從業者及醫療院所觀點檢視台灣醫療器材緊急使用授權的法制規範與實務挑戰 - 以 COVID-19檢驗試劑為例

Abstract

自2019年底爆發嚴重特殊傳染性肺炎(COVID-19)後，全球已造成逾695萬人死亡。該疾病的傳染性及致死率嚴重考驗著各國政府應變及資源取得及配置能力。為加速民眾快速取得預防及治療所需的藥物(含藥品及醫療器材)，各國政府啟動了緊急使用授權(Emergency Use Authorization，EUA) 的措施，以加速新開發未經正常查驗登記程序上市的藥物能夠儘早供給到市面。體外診斷試劑(In vitro diagnosis test)為此次疫情大量適用EUA的醫療器材。體外診斷試劑可快速篩出受感染的病人，使相關單位可快速匡列出感染患者進行隔離避免疾病擴散。本論文以體外診斷試劑為例來了解國內外EUA法規，並利用深度訪談法分別訪問了醫療器材輸入業者、倉儲物流公司及醫院檢驗科，以了解EUA供應鏈在各環節所面臨到的問題並提出建議。探討之議題包含國內EUA法規的完整性、申請流程、輸入業者產品的供應、醫療器材的儲存及運送、醫療院所使用的情形、到上市後及疫情後的相對應措施等。產品取得EUA只是一個開端，後續是否有足夠的醫療量能(人力及物力)來維持該項醫療服務亦是需要關注的焦點。

Since the outbreak of COVID-19 at the end of 2019, it has resulted in over 6.95 million deaths. The infectiousness and fatality rate of the disease have posed challenges to the ability to respond, to acquire and allocate resources of governments worldwide. To expedite the public's access to the pharmaceutical drugs and medical devices that are needed for prevention and treatment of the disease, governments around the world have initiated Emergency Use Authorization (EUA) or similar measures. These measures aim to accelerate the availability of newly developed drugs and medical devices on the market without undergoing the normal inspection and registration procedures. Among the medical devices, in vitro diagnostic (IVD) tests are widely applicable for the use of EUA during this pandemic. These tests can rapidly identify infected individuals, enabling health authorities to quickly identify and quarantine infected patients to prevent the spread of the disease. This paper takes in vitro diagnostic tests as an example to understand the EUA regulations in Taiwan, the U.S., European Committee and WHO. It utilizes in-depth interviews with medical device importers, warehouse logistics provider, and hospital testing laboratory to understand the challenges faced in the EUA supply chain at various stages and provide suggestions for improvements. Topics discussed include the comprehensiveness of Taiwan EUA regulations, the application process, the supply of products by importers, storage and transportation of medical device, usage in healthcare institutions, and subsequent measures in post-market and after the pandemic. Obtaining EUA for a product is just the beginning, whether there are sufficient medical capabilities (both personnel and resources) to sustain the healthcare service should be also taken into consideration when we discuss EUA as a whole.