我国儿童用药立法的必要性和可行性研究

Study on the Necessity and Feasibility of Legislation for Paediatric Medicines in China

目的:探讨我国儿童用药立法的必要性和可行性。方法:通过对儿童用药现状及存在的主要问题进行分析,论述立法的必要性;通过对现行儿童用药相关的立法基础进行分析,结合欧盟和美国的立法经验探讨立法可行性。结果:我国儿童用药保障体系存在的问题日益突出,但现有政策缺乏强制性,因此立法是系统解决儿童用药问题的客观需要。目前儿童用药立法所必需的现实基础、法律基础、先行探索和经验借鉴等基本条件也已比较成熟,立法具有可行性。结论:儿童用药立法必要且可行,因此应加快儿童用药立法。

Objective:To explore the necessity and feasibility of the legislation for paediatric medicines in China.Methods:The necessity of legislation for paediatric medicines was discussed by analyzing the current situation and revealing the main problems of paediatric medicines.The feasibility of legislation for paediatric medicines was clarified through the analysis of the domestic legislative basis and the experience gained abroad.Results:The poor situation of availability of appropriate medicines for children are becoming more and more prominent.However,the existing policy lacks the coordination and the compulsion,therefore it is necessary to guarantee the accessibility to paediatric medicines through the legislation.At present,the basic conditions,such as the realistic foundation,the legislative basis,the pilot exploration and the international experience for the legislation of paediatric medicines are relatively mature,thus the legislation is feasible.Conclusion:The legislation of pediatric medicines in China is necessary and feasible,and it should be accelerated.