摘要
域外罕见病药物法律以市场激励、软化技术规范的途径促进个体医疗平等权的实现,但是罕见病高成本与高社会价值的极端矛盾状态决定上述方式既无益于公平与效率的实现,更无法担当起价值整合的作用。我国罕见病立法应立足于公共健康而不应仅限于个体权利保障。以规制理性整合效率与公平,分析域外相关制度规制失灵的原因,在理论反思和制度参照的基础上构建符合我国国情的罕见病法律规制体系。
Rare disease orphan drug laws in many other countries focus on making personally medical equal right come true through providing market incentives and softening technical norms,but the radical contradiction between high cost and high social value of rare disease decides that the method described above does not only help to the realization of fairness and efficiency,but also afford to integrate different values.China's rare disease legislation should not only take the guarantee of individual right but also public health into consideration,should take efficiency and fairness into convergence through regulatory reason,and should analyse why regulation on related institutions malfunctions.In a word,China's rare disease legislation should construct a rationally legal regulation system of rare disease in accordance to China's circumstance basing on theoretic reflection and institutional reference.
出处
《河北法学》
CSSCI
北大核心
2011年第5期10-18,共9页
Hebei Law Science
关键词
成本—收益
成本—效率
规制理性
公共健康
cost-benefit
cost-efficiency
regulatory rationality
public health