• 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.

• Korean Security Journal
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• no.18
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• pp.119-141
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• 2009

Administrative execution by proxy is one of forced executions of administration and is also called as "enforced execution by proxy" in which administration institutions or the third party executes by proxy on behalf of parties who did not execute obligations under administration law and files claims to compensate expenses required in the proxy execution. Despite the actual site of administrative execution by law, social problems are generated because various violence and behaviors of infringement of human rights between executer and obligator are rampant and thus causing human damages since forced execution by physical force is carried out and cases of police indictments and petition to human rights committee are gradually increasing. Majority of people mobilized in this actual site of violence are supplied by private security companies which provide service contract and mobilization of people without qualification of guards or security service and irrational execution by proxy and violent actions by so-called service hooligans connected to violence organizations are now becoming social issues. In these actual sites of violence, structurally very complicated problems such as economic rights, right of residence, struggle for living, and intervention by outsiders are contained. This thesis has analyzed causes of outbreaks of violence and discussed about improvement countermeasure by paying attention to mobilization of people by private security companies. As the result, through revision and improvement of laws and systems, execution institution and policemen must be present at actual sites of execution by proxy to control physical execution of private security companies to be carried out legally and when violent collisions are occurring, it shall be stipulated that police should immediately intervene. Practices of execution by proxy of execution administration institutions shall be avoided and causes of occurrences of violence shall be eliminated by discrete decisions of execution by proxy, elimination of service contract conditions focused on accomplishments, and stipulation of responsibility of execution institutions when problems occur. Practices of solving petitions through collective actions of obligators shall be eliminated and strict enforcement of laws such as disturbance of official execution or compensation claims for expenses of execution by proxy must be carried out and intervention by the third parties must be intercepted. Mobilization of manpower by security companies shall be limited to people with prior registration who have acquired and finished qualification and education by security business law and before putting them on actual sites, it shall be obliged that execution plan with clear written records of working location, mission, and work rules must be submitted in advance to police station in charge and also they must be controlled to follow laws and statutes such as uniform and equipments. In addition, personal criminal responsibility for violent actions must be clearly stipulated and advanced securing soundness of security companies such as limits of service contracts with records of accidents is required. Order placement behaviors of special organizations under the pretext of rehabilitation business must be eradicated and companies with capability and strong intention of observation of laws must be able to receive orders by intercepting chains of contracts and sub-contracts. Issues of improvement countermeasure of social problem, living, and compensation including rights of residence and environment are excluded from the discussion.

• Journal of the Society of Disaster Information
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• v.13 no.2
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• pp.233-248
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• 2017

Uniform laws and regulations and reasonable design is necessary for the prevention of possible fire in super high-rise building. To this end, this study focused on super high-rise and massive building-related architectural review performance-based design (PBD) evaluation disaster impact assessment (DIA), and provided fire engineering measures for improving fire prevention on the basis of performance-based design by analyzing the buildings subject to these systems and problems in terms of contents. Above all, in the aspect of law and standard improvement, first, with regard to dual parts of two statutes though significant portion of them has the same contents in performance-based design (PBD) evaluation and disaster impact assessment (DIA), it is necessary to operate the systems after making them conform with each other and consolidating or abolishing them. Second, if it is impossible to consolidate or abolish performance-based design (PBD) evaluation and disaster impact assessment (DIA), the areas of contents of performance-based design (PBD) evaluation and disaster impact assessment (DIA) should be precisely classified and established. Next, engineering improvement measures against fire hazard in super high-rise building are as follows. First, it is necessary to revise the provisions of straight-run stairs in special escape stairs. And in case of installing a mechanical smoke exhaust system instead of smoke vent, sandwich pressurization used in the United Stated should be permitted. Second, with regard to smoke control system for special escape stairs, it was shown that there was necessity for revising the standards in order to enable air to be supplied according to section in case of fire, carrying out performance-based design, and the like from the early design stages to the completion stages. In the future, it is expected that an epoch-making contribution will be made to a decrease in casualties and property damage due to fire in case of super high-rise building where the results can be reflected after carrying out a study on maintenance and carrying out an additional study on other considerations of super high-rise building together with reflecting the improvement measures provided in the above-mentioned study.

• The Korean Journal of Air & Space Law and Policy
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• v.26 no.1
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• pp.271-297
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• 2011

Recently, risk of space accident possibility increased in according to commercial space activity and space debris. It failed launch satellite second times in South Korea. Therefore was discussed on liability and insurance issue. Generally, discuss of space insurance be divided two type. Firstly, space insurance relevant to launching satellite and in-orbit. Satellite Launch Insurance and In-Orbit Insurance by the Satellite Operator Secondly, space insurance relevant to Third Party Liability. The former is to protect owner of satellite and operator. The latter is to liable and indemnify owner of satellite and operator's liability. US, UK, France, Russia, South Korea forced to buy space insurance following to domestic law. This is a brief overview of risk allocation and insurance practices in the commercial space transportation industry today. We begin with traditional space transportation, i.e., commercial satellite launches. This is a mature industry with known players. Industry practices have developed and legislation has been adopted in the U.S. and other countries over the past decades to address liability and insurance issues. The primary focus here is on U.S. law, but the discussion of industry practice applies more generally. We then move on to a more exotic form of space transportation: Commercial human space flight. Several private companies are now signing up space tourists for commercial suborbital human space flight, advertised to become available in the near future. The United States amended its launch legislation in 2004 to promote commercial human space flight. But questions remain as to how this new industry will respond to the risk allocation regime established by the U.S. legislation, which leaves both the space flight operator and space tourist exposed to risk and potential liability. As a general proposition, state statutes and contractual waivers alone cannot be relied upon to provide adequate liability protection, and insurance will be required. Federally mandated contractual waivers by space flight participants or liability caps would be helpful to complement insurance solutions. Eventually, as the industry matures, such practices could be extended to an international legal regime. For all the issues mentioned above, I have studied the existing international treaties and several country's domestic law to the space by referring U.S's Commercial Space Launch Amendment Act of 2004 and concluded that uniform legal regime to govern these insurance issues should be established domestically and internationally in the future.

• Journal of Legislation Research
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• no.41
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• pp.229-260
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• 2011

European Union (EU) law has been a complex but at the same time fascinating subject of study due to its dynamic evolution. In particular, the Lisbon Treaty which entered into force in December 2009 represents the culmination of a decade of attempts at Treaty reform and harmonisation in diverse sectors. Amongst the EU private law fields, company law harmonisation has been one of the hotly debated issues with regards to the freedom of establishment in the internal market. Due to the significant differences between national provisions on company law, it seemed somewhat difficult to harmonise company law. However, Council Regulation 2157/2001 was legislated in 2001 and now provides the basis for the Statute for a European Company (or Societas Europaea: SE). The Statute is also supplemented by the Council Directive 2001/86 on the involvement of employees. The SE Statute is a legal measure in order to contribute to the internal market, and provides a choice for companies that wish to merge, create a joint subsidiary or convert a subsidiary into an SE. Through this option, the SE became a corporate form which is only available to existing companies incorporated in different Member States in the EU. The important question on the meaning of the SE Statute is whether the distinctive characteristics of the SE make it an attractive option to ensure significant numbers of SE registration. In fact, the outcome that has been made through the SE Statute is an example of regulatory competition. The traditional regulatory competition in the freedom of establishment has been the one between national statutes between Member States. However, this time is not a competition between Member States, which means that the Union has joined the area in competition between legal orders and is now in competition with the systems of company law of the Member States.Key Words : European Union, EU Company Law, Societas Europaea, SE Statute, One-tier System, Two-tier System, Race to the Bottom A quite number of scholars expect that the number of SE will increase significantly. Of course, there is no evidence of regulatory competition that Korea faces currently. However, because of the increasing volume of international trade and expansion of regional economic bloc, it is necessary to consider the example of development of EU company law. Addition to the existing SE Statute, the EU Commission has also proposed a new corporate form, Societas Private Europaea (private limited liable company). All of this development in European company law will help firms make their best choice for company establishment. The Delaware-style development in the EU will foster the race to the bottom, thereby improving the contents of company law. To conclude, the study on the development of European company law becomes important to understand the evolution of company law and harmonisation efforts in the EU.

• Korean Journal of Environment and Ecology
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• v.35 no.1
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• pp.81-91
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• 2021

The Democratic People's Republic of Korea did not have direct legislation on natural environmental conservation until the early 1970s when the regime was still in the early stage. The Law on Land was enacted in 1977 to provide the legal basis for protecting the natural environment, including land protection, protection zones, and forest formation and protection. The enactment of the Law on Environmental Protection in 1986 made progress on environmental conservation in the DPRK. The constitutional amendment in 1992 stipulated "the preservation and creation of the natural environment as the responsibility of the state." Based on the Framework Law on Environmental Protection, subordinate statutes in various fields were enacted after the1990s. While the committee designated and managed the protected zones in the early days, the Framework Law on Environmental Protection established the ground for the designation of legally protected areas, and the Law on Protection of Scenic Spots and Natural Monuments enacted in 1995, and the Law on Environmental Protection enacted in 2009 provided the details. Furthermore, the types of nature reserves include biosphere reserves, primeval forest reserves, animal reserves, plant reserves, and scenic reserves. The 2nd National Biodiversity Strategy and Action Plan established in 2007 based on the Convention on Biological Diversity(CBD) stated 326 protected zones in the DPRK. However, the 2018 United Nations list of Protected Areas shows only 31 registered zones, indicating the need to establish basic information on protected areas in DPRK. This study can provide basic information for a better understanding of the nature conservation system in the DPRK. Considering that environmental protection activities such as protection of endangered species and recovery of environmental pollution are subject to exceptions under the current sanctions against North Korea (UN Security Council, the United States), it will be possible to contribute to identifying possible inter-Korean cooperation projects in the field of the natural environment.

• The Korean Journal of Air & Space Law and Policy
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• v.18
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• pp.135-183
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• 2003

Aerospace force is a determining factor in a modem war. The combat field is expanding to space. Thus, the legitimacy of establishing aerospace force is no longer an debating issue, but "how should we establish aerospace force" has become an issue to the military. The standard limiting on the military use of space should be non-aggressive use as asserted by the U.S., rather than non-military use as asserted by the former Soviet Union. The former Soviet Union's argument is not even strongly supported by the current Russia government, and realistically is hard to be applied. Thus, the multi-purpose satellite used for military surveillance or a commercial satellite employed for military communication are allowed under the U.S. principle of peaceful use of space. In this regard, Air Force may be free to develop a military surveillance satellite and a communication satellite with civilian research institute. Although MTCR, entered into with the U.S., restricts the development of space-launching vehicle for the export purpose, the development of space-launching vehicle by the Korea Air Force or Korea Aerospace Research Institute is beyond the scope of application of MTCR, and Air Force may just operate a satellite in the orbit for the military purpose. The primary task for multi-purpose satellite is a remote sensing; SAR sensor with high resolution is mainly employed for military use. Therefore, a system that enables Air Force, the Korea Aerospace Research Institute, and Agency for Defense Development to conduct joint-research and development should be instituted. U.S. Air Force has dismantled its own space-launching vehicle step by step, and, instead, has increased using private space launching vehicle. In addition, Military communication has been operated separately from civil communication services or broadcasting services due to the special circumstances unique to the military setting. However, joint-operation of communication facility by the military and civil users is preferred because this reduces financial burden resulting from separate operation of military satellite. During the Gulf War, U.S. armed forces employed commercial satellites for its military communication. Korea's participation in space technology research is a little bit behind in time, considering its economic scale. In terms of budget, Korea is to spend 5 trillion won for 15 years for the space activities. However, Japan has 2 trillion won annul budget for the same activities. Because the development of space industry during initial fostering period does not apply to profit-making business, government supports are inevitable. All space development programs of other foreign countries are entirely supported by each government, and, only recently, private industry started participating in limited area such as a communication satellite and broadcasting satellite, Particularly, Korea's space industry is in an infant stage, which largely demands government supports. Government support should be in the form of investment or financial contribution, rather than in the form of loan or borrowing. Compared to other advanced countries in space industry, Korea needs more budget and professional research staff. Naturally, for the efficient and systemic space development and for the prevention of overlapping and distraction of power, it is necessary to enact space-related statutes, which would provide dear vision for the Korea space development. Furthermore, the fact that a variety of departments are running their own space development program requires a centralized and single space-industry development system. Prior to discussing how to coordinate or integrate space programs between Agency for Defense Development and the Korea Aerospace Research Institute, it is a prerequisite to establish, namely, "Space Operations Center"in the Air Force, which would determine policy and strategy in operating space forces. For the establishment of "Space Operations Center," policy determinations by the Ministry of National Defense and the Joint Chief of Staff are required. Especially, space surveillance system through using a military surveillance satellite and communication satellite, which would lay foundation for independent defense, shall be established with reference to Japan's space force plan. In order to resolve issues related to MTCR, Air Force would use space-launching vehicle of the Korea Aerospace Research Institute. Moreover, defense budge should be appropriated for using multi-purpose satellite and communication satellite. The Ministry of National Defense needs to appropriate 2.5 trillion won budget for space operations, which amounts to Japan's surveillance satellite operating budges.