药品立法与利益纷争——南京国民政府《管理成药规则》的制定与修正

Drug Legislation and Strife of Interest-the Making and Amendment of Rules for the Prepared Drugs Administration by the Nanjing National Government

民国时期卫生事业逐渐纳入国家法制范围内,南京国民政府制定了《管理成药规则》,试图建立中央集中化验和地方当局注册并行的双重管理方式,整顿和规范成药市场。该规则的制定受派系政争和废止中医案风波影响颇费周折,出台后又因立法本身的技术失误和执法触及多方利益而引发诸多矛盾,施行效果不佳。为彻底解决成药管理问题,国民政府卫生署与药商多次沟通,重新举办成药总登记,简化成药注册手续,并对《管理成药规则》大幅修正,部分满足药商诉求并压缩地方当局的利益空间。法规的演变历程展现了特定历史时期专门法规在利益关系博弈中制定和实施的曲折面相。

In the Republican period, health service was gradually incorporated into the national legal system, and the Nanjing national government formulated the Rules for the prepared drugs administration to establish a dual management system of centralized laboratory testing and parallel registration by local authorities, and to rectify and regulate the prepared drug market. The formulation of this rule was affected by the political disputes among factions and the controversy over the abolition of Chinese medicine. Besides, the introduction of the rule caused many contradictions due to technical errors in the legislation itself and the enforcement of the law that touched on the interests of many parties, which made the implementation of the rule ineffective. In order to solve the problem of the prepared drug administration, the health department of the national government and the pharmaceutical companies have repeatedly communicated with each other, re-organized the general registration of the prepared drug, simplified its registration procedures, and substantially amended the Rules for the prepared drugs administration, partially satisfying the demands of pharmaceutical companies and reducing the interests of local authorities. The evolution of the rules shows the twists and turns in the formulation and implementation of special regulations in the game of interests in a specific historical period.