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The Meaning and the Legislative Suggestion about Data Manipulation of Pharmaceutical Companies in the Aspect of the Medicine Approval System (의약품 품목허가 제도에서 제약기업 자료조작의 의미와 입법 개선 방안-대법원 2008. 11. 13. 선고 2008두8628 판결을 중심으로-)

  • Park, Sungmin;Shin, Youngkee
    • The Korean Society of Law and Medicine
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    • v.22 no.4
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    • pp.59-88
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    • 2021
  • The National Assembly of the Republic of Korea recently enacted laws to fortify sanctions about data manipulation of pharmaceutical companies. The medicine approval system is the result of legislative efforts to prevent accidents that caused damages to patients' life and health. The medicine approval system is based on the trust that the data submitted by pharmaceutical companies is not manipulated. The Supreme Court of Korea clarified that strict standard shoud be required to secure the medicine safety in Supreme Court Decision 2008Du8628 decided November 13, 2008. We agree. This paper suggest legislation to weaken the economic incentives for pharmaceutical companies to choose data manipulation by minimizing the expected profit. In addition to revoking the marketing authorization of the medicine, the 'unfair' profits the pharmaceutical company has earned must be recovered. In addition, in order to increase the possibility to discover data manipulation, it is necessary to strengthen the review capacity and to activate the whistle-blowing.

A Study about the Legal Nature of Negotiations between NHIS and Pharmaceutical Company (국민건강보험공단과 제약사 간 의약품 관련 협상 행위의 법적 성격에 관한 고찰)

  • DUCKGYU JANG
    • The Korean Society of Law and Medicine
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    • v.23 no.4
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    • pp.3-28
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    • 2022
  • Recently, the targets and clauses of negotiation between 'National Health Insurance Service (NHIS)' and Pharmaceutical companies has been expanded. Due to newly adopted 'Quality management clause', 'Compulsory supply maintenance clause' and 'Penalty for breach of contract clause', not only 'Ministry of Health and Wellfare (MOHW)'s 'drug listing' and 'Price cap' announcement, but also 'negotiation between NHIS and pharmaceutical companies' can be a legal sanction to the suppliers. Once secretary of MOHW order NHIS to negotiate with pharmaceutical company, NHIS notify this order to the company and enter into the negotiation. 'The order' exists in the public domain between the government (MOHW) and public institutions (NHIS) and does not constrain the legal rights of companies (Therefore companies cannot pile a lawsuit about the order). However, 'the notice' or 'negotiation' is an act which has a counterpart, can be a target of administrative litigation if the company get some disadvantages from the talks. Negotiations can be divided into four types according to "the target (whether it is listed on the insurance benefit list)" and "the purpose (whether the target is price or conditional)." In particular, negotiations on listed drugs, whose goal is to set unfavorable conditions for companies, can be illegal if there is no price. So we need to consider compensation for the company as an incentive to negotiate.

Comparative Study on the Aviation Monetary Penalty in Korea and the United States (한·미 항공 과징금 제도의 비교)

  • Lee, Chang-Jae
    • The Korean Journal of Air & Space Law and Policy
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    • v.35 no.2
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    • pp.41-74
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    • 2020
  • The monetary penalties system inherently has efficiency as DNA. In the event that administrative measures to recover unfair profits from businesses that violate the law, deprive business licenses, or order to suspend business, infringe the interests of ordinary consumers, a system that can achieve the same effect through financial sanctions. It is a monetary penalties. In addition, it is convenient for the government because it takes effect only by the administrative agency's unilateral imposition order compared to the trial process, which takes a long time and huge cost to prove the illegality. However, it is questionable whether procedural legitimacy is well established in Korea's aviation monetary penalties. Compared to foreign legislation, Korea's aviation monetary penalties system need to be improved. This paper was for the purpose of studying the improvement direction of the monetary penalties system disposed of in the Korean aviation field. This study suggests the direction by examining the US system, which is an aviation advanced country, in the aviation safety area. The research was conducted with the intention of exploring the direction as follows: First, the characteristics of the Federal Aviation Administration (FAA) aviation administrative sanctions and the US aviation penalty system will be outlined. Furthermore, with the recent paradigm shift in aviation safety management, this paper tried to look at new trends that focus on autonomous reporting of aviation safety as a proactive and preventive measure in conventional post-airline accident management administration, focusing on various systems including ASAP. This article also reviewed the formal process for imposing monetary penalties adopted by the FAA. Based on the above review, this paper also looked at ways to improve the reporting system for aviation safety in Korea.

Development of Parking Space Forecast Model for Large Traffic-inducing Facilities Considering Surrounding Circumstance (주변 환경을 고려한 대규모 교통유발시설 주차면산정 모형개발에 관한 연구 - 판매시설을 중심으로 -)

  • Park, Je jin;Oh, Seok Jin;Kim, Sung Hun;Ha, Tae Jun
    • KSCE Journal of Civil and Environmental Engineering Research
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    • v.37 no.3
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    • pp.593-601
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    • 2017
  • With the rapid industrial development and national economic advance since 1970, the national income of Korea has sharply increased. As a result, issues regarding city expansion, urban concentration, increase in the number of registered motor vehicles, and increase in traffic have caused transportation issues such as traffic congestion and problems with parking. Especially, enforcement ordinances and rules have been established on installation and management of parking lots to solve problems with parking which are raised as social problems such as conflict with neighbors but the flexible calculation of legal parking space has the limitations because of the diversity and complex functionality of purposes of facilities. Accordingly, this study attempted to supplement such demerit of the parking space demand forecast method based on the legally required number of parking spaces and average unit requirement in the parking space supply. This study estimated the required number of parking spaces by analyzing existing literature, collecting field research data, and analyzing the factors that have an impact on the parking demand. Also, it compared the required number of parking spaces based on the average unit requirement as well as the required number of parking spaces by the forecast model based on the cumulative number of motor vehicles parked. The result was that the required number of parking space based on average unit requirement was less than the cumulative number of motor vehicles parked by 9.99%. Meanwhile, the required number of parking spaces by the forecast model was more than the cumulative number of motor vehicles parked by 4.37%. Therefore, it is believed that the parking space forecast model is more efficient than the others in estimating there quired parking space. The parking space forecast model of this study consider different environmental factors to enable practical parking demand forecast considering the local characteristics and thus supply the parking space in an efficient way.

A Study on the Shinmoongo System: Issues of the Origin and Changes of Function and Institution (신문고 제도에 대한 몇 가지 쟁점: 기원과 운영, 기능.제도의 변천을 중심으로)

  • Kim, Young-Ju
    • Korean journal of communication and information
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    • v.39
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    • pp.250-283
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    • 2007
  • The Shinmoongo (Shinmoon-drum) system is known as the last means of petition, appeal, and, denunciation during the Chosun dynasty. The purpose of this study is first to examine the system's origin and changes of its function and operation. The study further looks at several issues around the striking gong system, an alternative appealing method, and its background and transition. Introduced by King Taejong, the Shinmoongo was a kind of the press (or communication) system which was intended to deliver various cases of personal appeal, social petition, national denunciation, etc. Since the 2nd year of King Sejong, the system had been changed into the legal system which mainly to settle personal mortifying problem. Originally, the system was institutionalized for the common people who were hard to appeal their mortifying affairs to the supervisory administration. This reporting system to a superior was utilized as an institutional device to remedy abuses from 'complaint to the King near his sedan chair' and 'direct complaint out of order' during the early disordered years of Chosun dynasty. The system was often abused for the devices of private interest by illustrious officials. Meanwhile, it carried out a role of checking power abuses of provincial governors and magistrates. There were many obstacles for the common people and lowly people to turn to the means. The drum was located at the palace of capitol, less accessible for most people at the time. The petition had to be processed through several steps in written forms. The punishment on a false drummer was heavy. It inhibited any appeal concerning the superior under the rigorous caste system. The Shinmoongo system is regarded as a legitimate press system. Also, it is taken as informal or semi-official press system such as 'document to send around', 'document for agitation', 'joint petition', 'striking gong to complain', 'complaint to the King near his sedan chair', 'scream to complain', etc. Connecting together, the tools resulted in the increase of regal power and decrease of divine authority.

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Returns and Resale Price Maintenance in Book Distribution (도서유통(圖書流通) 효율화(效率化)를 위한 공정거래정책(公正去來政策))

  • Shin, Kwang-shik
    • KDI Journal of Economic Policy
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    • v.13 no.2
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    • pp.141-161
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    • 1991
  • Resale price maintenance has long been employed in book distribution, perhaps longer than for any other product. Another unusual practice in the book trade that has proven to be quite durable in spite of its substantial cost in real resources is the returns policy. Publishers typically grant the right to return unsold books within a stipulated time for full credit against future orders. This paper investigates the functions and effects of resale price maintenance in the book trade, and argues that resale price maintenance and returns are substitute methods of providing the same economic function. Resale price maintenance can be used to compensate booksellers for initially stocking books with uncertain prospects and for providing a conduit through which manufacturers acquire information about consumer demand (market testing services). Permitting the return of unsold books for full credit places a floor under retail prices and transfers a considerable portion of the cost of introducing a new product line back to the publisher. Both reflect publishers' needs to have their books displayed. In the U.S. returns privileges were first proposed in 1913, roughly coincident with the Macy decision outlawing RPM. Publishers slowly granted return privileges, which become nearly universal by 1970. The decline in margins in recent years has been accompanied by an increase in returns as the return policy served to substitute for lost margins on successful titles as a methods of compensating full-line booksellers. In contrast, returns privileges are unusual in countries where price maintenance in books has been practiced. These observations are consistent with our analysis. In Korea, resale price maintenance of books is practiced under an exception to Korean antitrust law. The availability of effective price maintenance is likely to reduce the use of returns programs. Since consumers prefer to obtain books at outlets where they know the books are likely to be stocked rather than taking a chance on stores that carry a more limited line, it also provides a strong incentive for booksellers to expand. But the privilege of resale price maintenance should be confined to books which publishers want to be price maintained. Resale price maintenance and returns system differ in the transactions costs associated with inventory holding, and publishers' judgement on the comparative advantage of the two schemes should be honored. Publishers should also remain free to authorize sales at discount at any time not to impair the ability of booksellers to dispose of product variants that prove unpopular.

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A Study on Improvement of the investigation procedure for the National Security Violators - Focused on the Rights to Counsel - (안보사범에 대한 수사절차 개선방안 검토 - 피의자 신문시 변호인 참여권 문제를 중심으로 -)

  • Yoon, Hae-Sung;Joo, Seong-Bhin
    • Korean Security Journal
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    • no.46
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    • pp.113-140
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    • 2016
  • Right to counsel means a defendant has a right to have the assistance of counsel (i.e., lawyers), and if the defendant cannot afford a lawyer, requires that the government appoint one or pay the defendant's legal expenses. The right to counsel is generally regarded as a constituent of the right to a fair trial. Historically, however, not all countries have always recognized the right to counsel. The right is often included in criminal law and constitutional law etc. First, any person who is arrested or detained shall have the right to prompt assistance of counsel. When a criminal defendant is unable to secure counsel by his own efforts, the State shall assign counsel for the defendant as prescribed by act in article 12(4) of the constitutional law. Second, the defense counsel or a person who desires to be a defense counsel may have an interview with the defendant or the suspect who is placed under physical restraint, deliver or receive any documents or things and have any doctor examine and treat the defendant or the suspect in article 34 of the criminal law. Nonetheless, problems about guarantee of the rights to counsel to the national security violators like spy terrorist and etc will be important for Koreans to consider. That is because national security violators's cases are qualitatively different from general criminal offense's cases and historically, lawyer obstruct a investigation in the process of examination of a suspect for national security violators. Therefore, this study suggest a way that a restriction the rights to counsel with an attorney in cases of the national security violators. To this end, in this paper, I touch on restriction of right to counsel during interrogation in the England and Germany etc in comparison to that of Korea and review Korea's Supreme Court decision and Constitution Court decision to understand the prospective and trends for Korean investigation procedure improvement.

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Legal status of Priave Transaction Regarding the Geostationary Satellite Orbit (지구정지궤도의 사적 거래의 국제법상 지위에 관한 연구)

  • Shin, Hong Kyun
    • The Korean Journal of Air & Space Law and Policy
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    • v.29 no.2
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    • pp.239-272
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    • 2014
  • The rights and obligations of the Member States of ITU in the domain of international frequency management of the spectrum/orbit resource are incorporated in the Constitution and Convention of the ITU and in the Radio Regulations that complement them. These instruments contain the main principles and lay down the specific regulations governing the major elements such as rights and obligations of member administrations in obtaining access to the spectrum/orbit resource, as well as international recognition of these rights by recording frequency assignments and, as appropriate, any associated orbits, including the geostationary-satellite orbits used or intended to be used in the Master International Frequency Register (MIFR) Coordination is a further step in the process leading up to notification of the frequency assignments for recording in the MIFR. This procedure is a formal regulatory obligation both for an administration seeking to assign a frequency in its network and for an administration whose existing or planned services may be affected by that assignment. Regulatory problem lies in allowing administrations to fulfill their "bringing into use" duty for preserving his filing simply putting any satellites, whatever nationlity or technical specification may be, into filed orbit. This sort of regulatory lack may result in the emergence of the secondary market for satellite orbit. Within satellite orbit secondary market, the object of transaction may be the satellite itself, or the regulatory rights in rem, or the orbit registered in the MIFR. Recent case of selling the Koreasat belongs to the typical example of orbit transaction between private companies, the legality of which remains doubtedly controversial from the perspective of international space law as well as international transaction law. It must be noted, however, that the fact is the Koreasat 3 and its filed orbit is for sale.

Administrative Legislation Procedures, Pre-Notices, Listening to Opinions under the Administrative Law of the United States - Focusing on the Analysis of the 2019 Ruling, Federal Supreme Court Azar v. Allina Health Service, 587 U.S. 1804 - (미국 행정법상 행정입법절차와 사전통지, 의견청취 - Azar v. Allina Health Service, 587 U.S. 1804 2019 판결에 대한 분석을 중심으로 -)

  • Kim, Yong-Min
    • The Korean Society of Law and Medicine
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    • v.21 no.1
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    • pp.187-220
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    • 2020
  • Today, administrative legislation is becoming more and more important in that it not only sets the legal life relationship of the people in great detail and detail, but is closely related to the occurrence, extinction, and alteration of rights and obligations held by prisoners. In the United States, the types of administrative legislation are divided into substantive and interpretative regulations, so-called substantive regulations, which give prior notice and opportunity to comment on interested parties through formal or informal administrative procedures in accordance with Article 553 of the Federal Administrative Procedures Act. On the other hand, the interpretation regulation, which is "the regulation established by the Administration for the simple interpretation of statutes," does not require prior notice or comment because it does not affect the people's rights obligations. The Azar v. Allina Health Service, 587 U.S. 1804, 2019 ruling by the U.S. Constitutional Court, subject to this research paper, is about a dispute over a new decision to require Medicare to determine the amount of compensation for care providers that provide medical services for the poor, and should the regulations be regarded as substantive under the Administrative Procedures Act and should not be given a hearing or a simple internal process for processing. Given that the current administrative procedure law of our country stipulates the procedures for administrative pre-announcement through Articles 42.1 and 44.1, but that our courts have not judged violations of legislative pre-announcement procedures under the Administrative Procedures Act so far as to judge the illegality of administrative legislation, the dispute of the U.S. Constitutional Court will provide new implications for controlling legal orders beyond simple legal interpretation and has great significance in terms of readjustment of relevant regulations under future administrative procedures.

Water Transport Characteristics of Paddy Plow Pan Soils as Estimated by Particle Size Distribution Fractal Dimension (토양입자분포 프랙탈차원을 활용한 논토양 쟁기바닥층 물이동 추정)

  • Han, Kyung-Hwa;Cho, Hyun-Jun;Hur, Seung-Oh;Ha, Sang-Geun;Cho, Hee-Rae;Jeon, Sang-Ho
    • Korean Journal of Soil Science and Fertilizer
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    • v.43 no.1
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    • pp.1-7
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    • 2010
  • This study was carried out to investigate plow pan characteristics and to grasp the relationship between its particle size distribution fractal dimension ($D_m$) and water transport in paddy plow pan. Twenty four soil sampling sites with different management groups, ordinary and sandy-textured, were selected and investigated for physical properties of soils such as Yamanaka hardness in April, non-submerged condition, before rice seedling transplanting. The plow pan appearing depth and thickness was determined by penetration resistance profile. Undisturbed core samples with five replicates were sampled at plow pan layerwith 2 inch cores for measuring soil bulk density and saturated hydraulic conductivity. The particle size distribution fractal dimension ($D_m$) was calculated by the method following the procedure Tylerand Wheacraft (1992), using the USDA-based particle size analysis datawith fractions of 0-0.002, 0.002-0.053, 0.053-0.1, 0.1-0.25, 0.25-0.5, 0.5-1.0, and 1.0-2.0 mm. The plow pan of investigated fields appeared at a range from 5 to 30 cm depth, showing minimum value in sandy-textured management group and maximum value in ordinary management group. The thickness of plow pan were distributed from 5 to 17 cm, showing both minimum and maximum values in sandy-textured management group. Averagely, the plow appearing depth were deeper in ordinary management group than in sandy-textured management group, whereas the reverse in the thickness of plow pan. The particle size distribution fractal dimension ($D_m$) had higher value with finer textures, with higher fractality in coarser texture. Saturated hydraulic conductivities, $K_s$, of plow pan soils distributed from 0.5 to 1420 mm $day^{-1}$, having the highest value in sandy skeletal soils. The $K_s$ decreased with decreasing clay content and $D_m$, showing power function relationships. The coefficient of determination, $R^2$, of the fitted power functions were higher in $D_m$ as x-axis than in clay content. This means that $D_m$ could give us more effective estimation than clay content. Especially, sandy-textured paddy soils had higher $R^2$, compared to ordinary paddy soils. $K_s$ of relatively coarse-textured soils with less than 18%of clay content, therefore, was more dependent on particle size distribution than that of relatively fine-textured soils. From these results, it could be concluded that the fractal scaling gives us a unique quantity describing particle size distribution and then can be applied to estimate saturated hydraulic conductivity, especially more effective in coarse-textured soils.