論藥品製造業者於不良反應事件下之民事藥品責任——以德國損害賠償法第二次修正法對藥 品交易法之改革面向為考察中心

Drug Manufacturers' Civil Liability in Cases of Adverse Reactions: Using Amendments to the Medicinal Products Act of the New Law of Torts in Germany as an Example

隨著醫藥科技進展，不斷有新藥品進入市場，期望能更好地發揮治癒疾病或減緩疾病伴隨而來之痛苦等效果。惟若藥品具有無可容忍之有害作用，致使用者之生命、身體或健康受害，那麼在民事層面上，如何使其獲得適當賠償，於現代社會實為一相當重要之課題。其中，因藥品製造業者身為藥品得以面世的催生者，其資力狀況亦多相對雄厚，故往往身處求償風暴之中心。就我國現行法規言，並未另設有民事藥品責任制度，故常見藥品受害人依民法侵權責任或消保法商品責任等規定，向藥品製造業者請求損害賠償。但在此規範框架下，藥品受害人往往受累於因果關係之舉證責任，因舉證不足而遭受敗訴苦果。相對地，如何完善民事藥品責任之架構、面向與內容，為德國立法者長期關注之焦點。於第二次修正損害賠償法時，立法者選擇在藥品交易法第84條、第84a條規定中，分別透過轉換藥品缺陷領域之舉證責任、引進因果關係推定以及新增資訊請求權等設計，力圖緩和藥品受害人在藥品訴訟可能面臨之困境。整體而言，德國民事藥品責任所採取之規範模式，確有其值得借鏡之處，應可作為我國將來在進一步規劃民事藥品責任時之參考對象。

Thanks to advancements in pharmaceutical technology, new drugs for curing various diseases and alleviating pain effectively are being released continuously. However, in the case when certain drug causes adverse effects that are harmful to the health and life of the user, ensuring proper compensation for the injured party on a civil level becomes an important task in contemporary society. As the main actuators of pharmaceutical manufacturing and with comparatively affluent capital, drug manufacturers often find themselves in the spotlight in liability claims. Independent civil drug liability systems have yet to be established in the framework of Taiwan’s current laws and regulations. Conse-quently, the injured party often initiates liability claims against drug manufacturers based on general and individual tort law or product liability under the Taiwan Consumer Protection Act. Under the current framework, the burden of proof is placed on the injured party, who often loses cases due to the lack of proof and the inability to prove causation. In Germany, by contrast, legislators are able to enhance their focus on how to build a holistic structure that encompasses all dimensions and content concerning the liability system for drug. During the second amendment of the law of torts in Germany, legislators transferred the burden of proof for cases involving defective drugs, introduced presumed causation, and included a right to disclosure in Sections 84 and 84a of the Medicinal Products Act (The Drug Law), attempting to prevent the difficulties for the injured party in lawsuit. The civil liability model for drug cases in Germany can be a reference for Taiwan in developing its own changes to its domestic civil drug liability regime.