同情用药的伦理辩护与制度建设

Studying on The Ethical Defense and Institution Construction of Compassionate Use

同情用药是指在特定情况下允许对穷尽现有治疗手段的危重症患者使用可能具有疗效但尚未上市的药品我国同情用药制度起步较晚仍存在诸多挑战,欧盟、美国同情用药制度发展较早,在经历不断地发展完善后,日臻成熟梳理国内外同情用药制度发展沿革,并结合我国现有国情,从建立完备的制度保障,设立申请同情用药的多种通道,重视伦理委员会的建设,保障患者知情同意等方面提出针对性建议,以期对我国有序推进同情用药制度提供参考。

China’s compassionate use system started late, which still has many challenges, while the compassionate use system in European Union and United States has been developed earlier and has matured after continuous development and improvement. The development of compassionate use system at home and abroad was reviewed. Based on the status in China, some suggestions were put forward, mainly as establishing a complete system, developing multiple channels to apply for compassionate use, constructing ethics committees, and protecting patients’ right to informed consent, which can provide references for the orderly promotion of compassionate use system in China.