• 한국병원경영학회지
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• 제1권1호
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• pp.56-82
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• 1996

The objectives of this research are (i) to review the legal nature of medicine & medical affairs law, (ii) to identify legal defects in terms of the adequacy and feasibility of its provisions and in terms of the structural order among related laws and acts, and (iii) to find out a rational way for revision of the law. Major findings of this research are as follows: 1) The main defects of the Medicine & Medical Affairs Law of Korea are shortcomings of provisions necessary for securing people's right as well as medical practitioner's responsibility and in adequacy to its post as a mother-law in medical fields. 2) Some provisions of the law are inconsistent with other laws and acts, especially with Health Insurance Law. 3) Medicine & Medical Affairs Law of Korea is required to be totally revised in order to keep up with situational changes and to function as a mother-law in its field. On the basis of these findings this study suggests that all the concerned parties would cooperate to renew the law into very sound feature of the mother-law in health field.

• 의료법학
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• 제15권1호
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• pp.59-80
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• 2014

The Medical Affairs Law regulates that Medical Doctor and Korean Medical Doctor(KMD) can practice in the boundary of each licence. But there is no clear provision to explain what practice in the boundary of MD's permitted region and what is KMD's. Moreover practice over the boundary of licence could be punished as a violation of the Law. KMD's use of medical devices have been objects of legal conflicts in the field. Because there is no clear provision in the Law, judical precedents have played the role as practical and final regulations. In this study, analyses on some judical precedents could show some rationales whether an issued KMD's use of medical devices is in the boundary of license. The courts considered the theories based on the practice, the level of required specialty and education, and the probability of danger to a patient. The judical precedents should be reviewed more precisely in the respects that it is adaptable in "the written law system"and it is desirable to divide boundaries between MD's and KMD's.

• 의료법학
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• 제24권3호
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• pp.3-26
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• 2023

의료인이 환자에게 직접 조제한다는 이유로 의약품공급자로부터 의약품을 취득하여 보관하고 있다가 스스로에게 투약한 경우의 약사법상 쟁점을 검토하였다. 의료인이 자가 투약 행위를 한 경우 의약품공급자나 의료인이 약사법에 따라 형사처벌될 수 있다. 그 가벌성은 약사법에서 규정한 의약품 유통 질서 훼손에 있다. 첫째, 의약품공급자가 의료인에게 의약품을 판매하는 것은 약사법 제47조 제1항 제1호 나목 위반죄의 구성요건에 해당한다. 다만, 약사법상 허용되는 직접 조제를 위해 판매한 경우 형법상 정당행위에 해당하여 위법성이 조각된다. 그러나 의약품공급자가 의료인의 자가 투약 목적을 알면서도 의약품을 판매한다면 위법성이 조각되지 않아서 형사처벌될 수 있다. 둘째, 의료인이 약사법상 직접 조제를 위하여 의약품을 취득한다고 명시적, 묵시적으로 의약품공급자를 기망하고 의약품을 취득하여 자가 투약한 경우, 기망에 의한 의약품 교부로 의료인에게 형법상 사기죄가 성립할 수 있다. 셋째, 의료인의 자가 투약 시 약사법상 조제 행위가 수반되므로 약사법 제23조 제1항 위반죄의 구성요건에 해당한다. 이때 위법성이 조각되지 않는다. 왜냐하면 의료인의 자가 투약 행위는 약사법에서 의료인에게 부여한 특별한 지위를 남용한 것으로 의약품 유통 질서를 해치고 의약분업의 취지를 훼손하는 것이어서 형법상 정당행위로 볼 수 없기 때문이다.

• 한국의사학회지
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• 제26권2호
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• pp.175-185
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• 2013

Purpose : The current Medical Law and the Pharmaceutical Affairs Act, which are incapable of utilizing the research results and the advanced academic, clinical, and pharmaceutical system of the present-day Korean (Oriental) medicine, have limitations and create a paradox by provoking social conflict among the professionals in the field. The aim of this study was to find out the legal and systematic problems that contributed to a complicated conflict amongst Korean (Oriental) medicine doctors, doctors, pharmacists, and Korean (Oriental) pharmacists regarding the classification of their functions. Methods : We reviewed the history and characteristics of the legislation regarding the duties of Korean (Oriental) medicine doctors and Korean (Oriental) pharmacists as well as the relevant and important public health policies since the enactment of the National Medical Services Law in 1951. We focused on the laws and regulations that are made in the process of the separating functions of physicians and pharmacists and the dispute between the Korean (Oriental) medicine doctors and the Korean (Oriental) pharmacists in the 1990s and 2000s. Results : The legislations and amendments of the medical and pharmaceutical laws and regulations that reflect the modern academic, clinical, and pharmaceutical system of the Korean (Oriental) medicine and the research results could be summarized as follows: 1) A partial amendment of the Medical Law in 1987, which added the provision of "Oriental health guidance" as one of the duties of Korean (Oriental) medicine doctors, assured a place for Korean (Oriental) medicine doctors in the field of public health. 2) A partial revision of Pharmaceutical Affairs Act in 1994 established a new system for Korean (Oriental) pharmacists, bringing about the creation of dualistic pharmaceutical system that complements the dualistic medical system. 3) The Promotion of the Research and Development of Wonder Drugs by Using Natural Substances Act was legislated in 2000 in order to stimulate research and development of Korean (Oriental) medicine and its industrialization. 4) Oriental Medicine Promotion Act in 2003 was enacted to lay foundation to specify and promote technology and industry that are related to Korean (Oriental) medicine. Discussions and conclusions : Although the dualistic medical and pharmaceutical system is set up by the Medical Law and Pharmaceutical Affairs Act, it is shown that the relevant regulations have been developed from a perspective of the western medicine.

• 보건행정학회지
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• 제28권3호
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• pp.217-221
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• 2018

Korea Institute for Family Planning (KIFP) was established on July 1, 1971 (Law 2270) and Korea Health Development Institute (KHDI) was established on April 19, 1976 (Law 2857). Korea Institute for Population and Health (KIPH) was formed through the merger of KIFP and KHDI (Act 3417) on July 1, 1981. Korea Institute for Health and Social Affairs (KIHASA), the former KIPH, was renamed KIHASA on December 30, 1989 (Law 4181) with its additional function of research in social security. It was transferred on January 29, 1999 to the Office of State Affairs Coordination pursuant to the Law on the Establishment, Operation and Promotion of State-Sponsored Organizations (Law 5733). Annually it conducts approximately 50 short- and long-term research projects to accumulate a wide range of research experience. Also it studies and evaluates the primary issues of national health services, health and medical industries, social insurance, social security, family welfare, and population. it conducts joint research projects and active information exchange programs with related domestic and international organizations through seminars and conferences. It executes specific research and development projects according to the government's requests. it educates and trains people domestically and abroad by disseminating a wide-range of information on health and social affairs. it conducts national household surveys on areas of fertility, health and medical care of the disabled, the elderly, and low-income earners. The mid- and long-term research goals of KIHASA should be established and managed systematically. A new organization such as 'Center for Policy Evaluation' is needed to enhance research abilities and experiences. Able research personnels should be recruited and current researchers should try to develop their abilities.

• 의료법학
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• 제15권2호
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• pp.31-60
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• 2014

In this paper the good Samaritan civil liability is argued. In many cases some damage could be caused by an emergency medical service. In such situations the degree of duty of care taken by the service provider would be alleviated depending upon the degree of emergency. Then the service provided by anyone not carrying any duty to do so could be generally ruled by the 'Korean Civil Act' Article 735. This article is related to the management of affairs in urgency. The application of this article means the mitigation of civil liability of the service provider. If the service provider not carrying any duty to provide it "has managed the affairs" of the service "in order to protect the" victim "against an imminent danger to the latter's life", the provider "shall not be liable for any damages caused thereby, unless he acted intentionally or with gross negligence". Korea has another rule applied in such a situation, that is the Korean 'Emergency Medical Service Act' Article 5-2. This article is established for the exemption from responsibility for well-intentioned emergency medical service. It could be referred to as the Good Samaritan law. It provides: "In cases where no intention or gross negligence is committed on the property damage and death or injury caused by giving any emergency medical service or first-aid treatment falling under any of the following subparagraphs to an emergency patient whose life is in jeopardy, the relevant actor shall not take the civil liability ${\cdots}$" In this paper the two articles is compared in the viewpoints of the requirements for and effects of the application of them respectively. The 'Korean Civil Act' Article 735 is relatively general rule against the the Korean 'Emergency Medical Service Act' Article 5-2 in the same circumstance. Therefore the former could be resorted to only if any situation could not satisfy the requisites for the application of the latter. In this paper it has suggested that the former article be more specific for the accuracy of making decision to apply it; and that the latter be revise in some requirements including the victim, the service provider, and the service.

• 의료법학
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• 제17권2호
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• pp.125-144
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• 2016

모든 형태의 임상시험은 시험 자체가 불확실하며, 리스크가 다양하므로 피험자를 보호하기 위한 제도가 완비되어 있어야 한다. 그럼에도 불구하고 현행 임상시험에 관한 법률은 약사법과 의료기기법에서 일정한 규정을 두고 있으나 이는 '의약행정'을 원활하게 수행하기 위한 법목적에 비추어 피험자 보호에는 일정한 한계가 있다. 더 나아가 미성년 피험자를 대상으로 하는 임상시험은 약사법 등에서 직접적인 규정을 두지 않고, '소아를 대상으로 하는 임상시험 평가 가이드라인'이나 '의약품임상시험관리기준' 등에서 일정 부분 규율하고 있으나 이는 법적 효력이 없는 권고사항이라는 점에서 일정한 한계가 있다. 미성년자 대상 임상시험에 대한 법흠결 문제는 인체침습의 정도 면에서 통상적인 의료행위의 경우보다 강한 장기이식법상의 미성년자 취급제도와 기타 외국법상의 미성년자 임상시험 제도를 검토함으로서 입법적 해결이 가능하다고 할 것이다. 그러나 근본적으로는 현행법 체계상 약사법, 의료기기법 기타 가이드라인을 중심으로 이루어지고 있는 임상시험 규율체계를 이른바 "피험자보호법"이라는 법률제정을 통해 해결하는 것이 바람직하다고 본다.

• 의료법학
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• 제10권2호
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• pp.203-249
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• 2009

It is the so-called Shinchon Severance Hospital Case brought to an end by the decision of the Supreme Court that opened the real discourse of withholding or withdrawing of LST (Life-Sustaining Treatment) in the legal profession as well as medical profession in Korea. Everyone has sympathy with the validity and necessity of legal regulation on withdrawing-including withholding-of LST save the requirements & procedure of withdrawing of LST. In this situation, the legislative bill of amendment to the Korean Civil Law introducing of adult guardianship was pre-announced by the Ministry of Justice on September 18th 2009. The adult guardianship is a guardianship system that supports an mentally handicapped adult to deal with his affairs by support of a guardian. The object of adult guardianship includes affairs of body or well-being as well as property of adult wards. In particular, affairs of medical matters are of importance in the duty and authority of adult guardians. So, the introduction of adult guardianship is of much importance de lege lata as well as de lege ferena in the discussion of withdrawing of LST as a medical treatment. Since the legislation on withdrawing of LST intents to protect the right of death with dignity on the basis of patients' autonomy, the ratio legis of withdrawing of LST is variant from that of adult guardianship. In this context, it seems reasonable to legislate the withdrawing of LST separately from the adultguardianship. In the meantime, the adult guardianship of the legislative bill of amendment to the Korean Civil Law is related to the withdrawing of LST, since the main purpose of adult guardianship is to protect patients' quality of lives and to regulate guardianship contracts based on patients' autonomy. In that context, it seems reasonable to incorporate the legislation of withdrawing of LST into the adult guardianship system. In the latter case, it is not easy to adopt the withdrawing of LST into the legislative bill of the Korean Civil Law for the bill is pre-announced already as previously stated. However, the legislation of withdrawing of LST is not inferior to the legislation of adult guardianship as a matter of urgency. Moreover, it is likely that the legislative bill of Amendment to the Korean Civil Law generates discrepancies in interpretation of the requirements & procedure of withdrawing of LST as the amended German Civil Law did. In short, it is desirable for the legislator to revise the legislative bill despite delay.

• 보건행정학회지
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• 제11권1호
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• pp.87-106
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• 2001

There has been a series of struggles around the governmental enforcing separation of prescribing and dispensing since the consensus for the policy at May 10, 1995, and the strike among the physicians nationwide at June 19, 2000. This thesis is to review the process of the affair as a whole and find out some achievements and lessons from it. Most visible achievement is that physicians have obtained governmental apology for the enforcing the unprepared policy, and promise to revise the Law on the Pharmaceutical Affairs, to enlarge governmental support for the medical insurance program, to construct a presidential committee for the reformation of medical affairs, and so on. Besides these achievements, physicians have learned much on the relations among them and with society in general. However this is only the first scene on the road to an extensive transformation in the medical area following more critical Issues on the medical reformation.

• 의료법학
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• 제9권2호
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• pp.53-75
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• 2008

The end of life problem in the United States has been evolved from the development of concept of brain death over last 50 yr. The invention of ventilator and the development of emergency medicine also played a key role to elongate the end stage of life and which caused the American people to ask a question about the patients self determination and refusing the unwarranted medical treatment in the view of the death with dignity. With regard to the patient unable to self determination, surrogate decision was also considered. To guarantee the self determination, The patient self determination act also enacted on the level of Federal regulation in 1990s. But no law has effectively dealt with the situation when medical treatment became futile. Along with the significant debates on literature and court cases. The American Medical Association's Council on Medical and Judical Affairs presented formal opinion and the Texas was the first states to regulate the medical futile situation in 1999. Even though that definition was in controversy, the concept of medical futility mainly focused on the doctors' right to refuse the treatment.