생명윤리 법제에서 나타나는 문제점에 관한 연구

안영하(Young-Ha An),서순택(Soon Taek Seo),우제창(Jechang Woo),오정균(Chung-Kyoon Auh),엄애용(Aeyong Eom) 미국헌법학회 2014 美國憲法硏究 Vol.25 No.2

생명에 관한 연구는 인간 및 생명체를 직접 연구대상으로 함에 따라 과학성과 함께 윤리성의 확보가 전제되어야 한다. 급속한 과학기술의 발달에 따라 현재 진행되고 있는 생명에 관한 연구는 인류에게 큰 도움을 줄 수 있는 반면에, 윤리성이 결여된 연구는 인류에게 심각한 재앙을 초래할 위험성도 동시에 지니고 있기 때문이다. 본 논문은 우리의 실정에 맞는 생명윤리관련 법제의 구축과 정착을 목적으로 한 연구의 일환이다. 우리의 현실에 맞는 법제도의 구축 및 정착을 위한 1단계로서 생명윤리 법제 전반에 걸쳐 나타나고 있는 법적 문제점을 기존의 연구를 중심으로 검토하였다. 이를 위하여 생명윤리 및 안전에 관한 법률을 기초로 하여, 생명에 관한 연구에 대한 헌법적 문제와 생명윤리법 자체에 내제된 문제, 연구윤리와 관련된 조직의 문제 및 윤리위반에 관한 처벌의 형사정책적 문제로 구분하여 살펴보았다. 세부적으로는 헌법적 기본권과 관련하여 (1) 배아의 헌법상의 지위, (2) 인간의 존엄성과 관련된 문제, (3) 미국의 헌법상의 기본권과 관련된 생명윤리 및 연구지원정책에 대하여 검토하였다. 또한 생명윤리에 대한 기본법이라 할 수 있는 생명윤리 및 안전에 관한 법률에 대하여 다음과 같은 내용을 검토하였다. 생명윤리심의위원회(국가생명윤리심의위원회 및 기관생명윤리위원회), 인간을 대상으로 한 연구에서 피험자 보호문제(인간대상연구 및 유전자검사의 동의), 배아 등 생성과 연구관련사항의 정비, 인체유래물은행, 유전자 검사기관에 대한 문제, 인체유래물의 개념과 범위, 위임입법의 한계, 법규위임체계상의 문제, 생명윤리법의 적용 범위의 문제 등에 관하여 검토하였다. 마지막으로 생명윤리에 관한 처벌규정상의 문제와 관련하여 (1) 벌칙규정의 상한제한방식 및 (2) 법정형의 형평성에 대하여 검토하였다. 검토 결과 현행 생명윤리 법제는 헌법적 문제뿐만 아니라 생명윤리 및 안전에 관한 법률 자체에서도 여러 문제점을 내포하고 있음을 확인하였다. 여기서 제기된 문제점들을 바탕으로 이를 해결할 수 있는 생명윤리법제를 정비할 필요성이 있다. Ethicality and scientific character are required for researches on human beings or living animals, for those researches can result in a terrible disaster if they are devoid of ethicality as well as high-tech those researches will bring about a great improvement in human lives. The purpose of this study is to establish the life research related laws that is appropriate for Korean society. First, we examined generally legal problems in existing bioethics legislation based on the bioethics and safety act of Korea, focusing on constitutional and legal problems, bioethics institution, and penalty of bioethics violations. Furthermore, the following are studied in regard to constitutional fundamental rights: constitutional status of the embryos, respect of human dignity, protection of human subject, human genome study, and protection of human rights. Second, we also examined the bioethics and safety act closely to study the following: national bioethics committee and institutional bioethics committee, protection of human subject in the human subjects research project (consent to human subjects research and genetic test), prohibition of human cloning, rules on production and research of embryos, human material bank, genetic testing institution, concept and scope of human materials, limit of delegated legislation, and applicative scope of the bioethics and safety act. Lastly, we examined maximum sentences of penal provisions and fairness of legal penalty in regard to the bioethics punishment regulations. In this study, we found that the current bioethics and safety act has several problems, constitutionally or legally. Therefore, it may be necessary to revise the bioethics legislation partly from the results of this study.

생명윤리기본법의 내용과 효력

박인회 이화여자대학교 생명의료법연구소 2008 생명윤리정책연구 Vol.2 No.1

To make legal system more efficient, it should be ruled about bioethics issues by a general act which regulates general principles and control system and specific acts which which regulate specific issues with specific provisions. Bioethics general act has 16 articles which includes general provisions, basic principles, National bioethics committee, bioethics review board and principle provisions. In the part of general provisions, there are provisions about purpose, definitions, scope of application, responsibilities. In the part of basic principles, there are provisions about respect for man's life and dignity, guarantee of autonomy, protection of personal information, consideration of public welfare and safety, special protection of vulnerable persons and groups, consideration of future generation and international cooperation. In the part of National bioethics committee and bioehics review board, there are provisions which correct some flaws of existing “Bioethics and Safety Act” and clarify their rolls. In the part of principle provisions, there are provisions about respect for man's life and dignity, protection of human species, informed consent, protection of privacy, security of safety, ELSI(ethics, legal, social implications), public dialogue and education.

사회행동과학연구에서의 생명윤리와 기관생명윤리위원회(IRB)의 이해*

조성연(Songyon Cho) 한국보육지원학회 2018 한국보육지원학회지 Vol.14 No.2

Objective: The purpose of this paper is to understand the bioethics and the Institutional Review Board (IRB) in the social and behavioral research area through「The Bioethics and Safety Act」and to examine the IRB’s present situation, roles, responsibilities, and tasks. Methods: This paper reviewed articles, materials for education, and「The Bioethics and Safety Act」related with the IRB. Results: Bioethics included all the research in the social and behavioral area, and「The Bioethics and Safety Act」has been enforced in every research projects targeting human subjects since February 2, 2013. Accoding to the law, the IRB must review the research proposals for human subjects and was introduced in social and behavioral research as a self-regulating system. At present, all the related institutions including universities must establish and run the IRB. This paper introduced the definition of bioethics, the IRB’s roles and review types, the total number of registered IRB, and「The Bioethics and Safety Act」. Conclusion/Implications: Both the central government and the local government have to make an effort for the establishment and settlement of the IRB system. This paper also presented some of the problems of the IRB.

영국 인간 수정 및 배아발생에 관한 법률(HFEA) 개정의 내용 및 시사점 : 보조생식에 따른 부모의 법적 확정에 관한 'part 2'를 중심으로

김은애 이화여자대학교 생명의료법연구소 2009 생명윤리정책연구 Vol.3 No.2

The regulation on the assisted reproduction using the gamete and embryos is one of the most important issues in the field of the bioethics law and policy. As the assisted reproduction involving the third party as the gamete donor has been increased in Korea, 「Bioethics and Safety Act(hereafter, Bioethics Act」 has been enacted in 2005 and amended in 2008. Although the amended 「Bioethics Act」have provisions relevant to the assisted reproduction, most provisions deal with its medical procedures and the health of the egg donor. The legal parenthood is not properly addressed. In the UK, 「Human Fertilisation and Embryology Act(hereafter, HFE Act)」 has been enacted in 1990, and amended in 2008. The amended 「HFE Act」 consists of three parts. In particular, ‘part 2’ deals with the legal condition to authorize the parenthood in cases involving the assisted reproduction. Under this act, if the infertile couple(husband and wife, civil partners of each other, two persons who are living as partners in an enduring family relationship) meet the legal condition including the legal treaty as the parent in the written consent, their legal parenthood to the child who is born as the result of the assisted reproduction technology using donor’s gamete is secured. UK Human Fertilisation and Embryology Authority(hereafter, HFE Authority) provides official consent forms and the guidance in order to assure their parenthood. These consent forms and the guidance serve as the basic standard as well as the method and specific procedure to decide the legal parenthood. In ‘part 2,’ there are also the provisions that regulate posthumous reproduction and surrogacy. According to these provisions, posthumous reproduction and surrogacy, even if limited, are allowed as long as the legal condition is complied with. If the person who wants to use either of these two methods fulfills the legal condition including the legal treaty as the parent in the written consent, his or her legal parenthood to the child who is born as the result of these ways is also secured. The spectrum of the parenthood has been extended by the invention of the assisted reproduction technology using the donor’s sperm and egg. Nowadays we can store the gamete and embryos that are frozen for the later use. Accordingly the cases that need for the provision to authorize the parenthood have been augmented. Therefore, we have to exert all possible efforts to prepare the legal standard and the appropriate procedure to define the legal parenthood involving assisted reproduction technology. In this respect, the amended 「HFE Act」and the relevant forms prepared by HFE Authority will be good references to seek for the legal standard and the appropriate procedure in Korea.

「생명윤리 및 안전에 관한 법률」 유전자치료 조항에 대한 개선방안

김현철,김휘원 이화여자대학교 생명의료법연구소 2009 생명윤리정책연구 Vol.3 No.1

Due to the success of the treatment for ADA patient, gene therapy has been presented as a new treatment for serious diseases. Nowadays gene therapy is used more than 90 times a year around the world(2006). Though it has many benefits, as many studies has pointed out, it has various kinds of ethical problems, including its scientific uncertainty, clinical risks, and the potential violation of human dignity. The Bioethics and Safety Act has been established in order to address these problems in Korea in 2005. However two provisions relevant to gene therapy in the act are not regarded as proper measure to respond these problems. The aims of this paper is to review legal aspects of gene therapy in the Bioethics and Safety Act in 2008, and to find a way to improve the article of gene therapy in the act. First of all, vague and ambiguous expression of the definition of gene therapy should be crystallized into the definite one. Second, the gene therapy is in general prohibited, and in particular the gene therapy with respect to a spermatozoon, ovum, embryo or fetus is prohibited. There are three exceptional circumstances which allow gene therapy. The exceptional cases contain serious diseases such as hereditary diseases, cancers, and AIDS which may threaten life or cause any serious disability, and diseases whose gene therapy would be deemed considerably more effective than any other treatment. But, the range of these exceptions is too broad to regulate the use of gene therapy. Third, although gene therapy is not regarded as a tried and reliable remedy yet, the establishment and registration of gene therapy institution is easy and simple. The last, there are two kinds of laws relevant to gene therapy which are the Bioethics and Safety Act and Pharmaceutical Affairs Act. There are some inconsistency and confusions in implementing these two laws. This paper will address legal problems, articulate inconsistencies within these laws, and find better oversight system of gene therapy in Korea.

한국의 첨단의료와 생명윤리 규제의 현황과 한계

최은경(Eun Kyung Choi) 한국생명윤리학회 2020 생명윤리 Vol.21 No.2

2000년대 이후 한국의 의생명과학 연구는 크게 세 가지 법규-「생명윤리 및 안전에 관한 법률(이하 생명윤리법)」과 「약사법」 및 「의료기기법」 에 의해 규제된다. 즉, 「약사법」 은 새로운 의약품을 허가하는 임상시험 규제를 담당하며 임상시험이 아닌 임상 연구 등 인간대상연구는 「생명윤리법」 소관이 되는 것으로 구분된다. 그러나, 신의료기술, 3D 프린터 등 새로운 첨단의료의 발달로 인해 임상시험과 임상시험이 아닌 임상 연구의 경계가 점차 흐려지며 임상시험이 아닌 영역에서 새로운 시장을 창출하고 혁신을 요청하는 수요가 늘어남에 따라 기존 거버넌스 규칙에 대한 도전이 심화되고 있다. 이를테면, 한국에서 임상시험은 「약사법」 및 「의료기기법」 에 따라 임상시험실시기관에서만 시행해야 하나 임상시험 실시의 엄격한 기준에 따르지 않고 다양한 시술병원에서 긍정적 효과를 입증하여 시장 창출을 노리는 사례가 늘어나고 있어, 법 적용에 있어 다툼의 여지가 늘어나고 있다. 새로운 의약품 및 의료기기를 개발하거나 기존 의약품 및 의료기기의 새로운 용도를 개발하는 것은 「약사법」 및 「의료기기법」 의 ‘임상시험’으로 해석되어 적용 대상이 되나, 기존의 의료 시술에 이들 신의료기술을 적용하여 새로운 안전성과 효과를 얻을 수 있는지를 검토하는 것은 약사법과 의료기기법을 적용하기에 모호한 경우가 많다. 2019년 8월 「첨단재생의료 및 첨단바이오의약품 안전 및 지원에 관한 법률(이하 첨단재생바이오법)」이 실시되면서 이러한 규제 상의 공백을 메꿀 것으로 기대되고 있으나, 기존의 시술과 약품 개발에 준하는 규제를 제공하기에는 제한이 있다. 본 연구는 이러한 임상시험과 임상시험이 아닌 임상 연구의 경계를 도전하는 사례 두 가지로 세포치료술과 3D 바이오프린터 기술을 예로 들고자 한다. 세포치료술의 경우 병원에서 시술을 통해 효과가 입증되면 정부로부터 제한적 의료기술로 인정되어 임상 도입이 허용된다. 그러나 세포치료술과 같은 의료 시술의 효과를 확인하는 연구는 전통적 범주의 임상시험이 아니라는 것이 식약처의 입장이다. 의약품과 의료시술을 구분하는 이러한 입장은 안전성 유효성에 대한 근거가 부족한 임상시술의 윤리성을 평가하기 어렵게 만든다. 3D 바이오프린터 기술 또한 기술을 통해 만들어진 장비 각각이 새로운 의료기기에 해당되는지 아닌지 논란이 존재한다. 3D 바이오프린터로 제품을 하나 만들 때마다 각 제품 구성요소별 가이드라인을 제정해야 할 정도로 규격화된 규제와 맞지 않는 상황이 발생하고 있다.첨단 의료가 정밀 의학처럼 향후 환자 맞춤형(precised), 임상의 즉각적 적용형(fast-track)으로 진화되면 더욱 의료의 안전과 효과를 평가할 수 있는 표준화된 규제 방식을 개발하기 어렵고, 전통적 범주의 임상시험으로 해석되기 어려워질 가능성이 크다. 이러한 첨단의료의 시장 진입 노력은 향후 한국의 의생명과학 규제에 있어 새로운 도전이 될 것으로 생각된다. Since the 2000s, medical science researches in South Korea have been governed by three major laws – the Bioethics and Safety Act, the Pharmaceutical Affairs Act, and the Medical Devices Act. The Pharmaceutical Affairs Act is in charge of regulating clinical trials that authorize new medical products; meanwhile, human subject researches other than clinical trials are subjects to the Bioethics Act. However, the development of new cutting-edge medical research, such as new health technology and 3D printers, has gradually blurred the boundaries of clinical trials and non-clinical trials. Governance system has been challenged by demands from medicine and pharmaceutical industry, especially in areas other than clinical trials. For example, in South Korea, clinical trials should be conducted only in clinical trial institutions under the Pharmaceutical Affairs Act and the Medical Devices Act. Besides, the number of cases is growing to offer highly advanced treatments such as cellular therapy and conduct human subject research other than clinical trials, which can demonstrate positive effects without complying with the strict standards of clinical trials. Developing new medical products and devices or developing off-label uses of existing medicines and medical devices is subject to the application of "clinical tests" under the Pharmaceutical Affairs Act and the Medical Devices Act. Meanwhile, examining these new medical techniques with existing medical procedures is often ambiguous to apply to the Pharmaceutical Act. Although the Advanced Regenerative Medicine Act was enacted in August 2019 to fill these regulatory gaps, there is a limit to providing regulations equivalent to the previous level of regulations. This study explores two examples of challenging the boundaries of these clinical trials and non-clinical trials: cellular therapy and 3D bioprinter technology. In the case of cellular therapy, if it is proven effective through treatment in a hospital, the government recognizes the treatment as a "limited medical technology" and is allowed to introduce clinical trials. However, the KFDA believes that research on the effectiveness of medical treatment is not a traditional clinical trial. This position, which strictly distinguishes medicines from medical treatment, makes it difficult to assess the ethics and safety of medical treatments. 3D bioprinter technology is also controversial whether each of the equipment made by this technology is a new medical device. Every time 3D bioprinter makes products, evaluating compatibility with regulations, and developing guidelines toward the components of products becomes uneasy tasks for industries and authorities. If advanced medicine evolves into a pre-created, clinical, fast-track in the future, like precision medicine, it is likely to challenge a standardized regulatory approach, and difficult to interpret as traditional clinical trials. Such cutting-edge medical treatments are expected to pose a new challenge to Korea"s medical science regulations in the future.

전부개정 된 「생명윤리 및 안전에 관한 법률」의 연구대상자 보호 측면에서의 의의와 한계

김은애(EUNAE KIM) 한국생명윤리학회 2014 생명윤리 Vol.15 No.2

연구에 있어 가장 중요한 것은 연구대상자의 권리와 복지를 보호하는 일이고,연구 관련 법은 연구에 대한 법적 행정적 자율적 규제의 근간이 되는 것이기에 궁극적으로는 연구대상자 보호에 기여할 수 있다. 연구와 관련한 법적 규제에 있어 기본법적 지위를 가지는 「생명윤리 및 안전에 관한 법률」이 최근 전부개정 되어 시행 중이다. 이 법은 전부개정을 통해 기본 원칙을 포함하게 되었는데, 이는 곧 연구에 있어서의 기본원칙이 제시된 것이라고 볼 수 있다. 그리고 인간대상연구 및 인체유래물연구에 대해 생명윤리위원회로부터 연구 수행 전에 심의를 받도록 하는 일과 이러한 연구에 참여하는 연구대상자 및 인체유래물 기증자에게 연구에 대한 충분한 설명을 제공하고 이들로부터의 서면동의를 획득하는 일이 연구자의 법적 의무임을 명확히 하는 근거 규정을 포함하게 되면서 연구에 대한 법적 규제 범주가 인간대상연구와 인체유래물연구로 확대되었다. 또한 생명윤리위원회가 기관장 책임 하에 설치되어 연구에 대한 심의뿐만 아니라 기관에서 수행 중인 연구의 진행과정 및 결과에 대한 조사?감독, 그리고 기관의 연구자 및 종사자 교육, 취약한 연구대상자를 위한 보호 대책 수립, 연구자를 위한 윤리지침 마련과 같이 연구대상자의 권리와 복지 보호를 실현하기 위해 실질적으로 필요한 역할까지도 수행하도록 하기 위한 근거 규정도 포함하게 되었다. 이 밖에도 연구 참여를 위한 동의 획득 관련 규정이 명확해졌고, 위원회 등록제도 및 평가인증제도 관련 규정, 공용기관생명윤리위원회 지정관련 규정, 인체유래물은행 관련 규정이 새로이 마련되었다. 이 글에서는 이러한 「생명윤리법」의 최근 변화가 연구대상자 보호에 있어 어떠한 의의를 갖는지를 살펴보고, 변화에도 불구하고 아직도 한계점으로 지적될 수 있는 사항이 무엇인지를 확인하여 이 법이 연구 관련 기본법으로서의 위상을 확고히 하여 연구대상자 보호의 기반으로서의 역할을 충실히 할 수 있도록 하기 위해 개정 시 고려하여야 하는 점에 대해 제언하고자 한다. The most important principle to conduct the research is to protect the rights and welfare of human research participants. Ultimately, the research related law can contribute to the protection of the research participants because the legal regulation, the administrative regulation by the authority and self-regulation by the institution and the researchers are based on the standards of the law. Recently, 「Bioethics and Safety Act」 that has maintained the status as the framework act to regulate the research legally has whollyamended at 2012 and has been in effect from 2013. According to the whole amendment, the provision about the basic principles for the activities under this act has been includedin this act. In other words, the basic principles for the research involving human research participants as well as human materials and identifiable information have been created to protect the human research participants. And the scope of the research that this act applies to has been extended to the human research and human material research, so the researcher has taken on the legal obligation not only to submit the research protocol or plan to the Institutional Review Board for the review and approval before the conduct of the research but also to provide information about the research sufficiently to the human research participants or the human material donors and to obtain the written consent from them. Also, under this act, besides the review of the research, the Institutional Review Board has taken charge of the oversight of the research, the education for the researchers, the formulation of measures for the protection of the vulnerable persons and groups, the establishment of ethical guidelines for the researchers. Moreover, the provisions about the evaluation and accreditation to the Institutional Review Board, the designation of the public Institutional Review Board, the establishment and operation of the human material bank have been includedin this act. It is very meaningful that this act has been changed to build up the infrastructure for the protection of the human research participants. But, despite these significant changes, this act has still some limitations to protect the human research participants. Because this act has not included some important definitions such as the research, minimal risk as well as not presented enough detailed standards and procedures that are needed to make a determination and to take an action. Therefore, now it is time to find and analyze these limitations, to come up with a solution and to prepare the amendment of this act. Because, for many years to come, this act,as the framework act for the research, should be the foundation for the protection of the human research participant and be enable to present the right standards and practical ways for the institution, the Institutional Review Board and the researcherto protect the rights and welfare of human research participants.

인체유래물은행 관련 법적 기준의 문제점과 개선방안

유수정,구영신,최경석 이화여자대학교 생명의료법연구소 2022 Asia Pacific Journal of Health Law & Ethics Vol.15 No.3

The Bioethics and Safety Act(hereinafter referred to as the “Bioethics Act”) was fully revised in 2012, and came into effect in 2013. The Act was revised and expanded to include not only genetic and genetic information but also human materials introducing the term, ‘human material bank.’ The Bioethics Act stipulates that human material bank has the ability to collect and provide human materials to others, as well as to directly collect and use human materials to be used for research. There is no clear regulation on qualification requirements of the person to collect. There is confusion and difficulty in interpreting the relevant regulations on whether or not for the institutional review board of human material bank to pre-review when a human material bank directly collects or asks others to collect human materials. In addition, there is no clear management protocol for human material bank to prevent its over-collecting human materials. Thus, we point out the problems of the vague legal regulation regarding human material banks under the Bioethics Act. In order to secure citizens’ trust on the operation of human material biobank and improve its quality, we provide clear interpretation of the relevant current regulations in Bioethics Act and suggest concrete legal contents for the revision of the problematic regulations related to human material bank or the introduction of new regulations. 2012년 「생명윤리 및 안전에 관한 법률」이 전부개정되어, 2013년부터 시행된 생명윤리법에서의 유전자은행 관련 규정을 단지 유전자 및 유전정보만이 아니라 인체유래물까지 포함한 “인체유래물은행”으로 개정 확대하였다. 생명윤리법에서는 인체유래물은행이 수집·획득한 인체유래물을 타인에게 제공하는 기능뿐만 아니라 인체유래물연구에 쓰일 인체유래물을 직접 채취하여 이용할 수 있도록 정하고 있으나 인체유래물은행의 개설허가 및 채취자의 자격요건에 대한 명확한 규정이 없고, 인체유래물은행의 직접 채취 또는 채취 의뢰 시 기관위원회 사전 심의 여부에 대해서도 관련 법률 규정을 해석하는 데 혼란과 어려움을 겪고 있다. 그뿐만 아니라 인체유래물은행의 인체유래물 과잉 채취 방지를 위한 관리방안도 거의 마련되어 있지 않다. 따라서 본 논문에서는 생명윤리법상 인체유래물은행에 관한 법적 기준이 모호하고 불명확한 점에 대한 문제점을 지적하고, 인체유래물은행 운영의 신뢰 확보 및 질적 향상을 위해 현행 생명윤리법상 인체유래 물은행 관련 규정에 대한 명확한 해석뿐만 아니라, 현행 생명윤리법에서 인체유래물은행 관련 법 개정이 필요한 사항에 대한 개선방안을 제시하고자 한다.

What is Bioethics and Law? : From the Korean Perspective

Kim, Hyeon-Chul Ewha Institute for Biomedical Law & Ethics 2010 BIOMEDICAL LAW & ETHICS Vol.4 No.1

Law and Bioethics is a relatively new academic area of dealing with a broad range of legal issues relevant to the biomedical ethics. This article first reviews the unique features of the Law and Bioethics as a special field of law. Legal topics in the Law and Bioethics are not limited to one specific area of a traditional field of law, such as criminal law, but cover almost all spheres of the legal phenomena. In addition, since the Law and Bioethics treats ethical issues raised in a very technical and highly specialized areas - life science and the medical science, legal reasoning in this area requires a certain level of knowledge on the scientific subjects as well as reflexive attitude towards legal and ethical conclusions. Considering these unique features of the Law and Bioethics, this article investigates the three regulation models: the model centered around regulations by law and rules, the model centered around administrative regulations, and the model centered around self-regulation. With specific examples, each model will be examined in the context of the Law and Bioethics.

개정 생명윤리법의 내용과 평가

김민우(Kim, Min-Woo) 충북대학교 법학연구소 2012 과학기술과 법 Vol.3 No.2

There are so many benefits following by the development of biotechnology. The content of the 'Bioethics Law' is linked to biotechnology. The purpose of this Law 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. Science and technology is advancing at a very quick rate, especially in the area of biotechnology. The amendment bioethics law consist of 9 Chapters, 70 Articles, and 7 Additional provisions. The amendment act concrete its purpose much more than the old act. It has more character as an fundamental act in terms of bioethics and safety. Also this act will function as general principles of biomedical researchers. But ethical debates are still on going and spread widely. The main debates are the allowance of human embryonal researcher and somatic cell nuclear transfer therapeutic cloning. We take a first step to regulate the bioethical and biosafety problems. More efforts will be needed to solve these problems.