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BIOETHICS AND SAFETY ACT
BIOETHICS AND SAFETY ACT
INTRODUCTION
Details of Enactment and Amendment
- Enactment: This Act was enacted by the Act No. 7150 on January 29, 2004 by the name of the Bioethics and Safety Act, for the purpose
of contributing to the improvement of national health and living quality by ensuring the human dignity in biotechnology as well as
by creating the conditions in which the biotechnology is capable of being developed and utilized for the prevention, treatment, etc.
of human diseases.
Main Contents
- The State or local governments shall be responsible for the preparation of measures to deal efficiently with those matters concerning
bioethics and safety which are likely to be caused in the course of developing or utilizing the biotechnology, and a researcher,
etc. shall endeavor to make the biotechnology suitable for bioethics and safety.
- Under the President, there shall be established the National Bioethics Committee to deliberate on the matters concerning the establishment
of major policies respecting bioethics and safety in biotechnology, etc.
- An act of producing a somatic cell cloning embryo, implanting it in the uterus, maintaining any state of such implantation or giving
birth to a baby for the purpose of cloning a human individual as well as any other act of inducing or helping other persons to perform
the said act shall be prohibited.
- Any person shall not produce embryos for any purpose other than pregnancy, and residual embryos that remain after being used for
the pregnancy of an infertile couple may be used for the treatment for infertility, the development of contraception technology,
the research for treatment for rare or incurable diseases, etc.
- An act of transplanting the nucleus of a somatic cell shall be permitted only for the research for treatment for part of rare or
incurable diseases.
- The genetic testing which might give wrong information on a person to undergo that testing due to the uncertainty of scientific
verification shall be prohibited, and any other genetic testing related to a diagnosis of disease shall be conducted either by a
medical institution or at its request.
- Any employee of a gene bank shall neither provide genetic data, etc. which are acquired by him/her or come to his/her knowledge
in the course of performing his/her duties to other persons nor use those data for unreasonable purposes without any justifiable
reason.
- There shall be no discrimination due to genetic data in education, employment, promotion, insurance, and other social activities.
- The gene therapy shall be permitted only in case of the treatment for any disease which threatens life, such as a hereditary disease,
cancer, AIDS, etc., and The gene therapy with respect to a spermatozoon, ovum, embryo or fetus shall be prohibited.
- The Minister of Health and Welfare may, if the research, development or utilization of biotechnology causes or is likely to cause
serious risks to bioethics or safety, give orders to suspend such research, development or utilization or take other necessary measures.
- A genetic testing institution or authorized medical institution for embryo production shall, if it violates the matters prohibited
by this Act, be punished by imprisonment for not more than ten years according to types of such violation.
BIOETHICS AND SAFETY ACT
Act No. 7150, Jan. 29, 2004
Amended by Act No. 7413, Mar. 24, 2005
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:
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 the 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 any act of transplanting the nucleus of a human somatic
cell to a human or animal ovum the nucleus of which is removed;
5. The term "somatic cell cloning embryo" means any embryo that is produced by an act of transplanting the nucleus of a
somatic cell;
6. The term "genetic testing" means any act of analyzing chromosomes, genes, etc. from objects of that testing such as blood,
hair or saliva for the purpose of distinguishing the 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 the "genetic data, etc.") for the purpose of owning
them, and uses them directly or provides them to other persons; and
9. The term "gene therapy" means a series of acts which causes any genetic mutation for the purpose of preventing or treating
diseases.
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 deal efficiently with those matters concerning bioethics and safety
which are likely to be caused in the course of developing or using the biotechnology.
(2) Any person who intends to research, develop and use the 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 REVIEW BOARD
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; and
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>
1. The Minister of Education and Human Resources Development, the Minister of Justice, the Minister of Science and Technology, the
Minister of Commerce, Industry and Energy, the Minister of Health and Welfare, the Minister of Gender Equality and Family, 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 Nonprofit 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 Science and Technology and the Minister of Health
and Welfare, and the chief secretary shall be the latter.
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 the Presidential Decree.
Article 9 (Establishment and Functions of Institutional Bioethics Review Board)
(1) An institution which falls under any of the following subparagraphs shall establish a bioethics review board (hereinafter referred
to as an "institutional review board") to ensure the bioethics and safety in biotechnology:
1. An embryo research institute registered with the Minister of Health and Welfare under Article 18;
2. A gene bank permitted by the Minister of Health and Welfare under the main sentence of Article 32 (1);
3. A gene therapy institution referred to in Article 37 (2); or
4. Any other institution provided by the Ordinance of the Ministry of Health and Welfare which researches, develops or uses the biotechnology
likely to have serious ethical or social effects.
(2) An institutional review board 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 the "personal information"), such as names and resident registration numbers, if the spermatozoa, ova or objects
of genetic testing are provided to other persons; and
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 review board to deliberate thereon and report the results of such deliberation to the Minister
of Health and Welfare.
(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 the Ordinance of the Ministry of Health and Welfare in the scale, the number of researchers,
etc. shall, if it makes 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 review board, be deemed to establish that institutional
review board.
Article 10 (Composition and Operation of Institutional Review Board)
(1) An institutional review board shall be comprised of not less than five nor more than nine members including one chairperson, who
shall include one person not engaged in life sciences or medicine and another person not working at the institution concerned.
(2) The members of an institutional review board 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 review board 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 review board shall be provided for by the
Presidential Decree.
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) It shall not be permitted that a person involves any of the following acts:
1. Fertilizing a human ovum with an animal spermatozoon or fertilizing an animal ovum with a human spermatozoon: Provided, That an
act for testing the activity of the human spermatozoon medically shall be excluded;
2. Transplanting the nucleus of an animal somatic cell to a human ovum the nucleus of which is removed;
3. Fusing a human embryo and an animal embryo; and
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) Any person shall not produce embryos for any purpose other than pregnancy.
(2) In producing embryos for pregnancy purposes, it shall not be permitted that a person involves 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: Provided, That any case where married minors aim at having children shall be excluded;
(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
interests in money or property 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 and Welfare.
(2) Any medical institution which intends to be designated as a medical institution to produce embryos shall possess facilities, manpower,
etc. provided for by the Ordinance of the Ministry of Health and Welfare.
(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 the Ordinance of the Ministry of Health and Welfare.
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 the 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 the "consenters").
(2) The written consent under paragraph (1) shall include the following matters:
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 or not to consent that residual embryos should be used for any purpose other than pregnancy; and
5. Withdrawal of consent, the protection of rights and information of consenters and other matters provided for by the Ordinance of
the Ministry of Health and Welfare.
(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 the 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 the Ordinance of the Ministry of Health and Welfare.
Article 16 (Preservation Period and Disposal of Embryos)
(1) The preservation period of embryos shall be five years: Provided, That if the consenters determine that it is less than five years,
it shall be less than five years.
(2) An authorized medical institution for embryo production shall dispose of embryos that are 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 the Ordinance of the Ministry of Health and Welfare.
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:
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 the Presidential Decree;
and
3. Any other research which the National Committee deliberates on and which is provided for by the Presidential Decree.
Article 18 (Embryo Research Institute)
Any person who intends to research on residual embryos under Article 17 shall possess facilities, manpower, etc. provided for by the
Ordinance of the Ministry of Health and Welfare and shall be registered as an embryo research institute with the Minister of Health
and Welfare.
Article 19 (Approval of Embryo Research Plan)
(1) If any embryo research institute registered with the Minister of Health and Welfare under Article 18 (hereinafter referred to
as an "authorized embryo research institute") intends to research on embryos under Article 17, it shall, in advance, present
the Minister of Health and Welfare an embryo research plan, which shall be approved by him/her in accordance with the Ordinance of
the Ministry of Health and Welfare. The same shall apply to any modification of important matters provided for by the Presidential
Decree.
(2) An embryo research plan referred to in paragraph (1) shall include documents relating to the results of deliberation of an institutional
review board established under an authorized embryo research institute.
(3) The Minister of Health and Welfare 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 or not
to approve that plan.
(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 the Ordinance of the Ministry of Health and Welfare.
Article 20 (Provision and Management of Residual Embryos)
(1) If an authorized medical institution for embryo production provides residual embryos necessary for research to such authorized
embryo research institutes as obtain approval for embryo research plans under Article 19 (1), it shall do so gratuitously: Provided,
That it may require them to pay necessary expenses for the preservation and provision of residual embryos in accordance with the
Ordinance of the Ministry of Health and Welfare.
(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 the Ordinance of the Ministry of Health and Welfare.
(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 and Welfare in accordance with the Ordinance of the
Ministry of Health and Welfare.
(4) Article 16 (2) through (4) shall apply mutatis mutandis to the disposal of residual embryos which an authorized embryo research
institute does not intend to use for research after it is provided with them under paragraph (1) of this Article. In this case, an
"authorized medical institution for embryo production" shall be deemed an "authorized embryo research institute".
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:
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 that institute causes or is likely to cause serious risks to bioethics or safety; and
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 the Ordinance of the Ministry of Health and Welfare.
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 that 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 the 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 research on somatic cell cloning embryos shall possess facilities, manpower, etc. provided
for by the Ordinance of the Ministry of Health and Welfare and shall be registered with the Minister of Health and Welfare.
(2) Articles 19 through 21 shall apply mutatis mutandis to research on somatic cell cloning embryos. In this case, "residual
embryos" shall be deemed "somatic cell cloning embryos".
CHAPTER IV GENETIC TESTING
Article 24 (Genetic Testing Institution, etc.)
(1) A person who intends to conduct any genetic testing or who intends to collect objects of that testing directly and carry out research
on genes shall report matters such as the place in which a genetic testing or research facility is located, the head, said genetic
testing or items of such research to the Minister of Health and Welfare in accordance with the Ordinance of the Ministry of Health
and Welfare: Provided, That this shall not apply in case that a state organ conducts the genetic testing or carries out research
on genes.
(2) The provisions of paragraph (1) shall also apply in case of modifying important matters provided for by the Presidential Decree
from among matters as reported under the said paragraph.
(3) The Minister of Health and Welfare 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 the Ordinance of the Ministry of Health and Welfare.
(4) A genetic testing institution shall, if it intends to cease or suspend any business of genetic testing, report to the Minister
of Health and Welfare in accordance with the Ordinance of the Ministry of Health and Welfare.
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 that 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 the 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 the Presidential Decree.
(3) A genetic testing institution other than a medical institution shall not conduct any genetic testing related to a diagnosis of
disease: Provided, That this shall not apply in case that it does so at the request of the medical institution.
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 that testing or research or commission any other institution or person to do so, they shall obtain the written consent of persons
to undergo that testing including any of the following before such collection:
1. Purpose of genetic testing or research;
2. Whether or not 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 or not to include any personal information in case 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; and
5. Withdrawal of consent, the protection of rights and information of persons to undergo any genetic testing, and other matters provided
for by the Ordinance of the Ministry of Health and Welfare.
(2) If a person other than a genetic testing institution collects objects of genetic testing and commissions it to conduct that testing,
he/she shall obtain the written consent of other persons to undergo that testing under paragraph (1) and annex that written consent.
In this case, measures to protect personal information shall be taken in accordance with the Ordinance of the Ministry of Health
and Welfare.
(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: Provided, That if his/her own consent cannot be obtained
by reason of his/her mental and physical weakness or defection in conducting that testing for the purpose of diagnosing or treating
any disease, it may be omitted.
(4) Notwithstanding the provisions of paragraphs (1) through (3), any genetic testing may be conducted without any written consent
in the following cases:
1. In case that there is any urgent need or exceptional grounds to identify a dead body or an unconscious person; and
2. In case that 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 that
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 the Ordinance of the Ministry of Health and Welfare.
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 that 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 with objects of genetic testing offered
in accordance with paragraph (1): Provided, That the same shall not apply if a person to undergo that testing or his/her legal agent
gives written consent to include the personal information, and in this case, a copy of the written consent shall be attached.
(3) A genetic testing institution, a person conducting research into 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 the Ordinance of the Ministry of Health and Welfare if providing or being provided
with such objects under paragraph (1).
(4) Paragraphs (1) through (3) shall apply mutatis mutandis to cases where a person provided with given objects of genetic testing
offers them to another researcher or gene bank.
Article 28 (Destruction of Objects of Genetic Testing)
(1) The preservation period of objects of genetic testing shall be five years: Provided, That if such preservation period is separately
determined by a person to undergo that testing or his/her legal agent in written consent form under Article 26 (1), it shall prevail.
(2) A genetic testing institution, etc. shall destroy objects of genetic testing immediately after the preservation period thereof
expires: Provided, That this shall not apply in case that a person to undergo that testing or his/her legal agent requests in writing
that such objects should not be destroyed.
(3) If a person to undergo any genetic testing or his/her legal agent requests a genetic testing institution, etc. to destroy objects
of that 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. can not 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 under the conditions prescribed by the Ordinance of
the Ministry of Health and Welfare.
(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 the Ordinance of the Ministry of Health and Welfare.
Article 29 (Management and Inspection of Records)
(1) A genetic testing institution, etc. shall keep the following documents under the conditions prescribed by the Ordinance of the
Ministry of Health and Welfare:
1. Written consent forms under Article 26;
2. The results of genetic testing; and
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 the Ordinance of the Ministry of Health and Welfare.
Article 30 (Matters to be Observed by Genetic Testing Institutions, etc.)
(1) A genetic testing institution, etc. shall observe the following matters:
1. The details of written consents under Article 26;
2. The protection of genetic data; and
3. Other matters equivalent to those of subparagraphs 1 and 2 which are prescribed by the Ordinance of the Ministry of Health and
Welfare 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 the Ordinance of the Ministry of Health and Welfare.
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 and Welfare under
the conditions prescribed by the Presidential Decree: Provided, That this shall not apply in case that a national agency intends
to establish a gene bank itself.
(2) Notwithstanding the provisions of paragraph (1), if a person intends to establish a gene bank after obtaining approval for assisting
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 and Welfare at the time when the approval for assisting the research
funds is obtained from the head of the central administrative agency. In this case, the head of the central administrative agency
concerned shall consult in advance with the Minister of Health and Welfare thereabout.
(3) If a gene bank established under paragraph (1) moves its location or desires to alter any important matters as prescribed by the
Presidential Decree among the matters subject to permission for its establishment, it shall report to the Minister of Health and
Welfare thereon under the conditions prescribed by the Ordinance of the Ministry of Health and Welfare.
(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
and Welfare thereon under the conditions prescribed by the Ordinance of the Ministry of Health and Welfare.
(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 the 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
or not to offer such genetic data, etc. after deliberation by an institutional review board under Article 9 and report the results
to the Minister of Health and Welfare.
(3) The details for mention in 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 the Ordinance of the Ministry of Health and
Welfare.
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: Provided, That the head
of the gene bank shall be entitled to request expenses necessary for keeping and offering genetic data, etc. under the conditions
prescribed by the Ordinance of the Ministry of Health and Welfare.
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 the medical history or the records of treatment, etc. of a patient provided
to any other person than the patient under the proviso of Article 20 (1) of the Medical Service Act: Provided, That this shall not
apply in case that another medical institution requests these for the purposes of diagnosing or treating the same type of disease
as that of the patient concerned after taking measures for protection of such personal information.
CHAPTER VI GENE THERAPY
Article 36 (Gene Therapy)
(1) No person shall attempt to perform any gene therapy except in the following:
1. Treatment for such diseases as hereditary diseases, cancers, and AIDS which may threaten life or cause any serious disability;
2. Treatment for diseases presently beyond medical treatment or treatment for diseases whose gene therapy would be deemed considerably
more effective than any other treatment; and
3. Cases which are deemed necessary for prevention or treatment for diseases determined by the Minister of Health and Welfare subject
to deliberation by the National Committee.
(2) Notwithstanding the provisions of paragraph (1), no gene therapy shall be carried out regarding sperm, ova, embryos or fetuses.
Article 37 (Gene Therapy Institution)
(1) Any medical institution which intends to carry out any gene therapy shall report thereon to the Minister of Health and Welfare.
The same shall also apply in case that it is intended to alter any important matters as prescribed by the Presidential Decree.
(2) Any medical institution which has reported to the Minister of Health and Welfare under paragraph (1) (hereinafter referred to
as a gene therapy institution ) shall obtain written consent from a patient subject to gene therapy after explaining in advance
the following matters:
1. The purpose of treatment;
2. The expected results of treatment and the side effects; and
3. Other matters determined by the Ordinance of the Ministry of Health and Welfare.
(3) Requirements and procedures for the report of gene therapy institutions, written consent forms, and other necessary matters shall
be prescribed by the Ordinance of the Ministry of Health and Welfare.
CHAPTER VII SUPERVISION
Article 38 (Report, Investigation, etc.)
(1) The Minister of Health and Welfare 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 an institution subject to supervision ) or its employees to make or submit necessary reports or materials for the
administration of this Act under the conditions prescribed by the Ordinance of the Ministry of Health and Welfare, 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.
(2) The Minister of Health and Welfare may, if deemed necessary for ascertaining whether or not 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
the 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 this case, the public officials concerned shall bear certificates verifying their authority
and show them to the persons concerned.
(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 and Welfare may order an institution subject to supervision or its employees to destroy embryos or somatic
cell cloning embryos produced, kept or offered in violation of Article 13, 14, 15 (1), 16 (2), 17 through 19, 20 (1) and (4), 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 this case, Article 16 (4) or 28 (6) shall apply mutatis mutandis with respect to
the procedures and methods of destruction.
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 and Welfare may order it to improve the facilities or prohibit
the use of the whole or part of the facilities.
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 and Welfare may cancel
its designation, registration or permission or order it to suspend the whole or a part of the business for a fixed period of less
than one year:
1. In case that it violates Article 9 (1) and (3), 10 (1) and (3), 11 through 14, 15 (1) and (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, 36 or 37
(1)(the latter part) and (2);
2. In case that it fails to fulfill the matters to be observed under Article 21, 30 or 34;
3. In case that it fails to comply with an order under Article 38 (1), 39 or 40; and
4. In case that 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 the Ordinance of the Ministry
of Health and Welfare in consideration of the type, extent, etc. of the violations.
Article 42 (Hearing)
If the Minister of Health and Welfare intends to cancel the designation, registration or permission under Article 41 (1), he/she shall
hold a hearing.
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 and Welfare 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 the Presidential Decree:
1. In case that it violates Article 14, 15 (1) and (3), 16 (2) and (3), or 36;
2. In case that it fails to fulfill the matters to be observed under Article 21;
3. In case that it fails to comply with an order under Article 38 (1), 39 or 40; and
4. In case that 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 the Ordinance of the Ministry of Health and Welfare.
(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
and Welfare shall collect it following the procedure for dispositions on default of the payment of national taxes.
Article 44 (Fees)
The Minister of Health and Welfare 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 under the conditions prescribed by the Ordinance
of the Ministry of Health and Welfare.
CHAPTER VIII SUPPLEMENTARY PROVISIONS
Article 45 (Support to Adult Stem Cell Research)
The State or a local government may provide financial support necessary to foster 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 and Welfare may assist related organizations, research institutes, persons engaged in life science-related fields, etc.
in the whole or a part of necessary research funds under the conditions prescribed by the Presidential Decree.
Article 47 (Delegation and Entrustment, etc.)
(1) The Minister of Health and Welfare may delegate part of his/her authority under this Act to the head of an agency under his/her
control under the conditions prescribed by the Presidential Decree.
(2) The Minister of Health and Welfare may entrust part of the business falling under each of the following subparagraphs to the expert
institution or organization concerned under the conditions prescribed by the Presidential Decree:
1. The business of managing an authorized medical institution for embryo production under Article 14;
2. The business of managing an authorized embryo research institute under Article 18;
3. The business of managing a genetic testing institution under Article 24;
4. The business of managing a gene bank under Article 32; and
5. The business of managing a gene therapy institution under Article 37.
(2) If the Minister of Health and Welfare entrusts the business of management to the relevant expert institution or organization under
paragraph (2), he/she may subsidize expenses required for such management.
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
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:
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 material gain in violation of Article 13 (3);
6. 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); and
7. 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 a fine not exceeding thirty million Won:
1. A person who induces or assists another person to provide sperm or ova on condition of giving any such consideration as pecuniary
or material gain in violation of Article 13 (3);
2. A person who extracts sperm or ova without obtaining written consent to the production of embryos in violation of Article 15 (1);
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 that 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 that 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); and
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
a fine not exceeding twenty million Won:
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 the Ordinance of the Ministry of Health and Welfare 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 mutatis mutandis under
Article 20 (4);
3. A person who researches into residual embryos without being registered as an authorized embryo research institute in violation
of Article 18;
4. A person who researches into embryos without obtaining approval from the Minister of Health and Welfare in violation of Article
19 (1) (including cases where it shall apply mutatis mutandis under Article 23 (2);
5. A person who provides residual embryos on condition of consideration or fails to report to the Minister of Health and Welfare on
matters relating to the keeping, providing, etc. of residual embryos under the conditions prescribed by the Ordinance of the Ministry
of Health and Welfare in violation of Article 20 (1) or (3);
6. A person who produces or researches into 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); and
9. A person who violates an order for improvement, etc. under Article 40.
Article 54 (Joint Penal Provisions)
If a representative of a juristic person, or an agent, servant or other employee of a juristic person 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 (Fine for Negligence)
(1) Any person who falls under any one of the following subparagraphs shall be punishable by a fine for negligence not exceeding five
million Won:
1. A person who fails to make a report under Article 24 (1), (2) or (4);
2. A person who violates Article 28 (2) through (5);
3. A person who fails to keep any document referred to in any subparagraph of Article 29 (1) or refuses the inspection of records
or the delivery of copies under paragraph (2) of the said Article;
4. A person who fails to make a report under Article 32 (3) or (4);
5. A person who offers records including genetic data on a patient to any person other than the patient in violation of Article 35
(2); and
6. A person who conducts any gene therapy without filing a report in violation of Article 37 (1).
(2) The fine for negligence referred to in paragraph (1) shall be imposed and collected by the Minister of Health and Welfare under
the conditions determined by the Presidential Decree.
(3) Any person who is dissatisfied with the disposition of a fine for negligence under paragraph (2) may make objections to the Minister
of Health and Welfare within 30 days from the date on which he/she is informed of the disposition.
(4) If any person who has been subject to the disposition of a fine for negligence under paragraph (2) makes any objection under paragraph
(3), the Minister of Health and Welfare shall notify the fact without delay to the competent court, and the competent court which
receives the notification shall bring the case of the fine for negligence to a trial under the Non-Contentious Case Litigation Procedure
Act.
(5) If no objection is made 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: Provided, That Articles 11, 12, 49, 50, and 51 (1) 1 and
2 shall take effect on the date of its promulgation.
(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 entering into force this Act;
2. Five years have passed after their production; and
3. A consent has been obtained from the consenters: Provided, That this shall exclude cases where the consent can not be obtained
because the whereabouts, etc. of the consenters are unknown.
(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; and
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. (Proviso Omitted.)
Articles 2 through 4 Omitted.
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