預防接種受害救濟與藥害救濟之研究

預防接種受害救濟制度與藥害救濟制度於我國實務運作已超過20年。二者立法緣由與法制沿革雖有不同，其給付行政之性質與損害救濟之功能則並無二致。由其發展歷程觀察，補償制度之建置固然為行政效能之展現與國家進步之象徵，其具體成效、甚至於指標性個案補償與否之判斷，似仍不免令人遺憾。事實上，給付行政之擴張與發展已成為當代行政法之重要特徵。從社會安全維護之角度觀察，給付行政可發揮風險控制的效果。於今日之風險社會，國家職能與任務的轉變有別於過往，給付行政與國家責任彼此接壤之現象已不足為奇。在國際潮流的推動下，健康權已於我國獲得憲法位階之肯認。健康權之保障與國家責任界線之劃分，勢將成為矚目之焦點，就疫苗與藥品安全之保障而言，國家所扮演之角色不容忽視。而此等攸關健康權保障之重要課題，國家每需於多方利益重疊交錯甚而相互對立的複雜情境中，兼顧公益與私益之平衡，此亦行政法學調控機制之重要任務。本文認為，預防接種受害與藥害之發生，雖為風險選擇下難以全然避免之偶然，國家難以脫免其責。而基於結果責任之損失補償制度，既有助於受害者之損失填補，亦有助於疫苗與藥品供應方及受害者間之紛爭解決，並可避免行政機關因憚於國賠責任，反而怯於行事，造成有礙醫藥發展而損及社會公益的結果。有鑒於此，預防接種受害救濟與藥害救濟制度二者之制度整備，應從合憲性與合法性之多重角度審視，以賦予其更積極之時代意義。本文亦將從健康權之發展與保障談起，就預防接種受害救濟與藥害救濟制度二者之改革提出建言，以完備其法規制度建立之本旨與目標。

關鍵字

預防接種受害救濟；藥害救濟；風險社會；國家責任

並列摘要

Vaccine injury and drug injury compensation systems were implemented in 1988 and 1999 respectively in our country. Though the background leading to the establishment of these two different systems varied, the purpose to compensate for the misfortunate victims have been the same. Once acclaimed as advanced compensation systems, these two compensation systems were not proceeded without criticism, especially when the administrative authority decided not to compensate for some leading cases. As a growing concern, governmental licensing is without doubt the most important step to guarantee vaccine and drug safety. However, in modern risk society, to pursue absolute safety is not only impossible but also a fallacy. The safety issue concerning vaccine and drug must be well balanced with need. Regulatory measures which overemphasis safety and too precautious to license new innovations are equal to expose the whole public to hostile pathogens in the ever changing environment. Nowadays when right to health being regarded as a basic right and constitutional right, traditional administrative bureaucratic are facing dilemmas. Falling to provide the timely needed vaccine and drug for the public, as well as falling to serve as safety gate keeper might all constitute state compensation liability. Well-designed compensation system might help solve the above mentioned dilemma when the personal and public interest are balanced. While dealing with misfortune and risk, logics applied in traditional liability suits would not be applicable. A new perspective wound be necessary for the modern risk society, the criticism and argument for amendment for vaccine injury and drug injury compensation systems have just exemplified the urgent request.