Safety, Management, Etc. Of Human Tissue Act


Published: 2013-03-23

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CHAPTER I GENERAL PROVISIONS
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 Article 1 (Purpose)   print
The purpose of this Act is to provide for matters necessary for donation, management and transplant of human tissue for the physical completion and recovery of biological functions, thereby promoting a balanced supply and safety of human tissue, and contributing to the improvement of public health.
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 Article 2 (Basic Ideology)   print
(1) Donation, management and transplant of human tissue shall be carried out in a humanitarian spirit.
(2) Expression of intentions regarding donation of human tissue of a person shall be respected. In such cases, such intention shall be voluntary.
(3) A person in need of a transplant of human tissue shall have an equal opportunity to receive transplant regardless of social or economic conditions.
(4) Donation, management and transplant of human issue shall be conducted in ethically reasonable and medically accepted manners.
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 Article 3 (Definitions)   print
The terms used in this Act shall be defined as follows: <Amended by Act No. 7375, Jan. 27, 2005; Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>
1. The term "human tissue" means any of the following items (hereinafter referred to as "tissue"), which is not an organ under subparagraph 1 of Article 3 of the Internal Organs, etc. Transplant Act:
(a) Bones, joints, myofascia, skin, amnion, ligament, and tendon;
(b) Heart valves and veins;
(c) Body parts which may be recovered and transplanted for a person's health, physical recovery and prevention of disability, and which may be determined by Presidential Decree;
2. The term "tissue donor" means a person who donates specific tissue without compensation under Ordinance of the Ministry of Health and Welfare;
3. The term "tissue transplant" means transplantation of tissue which is donated from a tissue donor and safety of which is guaranteed for the purpose of treatment of illness of a patient;
4. The term "tissue bank" means an institution authorized under Article 13 (1) for the management of tissue for the purpose of transplantation;
5. The term "tissue management" means recovery, storage, processing, preservation, and allocation of tissue;
6. Article 3 of the Internal Organs, etc. Transplant Act shall apply mutatis mutandis to the definitions of the terms "living donor," "brain-dead donor," "family," or "surviving family member."
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 Article 4 (Applicability)   print
This Act shall apply to tissues obtained from a living, brain-dead, or deceased person with respect to donation, management, or transplantation, which are produced in the Republic of Korea or imported from abroad, for the purposes of physical completion and recovery of biological functions: Provided, That any of the following subparagraphs shall be excluded: <Amended by Act No. 10564, Apr. 7, 2011>
1. Tissue for self-transplantation;
2. Types of items or items governed by the Pharmaceutical Affairs Act, the Medical Devices Act, and other statutes.
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 Article 5 (Prohibition of Purchase or Sale, etc. of Tissue)   print
(1) No one shall do or promise to do any of the following acts in exchange for money, financial gain, or other consideration:
1. Giving tissue of a brain-dead donor or a deceased donor to a third person, receiving such tissue to give to a third person, or promising to do either act;
2. Giving one's own tissue to another person, receiving tissue from another to transplant into one's own body, or promising to do either act;
3. Assisting another to do any act under subparagraph 1 or 2.
(2) No person aware of an act in violation of paragraph (1) shall manage or transplant any tissue relating to such act.
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 Article 6 (Human Tissue Safety and Management Advisory Committee)   print
(1) The Human Tissue Safety and Management Advisory Committee (hereinafter referred to as "Committee") shall be established within the Ministry of Health and Welfare, to deliberate on the following matters when the Minister of Health and Welfare requests consultation in connection with donation, management and transplantation of tissue: <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>
1. Matters concerning authorization criteria for tissue banks and their operation;
2. Matters concerning management plans for imported tissue;
3. Matters concerning accuracy evaluation of tissue quality, tissue testing, or tissue management (hereinafter referred to as "quality control").
4. Other matters submitted by the Minister of Health and Welfare in connection with surveys, research, etc. on donation, management and transplantation of tissue.
(2) Matters necessary for organization and operation of the Committee shall be prescribed by Presidential Decree.
CHAPTER II MANAGEMENT OF TISSUE
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 Article 7 (Consent to Donate Tissue)   print
(1) Article 11 of the Internal Organs, etc. Transplant Act shall apply mutatis mutandis to consent to donate tissue.
(2) Consent under paragraph (1) shall include the following matters: <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>
1. The period of preservation of tissue and other matters concerning such preservation;
2. Matters concerning the right of the person who consents to donation, such as withdrawal of consent, and confidentiality of information;
3. Other matters prescribed by the Ordinance of the Ministry of Health and Welfare.
(3) When consent under paragraph (1) is obtained, a person who intends to recover tissue shall fully explain matters under paragraph (2) in advance.
(4) Matters necessary for consent forms, preservation of tissue, etc. shall be prescribed by Ordinance of the Ministry of Health and Welfare. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>
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 Article 8 (Requirements for Recovery of Tissue)   print
(1) Tissue may be recovered from a brain-dead donor or a deceased donor only in cases falling under either of the following: Provided, That in cases of a mentally ill person or a mentally retarded person, tissue may be recovered only in cases under subparagraph 1:
1. Where a person consents to recovery of tissue before brain death or death: Provided, That cases where such person's family or surviving family members clearly express objection to recovery of tissue, etc. shall be excluded;
2. Where it is unclear whether a person consented or objected to recovery of tissue before brain death or death and the person's family or surviving family members consent to recovery of tissue: Provided, That the parents' consent to recovery is required where a person is under 16 years of age.
(2) Where tissue is recovered from a living donor, the persons' consent is required: Provided, That where tissue is recovered from a minor, the parent's consent is required in addition to the persons' consent.
(3) A person who consents to recovery under paragraphs (1) or (2) may withdraw his or her consent to recovery anytime before the onset of tissue recovery surgery.
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 Article 9 (Prohibition of Allocation or Transplant of Tissue)   print
No tissue falling under any of the following subparagraphs shall be allocated nor transplanted: <Amended by Act No. 7375, Jan. 27, 2005; Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>
1. Tissue infected or suspected of being infected with contagious diseases unsuitable for transplant, such as hepatitis B or C, syphilis, Acquired Immune Deficiency Syndrome;
2. Tissue from a donor having Alzheimer's disease or a degenerative neurological disease;
3. Tissue from a donor with uncertain cause of death;
4. Tissue from a donor exposed to hazardous substances;
5. Tissue from a donor whose cancer might have spread and affected such tissue;
6. Tissue that is equivalent to those under subparagraphs 1 through 5, that is deemed unsuitable for transplant due to risk of causing harm to the life or body of a transplant recipient, and that is determined as such by Ordinance of the Prime Minster.
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 Article 10 (Guarantee of Safety of Tissue)   print
(1) The Minister of Food and Drug Safety shall examine suitability of the tissue processed by domestic tissue banks and the tissue imported from outside Korea for transplantation, as prescribed by Ordinance of the Prime Minster, and shall order destruction of the tissue the safety of which is not ensured. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>
(2) The criteria for determination of the suitability of tissues for transplantation under paragraph (1) shall be prescribed by Ordinance of the Prime Minister. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>
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 Article 11 (Quality Control of Tissue Banks)   print
(1) The Minister of Food and Drug Safety may order a tissue bank to be subject to quality control and may disclose the results thereof. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>
(2) The procedures for quality control under paragraph (1), disclosure of the results of quality control, and other matters necessary for quality control shall be prescribed by Ordinance of the Prime Minister. <Amended by Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>
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 Article 12 (Priority for Tissue Transplant)   print
Where a tissue bank distributes tissue among medical institutions that perform tissue transplants (hereinafter referred to as "tissue transplant hospital"), such tissue bank shall apply the priority ranking for distribution in consideration of the gravity of the urgency and expected results of tissue transplant in medical respect.
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 Article 13 (Authorization for Tissue Bank)   print
(1) A person who intends to establish a tissue bank shall acquire the facilities, equipment, human resources, quality control system, etc. prescribed by Presidential Decree and shall obtain authorization from the Minister of Food and Drug Safety. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>
(2) A person falling under any of the following subparagraphs may be granted authorization for a tissue bank: Provided, That no person falling under subparagraph 3 or 4 shall not engage in tissue donation or tissue recovery:
1. Medical institutions under Article 3 of the Medical Service Act;
2. Non-profit corporations whose main purpose is to engage in business related to human tissue;
3. Tissue processing business operators;
4. Tissue importers.
(3) Tissue banks shall engage in the following activities:
1. Recovery, storage, processing, preservation and distribution of tissue;
2. Management of tissue donors, and public relations and consultation for tissue donation;
3. Selection of tissue donors and tissue quality assurance;
4. Other matters necessary for ensuring safety of tissue transplants prescribed by Presidential Decree.
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 Article 14 (Renewal of Authorization for Tissue Bank)   print
(1) The Minister of Food and Drug Safety may order an authorized tissue bank to renew its authorization every three years. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>
(2) Matter necessary for the criteria and procedures for authorization renewal under paragraph (1) shall be prescribed by Presidential Decree.
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 Article 15 (Tissue Bank Rules)   print
(1) A tissue bank shall comply with detailed operating guidelines prescribed by the Minister of Food and Drug Safety in order to endure tissue safety. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>
(2) Where a tissue bank carries out activities in cooperation with other tissue banks, their cooperative relationship and contractual relationship shall be clarified.
(3) A tissue bank shall comply with non-profit principles when providing tissue necessary for surgery to a tissue transplant hospital: Provided, That a tissue bank may demand that such tissue transplant hospital reimburse the costs of donation, management, transplant, etc., as prescribed by Ordinance of the Ministry of Health and Welfare. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>
(4) Medical personnel who handle tissue, and other workers, prescribed by Ordinance of the Prime Minister, both of whom are employed by a tissue bank shall receive the required training prescribed by Ordinance of the Prime Minister. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>
(5) The procedures for provision of tissue, the volume of preserved tissue, the persons in charge of management, the reporting of management status, and other necessary matters shall be prescribed by Ordinance of the Prime Minister. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>
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 Article 16 (Rules regarding Recovery of Tissue)   print
(1) A tissue bank which intends to recover tissue shall comply with the following subparagraphs:
1. A tissue bank shall confirm consent under Articles 7 and 8 (1) and (2);
2. A tissue bank shall fully explain the following matters to donors or persons who are authorized to give consent:
(a) Matters relating to the completion of questionnaires on medical history, blood serum test, etc.;
(b) Details of surgery for tissue recovery;
(c) Advance explanation of funeral procedures after tissue donation;
(d) Other matters a person must be aware of before tissue donation.
(2) The details of the procedures, matters to be explained and other necessary matters, which shall be complied with when explaining under paragraph (1) to donors and persons authorized to give consent, shall be prescribed by Ordinance of the Ministry of Health and Welfare. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>
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 Article 17 (Importation of Tissue)   print
(1) No one, other than tissue banks, may import tissue.
(2) Specific matters concerning tissue importation shall be prescribed by Presidential Decree.
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 Article 18 (Priority of Autopsy or Postmortem Examination)   print
No recovery of tissue shall be performed before autopsy or postmortem examination where an autopsy or a postmortem examination is required under the Criminal Act or the Quarantine Act: Provided, that tissue recovery may be performed with authorization from the prosecutor of a competent District Prosecutors' Office or its branch office or the director of a competent quarantine station and with consent of the surviving family members, where a medical personnel charged with medical care determines that there is no correlation between the tissue to be recovered and the cause of death and that, if recovery is delayed until after autopsy or postmortem examination, the effective time for tissue recovery may be elapsed.
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 Article 19 (Compilation, Reporting, etc. of Records)   print
(1) A tissue bank shall keep records of data relating to the donation, management and transplantation of tissue and report such data to the Minister of Food and Drug Safety annually, as prescribed by Ordinance of the Prime Minister. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>
(2) A tissue transplant hospital shall notify tissue banks of the results of transplant, as prescribed by Ordinance of the Prime Minister. The tissue bank so notified shall include such notice in its report submitted under paragraph (1). <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>
(3) Where any serious side effects prescribed by Ordinance of the Prime Minister, such as infection, occur in connection with a tissue transplant, tissue banks and tissue transplant hospitals shall immediately report such occurrence to the Minister of Food and Drug Safety. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>
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 Article 20 (Maintenance of Records)   print
The head of a tissue bank or tissue transplant hospital shall maintain the records relating to donation, management and transplantation of tissue for 10 years, as prescribed by the Minister of Health and Welfare. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010>
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 Article 21 (Perusal, etc. of Records)   print
Where a donor or a donor's surviving family member demands perusal of, or issuance of copies of, the records relating to recovery or transplant of relevant tissue, the head of the relevant tissue bank shall allow perusal or issue copies of the records of overall process of tissue donation or the records relating to transplant: Provided, That when a medical personnel making diagnosis determines that such act might seriously interfere with the treatment or recovery of a tissue donor or a tissue recipient, such medical personnel may refuse to allow perusal or issuance of copies of the records.
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 Article 22 (Confidentiality)   print
(1) Unless otherwise provided for in this Act, a person who is employed by a tissue bank or a tissue transplant hospital or who engages in business relating to donation, management or transplantation of tissue shall not convey information falling under any of the following subparagraphs to persons other than those who engage in business relating to recovery and transplant of tissue of a relevant tissue donor:
1. Matters concerning tissue donors and recovered tissue;
2. Matters concerning transplant recipients and transplanted tissue;
3. Matters concerning persons who wish to donate tissue.
(2) Paragraph (1) shall not apply to the following cases:
1. Where a criminal investigation agency requests data relating to recovery or transplant of tissue;
2. Where a judge requests, in connection with a trial, any data relating to recovery or transplant of tissue.
CHAPTER III SUPERVISION
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 Article 23 (Reporting, Inspection, etc.)   print
(1) The Minister of Health and Welfare or the Minister of Food and Drug Safety may issue necessary orders to the head of a tissue bank or a tissue transplant hospital or its employee in regard to his/her duties, or may order reporting or submission of relevant documents, if deemed necessary in relation to donation, management or transplant of tissue. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>
(2) The Minister of Health and Welfare or the Minister of Food and Drug Safety may order relevant public officials to inspect relevant documents of tissue banks, etc. under paragraph (1), as prescribed by Ordinance of the Prime Minister. In such case, the relevant public officials in charge of inspection shall carry an identification indicating their authority and present it to interested persons. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>
(3) The head of a tissue bank or a tissue transplant hospital or its employee shall comply with an order or cooperate with inspection under paragraphs (1) and (2), unless there is good cause to the contrary.
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 Article 24 (Corrective Orders)   print
Where the head of a tissue bank or a tissue transplant hospital or its employee falls under any of the following subparagraphs, the Minister of Health and Welfare or the Minister of Food and Drug Safety may order the head of a relevant organization to make corrections within a set period: <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>
1. Failing to file a report under Article 19;
2. Failing to maintain the records under Article 20.
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 Article 25 (Revocation of Authorization)   print
(1) Where a tissue bank falls under any of the following subparagraphs, the Minister of Food and Drug Safety may revoke the authorization for the tissue bank or may suspend all or part of its business for a fixed period of not more than one year, as prescribed by Ordinance of the Prime Minister: Provided, That in cases of subparagraphs 2 and 3, the Minister of Health and Welfare may request the Minister of Food and Drug Safety to revoke the authorization or to order the partial or complete suspension of the business for a fixed period of not more than one year. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>
1. Failure to put facilities, equipment, human resources, quality control system, etc. in place under Article 13 (1);
2. Failure to comply with an order issued under Article 23 (1) or failure to cooperate with inspection under paragraph (2) of the aforesaid Article;
3. Failure to comply with a corrective order under Article 24.
(2) Where a tissue bank carries out its business in violation of an order to suspend business issued under paragraph (1), the Minister of Food and Drug Safety may revoke authorization for such tissue bank. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>
(3) No tissue bank whose authorization is revoked under paragraph (1) or (2) may obtain authorization for tissue bank within one year after the date of revocation of such authorization.
(4) Detailed criteria for administrative dispositions under paragraph (1) shall be prescribed by Ordinance of the Prime Minister in consideration of the types and degree of violations. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>
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 Article 26 (Reporting Discontinuation of Business, etc. and Transfer of Data)   print
(1) Where a tissue bank intends to close its business, such tissue bank shall report to the Minister of Food and Drug Safety matters relating to tissue donors, processed and preserved tissue, etc. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>
(2) The head of a tissue bank which closes its business under paragraph (1) or whose authorization is revoked under Article 25 shall transfer relevant data to the Minister of Food and Drug Safety, as prescribed by Presidential Decree. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>
CHAPTER IV SUPPLEMENTARY PROVISIONS
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 Article 27 (Assistance for Tissue Banks, etc.)   print
The State or local governments may provide necessary assistance for tissue banks or tissue donors within budget limits.
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 Article 28 (Delegation of Authority)   print
The Minister of Health and Welfare or the Minister of Food and Drug Safety may delegate part of his/her authority under this Act to the head of a subordinate agency, the Special Metropolitan City Mayor, the Metropolitan City Mayor, the Special Self-Governing City Mayor, the Do Governor, the Governor of the 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. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>
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 Article 29 (Obligation to Cooperate)   print
The Minister of Health and Welfare, the Minister of Food and Drug Safety, or the head of a tissue bank may request the heads of relevant agencies to take measures necessary for the safe and swift recovery, transport or transplant of tissue. In such case, the heads of relevant agencies shall comply with such request unless there is there is good cause to the contrary. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>
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 Article 30 (Hearings)   print
When the Minister of Food and Drug Safety intends to revoke authorization for a tissue bank under Article 25, he/she shall hold a hearing. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9932, Jan. 18, 2010; Act No. 11690, Mar. 23, 2013>
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 Article 31 (Cost-bearing)   print
(1) A person who receives tissue transplant shall bear the costs of recovery and transplant of tissue: Provided, that the payment of such costs shall be made as prescribed by other statutes if such other statutes provide otherwise.
(2) The costs under paragraph (1) shall be calculated in accordance with the National Health Insurance Act: Provided, That calculation of costs not provided in the National Health Insurance Act shall be made as prescribed by Ordinance of the Ministry of Health and Welfare. <Amended by Act No. 9932, Jan. 18, 2010>
CHAPTER V PENALTY PROVISIONS
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 Article 32 (Penalty Provision)   print
A person who distributes tissue falling under any subparagraph of Article 9 for transplantation into another person or who transplants such tissue, in violation of Article 9, 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.
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 Article 33 (Penalty Provisions)   print
(1) A person who gives, receives, or promises to give or receive money, etc. and violates Article 5 (1) 1 or 3 shall be punished by imprisonment with labor for not more than seven years.
(2) A person who gives, receives, or promises to give or receive money, etc. and violates Article 5 (1) 2 shall be punished by imprisonment with labor for not more than five years or by a fine not exceeding 30 million won, or may be punished by both such fine and imprisonment with labor.
(3) Any exchange of money, financial gain, or other consideration in violation of paragraph (1) or (2) shall be confiscated: Provided, That in cases where such confiscation is not feasible, an amount equivalent to the value thereof shall be collected.
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 Article 34 (Penalty Provisions)   print
A person falling under any of the following subparagraphs shall be punished by imprisonment with labor for not more than two years or by a fine not exceeding 10 million won:
1. A person who manages or transplants tissue in violation of Article 5 (2);
2. A person who establishes a tissue bank without authorization, in violation of Article 13;
3. A person who conveys information relating to tissue donors or recovered tissue in violation of Article 22.
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 Article 35 (Concurrent Imposition of Suspension)   print
Where a person who violates this Act is punished by imprisonment with labor for a limited term, he/she may also be punished by suspension of qualification for not more than 10 years.
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 Article 36 (Joint Penalty Provision)   print
Where the representative of a corporation, or an agent, or employee of or other person employed by the corporation or an individual commits any violations described in Article 33 (2) or 34 in conducting the business affairs of the corporation or individual, the corporation or individual shall, in addition to punishing the violator accordingly, be subject to a fine prescribed in the relevant provisions: Provided, That this shall not apply where such corporation or individual has not been negligent in exercising due attention and supervision concerning the relevant business affairs to prevent such violations.<Amended by Act No. 10610, Apr. 28, 2011>
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 Article 37 (Administrative Fines)   print
(1) A person who falls under any of the following subparagraphs shall be subject to an administrative fine not exceeding five million won:
1. A person who fails to confirm consent or give full explanation, in violation of Article 16 (1);
2. A person who recovers tissue in violation of the main sentence of Article 18.
(2) A person who falls under any of the following subparagraphs shall be subject to an administrative fine not exceeding three million won:
1. A person who fails to keep records or file a report, in violation of Article 19;
2. A person who fails to maintain records, in violation of Article 20;
3. A person who fails to comply with a request for perusal of records or issuance of copies, in violation of the main sentence of Article 21;
4. A person who fails to comply with an order under Article 23 (1);
5. A person who fails to comply with an order under Article 24;
6. A person who fails to report or transfer data, in violation of Article 26.
(3) Administrative fines under paragraph (1) and (2) shall be imposed and collected by the Minister of Health and Welfare, the Minister of Food and Drug Safety, the head of an affiliated institution, the Special Metropolitan City Mayor, the Metropolitan City Mayor, the Self-Governing City Mayor, the Do Governor, the Governor of the Special Self-Governing Province, or the head of a Si/Gun/Gu as prescribed by Presidential Decree. <Newly Inserted by Act No. 11690, Mar. 23, 2013>
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 Article 38 Deleted. <by Act No. 11690, Mar. 23, 2013>   print
ADDENDA
(1) (Enforcement Date) This Act shall enter into force on January 1, 2005.
(2) (Preparation for Organization of Human Tissue Safety and Management Advisory Committee) The Minister of Health and Welfare may carry out necessary duties for the purpose of organizing the Human Tissue Safety and Management Advisory Committee under Article 6 before the Act enters into force.
(3) (Preparation for Establishment of and Authorization for Tissue Bank) The Minister of Health and Welfare and the heads of tissue banks may carry out duties necessary for the establishment and authorization of tissue banks under Article 13 before the Act enters into force.
ADDENDUM <Act No. 7375, Jan. 27, 2005>
This Act shall enter into force on the date of its promulgation.
ADDENDA <Act No. 8852, Feb. 29, 2008>
Article 1 (Enforcement Date)
This Act shall enter into force on the date of its promulgation. (Proviso Omitted.)
Articles 2 through 7 Omitted.
ADDENDA <Act No. 9932, Jan. 18, 2010>
Article 1 (Enforcement Date)
This Act shall enter into force two months after the date of its promulgation. (Proviso Omitted.)
Articles 2 through 5 Omitted.
ADDENDA <Act No. 10564, Apr. 7, 2011>
Article 1 (Enforcement Date)
This Act shall enter into force six months after the date of its promulgation. (Proviso Omitted.)
Articles 2 through 9 Omitted.
ADDENDUM <Act No. 10610, Apr. 28, 2011>
This Act shall enter into force on the date of its promulgation.
ADDENDA <Act No. 11690, Mar. 23, 2013>
Article 1 (Enforcement Date)
(1) This Act shall enter into force on the date of its promulgation.
(2) Omitted.
Articles 2 through 7 Omitted.