| 英文摘要 |
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. |
