• Journal of Korea Technology Innovation Society
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• v.19 no.4
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• pp.736-767
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• 2016

Recently, the social issue about harmful effects of nano-materials including nano-products to human body and environment have been raised, which were not expected in times past. To prevent the risks of nano-materials on the environment and human body, the regulatory policies are reinforced to ensure public health in world trends. In Korea, governmental department has prepared the policy for 'National nano-safety Management Master Plan' since 2011. However, it is very hard to manage all kinds of nano-materials, due to lack of nano-safety law and a wide range of nano-technology application. This study aims to analyze the current situation of the national policy related to nano-safety management and legislation, and also review the limitation of current system to propose improvement plan for nano-safety.

• Journal of Marine Bioscience and Biotechnology
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• v.15 no.2
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• pp.67-81
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• 2023

This study examines a business survey on the utilization of fishery by-products with the aim to assess the feasibility of incorporating these by-products into various industries. The research involved surveying 312 biocompanies across the country and conducting an empirical analysis based on the collected data. South Korea, a leading seafood-producing country with a developed seafood processing industry, provides conditions necessary to utilize seafood by-products as raw materials for the marine bioindustry. Among the surveyed biocompanies, 38.5% expressed their intention to engage in industrial activities involving the use of fishery by-products in the future, indicating a significant level of interest within the bioindustry in utilizing marine and fishery by-products. Companies showed interest in diverse materials, such as scales, fish bones, skin, and kelp holdfast beyond those currently defined under the Fisheries By-products Recycling Promotion Act (officially unnamed, 2021). This suggests a need for improvements in the regulatory framework to accommodate these diverse biomaterials. Furthermore, we propose enhancing the efficiency of fishery by-product utilization by focusing on regional specialization in marine bioindustry. This involves utilizing existing legal framework for upcycling fishery by-products and fostering a regionally specialized marine bioindustry.

• The Korean Society of Law and Medicine
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• v.22 no.1
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• pp.91-124
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• 2021

In May 2019, the Ministry of Food and Drug Safety revised the "Pharmaceutical Determination and Adjustment Criteria" with the content of differentially calculating the price of generic drugs according to the registration of the drug substance and meeting the requirements for their own bioequivalence test. According to this revised rule, if their own bioequivalence test is not conducted, even the generic drugs that have already been approved would be lowered in price. I wondered whether this system was introduced with sufficient public legal considerations regarding its legislative purposes and means. Therefore, I reviewed the contents of the revised notice based on whether or not it is valid to determine and adjust the price of generic drugs in terms of the legitimacy of legislative purposes and the proportionality principle after introducing the history and background of the rule. First, I raised a question as to whether the purpose of preventing the overrun of generic drugs is indeed legitimate in terms of the legitimacy of the purpose. In order for the revised notice of "reduction of drug prices when the test requirements are not met," to meet the conformity principle, the premise that it is difficult to recognize safety and effectiveness through consignment (joint) bioequivalence test or that these tests are insufficient in safety and efficacy verification than their own test must be established. Nevertheless, it seems that suffficient review has not been carried out. In order to achieve the purpose of securing safety and effectiveness, the focus should be on 'reinforcement of the standards for bioequivalence test and the management of the bioequivalence test itself' rather than whether it is a their own test or a consignment (joint) test. Third, it is contrary to the necessity and substantiality principle that strict standards are uniformly applied to the products that can be considered to have been sufficiently verified for safety and effectiveness after a considerable period of time has passed after the product approval. In many cases, revised administrative legislations quickly enacted and amended in the state of lack of legal review or consensus, while the regulatory effects resulting from it are quite direct and specific to the regulated person. In this respect, I emphasized that the administrative legislative process also requires substantial review and prior control of the regulatory purposes and means, and that the participation of stakeholders in the legislative procedure is to be strengthened.

• The Journal of the Korea Contents Association
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• v.21 no.7
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• pp.206-221
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• 2021

The demand of social responsibility for corporate is increasing gradually. The corporate can't secure the royal customers only with the effort of securing the competitiveness through the product, service quality. The corporate should act actively in order to satisfy the social expectation required by customers. With this background, this study conducted the survey that can verify the effect of how usual interest in corporate social responsibility interacts in order to investigate the difference depending on the characters of customers and how the corporate social responsibility has led the brand performance. As a result, the legal and economic responsibilities were found to have significant influence in forming the corporate brand image and the favorability. The ethic responsibility was found to play a key role in forming the reliable image but have the negative impact in forming the achievement image, innovative image. In terms of the effect of social responsibility on the corporate brand performance, the usual interest on the social responsibility was found to have no impact as a regulatory effect.

• Korean small business review
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• v.41 no.3
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• pp.95-106
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• 2019

The Economic Gab-Jil, where the stronger are forcing the weaker to sacrifice, is not only a serious social problem, but also it exhausts the vitality of the national economy. Especially, the issue of 'cost reduction (CR) of delivery price' in automobile industry, and the issue of 'tolls' and 'retaliating' in the franchise business are becoming more controversial. This paper suggests some measures to rectify the problems by an analysis using a game-theoretic model. One of the ways to change the 'bad equilibrium', where economic Gab-Jil is prevalent, to the 'good equiblium' is to strengthen the bargaining power of the weak by legal and institutional measures. It is also a more market-friendly system that is self-enforcing, where the regulation is automatically enforced by the incentives of the participants, without relying solely on the enforcement power of regulatory or supervisory bodies

• The Korean Journal of Air & Space Law and Policy
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• v.31 no.2
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• pp.145-176
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• 2016

Aviation safety can be secured through regulations and policies of various areas and thorough execution of them on the field. Recently, for aviation safety management Korea is making efforts to prevent aviation accidents by taking various measures: such as selecting and promoting major strategic goals for each sector; establishing National Aviation Safety Program, including the Second Basic Plan for Aviation Policy; and improving aviation related legislations. Obstacle limitation surface is to be established and publicly notified to ensure safe take-off and landing as well as aviation safety during the circling of aircraft around airports. This study intends to review current aviation obstacle management system which was designed to make sure that buildings and structures do not exceed the height of obstacle limitation surface and identify its operating problems based on my field experience. Also, in this study, I would like to propose ways to improve the system in legal and regulatory aspects. Nowadays, due to the request of residents in the vicinity of airports, discussions and studies on aviational review are being actively carried out. Also, related ordinance and specific procedures will be established soon. However, in addition to this, I would like to propose the ways to improve shortcomings of current system caused by the lack of regulations and legislations for obstacle management. In order to execute obstacle limitation surface regulation, there has to be limits on constructing new buildings, causing real restriction for the residents living in the vicinity of airports on exercising their property rights. In this sense, it is regarded as a sensitive issue since a number of related civil complaints are filed and swift but accurate decision making is required. According to Aviation Act, currently airport operators are handling this task under the cooperation with local governments. Thus, administrative activities of local governments that have the authority to give permits for installation of buildings and structures are critically important. The law requires to carry out precise surveying of vast area and to report the outcome to the government every five years. However, there can be many problems, such as changes in the number of obstacles due to the error in the survey, or failure to apply for consultation with local governments on the exercise of construction permission. However, there is neither standards for allowable errors, preventive measures, nor penalty for the violation of appropriate procedures. As such, only follow-up measures can be taken. Nevertheless, once construction of a building is completed violating the obstacle limitation surface, practically it is difficult to take any measures, including the elimination of the building, because the owner of the building would have been following legal process for the construction by getting permit from the government. In order to address this problem, I believe penalty provision for the violation of Aviation Act needs to be added. Also, it is required to apply the same standards of allowable error stipulated in Building Act to precise surveying in the aviation field. Hence, I would like to propose the ways to improve current system in an effective manner.

• The Korean Society of Law and Medicine
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• v.18 no.1
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• pp.237-264
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• 2017

With the onset of the Human Genome Project, social concerns about 'genetic information discrimination' have been raised, but the problem has not yet been highlighted in Korea. However, non-medical institutions' genetic testing which is related to disease prevention could be partially allowed under the revised "Bioethics and Safety Act" from June 30, 2016. In the case of one domestic insurance company, DTC genetic testing was provided for the new customer of cancer insurance as a complimentary service, which made the social changes related to the recognition of the genetic testing. At a time when precision medicine is becoming a new standard for medical care, discipline on genetic information discrimination has become a problem that can not be delayed anymore. Article 46 and 67 of the Bioethics Act stipulate the prohibition of discrimination on grounds of genetic information and penalties for its violation. However, these broad principles alone can not solve the problems in specific genetic information utilization areas such as insurance and employment. The United States, Canada, the United Kingdom, and Germany have different regulations that prohibit genetic information based discrimination. In the United States, Genetic Information Non-Discrimination Act takes a form that adds to the existing law about the prohibition of genetic information discrimination. In addition, the range of genetic information includes the results of genetic tests of individuals and their families, including "family history". Canada has recently enacted legislation in 2017, expanding coverage to general transactions of goods or services in addition to insurance and employment. The United Kingdom deals only with 'predictive genetic testing results of individuals'. In the case of insurance, the UK government and Association of British Insurers (ABI) agree to abide by a policy framework ('Concordat') for cooperation that provides that insurers' use of genetic information is transparent, fair and subject to regular reviews; and remain committed to the voluntary Moratorium on insurers' use of predictive genetic test results until 1 November 2019, and a review of the Concordat in 2016. In the case of employment, The ICO's 'Employment Practices Code (2011)' is used as a guideline. In Germany, Human Genetic Examination Act(Gesetz ${\ddot{u}}ber$ genetische Untersuchungen bei Menschen) stipulates a principle ban on the demand for genetic testing and the submission of results in employment and insurance. The evaluation of the effectiveness of regulatory framework, as well as the form and scope of the discipline is different from country to country. In light of this, it would be desirable for the issue of genetic information discrimination in Korea to be addressed based on the review of related regulations, the participation of experts, and the cooperation of stakeholders.

• The Korean Journal of Air & Space Law and Policy
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• v.29 no.1
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• pp.3-32
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• 2014

Safety Management System is the aviation industry policy for while operating the aircraft, to ensure the safety crew, aircraft and passengers. For operating a safe aircraft, in order to establish the international technical standards, the International Civil Aviation Organization has established the Annex 19 of the Convention on International Civil Aviation. As a result, member country was supposed to be in accordance with the policy of the International Civil Aviation Organization, to accept the international standard of domestic air law. The South Korean government announced that it would promote active safety management strategy in primary aviation policy master plan of 2012. And, by integrating and state safety programmes(ssp) and safety management system(sms) for the safe management of Annex 19 is to enforce the policy on aviation safety standards. State safety programmes(ssp) is a system of activities for the aim of strengthening the safety and integrated management of the activities of government. State safety programmes(ssp) is important on the basis of the data of the risk information. Collecting aviation hazard information is necessary for efficient operation of the state safety programmes(ssp) Korean government must implement the strategy required to comply with aviation methods and standards of the International Civil Aviation Organization. Airlines, must strive to safety features for safety culture construction and improvement of safety management is realized. It is necessary to make regulations on the basis of the aviation practice, for aviation safety regulatory requirements, aviation safety should reflect the opinion of the aviation industry.

• The Korean Journal of Air & Space Law and Policy
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• v.31 no.2
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• pp.215-236
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• 2016

This paper is related to a study on safety management of cosmic radiation in the aviation area, and as a comprehensive study encompassing not only aviation crew but also aviation traffic users, presents issues on an exposure to the cosmic radiation which authors predict may be intensified in a time to come. Although the government of the Republic of Korea has recently activated regulations related to the cosmic radiation, the following improvement measures are further urged to be carried out not only as a regulatory improvement for pushing ahead with effectiveness but also as a supplementary tool. Firstly, a dose limit corresponding to the international standard needs to be applied. Since the dose limit imposed by the Korean government is improperly higher than the international dose limit of the cosmic radiation, the present dose limit needs to be re-established in a range of "not exceeding the international recommendation". Secondly, a new methodology is needed such that aviation companies observe a yearly effective dose limit of passengers. A fact that only aviation crew is specified but passengers are excluded in the related regulation is based on a recommendation presented by the International Commission on Radiological Protection (ICRP). According to the recommendation, Korean government excluded passengers in the "Cosmic Radiation Safety Requirements for Crew". Among the present aviation regulations, there exists a protection standard for protecting aviation traffic users. However, it presents a damage protection only for ticket-related issues. Since this regulatory weakness provides a cause of endangering national health, the authors believe that an improvement in the regulation is needed without sticking to the recommendation from the ICRP. To this end, new regulations are strongly demanded from aspects of not only legal but also regulatory areas. The dose limit in accordance with the international standard is established. However, at least a minute amount of cosmic radiation is continuously acting on all people of Korea. Since more and higher level of cosmic ration may exist in the aviation space, an improved method of representing the minute amount of cosmic radiation in figures. As a result, a desirable regulation may be established for protecting not only crew but also aviation traffic users from being exposed to the cosmic radiation via a legislation of the desirable regulation.

• The Journal of Fisheries Business Administration
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• v.30 no.2
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• pp.1-23
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• 1999

In the Northeast Asian region fisheries agreements of the past regarding high seas as an agreement area were transformed or new agreements were introduced in order to conform to the EEZ regime. However, the existing joint regulatory zone which “open” status is somewhat similar to the high sea not only disappear, but also two new systems were established. To begin with, parties of the agreement claimed their EEZs to be from the territorial sea baselines to the extent set forth, problem of the fishery access of the other party under the agreement is to be solved on the principle of reciprocity and on recognizing of the catch results achieved in the past. In regards to the overlapping zones like neutral zone of the East Sea of Korea(Sea of Japan) and neutral zone to the south of the Cheju Island, provisional measures zones in the Yellow Sea and in the East China Sea, and transitional zone of the Yellow Sea special fisheries management systems reflecting the legal character of the zone involved are applied. Moreover, as fisheries agreements defining open sea as an agreement zone are not able to conform to the EEZ regime, so new fisheries agreements must be taken out from old systems and conceptions, and must be understood and enforced from the new point view. Therefore, countermeasures needed to do so should be developed, and their basic structure is as follows. Firstly, the basic concept of the EEZ regime requires that the coastal states have sovereign rights on their sea zones' natural resources and bear responsibilities appropriate to their allowed jurisdiction. Each Northeast Asian state should adjust the structure of fishing industries and employ advanced fisheries management system, and should make efforts toward such issues of the state policy as increasing fishery resources and preserving ocean environment. Secondly, measures should be developed to solve the international fisheries disputes which are to occur under enforcement of the new fisheries agreements system. In regards to the acts of violation the fisheries laws in the foreign EEZ the principle of jail sentence prohibition is established by the UN Convention on the Law of the Sea, and every fisheries agreement reflects this principle. Therefore, the present question is to consider concrete measures to enable the easy release of the seamen, who violated fisheries laws slightly and well-intently, through establishment and management of the guarantee fund needed to make collateral reasonable. Thirdly, Korean-Russian and Russian-Japanese fisheries relations were formed on the basis of the EEZ regime, since 1992 and 1977 respectively, and are expected to maintain mutually beneficial cooperative character. As for Korean-Chinese-Japanese fisheries relations, the operational problems of overlapping zones, and problem of the permits for EEZ mutual access should be solved on the basis of the principle of reciprocity and equity rather than unilaterally from any side.