• Korea Trade Review
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• v.45 no.2
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• pp.177-189
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• 2020

The dispute settlement mechanism of the World Trade Organization (WTO) is in great peril. The Appellate Body has ceased to function last December as the United States has blocked the appointment of new Appellate Body members since 2017. The focus of this study is on the examination of US's discontent on the Appellate Body and various efforts to reform the Appellate Body. In a recent report, the US Trade Representative raises its concerns on the Appellate Body including 90 days mandatory deadline, transitional rules for outgoing Appellate Body members, scope of appeal, advisory opinions, precedent, recommendation, and overreach without offering any viable solutions. Some of WTO members and experts proposed several Appellate Body reform measures but agreement between WTO members is unlikely in a foreseeable future. Alternative dispute settlement mechanisms should be seriously considered such as interim appeal arbitration arrangements, separate dispute settlement mechanisms for trade remedies, unilateral retaliatory measures without WTO authorization. Rules-based multilateral dispute settlement system is imperative to small open economies like Korea. The Korean government should actively participate in Appellate Body reform discussions with other WTO members to keep the WTO dispute settlement system from collapsing.

• Journal of the Korean Society of Marine Environment & Safety
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• v.4 no.2
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• pp.69-83
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• 1998

Sea transportation has long been a vital component of the transport systems of the world. The great majority of imports and exports to and enlarge their national merchant marines. This effort is meant partly to arrest earlier trends of having their trade carried by ships from outside the region and partly to promote regional integration and improve the national balance of payments. However, sea transportation has been exposed to various types of threats on the high seas, in coastal waters and in port areas. Piracy is any robbery or other violent action, for private ends and without authorization by public authority, committed on the seas. Because piracy has been regarded as an offense against the law of nations, the public vessels of any state have been permitted to seize a pirate ship, to bring it into port, to try the crew(regardless of their nationality or domicile), and, if found guilty, to punish them and to confiscate the ship. Piracy has occurred in all stages of maritime history. The increased size of merchant vessels, the improved naval patrolling of most ocean highways, the regular administration of most islands and land areas of the world, and the general recognition by governments of piracy as an international offense resulted in a great decline in piracy in the 19th and 20th centuries. Piracy has, however, occurred in the 20th century, and the practice of hijacking ships has developed into a new form of piracy. The number of incidents of sea piracy against ships reported was 229 in 1997. Since 1991, 1,051 such acts have been reported. The purpose of this research is to examine the origin and development of the piracy to understand the current situation of such violence on the seas. In addition, what should be done by international community will be presented to prevent the piracy in the future.

• THE INTERNATIONAL COMMERCE & LAW REVIEW
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• v.41
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• pp.79-102
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• 2009

L/C transaction, the most important issue for the seller and the buyer is the theory of documentary transaction and the theory of strict compliance which are the principles of L/C transactions. According to the leading cases in England and America where the practice of L/C transactions was created and developed, the descriptions of the commodities specified on all the documents which are submitted based on an L/C, should be identical to the descriptions of commodities specified in the L/C. And further, many leading cases of L/C continuously repeat to emphasize strict compliance. However, the recent leading cases in and out of the country show that the principle of strict compliance is being weakened. The leading cases in America show two trends of weakening the principle of strict compliance. That is, on the contrary to strict compliance, tends to apply substantial compliance (which puts more value on the substance of the documents). These leading cases reflect the attitudes of the judicial and the legislative authorization that don't want to approve formal approach to the commercial law. Recently, the Supreme Court of Korea is giving a decision on the principle of strict compliance, "The documents attached to an L/C should strictly comply with the conditions in the L/C, but it doesn't mean that they should be perfectly identical without any mistake in words. In case the bank can understand through reasonable care that a small mistake in words is too trivial to give different meaning or to give damage to the conditions of the L/C, the documents are regarded to comply with the conditions of the L/C. However, the judgment should be based on whether the difference between the documents and the L/C can be admitted by the international standard bank transaction practice or not." This decision tells that the principle of strict compliance is quite much modified so application of this modification can't be ignored. However, from the viewpoint of the party who requests to open an L/C, there is a criticism that a bank's arbitrary judgement can be involved. Therefore, reviewing the original purpose of L/C transactions (activating international transactions), the principle of strict compliance may be thought old-fashioned because it emphasizes a form, but in reality, for prompt transaction and payment, the principle of strict compliance should be observed in L/C transactions. And further, if a legislative device is prepared to systematically compensate for several side-effects, the principle of strict compliance will improve dynamic flow of prompt and low-costly L/C transactions. On the other hand, it will be able to protect the interested parties.

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

• Journal of the Korea Academia-Industrial cooperation Society
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• v.19 no.6
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• pp.382-390
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• 2018

This study developed a model to evaluate the quality management system of a medical device manufacturing company, and applied it to medical device manufacturers to understand the impact on business performance in response to international regulations and industry's change. This study prepared preliminary items, defined four (4) major factors (Plan-Do-Check-Act) that consist of the evaluation layers and items per category according to prior research review and expert interview, and calculated the weight and importance using AHP. The study results showed that responsibility & authority and quality objective in Planning Category, product-related requirement and R&D in Doing Category, Measuring and monitoring in Check Category, and review of meeting Regulatory and regulation in Action Category are relatively more important factors. The evaluation model developed based on the calculated weight and importance to business performance was applied to medical device manufacturers to investigate and analyze the implementation level of QMS and its impact on business performance according to each category. Most medical device manufacturers to be studied showed a reasonable level of QMS and effective business performance. Almost all the evaluation layers and items in the four (4) factors had a significant influence on business performance. Although the medical device quality management system is aimed mainly at license acquisition, it is important that management environment factors not related directly to licensing and authorization are important to business performance, and it is effective when these factors are integrated and operated within and outside the manufacturer.

• International Commerce and Information Review
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• v.13 no.4
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• pp.351-373
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• 2011

Certificates of Origin(C/O) are necessary to gain benefits from preferential tariff treatment under the Free Trade Agreement(FTA). The C/O can be issued by issuing authorities or by exporters themselves. Recently, due to signed FTA such as Korean-EU FTA, issuance of self-declared C/O by exporters is increasing. In order to be qualified to issue self -declared C/O, exporters are required to acquire Approved Exporter status. An Approved Exporter is only required to present an invoice to substitute the certificate. The invoice contains an Approved Exporter number and a declaration that states the goods comply with the origin requirements. Either certification or notarization is not necessary. In result, the exporters are responsible for application of a preferential tariff under the self-declared C/O which issued incorrectly, even if it is not intentional. Therefore, in this paper, we studied authorization for Approved Exporter status and the practical use of its status. If companies obtain more Approved Exporter status, the effects of FTA would be maximized due to application of a preferential tariff under the C/O.

• Journal of Environmental Science International
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• v.26 no.11
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• pp.1209-1222
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• 2017

On June 5, 2008, the "Act on Special Cases Concerning the Simplification of Authorization and Permission Procedures for Industrial Complexes" (Act No. 9106) was enacted. When it was implemented in August 2008, many industrial complex development projects were established, and the number of industrial complexes growth rates of 3-6% during 2003-2007 rose to around 15% in 2008. With the increase in industrial complexes, the environmental impacts of individual projects were examined, but comprehensive regional reviews of environmental impacts were not undertaken. In this study, we determined changes in air quality by applying the industrial complex development plan that completed the consultation at the end of 2010 to assess the comprehensive regional environmental impacts and presented the adequacy review plan for future industrial development plans based on the study's results. When considering these industrial complex development plans, emissions in North Jeolla and South Chungcheong Provinces and Daegu City have increased significantly. Air quality analyses showed that the 24 h mean $SO_2$ concentration in Daegu increased by more than 50% in summer compared to air quality concentrations in summer. The 24 h mean $PM_{10}$ and $NO_2$ concentrations increased by approximately 12 and 30%, respectively, in North Jeolla Province in summer. Areas exceeding the air quality standard for 1 h mean $O_3$ concentration increased by more than $3,500km^2$. Based on the above analysis, changes in air quality should be anticipated through a comprehensive evaluation of long-term development plans. Furthermore, control of air quality in accordance with the development of future industrial complexes is possible.

• Environmental Analysis Health and Toxicology
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• v.31
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• pp.26.1-26.9
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• 2016

Objectives Korea's Act on the Registration and Evaluation of Chemicals (K-REACH) was enacted for the protection of human health and the environment in 2015. Considering that about 2000 new substances are introduced annually across the globe, the extent of animal testing requirement could be overwhelming unless regulators and companies work proactively to institute and enforce global best practices to replace, reduce or refine animal use. In this review, the way to reduce the animal use for K-REACH is discussed. Methods Background of the enforcement of the K-REACH and its details was reviewed along with the papers and regulatory documents regarding the limitation of animal experiments and its alternatives in order to discuss the regulatory adoption of alternative tests. Results Depending on the tonnage of the chemical used, the data required ranges from acute and other short-term studies for a single exposure route to testing via multiple exposure routes and costly, longer-term studies such as a full two-generation reproducibility toxicity. The European Registration, Evaluation, Authorization and Restriction of Chemicals regulation provides for mandatory sharing of vertebrate test data to avoid unnecessary duplication of animal use and test costs, and obligation to revise data requirements and test guidelines "as soon as possible" after relevant, validated replacement, reduction or refinement (3R) methods become available. Furthermore, the Organization for Economic Cooperation and Development actively accepts alternative animal tests and 3R to chemical toxicity tests. Conclusions Alternative tests which are more ethical and efficient than animal experiments should be widely used to assess the toxicity of chemicals for K-REACH registration. The relevant regulatory agencies will have to make efforts to actively adopt and uptake new alternative tests and 3R to K-REACH.

• Journal of Arbitration Studies
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• v.18 no.1
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• pp.31-47
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• 2008

An arbitrator's duty shall be independence and impartiality such as a judge who has procedurally absolute position. Independence is the freedom from others, impartiality is the status of having no-partial condition. Although these show relevance between independence and impartiality, in actuality, it is not easy to prove them. Therefore, arbitrator has to prove his or her position by opening the public of reality and by having an obligation of notification. Each country which applies Arbitration rules or Arbitration act stays the same as Korean Commercial Arbitration Board does. Hence, each country has the moral principles in order to establish a standard of judgement for essential factors and requests preferentially the impartiality and the publicity. In reality, court of justice in England excludes arbitrator who has the close relation to a person concerned. Justice in France cancelled an authorization of arbitrator because of having the economic interest to the person concerned. And also, In United States, Federal Court reverses an arbitration judgment without giving any partiality to a person concerned because of not opening a public about the relationship between arbitrator and a person concerned. Therefore, decision basis of the independence and the impartiality is standardized by the economic interest of a person concerned, professional relation, society connection, relationship between arbitrator and arbitration representative in the same case while in process of arbitration, arbitrator's nationality If arbitrator does not keep the independence and the impartiality by a position of judge, he or she has to make responsible. this duty is divided by two things: civil case and crime case. and if arbitrator does break this responsibility, he or she will get the cancellation of judge and compensation of damage. However, Korea is placed in the real circumstance without judge precedent and moral principles including the independence and impartiality. In order to getting the good reputation of international arbitration institution, this country will have to enact principles of the independence and impartiality for arbitrator.

• Proceedings of the Korean Institute of Navigation and Port Research Conference
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• v.2
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• pp.33-37
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• 2006

Since 1993, the civil aviation community through RTCA (Radio Technical Commission for Aeronautics) and the ICAO (International Civil Air Navigation Organization) have been working on the definition of GNSS augmentation systems that will provide improved levels of accuracy and integrity. These augmentation systems have been classified into three distinct groups: Aircraft Based Augmentation Systems (ABAS), Space Based Augmentation Systems (SBAS) and Ground Based Augmentation Systems (GBAS). The last one is an implemented system to support Air Navigation in CAT-I approaching operation. It consists of three primary subsystems: the GNSS Satellite subsystem that produces the ranging signals and navigation messages; the GBAS ground subsystem, which uses two or more GNSS receivers. It collects pseudo ranges for all GNSS satellites in view and computes and broadcasts differential corrections and integrity-related information; the Aircraft subsystem. Within the area of coverage of the ground station, aircraft subsystems may use the broadcast corrections to compute their own measurements in line with the differential principle. After selection of the desired FAS for the landing runway, the differentially corrected position is used to generate navigation guidance signals. Those are lateral and vertical deviations as well as distance to the threshold crossing point of the selected FAS and integrity flags. The Department of Applied Science in Naples has create for its study a virtual GBAS Ground station. Starting from three GPS double frequency receivers, we collect data of 24h measures session and in post processing we generate the GC (GBAS Correction). For this goal we use the software Pegasus V4.1 developed from EUROCONTROL. Generating the GC we have the possibility to study and monitor GBAS performance and integrity starting from a virtual functional architecture. The latter allows us to collect data without the necessity to found us authorization for the access to restricted area in airport where there is one GBAS installation.