제네릭 의약품 약가 조정 고시에 대한 비판적 고찰

박정연,Park, Jeong Yeon 대한의료법학회 2021 의료법학 Vol.22 No.1

2019년 5월 식약처는 원료의약품 등록 및 자체 생동성 시험 요건 충족 여부에 따라 제네릭 의약품의 가격을 차등 산정하는 것을 내용으로 하는 「약제의 결정 및 조정 기준」 고시를 개정하였다. 이는 기허가 제네릭 의약품에 대해서조차 자체 생동성 시험을 시행하지 않는 경우 기존 약가를 인하하는 것으로서 과연 그 입법목적과 수단에 관한 충분한 공법적 고려 하에 도입된 것인가 하는 의문이 든다. 이 글은 실질적으로는 위탁·공동 생동 시험을 제한하고자 자체 생동성 여부를 기준으로 제네릭 의약품의 약가를 결정·조정하는 개정 고시의 배경을 소개한 후 입법목적의 정당성 및 비례원칙의 관점에서 이를 비판적으로 검토하였다. 첫째, 목적의 정당성 측면에서 제네릭 의약품 난립 방지라는 목적이 과연 그 입법목적으로서 정당한 것인지에 대한 검토가 부족하였다는 점을 지적하였다. 둘째, '자체 생동 요건 미충족시 약가 인하'라는 내용의 개정 고시가 적합성 원칙에 부합하려면 위탁·공동 생동으로는 안전성·유효성을 인정하기 어렵다거나 적어도 위탁·공동 생동이 자체 생동에 비해 안전성·유효성 검증에 있어서 불충분하다는 전제가 성립해야 한다. 그럼에도 이에 대한 검토가 이루어지지 않은 것으로 보이는바, 안전성·유효성 확보라는 목적 달성을 위해서는 자체 생동이냐 위탁·공동 생동이냐보다 '생동성 인정 기준 및 생동성 시험자체의 관리 강화'에 초점이 맞추어져야 한다. 셋째, 필요성 및 상당성 판단에 있어서 품목허가 후 상당한 기간이 지나 충분히 안전성·유효성에 대한 검증이 이루어졌다고 볼 수 있는 제품에 대해서까지 일률적으로 개정된 고시 기준을 적용하는 것은 필요성 및 상당성 원칙에 반할 소지가 있다고 판단하였다. 개정 고시와 같은 행정입법은 많은 경우 법리적 검토나 공감대 형성이 부족한 상태에서 제·개정이 이루어지는 반면, 그에 따른 규제 효과는 피규제자에게 상당히 직접적이고 구체적이다. 이러한 점에서 행정입법 과정에 대해서도 규제목적과 수단에 대한 실질적인 검토가 요구되면, 사전통제로서 이해관계인 등의 절차참여제도가 보완되어야 함을 강조하였다. In May 2019, the Ministry of Food and Drug Safety revised the "Pharmaceutical Determination and Adjustment Criteria" with the content of differentially calculating the price of generic drugs according to the registration of the drug substance and meeting the requirements for their own bioequivalence test. According to this revised rule, if their own bioequivalence test is not conducted, even the generic drugs that have already been approved would be lowered in price. I wondered whether this system was introduced with sufficient public legal considerations regarding its legislative purposes and means. Therefore, I reviewed the contents of the revised notice based on whether or not it is valid to determine and adjust the price of generic drugs in terms of the legitimacy of legislative purposes and the proportionality principle after introducing the history and background of the rule. First, I raised a question as to whether the purpose of preventing the overrun of generic drugs is indeed legitimate in terms of the legitimacy of the purpose. In order for the revised notice of "reduction of drug prices when the test requirements are not met," to meet the conformity principle, the premise that it is difficult to recognize safety and effectiveness through consignment (joint) bioequivalence test or that these tests are insufficient in safety and efficacy verification than their own test must be established. Nevertheless, it seems that suffficient review has not been carried out. In order to achieve the purpose of securing safety and effectiveness, the focus should be on 'reinforcement of the standards for bioequivalence test and the management of the bioequivalence test itself' rather than whether it is a their own test or a consignment (joint) test. Third, it is contrary to the necessity and substantiality principle that strict standards are uniformly applied to the products that can be considered to have been sufficiently verified for safety and effectiveness after a considerable period of time has passed after the product approval. In many cases, revised administrative legislations quickly enacted and amended in the state of lack of legal review or consensus, while the regulatory effects resulting from it are quite direct and specific to the regulated person. In this respect, I emphasized that the administrative legislative process also requires substantial review and prior control of the regulatory purposes and means, and that the participation of stakeholders in the legislative procedure is to be strengthened.

동일 유동거리 런너를 가진 LSR 성형품의 변형에 관한 연구

박정연,윤길상,이정원,최종명,Park, Jeong-Yeon,Yoon, Gil-Sang,Lee, Jeong-Won,Choi, Jong Myeong 한국금형공학회 2013 한국금형공학회지 Vol.7 No.1

Recently, Silicone that one of the thermo-sets is used to making optical products such as LED lenses because of excellent thermal properties. LED lenses are required to keep the precise dimensions, so they must be molded to have the minimum deformation. Thermo-sets have the expansion characteristic on the part of thermal property, it is important to optimize the cure condition so that the deformation of the part become minimum. In this study, to investigate the relationship between the shrinkage by the curing and expansion by the thermal properties of the resin, reactive injection experiment was performed by setting the variables such as mold setting temperature, cure time. As a result, it was confirmed that there was a interval while the thermal properties were transferred to more active during the cure process. It is expected to help in determining the reactive injection molding conditions of the thermo-set parts as well as LED lens in order to reduce the amount of deformation.

실리콘 수지 혼합비율에 따른 Pre-form 형광체 막 특성 변화에 관한 연구

박정연,윤길상,진형준,Park, Jeong Yeon,Yoon, Gil Sang,Jin, Hyoung-Joon 한국섬유공학회 2016 한국섬유공학회지 Vol.53 No.1

The effect of the viscosity of phosphor slurry prepared by mixing two types of silicone resins with different viscosities in various ratios on the properties of pre-formed phosphor films was investigated. The pre-formed phosphor films manufactured using these phosphor slurries were evaluated for curing characteristics, breaking strength, shear strength, and optical properties. The test results demonstrated that increasing the amount of high-viscosity silicone resin in the composite resin resulted in decreased curing reaction rate, decreased breaking strength, and correlated color temperature, whereas the viscosity and adhesion strength of the composite resin increased. Among seven different mixing ratios of the low- and high-viscosity silicone resins prepared for the composite resin, white-light emission was realized for the ratio 70:30, and the pre-formed phosphor film with this ratio exhibited high breaking strength and low adhesion strength. The breaking strength thus obtained was 24.0 MPa, the adhesion strength was 0.17 MPa, the color temperature was 5,650 K, and the two chromaticity coordinates (CIE(x, y) (1931)) were (0.3293, 0.3251).

진료비청구 및 심사사례

박정연,Park, Jeong-Yeon 대한병원협회 1998 대한병원협회지 Vol.27 No.6

액체 종류에 따른 식물의 성장 특성 기초 실험

박정연,김정배,Park, Jeong-Yeon,Kim, Jeongbae 한국교통대학교 융복합기술연구소 2014 융ㆍ복합기술연구소 논문집 Vol.4 No.1

This study was experimentally performed to show the growth characteristics of one specified plant with various liquids, which can be purchased easily. To do that, this study measured the number of leaves attached to the plant sample and the height of liquids everyday during almost 15 days on summer season in the laboratory room. From the experiments, we revealed that the remained number of leaves can be related with the liquid height.

혈관모사 마이크로채널이 장착된 3D 종양 세포 배양 시스템의 제작 및 검증 연구

박정연,고범석,김기영,이동목,윤길상,Park, Jeong-Yeon,Koh, Byum-seok,Kim, Ki-Young,Lee, Dong-Mok,Yoon, Gil-Sang 한국금형공학회 2021 한국금형공학회지 Vol.15 No.2

Recently, three-dimensional (3D) cell culture systems, which are superior to conventional two-dimensional (2D) vascular systems that mimic the in vivo environment, are being actively studied to reproduce drug responses and cell differentiation in organisms. Conventional two-dimensional cell culture methods (scaffold-based and non-scaffold-based) have a limited cell growth rate because the culture cannot supply the culture medium as consistently as microvessels. To solve this problem, we would like to propose a 3D culture system with an environment similar to living cells by continuously supplying the culture medium to the bottom of the 3D cell support. The 3D culture system is a structure in which microvascular structures are combined under a scaffold (agar, collagen, etc.) where cells can settle and grow. First, we have manufactured molds for the formation of four types of microvessel-mimicking chips: width / height ①100 ㎛ / 100 ㎛, ②100 ㎛ / 50 ㎛, ③ 150 ㎛ / 100 ㎛, and ④ 200 ㎛ / 100 ㎛. By injection molding, four types of microfluidic chips were made with GPPS (general purpose polystyrene), and a 100㎛-thick PDMS (polydimethylsiloxane) film was attached to the top of each microfluidic chip. As a result of observing the flow of the culture medium in the microchannel, it was confirmed that when the aspect ratio (height/width) of the microchannel is 1.5 or more, the fluid flows from the inlet to the outlet without a backflow phenomenon. In addition, the culture efficiency experiments of colorectal cancer cells (SW490) were performed in a 3D culture system in which PDMS films with different pore diameters (1/25/45 ㎛) were combined on a microfluidic chip. As a result, it was found that the cell growth rate increased up to 1.3 times and the cell death rate decreased by 71% as a result of the 3D culture system having a hole membrane with a diameter of 10 ㎛ or more compared to the conventional commercial. Based on the results of this study, it is possible to expand and build various 3D cell culture systems that can maximize cell culture efficiency by cell type by adjusting the shape of the microchannel, the size of the film hole, and the flow rate of the inlet.

간병비 급여화의 법적 쟁점

박정연(Park Jeong Yeon) 충북대학교 법학연구소 2018 法學硏究 Vol.29 No.1

이 글은 간병비 급여화 정책, 간병과 간호의 규범적 관계에서 비롯되는 입법적고려사항, 노인 간병비 급여화의 문제 및 그와 관련된 법적 쟁점 등에 국한하여 간병비 급여화 문제를 다루었지만, 사실상 의료기관 내 간병서비스 대한 본격적인 급여화는 재정 문제 외에도 너무나 많은 난제들을 안고 있다. 우리나라 현실을 감안할 경우 서비스 제공주체인 간병인력에 대한 제도화가 필요하고, 이를 위해서는 자격제도, 서비스 표준화 등 서비스 질 관리, 간병인력의 근로조건과 처우, 수급 등 다양한 법적 쟁점들이 함께 논의되어야 하기 때문이다. 또한 간호사 수급문제와 업무의 구분58) 및 병상체계에 대한 개편 논의도 함께 다루어질 필요가 있다. 이와 같은 많은 해결과제에도 불구하고 간병이 이제 공적 보장의 대상이 되고 있음은 자명하다. 따라서 정책의 미숙함으로 인한 낭비와 혼란을 막고 현실을 충분히 반영한 합리적인 법제화가 가능하도록 하기 위해서는 간병비 급여화를 위한 현안들을 정리하고 이를 해결하기 위한 단계적 접근방법을 모색해야 할 것이다. Recently, the government has been promoting to pay for care within medical institutions as one of its policies to strengthen health insurance coverage. However, only the practical issues related to the policy direction and funding are discussed with regard to the care benefit, which is represented by the Integrated Nursing and Caring Service, but there has been no full discussion on the various legal issues accompanying the policy. This article examines how care within hospital is handled in the current social insurance system and deals with some legal issues that are accompanied or should be discussed together when paying for care within medical institutions. Firstly, I review the policy and the problems of Integrated Nursing and Caring Service that the government is promoting as a measure to pay for care, and examine the appropriate legislative method for care benefit considering the normative relationship between nursing and care. As another legal issue, the current law lacks measures paying for elderly care or care within Care Hospital. It is necessary for care hospital to restore its medical function for the implementation of the benefit for elderly care, and the introduction of the appropriateness evaluation system for care hospitals is considered as one of such measures. This article examines whether the introduction of such a system is not problematic or not from the point of view of the fundamental rights, and what issues must be addressed together with introduction of such system.

대학 피부미용 전공에서 TBL 수업 개발 연구

박정연(Jeong-Yeon Park),심현애(Hyeon-Ae Sim) 한국엔터테인먼트산업학회 2018 한국엔터테인먼트산업학회 학술대회 논문집 Vol.2018 No.11

초·중·고등학생의 화장 인식과 뷰티관리 행동 연구

박정연(Park, Jeong Yeon) 한국디자인문화학회 2017 한국디자인문화학회지 Vol.23 No.3

최근 청소년들의 외모관심도 증가는 다양한 뷰티행동변화를 가져오게 되었고, 이러한 현상은 초등학생까지 확대되어지고 있는 상황에서 관련 연구가 미흡한 실정이다. 따라서 본 연구는 초·중·고등학생의 화장인식과 뷰티관리 행동을 알아보고, 이에 따른 각 학교급별 올바른 뷰티관리 행동 문화 정착을 위한 교육자료로 제공하고자 시도되었다. 본 연구는 광주광역시 소재 학교의 초·중·고등학생 480명을 대상으로 설문조사 하였으며, 수집된 자료는 데이터 코딩과 데이터 크리닝 과정을 거쳐, SPSS v. 21.0 통계 패키지 프로그램을 활용하여 분석하였고, 그 결과는 다음과 같다. 첫째, 측정도구의 타당성 및 신뢰도는 KMO 값이 0.975로 나타나 요인분석 가정이 충족되었으며, 그 결과 총 3개의 요인이 도출되었고 각 요인을 ‘얼굴뷰티행동’ ‘네일뷰티 행동’ ‘헤어뷰티 행동’으로 명명하였다. 둘째, 초·중·고등학생의 화장행위 인식 중 화장의 기능은 ‘예뻐지고 자신감이 생겨서 자기만족도가 커진다’가 183명(40.0%)으로 가장 높게 나타났고, 인식하고 있는 화장과 피부상태와의 관련성은 ‘피부가 나빠질 것이라고 생각한다’가 218명(47.6%)으로 가장 높게 조사되었다. 바람직하다고 생각하는 학교 내 화장정도는 ‘피부 보호를 위해 약간의 기초화장은 필요하다’가 150명(32.8%)으로 가장 높은 응답을 보였고, 풀메이크업을 한 친구에 대한 인식과 화장을 전혀 하지 않은 구에 대한 인식은 ‘관심이 없다’가 각각 165명(36.0%), 194명(42.4%)으로 가장 높게 나타났다. 또한 각 문항별 인식의 경우 모든 문항에서 학교급에 따라 통계적으로 유의미한 차이가 나타났다(p<.05). 셋째, 초·중·고등학생의 뷰티관리 행동은 ‘얼굴뷰티행동’(M=3.26)이 가장 높게 나타났고, ‘네일뷰티행동’(M=3.05), ‘헤어뷰티행동’(M=2.90) 순으로 나타났다. 학교급에 따라 차이가 있는지를 분석한 결과 고등학교, 중학교, 초등학교 순으로 전반적인 뷰티행동과 하위요인별 헤어뷰티 행동, 얼굴뷰티 행동, 네일뷰티 행동이 높은 것으로 나타났다(p<.001). In recent years, the adolescents’ increasing interest in their appearance has brought various changes in beauty behavior, and this phenomenon has been expanding to elementary school students. However, studies about this phenomenon have been lacking. Therefore, this study aimed to find out children’s and adolescents’ awareness about Makeup Consciousness and their beauty care behavior, and tried to make educational materials for establishing the culture of beauty behavior appropriate for school levels. This study was conducted with 480 elementary, middle and high school students in Gwangju Metropolitan City. The collected data went through data coding and data cleaning, and were analyzed with 21.0 statistical package program. The results are as follows. First, the validity and reliability of the measurement tool was 0.975, and the factor analysis assumptions were satisfied. As a result, a total of 3 factors were derived and the factors were named ‘facial beauty behavior’, ‘nail beauty behavior’ and ‘hair beauty behavior’ respectively. Second, in terms of children’s and adolescents’ awareness about cosmetic behavior, the majority(183 respondents, 40.0%), said ‘to become beautiful, confident and self-satisfied’ was the function of make-up, and 218 respondents(47.6%) said ‘I think my skin condition will get worse’ regarding the relationship between make-up and skin condition. Regarding the level of make-up appropriate for school, 150 students(32.8%) answered ‘a little basic make-up is needed to protect my skin’, and as for the perception of students with full make-up and students without make-up, ‘not interested’ was the most frequent answer, by 165 students(36.0%) and 194 students(42.4%) respectively. As for the awareness about each item, there was a statistically significant difference in every item according to the level of school(p <.05). Third, as for the beauty care behavior of elementary, middle and high school students, ‘facial beauty behavior’ was the highest(M = 3.26), followed by ‘nail beauty behavior’(M = 2.90). As a result of analyzing the differences according to the school level, overall beauty behavior, hair beauty behavior, facial beauty behavior, and nail beauty behavior scored high in the order of high school, middle school and elementary school(p <.001).

피부미용 교육에서 문제중심학습 적용 사례연구

박정연(Park, Jeong Yeon) 한국디자인문화학회 2015 한국디자인문화학회지 Vol.21 No.4

사회의 요구와 교육의 발전으로 주입식 교육에서 벗어남에 따라 교수법에 대한 연구가 확대되고 있으며, 그 일환으로 학습자 중심의 교수학습 방법들이 대학수업에 적용되고 있다. 이 중 널리 활용되고 있는 교수법 중 하나로 문제중심학습(Problem-Based Learning; PBL)을 꼽을 수 있다. 따라서 본 연구는 피부미용 교육에서 PBL 교수법을 적용하여 학습자들이 인식하는 PBL효과를 알아보기 위해 시도되었다. 연구의 대상은 G대학 뷰티미용학과 3학년 피부미용 교과목을 수강하는 26명의 학생으로 하였다. 수업은 이론 및 실기 수업으로 15주에 걸쳐 진행되었으며, 1-11주차 까지는 강의식 수업으로 12-15주차는 PBL 수업방식이 적용되었다. 학생들은 PBL 수업이 이루어지는 동안 매주 성찰일지를 작성했으며, 성찰일지의 내용분석은 질적연구 도구인 NVIVO 10.0을 사용하였고, 그 결과는 다음과 같다. 학생들은 PBL 수업을 통해 학습내용에 대한 이해, 협동학습에 대한 이해, 실제적 경험, 문제해결력, 자아성찰과 같은 PBL학습 효과를 경험한 것으로 나타났다. 분류된 5가지 내용에 대해 성찰일지 작성 회차 별로 학습자들이 인식하는 PBL효과는 1, 2회차에서는 협동학습의 이해가 3회차에서는 문제해결능력이 4회차에서는 실제적 경험에 대한 인식이 가장 높은 빈도수를 보였다. 또한 4회에 걸쳐 작성된 성찰일지에서 PBL 효과 5가지의 총 산출 빈도수 238회에서 실제적 경험 53회, 협동학습의 이해 51회, 문제해결능력 47회, 학습내용의 이해 44회, 자아성찰 43회로 나타나 학습자들은 PBL 교수법을 통해 실제적 경험과 협동학습의 이해에 대한 학습효과를 많이 인식하는 것을 알 수 있었다. As education breaks away from teaching by rote following social demands and the development of education, research into teaching methods is expanding and as a part of that, learner-centered teaching and learning methods are being applied to university classes. Of these, PBL is a teaching method that is widely being used. Therefore, this study applied PBL teaching methods to Esthetic Education and attempted to observe the effectiveness of PBL as perceived by learners. 26 juniors taking a Esthetic class in the Department of Beauty and Cosmetology at G University participated in this study. The class was progressed for 15 weeks, divided into theory and practice, with weeks 1 to 11 being lecture type classes and with the PBL class method being applied to weeks 12 to 15. Students wrote in a Reflective Journal every week during the PBL class course and content analysis of their Reflective Journals was conducted through the qualitative research tool NVIVO 10.0 and the results are as follows. Students experienced the effectiveness of PBL such as learning content comprehension, an understanding of cooperative learning, practical experiences, problem-solving capabilities, and self-examination. Regarding the 5 categories, the effectiveness of PBL as perceived by learners according to entries in Reflective Journals was shown with an understanding of cooperative learning shown in the highest frequencies in the first and second entries, perceptions of problem solving abilities shown most in the third entry, and perceptions of practical experiences shown most in the fourth entry. Also, the 5 different effects of PBL in the four entries of the Reflective Journals appeared a total of 238 times with practical experiences appearing 53 times, an understanding of cooperative learning appearing 51 times, problem solving abilities appearing 47 times, learning content comprehension appearing 44 times, and self-examination appearing 43 times, showing that through PBL teaching methods, learners perceive learning effects regarding practical experiences and an understanding of cooperative learning most.