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Patent-Approval Linkage System and Health Insurance: Supplementing the System to Promote Innovation and Prevent Public Financial Loss

Euntae Park 1,  Jinok Byeon 2

1서울대학교 간호학과
2국민건강보험공단

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ABSTRACT

There has been a controversial debate over positive and negative impacts of the patent-approval linkage system adopted by the FTA between the United States and Korea. As drug price is closely connected to the introduction of generic drug, the patent-approval linkage system could result in the loss of public finance by delaying the entry of generic drugs to the market and maintaining an exclusive price of brand name drugs for a long duration. For these reasons, the Ministry of Health and Welfare worked on a partial amendment of the National Health Insurance Act that allows brand-name drug companies to reimburse the National Health Insurance Service for the loss caused by the overuse of the patent rights. The amendment intends to prevent brand-name companies from causing wrongful financial loss and to prepare the basis regulations for the reimbursement. Although the amendment was not approved, there is still a need for refine the system to reinforce the public interest and reduce the adverse effects of the patent-approval linkage system. In this study, we compared the loss security system in the patent-approval linkage system in Korea, Australia and Canada, and sought to gain implications to improve the system. We also analyzed differences in the characteristics of the health security system, permit authorities and judicature judgments among the three countries, and the study discusses a valid posterior reimbursement system for public loss in Korea.

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