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In dieser Arbeit ist zum ersten allgemeiner Überblick auf die Verschuldensprinzip, das grundsätzlich für die Unfalls-Haftung im Bereich der medizinischen Behandlungsfehler noch immerhin gelten, in aller Kürze angeführt und zugleich in rechtsvergleichender Weise auf die sozialrechtliche Typenentwicklung in Bezug auf die haftungsrechtlich motivierte Entschädigung. Gemäß dem § 46 Gesetzes zur Abhilfe für medizinische Beschädigungenund auf die Mediation-Schlichtung für medizinische Streitigkeiten ist die rechtssystematische Bedeutung des Kompensations- Zusicherungsgeschäfts als eine Art institutioneller Fremdversorgung zu erfassen. Demzufolge geht es hauptsächlich um die Problematik von tatbeständlichen Merkmalen der Kompensation im § 46 obigen Gesetzes(unten 1) und im Bezug auf die im voraus von GF-Ministerium bekanntgegebene AO (provisorische Fassung) von 8. 11. 2011. um die Analyse einer Reihe von KHG-Entscheidungen über ärztliche Geburtsbehandlungsfehler (unten 2). Dabei ist noch die Geltungsbereich mit entsprechendem Kompensationssystem in Japan zu vergleichen (unten 3). 1. Der terminologische Sinn von “höhere Gewalt” ist sowohl semantisch wie auch juristisch-rechtstechnisch eine negative Vorausaussetzung für haftbar machende Gefährdungstatbestand. Nicht nur im Inhalt und Umfang verträgt dieser Rechtsbegriff sich nicht mit dem anderen tatbeständlich parallell zu erfüllenden Merkmal, also “die Beschädigung aus unverschuldeter ärztlicher Geburtsvorsorge”, weil die jene enger als die diese auf dem Begriffsfeld ist, sondern auch im dogmengeschichtlichen, auch doch rechtstechnichen Sinne ist die Terminologie von “höhere Gewalt” ungeeignet, für den kompensatorischen Tatbetand als ein positives Merkmal, zu sein, statt derer, m. E. sollte der Begriff von “unkontrollierbarer Zufälligkeit” als Lösungsansatz verwendet werden. Dazu ist auch die ratio legis zur institutionellen Einführung des obigen Kompensations-Zusicherungsgeschäfts, das sich auf die Entschädigung des für Patienten unerträglichen Verlustes gerichtet, d. h. gerade die Augabe des nachteilsausgleichenden Einstehens für Unglück, nicht für Unrecht, zu berücksichtigen. 2. Die Typen der KHG-Entscheidungsfällen im Bereich von Gynäkologie könnten diagnostisch bzw. therapeutisch im folgenden differenziert sein werden; je nach der Kriterien von der Weise und dem Zeitpunkt zur Geburtshilfe, technischen Behandlungsfehlern beim Geburtsvorgang, und Besorgungsfehlern nach dem Geburt u. dgl. 3. Die japanische verschuldensunabhängige Kompensation ist eigentlich eine Art institutionelle Vorsorge, die anders als koreanische Versorgungssystem auf Grund privatsicherungsfinaler Vorleistung gewärleistet wird. Der kompensatorische Bereich beschränkt sich auf die schwere infantile Zerebralparese (Cerebralparese) beim medizinischen Geburtsbehandlung. Schließlich würde diese Arbeit erwünscht sein, zur Konkretisierung des Voraussetzungen für die Kompensation nach § 46 Abs. 1 u. 4 des obigen Gesetzes beitragen zu können, welcher spätestens am 8. 4. 2013. zur Geltung gebracht sein sollte.

This article analyzes the case (2008Da16776) which has the issue how patients have to prove causal relationship when patients claim against pharmaceutical companies alleging that patients were infected with virus due to contaminated blood products. The Supreme court held that: (1) if patients prove that they didn't have symptoms suggesting virus infection before administration of blood products, the virus infection had been confirmed after administration of blood products, and there were significant potential of contamination of the blood products with the virus, the defect in blood products or the negligence of pharmaceutical company in making blood products shall be presumed to cause the infection of the victim. (2) The pharmaceutical companies could reverse the presumption by proving the blood products were not contaminated, but the fact that the victims were treated with the blood products manufactured by other companies or had received blood transfusions is not enough to reverse the presumption. The case is the first decision whether the burden of proof about causal relationship could be reduced in pharmaceutical product liability lawsuit. Hereafter pharmaceutical product liability cases, it would be necessary to reduce the burden of proof about causal relationship in order to make substantive equality between patients and pharmaceutical companies.

The Korea health care system has been divided into Western and Oriental (Korea traditional) medicine since 1951. In accordance with dualistic medical system, there are many conflict cases between medical doctors and oriental medical doctors. Meanwhile, there were much discussions about the meaning and criteria of medical malpractice(negligence). Especially, many cases have been built up about the criteria of medical malpractice through lawsuits. But, comparatively, there's few the medical malpractice case of the oriental medical doctors. According to a recent ruling of the Supreme Court, the legal principles of medical doctor's malpractice case are equally applied to the criteria of the oriental medical doctor's malpractice case. But there are much considerations in addition to these principles for the dualistic medical system and academic distinctiveness. This study is intended to review the dualistic medical system, the criterion of medical malpractice, and analysis this issues. To make long story short, under our dualistic medical system, judging the medical and oriental malpractice should be considered relatively. However, it makes sense that we want medical doctor or oriental medical doctor to demand the reinforced negligence to restrict the unnecessary discretion. If there is lack of evidence-based medicine or the rationality suspected, the health care providers must give enough proof.

On March 11, 2011, the Korea National Assembly finally passed the bill on the Damage Relief on the Medical Malpractice and Mediation for Medical Dispute. One of the features of this Act is including “The Subrogation Payment System for Damage (abbreviated SPSD)”. This System is that 'Korean Medical Dispute Mediation- Arbitration Board' pays the damages, instead of the health care provider, for the patient who isn't paid damages by the health care provider despite of the Mediation or ruling. The purpose of this study is to search the problems and make improvement on SPSD. This System was introduced extreamly to the patients in order to induce them to the mediation. However,there remains several problems. In this articles, I have examined thoroughly the legal issues on SPSD. There are legal issues about the methods and ratio of the financial burden. In this connection, wide discretionary authority has been granted to administrative agencies specifically. On this account, this System clearly contains elements of a violation against the Constitutional Law. Moreover, this System can be broadly applied to the case of court ruling or the Korea Consumer Agency's mediation. But these measures go against the aim of legislation that the medical dispute can be resolved through the mediation or arbitration by this Act. In the end, these problems must be revised through the additional discussion.

According to the current law of national health insurance, the Minister of Health and Welfare can impose a suspension of business or license, and a fine with medical institutions who violate the law. In case that medical institutions raise an action for nullity with each penalty, they ask for replacing the suspension of business with a fine during the pendency of the action. But there is a long gap of time between an offense and administrative measures. One violation cause several types of administrative measures (suspension of business or fine, suspension of license etc.) and different government departments impose these penalties. It takes a lot of time to organize their opinions and they are liable to impose penalties after considerable space of time because of overwhelming tasks. Then the medical institutions can sustain a loss by getting unexpected administrative measures after their offense against the law. Thus, this article review whether extinctive prescription apply to the right of imposing fine on the law of national health insurance or not. Meanwhile, we have no regulations imposing a same fine to co-representatives of medical institution who infringe the law of national health insurance. On this point, this study review whether they have equal duty on that or not.

“Wrongful conception” is a medical malpractice claim in which the plaintiff is the parent of a normal, healthy infant whose conception was unplanned and unwanted. Medical malpractice in wrongful conception can be the result of a failure to provide informed consent to a patient, failure to properly perform a surgery, or a physician's negligent handling of a patient's problems. In the concrete, wrongful conception cases fall into two categories; those involving pre-conception negligence, such as a failed contraceptive, sterilization or failing of the controlling of embryo-number on the IVF, and those involving post-conception negligence, such as a failure to diagnose a pregnancy or to perform an abortion procedure. In addition, Medical malpractice can be the result of a failure to provide informed consent to a patient. When bad results occur by medical malpractice or failure to provide informed consent to a patient, the range of recovery of damages is decided by a traditional civil liability law. However the calculation of damages for wrongful conception is not easy because the high value of life is included in that case. So many courts opinions in foreign country and Seoul High Court decision in 1996 allow damages for the pregnancy, birthing process and sterilization costs, but refuses to allow damages for child rearing expenses. As to the range of recovery of damages for wrongful conception, one approach says that to allow damages in a suit such as this would mean that the physician would have to pay for the fun, joy and affection which plaintiff will have in the rearing and educating of the plaintiff's baby. To allow such damages would be against the dignity of the baby based on article 10 of the Constitution. However another approach says that damages are recoverable for all expenses related to child birth as well as for child rearing costs. Because the damages that the parents should bear a burden to the tort damage done is not a baby itself but child rearing costs. In other words, although the baby is healthy or not, economic burden of the parents can not be disregard. And denial of compensation for costs of child rearing may invalidate the role of liability law, grant the physician with a exemption certificate of liability. As a result, the medical field of procreation can be easily isolated from a liability of reparation. Therefore, on the liability law like the other medical malpractice action, parents who became pregnant or gave a birth by physician, wrongfully performed sterilization operation, etc. should be compensated for all damages relevant to unplanned and unwanted conception or birth as well as costs of child rearing.

Changes in a drug’s availability from prescription only to over-the-counter (OTC) status is of concern to physicians from both public health and individual patient perspectives. Government has generally been supportive of changes in medications from prescription(Rx) to over-the-counter (OTC) status in Korea, however, recognizing that there are both benefits and risks to any health care intervention, health care professionals are conservative in implementing changes to either the process or structure of health care. Changes in status of a drug from Rx to OTC can represent a change in both structure and process. Cost and convenience seem to be major factors in determining whether, given the choice, patients purchase a medicine over the counter or obtain it on prescription. With current arrangements, exemption from prescription charges provides an incentive to continue to obtain products on NHS prescription even when they are available over the counter. There is therefore no simple relation between the availability of over the counter medicines and the level of prescribing of deregulated products. The appropriate use of over the counter medicines—particularly those that have only recently been deregulated—places a burden of care on community pharmacists and calls for closer working relationships with general practitioners. In particular, systems for referral and for recording details of both prescribed and over the counter medicines need to be developed, and a direct route needs to be established for community pharmacists to report adverse drug reactions to over the counter products. Reclassification of prescription medicines—by making them available through pharmacies without a prescription—provides the opportunity for consumers to purchase a wider range of medicinal products without making a demand on NHS resources. There is, however, no simple relation between availability of over the counter medicines and demand for NHS prescriptions. In the late 1980s the UK government fuelled the over the counter market by making it easier to reclassify certain medicines from prescription only status to allow over the counter sale in pharmacies. To explore the influence of deregulation of medicines on NHS prescribing, this article presents analyses of consumer behaviour in using medicines and prescribers' attitudes to over the counter medication and collates findings from research. Policy makers should be aware that patients’ expectations in relation to OTC medicines may be in conflict with evidence-based practice.

If the medical staff privileges, which mean the eligibility to practice at open hospitals, are excluded in the United States, antitrust claims based on the violation of the Sherman Act have been raised a lot. The proliferation of these lawsuits in the United States, which are characterized as antitrust lawsuits, can be understandable situation. The reason is because doctors who don't belong to specific hospitals are seriously damaged, if the medical staff privileges are excluded and doctors cannot use facilities of open hospitals. In order to decide to allow the privileges of certain doctors, hospitals have to rely on peer review to maintain high quality of medical services, and it is not easy to find alternative of peer review in the professional areas like healthcare. However, there are possibilities that members of the peer review can abuse power to unfairly exclude privileges of potential competitors. In this sense, it is asserted in the U.S. antitrust lawsuits that the restraint of medical staff privilege can be the illegal restraint of trade in violation of section 1 of Sherman Act and can be monopolization or an attempt to monopoly by hospitals in violation of section 2 of Sherman Act. As Korea adopted open hospital system quite recently, there is still no case related with the exclusion of medical staff privileges. However, medical staff privilege system of Korea is not different from that of the United States in principle. Thus, the U.S. jurisprudence on the exclusion of medical staff privileges can be referred in the interpretation of "practice that interferes with or restricts the activities or contents of the business" based on Article 19.1.9 of Monopoly Regulation and Fair Trade Law of Korea.

The World Health Organization (WHO) tries to accomplish the goal of 'smoke free society', and developed countries regard the nicotine as an addictive drug. In order to better protect human health, all parties are required to adopt and implement effective legislative, executive, administrative or other measures for tobacco control in accordance with Article 4 the Framework Convention on Tobacco Control (FCTC). In order to achieve the objective of the FCTC and its protocols and to implement its provisions, Korea need to take an attention on the U.S. Family Smoking Prevention And Tobacco Control Act of 2009 and Final Rule. It is need to integrate and centralize of tobacco safety administration and smoking prevention for the national health promotion.