Analysis of the Legislative Evolution and Causes of Biologics Data Protection System in the United States
10.6039/j.issn.1001-0408.2017.10.02
- VernacularTitle:美国生物制品数据保护制度的立法演变与成因分析
- Author:
Xuefang YAO
;
Jinxi DING
;
Hongye REN
- Keywords:
Biologics data protection;
Legislative evolution;
Causes of the system;
United States
- From:
China Pharmacy
2017;28(10):1302-1306
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To study the legislative evolution and causes of biologics data protection system in the United States, and provide reference for designing biologics data protection system in China. METHODS:Started from analyzing the features of biologics data protection in the United States,through analyzing the legislative struggle of biologics data protection in the United States,the caused and its enlightenment to China were explored. RESULTS & CONCLUSIONS:After legislative discussion evolu-tion and struggle,the United States enacted the Biologics Price Competition and Innovation Act in 2010,established the world's firststrong protectionstandard of biologics data protection system,and determined the 12-year data protection period. The legisla-tive basis was to stimulate the strategic needs of innovation,the direct cause was that a biological analogue simplified application was established in the United States,and the key factors included biologics technical attributes and patent protection features. Cur-rently,biologics data protection system is not suitable for China,and China should implement the system from nothing,from weak to strong when the national condition matches or strategic choice needs. Meanwhile,a mature registration approval system is the ba-sis of establishing data protection system.
