• 의료법학
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• 제21권2호
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• pp.163-207
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• 2020

우리나라의 임상시험은 최근 10년간 그 규모가 성장하여 임상시험 산업의 주요 국가로 자리매김 하였다. 임상시험은 의료수준의 발전 및 치료 가능성의 확대를 위해 중요한 의미를 지니고 있다. 그러나 임상시험은 의약품 등의 안전성과 유효성을 증명하기 위한 것으로서 본질적으로 위험성을 내포하고 있으므로, 적절히 통제되어야만 임상시험대상자의 건강과 자기결정권이라는 법익을 보호할 수 있다. 이를 위해 임상시험을 수행하는 의사의 선관주의의무 이행이 특히 중요하다. 약사법과 그 하위법령은 시험자인 의사가 준수하여야 할 여러 의무를 규정하고 있다. 이 중 대상자 보호의무와 설명의무는 의사의 임상시험대상자에 대한 주된 선관주의의무를 구성한다. 이는 통상적인 의사의 진료행위에 있어서의 주의의무 및 설명의무와도 본질적으로 그 보호법익과 내용이 유사하다. 임상시험의 경우 통상적인 진료행위의 경우보다 가중된 설명의무가 요구된다. 임상시험에서의 구체적인 주의의무 기준 설정은 향후 판결과 연구를 통해 이루어져야 할 것이나. 주의의무의 기준을 막연히 높이거나 입증책임을 전환하는 등으로 임상시험을 수행하는 의사의 책임을 가중시킬 경우, 자칫 임상시험의 발전 및 환자의 새로운 치료법에 대한 접근성을 저해하고 손해의 공평·타당한 분담이라는 원칙에 위배될 우려가 있다. 이러한 의무들 외에도 임상시험에 대한 법령은 의사에 대해 여러 의무를 규정하고 있는바, 이러한 법령의 위반이 선관주의의무 위반에 해당함으로써 손해배상책임이 인정되는지의 문제는 해당 법령이 부수적으로라도 임상시험대상자의 안전과 이익을 보호하기 위한 것인지 여부, 대상자의 법익 침해의 유무와 정도, 법령위배행위의 태양 등을 종합적으로 고려하여 판단하여야 한다. 이와 같은 여러 의무의 충실한 준수가 이루어지도록 담보하고, 구체적 사안에서 임상시험대상자의 법익이 적절히 보호되었는지에 대해 사법(司法)적, 행정적 통제를 함으로써 법익 보호를 효과적으로 담보할 수 있을 것이다.

• 의료법학
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• 제13권1호
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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.