• Journal of agricultural medicine and community health
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• v.32 no.3
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• pp.139-153
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• 2007

Injury in agriculture is a serious public health issue with a major impact on the lives of Korean farmers. It is one of the leading causes of death and is also a major cause of longand short-term disability. In 2001, the social cost of one accident in agricultural machinery was estimated as 97.7-97.8 million won that is 4 fold of farm household income in Korea. Effective prevention and control of injuries requires a system of surveillance that monitors the incidence of injuries, their causes, treatment and outcomes. This requires an integrated system of data collection, analysis and interpretation and communication. Creating effective injury surveillance system in Korea requires to establish a framework for a national agenda. Discussions regarding the development of the framework should address, but not be limited to issues related to Data Holdings and Linkages; Capacity and Skills; Communication; Interconnection; and Surveillance Products. Ideally, an injury surveillance system would meet the information requirements across all sectors, while allowing each to have the ongoing information it needs for its policy and programming needs. This study was carried out to develop a surveillance system of agricultural injuries in Korea. Study subjects were residents who lived in a typical agricultural area (Yangpyung area in Kyung-gi province). The main data sources were reports of village headmen, compared with data of 'National Emergency Management Agency', 'National Health Insurance Corporation', 'Insurance of National Agricultural Cooperative', and 'Emergency Medical Centers'. Each data were reviewed to validate the strengths and weaknesses.

• 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.