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BIOETHICS AND SAFETY ACT
| BIOETHICS AND SAFETY ACT | No.21065 | 20251001 |
| BIOETHICS AND SAFETY ACT | No.20327 | 20240821 |
| BIOETHICS AND SAFETY ACT | No.16372 | 20191024 |
| BIOETHICS AND SAFETY ACT | No.15888 | 20190312 |
| BIOETHICS AND SAFETY ACT | No.15188 | 20171212 |
| BIOETHICS AND SAFETY ACT | No.14839 | 20170726 |
| BIOETHICS AND SAFETY ACT | No.14438 | 20161220 |
| BIOETHICS AND SAFETY ACT | No.13651 | 20151229 |
| BIOETHICS AND SAFETY ACT | No.12844 | 20141119 |
| BIOETHICS AND SAFETY ACT | No.12447 | 20140619 |
| BIOETHICS AND SAFETY ACT | No.11690 | 20130323 |
| BIOETHICS AND SAFETY ACT | No.11250 | 20130202 |
| BIOETHICS AND SAFETY ACT | No.10605 | 20110428 |
| BIOETHICS AND SAFETY ACT | No.9932 | 20100319 |
| BIOETHICS AND SAFETY ACT | No.9386 | 20100131 |
| BIOETHICS AND SAFETY ACT | No.9100 | 20081206 |
| BIOETHICS AND SAFETY ACT | No.8852 | 20080229 |
| BIOETHICS AND SAFETY ACT | No.8366 | 20070411 |
| BIOETHICS AND SAFETY ACT | No.7413 | 20050324 |
| BIOETHICS AND SAFETY ACT | No.7150 | 20050101 |
CHAPTER I GENERAL PROVISIONS
| Article 1 (Purpose) |
The purpose of this Act is to contribute to the improvement of national health and living quality by ensuring the bioethics and safety in biotechnology to prevent any infringement of human dignity and worth or risks to human health as well as by creating the conditions in which the biotechnology is capable of being developed and used for the purpose of preventing and treating human diseases.
| Article 2 (Definitions) |
The definitions of terms used in this Act shall be as follows: <Amended by Act No. 9100, Jun. 5, 2008>
| 1. | The term "biotechnology" means any science and technology identifying and utilizing biophenomena with respect to human embryos, cells, genes, etc.; |
| 2. | The term "embryo" means any fertilized ovum and any group of divided cells from such fertilization through the time when all organs are embryologically formed; |
| 3. | The term "residual embryos" means embryos that are produced by artificial insemination and that remain after being used for pregnancy; |
| 4. | The term "act of transplanting the nucleus of a somatic cell" means transplanting the nucleus of a human somatic cell to a human ovum the nucleus of which is removed; |
| 5. | The term "somatic cell cloning embryo" means any embryo that is produced by transplanting the nucleus of a somatic cell; |
| 6. | The term "genetic testing" means analyzing chromosomes, genes, etc. from objects of testing such as blood, hair or saliva for the purpose of distinguishing personal identity or testing for any specific disease or predisposition; |
| 7. | The term "genetic data" means any information which is acquired as a result of genetic testing; |
| 8. | The term "gene bank" means any institution which collects and maintains genetic data including objects of genetic testing, genes or any other personal information (hereinafter referred to as "genetic data, etc.") for the purpose of owning them, and uses them directly or provides them to other persons; |
| 9. | The term "gene therapy" means a series of acts which cause any genetic mutation for the purpose of preventing or treating diseases; |
| 10. | The term "stem cell line" means a cell line that can be constantly grown under the culturable conditions and that can be differentiated into diverse types of cells. |
| Article 3 (Scope of Application) |
Except as otherwise provided in other Acts, this Act shall apply to the bioethics and safety in biotechnology.
| Article 4 (Responsibilities) |
| (1) | The State or local governments shall take necessary measures to efficiently deal with those matters concerning bioethics and safety which are likely to be caused in the course of developing or using biotechnology. |
| (2) | Any person who intends to research, develop and use biotechnology shall ensure that it does not infringe upon human dignity and worth and is compatible with bioethics and safety. |
| Article 5 (Right to Self-Determination) |
Any person shall, if he/she becomes subject to the application of biotechnology, have a right to determine whether or not to consent to such application after hearing a full explanation for bioethics and safety.
CHAPTER II NATIONAL BIOETHICS COMMITTEE AND INSTITUTIONAL BIOETHICS COMMITTEE
| Article 6 (Establishment and Functions of National Bioethics Committee) |
| (1) | Under the President, there shall be established the National Bioethics Committee (hereinafter referred to as the "National Committee)to deliberate on the following matters concerning the bioethics and safety in biotechnology: |
| 1. | Matters concerning the establishment of national policies respecting bioethics and safety; |
| 2. | Matters concerning the categories, objects and scope of research for which residual embryos may be used under subparagraph 3 of Article 17; |
| 3. | Matters concerning the categories, objects and scope of research for which an act of transplanting the nucleus of a somatic cell may be performed under Article 22 (2); |
| 4. | Matters concerning the categories of such genetic testing as is prohibited under Article 25 (1); |
| 5. | Categories of diseases with respect to which the gene therapy is permitted under Article 36 (1) 3; |
| 6. | Other matters concerning the research, development or use of biotechnology likely to have serious ethical or social effects which the Chairperson of the National Committee refers to the National Committee for deliberation. |
| (2) | The Chairperson of the National Committee shall refer the matters which fall under paragraph (1) 1 through 5 and which are proposed by 1/3 or more of all the incumbent members to the National Committee for deliberation. |
| Article 7 (Composition of National Committee) |
| (1) | The National Committee shall be comprised of not less than sixteen nor more than twenty-one members, including one Chairperson and one Vice-Chairperson. |
| (2) | The Chairperson of the National Committee shall be appointed or commissioned by the President from among the members thereof, and the Vice-Chairperson shall be elected from among those members. |
| (3) | The members of the National Committee shall be the following persons: <Amended by Act No. 7413, Mar. 24, 2005; Act No. 8852, Feb. 29, 2008> |
| 1. | The Minister of Education, Science and Technology, the Minister of Justice, the Minister of Knowledge Economy, the Minister of Health, Welfare and Family Affairs, the Minister of Gender Equality, and the Minister of Government Legislation; |
| 2. | Seven or less persons who are commissioned by the President from among those persons of much professional knowledge and research experience on life sciences or medicine who represent academic circles, research circles or industrial circles; |
| 3. | Seven or less persons who are commissioned by the President from among those who represent religious, philosophical, ethical, social science or legal circles, non-governmental organizations (meaning nonprofit non-governmental organizations defined in Article 2 of the Assistance for Non-profit Non-Governmental Organizations Act) or women; |
| (4) | The term of office of the members of the National Committee who fall under paragraph (3) 2 and 3 shall be three years, and they may be consecutively commissioned. |
| (5) | The National Committee shall have two secretaries, who shall be the Minister of Education, Science and Technology and the Minister of Health, Welfare and Family Affairs and the chief secretary shall be the latter. <Amended by Act No. 8852, Feb. 29, 2008> |
| Article 8 (Operation of National Committee) |
| (1) | Under the National Committee, there may be established specialized committees to operate the National Committee efficiently. |
| (2) | General affairs of the National Committee shall be dealt with by the chief secretary. |
| (3) | The meetings and other activities of the National Committee shall be made public in principle. |
| (4) | Except as provided for in this Act, the composition and operation of the National Committee and a specialized committee and other necessary matters shall be provided for by Presidential Decree. |
| Article 9 (Establishment and Functions of Institutional Bioethics Committee) |
| (1) | An institution which falls under any of the following subparagraphs shall establish an institutional bioethics committee (hereinafter referred to as the "institutional committee") to ensure the bioethics and safety in biotechnology: <Amended by Act No. 9100, Jun. 5, 2008> |
| 1. | A medical institution to produce embryos designated by the Minister of Health, Welfare and Family Affairs under Article 14 (1); |
| 2. | An embryo research institute registered with the Minister of Health, Welfare and Family Affairs under Article 18; |
| 3. | A research institute for somatic cell cloning embryos registered with the Minister of Health, Welfare and Family Affairs under Article 23; |
| 4. | A genetic testing institute reported to the Minister of Health, Welfare and Family Affairs under Article 24 (1); |
| 5. | A gene bank permitted by the Minister of Health, Welfare and Family Affairs under the main sentence of Article 32 (1); |
| 6. | A gene therapy institute reported to the Minister of Health, Welfare and Family Affairs under Article 37 (1); |
| 7. | Any other institution which studies, develops or uses biotechnology which may have serious ethical or social effects and is provided for by Ministerial Decree of Health, Welfare and Family Affairs. |
| (2) | An institutional committee shall deliberate on the following matters concerning the research, development or use of biotechnology which is carried out by an institution falling under any subparagraph of paragraph (1): |
| 1. | Ethical and scientific validity of written plans for research on biotechnology; |
| 2. | Whether or not to obtain, in accordance with due process of law, the consent of patients or those persons who provide spermatozoa, ova or objects of genetic testing; |
| 3. | Measures for the safety of patients, persons providing spermatozoa, ova or objects of genetic testing, or those from whom the genetic data are collected and measures to protect the information by which the personal identity can be distinguished (hereinafter referred to as "personal information"), such as names and resident registration numbers, if the spermatozoa, ova or objects of genetic testing are provided to other persons; |
| 4. | Other matters concerning the research, development or use of biotechnology which is carried out by an institution falling under any subparagraph of paragraph (1). |
| (3) | If the research, development or use of biotechnology which is carried out by an institution falling under any subparagraph of paragraph (1) causes or is likely to cause serious risks to bioethics or safety, the head of that institution shall, without delay, convene the meeting of an institutional committee to deliberate thereon and report the results of such deliberation to the Minister of Health, Welfare and Family Affairs. <Amended by Act No. 8852, Feb. 29, 2008> |
| (4) | Notwithstanding the provisions of paragraph (1), an institution which falls under any subparagraph of paragraph (1) and which fails to meet the standards provided for by Ministerial Decree of Health, Welfare and Family Affairs in the scale, the number of researchers, etc. shall, if it enters into an agreement on the deliberation on matters referred to in subparagraphs of paragraph (2) and in paragraph (3) with any other similar institution which establishes an institutional committee, be deemed to establish that institutional committee. <Amended by Act No. 8852, Feb. 29, 2008> |
| Article 10 (Composition and Operation of Institutional Committee) |
| (1) | An institutional committee shall be comprised of not less than five members including one chairperson. In such cases, such institutional committee shall include one or more person not engaged in life sciences or medicine and another person not working at the institution concerned. <Amended by Act No. 9100, Jun. 5, 2008> |
| (2) | The members of an institutional committee shall be commissioned by the head of an institution which falls under any subparagraph of Article 9 (1), and the chairperson shall be elected from among those members. |
| (3) | Any member who takes part in the research, development or use to be deliberated on by an institutional committee shall not participate in the deliberation related to such research, development or use. |
| (4) | Other necessary matters concerning the composition and operation of an institutional committee shall be provided for by Presidential Decree. |
| Article 10-2 (Support, etc. to Institutional Committee) |
| (1) | The Minister of Health, Welfare and Family Affairs shall carry out the following business in order to provide appropriate supervision and support for the operation of an institutional committee. |
| 1. | Inspection of an institutional committee; |
| 2. | Evaluation of an institutional committee; |
| 3. | Education of the members of an institutional committee; |
| 4. | Other business necessary to supervise and support an institutional committee as provided for by Ministerial Decree of Health, Welfare and Family Affairs. |
| (2) | The Minister of Health, Welfare and Family Affairs may evaluate the performance of an institutional committee under paragraph (1) 2 and disclose the result thereof. |
| (3) | Matters pertaining to evaluation, disclosure of the evaluation result, education, etc. for an institutional committee shall be provided for by Ministerial Decree of Health, Welfare and Family Affairs. |
[This Article Added by Act No. 9100, Jun. 5, 2008]
CHAPTER III PRODUCTION OF EMBRYOS, ETC. AND RESEARCH THEREON
Section 1 Prohibition of Human Cloning, etc.
| Article 11 (Prohibition of Human Cloning) |
| (1) | Any person shall neither implant a somatic cell cloning embryo in the womb, maintain any state of such implantation, nor be delivered of a baby thereby. |
| (2) | Any person shall neither induce nor help other persons to perform an act under paragraph (1). |
| Article 12 (Prohibition of Implantation, etc. between Different Species) |
| (1) | Any person shall neither implant a human embryo in the animal womb nor implant an animal embryo in the human womb. |
| (2) | No person shall be permitted to conduct any of the following acts: <Amended by Act No. 9100, Jun. 5, 2008> |
| 1. | Fertilizing a human ovum with an animal spermatozoon or fertilizing an animal ovum with a human spermatozoon: |
| 2. | Transplanting the nucleus of an animal somatic cell to a human ovum, the nucleus of which is removed, or transplanting the nucleus of a human somatic cell to an animal ovum, the nucleus of which is removed; |
| 3. | Fusing a human embryo and an animal embryo; |
| 4. | Fusing embryos of human beings having different genetic data. |
| (3) | Any person shall not implant that which is produced by an act falling under any subparagraph of paragraph (2) in the human or animal womb. |
Section 2 Embryos Produced by Artificial Insemination
| Article 13 (Production of Embryos, etc.) |
| (1) | No person shall produce embryos for any purpose, other than pregnancy. |
| (2) | In producing embryos for pregnancy purposes, no person shall be permitted to conduct any of the following acts: |
| 1. | Fertilizing ova with spermatozoa after selecting them for the purpose of choosing any specific sex; |
| 2. | Fertilizing ova or spermatozoa of the deceased; |
| 3. | Fertilizing ova or spermatozoa of minors: |
| (3) | Any person shall neither provide or use spermatozoa or ova nor induce or help other persons to do so for the purpose of acquiring pecuniary or property gains or other considerations. |
| Article 14 (Medical Institution to Produce Embryos) |
| (1) | Any medical institution which intends to gather and preserve spermatozoa or ova for the purpose of performing an operation for artificial conception or to produce embryos by fertilizing them shall be designated as a medical institution to produce embryos by the Minister of Health, Welfare and Family Affairs. <Amended by Act No. 8852, Feb. 29, 2008> |
| (2) | Any medical institution which intends to be designated as a medical institution to produce embryos shall be equipped with facilities, manpower, etc. provided for by Ministerial Decree of Health, Welfare and Family Affairs. <Amended by Act No. 8852, Feb. 29, 2008> |
| (3) | The standards and procedures for designation of medical institutions to produce embryos, documents to be submitted for such designation and other necessary matters shall be provided for by Ministerial Decree of Health, Welfare and Family Affairs. <Amended by Act No. 8852, Feb. 29, 2008> |
| Article 15 (Consent to Production, etc. of Embryos) |
| (1) | A medical institution designated as a medical institution to produce embryos under Article 14 (hereinafter referred to as an "authorized medical institution for embryo production") shall, if it gathers spermatozoa or ova to produce embryos, obtain a written consent of providers of the said spermatozoa or ova, persons to undergo an operation for artificial conception and their spouses (hereinafter referred to as "consenters"). |
| (2) | The written consent under paragraph (1) shall include the following matters: <Amended by Act No. 8852, Feb. 29, 2008> |
| 1. | Matters concerning the purpose of production of embryos; |
| 2. | Period of preservation of embryos and other matters concerning such preservation; |
| 3. | Matters concerning the disposal of embryos; |
| 4. | Whether to consent that residual embryos should be used for any purpose, other than pregnancy; |
| 5. | Withdrawal of consent, the protection of rights and information of consenters and other matters provided for by Ministerial Decree of Health, Welfare and Family Affairs. |
| (3) | An authorized medical institution for embryo production shall fully explain to the consenters the matters falling under any subparagraph of paragraph (2) before obtaining written consent under paragraph (1). |
| (4) | Necessary matters concerning the form and preservation, etc. of the written consent referred to in paragraph (1) shall be provided for by Ministerial Decree of Health, Welfare and Family Affairs. <Amended by Act No. 8852, Feb. 29, 2008> |
| Article 15-2 (Medical Check-up, etc. for Ovum Donors) |
| (1) | An authorized medical institution for embryo production shall conduct a medical check-up for an ovum donor prior to ovum extraction as provided for by Ministerial Decree of Health, Welfare and Family Affairs. |
| (2) | An authorized medical institution for embryo production may not extract an ovum from any person who does not satisfy the health standards set by Ministerial Decree of Health, Welfare and Family Affairs. |
[This Article Added by Act No. 9100, Jun. 5, 2008]
| Article 15-3 (Restriction on Number of Ovum Extraction) |
An authorized medical institution for embryo production may not extract ova from the same ovum donor more than the number of times prescribed by Presidential Decree.
[This Article Added by Act No. 9100, Jun. 5, 2008]
| Article 15-4 (Compensation of Actual Cost for Ovum Donors) |
An authorized medical institution for embryo production may pay an ovum donor the amount of money provided for by Ministerial Decree of Health, Welfare and Family Affairs with regard to the items provided for by Ministerial Decree of Health, Welfare and Family Affairs, including compensations and travel expenses, depending on the treatment required for ovum donation and the period of time required for recovery.
[This Article Added by Act No. 9100, Jun. 5, 2008]
| Article 16 (Preservation Period and Disposal of Embryos) |
| (1) | The preservation period of embryos shall be five years: |
| (2) | An authorized medical institution for embryo production shall dispose of embryos not intended for any research under Article 17 from among those in whose case the preservation period under paragraph (1) of this Article elapses. |
| (3) | An authorized medical institution for embryo production shall record and keep particulars of the disposal of embryos. |
| (4) | Necessary matters concerning the procedures and methods of disposal of embryos as well as the record and keeping of particulars of such disposal shall be provided for by Ministerial Decree of Health, Welfare and Family Affairs. <Amended by Act No. 8852, Feb. 29, 2008> |
| Article 17 (Research on Residual Embryos) |
Those residual embryos whose preservation period under Article 16 elapses may, in vitro, be used for the purpose falling under any of the following subparagraphs only before the primitive streak forms embryologically: Provided , That if any person intends to use other residual embryos whose preservation period is determined as less than five years, he/she shall obtain consenters'new consent to the use for that purpose: <Amended by Act No. 8852, Feb. 29, 2008>
| 1. | Research for the development of infertility treatments and contraceptive methods; |
| 2. | Research for treatment for muscular dystrophy and any other rare or incurable disease provided for by Presidential Decree; |
| 3. | Any other research which is equivalent to those provided for in subparagraphs 1 and 2 and is provided for by Presidential Decree. |
| Article 18 (Embryo Research Institute) |
Any person who intends to study residual embryos under Article 17 shall possess facilities, manpower, etc. provided for by Ministerial Decree of Health, Welfare and Family Affairs and shall be registered as an embryo research institute with the Minister of Health, Welfare and Family Affairs. <Amended by Act No. 8852, Feb. 29, 2008>
| Article 19 (Approval of Embryo Research Plans) |
| (1) | If any embryo research institute registered with the Minister of Health, Welfare and Family Affairs under Article 18 (hereinafter referred to as an "authorized embryo research institute") intends to study embryos under Article 17, it shall, in advance, present to the Minister of Health, Welfare and Family Affairs an embryo research plan and obtain permission therefor from him/her in accordance with Ministerial Decree of Health, Welfare and Family Affairs. The same shall also apply to any modification of important matters provided for by Presidential Decree. <Amended by Act No. 8852, Feb. 29, 2008> |
| (2) | An embryo research plan referred to in paragraph (1) shall include documents relating to the results of deliberation of an institutional committee established under an authorized embryo research institute. |
| (3) | The Minister of Health, Welfare and Family Affairs shall, if an authorized embryo research institute which the head of any other central administrative agency assists with research expenses submits an embryo research plan, consult with the said head before determining whether to approve that plan. <Amended by Act No. 8852, Feb. 29, 2008> |
| (4) | The standards and procedures for approval of embryo research plans, documents to be submitted for such approval and other necessary matters shall be provided for by Ministerial Decree of Health, Welfare and Family Affairs. <Amended by Act No. 8852, Feb. 29, 2008> |
| Article 20 (Provision and Management of Residual Embryos) |
| (1) | If an authorized medical institution for embryo production provides residual embryos necessary for research to any authorized embryo research institute that obtained approval for embryo research plans under Article 19 (1), it shall do so gratuitously: |
| (2) | The procedures for provision of residual embryos and the calculation of expenses under paragraph (1) and other necessary matters shall be provided for by Ministerial Decree of Health, Welfare and Family Affairs. <Amended by Act No. 8852, Feb. 29, 2008> |
| (3) | An authorized medical institution for embryo production and an authorized embryo research institute shall report matters concerning the preservation, provision, etc. of residual embryos to the Minister of Health, Welfare and Family Affairs in accordance with Ministerial Decree of Health, Welfare and Family Affairs. <Amended by Act No. 8852, Feb. 29, 2008> |
| (4) | Article 16 (2) through (4) shall apply |
| Article 20-2 (Registration of Stem Cell Lines) |
| (1) | Any person who has established or imported a stem cell line shall register such stem cell line with the Minister of Health, Welfare and Family Affairs as provided for by Ministerial Decree of Health, Welfare and Family Affairs prior to providing such stem cell line pursuant to Article 20-3 or using it pursuant to Article 20-4. |
| (2) | If any person applying for registration of a stem cell line has obtained scientific verification from the head of any other central administrative agency, the Minister of Health, Welfare and Family Affairs shall use the verification data for registration pursuant to paragraph (1). |
| (3) | The Minister of Health, Welfare and Family Affairs may subsidize the whole or part of expenses incurred for verification, etc. of a stem cell line to the person who registered the stem cell line pursuant to paragraph (1). |
[This Article Added by Act No. 9100, Jun. 5, 2008] >>Enforcement Date: Jan. 1, 2010>>
| Article 20-3 (Provision of Stem Cell Lines) |
| (1) | If any person who has established or imported a stem cell line pursuant to Article 20-2 intends to provide such stem cell line, he/she shall undergo deliberation of an institutional committee as provided for by Ministerial Decree of Health, Welfare and Family Affairs. |
| (2) | Any person who has provided a stem cell line pursuant to paragraph (1) shall file a status report with regard to the provision of such stem cell line to the Minister of Health, Welfare and Family Affairs as provided for by Ministerial Decree of Health, Welfare and Family Affairs. |
| (3) | In cases where a stem cell line is provided pursuant to paragraph (1), it shall be provided for free of charge: |
| (4) | Matters pertaining to the provision and report of a stem cell line, methods of calculating expenses, etc. pursuant to paragraphs (1) through (3) shall be provided for by Ministerial Decree of Health, Welfare and Family Affairs. |
[This Article Added by Act No. 9100, Jun. 5, 2008] >>Enforcement Date: Jan. 1, 2010>>
| Article 20-4 (Use of Stem Cell Lines) |
| (1) | Any stem cell line registered pursuant to Article 20-2 may be used, in vitro, for research purposes falling under any of the following subparagraphs: |
| 1. | Research for diagnosis, prevention or treatment of diseases; |
| 2. | Basic research with regard to characteristics and differentiation of stem cell lines; |
| 3. | Other research designated by Presidential Decree after deliberation by the National Committee. |
| (2) | Any person who intends to use a stem cell line pursuant to paragraph (1) shall obtain approval of the head of the institution concerned with regard to the relevant research plan, after undergoing deliberation of the institutional committee as provided for by Ministerial Decree of Health, Welfare and Family Affairs. The same shall also apply to any modification of important matters provided for by Presidential Decree in the approved research plan. |
| (3) | Any person who has obtained approval, or approval for modification, pursuant to paragraph (2) shall report the fact to the Minister of Health, Welfare and Family Affairs as provided for by Ministerial Decree of Health, Welfare and Family Affairs. |
| (4) | Any person who has obtained approval pursuant to paragraph (2) shall submit a plan describing how to use the received stem cell line to the provider of the stem cell line. |
| (5) | The head of the institution that has approved research pursuant to paragraph (2) shall supervise whether the relevant researcher carries out research in conformity with the research plan. |
[This Article Added by Act No. 9100, Jun. 5, 2008] >>Enforcement Date: Jan. 1, 2010>>
| Article 21 (Requirements which Authorized Medical Institution for Embryo Production and Authorized Embryo Research Institute shall Comply with) |
An authorized medical institution for embryo production and an authorized embryo research institute shall comply with any of the following requirements: <Amended by Act No. 8852, Feb. 29, 2008>
| 1. | To handle embryos for any purpose entered in the written consent provided for in Article 15; |
| 2. | To manage the preservation, handling, disposal, etc. of residual embryos thoroughly; |
| 3. | For an authorized embryo research institute to take appropriate measures, such as the suspension of any research, if such research carried out by such institute causes or is likely to cause serious risks to bioethics or safety; |
| 4. | Other requirements which are equivalent to those provided for in subparagraphs 1 through 3 and which are deemed necessary to ensure the bioethics and safety and are provided for by Ministerial Decree of Health, Welfare and Family Affairs. |
Section 3 Somatic Cell Cloning Embryos
| Article 22 (Act of Transplanting Nucleus of Somatic Cell) |
| (1) | Any person shall not perform an act of transplanting the nucleus of a somatic cell for any purpose, other than research for the treatment for any rare or incurable disease provided for in subparagraph 2 of Article 17. |
| (2) | The categories, objects and scope of research provided in paragraph (1) for which an act of transplanting the nucleus of a somatic cell may be performed shall be provided for by Presidential Decree after being deliberated on by the National Committee. |
| Article 23 (Production of Somatic Cell Cloning Embryos and Research Thereon) |
| (1) | Any person who intends to produce or study somatic cell cloning embryos shall be equipped with facilities, manpower, etc. provided for by Ministerial Decree of Health, Welfare and Family Affairs and shall be registered with the Minister of Health, Welfare and Family Affairs. <Amended by Act No. 8852, Feb. 29, 2008> |
| (2) | Articles 19 through 21 shall apply |
CHAPTER IV GENETIC TESTING
| Article 24 (Genetic Testing Institutions, etc.) |
| (1) | A person who intends to conduct any genetic testing or who intends to collect objects of such testing directly and carry out research on genes shall report such matters as the place of a genetic testing or research facility, the head, items of the said genetic testing or research to the Minister of Health, Welfare and Family Affairs in accordance with Ministerial Decree of Health, Welfare and Family Affairs: |
| (2) | The provisions of paragraph (1) shall also apply in cases of modifying important matters provided for by Presidential Decree from among such matters as reported under the said paragraph. |
| (3) | The Minister of Health, Welfare and Family Affairs may subject a person who intends to conduct any genetic testing as reported under paragraph (1) (hereinafter referred to as a "genetic testing institution") to an assessment of accuracy of that testing and make the results thereof public in accordance with Ministerial Decree of Health, Welfare and Family Affairs. <Amended by Act No. 8852, Feb. 29, 2008> |
| (4) | A genetic testing institution shall, if it intends to cease or suspend the business of genetic testing, report to the Minister of Health, Welfare and Family Affairs in accordance with Ministerial Decree of Health, Welfare and Family Affairs. <Amended by Act No. 8852, Feb. 29, 2008> |
| Article 25 (Restrictions on Genetic Testing) |
| (1) | A genetic testing institution shall not conduct any genetic testing relating to either bodily appearance or character which might give wrong information on any person to undergo such testing due to the uncertainty of scientific verification and any other genetic testing which the National Committee deliberates on and which is provided for by Presidential Decree. |
| (2) | A genetic testing institution shall not conduct any genetic testing with respect to embryos or fetuses for any purpose, other than a diagnosis of muscular dystrophy or any other hereditary disease provided for by Presidential Decree. |
| (3) | A genetic testing institution, other than a medical institution shall not conduct any genetic testing related to a diagnosis of disease: |
| Article 26 (Consent to Genetic Testing) |
| (1) | If genetic testing institutions or persons carrying out research on genes directly collect objects of genetic testing to be used for such testing or research or commission any other institution or person to do so, they shall obtain the written consent of persons to undergo such testing including any of the following before such collection: <Amended by Act No. 8852, Feb. 29, 2008> |
| 1. | Purpose of genetic testing or research; |
| 2. | Whether to consent to use objects of genetic testing for any purpose, other than those provided for in subparagraph 1 or provide them to other persons and matters concerning the scope thereof; |
| 3. | Whether to include any personal information in cases of providing objects of genetic testing to other persons under subparagraph 2; |
| 4. | Matters concerning the preservation period and management of objects of genetic testing; |
| 5. | Withdrawal of consent, the protection of rights and information of persons to undergo any genetic testing, and other matters provided for by Ministerial Decree of Health, Welfare and Family Affairs. |
| (2) | If a person, other than a genetic testing institution collects objects of genetic testing and commissions it to conduct such testing, he/she shall obtain the written consent of other persons to undergo the testing under paragraph (1) and annex that written consent. In such cases, measures to protect personal information shall be taken in accordance with Ministerial Decree of Health, Welfare and Family Affairs. <Amended by Act No. 8852, Feb. 29, 2008> |
| (3) | If a person to undergo any genetic testing is a minor or a mental and physical weakling or defective, there shall be his/her own consent under paragraph (1) as well as the consent of his/her legal agent: |
| (4) | Notwithstanding the provisions of paragraphs (1) through (3), any genetic testing may be conducted without any written consent in the following cases: |
| 1. | Where there is any urgent need or exceptional grounds to identify a dead body or an unconscious person; |
| 2. | Where there are any special provisions in other Acts. |
| (5) | A person who intends to obtain the written consent under paragraphs (1) through (3) shall, in advance, give a full explanation for the purposes and methods of genetic testing, the forecasted result and effect thereof, etc. to other persons to undergo such testing or their legal agents. |
| (6) | The procedures for consent and the form of written consent under paragraphs (1) through (3) and other necessary matters shall be prescribed by Ministerial Decree of Health, Welfare and Family Affairs. <Amended by Act No. 8852, Feb. 29, 2008> |
| Article 27 (Provision of Objects of Genetic Testing) |
| (1) | If a genetic testing institution obtains the written consent to the use of objects of genetic testing for research from a person to undergo such testing under Article 26, it may provide such objects to any other person who conducts research on genes or who obtains the permission for the establishment of a gene bank under Article 32. |
| (2) | A genetic testing institution shall be prohibited from including personal information in the objects of genetic testing offered in accordance with paragraph (1): |
| (3) | A genetic testing institution, a person conducting research on genes or a person obtaining permission for the establishment of a gene bank under Article 32 (hereinafter referred to as a "genetic testing institution, etc.") shall keep a record of the provision of objects of genetic testing as prescribed by Ministerial Decree of Health, Welfare and Family Affairs if providing or being provided with such objects under paragraph (1). <Amended by Act No. 8852, Feb. 29, 2008> |
| (4) | Paragraphs (1) through (3) shall apply |
| Article 28 (Destruction of Objects of Genetic Testing) |
| (1) | The preservation period of objects of genetic testing shall be five years: |
| (2) | A genetic testing institution, etc. shall destroy objects of genetic testing immediately after the preservation period thereof expires: |
| (3) | If a person to undergo any genetic testing or his/her legal agent requests a genetic testing institution, etc. to destroy objects of such testing in its custody, it shall comply to such a request. |
| (4) | A genetic testing institution, etc. shall keep a record of the destruction of objects of genetic testing. |
| (5) | If a genetic testing institution, etc. is unable to continue to retain objects of genetic testing due to the suspension or closure of business or other unavoidable grounds, it shall dispose of or transfer them as prescribed by Ministerial Decree of Health, Welfare and Family Affairs. <Amended by Act No. 8852, Feb. 29, 2008> |
| (6) | Necessary matters concerning procedures and methods for destruction of objects of genetic testing, keeping a record of such destruction, and disposal or transferal thereof under paragraph (5) shall be prescribed by Ministerial Decree of Health, Welfare and Family Affairs. <Amended by Act No. 8852, Feb. 29, 2008> |
| Article 29 (Management and Inspection of Records) |
| (1) | A genetic testing institution, etc. shall keep the following documents as prescribed by Ministerial Decree of Health, Welfare and Family Affairs: <Amended by Act No. 8852, Feb. 29, 2008> |
| 1. | Written consent forms under Article 26; |
| 2. | The results of genetic testing; |
| 3. | The records on the provision of objects of genetic testing under Article 27 (3). |
| (2) | A genetic testing institution, etc. shall comply with a request made by a person to undergo any genetic testing or his/her legal agent for the perusal of records referred to in subparagraphs of paragraph (1) or the delivery of copies thereof. |
| (3) | Necessary matters concerning the application procedures, forms, etc. for the perusal of records or delivery of copies under paragraph (2) shall be prescribed by Ministerial Decree of Health, Welfare and Family Affairs. <Amended by Act No. 8852, Feb. 29, 2008> |
| Article 30 (Matters to be Observed by Genetic Testing Institutions, etc.) |
| (1) | A genetic testing institution, etc. shall observe the following matters: <Amended by Act No. 8852, Feb. 29, 2008> |
| 1. | The details of written consents under Article 26; |
| 2. | The protection of genetic data; |
| 3. | Other matters equivalent to those of subparagraphs 1 and 2 which are prescribed by Ministerial Decree of Health, Welfare and Family Affairs for preserving bioethics and safety. |
| (2) | A genetic testing institution, etc. shall be prohibited from making any false indication or exaggerated announcement regarding any genetic testing. |
| (3) | The scope of false indications or exaggerated announcement under paragraph (2) and other necessary matters shall be prescribed by Ministerial Decree of Health, Welfare and Family Affairs. <Amended by Act No. 8852, Feb. 29, 2008> |
CHAPTER V PROTECTION AND USE OF GENETIC DATA, ETC.
| Article 31 (Prohibition of Discrimination based on Genetic Data) |
| (1) | No person shall discriminate against another person in the social areas of education, employment, promotion, insurance, etc. on the grounds of genetic data. |
| (2) | Except as otherwise prescribed by other Acts, no person shall force another person to undergo any genetic testing or submit the results of that testing. |
| Article 32 (Permission for, and Report on, Gene Bank) |
| (1) | Any person who intends to establish a gene bank shall obtain permission therefor from the Minister of Health, Welfare and Family Affairs as prescribed by Presidential Decree: |
| (2) | Notwithstanding the provisions of paragraph (1), if a person intends to establish a gene bank after obtaining approval for subsidizing research funds from the head of a central administrative agency under other Acts and subordinate statutes, he/she shall be deemed to have obtained permission therefor from the Minister of Health, Welfare and Family Affairs at the time when the approval for subsidizing the research funds is obtained from the head of the central administrative agency. In such cases, the head of the central administrative agency concerned shall consult in advance with the Minister of Health, Welfare and Family Affairs thereabout. <Amended by Act No. 8852, Feb. 29, 2008> |
| (3) | If a gene bank established under paragraph (1) moves its location or desires to alter any important matters as prescribed by Presidential Decree among the matters subject to permission for its establishment, it shall report to the Minister of Health, Welfare and Family Affairs thereon as prescribed by Ministerial Decree of Health, Welfare and Family Affairs. <Amended by Act No. 8852, Feb. 29, 2008> |
| (4) | If the head of a gene bank desires to close or suspend the business of the gene bank, he/she shall report to the Minister of Health, Welfare and Family Affairs thereon as prescribed by Ministerial Decree of Health, Welfare and Family Affairs. <Amended by Act No. 8852, Feb. 29, 2008> |
| (5) | The standards for the facilities and equipment of gene banks and the procedures for permission under paragraph (1), and other necessary matters shall be prescribed by Presidential Decree. |
| Article 33 (Provision of Genetic Data, etc.) |
| (1) | Any person who desires to obtain genetic data, etc. from a gene bank shall submit to the head of the gene bank a plan for use of the genetic data, etc. |
| (2) | The head of a gene bank who has received a plan for use of genetic data, etc. submitted under paragraph (1) shall decide on whether to offer such genetic data, etc. after deliberation by an institutional committee under Article 9 and report the results to the Minister of Health, Welfare and Family Affairs. <Amended by Act No. 8852, Feb. 29, 2008> |
| (3) | Entries of a plan for use of genetic data, etc., procedures for submission thereof, and other necessary matters concerning the provision and management of genetic data, etc. shall be prescribed by Ministerial Decree of Health, Welfare and Family Affairs. <Amended by Act No. 8852, Feb. 29, 2008> |
| Article 34 (Matters to be Observed by Heads of Gene Banks) |
| (1) | The head of a gene bank shall be prohibited from including personal information in providing genetic data, etc. to another person under Article 33. |
| (2) | In providing genetic data, etc. to another person, the head of a gene bank shall do so free of charge: |
| Article 35 (Protection of Genetic Data, etc.) |
| (1) | The head or employee of a gene bank shall be prohibited from providing another person or taking undue advantage of genetic data, etc. obtained or learned while on duty, without any justifiable grounds. |
| (2) | No medical institution shall include genetic data in medical records, diagnosis and treatment records, etc. provided to other person than the patient under the proviso of Article 21 (1) of the Medical Service Act: |
| Article 35-2 (Management of Genetic Data, etc.) |
| (1) | A gene bank shall preserve and manage all genetic data, etc. after rendering them anonymous. |
| (2) | A gene bank shall put a person in charge of data management and security in order to protect personal information. |
| (3) | Matters pertaining to the preservation and management of genetic data, etc. pursuant to paragraph (1) and the duties, etc. of the security officer designated pursuant to paragraph (2) shall be provided for by Ministerial Decree of Health, Welfare and Family Affairs. |
[This Article Added by Act No. 9100, Jun. 5, 2008]
| Article 35-3 (Support to Gene Banks) |
The central government or local governments may, within the limits of budget, provide financial support for operation of gene banks.
[This Article Added by Act No. 9100, Jun. 5, 2008]
CHAPTER VI GENE THERAPY
| Article 36 (Gene Therapy) |
| (1) | No person shall attempt to perform any gene therapy except in the following: <Amended by Act No. 8852, Feb. 29, 2008> |
| 1. | Treatment for such diseases as hereditary diseases, cancers, AIDS, and others which threaten life or cause any serious disability; |
| 2. | Treatment for diseases presently beyond medical treatment or treatment for diseases for which gene therapy would be deemed considerably more effective than any other available treatment; |
| 3. | Other cases which are acknowledged as necessary for the prevention or treatment of diseases as determined by the Minister of Health, Welfare and Family Affairs. |
| (2) | Notwithstanding the provisions of paragraph (1), no gene therapy shall be carried out to sperm, ova, embryos or fetuses. |
| Article 37 (Gene Therapy Institutions) |
| (1) | Any medical institution which intends to carry out any gene therapy shall report thereon to the Minister of Health, Welfare and Family Affairs. The same shall also apply to any modification of important matters as prescribed by Presidential Decree. <Amended by Act No. 8852, Feb. 29, 2008> |
| (2) | Any medical institution which has reported to the Minister of Health, Welfare and Family Affairs under paragraph (1) (hereinafter referred to as a "gene therapy institution") shall obtain a written consent from a patient subject to gene therapy after explaining in advance the following matters: <Amended by Act No. 8852, Feb. 29, 2008> |
| 1. | The purpose of treatment; |
| 2. | The expected results of treatment and the side effects; |
| 3. | Other matters determined by Ministerial Decree of Health, Welfare and Family Affairs. |
| (3) | Requirements and procedures for the report of gene therapy institutions, written consent forms, and other necessary matters shall be prescribed by Ministerial Decree of Health, Welfare and Family Affairs. <Amended by Act No. 8852, Feb. 29, 2008> |
CHAPTER VII SUPERVISION
| Article 38 (Report, Investigation, etc.) |
| (1) | The Minister of Health, Welfare and Family Affairs may, if necessary for preserving bioethics and safety, order an authorized medical institution for embryo production, authorized embryo research institute, genetic testing institution, etc., or gene therapy institution (hereinafter referred to as "institution subject to supervision") or its employees to make or submit necessary reports or materials for the administration of this Act as prescribed by Ministerial Decree of Health, Welfare and Family Affairs, and may order it to suspend the research, development and use of biotechnology or take other necessary measures if such research, development and use causes, or is likely to cause, any serious harm to bioethics and safety. <Amended by Act No. 8852, Feb. 29, 2008> |
| (2) | The Minister of Health, Welfare and Family Affairs may, if deemed necessary for ascertaining whether the matters as provided for by this Act are observed, have the public officials concerned enter an institution subject to supervision or its office, etc. to inspect facilities, equipment, relevant books or documents, and other items or to make inquiries of any persons concerned, and collect the minimum quantity of test samples. In such cases, the public officials concerned shall bear certificates verifying their authority and show them to the persons concerned. <Amended by Act No. 8852, Feb. 29, 2008> |
| (3) | An institution subject to supervision or its employees shall comply with or respond to the orders, inspection, inquiry, etc. referred to in paragraphs (1) and (2) unless there are any justifiable grounds to the contrary. |
| Article 39 (Order for Destruction) |
The Minister of Health, Welfare and Family Affairs may order an institution subject to supervision, its employees, or any person who registered, provided or used a stem cell line pursuant to Articles 20-2 through 20-4 to destroy embryos, somatic cell cloning embryos, stem cell lines or ova produced, kept or offered in violation of Article 13, 14, 15 (1), 15-2, 15-3, 16 (2), 17 through 19, 20 (1) and (4), 20-2 (1), 20-3 (1) and (3), 20-4 (2), 22 (1) or 23 and objects of genetic testing extracted, kept or offered in violation of Article 24 (1), 25, 26 (1) through (3), 27 (1), (2) and (4), 28 (2) and (3) or 32 (1) and (2). In such cases, Article 16 (4) or 28 (6) shall apply mutatis mutandis with respect to the procedures and methods of destruction. <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9100, Jun. 5, 2008>
| Article 40 (Order for Improvement) |
If it is deemed that the research, extraction, or custody or the production of embryos carried out by an institution subject to supervision causes or is likely to cause any serious harm to bioethics and safety because its facilities, manpower, etc. do not meet the facility standards set in Article 14 (2), 18, 23 or 32 (5), the Minister of Health, Welfare and Family Affairs may order it to improve the facilities or prohibit the use of the whole or part of the facilities. <Amended by Act No. 8852, Feb. 29, 2008>
| Article 41 (Cancellation of Permission, etc. and Suspension of Business) |
| (1) | If an authorized medical institution for embryo production, authorized embryo research institute, genetic testing institution, gene bank, or gene therapy institution falls under any of the following subparagraphs, the Minister of Health, Welfare and Family Affairs may cancel its designation, registration or permission or order it to suspend the whole or part of the business for a fixed period of less than one year: <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9100, Jun. 5, 2008> |
| 1. | Where it violates Article 9 (1) and (3), 10 (1) and (3), 11 through 14, 15 (1) and (3), 15-2, 15-3, 16 (2) and (3), 17, 19 (1), 20, 22, 24 (2) and (4), 25, 26 (1) through (3) and (5), 27, 28 (2) through (5), 29 (1) and (2), 32 (3) and (4), 33 (2), 35, 35-2 (1) and (2), 36 or 37 (1) (the latter part) and (2); |
| 2. | Where it fails to fulfill the matters to be observed under Article 21, 30 or 34; |
| 3. | Where it fails to comply with an order under Article 38 (1), 39 or 40; |
| 4. | Where it fails to comply with or respond to the inspection, inquiry or collection under Article 38 (2). |
| (2) | The detailed standards for the administrative disposition under paragraph (1) shall be prescribed by Ministerial Decree of Health, Welfare and Family Affairs in consideration of the type, extent, etc. of the violations. <Amended by Act No. 8852, Feb. 29, 2008> |
| Article 42 (Hearing) |
If the Minister of Health, Welfare and Family Affairs intends to cancel the designation, registration or permission under Article 41 (1), he/she shall hold a hearing. <Amended by Act No. 8852, Feb. 29, 2008>
| Article 43 (Penalty Surcharge) |
| (1) | If, in taking the disposition of business suspension against an authorized medical institution for embryo production or a gene therapy institution falling under any of the following subparagraphs, the Minister of Health, Welfare and Family Affairs deems that such disposition is likely to cause excessive inconvenience to the users of the business concerned or otherwise impair the public interest, he/she may impose a penalty surcharge of not more than two hundred million Won in lieu of the disposition of business suspension under the conditions prescribed by Presidential Decree: <Amended by Act No. 8852, Feb. 29, 2008> |
| 1. | Where it violates Article 14, 15 (1) and (3), 16 (2) and (3), or 36; |
| 2. | Where it fails to fulfill the matters to be observed under Article 21; |
| 3. | Where it fails to comply with an order under Article 38 (1), 39 or 40; |
| 4. | Where it fails to comply with or respond to the inspection, inquiry or collection under Article 38 (2). |
| (2) | The amount of a penalty surcharge by the category, extent, etc. of violations subject to the imposition of a penalty surcharge under paragraph (1) and other necessary matters shall be prescribed by Ministerial Decree of Health, Welfare and Family Affairs. <Amended by Act No. 8852, Feb. 29, 2008> |
| (3) | If a person liable to pay a penalty surcharge under paragraph (1) fails to pay it within the fixed period, the Minister of Health, Welfare and Family Affairs shall collect it following the procedure for dispositions on default of the payment of national taxes. <Amended by Act No. 8852, Feb. 29, 2008> |
| Article 44 (Fees) |
The Minister of Health, Welfare and Family Affairs may impose fees on any person who intends to be granted the designation, registration, permission or approval or to report or alter the reported matters in accordance with this Act as prescribed by Ministerial Decree of Health, Welfare and Family Affairs. <Amended by Act No. 8852, Feb. 29, 2008>
CHAPTER VIII SUPPLEMENTARY PROVISIONS
| Article 45 (Support to Adult Stem Cell Research) |
The State or a local government may provide financial support necessary for promoting research on adult stem cells.
| Article 46 (Subsidy from National Treasury) |
To foster and support the research projects and education conducible to ensuring bioethics and safety in biotechnology, the Minister of Health, Welfare and Family Affairs may assist related organizations, research institutes, persons engaged in life science-related fields, etc. in the whole or part of necessary research funds as prescribed by Presidential Decree. <Amended by Act No. 8852, Feb. 29, 2008>
| Article 47 (Delegation and Entrustment, etc.) |
| (1) | The Minister of Health, Welfare and Family Affairs may delegate part of his/her authority under this Act to the head of an agency under his/her control as prescribed by Presidential Decree. <Amended by Act No. 8852, Feb. 29, 2008> |
| (2) | The Minister of Health, Welfare and Family Affairs may entrust part of the business falling under any of the following subparagraphs to the expert institution or organization concerned as prescribed by Presidential Decree: <Amended by Act No. 9100, Jun. 5, 2008> |
| 1. | Evaluation of an institutional committee and education of the members of an institutional committee under Article 10-2; |
| 2. | Management of an authorized medical institution for embryo production under Article 14; |
| 3. | Management of an authorized embryo research institute under Article 18; |
| 4. | Registration of a stem cell line under Article 20-2 (1); |
| 5. | Management of a genetic testing institution under Article 24; |
| 6. | Management of a gene bank under Article 32; |
| 7. | Management of a gene therapy institution under Article 37. |
| (3) | If the Minister of Health, Welfare and Family Affairs entrusts the business of management to the relevant expert institution or organization under paragraph (2), he/she may subsidize expenses required for such management. <Amended by Act No. 8852, Feb. 29, 2008> |
| Article 48 (Prohibition of Divulging Secrets, etc.) |
An institution subject to supervision or any present or former employee thereof is prohibited from divulging or appropriating any secrets to which he/she had access during the course of conducting his/her duties.
CHAPTER IX PENAL PROVISIONS
| Article 49 (Penal Provisions) |
| (1) | Any person who transplants a somatic cell cloning embryo into a womb, keeps the embryo implanted, or causes the implanted embryo to develop into a baby in violation of Article 11 (1) shall be punishable by imprisonment for not more than ten years. |
| (2) | Any attempt to commit the offense provided in paragraph (1) shall be punishable. |
| Article 50 (Penal Provisions) |
Any person who transplants a human embryo into an animal's womb or an animal's embryo into a human womb in violation of Article 12 (1) or transplants an embryo produced under any subparagraph of paragraph (2) of the said Article into a human or animal's womb in violation of paragraph (3) of the said Article shall be punishable by imprisonment for not more than five years.
| Article 51 (Penal Provisions) |
| (1) | Any person who falls under any of the following subparagraphs shall be punishable by imprisonment for not more than three years: <Amended by Act No. 91002, Jun. 5, 2008> |
| 1. | A person who induces or helps another person to transplant a somatic cell cloning embryo into a womb, keep the embryo implanted, or cause the implanted embryo to develop into a baby in violation of Article 11 (2); |
| 2. | A person who commits any act falling under any subparagraph of Article 12 (2); |
| 3. | A person who produces embryos for any purposes, other than conception in violation of Article 13 (1); |
| 4. | A person who commits any act falling under any subparagraph of Article 13 (2); |
| 5. | A person who provides or uses sperm or ova on condition of providing or being provided with any such consideration as pecuniary or property gains in violation of Article 13 (3); |
| 6. | A person who induces or brokers provision of spermatozoa or ova in return for monetary or property gains or other benefits in violation of Article 13 (3); |
| 7. | A person who performs any act of transplanting the nucleus of a somatic cell for any purpose other than research on treatment for rare or incurable diseases in violation of Article 22 (1); |
| 8. | A person who divulges or appropriates any secrets in violation of Article 48. |
| (2) | Any person who uses any residual embryo in violation of Article 17 shall be punishable by imprisonment for not more than three years or by a fine not exceeding fifty million won. |
| (3) | Any attempt to commit the offense provided for in paragraph (1) 1 shall be punishable. |
| Article 52 (Penal Provisions) |
Any person who falls under any one of the following subparagraphs shall be punishable by imprisonment for not more than two years or by fines not exceeding thirty million won: <Amended by Act No. 9100, Jun. 5, 2008>
| 1. | Deleted; <by Act No. 9100, Jun. 5, 2008> |
| 2. | A person who extracts sperm or ova without obtaining written consent to the production of embryos in violation of Article 15 (1); |
2-2. A person who fails to conduct a medical check-up on an ovum donor in violation of Article 15-2 (1);
2-3. A person who extracts an ovum in violation of Article 15-2 (2);
2-4. A person who extracts an ovum in violation of Article 15-3;
| 3. | A person who conducts any genetic testing in violation of Article 25; |
| 4. | A person who extracts objects of genetic testing without obtaining written consent to that testing or requests another person to conduct such testing without attaching a written consent form in violation of Article 26 (1) through (3); |
| 5. | A person who discriminates against another person on the grounds of genetic data, or forces another person to undergo any genetic testing or submit the results of such testing in violation of Article 31 (1) or (2); |
| 6. | A person who provides genetic data, etc. including personal information to another person in violation of Article 34; |
| 7. | A person who provides genetic data, etc. to another person without any justifiable grounds or takes undue advantage of such genetic data, etc. in violation of Article 35 (1); |
| 8. | A person who conducts any gene therapy in violation of Article 36 (1) or (2); |
| 9. | A person who fails to comply with an order for destruction under Article 39. |
| Article 53 (Penal Provisions) |
Any person who falls under any of the following subparagraphs shall be punishable by imprisonment for not more than one year or by fines not exceeding twenty million won: <Amended by Act No. 8852, Feb. 29, 2008; Act No. 9100, Jun. 5, 2008>
| 1. | A person who extracts or retains human sperm or ova or produces embryos without being designated as an authorized medical institution for embryo production in violation of Article 14; |
| 2. | A person who fails to destroy embryos as prescribed by Ministerial Decree of Health, Welfare and Family Affairs or fails to keep a record of the destruction of embryos in violation of Article 16 (2) or (3) (including cases where it shall apply |
| 3. | A person who researches on residual embryos without being registered as an authorized embryo research institute in violation of Article 18; |
| 4. | A person who studies embryos without obtaining approval from the Minister of Health, Welfare and Family Affairs in violation of Article 19 (1) (including cases as applicable |
| 5. | A person who provides residual embryos on condition of consideration or fails to report to the Minister of Health, Welfare and Family Affairs on matters relating to keeping, providing, etc. of residual embryos as prescribed by Ministerial Decree of Health, Welfare and Family Affairs in violation of Article 20 (1) or (3); |
| 6. | A person who produces or studies somatic cell cloning embryos without being registered in violation of Article 23 (1); |
| 7. | A person who fails to fulfill the matters to be observed by a genetic testing institution, etc. under Article 30 (1) or makes a false indication or exaggerated announcement regarding any genetic testing in violation of paragraph (2) of the said Article; |
| 8. | A person who opens a gene bank without permission in violation of Article 32 (1); |
8-2. A person who fails to preserve and manage genetic data, etc. after rendering them anonymous in violation of Article 35-2 (1);
| 9. | A person who violates an order for improvement, etc. under Article 40. |
| Article 54 (Joint Penal Provisions) |
If a representative of a corporation, or an agent, servant or other employee of a corporation or individual commits any offense listed in Articles 49 through 53 in connection with the functions of the juristic person or individual, the relevant juristic person or individual shall be punished by a fine provided for in the relevant Article, in addition to the punishment of the offender.
| Article 55 (Fines for Negligence) |
| (1) | Any person who falls under any one of the following subparagraphs shall be punishable by fines for negligence not exceeding five million won: <Amended by Act No. 9100, Jun. 5, 2008> |
| 1. | A person who provides or uses a stem cell line without registering it in violation of Article 20-2 (1); |
| 2. | A person who provides a stem cell line with considerations in violation of the main sentence of Article 20-3 (3); |
| 3. | A person who uses a stem cell line in violation of Article 20-4 (1); |
| 4. | A person who fails to make a report under Article 24 (1), (2) or (4); |
| 5. | A person who violates Article 28 (2) through (5); |
| 6. | A person who fails to keep any document referred to in any subparagraph of Article 29 (1) or refuses inspection of records or the delivery of copies under paragraph (2) of the said Article; |
| 7. | A person who fails to make a report under Article 32 (3) or (4); |
| 8. | A person who offers records including genetic data on a patient to any person other than the patient in violation of Article 35 (2); |
| 9. | A person who fails to put a person in charge of data management and security in violation of Article 35-2 (2); |
| 10. | A person who conducts any gene therapy without filing a report in violation of Article 37 (1). |
| (2) | The fines for negligence referred to in paragraph (1) shall be imposed and collected by the Minister of Health, Welfare and Family Affairs as determined by Presidential Decree. <Amended by Act No. 8852, Feb. 29, 2008> |
| (3) | Any person who is dissatisfied with disposition of fines for negigence under paragraph (2) may raise objections to the Minister of Health, Welfare and Family Affairs within 30 days from the date on which he/she is informed of such disposition. <Amended by Act No. 8852, Feb. 29, 2008> |
| (4) | If any person who has been subject to the disposition of fines for negligence under paragraph (2) raises objection under paragraph (3), the Minister of Health, Welfare and Family Affairs shall notify the fact without delay to the competent court, and the competent court which receives the notification shall bring the case of the fines for negligence to a trial under the Non-Contentious Case Litigation Procedure Act. <Amended by Act No. 8852, Feb. 29, 2008> |
| (5) | If no objection is raised and no fine for negligence is paid within the period referred to in paragraph (3), it shall be collected following the example of dispositions on default of national taxes. |
ADDENDA
| (1) | (Enforcement Date) This Act shall enter into force on January 1, 2005: |
| (2) | (Transitional Measures concerning Research on Residual Embryos) The residual embryos which meet the requirements provided in the following subparagraphs may be used for the purposes referred to in any subparagraph of Article 17 only before their primitive streaks appear embryologically: |
| 1. | They have been produced prior to the enforcement of this Act; |
| 2. | Five years have passed after their production; |
| 3. | Consent has been obtained from the consenters: |
| (3) | (Transitional Measures concerning Research on Somatic Cell Cloning Embryos) If a person who is carrying out research on somatic cell cloning embryos for research purposes referred to in subparagraph 2 of Article 17 at the time of the entry into force of this Act meets the requirements of the following subparagraphs, he/she may continue to conduct such research with approval therefor from the Minister of Health and Welfare: |
| 1. | He/she has been conducting research on somatic cell cloning embryos for not less than three years; |
| 2. | His/her research on somatic cell cloning embryos has been published in the related scientific journal at least once. |
| (4) | Omitted. |
ADDENDA<Act No. 7413, Mar. 24, 2005>
Article 1 (Enforcement Date)
This Act shall enter into force on the date of its promulgation; provided, matters of the following subparagraphs shall be enforced on the dates as classified in the respective subparagraphs:
| 1. | … <Omitted.> … the provisions of Article 2 through 4 of the Addenda shall be enforced on the date when Presidential Decree with regard to the organization of the Ministry of Gender Equality and Family under the amended provisions of Article 42 is implemented within three months after the promulgation of this Act; |
[June 23, 2005, the enforcement date of the office organization of the Ministry of Gender Equality and Family by Presidential Decree No. 18873 of June 23, 2005]
| 2. | Omitted. |
Articles 2 through 4 Omitted.
ADDENDA<Act No. 8366, Apr. 11, 2007>
Article 1 (Enforcement Date)
This Act shall enter into force on the date of its promulgation. (Proviso Omitted.)
Articles 2 through 21 Omitted.
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. 9100, Jun. 5, 2008>
| (1) | (Enforcement Date) This Act shall enter into force six months after the date of its promulgation; provided, the amended provisions of Articles 20-2 through 20-4 shall enter into force on January 1, 2010. |
| (2) | (Transitional Measures concerning Registration of Stem Cell Lines Already Established or Imported) A person who already established or imported a stem cell line prior to the enforcement date of the amended provisions of Articles 20-2 through 20-4, shall be regarded as having established or imported pursuant to the amended provisions of Article 20-2. In such cases, an application for registration shall be filed by June 30, 2010. |
ENFORCEMENT DECREE OF THE BIOETHICS AND SAFETY ACT
| ENFORCEMENT DECREE OF THE BIOETHICS AND SAFETY ACT | No.35811 | 20251001 |
| ENFORCEMENT DECREE OF THE BIOETHICS AND SAFETY ACT | No.34747 | 20240723 |
| ENFORCEMENT DECREE OF THE BIOETHICS AND SAFETY ACT | No.33913 | 20231212 |
| ENFORCEMENT DECREE OF THE BIOETHICS AND SAFETY ACT | No.30141 | 20191024 |
| ENFORCEMENT DECREE OF THE BIOETHICS AND SAFETY ACT | No.29950 | 20190702 |
| ENFORCEMENT DECREE OF THE BIOETHICS AND SAFETY ACT | No.28211 | 20170726 |
| ENFORCEMENT DECREE OF THE BIOETHICS AND SAFETY ACT | No.27918 | 20170228 |
| ENFORCEMENT DECREE OF THE BIOETHICS AND SAFETY ACT | No.27751 | 20170101 |
| ENFORCEMENT DECREE OF THE BIOETHICS AND SAFETY ACT | No.26703 | 20151210 |
| ENFORCEMENT DECREE OF THE BIOETHICS AND SAFETY ACT | No.25840 | 20150101 |
| ENFORCEMENT DECREE OF THE BIOETHICS AND SAFETY ACT | No.25751 | 20141119 |
| ENFORCEMENT DECREE OF THE BIOETHICS AND SAFETY ACT | No.25050 | 20140101 |
| ENFORCEMENT DECREE OF THE BIOETHICS AND SAFETY ACT | No.24454 | 20130323 |
| ENFORCEMENT DECREE OF THE BIOETHICS AND SAFETY ACT | No.24329 | 20130202 |
| ENFORCEMENT DECREE OF THE BIOETHICS AND SAFETY ACT | No.22906 | 20110422 |
| ENFORCEMENT DECREE OF THE BIOETHICS AND SAFETY ACT | No.22075 | 20100319 |
| ENFORCEMENT DECREE OF THE BIOETHICS AND SAFETY ACT | No.21865 | 20091130 |
| ENFORCEMENT DECREE OF THE BIOETHICS AND SAFETY ACT | No.21151 | 20081206 |
| ENFORCEMENT DECREE OF THE BIOETHICS AND SAFETY ACT | No.20679 | 20080229 |
| ENFORCEMENT DECREE OF THE BIOETHICS AND SAFETY ACT | No.20316 | 20071004 |
| ENFORCEMENT DECREE OF THE BIOETHICS AND SAFETY ACT | No.19513 | 20060701 |
| ENFORCEMENT DECREE OF THE BIOETHICS AND SAFETY ACT | No.18873 | 20050623 |
| ENFORCEMENT DECREE OF THE BIOETHICS AND SAFETY ACT | No.18621 | 20050101 |
| Article 1 (Purpose) |
The purpose of this Decree is to prescribe matters mandated by the Bioethics and Safety Act and other matters necessary for enforcing said Act.
| Article 2 (Meetings of the National Bioethics Committee) |
| (1) | The chairperson of the National Bioethics Committee (hereinafter referred to as the "National Committee") established under Article 7 (1) of the Bioethics and Safety Act (hereinafter referred to as the "Act") shall convene a meeting of the National Committee, in any of the following cases: |
| 1. | Where the President requests the convocation of a meeting; |
| 2. | Where at least 1/3 of all incumbent members of the National Committee request the convocation of a meeting; |
| 3. | Where the chairperson of the National Committee deems it necessary to convene a meeting. |
| (2) | Where convening a meeting, the chairperson of the National Committee shall notify the members of the National Committee of the date, time, venue, and agenda items of a meeting until seven days before it is held; provided, where there exists any inevitable cause, such as an urgent matter for deliberation, the chairperson may give notice to the members of the National Committee until the day immediately before the meeting is held. |
| (3) | Resolution by a meeting of the National Committee shall require the attendance of a majority of all incumbent members and consent from a majority of those present. |
| (4) | If deemed necessary for deliberation, the chairperson of the National Committee may request the chairperson of a specialized committee under Article 3 or a member thereof to attend a meeting. |
| Article 2-2 (Dismissal of members of the National Committee) |
Where a member referred to in Article 8 (3) 2 and 3 of the Act falls under any of the following, the President may dismiss the relevant member:
| 1. | Where a member becomes unable to conduct his or her duties due to a mental or physical disability; |
| 2. | Where a member commits a misdeed in connection with his or her duties; |
| 3. | Where a member is recognized to be unsuitable to be a member due to neglect of duties, injury to dignity, or other grounds; |
| 4. | Where a member himself or herself expresses that he or she has difficulties in conducting his or her duties. |
[This Article Added on Dec. 10, 2015]
| Article 3 (Establishment and functions of specialized committees) |
| (1) | The following specialized committees by field shall be established under the National Committee pursuant to Article 9 (1) of the Act: |
| 1. | Specialized Committee on Bioethics and Safety Policy: Deliberation on human subjects research, policies on bioethics and safety, and other matters not subject to deliberation by any other specialized committee; |
| 2. | Specialized Committee on Embryos: Deliberation on matters concerning the production and management of embryos, the use and research of residual embryos, residual eggs, somatic-cell cloning embryos, etc. (referring to somatic-cell cloning embryos, etc. under Article 20 (1) of the Act), or the use, etc. of embryonic stem cell lines; |
| 3. | Specialized Committee on Human Materials: Deliberation on human materials research and exemption from such deliberation, and deliberation on matters concerning Human Material Banks; |
| 4. | Specialized Committee on Genes: Deliberation on matters concerning genetic tests, gene therapies, etc.; |
| 5. | Specialized Committee on the Protection of Human Subjects: Deliberation on matters concerning the protection of human subjects, the affairs of institutional review boards under Article 10 (1) of the Act (hereinafter referred to as "institutional committees"), and the affairs of joint institutional bioethics committees under Article 12 of the Act; |
| 6. | Ad Hoc Specialized Committee: Deliberation on matters concerning any particular field by that committee established by the chairperson of the National Committee by a resolution thereof, which is to exist for a limited time only. |
| (2) | Specialized committees shall deliberate on any matters referred to a meeting thereof by the National Committee based on their relevant fields or any matters they deem necessary to be referred to a meeting thereof; and the chairpersons thereof shall report the results of deliberation to the National Committee. |
| Article 4 (Composition of specialized committees) |
| (1) | Each specialized committee shall be comprised of at least five, but not more than seven members, including one chairperson and one vice-chairperson. |
| (2) | The members of each specialized committee shall be the following persons, and shall include at least 1 person referred to in each subparagraph: <Amended on Mar. 23, 2013; Nov. 19, 2014; Jul. 26, 2017; Oct. 1, 2025> |
| 1. | Persons appointed by the Minister of Health and Welfare upon the recommendation of the head of the relevant Ministry, from among public officials in general service of Grade IV or higher or members of the Senior Executive Service of the Ministry of Science and ICT, the Ministry of Education, the Ministry of Justice, the Ministry of Trade, Industry and Resources, the Ministry of Health and Welfare, or the Ministry of Gender Equality and Family; |
| 2. | Persons commissioned by the Minister of Health and Welfare, after consultation with the Minister of Science and ICT, from among those who have abundant professional knowledge and research experience in the field of biological science, medical science, or social science; |
| 3. | Persons commissioned by the Minister of Health and Welfare, from among those engaged in judicial circles, ethical circles, religious circles, civic groups (referring to non-profit, non-governmental organizations defined in Article 2 of the Assistance for Non-Profit, Non-Governmental Organizations Act), or women’s organizations. |
| (3) | The chairperson of each specialized committee shall be elected from among and by the members thereof, and the vice-chairperson of each specialized committee shall be designated by the chairperson thereof. |
| (4) | The members commissioned pursuant to paragraph (2) shall hold office for a term of three years and may be commissioned consecutively for future terms; provided, the term of office of the members who are public officials shall coincide with the term of their official positions. |
| (5) | If a vacancy occurs in the office of a member, a member for filling a vacancy shall be commissioned, and the term of office of a newly commissioned member shall be the remainder of his or her predecessor’s term of office. |
| (6) | Each specialized committee shall have one secretary, who shall be designated by the Minister of Health and Welfare from among the relevant public officials. |
| Article 5 (Operation of specialized committees) |
| (1) | The chairperson of the relevant specialized committee shall convene a meeting, in any of the following cases: |
| 1. | Where the chairperson of the National Committee requests the convocation of a meeting; |
| 2. | Where at least 1/3 of all incumbent members of the relevant specialized committee request the convocation of a meeting; |
| 3. | Where the chairperson of the relevant specialized committee deems it necessary to convene a meeting. |
| (2) | If deemed necessary for deliberation, a specialized committee may request any relevant expert, etc. to make an appearance at the said committee to hear his or her opinions. |
| Article 5-2 (Dismissal of members of specialized committees) |
Where a member referred to in Article 4 (2) 1 through 3 falls under any of the following, the Minister of Health and Welfare may dismiss the relevant member:
| 1. | Where a member becomes unable to conduct his or her duties due to a mental or physical disability; |
| 2. | Where a member commits a misdeed in connection with his or her duties; |
| 3. | Where a member is recognized to be unsuitable to be a member due to neglect of duties, injury to dignity, or other grounds; |
| 4. | Where a member himself or herself expresses that he or she has difficulties in conducting his or her duties. |
[This Article Added on Dec. 10, 2015]
| Article 6 (Allowances and travel expenses) |
Allowances, traveling expenses, and other necessary expenses may be paid within the budget, to the members of the National Committee, the members of specialized committees, and relevant experts, etc. who appear at the National Committee or any specialized committee; provided, this shall not apply where public officials appear at the National Committee or any specialized committee in direct connection with affairs under their charge.
| Article 7 (Request for cooperation of relevant agencies) |
If necessary for deliberating on any agenda item, the National Committee or specialized committees may request relevant institutions, organizations, etc. to present relevant materials or opinions.
| Article 8 (Holding of public hearings) |
If necessary for deliberating on any agenda item, the National Committee may hold a public hearing or discussion, or request relevant experts, institutions, organizations, etc. to conduct investigations or research.
| Article 9 (Operating rules) |
Except as provided in this Decree, matters concerning the composition and operation of the National Committee and specialized committees, and other necessary matters, shall be determined by the chairperson of the National Committee by a resolution thereof.
| Article 10 (Standards for evaluation and certification of institutional committees) |
| (1) | The standards for certification of institutional committees under Article 14 (1) of the Act shall include the following: |
| 1. | Propriety of deliberations by institutional committees on matters falling under the items of Article 10 (3) 1 of the Act; |
| 2. | Propriety of performance systems for inspection and supervision of the process and outcomes of research being conducted by the relevant institution under Article 10 (3) 2 of the Act; |
| 3. | Propriety of education provided for the researchers and employees of the relevant institution under Article 10 (3) 3 (a) of the Act, and education provided for the members of institutional committees; |
| 4. | Establishment of measures for protecting human subjects in a vulnerable position, etc., under Article 10 (3) 3 (b) of the Act, and whether such measures are complied with; |
| 5. | Establishment of ethical guidelines for researchers under Article 10 (3) 3 (c) of the Act, and the propriety of such guidelines; |
| 6. | Independence of the composition of institutional committees, and the expertise of staff members supporting the operation thereof, both of which are necessary for smooth operation of institutional committees; |
| 7. | Whether to prepare standard operation guidelines for institutional committees in relevant institutions, and the propriety of such guidelines; |
| 8. | Systems for the management of related records and documents, and the propriety of such systems. |
| (2) | The valid term of certification shall be three years, but may be extended just for one year, depending on the result of evaluation. |
| (3) | Except as provided in this Decree, necessary matters concerning the details of standards for the evaluation and certification of institutional committees; the procedures and methods for evaluation, certification, and certification extension; the designs and indication methods of the certification mark; and other matters related thereto shall be prescribed by Decree of the Ministry of Health and Welfare. |
| Article 11(Restrictions on frequency of egg collection) |
| (1) | The frequency of egg collection under Article 27 (3) of the Act shall be three times in a lifetime, and eggs shall be collected at an interval of at least six months. |
| (2) | Where there occurred side effects of egg collection, eggs may be re-collected more than six months after the side effects are completely cured. |
| Article 12 (Rare or incurable diseases for which research on residual embryos is conducted) |
| (1) | "Rare or incurable diseases specified by Presidential Decree" in Article 29 (1) 2 of the Act means the following: <Amended on Feb. 28, 2017> |
| 1. | Rare diseases: |
| (a) | Multiple sclerosis, Huntington's disease, hereditary ataxia, amyotrophic lateral sclerosis, cerebral palsy, and spinal cord injury; |
| (b) | Congenital immunodeficiency syndromes, aplastic anemia, and leukemia; |
| (c) | Osteochondrodysplasia; |
| (d) | Adrenoleukodystrophy, Metachromatic Leukodystrophy, and Krabbe's disease; |
| 2. | Incurable diseases: |
| (a) | Myocardial infarction; |
| (b) | Liver cirrhosis; |
| (c) | Parkinson's disease, stroke, Alzheimer’s disease, and optic nerve damage; |
| (d) | Diabetes mellitus; |
| (e) | Acquired immunodeficiency syndrome. |
| (2) | "Research specified by Presidential Decree" in Article 29 (1) 3 of the Act means research determined and publicly notified by the Minister of Health and Welfare, after deliberation by the National Committee, which is deemed necessary for research on residual embryos for public health. |
| Article 13 (Matters regarding approval of changes to embryo research plan) |
"Important matter specified by Presidential Decree" in the latter part of Article 30 (1) of the Act means any of the following:
| 1. | The purposes of or period for research; |
| 2. | The quantity of residual embryos necessary for research; |
| 3. | The medical institution producing embryos which provides residual embryos; |
| 4. | The person in charge of research. |
| Article 14 (Restrictions on somatic-cell nuclear transplantation or parthenogenesis) |
| (1) | Research permitted to conduct somatic-cell nuclear transplantation or parthenogenesis pursuant to Article 31 (2) of the Act shall meet all the following requirements: <Amended on Jul. 2, 2019> |
| 1. | Research for producing somatic-cell cloning embryos or parthenogenesis embryos and establishing embryonic stem cell lines by using them; |
| 2. | Research using any of the following eggs: |
| (a) | Eggs cryopreserved for producing embryos, intended to be disposed of due to any reason, such as success in pregnancy; |
| (b) | Immature eggs or abnormal eggs, intended to be disposed of because there is no plan to produce embryos; |
| (c) | Eggs used for in vitro fertilization, intended to be disposed of due to failure in fertilization or abandonment of fertilization; |
| (d) | Eggs collected for medical treatment of infertility, intended to be disposed of because there is no appropriate donee; |
| (e) | Eggs collected from removed ovaries; |
| 3. | Research using somatic-cell cloning embryos or parthenogenesis embryos in vitro before the primitive streak appears during embryonic development. |
| (2) | With intent to provide residual eggs to persons planning to conduct research under paragraph (1), embryo-producing medical institutions shall obtain written consent from their donors; provided, where with intent to provide eggs under paragraph (1) 2 (e), the practitioners collecting the relevant eggs shall obtain written consent from their donors. |
| Article 15 (Approval of changes to embryonic stem cell lines research plan) |
"Important matter specified by Presidential Decree" in the latter part of Article 35 (2) of the Act means any of the following:
| 1. | The purposes of or period for research; |
| 2. | The person in charge of research; |
| 3. | Matters affecting the scientific and ethical validity of research plans using embryonic stem cell lines. |
| Article 16 (Permission for establishment of human material banks) |
| (1) | A person who intends to obtain permission for establishment of a Human Material Bank pursuant to Article 41 (1) of the Act shall be equipped with facilities, equipment, and human resources specified in Appendix 1. |
| (2) | A person who intends to obtain permission for establishment of a Human Material Bank shall, as prescribed by Decree of the Ministry of Health and Welfare, submit a written application for permission for establishment of a Human Material Bank to the Minister of Health and Welfare, along with documents determined by said Ordinance. |
| (3) | Where the Minister of Health of Welfare intends to grant permission for establishment of a Human Material Bank, he or she shall issue a certificate of permission to the applicant, as prescribed by Decree of the Ministry of Health and Welfare. |
| Article 17 (Changes subject to reporting by human material banks) |
"Important matter specified by Presidential Decree" in Article 41 (3) of the Act means any of the following:
| 1. | The location of the Human Material Bank; |
| 2. | The head of the institution; |
| 3. | The name of the institution; |
| 4. | The facilities, apparatus, and human resources of the Human Material Bank. |
| Article 18 (Changes subject to reporting by gene therapy institutions) |
"Important matter specified by Presidential Decree" in the latter part of Article 48 (1) of the Act means any of the following:
| 1. | The location of the gene therapy institution; |
| 2. | The head of the institution; |
| 3. | The name of the institution; |
| 4. | The diseases or such therapy items to which gene therapies are subjected. |
| Article 19 (Changes subject to reporting by genetic testing institutions) |
"Important matter specified by Presidential Decree" in Article 49 (2) of the Act means any of the following: <Amended on Dec. 28, 2021>
| 1. | The location of the genetic testing institution; |
| 2. | The head of the institution; |
| 3. | The name of the institution; |
| 4. | The purpose of a genetic test; |
| 4-2. | Genetic test items by purpose of genetic testing; |
| 5. | The facilities and human resources of the genetic testing institution. |
| Article 20 (Prohibited or restricted genetic tests) |
"Genetic tests specified by Presidential Decree" in Article 50 (1) of the Act means tests prescribed in Appendix 2.
| Article 21 (Genetic tests for embryos or fetuses) |
"Hereditary diseases specified by Presidential Decree" in Article 50 (2) of the Act means diseases prescribed in Appendix 3.
| Article 22 (Imposition and collection of penalty surcharges) |
| (1) | Where the Minister of Health and Welfare intends to impose a penalty surcharge pursuant to Article 58 (1) of the Act, he or she shall give written notice of the payment of the penalty surcharge specifying the type of violation involved and the amount of such surcharge. |
| (2) | A person who has been given notice pursuant to paragraph (1) shall pay the penalty surcharge to the collecting agency determined by the Minister of Health and Welfare within 20 days from the date of receipt of the notice. <Amended on Dec. 12, 2023> |
| (3) | Upon receiving penalty surcharges pursuant to paragraph (2), the collecting agency shall issue the receipts to the payers, and shall notify the Minister of Health and Welfare of the fact of receiving the penalty surcharges without delay. |
| Article 23 (Subsidies from National treasury) |
Institutions or organizations, or their employees, entitled to receive a subsidy for research expenses pursuant to Article 60 of the Act shall be as follows:
| 1. | Institutions or organizations performing activities of research or education on securing of bioethics and safety; |
| 2. | Bioethics policy research centers designated pursuant to Article 6 (1) of the Act; |
| 3. | Employees of any institution or organization referred to in subparagraph 1, who have performed research and education activities in any bioethics-related field for at least five years. |
| Article 24 (Delegation and entrustment of authority) |
| (1) | The Minister of Health and Welfare shall delegate the following authority to the head of the Korea Centers for Disease Control and Prevention pursuant to Article 61 (1) of the Act: <Amended on Sep. 11, 2020; Dec. 28, 2021> |
| 1. | Deleted; <Sep. 11, 2020> |
| 2. | Designation of embryo-producing medical institutions under Article 22 (1) of the Act, acceptance of reports on any changed matters under paragraph (4) of that Article, acceptance of reports on suspension or closure of business operations of such medical institutions under paragraph (5) of that Article, and transfer of embryonic or reproductive cells and relevant documents in custody under paragraph (6) of that Article; |
| 3. | Registration of embryo research institutes under Article 29 (2) of the Act, and acceptance of reports on closure of business operations under paragraph (3) of said Article; |
| 4. | Registration of research institutes for somatic-cell cloning embryos, etc. under Article 31 (3) of the Act; |
| 5. | Registration of embryonic stem cell lines under Article 33 (1) of the Act; |
| 6. | Receipt of reports on the current status concerning provision of embryonic stem cell lines under Article 34 (2) of the Act; |
| 7. | Receipt of reports on details of approval for use of embryonic stem cell lines or reports on details of approval for change thereof under Article 35 (3) of the Act; |
| 8. | Permission for Human Material Banks under Article 41 (1) of the Act, and acceptance of reports on the change or on suspension or closure of business operations under paragraph (3) of said Article; |
| 9. | Acceptance of reports or reports on change made by gene therapy institutions under Article 48 (2) of the Act; |
| 10. | Acceptance of a report or report on change from a genetic testing institution under Article 49 (3) of the Act, acceptance of a report on suspension or closure of business under paragraph (4) of that Article, ex officio cancellation of matters reported under Article 49 (5) of that Article (6), request for information on whether a business is closed under the former part of Article 49 (6) of the Act; |
| 11. | Orders, other necessary measures, entry for inspection, inquiries, or collection under Article 54 of the Act; |
| 12. | Orders for disposal under Article 55 (1) of the Act; |
| 13. | Orders for improvement of facilities or orders for prohibition of use of facilities under Article 55 (2) of the Act; |
| 14. | Orders for revocation of registration, etc., or orders for suspension of operation under Article 56 of the Act; |
| 15. | Holding hearings pursuant to Article 57 of the Act; |
| 16. | Imposing and collecting penalty surcharges under Article 58 of the Act; |
| 17. | Collecting fees under Article 59 of the Act. |
| (2) | The Minister of Health and Welfare shall entrust the following business affairs to an institution or organization specified in the relevant subparagraph pursuant to Article 61 (2) of the Act: <Amended on Dec. 28, 2021> |
| 1. | Business affairs regarding the acceptance of applications for the registration of institutional committees and the issuance of certificates of registration under Article 10 (4) of the Act: Institutions or organizations designated and publicly notified by the Minister of Health and Welfare in recognition of their expertise in the business affairs regarding the acceptance of applications for the registration of institutional committees, etc. from among non-profit corporations under Article 32 of the Civil Act; |
| 2. | Business affairs regarding education on the members of institutional committees under Article 13 (1) 2 of the Act: Institutions or organizations deemed to have expertise in business affairs of education on the members of institutional committees, and designated and publicly notified by the Minister of Health and Welfare, from among non-profit corporations under Article 32 of the Civil Act; |
| 3. | Business affairs regarding the evaluation and certification review of institutional committees and the publication of the results thereof under Article 14 (1) and (2) of the Act: Institutions or organizations designated and publicly notified by the Minister of Health and Welfare in recognition of their expertise in the business affairs of evaluation and certification review of institutional committees, from among non-profit corporations under Article 32 of the Civil Act; |
| 4. | Business affairs regarding the evaluation of proficiency in genetic testing under Article 49-2 (1) of the Act: Institutions or organizations designated and publicly notified by the Minister of Health and Welfare in recognition of their expertise in the business of evaluating proficiency in genetic testing, from among non-profit corporations under Article 32 of the Civil Act; |
| 5. | Business affairs regarding the acceptance of certification or recertification of testing capability and the notification of the results thereof under Article 49-2 (2) and (3) of the Act: Institutions or organizations designated and publicly notified by the Minister of Health and Welfare in recognition of their expertise in the business affairs of reviewing certification of testing capability from among non-profit corporations under Article 32 of the Civil Act. |
| Article 24-2 (Re-examination of regulation) |
The Minister of Health and Welfare shall review the validity of the standards for imposing administrative fines under Article 25 and Appendix 4 every three years (referring to the period ending on the date immediately preceding January 1 of the third year), with January 1, 2014 as the reference date, and shall then take measures for improvement, etc. of such standards.
[This Article Added on Dec. 30, 2013]
| Article 25 (Standards for imposing administrative fines) |
Standards for imposing administrative fines prescribed in Article 70 of the Act shall be as prescribed in Appendix 4.
ADDENDA <Presidential Decree No. 24329, Jan. 22, 2013>
Article 1 (Enforcement date)
This Decree shall enter into force on February 2, 2013.
Article 2 (Relationship to other statutes or regulations)
Citations of the previous provisions of the Enforcement Decree of the Bioethics and Safety Act in any other statutes or regulations as at the time this Decree enters into force, if corresponding provisions exist in this Decree, shall be deemed citations of such corresponding provisions of this Decree in lieu of the previous provisions.
Article 3 (Transitional measures concerning administrative fines)
The previous provisions shall apply to the imposition of administrative fines for violations committed before this Decree enters into force.
ADDENDA <Presidential Decree No. 24454, Mar. 23, 2013>
Article 1 (Enforcement date)
This Decree shall enter into on the date of its promulgation. (Proviso Omitted.)
Articles 2 through 4 Omitted.
ADDENDUM <Presidential Decree No. 25050, Dec. 30, 2013>
This Decree shall enter into force on January 1, 2014. (Proviso Omitted.)
ADDENDA <Presidential Decree No. 25751, Nov. 19, 2014>
Article 1 (Enforcement date)
This Decree shall enter into force on the date of its promulgation; provided, the amendments to Presidential Decrees to be amended pursuant to Article 5 of the Addenda, which were promulgated before this Decree enters into force but the enforcement dates of which have yet to arrive, shall enter into force on the enforcement date of the relevant Presidential Decree.
Articles 2 through 4 Omitted.
Article 5 Omitted.
ADDENDA <Presidential Decree No. 25840, Dec. 9, 2014>
Article 1 (Enforcement date)
This Decree shall enter into force on January 1, 2015.
Articles 2 through 7 Omitted.
Article 8 (Transitional measures for amendment to the Enforcement Decree of the Bioethics and Safety Act)
In applying the standards for imposing administrative fines for violations committed before this Decree enters into force, the previous provisions shall apply notwithstanding the amended provisions of subparagraph 2 (a) and (b) of Appendix 4 of the Bioethics and Safety Act.
Articles 9 through 16 Omitted.
ADDENDUM <Presidential Decree No. 26703, Dec. 10, 2015>
This Decree shall enter into force on the date of its promulgation.
ADDENDA <Presidential Decree No. 27751, Dec. 30, 2016>
Article 1 (Enforcement date)
This Decree shall enter into force on January 1, 2017. (Proviso Omitted.)
Articles 2 through 8 Omitted.
Article 9 (Transitional measures for amendment to the Enforcement Decree of the Bioethics and Safety Act)
In applying the standards for imposing administrative fines for violations committed before this Decree enters into force.
Articles 10 through 12 Omitted.
ADDENDUM <Presidential Decree No. 27918, Feb. 28, 2017>
This Decree shall enter into force on the date of its promulgation.
ADDENDA <Presidential Decree No. 28211, Jul. 26, 2017>
Article 1 (Enforcement date)
This Decree shall enter into force on the date of its promulgation; provided, the amendments to Presidential Decrees to be amended pursuant to Article 8 of the Addenda, which were promulgated before this Decree enters into force but the enforcement dates of which have yet to arrive, shall enter into force on the enforcement date of the relevant Presidential Decree.
Articles 2 through 7 Omitted.
Article 8 Omitted.
ADDENDUM <Presidential Decree No. 29950, Jul. 2, 2019>
This Decree shall enter into on the date of its promulgation. (Proviso Omitted.)
ADDENDUM <Presidential Decree No. 30141, Oct. 22, 2019>
This Decree shall enter into force on October 24, 2019.
ADDENDA <Presidential Decree No. 31013, Sep. 11, 2020>
Article 1 (Enforcement date)
This Decree shall enter into force on September 12, 2020.
Article 2 Omitted.
Article 3 Omitted.
ADDENDA <Presidential Decree No. 32268, Dec. 28, 2021>
Article 1 (Enforcement date)
This Decree shall enter into force on December 30, 2021.
Article 2 (Transitional measures concerning change of matters subject to reporting by genetic testing institutions)
Notwithstanding the amended provisions of subparagraph 4 of Article 19, the previous provisions shall apply where genetic testing items are changed before this Decree enters into force.
Article 3 (Transitional measures concerning criteria for imposition of administrative fines)
Notwithstanding the amended provisions of subparagraph 1 of Appendix 4, the previous provisions shall apply for purposes of applying the criteria for imposing administrative fines for any violation committed before this Decree enters into force.
Article 4 Omitted.
ADDENDUM <Presidential Decree No. 33913, Dec. 12, 2023>
This Decree shall enter into force on the date of its promulgation.
ADDENDUM <Presidential Decree No. 34747, Jul. 23, 2024>
This Decree shall enter into force on the date of its promulgation.
ADDENDUM <Presidential Decree No. 35811, Oct. 1, 2025>
This Decree shall enter into force on the date of its promulgation; provided, the amended provisions of Presidential Decrees, which were promulgated before the enforcement of this Decree but have not yet entered into force, shall enter into force on the respective enforcement dates of such Presidential Decrees.