shall be performed by organ transplant hospitals prescribed in Article 25: <Amended on Oct. 24, 2017>

1. Duties concerning the receipt of applications for registration and enrollment of potential donors of organs, etc., donors of organs, etc., or potential recipients of organs, etc.;

2. Duties concerning the physical examinations of persons who intend to register as donors of organs, etc. or potential recipients of organs, etc.;

3. Notifying the results of receipt of application for registration and enrollment of potential donors of organs, etc., donors of organs, etc., or potential recipients of organs, etc., to the National Organ Transplant Management Agency;

4. Advertising and counseling to promote donation of organs, etc.;

5. Other duties prescribed by Presidential Decree relating to the receipt of application for registration and enrollment under paragraph (1).

(4) Matters concerning forms for registration and retention thereof shall be prescribed by Ordinance of the Ministry of Health and Welfare.

Article 14(Registration of Donors of Organs) #

(1) A person who intends to be registered as a donor of organs, etc. or potential recipient of organs, etc. shall file an application for registration with a registration agency, as prescribed by Ordinance of the Ministry of Health and Welfare: Provided, That if a donor of organs, etc. is brain dead or deceased, one of his or her family members or survivors or the head of an institution determining brain death under Article 16 (4) (limited to where a brain dead or deceased person has registered his or her wish to donate organs, etc. under Article 15) may file an application for registration. <Amended on Feb. 20, 2024>

(2) When the head of a registration organization receives an application under paragraph (1), he or she shall decide whether to allow registration based on the following criteria:

1. In cases of a donor of organs, etc.: Whether a donor, family member, or survivor gives consent under Articles 12 and 22 and whether, as the result of physical examination conducted by the head of the registration organization (referring to physical examination conducted by a medical institution designated by the head of the registration organization, where the registration organization is not a medical institution; hereinafter the same shall apply), a donor is determined suitable as a donor of organs, etc.: Provided, that physical examination may be omitted where results of physical examination that determines the suitability as a donor of organs, etc. already exists;

2. In cases of a potential recipient of organ, etc.: Whether a person is suitable as a potential recipient of organ, etc. as the result of physical examination conducted by the head of the registration organization.

(3) Where the head of a registration organization decides to allow registration under paragraphs (2), he or she shall complete registration and shall, without delay, notify the applicant and the head of the National Organ Transplant Management Agency of the registration.

(4) The head of the National Organ Transplant Management Agency shall determine items and methods of physical examination under paragraph (2) and other matters relating to physical examination after obtaining approval from the Minister of Health and Welfare.

(5) When a person registered revokes consent to donate organs, etc., the head of a registration organization shall immediately cancel the registration.

Article 15(Registration of Potential Donors of Organs) #

(1) A person who intends to donate organs, etc. when he or she becomes brain-dead or deceased (in the case of a person who intends to donate peripheral blood or bone marrow, including the time of his or her living) may apply for registration of his or her wishes to donate organs, etc. with a registration organization, as prescribed by Ordinance of the Ministry of Health and Welfare. <Amended on Apr. 7, 2020>

(2) When the head of a registration organization receives an application for registration of a person's wishes to donate organs, etc. under paragraph (1), he or she shall complete registration after confirming whether the applicant himself or herself has agreed on it, and shall without delay notify the applicant and the head of the National Organ Transplant Management Agency of the result of registration.

(3) Among the registration organizations, the State, local governments or public institutions shall receive the applications for registration only, as prescribed by Ordinance of the Ministry of Health and Welfare, and other matters, such as registration of potential donors of organs, etc. and ex post facto management, may be allowed to be performed by the head of the National Organ Transplant Management Agency.

(4) Where the head of the National Organ Transplant Management Agency is intended to perform duties of registration and ex post facto management, etc. of the potential donors of organs, etc. under paragraph (3), the State, local governments and public institutions shall notify the head of the National Organ Transplant Management Agency of the result of receipt of applications, as prescribed by Ordinance of the Ministry of Health and Welfare.

(5) Where the Head of the National Organ Transplant Management Agency is notified of the result of receipt of applications and completes relevant registration under paragraph (4), he or she shall without delay notify the applicant of the result of registration.

(6) When a person who has registered under paragraphs (2) and (5) withdraws his or her wishes to donate organs, etc., the head of a registration organization or the National Organ Transplant Management Agency shall immediately cancel the registration.

Article 16(Medical Institutions Determining Brain Death and Brain Death Determination Committee) #

(1) A medical institution which intends to engage in determinations of brain death for removal and transplant of organs, etc. shall notify the head of the National Organ Transplant Management Agency, as prescribed by Ordinance of the Ministry of Health and Welfare.

(2) A medical institution which intends to engage in determinations of brain death shall acquire facilities, equipment, and human resources prescribed by Ordinance of the Ministry of Health and Welfare before notification under paragraph (1) and shall establish a brain death determination committee at the medical institution.

(3) A brain death determination committee under paragraph (2) shall be comprised of not less than four, but not more than six members, including two or more specialists and one or more members other than the medical personnel under Article 2 (1) of the Medical Service Act (hereinafter referred to as "medical personnel"), as prescribed by Presidential Decree.

(4) No institution other than the medical institutions which give notification under paragraph (1) (hereinafter referred to as "institution determining brain death") shall engage in determinations of brain death for removal and transplantation of organs, etc.: Provided, That when it is intended to make a determination of brain death at a medical institution other than institutions determining brain death, it may be done by utilizing the brain death determination committee under paragraph (2).

(5) Where a brain death determination committee under paragraph (2) is utilized to make a determination of brain death at a medical institution other than institutions determining brain death under the proviso to paragraph (4), detailed matters concerning the procedures for determination of brain death, such as preparation of a brain death examination report, or submission of a certificate of determination of brain death and minutes of a meeting, etc. shall be prescribed by Presidential Decree.

(6) Matters necessary for operation, etc. of brain death determination committees shall be prescribed by Presidential Decree.

Article 18(Determinations of Brain Death) #

(1) Where a request for determinations of brain death is made under Article 17 (2), the head of an institution determining brain death shall, without delay, appear at the scene and study the condition of a suspected brain-dead patient who has become the subject of determination of brain death (hereinafter referred to as "subject of determination of brain death"), and shall make a request for determinations of brain death to a brain death determination committee, attaching a brain death examination report jointly made by two or more specialists and a physician in charge of treatment, as prescribed by Ordinance of the Ministry of Health and Welfare.

(2) A brain death determination committee in receipt of a request for determinations of brain death under paragraph (1) shall make a determination of brain death with attendance of a majority of the committee members, including two or more specialists and one or more members other than medical personnel, and unanimous consent of the members present. In such cases, criteria for determinations of brain death shall be prescribed by Presidential Decree.

(3) A brain death determination committee may require specialists and a physician in charge of treatment who have prepared a brain death examination report, to appear before the brain death determination committee and to express opinions, if deemed necessary for determination of brain death.

(4) Where a brain death determination committee makes a determination under paragraph (2), it shall issue a certificate of determination of brain death, which every member present signs or affixes name and seal, and minutes of a meeting, as prescribed by Presidential Decree, and shall submit them to the head of the institution determining brain death.

(5) When the head of a brain death determination committee receives a certificate of determination of brain death and minutes of a meeting under paragraph (4), he or she shall forward their copies and records prescribed by Ordinance of the Ministry of Health and Welfare to the head of the National Organ Transplant Management Agency and shall forward a copy of the certificate to the person who requested the determinations of brain death.

Article 20(Organ Procurement Organizations) #

(1) The Minister of Health and Welfare may designate organ procurement organizations which shall perform the activities of identification and management of the suspected brain-dead patients and subjects of determination of brain death, management and assistance in the process of determination of brain death and removal of organs, etc., encouragement to donate organs, etc., and support for donors of organs, etc. and their survivors. <Amended on Jun. 13, 2023>

(2) An institution which may be designated as an organ procurement organization shall be as follows:

1. Medical institutions;

2. A non-profit corporation established mainly for the business concerning the donation and transplantation of organs, etc.

(3) Any organ procurement organization shall comply with the following subparagraphs:

1. Upon receipt of the notification on a suspected brain-death, it shall take such proper measures to procure organs as moving out to the site promptly;

2. It shall not give false information to the family members of the brain-dead person to induce donation of organs, etc. nor compel donation thereof;

3. Other matters prescribed by Ordinance of the Ministry of Health and Welfare.

(4) Each organ procurement organization shall have a district under its jurisdiction and conclude an agreement with the institutions determining brain death located at the district under its jurisdiction to find out potential brain-dead persons. In such cases, the district under the jurisdiction of each organ procurement organization shall be prescribed by Ordinance of the Ministry of Health and Welfare.

(5) Each organ procurement organization shall have medical personnel specializing in procurement of organs who are capable of managing subjects of determination of brain death. In such cases, matters concerning qualification, etc. of medical personnel specializing in procurement of organs shall be prescribed by Presidential Decree.

(6) Medical personnel specializing in procurement of organs referred to in paragraph (5) may inspect the medical records of only the suspected brain-dead patients or subjects of determination of brain death notified of under Article 17 (1) and conduct the inspections and medical treatments prescribed by Presidential Decree.

(7) A person who intends to be designated an organ procurement organization shall acquire facilities, equipment, human resources, etc. prescribed by Presidential Decree.

(8) The procedure for designation and duties of organ procurement organizations, and other necessary matters shall be prescribed by Ordinance of the Ministry of Health and Welfare.

Article 22(Requirements for Removal of Organs) #

(1) Organs, etc. of a living person may be removed only when the living person gives consent thereto: Provided, That, in cases of removal of organs, etc. from a minor 16 years of age or older and of removal of peripheral blood or bone marrow from a minor under 16 years of age, consent of the donor himself or herself and the parents of the donor (or a legal representative of the donor if the donor has no parent and removal of peripheral blood or bone marrow is for transplant into the donor's sibling) shall be obtained together. <Amended on Apr. 7, 2020>

(2) In cases falling under the proviso to paragraph (1) and where one of the parents is missing or otherwise unable to give consent due to extenuating circumstances prescribed by Presidential Decree, consent shall be obtained from the other parent and one person in the highest priority on the priority list of family members and survivors referred to in any item of subparagraph 6 of Article 4.

(3) Organs, etc. may be recovered from brain-dead persons and deceased persons only in any of the following cases:

1. Where the donor gives consent to removal of organs, etc. before brain death or death: Provided, That the same shall not apply where the donor's family member or survivor clearly refuses to give consent to removal of organs, etc.;

2. Where it is not clear whether the donor gave consent to removal of organs, etc. before brain death or death and where the donor's family member or surviving member gives consent to removal of organs, etc.: Provided, That, where the donor is a minor under 16 years of age, his or her organs, etc. shall be recovered only when the consent of the donor's parents (one parent if the other parent is deceased, missing, or is otherwise unable to consent due to any unavoidable cause prescribed by Presidential Decree) is obtained.

(4) A person who gives consent under any of paragraphs (1) through (3) may revoke his or her consent to removal of organs, etc. anytime before the surgery for removal of organs, etc. begins.

Article 26(Selection of Transplant Recipients) #

(1) When the head of the National Organ Transplant Management Agency receives notification of registration of donors of organs, etc. pursuant to Article 14 (3), he or she shall select transplant recipients from among potential recipients of organs, etc. according to the criteria for selection of transplant recipients prescribed by Presidential Decree. In such cases, the head of the National Organ Transplant Management Agency shall notify the head of the registration organization with which the donors of organs, etc. or the transplant recipients registered, and the head of such registration organization shall immediately notify such selection to the registered donors of organs, etc. or the transplant recipients and their family members or survivors.

(2) Notwithstanding paragraph (1), the head of a transplant hospital may select transplant recipients, in cases of an eyeball or cases falling under subparagraph 1 (d) of Article 4 or where any unavoidable reason prescribed by Presidential Decree exists, such as when delay in selection of transplant recipients may substantially risk viability of organs, etc. In such cases, the head of the transplant hospital shall notify the reason and the selection to the head of the National Organ Transplant Management Agency and shall notify such selection to the head of a registration organization, the donor of organs, etc., the transplant recipients and their family members or survivors. <Amended on Jan. 15, 2019>

(3) Notwithstanding paragraph (1), a living person who is 16 years or older and intends to donate organs, etc. under Article 11 (4) or a living person who is under 20 years of age and intends to donate peripheral blood or bone marrow may select transplant recipients of his or her organs, etc. In such cases, except when the donor intends to donate peripheral blood or bone marrow to his or her family member or his or her spouse's family member, approval of the head of the National Organ Transplant Management Agency shall be obtained in advance according to the criteria and procedures prescribed by Ordinance of the Ministry of Health and Welfare. <Amended on Apr. 7, 2020>

(4) Selection of transplant recipients shall be made through the procedures for selection of transplant recipients of the National Organ Transplant Management Agency pursuant to paragraph (1), except when a case falls under paragraph (2) or (3) or Article 11 (4).

Article 32(Assistance for Donors of Organs) #

(1) The State may pay funeral expenses, medical expenses, etc. within the budget to any of the following persons: <Amended on Oct. 24, 2017>

1. Donors of organs, etc.;

2. Family members or survivors of donors of organs, etc.;

3. Employers of employees (referring to employees defined in Article 2 (1) 1 of the Labor Standards Act; hereafter in this Article the same shall apply) who are donors of organs, etc.

(2) Where a donor of organs, etc. who is an employee donates organs, etc., the head of the agency with which the employee is affiliated shall grant sick leave, if the employee is a public official, and the employer of the employee shall grant a paid leave, if the employee is not a public official, for the period of hospital stay needed for physical examination for donation of organs, etc. or for removal of organs, etc. <Amended on Jul. 30, 2013>

(3) The State and local governments may implement programs for the commemoration of and honorable treatment for donors of organs, etc. and survivors. In such cases, the State and local governments may entrust an organ procurement organization under Article 20 with the execution of the programs, as prescribed by Presidential Decree. <Newly Inserted on Oct. 24, 2017; Dec. 21, 2021>

(4) The head of the National Organ Transplant Management Agency may devise the standard guidelines on the method and procedure for funeral assistance, family management, such as counseling for family members or survivors of a brain-dead person or a deceased person, and ex post facto administration, and advise related organizations, such as a special organization for management of subjects of determination of brain death, an organ procurement organization, a transplant hospital, to comply therewith. <Newly Inserted on Dec. 11, 2018>

(5) Matters necessary for the scope of, and the procedure for, payment under paragraph (1), details of projects under paragraph (3), etc. shall be prescribed by Ordinance of the Ministry of Health and Welfare. <Amended on Oct. 24, 2017; Dec. 11, 2018>

Article 36(Revocation of Designation) #

(1) Where a registration organization, an organ procurement organization, or a transplant hospital falls under any of the following cases, the Minister of Health and Welfare may revoke designation or order suspension of activities relating to registration of donors of organs, etc., potential donors of organs, etc., to procurement of organs, and to removal or transplantation of organs, etc., for up to one year:

1. Failing to acquire facilities, equipment, or human resources under the former part of Article 13 (1), 20 (7) or 25 (2);

2. Registering organs, etc. ineligible for registration under the latter part of Article 13 (1);

3. Failing to comply with an order issued under Article 34 (1) or failing to cooperate with an inspection under paragraph (2) of the same Article;

(2) Where an institution determining brain death falls under any of the following cases, the head of the National Organ Transplant Management Agency may order suspension of determinations of brain death for up to three years: <Amended on Dec. 11, 2018>

1. Failing to acquire facilities, equipment, or human resources under Article 16 (2);

2. Failing to establish a brain death determination committee under Article 16 (2);

3. Making a determination of brain death in violation of Article 18;

4. Failing to comply with an order issued under Article 34 (1) or failing to cooperate with an inspection under paragraph (2) of the same Article;

5. Failing to comply with a corrective order Article 35;

6. Failing to notify discontinuation of making determinations of brain death under Article 37 (3);

7. Otherwise violating this Act or an order issued under this Act.

(3) Where a special organization for management of subjects of determination of brain death falls under any of the following cases, the head of the National Organ Transplant Management Agency may revoke designation or order suspension of management of suspected brain-death patients for up to one year:

1. Failing to fulfill the requirements under Article 19 (2);

2. Failing to comply with an order issued under Article 34 (1) or failing to cooperate with an inspection under paragraph (2) of the same Article;

3. Failing to comply with a corrective order under Article 35;

4. Failing to report on closure of organization or discontinuation of activities under Article 37 (1).

(4) Where a registration organization, a special organization for management of subjects of determination of brain death, an organ procurement organization, or a transplant hospital continues activities in violation of an order for suspension issued under paragraph (1) or (3), the Minister of Health and Welfare or the head of the National Organ Transplant Management Agency may revoke the designation thereof.

(5) A registration organization, a special organization for management of subjects of determination of brain death, an organ procurement organization, or a transplant hospital, the designation of which has been revoked under paragraph (1), (3), or (4), shall not obtain designation as a registration organization, a special organization for management of subjects of determination of brain death, an organ procurement organization, or a transplant hospital within one year after the date of revocation of designation.

Article 53(Administrative Fines) #

(1) Any of the following persons shall be subject to an administrative fine not exceeding five million won:

1. A person who fails to comply with a request for rectification, in violation of Article 3 (3);

2. A person who fails to record, or falsely records, ex post facto progress, in violation of Article 28 (1);

3. A person who fails to retain records of ex post facto progress, in violation of Article 29 (2).

(2) Any of the following persons shall be subject to an administrative fine not exceeding three million won: <Amended on Dec. 11, 2018>

1. A person who fails to notify the results of registration to the head of the National Organ Transplant Management Agency, in violation of Article 14 (3) or 15 (2);

2. A person who fails to notify of or report on a suspected brain-dead patient, in violation of Article 17 (1);

3. A person who fails to confirm consent, approval, or the identity of a donor or fails to provide necessary explanation, in violation of Article 23;

4. A person who fails to notify selection of a transplant recipient to a donor of organs, etc., a transplant recipient, and his or her family member or survivor, in violation of the latter part of Article 26 (1) or the latter part of paragraph (2) of the same Article;

5. A person who fails to transfer relevant data to the head of the National Organ Transplant Management Agency, in violation of Article 37 (4).

(3) Any of the following persons shall be subject to an administrative fine not exceeding two million won:

1. A person who fails to comply with an order under Article 34 (1) or who refuses, obstructs, or evades an inspection under paragraph (2) of the same Article;

2. A person who uses a name that includes the words "National Organ Transplant Management Agency," "registration organization," "institution determining brain death," "special organization for management of subjects of determination of brain death", "organ procurement organization", or "transplant hospital," in violation of Article 39.

(4) Any of the following persons shall be subject to an administrative fine not exceeding one million won: <Amended on Dec. 11, 2018>

1. A person who fails to cancel the registration, in violation of Article 14 (5) or 15 (6);

2. A person who fails to comply with a request for perusal of, or issuance of copies of, records, in violation of Article 30;

3. A person who fails to report or notify, as prescribed in Article 37 (1) or (3).

ORGANS TRANSPLANT ACT

Article 1(Purpose) #

Article 2(Fundamental Concepts) #

Article 3(Respect for Donors of Organs) #

Article 4(Definitions) #

Article 5(Scope of Application) #

Article 6(Responsibility of the State and Local Governments) #

Article 6-2(Designation of Life-Sharing Week and Construction of Parks) #

Article 7(Prohibition of Purchase or Sale of Organs) #

Article 7-2(Formulation of Master Plans) #

Article 8(Organ Transplant Ethics Committee) #

Article 9(Composition and Operation of Committee) #

Article 10(National Organ Transplant Management Agency) #

Article 11(Prohibition of Removal and Transplants of Organs) #

Article 12(Consent to Donate Organs) #

Article 13(Organ Transplant Registration Organizations) #

Article 14(Registration of Donors of Organs) #

Article 15(Registration of Potential Donors of Organs) #

Article 16(Medical Institutions Determining Brain Death and Brain Death Determination Committee) #

Article 17(Reporting on Suspected Brain-Dead Patients and Requesting on Determinations of Brain Death) #

Article 18(Determinations of Brain Death) #

Article 19(Special Institutions for Management of Subjects of Determination of Brain Death) #

Article 20(Organ Procurement Organizations) #

Article 21(Causes and Time of Death of Brain-Dead Persons) #

Article 22(Requirements for Removal of Organs) #

Article 23(Matters to be Observed When Removing Organs) #

Article 24(Priority of Autopsy or Postmortem Examination) #

Article 25(Organ Transplant Hospitals) #

Article 26(Selection of Transplant Recipients) #

Article 27(Prohibition on Removal of Organs by Doctors Determining Brain Death) #

Article 27-2(Management of Persons Who Have Received Transplant of Organs Overseas) #

Article 28(Preparation and Submission of Records) #

Article 29(Retention of Records) #

Article 30(Perusal of Records) #

Article 30-2(Compilation and Management of Statistics on Donation, Removal, and Transplant of Organs) #

Article 31(Confidentiality) #

Article 32(Assistance for Donors of Organs) #

Article 32-2(Support for Exchange Activities including Exchange of Correspondence between Donors of Organs and Persons Who Have Received Transplant of Organs) #

Article 33(Assistance for National Organ Transplant Management Agency) #

Article 34(Reporting and Inspections) #

Article 35(Corrective Orders) #

Article 36(Revocation of Designation) #

Article 37(Reporting and Notifying Closure of Organization and Transfer of Data) #

Article 38(Obligation to Cooperate) #

Article 38-2(Request for Data) #

Article 39(Prohibition on Use of Name of National Organ Transplant Management Agency) #

Article 40(Delegation of Authority) #

Article 41(Hearings) #

Article 42(Responsibility for Costs of Removal and Transplantation of Organs) #

Article 43(Fees) #

Article 44(Penalty Provisions) #

Article 45(Penalty Provisions) #

Article 46(Penalty Provisions) #

Article 47(Penalty Provisions) #

Article 48(Penalty Provisions) #

Article 49(Penalty Provisions) #

Article 50(Penalty Provisions) #

Article 51(Concurrent Imposition of Suspension of Qualification) #

Article 52(Joint Penalty Provisions) #

Article 53(Administrative Fines) #

Article 54(Procedures for Imposition and Collection of Administrative Fines) #