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엄석기,Eom, Seok-Ki 대한예방한의학회 2014 대한예방한의학회지 Vol.18 No.1
Objective : The purpose of this study was to lay the groundwork for understanding the details and scope of the legal definition of medicinal products, following the changes in the relevant laws and regulations. This will let readers properly understand the origins of the ongoing conflicts on herbal drugs and new drugs from natural products that are present in the medical field and the medical industry. Possible solutions are proposed in the end. Method : I analyzed the changes in definition of medicinal products since 1945 that have been used in relevant laws and regulations(i.e. Pharmaceutical Affairs Act) and drug approval process(i.e. New Drug Application and Investigational New Drug Application). Results : Legal definition of medicinal products has changed in accordance with the changes in the pharmaceutical industry, such as the establishment of dualistic medical and pharmaceutical System and the introduction of the substance patent. Due to those changes, boundaries of Western medicinal products and health food expanded, while those of herbal medicine products relatively downscaled. Conclusion : Legal definition of medicinal products-i.e. Herbal Drugs, Crude Drugs, and New Drugs from Natural Products-should be reestablished according to academic legitimacy and dualistic medical and pharmaceutical System.
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한의사·한약사 임무 및 공공제도 중심의 의약법규 제·개정 고찰
엄석기,신민섭,권순조 한국의사학회 2013 한국의사학회지 Vol.26 No.2
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.
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논문(論文) : 한약제제,생약제제,천연물신약 등의 법규상 개념 정의의 문제점과 개선안
엄석기 ( Seok Ki Eom ) 대한한의학원전학회(구 대한원전의사학회) 2014 대한한의학원전학회지 Vol.27 No.4
Objectives : This study was to analyze definitions of herbal medicinal preparations, crude drug preparations, and new drugs from natural products in the relevant laws and regulations, understand the related problems, and propose directions for improvement. Methods : I analyzed the legal definitions in respect of herbal medicinal preparations, crude drug preparations, and new drugs from natural products in relevant laws and regulations since 1945, explained the problems, and suggested the solution-considering the academic stance of Traditional Korean Medicine and the dualistic medical and pharmaceutical system. Results : Regarding the current laws and regulations that are relevant to herbal medicinal preparations, we should 1) clarify the boundaries between the duty of physicians and that of pharmacists, 2) limit the principles of Korean Medicine as well as the contents of the related textbooks, 3) find a way to protect the intellectual property rights for herbal medicinal preparations, and 4) establish a separate standard for drug classification regarding herbal medicinal preparations. In case of crude drug preparations, we should 1) clarify the meaning and limitations of the phrase, "the point of view of Western medicine," and 2) establish a classification standard for drugs that are used in Korean Medicine and clarify the boundaries between herbal drug preparations and crude drug preparations. Furthermore, laws and regulations apropos of new drugs from natural products do not actually fit the concept of "new drug," and due to subordinate laws, a supplement to a new drug submission is contradictorily misclassified as a new drug from natural products. Conclusions : The problems of legal definitions of herbal medicinal preparations, crude drug preparations, and new drugs from natural products have emerged in the process of giving approval to drugs that are made of herbs and natural products under the dualistic medical and pharmaceutical System. Laws and regulations that differentiate the process of approving herbs that are used in Korean Medicine and the others should be established.
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엄석기(Seok Ki Eom) 한국의사학회 2014 한국의사학회지 Vol.27 No.2
Objectives : The purpose of this study was to analyze and identify the problems of the changes in regulations that are relevant to approval, notification, and review of herbal medicinal preparations and crude drug preparations. Methods : I collected the regulations of approval, notification, and review of medicinal products mostly from official gazettes, analyzed enactment and amendments regarding herbal medicinal preparations and crude drug preparations, and studied it from the view point of Korean medicine field. Results : Regulations in regards to approval, notification, and review of herbal medicinal preparations and crude drug preparations were first established in 1978. Herbal drugs started to be categorized as crude drug preparations in 1981 and the regulatory outlines were completed in 1999. From 2008 to 2012, the regulatory standards that let crude drug preparations be new drugs from natural products were established. Through those procedures, the followings became crude drug preparations: 1) wholly new prescriptions that are not recorded in Korean Medical Classics, 2) prescriptions that are recorded in Korean Medical classics but prepared with new standard, composition and efficacy, 3) prescriptions that are recorded in Korean Medical classics but prepared with new formulation, and 4) herbal drugs. In case of herbal medicinal preparations, however, only regulations that are related to 1) drugs prepared with new compositions that are not recorded in Korean Medical Classics, 2) drugs with same prescription and same formulation, and 3) drugs with new formulation were arranged. Conclusions : Actual circumstances on crude drug-oriented regulations regarding approval, notification and review and future forms of prescription and drug administration in Korean Medical Institutions can be expected due to expansion in range of herbal medicinal preparations and shrink in that of on-site preparations. Reasonable improvement in efficient usage of modernized herbal medicinal preparations in Korean medical institutions and prospective cooperation from related pharmaceutical industry are needed.
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한약, 한약재, 생약과 천연물의 법규상 개념 및 정의의 문제점과 개선안
엄석기 ( Seok Ki Eom ) 대한한의학원전학회(구 대한원전의사학회) 2014 대한한의학원전학회지 Vol.27 No.2
Objectives : This study was to analyze the definitions of herbs, herbal drugs, crude drugs and natural products in the relevant laws and regulations, understand the related problems, and propose directions for improvement. Methods : I analyzed the legal definitions in respect of herbs, herbal drugs, crude drugs and natural products in relevant laws and regulations since 1945, explained the problems, and suggested the solution-considering the academic stance of Traditional Korean Medicine and the dualistic medical and pharmaceutical system. Results : Herbs are defined as “refined things that are cut and dried in their most original state.” The definition of crude drugs includes herbs and the “cell contents, secretion, extracts, minerals and other parts of animals and plants that are used medicinally.” The concept of natural products is expanded to adding tissue cultures to the definition of crude drugs. Conclusions : The definition of herbs should at least include all products that are “processed, extracted and prepared” as well as contents that consist of various forms of hospital-prepared herbs. The term “herbal drug” corresponds to a traditional term of “drug,” and this should be established as a concept to explain “drugs in raw materials that are used to prepare herbs and/or manufacture herbal medicine.” The legal definition of herbs should include the concept of crude drugs. Herbal drug preparations and crude drugs should be included in the definition of herbal drugs
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엄석기(Seok Ki Eom),김세현(Se Hyun Kim) 한국의사학회 2015 한국의사학회지 Vol.28 No.1
Objectives : The purpose of this study is to analyze and identify the problems of current laws and regulations regarding preparation and processing of herbal medicines at hospitals of Korean Medicine. Possible solutions are proposed in the end Methods : Based on the status of hospitals of Korean Medicine and characteristics of Korean Medicine and Korean Medicine industry, I analyze the laws and regulations in regards to preparation and processing of herbal medicines and propose possible solutions. Results : Regulations for the agents, places, and cautions in respect of preparation and processing of herbal medicines are inadequate. Meanwhile, the definition of drug preparation in the Pharmaceutical Affairs Act does not apply to processing and preparation of herbal Medicines at hospitals of Korean Medicine, since herbal medicines accompanies chemical and physical change. Discussions & Conclusions : New regulations for on-site preparation at hospitals of Korean Medicine are necessary. Also, the definition for herbal medicines preparation, which states possible chemical and physical changes of herbal medicines, should be specified in Pharmaceutical Affairs Act.
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