• 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.

• Radiation Oncology Journal
• /
• v.11 no.2
• /
• pp.249-258
• /
• 1993

Between March 1983 and December 1989, ninety-six patients with intracranial glioma were treated in the Department of Therapeutic Radiology, Kangnam St. Mary's Hospital, Catholic University Medical College. We retrospectively reviewed each case to evaluate variable factors influencing the treatment results and to develop an optimal therapy Policy. Median follow-up is 57 months (range: 31~133 months). Of the 96 patients, 60 $(63\%)$ were males and 36 $(37\%)$ were females. Ages ranged from 3 to 69 years (median 42 years). The most common presenting symtoms were headeche $(67\%)$ followed by cerebral motor and sensory discrepancy $(54\%),$ nausea and vomiting $(34\%),$ seizure $(19\%),$ mental change $(10\%)$ and memory and calculation impairment $(8\%).$ Eighty five $(88.5\%)$ patients all, except 11 $(11.5\%)$ brain stem lesions, were biopsy proven intracranial glioma. The distribution by histologic type was 64 astrocytomas $(75\%),$ 4 mixed oligoastrocytomas $(5\%),$ and 17 oligodendrogliomas $(20\%).$ Fourty nine patients $(58\%$ were grade I, II histology and 36 $(42\%)$ patients were grade III, IV histology. Of the 96 patients, 64 $(67\%)$ recieved postoperative RT and 32 $(33\%)$ were treated with primary radiotherapy. Gross total resection was peformed in 14 $(16\%)$ patients, subtotal resection En 29 $(34\%),$ partial resection in 21 $(25\%),$ and biopsy only in 21 $(25\%).$ Median survival time was 53 months (range 2~ 133 months), and 2- and, 5-year survival rate were $69\%,49\%$ respectively. 5-year survival rate by histologic grade was grade I, $70\%,$ grade II, $58\%,$ grade III, $28\%,$ and grade IV, $15\%.$ Multivariated analysis demonstrate that age at diagnosis (p=0.0121), Karnofsky performance Status (KPS) (p=0.0002), histologic grade (p=0.0001), postoperative radiation therapy (p=0.0278), surgical extent (p =0.024), cerebellar location of tumor (p=0.0095) were significant prognostic factors influencing on survival.

• KOREAN JOURNAL OF CROP SCIENCE
• /
• v.61 no.1
• /
• pp.17-24
• /
• 2016

Drought caused by global climate change is one of serious problems for rice cultivation. However, it was little reported the impact of drought on rice cultivation in Korea. In here, to assess impact of drought on rice varieties in Korean climate condition, growth characteristics and yield components of rice were compared on irrigated and partially irrigated rice paddy field. First, we have chosen 11 rice varieties including 'Saeilmi' and 'Shindongjin' which are widely cultivated in Korea. For partially irrigated rice paddy treatment, we have withheld irrigation from 25 days after transplanting and water supply was totally dependent on rainfall for rice cultivation. When we examined early plant height and tiller number of these varieties on partially irrigated rice paddy were reduced 1.6% to 18.4% and 10.4% to 33.1%, respectively, and these reduction rate were highly correlated with yield loss in our experimental conditions. Among rice yield components, panicle number was decreased 10.5% to 30.1% according to rice varieties and reduced panicle number was highly correlated with yield loss. Grain number per panicle, grain filling rate and 1,000 seeds weight did not have correlation with yield loss of rice varieties. These result means that growth stage, especially the tillering stage, is seriously affected by drought on rice cultivation in Korea. And we suggest that 'Saeilmi', 'Ilmi' and 'Ilpum' are good for rice cultivation on drought prone rice field in Korea.

• The Journal of the Korea Contents Association
• /
• v.12 no.9
• /
• pp.156-171
• /
• 2012

It is the time of the Korean Wave booming throughout the world, placing Korean culture in the center of the world and its added value is unaccountable. At this prosperity, the preserving of the archetype of Korean dancing and digital contents making is becoming a task not only for the government but also for the private sector because culture industry has enormous added values. To achieve such goals, contents development is an urgent matter but establishing the value of the archetype of Korean traditional dancing must have priority. The public has to take an active role in rediscovering the values of traditional culture, and as the representative of Korean identity traditional dancing must be the object of a systematic art policy. This study will review the current status of 'digital contents program of the archetype of culture' for traditional dancing and will reconsider the modern value of preserving the archetype of culture to make a suggestion to the direction of culture art policies in the near future. The study acknowledged the lack of technical personnel majoring in the archetype of traditional dancing and the need of reviewing the credibility of historical research procedures. Even with the studies by industry-university collaboration and positioning of specialists, effective policies that will form the foundation for private firms to train personnels is in urgent need. In other words, training personnels, allocation of resource, securing funds, policies promoting collaboration between private and individual businesses, and the commercial recognition at private firms are still far from establishing. This is due to the fact that archetype of culture is not a business that creates revenue immediately, therefore the recognition of traditional dancing as an investable item by business-oriented firms or movements are difficult to find. To overcome such situation, software oriented policies that establish open communication and sharing with the public should be done at first rather than the quantity oriented hardware policies of contents development. Through this process the public can change the attitude on traditional dancing and traditional dancing could be newly recognized as a creative repository of culture and as public businesses giving birth to economic value.

• Tuberculosis and Respiratory Diseases
• /
• v.55 no.6
• /
• pp.570-578
• /
• 2003

Background : Ambient particles during Asian dust events are usually sized less than $10{\mu}m$, known to be associated with the adverse effects on the general populations. But, there has been no considerable evidence linking these particles to the adverse effects on airways. The objectives of this study was to investigate the possible adverse effects of Asian dust events on respiratory function and symptoms in subjects with bronchial asthma. Patients and Methods : From march to June 2002, Asthmatic patients who were diagnosed with bronchial challenge test or bronchodilator response were enrolled. We divided them into three groups; mild, moderate, and severe, according to the severity. Subjects with other organ insufficiency such as heart, kidney, liver, and malignancy were excluded. All patients completed twice daily diaries and recorded peak flow rate, respiratory symptom, and daily activity. Daily and hourly mean pollutant levels of particulate matter < $10{\mu}m$ in diameter($PM_{10}$), nitrogen dioxide($NO_2$), sulphur dioxide($SO_2$), ozone($O_3$) and carbon monoxide(CO) were measured at the 10 different monitoring sites. Results : Dust events occured 14 times during the study period. Daily averages of 4 air pollutant were measured with an increased level of $PM_{10}$, decreased level of $NO_2$ and $SO_2$, and no change in CO during dust days compared to those during control days. An increase in $PM_{10}$ concentration was associated with an increase of subjects with PEF variability of >20% (p<0.05), night time symptom(p<0.05), and a decrease in mean PEF (p<0.05), which were calculated by the longitudinal data analysis. Otherwise, there was no association between $PM_{10}$ level and bronchodialtor inhaler, and daytime respiratory symptoms. Conclusion : This study shows evidence that ambient air pollution, especially $PM_{10}$, during Asian dust events, could be one of the many aggravating factors at least in patients with airway diseases. This data can be used as a primary source to set up a new policy on air environmental control and to evaluate the safety of air pollution index. We also expect that this research will help identify precise components of dust, which are more linked to the adverse effects.

• Korean Journal of Environment and Ecology
• /
• v.29 no.4
• /
• pp.580-589
• /
• 2015

The artificially grown forests of larch, planted in accordance with the nationwide afforestation policy in the 1970s, are located inside national parks. This study intended to induce a forestation system by which the forests develop into an ecologically healthy and broadleaved ecosystem with broad species diversity. For this, the aspects of natural regeneration of broadleaves from 2010 to 2013 after thinning by density (30%, 50%, and 70%) in 2009 were surveyed using the larch forest in the Woljeong Temple region inside Odaesan National Park. There were no trees that were larger than 2 cm in in diameter at breast height among the trees recently introduced between 2012 and 2013. A significant number of herbs have been introduced to the subsurface alongside young arboreal trees species such as Bumalda bladdernut, Acer triflorum, Cornus controversa etc and shrubs. However, many woody species did not survive the competition with herbs and repeated withering and regeneration. The number of woody species generated within the 30% cutting area was 440 species in 2013 and this figure has been increasing twofold each year. The number of woody plants within the 50% cutting area also showed an upward tendency and most plants did not survive in the competition with herbs and Sasa borealis and withered in only 1 ~ 2 years after generation. Unlike other thinning areas, the 70% cutting area showed 608 broadleaved trees, reflecting a decrease from 748 trees in 2012. This appeared to be attributed to the luxuriance of S. borealis and the sharp increase of fatsia following the inflow of total sunlight to the forest floor. Herbs were hardly generated due to the influence of S. borealis. Regarding the density for thinning at 50% or upper height, the forest treatment division shall maintain a proper density in the course of inducing artificial forestation of larch into natural broadleaved forests considering the luxuriance of sasa borealis and herbs due to the inflow of total sunlight to the forest floor.

• Korean Journal of Environment and Ecology
• /
• v.32 no.1
• /
• pp.30-38
• /
• 2018

The purpose of this paper is to provide reference data about propagation, restoration, and preparation of policy of endangered Sarcandra glabra (Thunb.) Nakai by investigating growth response and variation of ecological niche breadth according to moisture and nutrient under the condition of elevated $CO_2$ concentration and elevated temperature. We divided the investigation into the controlled group and treated group (elevated $CO_2$ concentration and elevated temperature) and then varied the moisture and nutrient treatment for testing. The results showed that the ecological niche breadth was wide at moisture and nutrient gradients of 0.899 and 0.844, respectively, under control. Also, the ecological niche breadth regarding the moisture and nutrient gradients under treatment simulating global warming was wider as 6.60% and 2.09%, respectively. Therefore, moisture and nutrient will not be the restriction factors concerning the growth of Sarcandra glabra under continued global warming. However, it will be advisable to specify the nutrient content condition in the soil to be 10% for population restoration when growing Sarcandra glabra in the green house which is not affected by external environment since the studies of rearing reaction reported that Sarcandra glabra prefer 10% of nutrient content than 0-5%. Furthermore, it is necessary to protect evergreen broad-leaved forest where is the natural habitat of Sarcandra glabra that has relatively high nutrient content.

• Korean journal of communication and information
• /
• v.46
• /
• pp.511-555
• /
• 2009

Media-related regulations can be classified into two categories; regulations of individual media contents and regulations regarding the entry to and withdrawal from a certain field. In this dissertation, ownership regulations are regarded as legal and political measures so as to prevent the monopoly and oligopoly of public opinion, and to secure its diversity. Every country has its own regulation model according to its particular media environment. Korea too is obliged to actively respond to its environmental changes, at the same time vitalizing the media industry and protecting consumers' rights and interests. Strong political intentions to protect the public interest is necessary when it comes to media regulation policies, especially in the circumstances that public interest is an industrial priority. As the convergence of broadcasting and telecommunications is leading to a major shift in the media industry, the regulation of cross-media ownership is an issue involving potential conflicts among media-owners, non-governmental organizations and the authorities concerned, depending on their various viewpoints regarding the media industry. In this paper, an attempt was made to search necessity of redefining 'public interest', which is the logic behind the restriction of cross-media ownership, and to reconceptualize issues on the centralization and diversity of media. First, an examination of the actual conditions of newspaper companies was carried out in order to reinvestigate domestic cross-media ownership issues, which is represented by the cross-ownership issue of newspapers and broadcasting stations. Next, the dilemma of policies stimulated by the fusion of media was discussed based on cross-media ownership restrictions, and the need for efficient conflict control was suggested. Finally, proposals on the independency and public confidence of media-related policy-making authorities, the rationalization of regulation models, an itemized discussion on cross-media ownership regulation issues, the elaboration of measures for a balanced development among media were made. It could be found that a number of foreign countries were still facing challenges to prevent monopoly and oligopoly of the public opinion and the industry. A solution to settle disagreements about the dilemma of the media industry, including the cross-media ownership regulation issues, must be arranged on the grounds of 'mutual respect of public interest and industrial interest', In Korea, an ease on the ownership regulations adapting to the change in the media industry may be considered, however the softening of the cross-media ownership regulations must be approached with the utmost care. Paradoxically Relieving cross-media ownership regulations may be considered the foundation of a richer field of journalism, where there is no need for concern over the monopoly and oligopoly of public opinion.

• 대한공업교육학회지
• /
• v.43 no.2
• /
• pp.1-23
• /
• 2018

This study analyzes the status of the NCS (National Competency Standards) based curriculum in which the apprenticeship program of vocational education and training high schools (VET high schools) participating in the apprenticeship system is included to present suggestions for organizing and evaluating the apprenticeship curriculum. For this, data on the status of curricula of 141 courses (75.8%) in 116 VET high schools participating in the apprenticeship system were analyzed. The results of the study are as follows. First, the average time assigned for the apprenticeship program was 1,054.2 hours and the apprenticeship program was organized in 12.4 courses in the school curriculum. The degree of evaluation per NCS competency unit of courses was found to be 95.4% for evaluation per competency unit and 5.6% for evaluation regardless of competency unit. Second, the average number of courses including apprenticeship programs in time assigned for the courses in school curriculum (when appropriate) was 11.5 (93.1%) and the average number of courses including apprenticeship programs in the contents of the school curriculum courses (when appropriate) was 10.6 (85.5%). Third, it was found that courses organized only for 'common competency units' were 8.5 (68.5%) and the number of courses in which 'student option competency units' were included was found to be 3.9 (31.5%). In addition to these study results, policy suggestions such as applying suspension on the approval period for change of curriculum by metropolitan and provincial offices of education, inspection on curriculum and enhanced consulting by metropolitan and provincial offices of education, providing plans to evaluate 'student option competency units', newly establishing 'subjects specialized for companies' or 'student option subjects' in national level curriculum are proposed.

• KDI Journal of Economic Policy
• /
• v.30 no.2
• /
• pp.129-155
• /
• 2008

The rate of antibiotics prescription for an acute airway infection significantly varies depending upon the diagnosis type, specialty, and the location of the hospital along with many other related factors. The objective of this study is to empirically investigate the possible relationship between the antibiotics prescription rates for an acute airway infection and the degree of competition in the hospital market regions of mainly the providers of primary medical care services such as clinics, internal medicines, pediatrics and otorhinolaryngology department. Using the data from Health Insurance Review and Assessment Service (HIRA) regarding the hospitals' antibiotics prescription rates for the acute airway infection and controlling for selected variables of demand and supply sectors, this study tries to figure out that the degree of competition in the hospital market, regardless of what type of competition indexes we employed, has a statistically significant effect on the variations of antibiotics prescription rate of the clinics in local areas. This result implies that as an economic consideration itself, the change in the degree of competition in the hospital market can play a crucial role influencing the treatment behaviors of the medical doctors. More specifically, this study reveals that as the degree of competition increases the antibiotics prescription rate goes up. This result means that if the market becomes more competitive in a specific region so that it might cause a reduction in doctor's income, doctors with rational decision-making process, recognize that the benefit created from inducing patients' seemingly unnecessary demand for medical care (income effect) would be higher than the costs associated with sustaining their targeted income (substitution effect). It is because that the doctors are more likely to prescribe antibiotics which create relatively higher margins than other medical care services in order to sustain their targeted income when the hospital market competition becomes tighter. Even though this study empirically confirms that antibiotics prescription can be affected by the economic incentives, it still raises following issues as limitations of the study: first issue is about the representativeness of the hospital regions segregated for this study, which might be weak in explaining whether these regions are mutually exclusive in reality. Patients actually consider the quality of services, transportation cost, time costs, and any other related factors choosing the doctors or hospitals, and in that sense, this study rules out 'border-crossing' in using the medical care services. Second issue arises in capturing the data of antibiotics prescription rate. Since we use the average rate for each medical institution, we cannot figure out the average rate for each patient so that we are not able to control for the variation of patients' medical conditions. It is because of the unavailability of data regarding each patient's medical condition from HIRA. Thirdly, since this study mainly analyzes the medical institutions providing primary care such as clinics, internal medicines, pediatrics, and otorhinolaryngology department, it is skeptical of whether those institutions can represent the hospital market in respective regions and truly reflect the degree of competition. It needs to extend the study areas and disease types as well as any micro data for future studies.