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The Legal Status of the Artificial Embryo and the Human Material through the Biotechnological Process in Civil Law* Yoo, Ji Hong Department of Law Graduate School, Kyungpook National University Daegu, Korea (Supervised by Professor Kang, Tae Seong) (Abstract) Biotechnology(BT) is the next generation...

The Legal Status of the Artificial Embryo and the Human Material through the Biotechnological Process in Civil Law* Yoo, Ji Hong Department of Law Graduate School, Kyungpook National University Daegu, Korea (Supervised by Professor Kang, Tae Seong) (Abstract) Biotechnology(BT) is the next generational core technology which makes 'Revolutionary Wealth' with Information Technology(IT). But it has been rapidly developed as 'a double-edged sword' which has the fatal hazard to violate human life and rights such as the cloning of humans. In this doctoral dissertation, the author examines the legal status of 'the unborn life' and 'the human material' in order to set up the proper direction of Biotechnology on a legal point of view. In Chapter 2, the author examines the development process of Biotechnology at the 5 essential part and surveys international discussions for the Biotechnology and the Bioethics Law. Especially, it must be the measure(barometer) which decide 'the actual profit for legal discussion' to examine 'the scientific development process'. 'The Gene' established the new scientific field of 'Biotechnology'. and 'the Human Genom Project(hereafter the HGP)' gave us the hope to treat incurable diseases from analyzing 'three billion genome sequence' of human. The juridical issues relating to gene are in two part. First, is 'cell or gene' the thing? or the part of the human body still? Second, is it 'the invention of a thing' or 'the invention of medical procedure' to identify 'human disease genes'? In Vitro Fertilization(hereafter IVF) has been developed since Louis Brown was born in 1978. On the juridical point of view, the view of the majority is opposed to IVF, which is because IVF has two bad influences. First, IVF destroys many fertilized eggs after 'super ovulation'. Second, IVF may lead to many crimes such as 'the cloning of human' or '(human-animal)interspecific fertilization' through the utilization of biotechnology. The cloning of life was completed technically through the birth of 'Dolly' of the cloned sheep developed from the Roslin Institute near Edinburgh, Scotland in 1996. This cloned sheep caused the Bioethics Law legislated all around the world. The cloning of life has two major issues on a juridical point of view. First, the legal status of 'the embryo(the fertilized egg)' should be compared with the unborn fetus. Second, the legal status of 'human cell' become an issue, namely it should be discussed whether the cell separated from the body is 'a thing' or 'a part of the human body' still. 'Stem cell' is undifferentiated cell and composed mainly of 'Adult Stem cell', 'Totipotent Stem cell', 'Embryonic Stem cell', 'induced Pluripotent Stem cell'. On a juridical point of view, the development of 'Adult Stem cell' and 'induced Pluripotent Stem cell' enables 'Embryonic Stem cell' measured essentially in law regardless of 'actual necessity'. because the indispensability of 'Embryonic Stem cell' has disappeared. Dr. 'Woo-Suk Hwang' produced the cloned animal(the cloned cow, young-long) fifthly in the world, and extracted the stem cell from somatic cell cloning embryo(somatic cell cloning embryonic stem cell) firstly in the world. he produced a great achievement for korean biotechnology. The juridical issues relating to Dr. Woo-Suk Hwang are in two part. The first is the investigation(and reveal) of 'the truth'. The Hwang Affair should be revealed according to the court's decision for the sake of the development of korean biotechnology. The second is the change of research direction. 'Embryonic Stem cell' and 'the cloning of human' will not be permitted all around the world. Therefore research direction should be switched from 'Embryonic Stem cell' to 'Adult Stem cell' or 'induced Pluripotent Stem cell'. The bioethics laws are divided into two parts all over the world. In Germany and France, 'the humanity(the attribute as the subject of rights) of a embryo' is permitted. But in USA and England, 'the humanity of a embryo' is not permitted. The position of our nation seems likely to be similar to that of USA or England. The Korean Law on Bioethics and Biosafety(Law No. 7150, hereafter the Bioethics Law) should be examined in three part on the whole. First, 'the humanity of a embryo' should be reexamined out of consideration to development of 'Adult Stem cell' and 'induced Pluripotent Stem cell'. Second, In the creation of a 'somatic cell cloning embryo', the aim and period should be expressly limited obviously. Third, In the form of 'The National Bioethics Committee', the component proportion of members should be readjusted reasonably. In Chapter 3, the author examines the legal status of a 'artificial embryo' in Civil Law. The importance of this argument has been increased due to the necessity for 'the destroy of the cloned embryo' and 'the utilization of embryonic stem cell'. When Civil Law was legislated, the unborn life was only ‘fetus’ which was ‘in mother's body’ and generated ‘by sexual intercourse’. But biotechnology has developed rapidly since then. The methods of creating embryo(or fetus) are diversified ranging to 'sexual intercourse', 'In Vitro Fertilization', 'somatic cell cloning'. and The forms of existence range to 'Newborn', 'Fetus', 'Extreme prematurity', 'fertilized egg' confusing us to distinguish them. From a viewpoint of Civil Law, The view of scholars about the legal status of 'the fertilized egg in vitro' is generally divided into three types, 'the body tissue separated from body', 'the intermediate existence between a human and a thing', 'the exactly equal existence to fetus'. On closer examination, 'the Genetic Identity' and 'the Growth Potential' which are the essence of life is fully completed when fertilization. So it is reasonable that the legal status of 'the fertilized egg in vitro' is thoroughly equal to that of fetus. The author examines the validity of creating 'the fertilized egg in vitro'. The frozen embryos cause the problems of 'the violation of human life', 'the genetical engineering of human', 'the bad use for the criminal purpose', 'the birth of the cloned human'. And after birth, The frozen embryos must lead to many problems in 'domestic relations' and in 'inheritance'. Therefore 'the fertilization in vitro' and 'the storage of the frozen embryos' should be absolutely prohibited even though they can contribute to the treatment of incurable disease. The author examines the legal status of fetus in Civil Law. It is reasonable that the clauses of Civil Code for protection of fetus are interpreted as exceptional provisions in regard to 'the Article 3'. So It is resonable that the fetus acquires 'the Capacity for Enjoying Private Right' immediately in a womb when fetus state and lose that right when stillbirth. The author examines the theory of legislation. it is reasonable that the Article 3 will be revised as follows. 'the human is the subject of rights and obligations for survival from the fertilization.' In chapter 4, the author examines 'the legal status of human material separated through the biotechnological process. There are five kinds of theories from a viewpoint of Civil Law as follows. 'It is just a thing', 'Only gamete is not a thing', 'Organ is not a thing', 'It is not a thing if only there is the intention to inject it back into the body', 'It is just a part of human body in spite of separation from the body'. In this dissertation, the author concludes that 'human material' separated from the body is still a part of human body on the grounds of 'the several regulations over the world', 'the judicial precedents regarding this', 'the essence of scientific facts'. The first is 'the several regulations' over the world. According to 'French Civil Law the third clause of Article 6-1' and 'Helsinki Declaration the first clause', the human material is excluded from 'the Attribute of a Thing'. The second is 'the judicial precedents regarding this'. In ‘the Moore case’ and ‘the Cornelio case’, the U.S. courts judged that the human material is excluded from 'the Attribute of a Thing'. In Germany, it was judged that the stored sperm separated from body was still the part of human body if only there is the intention to inject it back into that body. The third is 'the essence of scientific facts'. Presently 'the somatic cell cloning of human embryo' has became a common technology all over the world. Through just one cell, the offerer of that cell can be cloned at any time. The author examines the infringement cases on the rights through using 'human material'. At present, it is anticipated that just one cell can infringe the essence of 'personal rights' such as 'the leaking of genetic information', 'the cloning of human'. So the human material should be admitted as 'the part of human body' and 'the object of personal rights'. The author examines 'the Donation' and 'the Processing' in Civil Law. First, 'the donation without compensation' which is expressed in a special act relating to human material is not equal to 'the Donation in Civil Law' but it is just provisions in public law. Second, 'the Processing in Civil Law' is examined. All sorts of cells can change from just 'one cell' to '(the cloned) human' in the essential respect if only that cell is processed with the egg. So 'the Processing in Civil Law' can not be applicable to the human material. The author examines the protection of private right in regard to human material. In Germany, just for the infringement for a human body, 'the Solatium' can be demanded in 'Slight Negligence'. So there are practical benefits obviously. In Korean Civil Law, the practical benefits are in the aspect of 'burden of proof'. In the infringement for a human body, the demand of 'the Solatium' is permitted fairly. But in the infringement for a thing, in order to demand 'the Solatium', the claimer should prove 'the occurrence of special mental damage' and 'the Negligence' If all the points about the human material are examined, it is reasonable that the legal status of human material in Civil Law is still 'a part of human body' even though it is separated from human body. In chapter 5, the author examines 'the protection method' for the research result of human material. Until now, the human material has been treated and protected similarly to 'the invention of chemical substances' in the patent practice. But the realistic situation has changed utterly because of the development of biotechnology. 'The three billion genome sequences of a human' are analyzed completely through 'HGP'. From now on, the gene function should have been confirmed through the analyzed genome sequence. So to speak, as if we search for 'a needle' in 'the heap of scrap metal', the researchers should search for the genes relating to incurable diseases. The author examines three major issues on a juridical point of view. The first is whether human material is a thing or a treatment methods of diseases. The second is how a treatment methods(medical procedure) can be protected. The third is 'the compulsory licensing'. First, the human material can not be treated as 'a thing' in Civil Law. So it is reasonable that the research result of gene(human material) should be treated as treatment method(medical procedure) in the patent practice because 'that research result' is applicable to the treatment of diseases. Second, 'the approval of patentability for medical procedure' can be determined by the policy(in other words, it is not an unchangeable law). 'the disapproval of patentability for medical procedure' is due to concern about the monopoly on treatment method. So if 'the monopoly on treatment method' can be resolved, the patentability for medical procedure can be approved. As a matter of fact, it is the issue for 'the securing of a license'. This issue can be resolved through the revision of law relating to this and also can be resolved through 'compulsory licensing' in current Patent Law without the revision of law. Third, the author examines 'the compulsory licensing' in order to secure the licenses. First of all, the author examines the situation of compulsory licensing for 'the patented medical drugs'. 'The compulsory licensing' mostly has not exercised in the world but just has been fully utilized for the purpose of 'the sword for show(treat)'. And through negotiations, it can be possible for 'the patented medical drugs' to be supplied inexpensively. This negotiations became the way for 'the Declaration on the TRIPs Agreement and Public Health in 2001'. In the medical procedure, 'The securing of a license for the purpose of humanism' can be effectively ensured through 'the compulsory licensing'. especially, it is more reasonable that 'the medicine-related organizations' establish 'the integrated management system' for the patents of medical procedure(treatment method for diseases). There are some remarkable conclusions on juridical examination for Biotechnology. First, the juridical judgement should be made not from 'the actual necessity' but from 'the principle(theoretical) examination'. This conclusion has been founded through the fact that 'iPS cell' was developed in order to avoid 'the criticism in ethics' or 'the prohibition by law' for the embryonic stem cell. Second, biotechnology has developed 'the treatment of incurable diseases', 'the good health and long life'. But there is 'the (principle) line' which we should stop in front of by accepting the death as destiny. 'The destruction of human embryo' must be 'the line'. Third, Just one cell can enable the cloning of human. Therefore 'in examining the legal status of human materials', the scope of 'the Attribute of Humanity' should be expanded and that of 'the Attribute of a Thing' should be reduced. Fourth, the advanced technologies for 'treatment method(medical procedure)' should be patented as 'the invention of medical procedure(method)', so they should be accepted, released in public. If we graft the current information technology(IT) on these advanced biotechnology(BT), we can develop the world-class biotechnology in the Republic of Korea.

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