臺灣加入跨太平洋夥伴全面進步協定對全民健康保險藥價政策之影響評估【本期企劃】 試閱
Impact Assessment of Taiwan’s Accession to the CPTPP on Pharmaceutical Pricing Policy under National Health Insurance System
隨著臺灣在2021年9月22日正式遞交加入跨太平洋夥伴全面進步協定（CPTPP）之申請書，對於新加入之成員而言，除需面臨市場開放談判之問題外，其國內規章能否符合CPTPP協定要求之高標準規範，亦為入會程序審視的重點。其中，攸關公共健康之藥品專利延長、試驗資料保護、專利連結制度與健康保險藥品訂價政策，更是CPTPP協定關注與規範之重點。本文著眼於我國全民健康保險制度藥價政策，檢視我國加入CPTPP協定對健康保險藥價政策之制定與執行之可能影響。具體而言，對現行健康保險制度下之新藥收載、藥價給付、藥價調整、藥物費用分配比率目標制、藥品給付協議制度與藥品差額負擔等政策，探討其與CPTPP協定之合致性及是否違反協定之規範。此外，如考量外國藥商進入臺灣市場意願，與協助臺灣藥商爭取外國藥品代理等因素，進一步探討如何在CPTPP協定之規範基礎上，調和健康保險制度之藥價政策與法制，期能兼顧人民用藥安全與取得充裕藥品之需求，並達成健康保險永續性之目標。
With Taiwan’s formal application to the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP) on September 22, 2021, Taiwan, as a new applicant, has to go through a series of accession review over the compliance of domestic regulations with the”high standards” required by the Agreement in addition to the issue of market access negotiations in the future. Among them, members to the CPTPP placed more attentions and normative focuses on issues of public health concerns such as pharmaceutical patent extension, test data protection, patent linkage system and pharmaceutical pricing policies under a national health system. This article examines the pharmaceutical pricing policy under Taiwan’s national health insurance system with a particular focus on the possible impact of accession to the CPTPP on the policy formulation and implementation. Specifically, this article examines the compatibility of current policies under the National Health Insurance System with the CPTPP Agreement (including if there is any violations therein) such as the listing of new drugs, the reimbursement and adjustment of drug prices, drug expenditure target, managed entry agreement and copayment of price differences. In addition, if considering the incentives of foreign pharmaceutical companies to enter the Taiwan market and the assistance of Taiwan pharmaceutical companies to compete for a licensed agents of foreign drugs as policy goals, this article discusses regulatory directions to accommodate current laws and policies with the fundamental norms of the CPTPP so as to strike a balance between the assurance of safety and sufficient accessibility of medicines for the people and the preservation a sustainable healthcare system.
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