시판후의약품 허가사항 초과사용(Off-Label Use)과 그 홍보활동으로 인한 법적 책임- Qui Tam Action 도입론의 비판적 검토를 중심으로 -

The current rapid increase of health care costs, especially drugs expenses have encouraged some legal scholars in South Korea to assert that it is needed to introduce the prohibition of pharmaceutical companies’ off-label use promotions and qui tam actions used in case of violation of such prohibition in the United States to South Korea in order to control the expansion of the costs. However, pharmaceutical companies’ off-label use promotions can be legally admitted under the Enforcement Decree of the Pharmaceutical Affairs Act of South Korea, to the restricted extent in which such promotions have solid ground such as objective clinical trial literatures. Considering South Korea’s lenient attitude to the promotions could have positive functions in terms of pharmaceutical companies’ provision of medical information to and continued medical education for physicians, it seems that the introduction of the United States legal system stated above which is strange to the legal culture in South Korea would require more meticulous consideration and review. Furthermore, under the National Health Insurance Act. the risk of excessive use of drugs seems to be well refrained by the retribution of drug expenses and imposition of civil penalty on physicians who use drugs not in compliance with the prescription guideline provided by the government. Rather, it is needed to establish object standards to verify clinical trial data which is used for ground of pharmaceutical companies’ off-label use promotions by utilizing the achievement of the evidence-based medicine and set interpretation criteria which can lead to the fair division of liability between physicians and pharmaceutical companies in case of the retribution of drug expenses being implemented by the National Health Insurance Service.