随着医药科技的迅猛进步和药品监管政策的日益严密，药品安全性及其潜在的损害救济问题已逐渐引起社会各界的深切关注。在这一背景下，确保药品使用的安全性，以及为受害者提供及时有效的救济措施，已成为亟待解决的问题。由药品不良反应损害引起的医疗纠纷不断增多，但我国相关领域的法律法规仍不完善，对于药品不良反应损害救济的问题尚未进行具体的规定，使得此类纠纷的解决受到阻碍。目前域外的许多国家与地区均对药品不良反应损害救济确立了严格责任制或者是无过错责任制，并且建立了保险赔偿制、基金赔偿制、企业赔偿制与政府赔偿制多种赔偿模式，建立了相对完善的药品不良反应损害救济制度。

文章分别从危险预防以及风险分散不同种角度来进行对药品不良反应的民事法律责任进行分析。随后分别比较德国、日本与美国三国现行的药品不良反应损害救济制度，并在其中总结出我国可以吸收借鉴的制度设计部分。最后明确我国现行的药品不良反应损害救济制度存在的可完善之处，并从立法层面和配套制度两个层面来探讨我国在药品不良反应救济方面应进行的工作。

With the rapid progress of medical science and technology and the increasingly strict drug regulatory policies, the issue of drug safety and its potential damage relief has gradually attracted deep concern from all walks of life. In this context, ensuring the safety of drug use and providing timely and effective relief measures to victims have become urgent issues to be addressed. The number of medical disputes caused by adverse drug reactions is increasing, but the laws and regulations in relevant fields in China are still imperfect, and there are no specific provisions on the relief of adverse drug reactions, which hinders the resolution of such disputes. At present, many countries and regions outside the region have established a strict responsibility system or a no-fault responsibility system for the relief of adverse drug reaction damages, and have established a variety of compensation models such as insurance compensation system, fund compensation system, enterprise compensation system and government compensation system, and established a relatively complete adverse drug reaction damage relief system.

This paper analyzes the civil liability of adverse drug reactions from the perspectives of risk prevention and risk diversification.Then, the current adverse drug reaction damage relief systems in Germany, Japan and the United States were compared, and the system design parts that China can absorb and learn from were summarized. Finally, the improvement of the current adverse drug reaction damage relief system in China is clarified, and the work that should be carried out in China in the relief of adverse drug reactions is discussed from the two levels of legislation and supporting system.