我国药品集中带量采购制度理论与实践浅析

Analysis on the Theory and Practice of Centralized Volume-Based Drug Procurement System in China

我国药品集中带量采购(以下简称集采)是发挥医保战略性购买功能、重构医药价格形成机制、规范药品流通秩序、降低患者药费负担、促进合理安全用药的制度创举。本文从制度创建的视角,系统性回顾了我国开展药品集采工作五年以来的制度内涵、运行效果和多方影响。制度运行的核心机制包括政府组织、联盟采购、平台操作的工作机制,质量优先、保障供应、为用而采的规则机制,以及集采与使用的运行维护机制;药品价格形成的核心机制包括量价挂钩的市场交换机制和“四个确保”的市场契约机制;制度实施涉及招标采购、供应配送、配备使用、接续工作4个关键环节和18个核心要素。集采政策实施后,临床用药替代效应明显、药品可及性提高、药品费用显著下降且主要惠及患者、药品市场集中度提高和产业格局逐步重塑。

In China,the centralized volume-based procurement of drugs is a system innovation that leverages the strategic purchasing function of healthcare insurance,to reconstruct the pharmaceutical price formation mechanism,standardize the order of drug circulation,reduce the burden of patients’drug costs,and ensure rationality and safety of drug use.This study aims to systematically review the policy connotations,operational effects,and multi-influences from the perspective of system establishment.The core mechanism includes the working mechanism of government organization,alliance procurement,and platform operation,the rule mechanism of giving priority to drug quality,guaranteeing supply and procurement based on clinical needs,as well as the operation and maintenance mechanism of centralized procurement and use.The core drug price formation mechanism includes the market exchange mechanism of“price for volume”and market contract mechanism of“four guarantees”.The implementation of the system involves 4 key links(bidding procurement,supply and delivery,distribution and use,and continuation work)and 18 core elements.After the implementation of the centralized volume-based procurement policy,there were obvious clinical substitution effects of drug use,improvement in drug accessibility,significant decrease in drug costs which mainly benefits patients,increase in drug market concentration,and gradual reshaping of the industrial pattern.