目的:为促进我国儿童用药相关立法工作的开展、保障儿童用药提供借鉴.方法:介绍并分析美国儿童用药立法历程及现行《最佳儿童药品法》《儿科研究公平法》实施以来对美国儿童用药的影响,提出保障我国儿童用药可及性和安全性的建议.结果与结论:《最佳儿童药品法》中的"6个月的儿科独占保护期"政策激励了药企开展儿科研究的积极性,但是同时影响了其仿制药的上市.《儿科研究公平法》通过强制措施强制药企开展儿科评估,在保障儿童用药安全方面取得了显著的效果,但是对于尚未广泛应用于儿童患者的已上市药品无足够强制力.激励与强制措施并行是促进儿童用药发展的有效途径,建议我国采取修改《处方管理办法》中关于"一品双规"的条款、在保证药品安全性前提下加速相关儿童用药的审批、对相关儿童药品生产企业实行税收优惠政策、推进儿童用药纳入医保报销目录、赋予国家食品药品监督管理总局强制药企开展儿科研究的权力等措施,保障我国儿童用药的可及性和安全性.%OBJECTIVE:To provide reference for promoting the development of related legislation work on ensuring pediatric drug use in China. METHODS:The legislation process of pediatric drug use in US,the effects of current Best Pharmaceuticals for Children Act and Pediatric Research Equity Act on pediatric drug use in US were intrduced and analyzed,suggestions on guarantee-ing the accessibility and safety on pediatric drug use in China were put forward. RESULTS & CONCLUSIONS:The policy"6-month period of pediatric exclusive protection"in Best Pharmaceuticals for Children Act has motivated the enthusiasm of phar-maceutical companies developing pediatric studies,while it affects the marketing of generic drugs. Pediatric Research Equity Act has achieved remarkable effect in terms of ensuring the safety of pediatric drug use by forcing pharmaceutical companies to carry out pediatrics assessments,while there is no enough force for the marketed drugs that has not been widely used for children. En-couragement and enforcement are useful methods for promoting development of pediatric drug use. It is suggested to take measures like modifing"one drug two forms"in Prescription Management Regulations,accelerating approvals of related pediatric drugs on the premise that safety is guaranteed,implementing tax preference for related pharmaceutical companies that produced pediatric drugs,promoting the entry of drug reimbursement list and empowering CFDA to force pharmaceutical companies to implement pedi-atric studies to promote the accessibility and safety of pediatric drugs.
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