국내 의약품 유통 규제 및 주요 법적 문제 = Regulation of Distribution of Pharmaceutical Products and Main Legal Issues in Korea

다국어 초록 (Multilingual Abstract)

Pharmaceutical products are the goods which influence directly to health of the people, and the price therefor are reimbursed from the National Health Insurance fund which is public fund. Therefore, the whole distribution courses for pharmaceutical products including R&D, importing and manufacturing, and sale of them is regulated strictly by the Pharmaceutical Affairs Act (the PAA), and the National Health Insurance Prices for Pharmaceutical products listed on the National Health Insurance System are decided as the Public Notices by the Ministry of Health and Welfare. In dealing with main legal issues in the distribution of the Pharmaceutical products, the aforementioned characteristic of regulation and nature of Pharmaceutical industry should be considered and reasonable interpretation and application of the relevant law is required. First, I believe that in application of `dual punishment provisions` of the PAA/Medical Affairs Act, I believe that the regulations over any academic or research activities which may objectively improve medical standard and increase benefits of patients should be relaxed based on understanding that the methods for competition, marketing, advertisement and promotion activities for Pharmaceutical products are limited. In application of the Monopoly Regulation and Fair Trade Act which prohibits unfair trade practices, especially `Abuse of superior status in the Transaction` and `Resale Price Maintenance` to pharmaceutical industry, reasonable needs for importers/manufacturers to control over their wholesalers or distributors and application of the National Health Insurance system under the National Health Insurance Act should be considered. In deciding the product liability for Pharmaceutical products, I believe that it can be the main standard whether research, manufacture/import, distribution, and indication/advertisement for the relevant pharmaceutical products has complied with all the conditions and standards required by the PAA and its subordinate regulations.