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.

인간의 존엄과 가치, 그리고 胚芽 - 생명윤리및안전에관한법률 제1장을 중심으로

박선영(PARK Sun-Young) 한국헌법학회 2007 憲法學硏究 Vol.13 No.1

  Nowadays biotechnology or bioengineering is being rapidly developed offering many possibilities in the life, including human embryonic researches, on the other hand, constitutional approach on the scientific studies, in particular, on the focus of ‘human dignity’ are still ambiguous. This article recognizes that scientific and technological developments have been, and can be, of great benefit to humankind in increasing inter alia life expectancy and improving quality of life, and emphasizes that such developments should always seek to promote the welfare of individuals, families, groups or communities and humankind as a whole in the recognition of the dignity of the human person and the universal respect for, and observance of, human rights and fundamental freedoms.<BR>  Human embryo is an in vitro fertilized human ovum, with certain rights and protection granted by substantive law, composed of one or more living human cells and human genetic material so unified and organized that it will develop in uterus into an unborn child. Nevertheless the human embryo research raises many bioethics problems and violates the dignity of human being, the Korean Bioethics and Biosafety Law(Law No. 7150, hereafter the Bioethics Law) doesn"t works at all because of the inappropriate aim of the law. The Bioethics Law ought to serve and protect the dignity of human being than any other related laws.<BR>  In this thesis, I attempted to make a study of the Bioethics Law from a viewpoint of human dignity in the constitutional law. With respect to the human dignity, this essay tried to critical analyse of the Chapter I in the Bioethics Law in effect from 2005 allowing cloning of human cells if it is carried out for pure research purposes to find remedies for incurable diseases. The most problematic aspect of the Bioethics Law is that embryos tissue would be allowed to used for research purposes. This article frames human dignity, specially focusing on at first, the concept and the legal status of human embryo as a potential human being, and secondly ‘informed consent’ that are worldwide declared such as N?remberg Code and Helsinki Declaration which stress that human subject should be never measure and voluntary consent is absolutely important. It is no surprise that these international norms for protection of bioethics have been developed and some progress has been achieved, serious dispute of human rights and biosafty.<BR>  Human Dignity in the constitutional law should be the extreme measure of the biotechnological norm and the powerful sanction, because the human embryo is de facto biologically human being, gradually acquiring certain capacities, namely entitled to rights worthy of respect and protection, namely human dignity of embryo. So the constitutional concerns involving the application of technology to humans should be of utmost concern, as the area is extremely complex, but the concept of human dignity should be based upon an acceptance of fundamental and superior values within the bioethics.

줄기세포주 등록과 관련된 생명윤리법 규정의 해석 : 서울고등법원 2013. 10. 25. 선고 2012누22616 판결

민혜영 이화여자대학교 법학전문대학원 2014 Ewha Law Review Vol.4 No.1

생명윤리법은 줄기세포주와 관련된 연구에 있어서 생명윤리적, 과학적 측면의 규제를 할뿐만 아니라 연구의 활성화를 위한 여건을 마련하는 역할을 하고 있다. 본 사건에서 줄기세포 주 수립 당시의 생명윤리법은 1. 난자 수급과정상의 윤리적 문제를 규율하는 규정을 두지 않았기에 개정 생명윤리법상 윤리절차적 규정을 적용할 수 있겠는가 하는 점, 2. 단성생식배아와 관련된 명시적 규정이 없었기에 이로부터 유래하는 줄기세포주를 등록대상 줄기세포주에 포섭할 수 있는가 하는 점이 문제된다. 개정 「생명윤리법」 제1조는 연구 여건 조성 및 국민의 건강과 삶의 질 향상을 목적으로 함을 명시하고 있다. 이러한 생명윤리법의 목적을 고려하여 해석하면, 난자 수급과정에서의 윤리와 관련된 개정 생명윤리법상의 규정은 최소한 지켜야하는 윤리적 선을 정한 것에 불과하다. 따라서 이러한 규정이 없었던 본 사건 줄기세포주 수립시에도 당해 규정상의 기준을 따랐어야 하는 것으로 보아야 한다. 한편 개정 생명윤리법상 난자 수급과정과 관련된 윤리적 문제로 형사처벌을 하는 규정을 소급 적용하는 것은 죄형법정주의의 원칙에 반한다. 그런데 줄기세포주 등록제도는 본 사건의 연구자인 원고에게는 시혜적인 규정이기도 하다. 따라서 형벌규정을 제외한 윤리관련 절차적 문제를 다루고 있는 규정을 소급하여 적용하는 것은 죄형법정주의의 원칙에 반하지 않는다. 따라서 개정생명윤리법상의 윤리절차적 규정을 본 사건에도 적용할 수 있다. 설사 명시적인 규정이 없었기에 윤리절차적 규정을 본 사건에 적용할 수 없다고 하더라도 다음과 같이 등록신청을 반려할 수 있는 사유가 있다. 개정 「생명윤리법」 부칙 제2항은 그 대상을 ‘개정규정의 시행일 전에 이미 수립된 줄기세포주’로 규정하고 있다. 그런데 동법 제2조의 정의 규정 등 동법에서 규정하고 있는 다른 법조문과의 체계적 연관에 따른 논리적 의미와 개정 생명윤리법의 목적을 고려하면 단성생식배아 줄기세포주는 부칙 제2항의 ‘줄기세포주’에서 제외되는 것으로 해석할 수 있다. 또한 개정 「생명윤리법」은 제55조에서 제20조의2 제1항을 위반하여 “줄기세포주를 등록하지 아니하고 해당 줄기세포주를 제공하거나 이용한 자는 500만원 이하의 과태료에 처한다”라고 규정하고 있는데 이는 형벌규정이 아니라 행정벌규정이다. 따라서 동법 제20조의2 제1항 및 이와 관련된 부칙 제2항의 해석과 관련하여서는 죄형법정주의보다는 행정법의 일반원칙을 적용하여야 한다. 그런데 등록요건을 충족하는 줄기세포주의 범위를 좁게 해석하여 등록신청에 대한 반려처분을 하는 것은 신뢰보호의 원칙, 비례의 원칙, 자기구속의 원칙에 위배되지 않는다. 따라서 과학적 문제를 이유로 본 사건 줄기세포주가 등록대상 줄기세포주가 아니라는 해석하에 등록신청을 반려처분하는 것은 위법하지 않다. Bioethics law has a role in bioethical and scientific regulation, as well as in setting conditions for vitalization of research. In this case, bioethics law at the time of the establishment of stem cell lines will be discussed as follows: 1) Since there is no code that regulates the ethical issues of egg supply processes, can the procedural code of the revised bioethics law be applied? 2) When there is no clear code applicable to embryo derived from parthenogenesis, can stem cell lines from that embryo be registered? Article 1 of the revised bioethics law stipulates that the purpose of this law is to improve people’ health and the quality of their lives. Taking into consideration the purpose of the provision, the revised bioethics law represents the minimum of ethics relating to the egg supply processes. Therefore, these regulations should be complied with, even in the absence of any clear instructions as to which laws should be applied to this case. Meanwhile, retroactive application of criminal penalty provisions over such ethical issues could violate the principle of ‘ulla poena sine lege’ But stem cell line registration system is beneficial to the plaintiff of the case, a researcher. So retroactively applying the provision to these ethical procedures is not against the principle of ‘ullapoena sine lege’ Therefore, the ethical procedural provision of the revised bioethics law can be applied to this case. Even in the absence of a clear law allowing the application of ethical procedural provisions to this case, there is a ground to refuse request for registration. Supplementary provision Article 2 defines the object of registration as ‘temcell lines already established before the effective date of the amended provisions’ But considering systematic association with the other provisions and the purpose of the revised bioethics law, stem cell lines of embryo derived from parthenogenesis can be excluded from ‘tem cell lines’of supplementary provision Article 2. Also, Article 55 of the revised bioethics law reads as follows: “t]o the person, providing or using stem cell lines that are not registered, a fine of 5 million won or less will be charged” This provision does not impose criminal punishment, but administrative fine. So in interpreting Article 20.2.1 and supplementary provision Article 2, not ‘nullapoena sine lege’ but ‘general principles of administrative law’ should be applied. A return disposition that narrowly interprets the scope of stem cell lines satisfying registration requirements does not violate ‘the principle of trust protection’, ‘the principle of proportionality’, or ‘the principle of self-enforcement’. Therefore the return disposition of registration request is not illegal.

생명윤리에 관한 법규범력 확보와 그 한계

황만성 원광대학교 법학연구소 2011 의생명과학과 법 Vol.6 No.-

Debate over the relationship of law and bioethics is growing - what the relationship has been and what it should be in the future. While someone has praised law and rights-talk for creating modern bioethics, others has instead blamed law for hijacking bioethics and stunting moral reflection. Indeed, as modern bioethics approaches the 40-year mark, historians of bioethics are presenting divergent accounts. In one accoun,t bioethics largely grew out of philosophy and theology, not law. In another account, law has deeply shaped bioethics from the start, forging its central commitment to the rights of patients and research subjects and the field's imposition of broad fiduciary responsibilities on health care professionals and researchers. In addition to debating how to properly describe law's historical relationship to bioethics, commentators have argued over whether law's influence in bioethics is now good or bad. The issues of bioethics step into the realm of law suddenly through the so-called Shinchon Sevrance Hospital Case. The Case opened the discourse of bioethical issues in earnest. Now issues of bioethics are switching from private, ethical problems to public, legal problems. In case of the realization of dispute, the intervention of court is unavoidable, but it does not produce good results. So it is necessary to recognize the limitations of legal regulation as well as it's necessity. In recent years, we learned that scientists have created social risks forcing us to think through these issues very carefully. Most of bioethical issues are at the leading edge of a series of moral hazards. Sometimes we may face that it is needed to prevent some wrong-doing before becoming huge criminal behaviour. Certain criminal policy must be designed to analyse the science-related crimes.

생명윤리에 관한 법규범력 확보와 그 한계

황만성 원광대학교 법학연구소 2011 의생명과학과 법 Vol.6 No.-

Debate over the relationship of law and bioethics is growing - what the relationship has been and what it should be in the future. While someone has praised law and rights-talk for creating modern bioethics, others has instead blamed law for hijacking bioethics and stunting moral reflection. Indeed, as modern bioethics approaches the 40-year mark, historians of bioethics are presenting divergent accounts. In one accoun,t bioethics largely grew out of philosophy and theology, not law. In another account, law has deeply shaped bioethics from the start, forging its central commitment to the rights of patients and research subjects and the field's imposition of broad fiduciary responsibilities on health care professionals and researchers. In addition to debating how to properly describe law's historical relationship to bioethics, commentators have argued over whether law's influence in bioethics is now good or bad. The issues of bioethics step into the realm of law suddenly through the so-called Shinchon Sevrance Hospital Case. The Case opened the discourse of bioethical issues in earnest. Now issues of bioethics are switching from private, ethical problems to public, legal problems. In case of the realization of dispute, the intervention of court is unavoidable, but it does not produce good results. So it is necessary to recognize the limitations of legal regulation as well as it's necessity. In recent years, we learned that scientists have created social risks forcing us to think through these issues very carefully. Most of bioethical issues are at the leading edge of a series of moral hazards. Sometimes we may face that it is needed to prevent some wrong-doing before becoming huge criminal behaviour. Certain criminal policy must be designed to analyse the science-related crimes.

'생명윤리및안전에관한법률'에 대한 비판적 검토

홍석영(HONG Suk-Young) 한국생명윤리학회 2004 생명윤리 Vol.5 No.1

This essay critically reviews the 'Bioethics & Biosafety Law' (Law No.7150). The law was passed on December 29th 2003 at National Assembly and promulgated on January 25th 2004. The law will take effect wholly on January 1th 2005. But the law has many problems in respect to the bioethics and the dignity of human life. 1. The aim of this law is inappropriate. The aim of this law is to be the guarantee of the bioethics and biosafety, 2. With regard to the application scope, this law is possible to be a lower law than other related laws. 3. The role and constitution of the 'National Bioethics Committee' is problematic especially in the constitution. 4. The articles related to the human embryo research are to be mostly eliminated or fully amended. Because the human embryo research raises many bioethics problems and violates the dignity of human life. 5. The articles related to the genetic test are to be specified. Therefore this law is to be amended before to take effect. The 'Bioethics & Biosafety Law' ought to serve and protect the dignity of human life.

人間胚芽複製의 問題點과 解決方案

서계원(Suh Kye Won) 한국생명윤리학회 2005 생명윤리 Vol.6 No.1

Few sciences have held out such therapeutic promise and corresponding stirred so much controversy in countries throughout the world as the developing science surrounding human embryonic stem cells. Since the first reported development of several lines of human embryonic stem cells in 1998, many governments around the world have attempted to address the thorny ethical issues raised by human embryonic stem cell research by the passage of laws. Stem cells are the precursor cells from which all cells that compose the human body are derived. If used right, stem cells can contribute in a big way to treatment of incurable diseases caused by cell damage. Examples include cerebral nerve ailments such as brain tumors and dementia, motor disturbances such as arthritis, diabetes, and heart disease. Embryonic stem cells have been touted for their greater potential to develop cures for terminal diseases than adult stem cells, although no tangible success has been reported. In fact, from an ethical and anthropological standpoint, so-called therapeutic cloning, creating human embryos with the intention of destroying them, even if undertaken with the goal of possibly helping sick patients in the future, seems very clearly incompatible with respect for the dignity of human being, making one human life nothing more than the instrument of another. "The Law on Bioethics and Biosafety(the Bioethics Law)" passed December 29 of 2003, prohibits the cloning of human embryos because it can lead to the cloning of humans. But it does allow for cloning when part of research into the treatment of incurable diseases. According to the law, infertility clinics are able to use remaining embryos from external fertilization operations, which have been frozen and stored for more than five years, for research purposes, when they have received informed consent from couples of original owner. The bioethics law took effect on January 1 of 2005, allowing cloning of human cells if it is carried out for pure research purposes to find remedies for incurable diseases. "The National Bioethics Committee" is supposed to determine the exact range of permissibility, to extent the research should be allowed. The most problematic aspect of the law is that embryos tissue will be allowed to used for research purposes. As embryos are recognized as life, it may be against the spirit of the Constitution regarding respect for human dignity and life to use human embryos for research. Currently one of the issues in the law is whether to enact legislation of a comprehensive bioethics regulation or to enact at least individual acts covering issue by issue. It needs to lead to an active discussion of all the ethical and legal points of contention. This article first differentiates human embryonic stem cells from other types of stem cells and frames the ethical and legal controversy surrounding human embryonic stem cell research, then surveys laws governing human embryonic stem cell research in various scientifically advanced countries located throughout Europe, USA, Japan and Korea and proposes the direction for the desirable amendment of the existing Bioethics Law in Korea, specially focusing on human embryonic stem cell research. The subject of human embryonic cloning can be best addressed by a juridical instrument, since the rule of law is essential to the promotion and protection of human life. It is by the rule of law, based on right reason, that societies can properly regulate whatever appears to challenge our fundamental notions of human life and dignity.

생명윤리법의 발전에 따른 재산법 분야의 변화

오세혁,이은영 이화여자대학교 생명의료법연구소 2008 생명윤리정책연구 Vol.2 No.1

Bioethical Law(= Bioethics and Law) is a branch of law that make researches in legal implications as well as ethical implications of life science and biotechnology. The development of life science and biotechnology leads to some new enactments, for example, Bioethics and Safety Act 2004. Furethermore, it brings about changes of many existing law in general. Life science and biotechnology especially present urgent legal problems in major fields of civil law i.e. law of property, law of obligation, and law of status. Nowadays legal scholars and practitioner in civil law deal with hot issues resulting from the development of biotechnologies, for example, capacity of enjoyment of rights & legal capacity, nature of property as object of rights, validity of contracts, and damages suffered by torts. Moreover, the development of biotechnology has an effect on the most fundamental principle of civil law i.e. the principle of autonomy and key concepts including property, liability, consent, agency power etc. So basic legal institutions including ownership, dealings, damages should be revised and reconstructed in accordance with the developments of biotechnology and bioethical law.

생명윤리법의 발전에 따른 형사법의 변화

吳世赫(Oh, Se-Hyuk),丁華聲(Jeong, Hwa-Seong) 중앙대학교 법학연구원 2008 法學論文集 Vol.32 No.1

‘Bioethics and Law’ is a branch of law that make researches in legal implications as well as ethical implications of life science and biotechnology. The development of life science and biotechnology leads to some new enactments, for example, 「Bioethics and Safety Act 200 4」. Furthermore, it brings about changes of many existing law in general. Life science and biotechnology especially present urgent legal problems in major fields of criminal law i.e. laws of crime & penalty, and criminal procedure law. Nowadays legal scholars and practitioner in criminal law deal with hot issues resulting from the development of biotechnologies, for example, sex discernment of fetus, embryo cloning, brain death, organ transplantation & organ sales, surrogate mother. Moreover, the development of biotechnology has an effect on the traditional issues of criminal law including the beginning and end of human beings etc. So basic legal rules and dogmatics in respect to abortion, euthanasia should be revised and reconstructed in accordance with the developments of biotechnology and bioethical law.

생명윤리법의 모델-생명윤리기본법을 중심으로

김현철 梨花女子大學校 法學硏究所 2015 法學論集 Vol.19 No.3

We can design a model of bioethics law on various perspectives. This article has focus on the concept of responsive law by Nonet and Selznick, and argues the possibility of formative law model which gives shape to responsive law. Formative law does not regulate certain acts directively, but plays a indirect role to create main systems and carry out policies for the society-inner formation of desirable acts socially. Formative law model may correspond to self-regulation or co-regulation by regulation model. Formative law model can connect to framework act by legislation model. Especially bioethics may be suitable for the application of framework act model. This model can be called a framework act model on bioethics. A framework act model on bioethics has some implications and advantages in current Korean situation. 생명윤리법에 관한 법의 모델은 다양한 관점에서 구상할 수 있다. 이 글에서는 특히 노네와 셀즈닉의 응답적 법 개념에 주목한다. 그리고 그 응답적 법 개념을 보다 구체화하여 형성적 법이라는 모델이 가능하다는 점을 주장한다. 그런 형성적 법은 직접 어떤 행위를 규제하기 보다는 바람직한 행위가 사회 내부에서 형성될 수 있도록 필요한 제도를 마련하고 정책을 수행하는 간접적인 역할을 수행한다. 이런 형성적 법은 규제 모델로 보면 자율규제나 공동규제에 해당할 수 있을 것이다. 이런 형성적 법 개념을 구체적인 입법모델로 연결시키면, 이른바 기본법이라는 입법 모델로 연결될 수 있다. 특히 생명윤리 분야는 기본법 모델을 적용하기 적합한 영역이다. 이런 생명윤리법 모델을 생명윤리기본법 모델이라고 할 수 있다. 이 생명윤리기본법 모델은 여러 가지 의의와 장점을 가지고 있으며, 향후 이런 방향으로 입법화가 진행되는 것이 필요하다.