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SAFETY AND MANAGEMENT OF HUMAN TISSUE ACT — 법갈피

영문법령 / SAFETY AND MANAGEMENT OF HUMAN TISSUE ACT

SAFETY AND MANAGEMENT OF HUMAN TISSUE ACT

법률일부개정시행 2024-01-23식품의약품안전처,보건복지부 · 제20107호 · 공포 2024-01-23

CHAPTER I GENERAL PROVISIONS

Article 1(Purpose) #

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 the balanced supply and safety of human tissue, and contributing to the improvement of public health.

Article 2(Basic Ideology) #

(1) Donation, management, and transplant of human tissue shall be carried out in a humanitarian spirit.

(2) Expression of intention regarding donation of human tissue of a person shall be respected. In such cases, such intention shall be voluntary.

(3) A person needing 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 an ethically reasonable and medically accepted manner.

Article 3(Definitions) #

The terms used in this Act are defined as follows: <Amended on Jan. 27, 2005; Feb. 29, 2008; Jan. 18, 2010; Jan. 28, 2014; Feb. 4, 2016; Dec. 11, 2018>

1. The term "human tissue" means any of the following (hereinafter referred to as "tissue"), which is not an organ, etc. defined in subparagraph 1 of Article 4 of the Organs Transplant Act:

(a) Bones, cartilage, fasciae, skin, amnia, ligaments, and tendons;

(b) Heart valves and blood vessel;

(c) Body parts determined by Presidential Decree, which are recoverable and transplantable for a person's health, physical recovery, and prevention of disability;

2. The term "tissue donor" means a person who donates specific tissues for another person's functional recovery without compensation, and is registered as a tissue donor pursuant to Article 7-2 (1);

2-2. The term "candidate for tissue donation" means a person who has an intention to donate tissues at the time of death in the future, and is registered as a candidate for tissue donation pursuant to Article 7-2 (1);

Article 6(Human Tissue Safety and Management Advisory Committee) #

(1) A Human Tissue Safety and Management Advisory Committee (hereinafter referred to as the "Committee") shall be established within the Ministry of Health and Welfare to deliberate on the following matters, upon request for advice from the Minister of Health and Welfare and the Minister of Food and Drug Safety in connection with the donation, management, transplantation, etc. of tissues: <Amended on Feb. 29, 2008; Jan. 18, 2010; Jan. 28, 2014; Feb. 4, 2016>

1. Matters concerning the formulation of a basic policy on the donation, management, transplantation, etc. of tissues;

2. Matters concerning permission standards for tissue banks and operation thereof;

3. Matters concerning the operation of public tissue banks pursuant to Article 16-3 (hereinafter referred to as "public tissue bank") and the appropriation of tissue distribution;

4. Matters concerning plans for the management of imported tissues;

5. Matters concerning the review of the quality, testing or management of tissues (hereinafter referred to as "quality control");

6. Other matters submitted by the Minister of Health and Welfare for discussion in connection with the inspection, research, etc. of donation, management, and transplantation of tissues.

(2) The Committee shall be comprised of not more than 15 members, including one chairperson and one vice chairperson; the chairperson and the vice chairperson shall be elected by mutual vote among members; and members shall consist of the following persons. In such cases, members who are not public officials shall constitute a majority of the entire membership: <Newly Inserted on Dec. 11, 2018>

1. A person designated by the head of his or her affiliated institution from among public officials in Grade III or equivalent Grade or members of the Senior Executive Service who are engaged in the work of donating, managing, and transplanting tissues in the Ministry of Health and Welfare or the Ministry of Food and Drug Safety;

2. A person designated by the Minister of Health and Welfare from among persons who have broad knowledge and experience on donation, management and transplant of tissues.

(3) The term of office of a member under paragraph (2) 2 shall be two years. <Newly Inserted on Dec. 11, 2018>

(4) Other matters necessary for organization and operation of the Committee shall be prescribed by Presidential Decree. <Amended on Dec. 11, 2018>

Article 7-3(Designation of Tissue Donation Registry) #

(1) An entity intending to perform the duties of registration of tissue donors and candidates for tissue donation shall obtain designation of a tissue donation registry from the Minister of Health and Welfare after being equipped with facilities, human resources, etc. prescribed by Presidential Decree. The same shall apply to the modification of significant matters prescribed by Ordinance of the Ministry of Health and Welfare among the matters designated.

(2) Entities eligible for designation as a registry are as follows: <Amended on Feb. 4, 2016>

1. The State or local governments;

2. Medical institutions;

3. Nonprofit corporations established with the purpose of carrying on tissue donation and transplantation business;

4. Public institutions defined in Article 4 of the Act on the Management of Public Institutions.

(3) The duties of a registry shall be as follows:

1. Receipt and registration of tissue donors and notification of the result thereof to the National Tissue Donation Management Agency and the Minister of Food and Drug Safety;

2. Receipt and registration of candidates for tissue donation and notification of the result thereof to the National Tissue Donation Management Agency;

3. Management of personal information on tissue donors and candidates for tissue donation and provision of information related to donation;

4. Publicity and consultation with regard to tissue donation;

5. Other duties prescribed by Ordinance of the Ministry of Health and Welfare concerning registration of tissue donors and candidates for tissue donation.

(4) Notwithstanding paragraph (1), any of the following persons may perform the duties of a registry without taking any procedures for designation:

1. An entity designated as an organ transplantation registry pursuant to Article 13 of the Organs Transplant Act;

2. An entity authorized as a tissue bank pursuant to Article 13 (2) 1 and 2;

3. An entity designated as a tissue donation support institution.

(5) Other matters necessary for procedures for designation of registries, operation thereof, etc. shall be prescribed by Ordinance of the Ministry of Health and Welfare.

[This Article Newly Inserted on Jan. 28, 2014]

Article 10(Securing Safety of Tissues) #

(1) A tissue bank shall examine the availability of the tissue recovered and processed directly in Korea or the tissue imported from outside Korea for transplantation before distributing such tissue to another tissue bank or a medical institution performing tissue transplantation (hereinafter referred to as "tissue transplant hospital"), as prescribed by Ordinance of the Prime Minster. In such cases, if the tissue bank finds a tissue to be unavailable for distribution or transplantation, it shall destroy the tissue, as prescribed by Ordinance of the Prime Minister, and report the fact to the Minister of Food and Drug Safety. <Amended on Dec. 11, 2018>

(2) A tissue bank that intends to recover tissue shall inquire of the tissue donor or his or her survivor about his or her medical history and record of administered medicines. <Newly Inserted on Dec. 11, 2018>

(3) A tissue bank that intends to recover tissue shall request the Health Insurance Review and Assessment Service under the National Health Insurance Act (hereinafter referred to as "Review and Assessment Service") to inspect the medical history and record of administered medicines of a tissue donor. In such cases, the Review and Assessment Service shall comply with such request, without good cause, and notify the tissue bank of the result. <Newly Inserted on Mar. 18, 2014; Dec. 11, 2018>

(4) Notwithstanding paragraph (3), upon receipt of results of inspection from a tissue donation support institution pursuant to Article 16-2 (7), the tissue bank need not request the inspection of medical history and records of administered medicines from the Review and Assessment Service. <Newly Inserted on Mar. 18, 2014; Dec. 11, 2018>

(5) Upon inquiry under paragraph (2) or upon receipt of notice under paragraph (3) or (4), the tissue bank shall inspect whether a tissue falls under any of the subparagraphs of Article 9, and if the tissue bank finds the tissue to be unavailable for distribution or transplantation, it shall destroy such tissue as prescribed by Ordinance of the Prime Minister and report the fact to the Minister of Food and Drug Safety. <Newly Inserted on Mar. 18, 2014; Dec. 11, 2018>

(6) Notwithstanding the latter part of paragraph (1) and paragraph (5), a tissue bank may directly use a tissue unavailable for distribution and transplantation or supply it to another tissue bank that seeks to use it without destroying it, if it falls under any of the following. In such cases, the tissue bank shall report to the Minister of Food and Drug Safety the use and demand-supply status of the tissue, such as its use and quantity and the name of the tissue bank that uses or is supplied with it, as prescribed by Ordinance of the Prime Minister: <Newly Inserted on Dec. 11, 2018>

1. Where it is used for medical research for a person’s health, physical recovery, and prevention of disability;

2. Where it is used for evaluation, verification and management of the quality level of tissue.

(7) Matters necessary for the criteria for determining whether a tissue is available for transplantation under paragraph (1), the methods and procedures for inspection under paragraphs (2) through (5), and the methods and procedures for report under paragraph (6) shall be prescribed by Ordinance of the Prime Minister. <Amended on Feb. 29, 2008; Jan. 18, 2010; Mar. 23, 2013; Mar. 18, 2014; Dec. 11, 2018>

Article 15(Matters to Be Observed by Tissue Banks) #

(1) The head of a tissue bank shall observe matters prescribed by Ordinance of the Prime Minister for the safety of tissues, such as tissue management, quality assurance, etc. <Amended on Mar. 18, 2014>

(2) Where a tissue bank performs duties in cooperation with other tissue banks, their cooperative relationship and contractual relationship shall be clarified: Provided, That where it recovers tissues, it may use the facilities of other tissue banks or medical institutions, as prescribed by Ordinance of the Prime Minister. <Amended on Jan. 28, 2014>

(3) Where a tissue bank provides another tissue bank or tissue transplant hospital with tissues necessary for surgery, it shall follow non-profit principles: Provided, That the tissue bank may request that the other tissue bank or tissue transplant hospital reimburse the following expenses as prescribed by Ordinance of the Ministry of Health and Welfare: <Amended on Feb. 29, 2008; Jan. 18, 2010; Jan. 28, 2014>

1. Expenses incurred in donation, management, transplantation, etc.;

2. Expenses needed where tissues are not produced by the tissue bank which is a noncommercial corporation or medical institution.

(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 on Feb. 29, 2008; Jan. 18, 2010; Mar. 23, 2013>

(5) The head of a tissue bank shall have the personnel of the tissue bank who are to undergo education pursuant to paragraph (4), undergo education. <Newly Inserted on Mar. 18, 2014>

(6) Procedures for providing tissues, the scale of tissues to be stored, chief manager, report on the present condition of management and other necessary matters, shall be prescribed by Ordinance of the Prime Minister. <Amended on Feb. 29, 2008; Jan. 18, 2010; Mar. 23, 2013; Mar. 18, 2014>

(7) The head of a tissue bank shall seal the final containers or packages of tissues, the processing of which is completed so that transplantation is possible, as prescribed by Ordinance of the Prime Minister, and he or she shall not distribute tissues after opening the sealed containers or packages, or repacking them. <Newly Inserted on Mar. 18, 2014>

Article 16-2(Tissue Donation Support Institutions) #

(1) To support the stable supply of and demand for tissues, the Minister of Health and Welfare may designate tissue donation support institutions performing the following duties: <Amended on Feb. 4, 2016>

1. Management of potential tissue donors and discovery of tissue donor candidates in cooperation with other relevant institutions, such as tissue banks, medical institutions, organ procurement organizations, etc.;

2. Perusal of medical records to determine the availability for tissue donation by potential tissue donors (in such cases, the perusal shall be made by medical persons defined in Article 2 of the Medical Service Act);

3. Management of and support for tissue donors and their survivors;

4. Inspection, research and education concerning tissue donation;

5. Other duties prescribed by Ordinance of the Ministry of Health and Welfare for encouraging tissue donation.

(2) Entities qualified as a tissue donation support institution are as listed hereunder:

1. Medical institutions;

2. Non-profit corporations established with the main purpose of business related to tissue donation and transplant.

(3) Where an entity designated as a tissue donation support institution intends to modify the designation matters prescribed by Ordinance of the Ministry of Health and Welfare, it shall report such fact to the Minister of Health and Welfare.

(4) Entities intending to be designated as a tissue donation support institution shall have the facilities, human resources, etc. prescribed by Presidential Decree.

(5) A tissue donation support institution may request the Review and Assessment Service to inspect the medical history and record of administered medicines. In such cases, the Review and Assessment Service shall comply with the request without good cause, and notify the results thereof. <Newly Inserted on Mar. 18, 2014>

(6) A tissue donation support institution in receipt of notification under paragraph (5) may verify whether tissues fall under any subparagraph of Article 9. Where a donor's tissues are unavailable for distribution and transplant, it shall notify the relevant person, or family members or survivors thereof. <Newly Inserted on Mar. 18, 2014>

(7) Where a tissue donation support institution transfers tissue donors to a tissue bank, it shall notify the tissue bank of the result of verification under paragraph (6). <Newly Inserted on Mar. 18, 2014; Dec. 11, 2018>

(8) Article 10 (7) shall apply mutatis mutandis to matters necessary for the methods of inspection, procedures, etc. under paragraphs (5) through (7). <Newly Inserted on Mar. 18, 2014; Dec. 11, 2018>

(9) Where the family member or survivor of a potential tissue donor requests the provision of information and consultation regarding tissue donation, the head of a medical institution shall promptly inform the head of a tissue donation support institution of the fact. <Newly Inserted on Feb. 4, 2016>

(10) If necessary for the provision of information and consultation regarding tissue donation, the head of a tissue donation support institutions may request the head of an organ procurement organization to provide information on the name, gender, the date of birth of a potential brain-dead organ donor and persons who are subject to determination of brain death and the name of medical institutions where they are hospitalized. In such cases, the head of the organ procurement organization shall provide such information. <Amended on Feb. 4, 2016>

(11) Matters necessary for procedures for designation, and the management, etc. of tissue donation support institutions, shall be prescribed by Ordinance of the Ministry of Health and Welfare. <Amended on Mar. 18, 2014; Feb. 4, 2016>

[This Article Newly Inserted on Jan. 28, 2014]

Article 25(Revocation of Permission) #

(1) Where a tissue bank falls under any of following cases, the Minister of Food and Drug Safety may revoke the permission for the tissue bank or may fully or partially suspend operation of its business for a specified period of up to one year, as prescribed by Ordinance of the Prime Minister: Provided, That in cases falling under subparagraphs 6 and 7, the Minister of Health and Welfare may request the Minister of Food and Drug Safety to revoke the permission or to issue an order to fully or partially suspend operation of its business for a specified period of up to one year: <Amended on Feb. 29, 2008; Jan. 18, 2010; Mar. 23, 2013; Jan. 28, 2014; Mar. 18, 2014; Feb. 4, 2016; Dec. 11, 2018; Aug. 17, 2021>

1. Where it fails to examine the availability for transplantation or to destroy or report a tissue unavailable for distribution or transplantation, in violation of Article 10 (1);

1-2. Where it fails to request the inspection of the medical history and records of administered medicines of a tissue donor and verify the result of such inspection, or fails to destroy tissues unavailable for distribution or transplantation, in violation of the former part of Article 10 (3) or paragraph (5) of the same Article;

1-3. Where it fails to report the use and demand-supply status of a tissue, in violation of Article 10 (6);

2. Where it fails to have facilities, equipment, human resources, quality control system, etc. prescribed in the former part of Article 13 (1);

2-2. Where it fails to obtain permission for any modification of significant matters pursuant to the latter part of Article 13 (1);

2-3. Where it obtains permission, permission for modification, permission for renewal, approval, or approval for modification under Article 13 (1), 14 (2), or 17 (2) by fraud or other improper means;

3. Where it violates Article 13-2;

4. Where it violates Articles 15 and 15-2 through 15-4;

5. Where it fails to observe the matters in recovering tissues under Article 16 (1);

5-2. Where it fails to make registration or registration of modification, in violation of Article 17-2;

6. Where it fails to comply with an order under Article 23 (1) or refuses the inspection under paragraph (2) of the same Article;

7. Where it fails to comply with the corrective order under Article 24;

8. Where it fails to comply with the order under Article 24-2 (1) or (2).

(2) Where a registry or tissue donation support institution falls under any of the following cases, the Minister of Food and Drug Safety may revoke the designation or issue an order to fully or partially suspend operation of its business for a specified period of up to one year: <Newly Inserted on Jan. 28, 2014; Mar. 18, 2014>

1. Where it fails to meet the standards for facilities, human resources, etc. under Article 7-3 (1) or 16-2 (4);

2. Where it fails to take necessary measures, in violation of the latter part of Article 16-2 (6) or paragraph (7) of the same Article;

3. Where it fails to comply with the order under Article 23 (1) or refuses the inspection under paragraph (2) of the same Article;

4. Where it fails to comply with the corrective order under Article 24.

(3) Where a registry, tissue donation support institution or tissue bank operates its business in violation of an order for suspension under paragraphs (1) and (2), the Minister of Health and Welfare or the Minister of Food and Drug Safety may revoke the permission or designation. <Amended on Feb. 29, 2008; Jan. 18, 2010; Mar. 23, 2013; Jan. 28, 2014>

(4) Where permission or designation of a registry, tissue donation support institution or tissue bank is revoked pursuant to paragraphs (1) through (3), the registry, tissue donation support institution or tissue bank shall not obtain permission or designation within one year from the date of revocation of such permission or designation. <Amended on Jan. 28, 2014>

(5) Detailed criteria for administrative disposition under paragraph (1) shall be prescribed by Ordinance of the Prime Minister in consideration of the types, severity, etc. of violations. <Amended on Feb. 29, 2008; Jan. 18, 2010; Mar. 23, 2013; Jan. 28, 2014>

(6) Detailed standards for the administrative dispositions under paragraph (2) shall be prescribed by Ordinance of the Ministry of Health and Welfare in consideration of the types, severity, etc. of violations. <Newly Inserted on Jan. 28, 2014>

[Title Amended on Jan. 28, 2014]

Article 34(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 Jan. 28, 2014; Mar. 18, 2014; Feb. 4, 2016; Dec. 11, 2018; Aug. 17, 2021>

1. A person who manages or transplants tissues in violation of Article 5 (2);

2. A person who obtains designation deceitfully or otherwise fraudulently or makes modification without reporting, in violation of Article 7-3 (1) or 16-2 (1) and (3);

2-2. A person who distributes tissues falling under subparagraph 6 of Article 9 for transplantation to another person or who transplants such tissues;

2-3. A person who fails to examine the availability for transplantation or to destroy or report tissues unavailable for distribution or transplantation, in violation of Article 10 (1);

3. A person who fails to request the inspection of medical history or records of administered medicines or to verify the findings of such inspection or who fraudulently verifies the findings of such inspection, in violation of the former part of Article 10 (3) or paragraph (5) of the same Article;

4. A person who fails to report or destroy unavailable tissues, in violation of Article 10 (5);

5. Where a person other than a medical person peruses medical records, in violation of the proviso to Article 16-2 (1) 2;

6. A person who fails to take necessary measures, in violation of the latter part of Article 16-2 (6) or paragraph (7) of the same Article;

7. The head of a tissue bank who imports tissues without obtaining approval or approval for modification, in violation of Article 17 (2);

7-2. A person who obtains approval or approval for modification under Article 17 (2) by fraud or other improper means;

8. A person who divulges matters concerning tissue donors or recovered tissues, in violation of Article 22;

9. A person who fails to comply with the order pursuant to Article 24-2 (1) or (2);

10. An entity that uses the title "tissue bank" in its trade name or uses any label or advertisement by which it may be misunderstood as a permitted tissue bank, in violation of Article 29-2.

SAFETY AND MANAGEMENT OF HUMAN TISSUE ACT

Article 1(Purpose) #

Article 2(Basic Ideology) #

Article 3(Definitions) #

Article 4(Scope of Application) #

Article 5(Prohibition of Purchase or Sale of Tissue) #

Article 5-2(Responsibilities of the State) #

Article 6(Human Tissue Safety and Management Advisory Committee) #

Article 6-2(National Tissue Donation Management Agency) #

Article 7(Consent to Donate Tissues) #

Article 7-2(Registration of Tissue Donors) #

Article 7-3(Designation of Tissue Donation Registry) #

Article 8(Requirements for Recovery of Tissues) #

Article 9(Prohibition of Distribution or Transplantation of Tissues) #

Article 10(Securing Safety of Tissues) #

Article 11(Quality Control of Tissue Banks) #

Article 12(Priority Order for Distributing Tissues) #

Article 13(Permission for Tissue Banks) #

Article 13-2(Medical Managers) #

Article 13-3(Succession to Status) #

Article 13-4(Succession to Effect of Disposition of Administrative Sanctions) #

Article 14(Validity Period of Permission for Tissue Banks) #

Article 15(Matters to Be Observed by Tissue Banks) #

Article 15-2(Mark of Tissues and Matters to Be Indicated) #

Article 15-3(Matters to Be Entered on Accompanying Documents) #

Article 15-4(Caution in Indication) #

Article 16(Matters to Be Observed in Recovering Tissues) #

Article 16-2(Tissue Donation Support Institutions) #

Article 16-3(Public Tissue Bank) #

Article 17(Import of Tissues) #

Article 17-2(Registration of Producers of Exporting Countries) #

Article 18(Priority of Autopsy or Postmortem Examination) #

Article 19(Preparing and Reporting of Records) #

Article 20(Maintenance of Records) #

Article 21(Perusal of Records) #

Article 22(Confidentiality) #

Article 23(Reporting and Inspection) #

Article 24(Corrective Orders) #

Article 24-2(Orders of Collection and Destruction) #

Article 25(Revocation of Permission) #

Article 26(Report on Closure of Business and Transfer of Data) #

Article 26-2(Human Tissue Supervisors) #

Article 27(Projects to Aid Tissue Donation) #

Article 27-2(International Cooperation) #

Article 28(Delegation of Authority) #

Article 29(Obligation to Cooperate) #

Article 29-2(Prohibition against Use of Identical Titles) #

Article 29-3(Request for Data) #

Article 30(Hearings) #

Article 31(Cost-Bearing) #

Article 32(Penalty Provisions) #

Article 33(Penalty Provisions) #

Article 34(Penalty Provisions) #

Article 35(Concurrent Imposition of Suspension) #

Article 36(Joint Penalty Provisions) #

Article 37(Administrative Fines) #

Article 38 #