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§27 Abs. 3 das Gesuntheitsdienstgesetz (the Medical Service Act) in Korea lautet: Niemand in der Absicht, sich oder einem Dritten einen Vermögensvorteil zu verschaffen, der Medizininstitut bzw. dem Mediziner (die Medizinerin) den Patienten vorstellen, übweweisen, verleiten oder einen anderen zu dieser Handlung anstiften darf, wie z.B. die Selbstbeteiligung des Patienten nach dem Krankenkassengesetz (the National Health Insurance Act) oder dem Gesetz über Beistand der ärztlicher Betreuung (the Medical Care Assistance Act) skontieren oder befreien, Geld offerieren oder dem Allgemeinheit das Verkehrswesen anbieten usw. Nach dem Wortlaut ist jedoch unklar, ob unter diese Vorschriften der Fall subsumiert werden kann, wenn eine Medizininstitut bzw. ein(e) Mediziner(in) in der Absicht, sich einen Vermögensvorteil zu verschaffen, sich den Patienten verleitet. Nach dem Korean Supreme Court ist eine Medizininstitut bzw. ein(e) Mediziner(in) nur dann das Subjekt der Verleitungshandlung, wenn sie bzw. er ein Mittel gegen fairen oder ordungsmäßien Medizinmarkt verwendet oder dem Patienten eine ärztlich rechtswidrige Behandlung (z.B. einen rechtswidrigen Schwangerschaftsabbruch) verspricht. In diesem Beitrag wird dagegen die Auffassung mittels der teleologischen Reduktion vertritt und argumentiert, dass ein ärztlich rechtswidriges Behandlung nach dem Rechtsgut und dem Normzweck unter §27 Abs. 3 das Gesuntheitsdienstgesetz nicht subsumiert werden, sondern allein nach eigenem Unrecht bestraft werden kann.

Humankind history is faced with one gigantic turning point due to development of Living genetically Modified Organisms. Food production by means of LMO is on the acceleration in an effort to solve the shortage of food problems. Food is also used as alternative energy source. Use of LMO product is not only limited to food and energy, but is actively utilized in various fields of medicines. This paper is first to check out the state of biomedicine developed and associated problems from industries that use LMO, after which we made an attempt on legislative approach to find out means of relief, through examples of such laws legislated for the sufferer from the adverse effect of the biomedicine. As for the liable subject to bear the responsibility for compensatory damage in a way of relieving the victim owing to adverse effect of biomedicine, those who manufactured and sold biomedicine and who are related to the damage to the victim due to the accident and medical doctors and pharmacists who prescribe and administer the medicine in question have been looked into. Accidents involving medicines and medical supplies could take place without reason for imputation on part of the liable subjects or fault of the victim, in which case the victim can’t receive damage compensation from any of both parties. When such accidents happened turn out to be no fault accidents, introduction of damage relief measures might have to be reviewed against side effects of medicine and medical supplies as no fault compensation in order for actual relief to be possible. Talking about technicality of legislation, we can suggest a method of strengthening the accountability of manufacturer for stereotypical agenda on biomedicines by newly legislating special regulation with an issue that resists claim on risks associated with the development of medicine and incorporating the same into Manufactured Product Liability Law. After all, when an accident happens associated with biomedicine, the damage will be done to the consumer. And the consumer will be exposed to fatal danger even without the time to cope with potential risks associated with medicine and medical supplies they take. Therefore, it is necessary to protect the potential victim by having the manufacturer of biomedicines bear the liability of medical risks.

Asbestos has been used for roofing, walling and the like for the constructions since 60’s~70’s owing to its excellent fire resistance and heat insulative nature. However, it has banned to be used in major countries all over the world since WHO-affiliated International Agency for Research on Cancer (IARC) stipulated asbestos by a top carcinogen causing lung cancer, malignant mesothelioma and so on in 1986. Therefore, we had prohibited the use of asbestos on brakes for automobile since 2007 and on most of the products other than some cases of having no alternatives such as munitions from 2009. Nevertheless, diseases from asbestos have a long incubation period of 10~40 years, therefore, even if being exposed to asbestos, preliminary prevention is rather more important than instant possible damage as damages can be greater decades later. Accordingly, this thesis has a purpose to seek a plan in order to guarantee the rights of national health from harmfulness of asbestos by comparing and reviewing the policies on asbestos in advanced countries such as France, Japan, Netherlands and such like.

To strengthen the protection of human research subjects and human materials, the Korean Ministry of Health and welfare proposed the amendment bill of Bioethics and Safety Law(2010) to the Congress. It includes so many meaningful clauses. According to the bill, the scope that this act shall apply will be expended to the research involving human subjects and human materials. In the bill, there are the principles of this act; the protection of the life, health, and dignity of the human subjects, the obtaining of the adequate informed consent, the protection of the human subject’s information confidentiality and the human subject’s privacy, the assessment and minimizing of the risks involved and the guarantee of the safety for the human subjects, the preparation of the special protection program for the vulnerable human subjects, and so on. According to the bill, Institutional Bioethics Review Board(the same as Institutional Review Board) will be responsible for the auditing and monitoring on the research that was approved by IBRB, conducting the education program for the researchers, IBRB members and administrative staffs, preparing of the special protection program for the vulnerable human subjects, and forming the guidelines for the researchers as well as the review of the research protocols. And the State and local governments shall take necessary measures to support the expending of the social infrastructure. In addition to, IBRB will have to be assessed and to be gained the accreditation by the Korean Ministry of Health and welfare. So, if Bioethics and Safety Law is amended, it will contribute enormously to enhance the level of the human research subjects protection. Also, if this Law is amended, IBRB will play a major role for the conduct of the ethically, scientifically, and legally proper research. But now, as a matter of fact, the capability of IBRB members and IBRB office members is not enough to charge of this role because some people and some organizations does not know the importance of IBRB exactly. In spite of, IBRB shall be able to this role to protect the human subjects and to develop the level of the research On the international level. Therefore, the State, local governments and the Organization shall back up the administrative and financial terms of the IRB and IRB Office.

Since mid-1960s the reports from the Surgeon General, the World Health Organization, and other health experts state that there is no risk-free level exposure to smoking and secondhand smoke. Tobacco smoke is made up of more than 7,000 chemicals. Hundreds are toxic, and at least 70 are carcinogens. The chemicals in tobacco smoke reach smoker's lungs quickly every time smoker inhale causing damages immediately. Inhaling even the smallest amount of tobacco smoke can also damage smoker's DNA, which can lead to cancers. Smoking is responsible for more than 87% of lung cancers, but there are a host of other chronic diseases directly related to exposure to tobacco smoke. It's also a major cause of heart disease, stroke, aortic aneurysm, peripheral arterial disease and most of the other diseases. In the United States, each year with more than from 440,000 to 520,000 deaths caused by smoking and exposure to involuntary smoke. They conclude that smoking is the single most important source of preventable morbidity and mortality. The United States of America have about 60-year history of tobacco litigation. Tobacco litigation has been an important tool in tobacco control strategies aimed at limiting the activities of tobacco companies and providing redress to people who have become ill as a result of their use of tobacco products. Tobacco litigation is a kind of tort litigation. Quite often, as in the asbestos and other mass tort litigation episodes, tobacco litigation can play an educa tional role, warning the public about the magnitude of health risks that might otherwise be less clearly perceived. Tobacco litigation allows smokers, their families or other victims of smoking to sue tobacco companies in order to be compensated for the harm they have suffered. Potential benefits of tobacco litigation include compensation for smoking-related damages, strengthening regulatory activity, publicity, documents disclosure and changing tobacco industry behavior. And also tobacco litigation can limit the political activities of tobacco industry, protect human rights of smokers and non-smokers, increase burden to tobacco price-up and enhance the effects of law and politics in public health.

Verdicts related to major medical litigation given by the Seoul Central District Court, the Seoul High Court and the Supreme Court in 2010 were analyzed. It’s shown that in cases of the medical negligence regarding the occurrence of neonatal cerebral palsy, the plaintiff claims were dismissed using criteria proposed by associations of Obstetrics and Gynecology and Pediatrics in US, and thereof the burden of plaintiffs to prove the medical negligence has increased. In addition, in case of that the expected survival period of infants gets longer, payments for treatment and nursing after survival period determined by judges are made and it was judged to compensate it as a periodical indemnity. In case for the explanation obligation the most frequently mentioned in the medical litigation, in addition to cases of invoking the existing theory of explanation obligation, verdicts to mention the instructions of theory regarding instruction explanation obligation and the possibility of compensation for damages on property are given. Particularly, in cases for a liability of reparation by exaggerating the effects and not disclosing the risks related to treatment with stem cells, even if the treatment not approved by Food and Drug Administration is in violation of the Pharmaceutical Affairs Law, it’s not illegal as violation in Pharmaceutical Affairs Law itself. But there is a certain verdict to present the possibility of an extension of the theory of explanation obligation by acknowledging the liability of reparation caused by illegal acts with no explanations of effects and risks of treatment with stem cell by doctors and pharmaceutical companies. In an incident in which a mental patient fell and died through the opened door of the roof at the hospital, a liability of reparation was acknowledged due to defects in structure installation management and this verdict drew an attention since the overall management responsibility about patients including structures was acknowledged to the hospital besides the obligations on medical practice. In case of the verdict without giving the opportunity to state the opinion with respect to the main legal issues, the responsibility of the court was emphasized since the court did not fulfill the explanation obligations. There were some cases in which payments for nursing and caring to a patient in vegetative state during the plastic surgery was admitted. However, in dental-related incidents, the proportion of cases in which plaintiff won was low since the difficulty of proving may be reflected. In the area of administrative litigation, unlike the existing position regarding arbitrary medical charge cover collected from patients in hospital, the verdict to admit the legitimacy of collection of medical treatment was given and attracted the attention of people. Verdict in which the expression related to medical advertisement was not exaggerated disposed the original verdict and pointed out the problem of excessive regulations on medical advertisement. The effort to analyze the trend of verdicts of court through reviewing the decisions and to organize should be continued, but the full decision should be disclosed as a base, and people and systems to enable the all time monitoring should be prepared.

Recently, many nations said “yes” to human embryonic stem cell research, signing an executive order to permit funding for the research in the mame of achieving health and life of humankind. Human Embryo Research is permitted by our Bioethics & Biosafety Act. But, illegal research cannot be divorced from civil liability since it requires the destruction of eggs of fertilized eggs and personal rights of embryo-creator. After all, though we allow to do research embryo, we should control the capacity of abuse of embryo research for embryo-creator. If research violate the law(Bioethics & Biosafety Act or Civil Law, etc), it comes to a delict by pecuniary loss and non-pecuniary loss. When it comes to pecuniary loss, Human Embryo is not body but special property. Supreme Court maintained a stance that mental suffering is generally deemed as compensable for damages for the loss of property where a person's property right is invaded by a tort or non-performance of obligation. Thus, where mental suffering occurs, which cannot be compensated by recovery of property losses, the situation must be a special circumstance and the injured could claim consolation money for such losses only if the offender knew or would have known of such special circumstances(Supreme Court Decision 96Da31574 delivered on Nov, 26, 1996, etc.). That is to say, Supreme Court regards mental suffering through person's property right invaded by a tort as damages that have arisen through special circumstances. According to Civil law article 393 (2), the injured could claim consolation money for such losses only if only if the offender had foreseen or could have foreseen such circumstances. Also our court will solve through damages for non-pecuniary loss by complementary function of consolation money in that pecuniary loss could be difficult to valuate.

This thesis has studied about the legal characteristic of injection of the trial drug, the position of the pharmaceutical firm as a contractor of the clinical trial, the possibility of compulsory performance of consistent injection of the trial drug, and the damage claim caused in the process of the clinical trial from the viewpoint of protecting the trial subject in the clinical trial. According to court's judgement in the United States, the lawsuit of the trial subject, although the trial subject had expected consistent injections, was dismissed because there was no direct contract between pharmaceutical and trial subject. However, Helsinki Declaration prescribe the medical research as follows. 'All patients who participated in the research should be able to use the best precaution, diagnosis, and treatment proved by the final outcome of the research'. The trial subject is entitled to demand only the pharmaceutical firm which developed and provided the trial drug, and the pharmaceutical firm has the obligation to supply the trial drug to the trial subject. Therefore, it would be not enough to protect the trial subject if the pharmaceutical firm which makes the trial drug is ruled out. In addition, especially, in case the trial drug has a constant effect with the aim of treatment, if the injection of the trial drug is suddenly stopped, the trial subject would not have the benefit of treatment by the trial drug. In this case, the best remedy against the damage is to urge a constant injection of the trial drug. Thus, in certain case, it is reasonable to consider that the pharmaceutical firm has the obligation to supply the trial drug to the trial subject constantly, and it is also necessary to compel it through effective means in case the pharmaceutical firm do not fulfill its obligation to supply the trial drug. However, as an essential prerequisite for the assertion mentioned above, it should be judged under the principle of good faith considering the concrete situation, that is, what roles the pharmaceutical firm has played.