• Korea Trade Review
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• v.48 no.3
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• pp.131-150
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• 2023

The purpose of this study was to find a countermeasure to the U.S. import refusals for the Korean healthcare and life sciences industry. To this end, an analysis of trends during the pandemic was conducted using the KITA Border Rejection Database, which includes information on items and types of import refusals. The reason for rejection was also analyzed according to the FDA violation codes. The degree of countermeasure for import refusals was identified by measuring the unit rejection rate (URR). The results of the analysis showed that the major U.S. import refusals for the Korean healthcare and life sciences industry had expanded from contact lenses to COVID-19 diagnostic kits and drugs after the pandemic broke out. The major reasons for import refusals were non-compliance with the Predicate Device and Drugs Act and non-approval by the FDA for products and facilities. On the other hand, the unit rejection rate (URR) of major items in the Korean healthcare and life sciences industry was measured higher than the industry average. The results therefore showed a low level of response to U.S. import refusals. The results of the analysis of reasons for import refusals by item according to FDA violation codes were as follows. First of all, the main violation for contact lenses and COVID-19 diagnostic kits corresponded to misbranding. This was often due to the fact that Korean companies did not provide the relevant notices and information required by the FDA. Many cases also failed to demonstrate a substantial equivalency compared to predicate devices already on the market. On the other hand, applications for new unapproved drugs were not accepted as they had yet to pass relevant regulations that would prove their safety and efficacy. In conclusion, import refusals for the Korean healthcare and life sciences industry were found to be closely related to technical barriers to trade (TBT).

• Journal of Distribution Research
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• v.17 no.5
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• pp.1-23
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• 2012

The conflict between major corporations and small and medium-sized businesses is being aggravated, the trickle down effect is not working properly, and, as the controversy surrounding the effectiveness of the business limiting system continues to swirl, the plan proposed to protect the business domain of small and medium-sized businesses, resolve polarization between these businesses and large corporations, and protect small family run stores is the suitable business type designation system for small and medium-sized businesses. The current status of carrying out this system of selecting suitable business types among small and medium-sized businesses involves receiving applications for 234 items among the suitable business types and items from small and medium-sized businesses in manufacturing, and then selecting the items of the consultative group by analyzing and investigating the actual conditions. Suitable business type designation in the service industry will involve designation with priority on business types that are experiencing social conflict. Three major classifications of the service industry, related to the livelihood of small and medium-sized businesses, will be first designated, and subsequently this will be expanded sequentially. However, there is the concern that when designated as a suitable business type or item, this will hinder the growth motive for small to medium-sized businesses, and designation all cause decrease in consumer welfare. Also it is highly likely that it will operate as a prior regulation, cause side-effects by limiting competition systematically, and also be in violation against the main regulations of the FTA system. Moreover, it is pointed out that the system does not sufficiently reflect reverse discrimination factor against large corporations. Because conflict between small to medium sized businesses and large corporations results from the expansion of corporations to the service industry, which is unrelated to their key industry, it is necessary to introduce an advanced contract method like a master franchise or local franchise system and to develop local small to medium sized businesses through a franchise system to protect these businesses and dealers. However, this method may have an effect that contributes to stronger competitiveness of small to medium sized franchise businesses by advancing their competitiveness and operational methods a step further, but also has many negative aspects. First, as revealed by the Ministry of Knowledge Economy, the franchise industry is contributing to the strengthening of competitiveness through the economy of scale by organizing existing individual proprietors and increasing the success rate of new businesses. It is also revealed to be a response measure by the government to stabilize the economy of ordinary people and is emphasized as a 'useful way' to revitalize the service industry and improve the competitiveness of individual proprietors, and has been involved in contributions to creating jobs and expanding the domestic market by providing various services to consumers. From this viewpoint, franchises fit the purpose of the suitable business type system and is not something that is against it. Second, designation as a suitable business type may decrease investment for overseas expansion, R&D, and food safety, as well negatively affect the expansion of overseas corporations that have entered the domestic market, due to the contraction and low morale of large domestic franchise corporations that have competitiveness internationally. Also because domestic franchise businesses are hard pressed to secure competitiveness with multinational overseas franchise corporations that are operating in Korea, the system may cause difficulty for domestic franchise businesses in securing international competitiveness and also may result in reverse discrimination against these overseas franchise corporations. Third, the designation of suitable business type and item can limit the opportunity of selection for consumers who have up to now used those products and can cause a negative effect that reduces consumer welfare. Also, because there is the possibility that the range of consumer selection may be reduced when a few small to medium size businesses monopolize the market, by causing reverse discrimination between these businesses, the role of determining the utility of products must be left ot the consumer not the government. Lastly, it is desirable that this is carried out with the supplementation of deficient parts in the future, because fair trade is already secured with the enforcement of the franchise trade law and the best trade standard of the Fair Trade Commission. Overlapping regulations by the suitable business type designation is an excessive restriction in the franchise industry. Now, it is necessary to establish in the domestic franchise industry an environment where a global franchise corporation, which spreads Korean culture around the world, is capable of growing, and the active support by the government is needed. Therefore, systems that do not consider the process or background of the growth of franchise businesses and harm these businesses for the sole reason of them being large corporations must be removed. The inhibition of growth to franchise enterprises may decrease the sales of franchise stores, in some cases even bankrupt them, as well as cause other problems. Therefore the suitable business type system should not hinder large corporations, and as both small dealers and small to medium size businesses both aim at improving competitiveness and combined growth, large corporations, small dealers and small to medium sized businesses, based on their mutual cooperation, should not include franchise corporations that continue business relations with them in this system.

• The Korean Journal of Air & Space Law and Policy
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• v.26 no.1
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• pp.3-30
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• 2011

According to the Article 86 of the United Nations on the Law of the Sea(UNCLOS) the provisions of high seas apply to all parts of the sea that are not included in the exclusive economic zone, in the territorial sea or in the internal waters of a State, or in the archipelagic waters of an archipelagic State. Article 87 also stipulates the freedom of the high seas. International laws on the flight over the high seas are found as follows; Firstly, as far as the nationality of the aircraft is concerned, its legal status is quite different from the ship where the flags of convenience can be applied practically. There is no flags of convenience of the aircraft. Secondly, according to the Article 95 of UNCLOS warships on the high seas have complete immunity from the jurisdiction of any State other than the flag State. We can suppose that the military(or state) aircraft over the high seas have also complete immunity from the jurisdiction of any State other than the flag State. Thirdly, according to the Article 101 of UNCLOS piracy consists of any act of voluntary participation in the operation of a ship or of an aircraft with knowledge of facts making it a pirate ship or aircraft. We can conclude that piracy can de done by a pirate aircraft as well as a pirate ship. Fourthly, according to the Article 111 (5) of UNCLOS the right of hot pursuit may be exercised only by warships or military aircraft, or other ships or aircraft clearly marked and identifiable as being on government service and authorized to that effect. We can conclude that the right of hot pursuit may be exercised only military aircraft, or aircraft clearly marked and identifiable as being on government service and authorized to that effect. Fifthly, according to the Article 110 of UNCLOS a warship which encounters on the high seas a foreign ship, is not justified in boarding it unless there is reasonable ground for suspecting that: (a) the ship is engaged in piracy, (b) the ship is engaged in the slave trade, (c) the ship is engaged in an authorized broadcasting and the flag State of the warship has jurisdiction under article 109, (d) the ship is without nationality, or (e) though flying a foreign flag or refusing to show its flag, the ship is, in reality, of the same nationality as the warship. These provisions apply mutatis mutandis to military aircraft. Sixthly, according to the Article 1 (5)(dumping), 212(pollution from or through the atmosphere), 222(enforcement with respect to pollution from or through the atmosphere) of UNCLOS aircraft as well as ship is very much related to marine pollution. Seventhly, as far as the crime on board aircraft over the high seas is concerned 1963 Convention on the Offences and Certain Other Acts Committed on Board Aircraft(Tokyo Convention) will be applied, and as for the hijacking over the high seas 1970 Convention for the Suppression of Unlawful Seizure of Aircraft(Hague Convention) and as for the sabotage over the high seas 1971 Convention for the Suppression of Unlawful Acts Against the Safety of Civil Aviation(Montreal Convention) will be applied respectively. These three conventions recognize the flag state jurisdiction over the crimes on board aircraft over the high seas. Eightly, as far as reconnaissance by foreign aircraft in the high seas toward the coastal States is concerned it is not illegal in terms of international law because its act is done in the high seas. Ninthly as for Air Defence Identification Zone(ADIZ) there are no articles dealing with it in the 1944 Chicago Convention. The legal status of the foreign aircraft over this sea zone might be restricted to the regulations of the coastal states whether this zone is legitimate or illegal. Lastly, the Arctic Sea is the frozen ocean. So the flight over that ocean is the same over the high seas. Because of the climate change the Arctic Sea is getting melted. If the coastal states of the Arctic Sea will proclaim the Exclusive Economic Zone(EEZ) as the ocean is getting melted, the freedom of flight over that ocean will also be restricted to the regulations of the coastal states.

• Journal of the Society of Cosmetic Scientists of Korea
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• v.23 no.1
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• pp.5-20
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• 1997

War and poverty depress the consumption of cosmetics, while peace and prosperity encourage their proliferation. With the end of World War II, the US, Europe and Japan witnessed rapid growth of their cosmetic industries. The ending of the Cold War has stimulated the growth of the industry in Eastern Europe. Improved economies, and mass communication are also responsible for the fast growth of the cosmetic industries in many Asian nations. The rapid development of the cosmetic industry in mainland China over the past decade proves that changing economies and political climates can deeply affect the health of our business. In addition to war, economy, political climate and mass communication, factors such as lifestyle, religion, morality and value concepts, can also affect the growth of our industry. Cosmetics are the product of the society. As society and the needs of its people change, cosmetics also evolve with respect to their contents, packaging, distribution, marketing concepts, and emphasis. In many ways, cosmetics mirror our society, reflecting social changes. Until the early 70's, cosmetics in the US were primarily developed for white women. The civil rights movement of the 60's gave birth to ethnic cosmetics, and products designed for African-Americans became popular in the 70's and 80's. The consumerism of the 70's led the FDA to tighten cosmetic regulations, forcing manufacturers to disclose ingredients on their labels. The result was the spread of safety-oriented, "hypoallergenic" cosmetics and more selective use of ingredients. The new ingredient labeling law in Europe is also likely to affect the manner in which development chemists choose ingredients for new products. Environmental pollution, too, can affect cosmetics trends. For example, the concern over ozone depletion in the stratosphere has promoted the consumption of suncare products. Similarly, the popularity of natural cosmetic ingredients, the search of non-animal testing methods, and ecology-conscious cosmetic packaging seen in recent years all reflect the profound influences of our changing world. In the 1980's, a class of efficacy-oriented skin-care products, which the New York Times dubbed "serious" cosmetics, emerged in the US. "Cosmeceuticals" refer to hybrids of cosmetics and pharmaceuticals which have gained importance in the US in the 90's and are quickly spreading world-wide. In spite of regulatory problems, consumer demand and new technologies continue to encourage their development. New classes of cosmeceuticals are emerging to meet the demands of increasingly affluent Asian consumers as we enter the 21st century. as we enter the 21st century.

• Journal of Distribution Science
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• v.9 no.1
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• pp.17-27
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• 2011

As the world becomes more globalized, business competition becomes fiercer, while consumers' needs for less expensive quality products are on the increase. Business operations make an effort to secure a competitive edge in costs and services, and the logistics industry, that is, the industry operating the storing and transporting of goods, once thought to be an expense, begins to be considered as the third cash cow, a source of new income. Logistics centers are central to storage, loading and unloading of deliveries, packaging operations, and dispensing goods' information. As hubs for various deliveries, they also serve as a core infrastructure to smoothly coordinate manufacturing and selling, using varied information and operation systems. Logistics centers are increasingly on the rise as centers of business supply activities, growing beyond their previous role of primarily storing goods. They are no longer just facilities; they have become logistics strongholds that encompass various features from demand forecast to the regulation of supply, manufacturing, and sales by realizing SCM, taking into account marketability and the operation of service and products. However, despite these changes in logistics operations, some centers have been unable to shed their past roles as warehouses. For the continuous development of logistics centers, various measures would be needed, including a revision of current supporting policies, formulating effective management plans, and establishing systematic standards for founding, managing, and controlling logistics centers. To this end, the research explored previous studies on the use and effectiveness of logistics centers. From a theoretical perspective, an evaluation of the overall introduction, purposes, and transitions in the use of logistics centers found issues to ponder and suggested measures to promote and further advance logistics centers. First, a fact-finding survey to establish demand forecast and standardization is needed. As logistics newspapers predicted that after 2012 supply would exceed demand, causing rents to fall, the business environment for logistics centers has faltered. However, since there is a shortage of fact-finding surveys regarding actual demand for domestic logistic centers, it is hard to predict what the future holds for this industry. Accordingly, the first priority should be to get to the essence of the current market situation by conducting accurate domestic and international fact-finding surveys. Based on those, management and evaluation indicators should be developed to build the foundation for the consistent advancement of logistics centers. Second, many policies for logistics centers should be revised or developed. Above all, a guideline for fair trade between a shipper and a commercial logistics center should be enacted. Since there are no standards for fair trade between them, rampant unfair trades according to market practices have brought chaos to market orders, and now the logistics industry is confronting its own difficulties. Therefore, unfair trade cases that currently plague logistics centers should be gathered by the industry and fair trade guidelines should be established and implemented. In addition, restrictive employment regulations for foreign workers should be eased, and logistics centers should be charged industry rates for the use of electricity. Third, various measures should be taken to improve the management environment. First, we need to find out how to activate value-added logistics. Because the traditional purpose of logistics centers was storage and loading/unloading of goods, their profitability had a limit, and the need arose to find a new angle to create a value added service. Logistic centers have been perceived as support for a company's storage, manufacturing, and sales needs, not as creators of profits. The center's role in the company's economics has been lowering costs. However, as the logistics' management environment spiraled, along with its storage purpose, developing a new feature of profit creation should be a desirable goal, and to achieve that, value added logistics should be promoted. Logistics centers can also be improved through cost estimation. In the meantime, they have achieved some strides in facility development but have still fallen behind in others, particularly in management functioning. Lax management has been rampant because the industry has not developed a concept of cost estimation. The centers have since made an effort toward unification, standardization, and informatization while realizing cost reductions by establishing systems for effective management, but it has been hard to produce profits. Thus, there is an urgent need to estimate costs by determining a basic cost range for each division of work at logistics centers. This undertaking can be the first step to improving the ineffective aspects of how they operate. Ongoing research and constant efforts have been made to improve the level of effectiveness in the manufacturing industry, but studies on resource management in logistics centers are hardly enough. Thus, a plan to calculate the optimal level of resources necessary to operate a logistics center should be developed and implemented in management behavior, for example, by standardizing the hours of operation. If logistics centers, shippers, related trade groups, academic figures, and other experts could launch a committee to work with the government and maintain an ongoing relationship, the constraint and cooperation among members would help lead to coherent development plans for logistics centers. If the government continues its efforts to provide financial support, nurture professional workers, and maintain safety management, we can anticipate the continuous advancement of logistics centers.

• Tuberculosis and Respiratory Diseases
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• v.44 no.4
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• pp.822-835
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• 1997

Background : There have been many in vitro evidences that interleukin-4(IL-4) might be the most important cytokine inducing IgE synthesis from B-cells, and interferon-gamma(IFN-$\gamma$) might be a main cytokine antagonizing IL-4-mediated IgE synthesis. Recently some reports demonstrated that IFN-$\gamma$ might be used as a new therapeutic modality in some allergic diseases with high serum IgE level, such as atopic dermatitis or bronchial asthma. To evaluate the in vivo effect of IFN-$\gamma$ in bronchial asthma we tried a clinical study. Methods : Fifty bronchial asthmatics(serum IgE level over 200 IU/ml) who did not respond to inhaled or systemic corticosteroid treatment, and 17 healthy nonsmoking volunteers were included in this study. The CD 23 expressions of peripheral B-cells, the IL-4 activities of peripheral T-cells, the serum soluble CD23(sCD23) levels, and the superoxide anion(${O_2}^-$) generations by peripheral PMN were compared between bronchial asthmatics and normal subjects. The IL-4 activities of peripheral T-cells were analyzed by T-cell supernatant (T-sup)-induced CD23 expression from tonsil B-cells. In bronchial asthmatics the serum IgE levels and histamine $PC_{20}$ in addition to the above parameters were also compared before and after IFN-$\gamma$ treatment. IFN-$\gamma$ was administered subcutaneously with a weekly dose of 30,000 IU per kilogram of body weight for 4 weeks. Results : The ${O_2}^-$ generations by peripheral PMNs in bronchial asthmatics were higher than normal subjects($8.23{\pm}0.94$ vs $5.00{\pm}0.68\;nmol/1{\times}10^6$ cells, P<0.05), and significantly decreased after IFN-$\gamma$ treatment compared to initial values($3.69{\pm}0.88$ vs $8.61{\pm}1.53\;nmol/1{\times}10^6$ cells, P<0.05). CD23 expression of peripheral B-cells in bronchial asthmatics was higher than normal subjects($47.47{\pm}2.96%$, vs $31.62{\pm}1.92%$, P<0.05), but showed no significant change after IFN-$\gamma$ treatment. The serum sCD23 levels in bronchial asthmatics were slightly higher than normal subjects($191.04{\pm}23.3\;U/ml$ vs $162.85{\pm}4.85\;U/ml$), and 11(64.7%) of 17 patients showed a decreasing pattern in their serum sCD23 levels after IFN-$\gamma$ treatment. However the means of serum sCD23 levels were not different before and after IFN-$\gamma$ treatment. The IL-4 activities of peripheral T-cells in bronchial asthmatics were slightly higher than normal subjects($22.48{\pm}6.81%$ vs $18.90{\pm}2.43%$), and slightly increased after IFN-$\gamma$ treatment($27.90{\pm}2.56%$). Nine(60%) of 15 patients showed a decreasing pattern in their serum IgE levels after IFN-$\gamma$ treatment. And the levels of serum IgE were significantly decreased after IFN-$\gamma$ treatment compared to initial values ($658.67{\pm}120.84\;IU/ml$ vs $1394.32{\pm}314.42\;IU/ml$, P<0.05). Ten(83.3%) of 12 patients showed an improving pattern in bronchial hyperresponsiveness after IFN-$\gamma$ treatment, and the means of histamine $PC_{20}$ were significantly increased after IFN-$\gamma$ treatment compared to initial values ($1.22{\pm}0.29mg/ml$ vs $0.69{\pm}0.17mg/ml$, P<0.05). Conclusion : Our results suggest that IFN-$\gamma$ may be useful as well as safety in the treatment of bronchial asthmatics with high serum IgE level and that in vivo effects of IFN-$\gamma$ may be different from its in vitro effects on the regulations of IgE synthesis or the respiratory burst of PMN.