我国药品安全监管:制度变迁和现实挑战(1949—2005)

Drug safety regulation in China:institutional transition and current challenges(1949—2005)

药品存在多种风险,随着工业化的推进,各国都对药品安全实行严格的政府监管。我国政府从建国伊始就设立药政、药检机构,并对医药行业进行指令性的行政管理,以确保人民群众的药物安全和可及。成立于1998年的国家药监局是国务院机构改革的产物,其在形式上解决了医药领域多头管理、职权交叉、政企不分等问题,并运用行政许可、信息公开等手段对药品安全进行监管,试图达到"以监管为中心,监、帮、促相结合"的政策目标。然而从国家药监局成立至2005年,我国药监领域出现诸多问题,表现为药害事故频发,低水平新药泛滥,行政许可领域腐败现象严重,民族制药工业经济效益不佳,药品使用环节监管无力等。政策目标多元,法律地位模糊,机构声誉不佳,监管能力不足和内部认同度低可以部分地解释这一"没有赢家"的政策结果。

Drug safety regulation has been the indisputable responsibility of modern states in line with the development of industrialization due to the serious concerns of various risks of drug. To realize the accessibility and safety of medicine for the people, Chinese government established drug administrations and drug control institutes national wide after liberation, as well as a central planned authority in administrating the pharmaceutical industry. Since the establishment in 1998 by State Council, State Drug Administration （SDA） ended fragmentized authorities and line department in pharmaceutical regulation, which was deemed as a great progress in administrative reform. SDA also introduced advanced regulatory tools like administrative license, information disclosure in order to achieve multiple policy goals. Unfortunately, continuous corruption cases in drug administrations and serious drug accidents lead ob- servers to believe in a deteriorating trend of drug safety situation during the past decade in China. The so called ＇ no winner＇ policy consequences could partly be explained by multiple-unclear policy goals, blurred legal status, uncredited institutional reputation, and weak regulatory capacity.