• Childhood Kidney Diseases
• /
• v.2 no.2
• /
• pp.138-144
• /
• 1998

Purpose : The use of cyclosporine and mitomycin in various immunologic or neoplastic disorders has been known to cause wide-ranged nephrotoxic effects including thrombotic microangiopathy. However, the mechanism of nephrotoxicity of these drugs has not been studied adequately, so that present experimental study has been undertaken to find out whether these drugs can cause direct damage to the kidney and to clarify the pathogenetic mechanism of nephrotoxic effect of these drugs. Materials and methods : Sprague-Dawley rats weighing 250-300 gm were used for experimental animals and unilateral renal perfusion technique, modified from the method described by Hoyer et al was used. Isolation of left kidney from systemic circulation was made by clamping aorta and left renal vein and a hole was punctured in the anterior wall of the left renal vein. Cyclosporine (2.5 mg in 4 ml solution) and mitomycin (1.6 mg in 4ml solution) were infused through left renal artery and normal saline was used in control rats. Forty-eight hours after infusion of the drugs, animals were sacrificed and left kidney removed and processed for histologic examination. Total ischemic time of left kidney was less than 15 minutes: Results : Cyclosporine-perfused group showed severe swelling of glomerular endothelial ceil along with swelling of glomerular epithelial cell and interstitial vascular endothelial cell. Mitomycin-perfused group also showed severe swelling of glomerular endothelial and epithelial cells. And in addition to these findings, they demonstrated platelets aggregation, swelling and degranulation of platelets and fibrin accumulation in some of the capillaries, indicating occurrance of thrombotic microangiopathy. Conclusion : present experiment indicates that cyclosporine and mitomycin can cause direct toxic injury to renal endothelial cell. And this direct toxic damage to endothelial cell seems to be an important initiating event for the development of thrombotic microangiopathy.

• The Korean Society of Law and Medicine
• /
• v.21 no.1
• /
• pp.223-259
• /
• 2020

With COVID-19 spreading rapidly around the world, research and development issues on treatments and vaccines for the virus are of high interest. Among them, Remdesivir was the first to show noticeable therapeutic effects and began clinical trials, with each country authorizing the use of the drug through emergency approval. However, Gilead Co., Ltd., the developer of Remdesivir, received a lot of criticism from civic groups for submitting the application for the marketing authorization as an orphan drug. This is because when a new drug got a marketing authorization as an orphan drug could be granted an exclusive status for seven year. The long-term exclusive status of an orphan drug comes from the policy purpose of motivating pharmaceutical companies to develop treatment opportunities for patients suffering from rare diseases, which was not appropriate to apply to infectious disease treatments. This paper provides a review of the problems and improvement directions of the domestic system through comparative legal consideration against the United States, Europe and Japan for the statutes which give exclusive status to medicines. The domestic system has a fundamental problem that it does not have explicit provisions in the statute in the manner of granting exclusive status, and that it uses the review system to give it exclusive status indirectly. In addition, in the case of orphan drugs, the "Rare Diseases Management Act" and the "Regulations on Examination of Items Permission and Reporting of Drugs" provide overlapping review periods, and despite the relatively long monopoly period, there seems to be no check clause to recover exclusive status in the event of a change in circumstances. Given that biopharmaceuticals are difficult to obtain patents, the lack of such provisions is a pity of domestic legislation, although granting exclusive rights may be a great motivation to induce drug development. In the United States, given that the first biosimilar also has a one-year monopoly period, it can be interpreted that domestic legislation is quite strictly limited to granting exclusive status to biopharmaceuticals. The need for improvement of the domestic system will be recognized in that it could undermine local pharmaceutical companies' willingness to develop biopharmaceuticals in the future, and in that it is also necessary to harmonize international regulations. Taking advantage of the emergence of COVID-19 as an opportunity, we look again at the problems of the domestic system that grants exclusive rights to medicines and hope that an overall revision of the relevant legislation will be made to establish a unified legal basis.

• Pediatric Infection and Vaccine
• /
• v.10 no.2
• /
• pp.167-177
• /
• 2003

Purpose : To know the trends of antimicrobial susceptibility is critical for antimicrobial treatment. We studied the organisms isolated from blood, urine, stool, and cerebrospinal fluid from 1997 to 2001 to reveal the trends of their antimicrobial susceptibility. Methods : We conducted a retrospective study with isolates obtained from 0~18 year old outpatients and inpatients from 1997 to 2001 at Department of Pediatrics, Hanil general hospital. We gathered the data through the laboratory test files and the origin of microorganisms cultured from blood, urine, stool and cerebrospinal fluid and their antimicrobial susceptibility. Results : Microorganisms were isolated from 226(3.3%) out of 6,974 blood cultures, 365 (8.0%) out of 4,549 urine cultures, 50(1.9%) out of 2,593 stool cultures and 9(1.4%) in 655 cerebrospinal fluid cultures. The most frequently isolated organisms from blood cultures was Staphylococcus epidermidis(33.5%) which was followed by Staphylococcus aureus(19.7%), Escherichia coli(13.8%), and Burkholderia cepacia(9.0%). Among the urine cultures, E. coli was the most common(74.7%) which was followed by Group D Enterococcus(11.3%), Klebsiella pneumoniae(7.1%) and Proteus mirabilis(2.5%). The positive stool cultures all yield Salmonella species. Group D Salmonella was obtained most frequently. Among the positive cerebrospinal fluid cultures, Group B Streptococcus was isolated most frequently. Among the 40 cases of S. aureus in blood cultures, 27 cases were methicillin-resistant. The rates of susceptibility for amikacin, ceftizoxime and ceftriaxone of E. coli isolated from blood cultures were 80%, 100% and 60% in 1997 and 60%, 80% and 60% in 2001. The rates of susceptibility for amikacin, ceftizoxime and ceftriaxone of K. pnumoniae isolated from urine cultures. were 80%, 100% and 80% in 1997 and 50%, 83% and 50% in 2001 Enterococcus was isolated from 6.7% to 15.8% and vancomycin-resistant Enterococcus was observed in 17% of Group D Enterococcus isolated from urine cultures. The rates of susceptibility for amikacin, ceftizoxime and ceftriaxone of Group D Salmonella were 96%, 96% and 92% during the study period. Conclusion : Among the blood cultures S. epidermidis, S. aureus, E. coli and B. cepacia were isolated in order of frequency and among the urine cultures E. coli, Group D Enterococcus, K. pneumoniae and P. mirabilis were isolated in order of frequency. During the study period there was no big difference in major organisms isolated from blood and urine. The methicillin-resistant S. aureus was observed in 67% of S. aureus isolated from blood cultures but vancomycin-reistant S. aureus or vancomycin intermediate resistant S. aureus was not observed. The rates of susceptibility to amikacin and the third generation cephalosporin of E. coli isolated from blood cultures and K. pneumoniae from urine cultures have decreased. The isolation rates of Group D Enterococcus and vancomycin resistant Enterococcus have increased.

• The Korean Journal of Air & Space Law and Policy
• /
• v.33 no.2
• /
• pp.35-59
• /
• 2018

Professor Bin Cheng said that outer space was res extra commercium, while the moon and the other celestial bodies were res nullius before the 1967 Outer Space Treaty(OST). However, Article 2 of the OST made the moon and other celestial bodies have the legal status as res extra commmercium, not appropriated by any country or private enterprises or individual person, but the resources there can be freely available, as those on the high seas. The non-appropriation principle was introduced to corpus juris spatialis internationalis. Whether or not the non-appropriation principle is binding for the non-parties of the OST, many scholars see this principle as an international customary law, even developing into jus cogens. Article 11(2) of the Moon Agreement(MA) reconfirms the nonappropriation principle of Article 2 of the OST, but it has much less effect than the OST because the MA binds only the 18 parties involved. The MA applies only to the moon and celestial bodies other than the Earth in the Solar System, the OST's application scope extends to the Galaxy because the OST has no such substantive enactment. As referred to in the 2015 CSLCA of USA or Luxembourg's Law of Space Resources, allowing individuals and enterprises run by other countries to commercially explore and utilize the space resources, the question may arise whether this violates the non-appropriation principle under Article 2 of the OST and Article 11 of the MA. In the case of the CSLCA, the law explicitly specifies that sovereignty, possessory rights, and judiciary rights to a specific celestial body cannot be claimed, let alone ownership. This author believes that this law respects the legal status of outer space and the celestial bodies as res extra commmercium. As long as any countries or private enterprises or individuals respect the non-appropriation principle of outer space and the celestial bodies, they could use, exploit it. Another question might be raised in the difference between res extra commercium on the high seas and res extra commercium in outer space and the celestial bodies. Collecting resources on the high seas and exploiting space resources should be interpreted differently. On the high seas, resources can be collected without any obstacles like fishing, whereas, in the case of the deep sea-bed area, the Common Heritage of Mankind principles under the UNCLOS should be operated by the International Seabed Authority as an international regime. The nature or form of the sea resources found on the high seas are thus different from that of space resources, which are fixed on the moon and the celestial bodies without water. Thus, if individuals or private enterprises collect these resources from outer space and the celestial bodies, they might secure a certain section and continue collecting or mining works without any limitation. If an American enterprise receives an approval from the U.S. government, secures the best location and collects resources on the moon, can other countries' enterprises access to this area? How large the exploiting place can be allotted on the moon? How long should such a exploiting activity be lasted? Under the current international space law, these matters might be handled according to the principle of "first come, first served." As a consequence, the international community should provide a guideline or a proposal for the settlement of any foreseeable disputes during the space activity to solve plausible space legal questions in the near future.

• Food Science and Industry
• /
• v.52 no.2
• /
• pp.188-201
• /
• 2019

In the past, food additives were classified and managed as chemical synthetic and natural additives according to the manufacturing process, but it was difficult to confirm the purpose or function of food additives.CODEX, an internationalstandard, classifies food additives according to their practical use, based on scientific evidence on the technical effects of food additives, instead of classifying them as synthetic or natural. Therefore, very recently, the food additive standards in Korea have been completely revised in accordance with these global trends. Currently, the classification system of food additives is divided into 31 uses to specify their functions and purposes instead of manufacturing methods. Newer revision of the legislative framework for defining and expanding the scope of the Act as an enlarged area is required. Competition for preempting new food products based on bio-based technology is very fierce in order to enhance the safety of domestic people and maximize the economic profit of their own countries. In this age of infinite competition, it is very urgent to revise or supplement the current regulations in order to revitalize the domestic food industry and enhance national competitiveness through the development of food additives using new biotechnology. In this report, current laws on domestic food ingredients, food additives and manufacturing methods, and a comparison of domestic and foreign advanced countries' regulations and countermeasures strategies were reviewed to improve national competitiveness of domestic advanced biotechnology-based food additives industry.

• The Korean Journal of Air & Space Law and Policy
• /
• v.28 no.2
• /
• pp.223-258
• /
• 2013

1967 Outer Space Treaty(Treaty on Principles Governing the Activities of States in the Exploration and Use of Outer Space, including the Moon and Other Celestial Bodies; OST) is a treaty that forms the basis of international space law. OST is based on the 1963 Declaration of Legal Principles Governing the Activities of States in the Exploration and Use of Outer Space announced by UNGA resolution. As of May 2013, 102 countries are states parties to OST, while another 27 have signed the treaty but have not completed ratification. OST explicitly claimed that the Moon and Other Celestial Bodies are the province of all mankind. Art. II of OST states that "outer space, including the Moon and other celestial bodies, is not subject to national appropriation by claim of sovereignty, by means of use or occupation, or by any other means", thereby establishing res extra commercium in outer space like high seas. However 1979 Moon Agreement stipulates that "the moon and its natural resources are the Common Heritage of Mankind(CHM)." Because of the number of the parties to the Moon Agreement(13 parties) it does not affect OST. OST also established its specific treaties as a complementary means such as 1968 Rescue Agreement, 1972 Liability Convention, 1975 Registration Convention. OST bars states party to the treaty from placing nuclear weapons or any other weapons of mass destruction in orbit of Earth, installing them on the Moon or any other celestial body, or to otherwise station them in outer space. It exclusively limits the use of the Moon and other celestial bodies to peaceful purposes and expressly prohibits their use for testing weapons of any kind, conducting military maneuvers, or establishing military bases, installations, and fortifications. However OST does not prohibit the placement of conventional weapons in orbit. China and Russia submitted Draft Treaty on the Prevention of the Placement of Weapon in Outer Space and of the Threat or Use of Force against Outer Space Objects(PPWT) on the Conference on Disarmament in 2008. USA disregarded PPWT on the ground that there are no arms race in outer space. OST does not have some articles in relation to current problems such as space debris, mechanisms of the settlement of dispute arising from state activities in outer space in specific way. COPUOS established "UN Space Debris Mitigation Guidelines" based on "IADC Space Debris Mitigation Guidelines" and ILA proposed "International Instrument on the Protection of the Environment from Damage Caused by Space Debris" for space debris problems and Permanent Court of Arbitration(PCA) established "Optional Rules for Arbitration of Disputes Relating to Outer Space Activities" and ILA proposed "1998 Taipei Draft Convention on the Settlement of Space Law Dispute" for the settlement of dispute problems. Although OST has shortcomings in some articles, it is very meaningful in international law in considering the establishment of basic principles governing the activities of States in the exploration and use of outer space, including the Moon and Other Celestial Bodies. OST established the principles governing the activities of states in the exploration and use of outer space as customary law and jus cogens in international law as follows; the exploration and use of outer space shall be carried out for the benefit and in the interests of all countries and shall be the province of all mankind; outer space shall be free for exploration and use by all States; outer space is not subject to national appropriation by claim of sovereignty, by means of use or occupation, or by any other means. The principles of global public interest in outer space imposes international obligations erga omnes applicable to all States. This principles find significant support in legal norms dealing with following points: space activities as the "province of all mankind"; obligation to cooperate; astronauts as envoys of mankind; avoidance of harmful contamination; space activities by States, private entities and intergovernmental organisations; absolute liability for damage cauesd by certain space objects; prohibition of weapons in space and militarization of the celestial bodies; duty of openness and transparency; universal application of the international space regime.

• Clinical and Experimental Pediatrics
• /
• v.51 no.2
• /
• pp.162-169
• /
• 2008

Purpose : Oxcabarzepine (OXC), newly recommended antiepileptic drug, has been prescribed for patients with partial seizures and generalized tonic clonic seizures in Korea from 1999. There are limited reports about an efficacy of OXC therapy in epileptic children in Korea. This study evaluated the efficacy and safety of OXC in the light of our experience. Methods : The patients, who had visited the pediatric neurology clinic of Korea University Guro Hospital from January 2001 to December 2006, were included. The data of 144 patients who were administrated OXC as monotherapy or polytherapy, was summarized retrospectively and we evaluated the efficacy and safety of OXC. Results : After 6 months of OXC therapy, 77 patients (53.5%, n=144) achieved seizure freedom, 48 patients (33.3%) experienced >50% improvement. After 12 months of OXC therapy, cessation of seizure was observed in 88 patients (61.1%, n=133), and 27 patients (18.8%) manifested an improvement. Monotherapy group showed superior efficacy to polytherapy one. The frequent side effects of OXC were drowsiness (20.1%), headache (12.5%), dizziness (9.7%) and rash (8.3%). They did not related to patient's age or sex, and dosage of OXC. Twenty four patients (16.7%) experienced hyponatremia, but which were neither symptomatic nor significant one. Conclusion : The efficacy and safety of OXC in our patients were excellent and had less significant side effects than established international one. We expect this report contributes toward OXC therapy in epileptic children.

• Journal of Internet Computing and Services
• /
• v.17 no.4
• /
• pp.145-159
• /
• 2016

This study points out the problems of absence of the legislation for standard regulation on Video on Demand(VoD) advertisement which grows so fast lately, for this it recommends making legal references, which have the definition of non-linear broadcasting & VoD advertisement and VoD advertisement standard regulation in the merged Broadcasting Act, and adopting co-regulation system. Pay TV operators providing VoD service have the opportunities to make money as subscribers uses it increasingly. In case of linear service, the Broadcasting Act regulates the advertisement strictly, but not the VoD ads. The reason why is that Korean legislation including the Broadcasting Act does not have legal reference to regulate it, instead of that, it rely on the self-regulation system which is operated by pay-tv players who provide the VoD ads. So, there is the limitation to protect the minors such as children and youth from the harmful VoD ads, to be invulnerable for advertisers to influence to advertising agents, and to ensure the regulatory effectiveness under player-centric self-regulatory regime. In this context, this study analyses the how to regulate VoD ads standard with a three-pronged approach. First, it analyses the VoD ads regulation system in overseas countries, UK, Canada, EU and Ireland. Each country has the legal reference to regulate it in the Broadcasting Act or lower statures and adopts the co-regulatory regime the NRA and the 3rd entity operate together. Second, it reviews the objectives and scope of VoD ads standard. This study recommends that the objective of it is users protection and the scope of it is standard regulation not commercial practice. Third, this study researches how to legislate for regulation of VoD ads standard. Considering VoD service's characteristics(non-linear service) and legal position of Ads agency(i.e. pay tv operators), it suggest that legal reference will be in the integrated Broadcasting bill, which is the general law, not individual. If it is available to regulate VoD ads standard with co-regulatory regime, it expects the enhancement of user protection from the harmful VoD ads and make up sustainability of the pay-tv players' self-regulation.

• Korean Journal of Environment and Ecology
• /
• v.23 no.2
• /
• pp.177-186
• /
• 2009

In the flora of the whole area of Jakeundang at Byeonsanbando National Park, a total of 105 taxa were identified including 50 families, 88 genera, 98 species, 6 varieties and 1 form. These were again divided into 31 taxa (29.5%) of woody plants and 74 taxa (70.5%) of herbaceous plants. In addition, 4 taxa of the Korea Forest Service, designated rare plants in the flora were identified to grow there including Phacelurus latifolius (Preservation priority order: No. 194), Aristolochia contorta (No. 151), Koelreuteria paniculata (No. 115), and Glehnia littoralis (No. 203). Indigofera koreana, Viola seoulensis that are on the list of Korean endemic plants were also identified and the plants approved for export were identified similarly to rare plants. In addition, among the floral region-based specific plants, the plant group belonging to class V, class IV and II didn't appear and a total of 16 taxa 3 taxa including Elymus mollis, Salsola collina and Koelreuteria paniculata in class III, and 13 taxa including Ischaemum anthephephoroides, Phacelurus latifolius, Asparagus cochinchinensis, Melandryum oldhamianum for. roseum, Calystegia soldanella, Messerschmidia sibirica, Scutellaria strigillosa and Aster spathulifolius, etc. in class I were identified. Among the naturalized plants in the surveyed sites, 6 families, 10 genera, and 10 taxa were identified to grow, such as Bromus unioloides, Phytolacca americana, Lepidium apetalum, Robinia pseudoacacia, Oenothera biennis and Xanthium canadense, etc. and the naturalization rate was analyzed to be 9.5% of all 105 taxa of vascular plants. This research analyzed the coverage ratio and importance value by dividing the community into a sand dunes and back swamp and divided the sand dune area into Vitex rotundifolia community and the back swamp into Phacelurus latifolius community. Jakeundang is designated as a sand dune plants observation area and managed by the office of Byeonsanbando National Park. To preserve this place, it is desirable to take a systematic management measure, such as a visit to this place on a subscription basis or education and publicity on sand dune plants.

• Journal of the Korean Institute of Landscape Architecture
• /
• v.39 no.6
• /
• pp.86-97
• /
• 2011

This study analyzed the necessity of the tentatively-named "Framework Act on Landscape Architecture" as an umbrella law in the field of landscape architecture regarding legal, industrial, and academic aspects and is intended to provide basic data to suggest the optimal legal system and legislative proceedings to control it. This study can be summarized as follows: First, a form of framework act on landscape architecture is appropriate for a compromise between ideal type and political framework. Some content is suitable for proclamatory character including present and future issue related to the landscape architecture fields. Second, legislative proceedings are more reasonable as motions coming from assembly proposals rather than government. Motions by assembly proposal recommend the following procedure: submission of a legislative bill by an assemblyperson, passing of a permanent commission, review by government, leading approval by emphasis on correspondence with the principle to carry out government affairs, proclamation. Third, a frame based on content and form can be made up of a total of 7 chapters 34 articles. The function must include the following: the suggestion of direction for government policy, the systematization of the institution and what it includes, the control of government administration, a public service system regarding public relations for landscape architecture and so on. The results of this study will form a social consensus about the necessity of a framework act regarding landscape architecture fields and contribute to informing the importance of landscape architecture as related to other industrial fields.