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The Study of Comparative Legal Review According to Data Exclusivity of Pharmaceutical Marketing Authorization - In preparation for the development of drugs and vaccine of COVID-19 - (의약품 자료독점권(Data Exclusivity)에 대한 비교법적 고찰 - COVID-19 치료제 및 백신 개발을 대비하여 -)

Park, Jeehye
- 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.
https://doi.org/10.29291/kslm.2020.21.1.223 인용 PDF

Korean and Worldwide Research Trends on Rare Plant and Endemic Plant in Korea (한국의 희귀 및 특산식물에 대한 국내·외 연구동향)

Chae, Hyun-Hee;Kim, Young-Chul;Son, Sung-Won
- Korean Journal of Environment and Ecology
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- v.36 no.3
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- pp.257-276
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- 2022
Studies on rare and endemic plant conservation should be performed nationally to conserve plant diversity. Studies targeting a specific taxon have been reported based on the necessity of conserving plant diversity. From this point of view, there is an increasing necessity to compare and evaluate the studies for conservation. Moreover, it is necessary to analyze and review the direction for study subjects and items required for effective conservation of rare and endemic plants in Korea, based on the analysis results of collected data. We analyzed trends of studies on rare and endemic plants worldwide. In particular, we collected and analyzed the study trend in Korea. Study fields of the rare and endemic plants were divided into six classifications, of which the conservation ecology classification was sub-divided into the species traits, population study, and biological interaction. We have collected conservation ecology studies showing significant differences in regions and countries. They have been actively conducted in Europe and North America by region and in Japan and the United States by country. On the contrary, studies on basic ecology accounted for the most, followed by conservation genetics and restoration ecology in Korea. It was revealed that the portion of conservation ecology conducted in Korea was lower than that of the world. Moreover, studies mainly focused on a specific taxon of rare and endemic plants, such as endangered plants designated by the Korean Ministry of Environment. Particularly in Korea, conservation genetics and restoration ecology studies accounted for high percentages. Considering the worldwide study trends, particularly those in Europe and North America that lead the study of conservation ecology, we suggest approaches to increase the percentages of conservation ecology, including securing the information on species traits, population structure and population dynamics, and interaction between animals and plants are necessary for effective conservation of rare and endemic plants in Korea.
https://doi.org/10.13047/KJEE.2022.36.3.257 인용 PDF KSCI