论同情用药的立法价值取向及制度完善——以美国法为镜鉴

On Legislative Value Orientation and Institutional Improvement of Compassionate Medication

《药品管理法》于2019年修订时增加了同情用药制度,但规定过于原则,且立法的价值取向不明。美国此项制度演变清晰地呈现了自由主义与硬家长主义两种价值冲突的困境,仅采用自由主义的方法或硬家长主义式的措施无法同时满足绝症患者挽救生命和行政机关监管的需求。随后,立法价值取向开始出现软家长主义。软家长主义不对选择进行限制以及对选择真实性的关注,恰恰可以满足无可用药物治疗的患者与监管主体的各自需求。所以,我国的同情用药有必要引入软家长主义的立法价值进行制度设计。基于此,同情用药的审查主体应当为医学伦理委员会,而非药品监管部门。软家长主义还可以通过影响患者选择的心理过程,调整医保的覆盖范围,合理分配法律责任,完善临床试验的规定,最终实现患者选择的自由,同时兼顾公民生命健康权保障的目的。

The "Drug Administration Law" was revised in 2019, and a system of compassionate use of drugs was added into it, but the provision is too principled and the value orientation of the legislation is unclear. The evolution of the American system clearly shows the dilemma of the conflict between liberalism and hard paternalism in its development. Only adopting liberal methods or hard paternalistic measures cannot meet the needs of life-saving by terminally ill patients and supervision by administrative agencies. The legislative value orientation of America began to appear soft paternalism. Soft paternalism does not restrict choices and pays attention to the authenticity of choices, where the respective needs of both parties lie. Therefore, it is legitimate to introduce soft paternalism in the design of the compassionate use system. Based on soft paternalism, the subject of review should be the medical ethics committee, not the drug regulatory department. Soft paternalism can also affect the psychological process of patient choice, adjust the coverage of medical insurance, rationally allocate legal responsibilities, and improve the regulations of clinical trials, ultimately realizing the freedom of patient choice, while taking into account the purpose of protecting citizens’ rights to life and health.