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Die klinische Forschung unterliegt nicht nur medizinischen, sondern auch ethischen Standards. Über die ärztlichen bzw. medizinischen Standards wacht der Arzt und kontrolliert sich selbst. Über die ethischen Standards wachen unabhängige Ethikkommissionen. Die Ethikkommissionen haben ihre Entwicklungsgeschichte in den USA vollzogen, bis sie sich dann nach und nach auch in den europäischen Ländern etablierten. Die Beurteilung des ethischen Standards in der klinischen Prüfung sollte nicht mehr nur einem Einzelnen, dem Prüfer, sondern in unserer pluralistischen Gesellschaft einer interdisziplinär zusammengesetzten Kommission, bestehend aus Medizinern, Juristen, moralphilosophisch ausgebildeten medizinischen Laien und medizinischen Laien, die die Belange der Versuchspersonen vertreten, überlassen werden. Die Tätigkeit der Ethikkommission ist anerkannt Dienstleistung und wird auch durch das Grundrecht der Berufsfreiheit geschützt. Die Einrichtung von Ethikkommissionen ist daher nicht nur rein symbolische Handlung, da sich Ethikkommissionen fest etabliert haben, um ethische Konflikte in der Medizin und der Forschung als Diskurs zu institutionalisieren, um Transparenz für die Öffentlichkeit und die Politik zu schaffen und um einzelne moralische Fälle in der klinischen Forschung konkret zu begutachten. Zu Prozessen gegen Ethik- Kommissionen, deren Mitglieder, Gutachter oder Sachverstandige ist es dagegen bisher nicht gekommen, obwohl deren Haftung ebenso lange diskutiert und in der Literatur grundsatzlich bejaht wird. Nachdem aber auf der einen Seite heute praktisch alle klinischen Versuche an Menschen Ethik-Kommissionen zur Begutachtung vorgelegt werden und auf der anderen Seite trotzdem weiterhin immer wieder Versuchspersonen unerwartete Schaden erleiden, ist es wohl nur eine Frage der Zeit, bis auch Klagen gegen diesen Personenkreis erhoben werden. In den USA ist das bereits geschehen. Die Versicherungswirtschaft stellt sich jedenfalls insoweit darauf ein, als sie Ethik-Kommissionen von Universitatskliniken in Betriebsh- aftpflichtversicherungen einschließt, tut sich jedoch nach meinen Informationen nach wie vor schwer, Versicherungen fur einzelne Mitglieder anzubieten, die dieses Haftungsrisiko abdecken. Aufgabe der Ethik-Kommission ist es, den Schutz der Rechte, die Sicherheit und das Wohlergehen von Personen zu sichern, die an einer klinischen Prufung teilnehmen. Die Sicherungspflichten der Ethikkommissionen, ihrer Mitglieder und Gutachter konnen zugleich vertragliche Schutzpflichten sein, sofern zu den Versuchspersonen ein Schuldverhaltnis besteht.

Across the ages and in all countries of the world, medical dispute caused by either medical accident or medical malpractice always exists. “There is dispute where patient is” as it says the relationship between a patient and a medical institution is an inseparable relation. In China the demand for the medical welfare is getting higher as the quality of life becomes improved with rapid economic development. In this context, China stipulated Tort Law of P.R.C in December 2009, which is the world’s only single law. Before the stipulation of the Tort Law, the medical dispute was resolved in pursuant to either General Principles of the Civil Law of P.R.C or Regulations on Resolving Medical Accident. However, the former has no specific regulation on medical dispute, and is composed of abstract and general regulations. Furthermore, the latter has the deficiency in resolving personal action and infringement of right since its legal feature is administrative regulation. As a result, it was difficult to resolve medical disputes under these systems. It is expected that the stipulation of the Tort Law could improve this legal problem. However, the Article 7 of the Tort Law regulating liability for medial damage cannot solve all of these problems. In other words, some deficiencies and problems in both content and structure of the Law still exist. Consequently, the paper will analyze Chinese medical dispute first. Next, it will discuss how the Tort Law is applied in favor. Finally, it will examine the problems in the application of the Law.

No one can deny that in contemporary society, not only doctors but nurses play indispensable role for the health of nationals. In this acc ord, there came a necessity that law to protect the health right of na tionals and improve the position of nurses should be established as i ndependent law in tune with social reality and the trend of nursing s cience academic circle. However, though there is increasing demand of diverse and specialized nursing services like home nursing and aged nursing etc, present ｢Medical Services Act｣ prescribes the work of nur se as assisting doctor's assistant in medical action, so the reality is t hat the Act does not comprehend the work of nurse that is ever dive rsifying and specialized in tune with social changes. Therefore, there are impending demand to raise the quality of nur sing service by clarifying the work scope of nurse and effectively re gulating on nurses while securing the health right of the nationals by establishing independent law to promote the health of nationals and i mprove the position of nurse. In South Korea, the majority of profess ional occupations are regulated by individual laws, and also in major advanced countries of the world, nurse related laws are separately est ablished and operated, so when it is considered that nurses play imp ortant role for the health of nationals, it is deemed that nurse related laws also need be established as independent law in view of social r eality and nursing science academic circle. The past and present roles of nurses are undergoing unprecedente d changes, and only law that reflects such changes can exercise soci al capability of norm. Therefore, partial modification of medical act al one by situation involves limitation to regulate the nursing work of n urses, and the medical act in that sense is insufficient to serve as n ormative instruction for nursing work and is not suitable as standard t o judge the point of responsibility in nursing act. Hence, in this study, the foundation of 「Bill for promotion of nati onal health and improvement of nurse position」 was prepared through survey on the relation with medical law based on nursing act (bills) ini tiated so far, and after, and after the work scope of nurse was speci fically classified by distinguishing from doctor, problems of comprehe nsive rules of present medical act were reviewed. Also, for protectio n of the health right of nationals, the problems of nurse work conditi on and treatment improvement were examined.

If patentees' rights can't be protected enough, their inventing has n o choice but to be daunting. Also there is a need to protect and prom ote inventing enough for research and development of technologies. So inventors are endowed with the exclusive rights, Patent, so that their rights can be protected. However, if they are exercising their rig hts unfairly, people, users can be helped with Compulsory Licensing. Compulsory Licensing can be an effective measures to restrict pat entees' rights abuse in case patentees, especially pharmaceutical com panies, infringe Rights for Public Health with the high supply price. Of course, Compulsory Licensing should be built on Subsidiarity Pri nciple.

The increase of the aging population has caused problems to those people who don't have ability to manage their own affairs due to an il lness such as dementia. To solve many issues related to property ma nagement and protection of human rights, the proposed amendment to the Civil Act which will cover adult guardianship was declared in Se ptember 2009. Afterwards, as the Civil Act was amended in March 7, 2011 as Act number 10429, the existing system of incompetency and quasi-incompetency was abolished and instead Adult Guardianship System has been introduced, being scheduled to be in force on July 1, 2013. With regard to medical treatments, not only stoppage of treatments to a patient, but also all medical activities by themselves may cause health care hazards. As the worst result such as loss of life may be caused seriously, consents to those activities are also regarded as im portant issue. One of the most challenging issues in the adult guardianship of the amended civil act is whether or not duties of adult guardians set forth in Article 947-2 of the Civil Act include consents to medical activities to their guardianees. Considering the fact that in many cases long-term disease or disability of a guardianee leads to the decision on adult gu ardianship, it is a very important concern for anyone to secure medic al treatments to a guardianee in the adult guardianship. As the adult guardianship system imposes the obligation to care the guardianee on the adult guardian, it is an important duty of the guardian to make me dical treatment and hospitalization arrangements in consideration of the changes in health status of the guardianee. However, in the event that medical treatments such as surgery are required to a guardianee who doesn't have ability to consent, who is supposed to decide on it? Acc ordingly, it is an important issue for an adult guardian to have the aut hority to consent to medical treatments. This study claims to specify the scope of consent in more details in the civil act because neither Article 947-2 of the amended civil act n or the medical treatment act fails to specify the authority to consent given to adult guardians. This study aims to examine and clarify the authority of adult guardian to consent to medical activities.

The trial, generally, makes an application of law for concrete matters in dispute and must confirm the facts applied to requisites of law from the premises. Ultimately, as the trial must be done in the way of fact finding and application to law, it is the legal judgement to draw a conclusion with making the confirmed fact a minor premise and the law a major premise. But, due to the limitation of cognoscitive power of human, there is non liquet without confidence on the truth about factum probandum after judges examine evidences. In this case that it's inapplicable to regulations, the effect of law applied to regulations won't be able to be judged. In case that existence of the certain fact is unproven at lawsuit due to unidentified truth, it's called burden of proof, Beweislast, to indicate the risk of one party to a suit who can't help taking disadvantageous law judgement for the reason. There are many theories and controversies about whether it's reasonable for anyone who will have to burden a responsibility for proof ;nevertheless, in relation to distribution of taking a responsibility for proof, it can be called a traditionally basic principle in the longest history that the person who wants to take the effect of law will take the responsibility for proof in the general cases. But, this basic principle has so far changed in various ways since the theory on responsibility for proof started to be academically established. And the principle is now asked to change. Above all, this phenomenon became more noticeable in the modern lawsuit such as lawsuit for public nuisance, malpractice suit, productliability suit, etc. As it's extremely hard for a victim to prove the casual relationship between occurrence and cause of damage by the victim's own effort, it's actually rejected to relieve the victim if the victim should be asked to prove the whole process of casual relationship. The case of a claim for damages(malpractice suit) about medical malpractice to be dealt with this article is confronted with two difficulties different with a general claim for damages. One is hard to reenact an objective fact, itself, caused with medical malpractice, and the other is hard to prove an existence of the objective fact. Therefore, the manner to burden unilaterally a patient with a responsibility for proof can't conform with ideals of a claim for damages system, that is, the guiding principle based on a fair and proper burden for damages. In the end, to realize the adversary system(Prinzip der Parteigleichheit)between the litigant, doctor, and the patient in the medical malpractice suit, it's asked to mitigate or change the burden of proof so that the patient can claim easily for damages by relaxing the burden of the patient within the limit of making doctors be wrongfully unharmed. There are various arguments about how much a responsibility for proof of the patient, plaintiff, should be relaxed in the medical malpractice suit. The arguments can be largely classified to mitigation, conversion and interference of a responsibility for proof. In the medical malpractice suit, there are probability, de facto presumption and presupposition and coincidence to be mainly discussed as relaxing a responsibility for proof of the casual relationship. In this article, theories based on presupposition and coincidence in the malpractice suit would be reviewed by focusing on theories and precedents.

Informed consent is the process by which a fully informed patient can participate in choices about her health care. It originates from the legal and ethical right the patient has to direct what happens to her body and from the ethical duty of the physician to involve the patient in her health care. The informed consent doctrine is generally implemented through good healthcare practice: pre-operation discussions with patients and the use of medical consent forms in hospitals. However, reliance on a signed form should not undermine the basis of the doctrine in giving the patient an opportunity to weigh and respond to the risk. Informed consent for the establishment as the first element, there is the capacity to consent to the patient that, second, that there is an appropriate description (description requirement), the third, patients who received a description. Subjects randomly according to a conscious de cision that you agree (consent Requirements) of three things can be. This is based on the patients' rights and obligations regarding security and health will be reviewed in the field.

호주에서 전통의학의 법적 규제 구조를 연구하기 위해서는 역사적과 사회 적인 문제도 논의할 필요가 있다. 먼저 규제 체제의 운영방법에 대해 설명하 고 그 다음에 시스템을 실제로 어떻게 운영하는지에 대하여 논의하고자 한다. 호주의 동아시아의학에 대한 국가규제는 2012년 7월부터 발효되었다. 동 아 의학은 중의학으로 알려져 있지만 한국, 일본과 베트남의 의약품도 포함 되고 있다. 이것은 동아시아 본토 이외, 동아시아의학이 처음으로 산업으로 국가계획에 포함되어 있다. 호주 정부가 국민에게 약품 복리계획도 만들어주고 있기 때문에 국민의 의약진료지출이 많이 감소하고 있다. 일반적으로 대부분 호주사람들이 개인 의료보험에 가입해서 많은 의료서비스를 얻을 수 있다. 지금 호주에서 근무하는 동아시아 의사들이 대부분 중국 출신이고 그 인 원수는 19세기의 생물의사보다 많다. 이러한 상황은 두 가지 주요 요인의 영향을 받아서 반전하였다. 하나는 백호주의 통합정책이다. 이 정책에서 호 주에서 살고 있는 황색인종들을 배척하고 의료행위도 강하게 규제하기 때문 에 동아의학의 발전공간이 없다. 또 하나는 1970년부터 호주에서 동아시아 의학의 발전이 시작되었다. 한편으로, 그대 동아시아의학의 인기는 북미, 서유럽, 뉴질랜드에서 상승 하고 있다. 여러 가지 요인이 있지만 그 중에 하나는 이민 정책이 자유화되 고 동아시아이민수가 증가되는 것이다. 또 다른 요인은 실제 반문화도 나타나는 것이다. 사람들이 동아의학에 대한 관심이 점점 많아졌다.

There are constant disputes about euthanasia not only from the point of philosophy and ethics but of law. For example, there have been sensitive issues such as the accident in Boramae hospital in Seoul and Ms Kim's euthanasia happening. Although intensive studies on euthanasia are really necessary, even the basic concept about euthanasia has not been established let alone the legislation. This article deals mainly with the basic concept of euthanasia, arguments on various types of the concept, and introduction of domestic instances. Ultimately, the goal of this article is to discuss the problems of permitting stopping meaningless remedy for the life prolongation. There have been a variety of arguments on using the term euthanasia. However, it is better to divide euthanasia into two perspectives, that is, active and passive one. Moreover, the Constitutional and the Supreme Court's supportive view of permitting euthanasia is not reasonable in terms of the Principle of Protecting Life. Now, the patient's right of decision is not included in the arguments on euthanasia. Of course, it is true that the families of the patient are suffering from psychologically and financially. However, it is very dangerous idea to try to solve and diminish their agonies by the patient's death through euthanasia. Rather, it will be helpful for the government to support them by promoting social welfare.

The first test tube baby was born in 1978 since many social, religious, ethical concerns, despite assisted reproductive healthcare industry has been developed spectacularly. The goal of treatment in infertile couples, or to the pursuit of individual happiness through surrogacy and assisted reproductive technology used around the world, if the birth is a growing trend. Korea also is difficult to conceive a baby for the couple enough to support the cost of assisted reproductive technology (ART) Assisted Reproductive Technology where we are situated very close to. However, if the light through the darkness as assisted reproductive technology (ART) azoospermia or ovaries, uterus there is a problem to get the baby they made possible, while the donor, egg donor, and genes on the relationships with parents, surrogate mother gave birth played with the like a tangled skein relations and accordingly the legal status of the baby can be a problem. Yet our legislation babies born through assisted reproductive technology (ART), these regulations do not have to. Babies born with assisted reproductive technology (ART) to grow in reality for the benefit of all of these laws is urgent to make.