药品数据保护制度对药品可及性负效应研究――基于美国拉莫三嗪案例的实证分析

通过美国上市的拉莫三嗪案例，探究药品数据保护制度与药品可及性之间的关系。研究表明，药品数据保护制度延迟仿制药上市周期，法及时有效地平抑创新药垄断高价，从而降低了用药可及性。建议我国合理设计药品数据保护制度的应用范围，并设置首仿药制度和配套措施，控制药品数据保护制度负效应，保障公众健康福利。
This paper explores the relevance between data protection system and drug availability through the American lamotrigine(lamictal？ )case. Results indicated that drug data protection system delays the marketing of genetics, hinders the pricing regulation of innovative drugs timely and effectively, and affects drug availability severely. With reference to America, it is urgent to design the scope of data protection system reasonably, and set the first generic drug regime and other supporting measures so as to reduce the negative effects of drug data protection system and improve the health benefits of the public