ORGANS TRANSPLANT ACT
Wholly Amended by Act No. 10334, May 31, 2010
Amended by Act No. 11005, Aug. 4, 2011
Act No. 11976, Jul. 30, 2013
Act No. 14928, Oct. 24, 2017
Act No. 15900, Dec. 11, 2018
Act No. 16256, Jan. 15, 2019
Act No. 17214, Apr. 7, 2020
CHAPTER I GENERAL PROVISIONS
The purpose of this Act is to prescribe matters concerning the donation of organs, etc. and matters necessary for the removal and transplantation of organs, etc. of a person for the purpose of restoring functions of organs, etc. of another person, and thus to ensure appropriate removal and transplants of organs, etc. and to contribute to improving national health.
| Article 2 (Fundamental Concepts) |
| (1) | Removal and a transplant of organs, etc. shall be performed in a humanitarian spirit. |
| (2) | Expressions of intent to donate one's own organs shall be respected. In such cases, such intent of a person who intends to donate organs, etc. shall be voluntary. |
| (3) | The opportunity to receive a transplant of organs, etc. shall be given equally to all people who are in need of a transplant of organs, etc. |
| (4) | Removal and a transplant of organs, etc. shall be performed in an ethically reasonable and medically accepted manner. |
| Article 3 (Respect for Donors of Organs) |
| (1) | The spirit of love and sacrifice of donors of organs, etc. for other persons shall be respected at all times. |
| (2) | No one shall treat any donor of organs, etc. with discrimination by reason of donation of organs, etc. |
| (3) | The State or a local government may request a person who is deemed to give disadvantage to or discriminate against any donor of organs, etc. in violation of paragraph (2) of the rectification thereof. |
The terms used in this Act are defined as follows: <Amended on Jan. 15, 2019; Apr. 7, 2020>
| 1. | The term "organs, etc." means any of the following, which needs transplants for the purposes of functional recovery of damaged or dead internal organs: |
| (a) | Kidney, liver, pancreas, heart, or lung; |
| (b) | Peripheral blood (limited to harvesting stem cells for a transplant), bone marrow, or an eyeball; |
| (c) | Hands, arms, feet, or legs as a composite of bones, skin, muscles, nerves, blood vessels, or the like; |
| (d) | Matters determined and publicly notified by the Minister of Health and Welfare, subject to deliberation by the Organ Transplant Ethics Committee pursuant to Article 8 (2) 4; |
| (e) | Other internal organs or tissue prescribed by Presidential Decree that can be removed and transplanted for functional recovery; |
| 2. | The term "donor of organs, etc." means a person who, being registered under Article 14, donates a specific organ, etc. from his or her body, without consideration, for the purposes of functional recovery of organs, etc. of another person; |
| 3. | The term "potential organ or tissue donor" means a person who has indicated his or her intention to donate organs, etc. in the future at the time of his or her brain death or death (including the time of his or her living in the case of peripheral blood or bone marrow), as registered pursuant to Article 15; |
| 4. | The term "potential recipient of organs, etc." means a person who registers under Article 14 to receive transplants of organs, etc. of another person for the purposes of functional recovery of his or her organs, etc.; |
| 5. | The term "living person" means a person, other than a brain-dead person, and the term "brain-dead person" means a person whose brain is diagnosed as having irreversibly and completely ceased to function in accordance with the criteria for determinations for brain death and the procedures for determinations for brain death under this Act; |
| 6. | The term "family member" or "surviving family member" means a relative of a living person, a brain-dead person, or a deceased person, who falls under any of the following items: Provided, That a person under 14 years of age is excluded therefrom: |
| (e) | First cousins or closer relatives, where a donor has no family member or surviving family member who falls under items (a) through (d). |
| Article 5 (Scope of Application) |
This Act shall apply to the organs, etc. removed and transplanted from living persons, etc. for the purposes of functional recovery of organs, etc. of other persons.
| Article 6 (Responsibility of the State and Local Governments) |
| (1) | The State and local governments shall guarantee equal opportunities to receive organ transplants for all persons who need organ transplants and shall endeavor to ensure appropriate removal and transplants of organs, etc. |
| (2) | The State and local governments shall perform the following activities to promote removal and transplants of organs, etc. within the budget: <Amended on Jul. 30, 2013> |
| 1. | Notation of being a person who wishes to be a donor of organs, etc. on certificates issued by the State and local governments, such as driver's licenses (limited to persons who want such notation, among those registered as a person who wishes to be a donor of organs, etc. under Article 15); |
| 2. | Aid for various advertising and public relations campaigns relating to donation and transplantation of organs, etc.; |
| 3. | Formulation and implementation of policies supporting donors of organs, etc.; |
| 4. | Education for medical personnel and persons working for medical institutions regarding donation and transplant of organs, etc. |
| Article 6-2 (Designation of Life-Sharing Week and Construction of Parks) |
| (1) | One week starting from a second Monday of every September shall be designated as the Life-Sharing Week, in order to honor the spirit of love and sacrifice of donors of organs, etc. for other persons and to disseminate the life-sharing culture. |
| (2) | The State and local governments may host commemorative events that meet the purport of the Life-Sharing Week. |
| (3) | The State and local governments may construct parks or sculptures to be used for educational purposes, such as honoring the spirit of love and sacrifice of donors of organs, etc. for other persons and disseminating the life-sharing culture. |
[This Article Newly Inserted on Oct. 24, 2017]
| Article 7 (Prohibition of Purchase or Sale of Organs) |
| (1) | No person shall give, receive or promise to give or receive money, any financial gain, or other consideration, to do any of the following acts: |
| 1. | Giving organs, etc. of another to a third person, receiving organs, etc. of another to give such organs, etc. to a third person, or promising to do either act; |
| 2. | Giving one's own organs, etc. to another, receiving organs, etc. of another to transplant into one's own body, or promising to do either act; |
| 3. | Abetting, assisting, or aiding another to do any act falling under subparagraph 1 or 2. |
| (2) | No person shall abet, assist, or aid another to do any act falling under paragraph (1) 1 or 2. |
| (3) | No person who learns of a violation of paragraph (1) or (2) shall remove or transplant organs, etc. involved in such violation. |
CHAPTER II ORGAN TRANSPLANT ETHICS COMMITTEE AND ORGAN TRANSPLANT MANAGEMENT AGENCY
| Article 8 (Organ Transplant Ethics Committee) |
| (1) | There is hereby established an Organ Transplant Ethics Committee (hereinafter referred to as the "Committee") in the Ministry of Health and Welfare to deliberate important matters regarding the removal and transplant of organs, etc. and determinations of brain death, etc. <Amended on Jan. 15, 2019> |
| (2) | The Committee shall deliberate on the following: <Amended on Jan. 15, 2019> |
| 1. | Matters relating to criteria for determinations of brain death; |
| 2. | Matters relating to the criteria for selection of organ, etc. transplant recipients (hereinafter referred to as "transplant recipient"); |
| 3. | Matters relating to the criteria for designation of organ transplant registration organizations under Article 13 (1), special institutions for management of the persons who are subjects of determination of brain death under Article 19 (1), organ procurement organizations under Article 20 (1), and organ transplant hospitals under Article 25 (1); |
| 4. | Scopes of organs, etc.; |
| 5. | Other matters submitted by the Minister of Health and Welfare to meetings in relation to removal and transplant of organs, etc. |
| Article 9 (Composition and Operation of Committee) |
| (1) | The Committee shall be comprised of not less than 15, but not more than 20 members, including the Chairperson, and members shall be appointed or commissioned by the Minister of Health and Welfare from among persons licensed to practice medicine or law, judges, public prosecutors, public officials, and other persons having abundant knowledge and good social standing. In such cases, members who are not public officials shall comprise a majority of the total members of the Committee. <Amended on Dec. 11, 2018> |
| (2) | The Chairperson shall be elected by the Committee from among its members. |
| (3) | An expert committee may be established for each area for efficiently operating the Committee. |
| (4) | Matters necessary for the composition, operation, etc. of the Committee and its expert committees shall be prescribed by Presidential Decree. |
| Article 10 (National Organ Transplant Management Agency) |
| (1) | In order to appropriately manage matters relating to transplantation of organs, etc., an organ transplant management agency (hereinafter referred to as the "National Organ Transplant Management Agency") shall be established, and the National Organ Transplant Management Agency shall be designated by Ordinance of the Ministry of Health and Welfare from among institutions under the Ministry of Health and Welfare. |
| (2) | Duties of the National Organ Transplant Management Agency shall be as follows: |
| 1. | Selection of transplant recipients; |
| 2. | Registration and management of persons who wish to be donors of organs, etc., and management of data relating to personal information and physical examination results of donors of organs, etc. and potential recipients of organs, etc.; |
| 3. | Guidance and supervision over organ transplant registration organizations under Article 13, institutions making determinations of brain death under Article 16, special organizations for management of subjects of brain death determination under Article 19, organ procurement organizations under Article 20, and organ transplant hospitals under Article 25; |
| 4. | Surveys and research on removal and transplants of organs, etc. and management of information and statistics, and public relations campaigns; |
| 5. | Other duties prescribed by Presidential Decree in relation to removal and transplantation of organs, etc. |
| (3) | Matters necessary for, among other things, the operation of the National Organ Transplant Management Agency shall be prescribed by Presidential Decree. |
CHAPTER III REMOVAL AND TRANSPLANTS OF ORGANS
SECTION 1 Common Provisions
| Article 11 (Prohibition of Removal and Transplants of Organs) |
| (1) | None of the following organs, etc. shall be removed nor transplanted: |
| 1. | Organs, etc. infected with a communicable pathogen unsuitable for transplantation of organs, etc.; |
| 2. | Organs, etc. affected by cancer cells; |
| 3. | Other organs, etc. at risk of causing harm to the life or body of a transplant recipient and prescribed by President Decree. |
| (2) | No organ, etc. shall be removed when a transplant recipient is not selected: Provided, That the same shall not apply to organs, etc., such as eyeballs, which may be transplanted long after removal and prescribed by Presidential Decree. |
| (3) | No organ, etc. shall be removed from any of the following living persons: Provided, That peripheral blood and bone marrow may be removed from a living person who falls under subparagraph 1: <Amended on Aug. 4, 2011; Apr. 7, 2020> |
| 1. | Persons under 16 years of age; |
| 2. | Pregnant women and persons for whom three months have not passed from the date of delivery; |
| 3. | Mentally ill persons and developmentally challenged persons; Provided, That this shall not apply to any person deemed by a mental health specialist to have the capacity to consent; |
| 4. | Persons addicted to narcotics, marijuana, or psychotropic drugs. |
| (4) | No organ, etc. (excluding peripheral blood and bone marrow) shall be removed from any living minor who is 16 years of age or older, except where the recipient is the living person's spouse, lineal ascendants and descendants, siblings, and first cousins or closer relatives. <Amended on Apr. 7, 2020> |
| (5) | Organs, etc. that may be removed from living persons shall be limited to the following: <Amended on Jan. 15, 2019; Apr. 7, 2020> |
| 1. | One of a pair of healthy kidneys; |
| 2. | Parts of organs, etc. prescribed by Presidential Decree, such as livers, peripheral blood, bone marrow, and lungs within medically acceptable bounds. |
| Article 12 (Consent to Donate Organs) |
| (1) | Consent of a donor of organs, etc. or a person who wishes to be a donor of organs, etc. or of his or her family member or surviving family member under this Act, relating to donation of organs, etc., shall be as follows: |
| 1. | Consent of the donor: Consent by means of documents signed by the donor or consent by means of a will under the provisions relating to wills under the Civil Act; |
| 2. | Consent of a family member or surviving family member: Written consent of one person having the highest priority on the priority list of family members and surviving family members under any item of subparagraph 6 of Article 4: Provided, that, where the person in the highest priority is a minor, consent of a family member or surviving family member who is not a minor and who is in the next highest priority, is required in addition to consent of the minor, and where the person in the highest priority is missing or is unable to give consent due to inevitable reasons prescribed by Presidential Decree, a person in the next highest priority may give consent thereto. |
| (2) | Where a family member or surviving family member refuses to give consent to the removal of any organ, etc. of a brain-dead person or deceased person under the proviso to Article 22 (3) 1, one person in the highest priority on the priority list of family members and surviving family members under any item of subparagraph 6 of Article 4 shall express such refusal. |
| (3) | Where one person in the highest priority is confirmed under paragraphs (1) 2 and (2) and more than two persons are in the highest priority group, the person who may give consent shall be determined by the degree of a relationship and seniority (the degree of a relationship is considered first). |
SECTION 2 Registration of Persons Who Wish to Be Donors of Organs, Donors of Organs and Potential Recipients of Organs
| Article 13 (Organ Transplant Registration Organizations) |
| (1) | An entity that intends to engage in activities relating to registration of donors of organs, etc., persons who wish to be donors of organs, etc., 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; |
| 4. | Non-profit corporations established mainly for the business concerning the donation and transplantation of organs, etc.; |
| (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 persons who wish to be 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 persons who wish to be donors of organs, etc., donors of organs, etc., or potential recipients of organs, etc., to the National Organ Transplant Management Agency; |
| 4. | Advertising and counselling 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 register as a donor of organs, etc. or potential recipient of organ, etc. shall apply to register with a registration organization, as prescribed by Ordinance of the Ministry of Health and Welfare: Provided, That where a donor of organs, etc. is a brain-dead person or deceased person, a family member or surviving family member may apply to register. |
| (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 surviving family member 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 Persons Who Wish to Be 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 persons who wish to be donors of organs, etc. and ex post facto management, may be allowed to be carried out 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 persons who wish to be 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. |
SECTION 3 Determinations of Brain Death
| 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 17 (Reporting on Suspected Brain-Dead Patients and Requesting on Determinations of Brain Death) |
| (1) | The head of a medical institution that treats a person suspected of brain-dead (hereinafter referred to as "suspected brain-dead patient") shall make notification to the head of an organ procurement organization under Article 20, and the head of the organ procurement organization so notified shall report it to the head of the National Organ Transplant Management Agency. |
| (2) | A person who desires a determination of brain death for donation of organs, etc. of a suspected brain-dead patient shall request determinations of brain death to the head of an institution determining brain death, attaching records of tests for the suspected brain-dead patient and medical references from a physician in charge of treatment, as prescribed by Ordinance of the Ministry of Health and Welfare. |
| (3) | Any of the following persons may request determinations of brain death pursuant to paragraph (2): |
| 1. | A family member of a suspected brain-dead patient; |
| 2. | A legal representative of a suspected brain-dead patient or a physician who treated the suspected brain-dead patient, where a suspected brain-dead patient has no family member; in such cases, request may be made only where the suspected brain-dead patient is a person who wishes to be a donor of organs, etc. under Article 15. |
| (4) | Criteria for suspected brain-dead patients that are liable for notification under paragraph (1) and procedures and methods necessary for reporting by the head of an organ procurement organization to the head of the National Organ Transplant Management Agency shall be prescribed by Ordinance of the Ministry of Health and Welfare. |
| 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 19 (Special Institutions for Management of Subjects of Determination of Brain Death) |
| (1) | The head of the National Organ Transplant Management Agency may designate special institutions for management of subjects of determination of brain death which may comprehensively perform activities relating to donation of organs, etc., determinations of brain death, and organ removal and transplant for suspected brain-dead patients. |
| (2) | An institution which may be designated as a special institution for management of suspected brain-dead patients pursuant to paragraph (1) shall meet all of the following requirements: |
| 1. | It must be a registration organization designated under Article 13 (1); |
| 2. | It must be an institution determining brain death, notified under Article 16; |
| 3. | It must be an organ transplant hospital designated under Article 25; |
| 4. | It must have facilities, equipment and human resources prescribed by Ordinance of the Ministry of Health and Welfare. |
| (3) | The procedure for designation and duties of a special institution for management of suspected brain-dead patients, and other necessary matters shall be prescribed by Ordinance of the Ministry of Health and Welfare. |
| Article 20 (Organ Procurement Organizations) |
| (1) | The Minister of Health and Welfare may designate organ procurement organizations which shall perform the activities of comprehension and management of the suspected brain-dead patients and subjects of determination of brain death, 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. |
| (2) | An institution which may be designated as an organ procurement organization shall be as follows: |
| 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 21 (Causes and Time of Death of Brain-Dead Persons) |
| (1) | When a brain-dead person dies due to removal of organs, etc. under this Act, the cause of death shall be deemed a disease or act causing brain death. |
| (2) | The time of death of a brain-dead person shall be the time when a brain death determination committee makes the determination on his or her brain death under Article 18 (2). |
SECTION 4 Removal and Transplants of Organs
| 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 surviving family members 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 surviving family member 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 23 (Matters to be Observed when Removing Organs) |
A physician who intends to remove organs, etc. shall comply with the following:
| 1. | He or she shall confirm consent given under Article 22 and approval under the latter part of Article 26 (3); |
| 2. | He or she shall confirm the identity of the donor, in cases of a living person, and shall fully explain the following items to the donor and his or her family member: |
| (a) | Condition of the donor of organs, etc.; |
| (b) | Details of organ removal surgery and possible effects on health; |
| (c) | Treatment plan after removal of organs, etc.; |
| (d) | Other matters which a donor of organs, etc. shall be notified of in advance in connection with removal of organs, etc. |
| Article 24 (Priority of Autopsy or Postmortem Examination) |
Where autopsy or postmortem examination is required under the Criminal Act or the Quarantine Act, no removal of relevant organs, etc. for transplantation may be performed before such autopsy or postmortem examination: Provided, That organs, etc. may be recovered with approval of a public prosecutor of a competent District Public Prosecutors' Office or its branch office and the director of a competent quarantine station and with consent of surviving family members, where a physician in charge of treatment finds that there is no correlation between organs, etc. to be recovered and the cause of death and that removal cannot be performed within a time frame that allows for removal, if delayed until after autopsy or postmortem examination.
| Article 25 (Organ Transplant Hospitals) |
| (1) | A medical institution intending to remove organs, etc. for transplantation or to transplant such organs shall obtain designation as an organ transplant hospital (hereinafter referred to as "transplant hospital") from the Minister of Health and Welfare. |
| (2) | A medical institution intending to obtain designation as a transplant hospital shall acquire facilities, equipment, and human resources prescribed by Presidential Decree. |
| (3) | No institution, other than transplant hospitals may recover organs, etc. for transplantation, or transplant such organs: Provided, That medical institutions, other than transplant hospitals, may recover organs, etc. if they have acquired facilities, human resources, equipment, etc. prescribed by Ordinance of the Ministry of Health and Welfare. |
| 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 surviving family members. |
| (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 surviving family members. <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 27 (Prohibition on Removal of Organs by Doctors Determining Brain Death) |
None of the following persons may participate in surgery to recover or transplant organs, etc. of a brain-dead person:
| 1. | A specialist who prepares a brain death examination report on a relevant brain-dead person and a physician who treated such brain-dead person; |
| 2. | A physician who attends a meeting of a brain death determination committee which makes a determination of brain death for a relevant brain-dead person. |
| Article 27-2 (Management of Persons Who Have Received Transplant of Organs Overseas) |
A person who has received a transplant of organs, etc. overseas shall submit documents describing matters prescribed by Ordinance of the Ministry of Health and Welfare, such as a medical institution where he or she received the transplant, to the National Organ Transplant Management Agency within 30 days after his or her return to Korea.
[This Article Newly Inserted on Apr. 7, 2020]
SECTION 5 Preparation and Perusal of Records
| Article 28 (Preparation of Records and Notifying Removal of Organs) |
| (1) | A physician who recovers or transplants organs, etc. shall prepare records of ex post facto progress of the transplant recipient, as prescribed by Ordinance of the Ministry of Health and Welfare, and shall submit such records to the head of a medical institution that recovers or transplants relevant organs, etc. |
| (2) | The head of a medical institution in receipt of records pursuant to paragraph (1) shall, as prescribed by Ordinance of the Ministry of Health and Welfare, notify the head of the National Organ Transplant Management Agency of the details of such records once every six months within one year, and once annually within one year, from the transplant: Provided, That this shall not apply where it is impractical to prepare and submit the records because of refusal of treatment, or other grounds prescribed by Ordinance of the Ministry of Health and Welfare. |
| (3) | The head of a medical institution that recovers organs, etc. of a brain-dead patient shall, without delay, give written notice to the chief of a competent District Public Prosecutors' Office or its branch office of such removal. |
| Article 29 (Retention of Records) |
| (1) | The head of an institution determining brain death shall retain certificates of determinations of brain death and minutes of meetings under Article 18 (4) and other records relating to determinations of brain death prescribed by Ordinance of the Ministry of Health and Welfare for 15 years. |
| (2) | The head of a medical institution shall retain records relating to removal or transplantation of organs, etc., and ex post facto progress of the transplant recipient under Article 28 (1), as prescribed by Ordinance of the Ministry of Health and Welfare. |
| (3) | The head of the National Organ Transplant Management Agency shall establish a database and systematically manage the records received pursuant to Article 28 (2). |
| Article 30 (Perusal of Records) |
The head of a medical institution shall allow perusal or issuance copies of records relating to removal or transplantation of organs, etc., in any of the following cases: Provided, That a request may be refused where a treating physician concludes that, if a person who donated organs, etc. or received a transplant learns of details of such records, it would substantially interfere with the person's treatment or removal:
| 1. | Where a person who donated organs, etc. or his or her family member or surviving family member requests perusal of, or issuance of copies of, records relating to removal of relevant organs, etc.; |
| 2. | Where a person who received a transplant or his or her family member or surviving family member requests perusal of, or issuance of copies of, records relating to transplantation of relevant organs, etc. |
| Article 30-2 (Compilation and Management of Statistics on Donation, Removal, and Transplant of Organs) |
| (1) | The Minister of Health and Welfare shall collect and analyze data on the donation, removal, transplant, etc. of organs, etc. in a continuous and systematic manner and compile and manage statistics thereon. In such cases, the Statistics Act shall apply mutatis mutandis to the collection of statistical data, the compilation of statistics, etc., and Article 58 (1) 1 of the Personal Information Protection Act shall apply to personal information to be processed for the purpose of producing statistics. |
| (2) | The Minister of Health and Welfare may request the following persons to submit data or to state opinions, etc. necessary for compiling and managing statistics under paragraph (1), as prescribed by Ordinance of the Ministry of Health and Welfare. In such cases, the persons in receipt of a request to submit data or to state opinions shall comply therewith unless there is good cause: |
| 1. | Medical personnel or medical institutions removing and transplanting organs, etc.; |
| 3. | A registration organization, an institution determining brain death, a special institution for management of the persons who are subjects of determination of brain death, or an organ procurement organization; |
| 4. | Other corporations, institutions, or organizations engaged in the business of donation, removal, or transplant of organs, etc. |
[This Article Newly Inserted on Jan. 15, 2019]
| Article 31 (Confidentiality) |
| (1) | No person employed at the National Organ Transplant Management Agency, a registration organization, an institution determining brain death (including a medical institution under Article 16 (5)), a transplant hospital (including a medical institution under the proviso to Article 25 (3)), or a special organization for management of subjects of determination of brain death, and who is persons prescribed by Presidential Decree, shall engage in any of the following acts with any person, other than those who engage in registration of donors of relevant organs, etc., management of subjects of determination of brain death, procurement, removal and transplantation of organs, etc., except as otherwise provided in this Act: |
| 1. | Revealing matters concerning donors of organs, etc. and recovered organs, etc.; |
| 2. | Revealing matters concerning transplant recipients and transplanted organs, etc.; |
| 3. | Revealing matters concerning persons who wish to be donors of organs, etc. and potential recipients of organs, etc. |
| (2) | Paragraph (1) shall not apply to any of the following cases: |
| 1. | Where a criminal investigative agency requests data relating to removal or transplantation of organs, etc. for a criminal investigation; |
| 2. | Where a judge orders submission of data relating to removal or transplantation of organs, etc., in connection with a trial; |
| 3. | Where a list of persons registered as persons who wish to be donors of organs, etc. is provided to agencies issuing relevant certificates in order to give notation as to being persons who wish to be donors of organs, etc. under Article 6 (2) 1; |
| 4. | Where a person who donated organs, etc. or a potential recipient of organs, etc. himself or herself agrees to provide the information for the purpose of public interest, such as public relations business for donation of organs, etc. |
CHAPTER IV ASSISTANCE FOR DONORS OF ORGANS
| 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 surviving family members of 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 may execute commemoration and honorable treatment projects for donors of organs, etc., or their surviving family members. <Newly Inserted on Oct. 24, 2017> |
| (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 surviving family members 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 33 (Assistance for National Organ Transplant Management Agency) |
The State or local governments may provide necessary budgets to the National Organ Transplant Management Agency, registration organizations, institutions determining brain death, special organizations for management of subjects of determination of brain death, organ procurement organizations, and transplant hospitals.
| Article 34 (Reporting and Inspections) |
| (1) | The Minister of Health and Welfare or the head of the National Organ Transplant Management Agency may issue necessary orders or may order reporting or submission of relevant documents to the heads of registration organizations, institutions determining brain death, special organizations for management of subjects of determination of brain death, organ procurement organizations, or transplant hospitals, or their employees, in connection with their duties, if deemed necessary for donation, removal, transplant, etc. of organs, etc. |
| (2) | The Minister of Health and Welfare or the head of the National Organ Transplant Management Agency may order relevant public officials to inspect relevant documents of registration organizations under paragraph (1). In such cases, relevant public officials in charge of inspection shall carry a certificate indicating their authority and present it. |
| (3) | In cases falling under paragraphs (1) and (2), the heads of registration organizations, institutions determining brain death, special organizations for management of subjects of determination of brain death, organ procurement organizations, or transplant hospitals, and their employees shall comply with such orders unless any justifiable ground exists. |
| Article 35 (Corrective Orders) |
Where the heads of registration organizations, institutions determining brain death, special organizations for management of subjects of determination of brain death, organ procurement organizations, or transplant hospitals, or their employees fall under any of the following subparagraphs, the Minister of Health and Welfare or the head of the National Organ Transplant Management Agency may order the head of a relevant organization to correct a violation within a set period of up to three months: <Amended on Jan. 15, 2019>
| 1. | Failing to notify registration of a donor of organs, etc. under Article 14 (3); |
| 2. | Failing to notify the results of registration and receipt of an application by a person who wishes to be a donor of organs, etc. under Article 15 (2) and (4); |
| 3. | Failing to immediately appear at a scene and study the condition of a subject of determination of brain death under Article 18 (1); |
| 4. | Failing to forward copies of certificates of determinations of brain death and minutes of meetings, etc. under Article 18 (5) to the head of the National Organ Transplant Management Agency; |
| 5. | Failing to comply with a matter to be observed under Article 20 (3); |
| 6. | Failing to prepare records of removal and transportation of organs, etc. and ex post facto progress of the transplant recipient of organs, etc. under Article 28 (1); |
| 7. | Failing to give notification under Article 28 (2) or (3). |
| 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., persons who wish to be 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 37 (Reporting and Notifying Closure of Organization and Transfer of Data) |
| (1) | When a registration organization, a special organization for management of subjects of determination of brain death, an organ procurement organization, or a transplant hospital intends to dissolve the organization or intends to discontinue registration of donors of organs, etc., persons who wish to be donors of organs, etc., management of subjects of determination of brain death, procurement of organs, or removal or transplantation of organs, it shall report to the Minister of Health and Welfare or the head of the National Organ Transplant Management Agency, as prescribed by Ordinance of the Ministry of Health and Welfare. |
| (2) | Upon receipt of a report under paragraph (1), the Minister of Health and Welfare or the head of the National Organ Transplant Management Agency shall review the report, and if it complies with this Act, he or she shall accept it. <Newly Inserted on Dec. 11, 2018> |
| (3) | When an institution determining brain death intends to discontinue making such determinations of brain death, it shall notify the head of the National Organ Transplant Management Agency thereof. <Amended on Dec. 11, 2018> |
| (4) | The head of a registration organization, an institution determining brain death, a special organization for management of subjects of determination of brain death, an organ procurement organization, or a transplant hospital which intends to dissolve the organization or intends to discontinue its activities under paragraph (1) or (3), or the head of a registration organization, an institution determining brain death, a special organization for management of subjects of determination of brain death, or an organ procurement organization which receives a suspension order or the designation of which is revoked under Article 36, shall transfer relevant data to the head of the National Organ Transplant Management Agency, as prescribed by Presidential Decree. <Amended on Dec. 11, 2018> |
CHAPTER Ⅵ SUPPLEMENTARY PROVISIONS
| Article 38 (Obligation to Cooperate) |
The Minister of Health and Welfare or the head of the National Organ Transplant Management Agency may request the head of a relevant agency to take measures necessary for safe and prompt removal, transportation, and transplantation of organs, etc. In such cases, the head of the relevant agency shall comply with such request unless there is good cause.
| Article 39 (Prohibition on Use of Name of National Organ Transplant Management Agency) |
No person, other than the National Organ Transplant Management Agency, registration organizations, institutions determining brain death, special organizations for management of subjects of determination of brain death, organ procurement organizations, or transplant hospitals under this Act shall use such names.
| Article 40 (Delegation of Authority) |
The Minister of Health and Welfare may delegate any part of his or her authority under this Act to the head of a subordinate agency, the Special Metropolitan City Mayor, a Metropolitan City Mayor, a Do Governor, the Governor of a Special Self-Governing Province, or the head of a Si/Gun/Gu (referring to the head of an autonomous Gu; hereinafter the same shall apply), as prescribed by Presidential Decree.
The Minister of Health and Welfare or the head of the National Organ Transplant Management Agency shall hold a hearing when he or she intends to take measures for revocation pursuant to Article 36 (1), (3) and (4).
| Article 42 (Responsibility for Costs of Removal and Transplantation of Organs) |
| (1) | Costs of removal and transplantation of organs, etc. shall be borne by the person receiving transplantation of relevant organs, etc.: Provided, That costs borne by the person receiving a transplant shall be prescribed by other Acts and subordinate statutes, if such other Acts and subordinate statutes expressly provide otherwise for payment of costs by persons receiving a transplant. |
| (1) | A person who intends to register as a potential recipient of organ, etc. shall pay fees to the head of a registration organization. |
| (2) | Matters necessary for amounts, etc. fees under paragraph (1) shall be prescribed by Ordinance of the Ministry of Health and Welfare. |
CHAPTER VII PENTALTY PROVISIONS
| Article 44 (Penalty Provisions) |
| (1) | Any of the following persons shall be punished by imprisonment with labor for an indefinite term or imprisonment with labor for a limited term of not less than two years: |
| 1. | A person who recovers or transplants an organ, etc. infected by a communicable pathogen, affected by cancer cells, or at risk of causing harm to the life or body of a transplant recipient, in violation of Article 11 (1); |
| 2. | A person who recovers an organ, etc. for which no transplant recipient has been selected, in violation of Article 11 (2); |
| 3. | A person who recovers an organ, etc. from a person falling under any subparagraph of Article 11 (3), in violation of the same paragraph; |
| 4. | A person who recovers an organ, etc. from a minor under 16 years of age, in violation of Article 11 (4); |
| 5. | A person who recovers an organ, etc. which may not be recovered from a living person, in violation of Article 11 (5); |
| 6. | A persons who recovers an organ, etc. from a person who is not determined brain dead under Article 18; |
| 7. | A person who determines brain death in violation of Article 18 (2); |
| 8. | A person who recovers an organ, etc. without obtaining consent of a donor, in violation of Article 22 (1) or (2); |
| 9. | A person who recovers an organ, etc. from a brain-dead patient, in violation of Article 22 (3). |
| (2) | A person who violates any subparagraphs of paragraph (1), thereby causing the death of another shall be punished by capital punishment, the imprisonment with labor for an indefinite term, or imprisonment with labor for a limited term of not less than five years. |
| Article 45 (Penalty Provisions) |
| (1) | A person who gives or receives or promises to give or receive an organ, etc., or a person who abets, assists, or aids in giving or receiving an organ, etc., in violation of Article 7 (1) 1 or 3, or who recovers or transplants an organ, etc., in violation of paragraph (3) of the same Article shall be punished by imprisonment with labor for a limited term of not less than two years. |
| (2) | A person who gives or receives or promises to give or receive an organ, etc., in violation of Article 7 (1) 2, or who abets, assists, or aids in any activity falling under paragraph (1) 1 or 2 of the same Article in violation of paragraph (2) of the same Article shall be punished by imprisonment with labor for not more than 10 years, or by a fine not exceeding 100 million won. In such cases, imprisonment with labor and a fine may be imposed concurrently. <Amended on Oct. 24, 2017> |
| (3) | A person who receives money, any financial benefit, or other consideration in relation to selection or approval of selection of a transplant recipient under Article 26 (1) through (3) shall be punished by imprisonment with labor for not more than 7 years or by a fine not exceeding 70 million won. In such cases, imprisonment with labor and a fine may be imposed concurrently. <Amended on Oct. 24, 2017> |
| (4) | Money or financial benefit received in committing any offense prescribed in paragraphs (1) through (3) shall be confiscated: Provided, That, where such confiscation is unfeasible, an amount equivalent to the value thereof shall be collected. |
| Article 46 (Penalty Provisions) |
| (1) | When a specialist under Article 18 (1) or a physician in charge of treatment falsely prepares a brain death examination report and makes a determination of brain death on a person who is not brain dead, he or she shall be punished by imprisonment with labor for a limited term of not less than one year. |
| (2) | A person who commits an offense prescribed in paragraph (1), thereby causing an injury to another shall be punished by imprisonment with labor for a limited term of not less than two years. |
| (3) | A person who commits an offense prescribed in paragraph (1), thereby causing death of another shall be punished by capital punishment, imprisonment with labor for an indefinite term, or imprisonment with labor for a limited term of not less than five years. |
| Article 47 (Penalty Provisions) |
| (1) | When a specialist under Article 18 (1) or a physician in charge of treatment negligently prepares a brain death examination report and makes a determination of brain death on a person who is not brain dead, he or she shall be punished by imprisonment without labor for not more than five years, or by a fine not exceeding 50 million won. <Amended on Oct. 24, 2017> |
| (2) | A person who commits an offense prescribed in paragraph (1), thereby causing an injury to another, shall be punished by imprisonment without labor for not more than seven years, or by a fine not exceeding 70 million won. <Amended on Oct. 24, 2017> |
| (3) | A person who commits an offense prescribed in paragraph (1), thereby causing death of another, shall be punished by imprisonment without labor for not more than 10 years, or by a fine not exceeding 100 million won. <Amended on Oct. 24, 2017> |
| Article 48 (Penalty Provisions) |
Any of the following persons shall be punished by imprisonment with labor for not more than five years, or by a fine not exceeding 50 million won: <Amended on Oct. 24, 2017>
| 1. | The head of a medical institution who makes a determination of brain death without notifying the head of the National Organ Transplant Management Agency, in violation of Article 16 (1), or who makes a determination of brain death during the period of suspension of determinations of brain death under Article 36 (2); |
| 2. | The head of a medical institution who makes a determination of brain death without acquiring facilities, equipment, or human resources under Article 16 (2) or (3) or without establishing a brain death determination committee: Provided, That this shall not apply where a brain death determination committee, installed in an institution determining brain death, makes determinations of brain death under the proviso of Article 16 (4); |
| 3. | A person who recovers an organ, etc. from a deceased person, in violation of Article 22 (3); |
| 4. | A person who recovers or transplants an organ, etc. in violation of Article 25 (3); |
| 5. | A person who selects a transplant recipient failing to comply with the criteria for selection of transplant recipients, in violation of the former part of Article 26 (1); |
| 6. | A person who selects a transplant recipient or transplants organs, etc. in violation of Article 26 (4); |
| 7. | A person who recovers an organ, etc. from a brain-dead person or participates in transplant surgery, in violation of Article 27. |
| Article 49 (Penalty Provisions) |
Any of the following persons shall be punished by imprisonment with labor for not more than three years, or by a fine not exceeding 30 million won: <Amended on Oct. 24, 2017>
| 1. | A person who fails to notify the grounds for selection of a transplant recipient and the results of such selection to the head of the National Organ Transplant Management Agency, in violation of the latter part of Article 26 (2); |
| 2. | A person who fails to give written notice of the removal of organs, etc. from a brain-dead person to the chief of a competent District Public Prosecutors' Office or its branch office, in violation of Article 28 (3); |
| 3. | A person who engages in any activity falling under any subparagraph of Article 31 (1), in violation of Article 31. |
| Article 50 (Penalty Provisions) |
Any of the following persons shall be punished by imprisonment with labor for not more than two years, or by a fine not exceeding 20 million won: <Amended on Oct. 24, 2017>
| 1. | A person who negligently recovers or transplants an organ, etc. infected by a communicable pathogen, affected by cancer cells, or unsuitable for transplantation, in violation of Article 11 (1); |
| 2. | A person who registers donors of organs, etc. without obtaining designation as a registration organization, in violation of Article 13 (1); |
| 3. | A person who fails to forward copies of a certificate of determinations of brain death and minutes of a meeting and relevant data to the head of the National Organ Transplant Management Agency, in violation of Article 18 (5); |
| 4. | A person who recovers an organ, etc. in violation of Article 24; |
| 5. | A person who selects a transplant recipient and donates an organ, etc. without obtaining approval from the head of the National Organ Transplant Management Agency, in violation of Article 26 (3); |
| 6. | A person who fails to prepare, or falsely prepares, records relating to removal or transplantation of organs, etc., in violation of Article 28 (1); |
| 7. | A person who fails to retain records relating to determinations of brain death, including certificates of determinations of brain death, for 15 years, in violation of Article 29 (1); |
| 8. | A person who fails to retain records relating to removal or transplantation of organs, etc., in violation of Article 29 (2). |
| Article 51 (Concurrent Imposition of Suspension of Qualification) |
Where a person who violates this Act is punished by imprisonment with labor for a limited term, suspension of qualifications for not more than 10 years may be concurrently imposed.
| Article 52 (Joint Penalty Provisions) |
When a representative of a corporation, or an agent, employee or other servant of the corporation or an individual commits an violation under Articles 45 (2) or (3), and 47 through 50 in connection with the business of the corporation or the individual, the corporation or the individual shall be punished by a fine under respective Articles, in addition to punishment of such violator: Provided, That the same shall not apply where such corporation or individual has not been negligent in giving due attention and supervision concerning the relevant duties to prevent such violation.
| 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 surviving family member, 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). |
| Article 54 (Procedures for Imposition and Collection of Administrative Fines) |
Administrative fines under Article 53 shall be imposed and collected by the Minister of Health and Welfare or the head of a subordinate agency.
ADDENDA <Act No. 10337, May 31, 2010>
| (1) | (Enforcement Date) This Act shall enter into force one year after the date of its promulgation. (Proviso Omitted.) |
| (2) | (Relationship with other Acts and Subordinate Statutes) Where other Acts and subordinate statues cite the previous provisions of the Internal Organs, etc. Transplant Act as at the time this Act enters into force, it shall be deemed a citation of the relevant provisions of this Act in lieu of the previous provisions, if provisions corresponding thereto exist herein. |
ADDENDA <Act No. 11005, Aug. 4, 2011>
Article 1 (Enforcement Date)
This Act shall enter into force one year after the date of its promulgation. (Proviso Omitted.)
Articles 2 through 4 Omitted.
ADDENDUM <Act No. 11976, Jul. 30, 2013>
This Act shall enter into force six months after the date of its promulgation.
ADDENDUM <Act No. 14928, Oct. 24, 2017>
This Act shall enter into force six months after the date of its promulgation.
ADDENDA <Act No. 15900, Dec. 11, 2018>
Article 1 (Enforcement Date)
This Act shall enter into force on the date of its promulgation: Provided, That the amended provisions of the latter part of Article 9 (1) shall enter into force three months after the date of its promulgation. Article 2 (Transitional Measures concerning Member Composition of Organ Transplant Ethics Committee)
| (1) | Where the Committee fails to meet the amended provisions of the latter part of Article 9 (1) as at the time of appointing or commissioning its members after this Act enters into force, it shall commission non-public official members until the requirements under the amended provisions are met. |
| (2) | The member composition of the Organ Transplant Ethics Committee shall be governed by the previous provisions until the amended provisions of the latter part of Article 9 (1) are met, pursuant to paragraph (1). |
ADDENDUM <Act No. 16256, Jan. 15, 2019>
This Act shall enter into force on the date of its promulgation: Provided, That the amended provisions of Article 30-2 shall enter into force six months after its promulgation.
ADDENDA <Act No. 17214, Apr. 7, 2020>
Article 1 (Enforcement Date)
This Act shall enter into force six months after the date of its promulgation.
Article 2 (Applicability to Management of Persons Who Have Received Transplant of Organs Overseas)
The amended provisions of Article 27-2 shall begin to apply to a person who has received a transplant of organs, etc. overseas after this Act enters into force.