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应对 COVID-19 大流行期间和之后的药品短缺问题:38 个国家政府政策措施和进展汇编。

Tackling medicine shortages during and after the COVID-19 pandemic: Compilation of governmental policy measures and developments in 38 countries.

机构信息

WHO Collaborating Centre for Pharmaceutical Pricing and Reimbursement Policies, Pharmacoeconomics Department, Gesundheit Österreich GmbH (GÖG / Austrian National Public Health Institute), Stubenring 6, 1010 Vienna, Austria; Department of Health Care Management, Technische Universität Berlin, Straße des 17. Juni 135, 10623 Berlin, Germany.

出版信息

Health Policy. 2024 May;143:105030. doi: 10.1016/j.healthpol.2024.105030. Epub 2024 Feb 24.

Abstract

In response to increasing shortages of medicines, governments have implemented legislative and non-legislative policy measures. This study aimed to map these policies across high-income countries in Europe and beyond as of 2023 and to analyse developments in governmental approaches since the beginning of the pandemic. Information was collated from 38 countries (33 European countries, Australia, Brazil, Canada, Israel and Saudi Arabia) based on a survey conducted with public authorities involved in the Pharmaceutical Pricing and Reimbursement Information (PPRI) network in 2023. 34 countries requested pharmaceutical companies to notify national registers of upcoming shortages and 20 countries obliged manufacturers and/or wholesalers to stock supply reserves of critically needed medicines. Further common measures included export bans for defined medicines (18 countries), regulatory measures to facilitate import and use of alternative medicines (35 countries) and multi-stakeholder coordination (28 countries). While the legislation of 26 countries allows imposing sanctions, particularly for non-compliance to reporting requirements, fines were rather rarely imposed. Since 2022, at least 18 countries provided financial incentives, usually in the form of price increases of some off-patent medicines. Overall, several policies to address medicine shortages were taken in recent years, in some countries as part of a comprehensive package (e.g., Australia, Germany). Further initiatives to secure medicine supply in a sustainable manner were being prepared or discussed.

摘要

针对药品短缺问题,各国政府已实施立法和非立法政策措施。本研究旨在绘制截至 2023 年欧洲和其他高收入国家的这些政策,并分析大流行开始以来政府方法的发展情况。根据 2023 年对参与药品定价和报销信息(PPRI)网络的公共当局进行的调查,从 38 个国家(33 个欧洲国家、澳大利亚、巴西、加拿大、以色列和沙特阿拉伯)收集了信息。34 个国家要求制药公司向国家短缺登记处通报即将出现的短缺情况,20 个国家要求制造商和/或批发商储备急需药品的供应储备。进一步的常见措施包括对特定药品实施出口禁令(18 个国家)、采取监管措施促进替代药品的进口和使用(35 个国家)以及多利益攸关方协调(28 个国家)。虽然 26 个国家的立法允许实施制裁,特别是对不遵守报告要求的制裁,但很少实施罚款。自 2022 年以来,至少有 18 个国家提供了财政激励措施,通常是以提高一些非专利药品价格的形式。总的来说,近年来采取了几项应对药品短缺的政策,在一些国家,这些政策是一揽子计划的一部分(如澳大利亚、德国)。还在筹备或讨论进一步的举措,以可持续的方式确保药品供应。

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