• The Korean Society of Law and Medicine
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• v.21 no.2
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• pp.163-207
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• 2020

Korea has been positioned as the leading country in the industry of clinical trials as the clinical trail of Korea has developed for the recent 10 years. Clinical trial has plays a significant role in the development of medicine and the increase of curability. However, it has inevitable risk as the purpose of the clinical trial is to prove the safety and effectiveness of new drugs. Therefore, the clinical trial should be controlled properly to protect the health of the subjects of clinical trial and to ensure that they exercise a right of self-determination. In this context, the fiduciary duties of doctors who conduct clinical trials is especially important. The Pharmaceutical Affairs Act and the relevant regulations define several duties of doctors who conduct clinical trials. In particular, the duty to protection of subjects and the duty to provide information constitute the main fiduciary duties to the subjects. Those are essentially similar to the fiduciary duties of doctors in usual treatment from the perspective of the values promoted by the law and the content of the law. Nonetheless, clinical trials put more emphasis on the duties to provide explanation than in usual treatment. Further research and study are required to establish the concrete standard for the duty of care. However, if the blind pursuit of higher standards for the duty of care or to pass the burden of proof to doctors may result in disrupting the development of clinical trials, limiting the accessibility of patients to new treatment and even violating the principle of sharing damage equally and properly. In addition to these duties, the laws of clinical trials define several duties of doctors. Any decision on whether the violation of the law constitutes the violation of the fiduciary duty and justifies the demand for compensation of damages should be based on whether relevant law aims to protect the safety and benefit of subjects, even if in an incidental way, the degree to which such violation breaches the values promoted by the law and the concrete of violation of benefit of law, the detailed acts of such violation. The legal interests of the subjects can be protected effectively by guaranteeing compliance with those duties and establishing judicial and administrative controls to ensure that the benefit of subjects are protected properly in individual cases.

• The Korean Society of Law and Medicine
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• v.13 no.1
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• pp.199-247
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• 2012

According to the review and analysis of medical cases that are assigned to the Supreme Court and all local High Court in 2011 and that are presented in the media, it was found that the following categories were taken seriously, medical and pharmaceutical product liability, the third principle of trust between medical institutions, negligence and causation estimation, responsibility limit, the meaning of medical records and related judgment of disturbed substantiation, Oriental doctors' duties to explain the procedures, IMS events, whether one can claim for each medical care operated by non-physician health care institutions to the nonmedical domain in the National Health Insurance Corporation, and the basis of norms for each claim. In the cases related to medical pharmaceutical product liability, Supreme Court alleviated burden of proof for accidents with medical and pharmaceutical products prior to the practice of Product Liability Law and onset the point of negative prescription as the time of damage strikes to condition feasibility of the specific situation. In the cases related to the 3rd principle of trust between medical institutions, the Supreme Court refused to sentence the doctor who has trusted the judgment of the same third-party doctors the violations of the care duty. With respect to proof of a causal relationship and damages in a medical negligence case, the Supreme Court decided that it is unjust to deny negligence by the materials of causal relationship rejecting the original verdict and clarified that the causal relationship shall not deny the reasons to limit doctors' responsibilities. In order not put burden on patients with disadvantages in which medical records and the description of the practice or the most fundamental and important evidence to prove negligence and causation are being neglected, the Supreme Court admitted in the hospital's responsibility for the case of the neonate death of suffocation without properly listed fetal heart rate and uterine contraction monitor. On the other hand, the Seoul Western District Court has admitted alimony for altering and forging medical records. With respect to doctors' obligations to description, the Supreme Court decided that it is necessary to explain the foreseen risks by the combination of oriental and western medicines emphasizing the right of patient's self-determination. However, questions have arisen whether it is realistically feasible or not. In a case of an unlicensed doctor performing intramuscular stimulation treatment (IMS), the Supreme Court put off its decision if it was an unlicensed medical practice as to put limitation of eastern and western medical practices, but it declared that IMS practice was an acupuncture treatment therefore the plaintiff's conduct being an illegal act. In the future, clear judgment on this matter should be made. With respect to the claim of bills from non-physical health care institutions, the Supreme Court decided to void it for the implementation of the arrangement is contrary to the commitments made in the medical law and therefore, it is invalid to claim. In addition, contrast to the private healthcare professionals, who are subject to redemption according to the National Healthcare Insurance Law, the Seoul High Court explicitly confirmed that the non-professionals who receive the tort operating profit must return the unjust enrichment and have the liability for damages. As mentioned above, a relatively wide range of topics were discussed in medical field of 2011. In Korea's health care environment undergoing complex changes day by day, it is expected to see more diverse and in-depth discussions striding out to the development in the field of health care.