Esplugues F J, Andújar I, Esplugues J V
Department of Pharmacology, University of Valencia, Valencia, Spain.
CIBEREHD (Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas), Madrid, Spain.
Front Pharmacol. 2024 Sep 19;15:1447324. doi: 10.3389/fphar.2024.1447324. eCollection 2024.
Pharmaceutical spending accounts for a significant portion of public healthcare budgets. To manage these costs, EU countries implement various cost-containment policies, including competitive tendering for pharmaceuticals. This study examines the impact of EU public procurement regulations on medication procurement practices.
A search for all published tenders of adalimumab in Spain from 2018 to 2024 in the Spanish Public Sector Procurement Database, a period that coincides with the implementation of European legislation and the emergence of adalimumab biosimilars. All available documentation for each tender was reviewed, including the tender offer, technical specifications, specific administrative clauses, appointments of evaluation commissions, supporting memorandum, and evaluation reports.
Our findings reveal substantial price reductions following the introduction of adalimumab biosimilars, yet highlight significant variability in tender criteria and practices across different regions. Despite adherence to EU directives, the inconsistent application of economic and non-economic factors and an erratic criteria concerning price undermine the intended balance of quality and cost, complicating procurement processes and potentially affecting the availability of a given treatment for patients.
药品支出在公共医疗预算中占很大一部分。为了控制这些成本,欧盟国家实施了各种成本控制政策,包括药品竞争性招标。本研究考察了欧盟公共采购法规对药品采购实践的影响。
在西班牙公共部门采购数据库中搜索2018年至2024年西班牙所有已公布的阿达木单抗招标信息,这一时期恰逢欧洲立法的实施以及阿达木单抗生物类似药的出现。审查了每份招标的所有可用文件,包括投标书、技术规格、具体行政条款、评估委员会的任命、支持备忘录和评估报告。
我们的研究结果显示,阿达木单抗生物类似药推出后价格大幅下降,但也凸显了不同地区招标标准和做法存在显著差异。尽管遵守了欧盟指令,但经济和非经济因素的不一致应用以及价格标准的不稳定破坏了质量和成本的预期平衡,使采购过程复杂化,并可能影响患者获得特定治疗的机会。