藥品可及性的跨大陸比較分析

Abstract

藥品可及性延遲是藥證取得、藥品定價、藥品納入健保延遲所得到的結果，這 會對個人的健康和財政狀況造成負面影響。本文利用各國衛生主管機關公開的資 料，比較分析北美、歐洲、亞洲等不同大陸間的藥品可及性、新藥申請、藥品定 價等過程及系統，並透過 Cyramza (Ramucirumab) 和 Zejula (Niraparib)這兩個藥 品的案例分析，來強化論述。此分析總結出藥證取得延遲通常各國相似，但是藥 品納入健保卻因為各國投入健保的預算及當地未滿足醫療需求不同，而造成相當 大的延遲差異，總體來說，這個比較分析報告提供了不同大陸間製藥產業的法規 和定價系統有價值的洞見，以期待能增加藥品可及性。

Drug access delays, including market authorization, pricing, and reimbursement delays, can significantly impact individuals' health and wealth. The study analyzes drug access, new drug approval processes, and pricing systems in several continents, including North America, Europe, and Asia, based on data disclosed by their regulatory authorities. The analysis relies on two case studies (Cyramza (Ramucirumab) and Zejula (Niraparib)) to strengthen the finding. This report finds that the market authorization waiting time is usually similar within countries. However, reimbursement delays can vary significantly because of the healthcare budget and national unmet medical needs differences. Overall, the comparative analysis provides valuable insights into the pharmaceutical industry's regulatory frameworks and pricing mechanisms in different regions, emphasizing the need for ongoing policy development to improve drug access and affordability globally.