根据欧盟HTA法规,联合临床评估的法律影响
Nicolas S H Xander1,2, Maureen P M H Rutten-van Mölken1,2, Louis Bertin3
1Erasmus School of Health Policy & Management, Erasmus University Rotterdamhttps://ror.org/057w15z03, Rotterdam, Netherlands.
Health economics, policy, and law
|March 2, 2026
概括
根据欧盟卫生技术评估 (HTA) 条例,联合临床评估 (JCA) 的差异可以证明国家不考虑,影响患者获取. 管理利益冲突 (CoI) 也带来了挑战,可能会推迟获得新药的机会.
科学领域:
- 卫生政策 卫生政策
- 监管科学 监管科学
- 制药法 制药法 制药法
背景情况:
- 联合临床评估 (JCA) 是根据"健康技术评估 (HTA-R) "的欧盟法规2021/2282规定的任务.
- 实施的挑战和JCA的法律影响仍然在很大程度上未被探索.
- 患者群体,干预,比较和结果 (PICOs) 和专家利益冲突 (CoI) 管理方面的差异是关键的实际问题.
研究的目的:
- 调查PICO差异在JCA中的法律影响.
- 在JCA专家小组中研究管理COI的法律影响.
- 讨论患者获得药物的潜在后果.
主要方法:
- 对欧盟HTA-R条款和国家HTA程序的法律分析.
- 检查由PICO变化产生的潜在法律挑战.
- 评估利益冲突管理策略及其影响.
主要成果:
- 联合评价委员会的报告没有约束力;PICO差异可以在法律上证明国家不考虑.
- 对负面退款决定的法律诉讼由国家司法管辖区管辖.
- 过于严格的COI管理可能会使较小的成员国的观点沉默,需要国家专家的参与.
结论:
- 在JCA中,PICO差异和CoI管理带来了法律挑战,影响了患者的访问.
- 这些问题可能会增加开发人员和国家HTA机构的工作量,导致延误.
- 在JCA中优先考虑彻底的范围和科学卓越,可以简化国家HTA并加速患者的访问.
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