專利連結制度對學名藥產業與健保的影響及評估

為了強化國內專利概念及鼓勵國產藥品業者的發展，以及加強我國製藥研發能力和拓展國際市場，立法院於 2017 年 12 月 29 日通過藥事法部分條文修正草案，建立專利連結制度。然而部分媒體卻把這項法案宣傳成會拖垮健保的法案，也有一些媒體謠傳此法案會造成臺灣學名藥產業的重大打擊。為了使社會大眾更了解此法案的內容與相關影響，本文第一章先簡介論文的研究動機和方法，本文第二章對於臺灣醫藥產業簡單介紹，第三章呈現專利連結法案的細部內容以及比對國內外法案的差異點，第四章以回溯性資料找出藥證、專利和健保價格之間的關聯性，在量化分析方面，分析健保資料庫，計算出延後核發藥證可能的花費，找出對於健保和學名藥產業的影響。希望藉由本研究內容，讓大眾了解專利連結法案的內容，並且藉由計算出的增加費用數據，讓即將實施的專利連結法案所造成的影響有所依據。

關鍵字

藥事法；專利連結；橘皮書；全民健康保險；學名藥

並列摘要

To strengthen the concept of domestic patent law, to encourage the development of domestic pharmaceutical manufacturers, and to fortify pharmaceutical industry’s research and development (R & D) capabilities and expansions in the international market, the Legislative Yuan passed the draft amendments to the provisions of the Pharmaceutical Affairs Act on December 29, 2017 to establish a Patent Linkage System . Some media entities have propagated this act as an act which could drag down health insurance, and others have rumored that this could dampen generic drug industry in Taiwan. In order to raise the awareness of the general public about the content of this act and its influences, the first chapter of this thesis first introduces the research motivation and method of the thesis.The second chapter of this thesis briefly introduces pharmaceutical industry in Taiwan. The third chapter presents the details of the Patent Linkage Act and compares differences between the domestic and foreign regulations related to this act. The fourth chapter focuses on the correlation among drug certificates, patents and health insurance prices using retrospective data. In terms of quantitative analysis, I analyzed data from the National Health Insurance（NHI）and calculated the cost of delaying the issuance of drug certificates. The impact of this act on the health insurance and generic drug industry was also summarized in this chapter. The goal of this study is to inform the public of the Patent Linkage Act and its impact based on the cost analysis calculated from the NHI data.