• 의료법학
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• 제14권1호
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• pp.11-36
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• 2013

Korea has been recognized as a safe country about the substance abuse, but now is not safe country because there are over 10 thousand drug related offenses in a year since 1999. Seventy percent of them are drug abusers, so Korea government must have stronger political strategies about the prevention and the treatment of the drug abuse. Till now Korea government has focused on the imprisonment rather than the treatment for the drug abusers. So the relapse rates are over 40% among the incarcerated drug abusers. Now we need more treatment strategies and development of treatment methods to decrease the relapse rates. Substance abuse is a brain disease with a chronic relapsing nature and has a bio-psycho-social etiology. So treatment process has three steps, motivation enhancement treatment for substance-free lifestyle, rehabilitation aimed at maximizing multiple aspects of life functioning, and relapse prevention. To improving the treatment strategies the Government must execute the national survey about the substance abuse, enforce a law to operate the drug court and to sentence a treatment order with a probation, and establish a national addiction institute for study and education about the substance abuse.

• International Journal of Computer Science & Network Security
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• 제22권6호
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• pp.246-250
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• 2022

The article analyzes the regulations of current criminal law and current issues, combating drug crime on the Internet, as well as measures to combat drug crime in the field of modern information technology. In connection with the growth of crimes in the field of drug trafficking committed with the use of information and telecommunications technologies, the urgent task of the state is to find effective ways to reduce drug crime. The article considers criminologically significant aspects of the mechanism of illicit drug trafficking, which is carried out with the use of information and telecommunication technologies and means of remote communication.

• 약학회지
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• 제52권6호
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• pp.452-465
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• 2008

Hair analysis for drugs of abuse offers the crucial potential advantage when compared to urine, such as the longer time window of drug intake, which makes retrospective investigation of chronic and/or past consumption. This paper reviews the physiological basis of hair growth, mechanism of drug incorporation, analytical methods, result interpretation and practical application of hair analysis. Moreover, to facilitate the court's decision regarding specific circumstances surrounding the crime, this review demonstrated that the results of hair analysis not only should be admitted as scientific evidence of drug use but also could legally improve reliability of the evidence.

• 의료법학
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• 제15권2호
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• pp.63-89
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• 2014

In 1976, the Dalkon Shield-intrauterine device injured several thousand women in U.S.A. which caused the changes of medical deivce regulation. The Medical Device Regulation Act or Medical Device Amendments of 1976 (MDA) was introduce. As part of the process of regulating medical devices, the MDA divides medical devices into three categories. The class II, and III devices which have moderate harm or more can use the section 510 (k), premarket notification process if the manufacturer can establish that its device is "substantially equivalent" to a device that was marketed before 1976. In 21 U.S.C. ${\S}$ 360k(a), MDA introduced a provision which expressly preempts competing state laws or regulations. After that, the judicial debates had began over the proper interpretation and application of Section 360(k) In February 2008, the U.S. Supreme Court ruled in Riegel v. Medtronic that manufacturer approved by the Food and Drug Administration (FDA)'s pre-market approval process are preempted from liability, even when the devices have defective design or lack of labeling. But the Supreme Court ruled in Medtronic Inc. v. Lora Lohr that the manufactures which use the section 510 (k) process cannot be preempted and in Bausch v. Stryker Corp. that manufactures which violated the CGMP standard are also liable to the damage of patient at the state courts. In 2009, the Supreme Court ruled in Wyeth v. Levine that patients harmed by prescription drugs can claim damages in state courts. This may cause a double standard between prescription drugs and medical devices. FDA Preemption is the legal theory in the United States that exempts product manufacturers from tort claims regarding Food and Drug Administration approved products. FDA Preemption has been a highly contentious issue. In general, consumer groups are against it while the FDA and pharmaceutical manufacturers are in favor of it. This issues also influences the theory of product liability of U.S.A. Complete immunity preemption is an issue need to be more declared.

• 의료법학
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• 제12권1호
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• pp.257-285
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• 2011

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.

• 의료법학
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• 제12권1호
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• pp.177-225
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• 2011

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.

• 의료법학
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• 제12권2호
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• pp.65-117
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• 2011

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.

• 의료법학
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• 제13권2호
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• pp.11-38
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• 2012

The Supreme Court stand in the position in specific lawsuit that it doesn't allow the discretionary not covered service, but recently in revocation suit of fine disposal that is imposed on medical fee of leukemia patient, it altered the existing adjudgement and admitted the discretionary not covered service exceptionally. It put forward the allowable condition roughly in that case. According as this alteration, it has become more important to embody the allowance conditions of exceptions. The Supreme Court presented three things, which are procedural condition, medical condition and subscriber's agreement. Concerning procedural condition, several present conciliation procedures are as follows: medical care benefit arret request, relative value conciliation etc, prior request on anti-cancer drug among chemicals which exceed acceptance criteria, request of non benefit object on common drugs. To be granted the existence of those system, there should be no obstacle to use that. Even if it were so, we should take circumstances into consideration; individual situation is unescapable concerning substance and urgency of the discretionary not covered service, process of the procedure, time required etc. Regarding medical condition, safety and effectiveness will be verified through evaluation procedures of new medical skill. About the necessity, the Supreme Court made clear through a sentence that it allow the discretionary not covered service, in case that needs to treat a patient out of the standard of medical benefit. Strict interpretation is right and it answer the purpose of the sentence that the supreme court permit the discretionary not covered service, exceptionally. We need to differentiate medical necessity and medical validity. Subscriber's agreement should holds true if it entails full explanation, and if it is preliminary, explicit and individual. On this account, it should be difficult to admit that someone agree effectively when he call for the affirmation that he is recipient of medical care. Reasonable expense needs to be a part of review whether the agreement is valid. Meanwhile If we adjust system of medical expense and eventually reorganize a fee for consultation payment system (Fee-for-service controlled by item to DRG (Diagnosis Related Groups)), controversial area of the discretionary not covered service will be decreased and that will guarantee the discretion of the doctor.

• 의료법학
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• 제21권3호
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• pp.77-116
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• 2020

현대 과학의 경험과 성과가 반영된 의약품의 사용으로 인류에게 질병의 치료와 건강 상태의 개선이라는 혜택이 주어지고 있다. 그러나 의약품은 질병의 치료라는 혜택 이외에도 본질적으로 피할 수 없는 부작용도 내포한다. 각국은 부작용으로 인한 피해의 최소화를 위해 시장진입 규제나 시판후조사 등의 조치를 취하고 있으나, 부작용의 발생은 피할 수 없다. 부작용으로 인한 손해의 발생이 불가항력이라도 그 점이 사전에 알려진 것이었다면, 의약품의 종류와 사용 형태에 따라서 처방한 의사나 복약지도를 담당하는 약사 등이 손해를 배상해야 한다. 의약품에 결함이 있어 손해가 발생하는 경우도 있는데, 손해 배상의 일반원칙을 그대로 적용해서는 결함으로 인한 부작용 피해자가 손해를 배상받기 쉽지 않다. 우리나라를 비롯한 여러 나라가 제조물 책임법을 통하여 피해자의 보호를 도모하고 있으며, 의약품도 제조물에 포섭되기 때문에 제조물 책임법을 통한 손해배상을 문의할 수 있는데, 이 때 주로 설계상의 결함이나 표시상의 결함이 문제될 수 있다. 제조물 책임법이 제정·시행되기 이전에도 의약품의 부작용으로 인한 손해는 발생하여왔다. 이러한 경우를 위해서 판례는 제조물 책임법과 유사한 법리를 발전시켜 왔고, 의약품 결함은 혈액제제와 관련하여 판례가 형성되어 왔다. 제조물 책임법 시행 이전에 제조된 의약품으로 인한 손해는 향후에도 발생할 수 있기에 판례 법리는 중요한 검토의 대상이다.

• 의료법학
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• 제15권1호
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• pp.263-302
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• 2014

The court handed down meaningful rulings related to medical sectors in 2013. This paper presents the ruling that the care workers could be the performance assistants of the care-giving service although the duties of care worker are not included in the liability stipulated in the medical contract signed with the hospital for reason of clear distinction of duties between care workers and nurses within the hospital in connection with the contract which was entered into between the hospital and patients. In relation to negligence and causal relationship, the court recognized medical negligence associated with the failure to detect the brain tumor due to the negligent interpretation of MRI findings while rejecting the causal relationship with consequential cerebral hemorrhage. The court also recognized negligence based on the observation on the grounds of inadequate medical records in a case involving the hypoxic brain damage caused during the cosmetic surgery. In terms of the scope of compensation for damages, this paper presents the ruling that the compensation should be estimated based on causal relationship only in case the breach of the 'obligation of explanation' is recognized, however rejecting the reparation for de factor property damages in the form of compensation, and the ruling that the lawsuit could be instituted in case that the damages exceeded the agreed scope despite the agreement that the hospital would not be held responsible for any aftereffects of surgery from the standpoint of lawsuit, along with the ruling that recognized the daily net income by reflecting the unique circumstances faced by individual students of Korean National Police University and artists of Western painting. Many rulings were handed down with respect to medical certificate, prescription, etc., in 2013. This paper introduced the ruling which mentioned the scope of medical certificate, the ruling that related to whether the diagnosis over the phone at the issuance of prescription could constitute the direct diagnosis of patient, along with the ruling that required the medical certificate to be generated in the name of doctor who diagnosed the patients, and the ruling which proclaimed that it would constitute the breach of Medical Act if the prescription was issued to the patients who were not diagnosed. Moreover, this paper also introduced the ruling that related to whether the National Health Insurance Service could make claim to the hospitals for the reimbursement of the health insurance money paid to pharmacies based on the prescription in the event that the hospitals provided prescription of drugs to outpatients in violation of the laws and regulations.