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.

진료비청구 및 심사사례

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

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.

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.

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).

의료보험(醫療保險) 실시이후(實施以後) 지역주민(地域住民)의 의료기관이용행태(醫療機關利用行態) 변화(變化) 추이(推移)와 그 요인(要因)에 관한 조사연구(調査硏究)

박정연,Park, Jung-Yeon 한국보건간호학회 1989 韓國保健看護學會誌 Vol.3 No.2

The objectives of this study was to analyze the major causes of decreasing utilization rate of health care institutios in pilot-project area of regional medical insurance, Kwang-hwa and Kun-wi country. After the implementation of medical insurance, utilization rate of health institutions turned out' to be lower than it was estimated, when the pilot-project of regional medical insurance was planned. It might be due to changes in inhabitant's behavioral attitude toward medical insurance. So this study was made to find measures for financial stability by increasing utilization rate of health care institutions and to be available for basic demand-supply program of medical care. The hypothesis of this study was as follows; First. there is difference in understanding health care institutions between Kun-wi and Kwang-hwa. Second. respondesnts of inquiry survey have exact knowledge of their past experience of treatment taken prior to enforcement of medical insurance, Questionaire survey was made as to each 700 household among total 11, 884 households in Kun-wi and 20,919 households in Kwang-hwa. In case of Kun-wi, 70% of inquired households (491) gave their answers. In Kwang-hwa, the number was 560 households (80% of inquireds). Dollected data was processed and analyzed by way of using SPSS batch system. To evaluate facto rs distribution aspects of data and to make comparison between two area, percentage and $X^2$ distribution were applied. The results were as follows; L The utilization rate of health care institutions in Kun-wi and Kwang-hwa was lower than it was estimated. when pilot-project of medical insurance was planned. 2. Prior to the implementation of medical insurance. inhabitants in two area chose the medical institutions considering such factors. First was medical care fee cheap. second in habitant's residence, Third was the institutions conveniently easy of access. 3. After the implementation of medical insurance. 26.1% of inqurieds in Kun-wi and 41.6% in Kwang-hwa, changed medical institutions. In case of Kwn-wi, from health care institution (p 0.05), and in case of Kwang-hwa, vice versa, from general medical institutions to health care institutions. 4. Evaluation by factors were made such as follows. Inquired gave high marks to following facts: In case of Kun-wi, general medical institutions were difficult of access and relation between patients: was not friendly, but burden of medical expenditure was light. Effects of treatment and facilities was good. In case of Kwang-hwa, inquired gave high evaluation marks to the follow ing facts; facilities of medical institutions was not good, but the burden of medical expenditure was light. 5. After the implementation of medical insurance, the services was evaluated as good, but inquired hopec for lessening the burden of medical expenditure. 6. In case of exact understanding of cost-sharing, the evaluation rate in Kwang-hwa was higher than that of Kun-wi (p < 0.005). And positive attitude toward necessity of medical insurance was also good in Kwang-hwa (p < 0.05). 7. In case of inquired's attitude toward medical institutions, Kwang-hwa showed positive response (p < 0.05) 8. In the case of comparison between general medical institution and health care institution, two area showed similar positive response; medical manpower, facilities of medical institutions and effest: of treatement was good. 9. In comprehensive evaluation of benefit-service; the general medical institution's positiveness was higher than that of health care institutions in Kun-wi. But in Kwang-hwa vice-versa. 10. If the medical expenditure of general medical institution and health care institutions was equal 77% of inquireds in Kun-wi and 59.1% in Kwang-hwa answered that they chose general medical insurance. Considering results above mentioned, the conclusion of this study was made as follows. 1. In Kwang-hwa county, where the understanding of health care institutions's was good, the utilization's of h

87년 민주화 이후 역대 정부의 사회복지정책과 사회권 : 사회복지 국정목표 및 방향에 관한 내용 연구

박정연 ( Park Jeong Yeun ) 민주사회정책연구원 2017 민주사회와 정책연구 Vol.32 No.-

이 연구는 마셜의 시민권의 구성요소로서 주창한 사회권이 1987년 정치적 민주화이후 역대 정부의 사회복지정책 국정목표와 기본방향에서 어떻게 실현, 확장되고 있는지 살펴보는 것을 목적으로 한다. 사회복지정책 관련 국정보고서, 국정간행물, 신문, 통계자료, 연구논문 등의 문헌연구 중심의 사례연구를 하였다. 민주화 이후 사회권의 대두와 함께 사회복지정책의 발전은 민주주의 하에 외형적으로나 가시적으로 사회권이 확장되고 있는 것처럼 보인다. 취임사로 시작하는 국가정책의 기조는 특성상 미사여구(레토닉)적일 수밖에 없고, 정책의 차이가 드러나지 않기 때문이다. 사회복지정책 국정목표와 방향에 대해 「생산적 복지와 사회권」, 「재정부담 주체로서 국가책임과 사회권」, 「권리부여와 사회권」 등으로 분석하였다. 구체화된 국정목표와 방향에서 사회권의 실현정도는 대통령의 지향이나 정부의 성격에 따라 진일보한 측면과 후퇴 모두 선별적 방식으로 나타나고 있다. 이후 새 정부는 점점 심화되고 있는 사회위험에 대비, 사회권 보장을 정부 출범 시부터 국정목표로서, 국가의 책임으로 구체화시켜야 한다. 민주주의의 발전이 사회권을 발달시키며, 역으로 사회권의 확장이 실질적 민주주의를 가능하게 하기 때문에, 이후 실질적인 민주주의를 발전시키는 것이 사회권 확보에 있어서 중요하다. 사회권이 확보된 사회복지정책은 보편적 복지국가로의 안정적경로를 제공할 것이다. This article has an aim to survey and confirm how to be realized and extended the people`s social right in the part of the goal of all former governments ever since the political democratization in 1987, related with Marshall`s social right theory. The case study was carried out with documents such as the social welfare policy report, national government publications, newspapers, statistical data, and research papers. It seems to be true that the social right is to be extended visibly and in appearance under the democracy with its strong needs. Because the address of the president could be just the rhetoric and the policies have no difference. This study analysed the social right about the government aims and directions of social welfare policy related with the 3 elements : Productive welfare, responsibility of states as the finance burden agent, and grant of right. The degree of social right realization under the specific government aims and directions has been developped or reduced according to the color of president or government, but they were all appeared in selective way. Therefore, new government must state the social right from its beginning on the government aim as the responsibility of states, to prevent the growing social danger. As the better democracy makes the better social right, and vice versa, it is important to develop the essential democracy to secure social right. The social welfare policy with the guaranteed social right will provide the stable way toward the universal social welfare state.

마이크로 핫엠보싱 공정 시 패턴크기에 따른 PS 필름의 변형특성 비교

박정연(J.Y. Park),손정언(J.E. Son),윤길상(G. S. Yoon) 한국소성가공학회 2020 한국소성가공학회 학술대회 논문집 Vol.2020 No.6

아로마테라피가 스트레스에 미치는 영향에 대한 메타분석

박정연(Jeong Yeon Park),박채영(Chae Young Park) 한국인체미용예술학회 2017 한국인체미용예술학회지 Vol.18 No.3

This study is intended to look into the effects of aromatherapy on stress. To achieve this, it collected at the effects of aromatherapy about stress based on the several accumulating quantitative and qualitative research related to verifying the effectiveness of aromatherapy, and that applied a meta-analysis to calculate the analysis results. The focus of this study was master s and doctoral papers released in Korea from 2004 to 2015. Of these papers, there was a final selection of 12 papers that had identified the effects of stress by conducting experimental aromatherapy treatments with an experimental group and a control group, and had clearly specified statistical figures (mean, standard deviation) for calculating the effect size. Though different results among these studies were produced, the statistical methods of meta analysis, which can indicate the integrated results of high statistical power without being biased toward the results of only some studies, were used to examine the collected data. The effect size and the integrated effect size of individual research for the finally selected 12 papers by dependent variables showed that there were 8 papers concerning stress, 5 concerning psychological stress, 5 concerning physical stress, and 3 about state anxiety. In addition, a meta analysis showed that aromatherapy had significant effects for the management of psychological stress, physical stress, and state anxiety. This suggests that the prevention of various stress diseases and the reduction of stress in everyday life must find ways to use aromatherapy as management therapy. The various programs look likely to be used in the esthetic field by integrating aromatherapy and massage with modern individuals who prefer naturopathy due to side effects of drug toxicity in terms of cosmetology.