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[巴西紧急情况下卫生系统中监管机构的作用]

[The role of regulatory agencies within health systems during emergencies in BrazilPapel de los organismos regulatorios en los sistemas de salud en situaciones de emergencia en Brasil].

作者信息

Pepe Vera Lúcia Edais, de Albuquerque Mariana Vercesi, Oliveira Catia Veronica Dos Santos

机构信息

Escola Nacional de Saúde Pública Sergio Arouca Fundação Oswaldo Cruz. Rio de Janeiro-RJ Brasil Escola Nacional de Saúde Pública Sergio Arouca, Fundação Oswaldo Cruz. Rio de Janeiro-RJ, Brasil.

出版信息

Rev Panam Salud Publica. 2024 Dec 18;48:e130. doi: 10.26633/RPSP.2024.130. eCollection 2024.

DOI:10.26633/RPSP.2024.130
PMID:39697267
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11653960/
Abstract

The performance of health systems is related to ensuring the right to health, an important component of human rights that includes the right to health protection. Regulatory action by the state aims to reduce risks to health and thus help improve health system performance, particularly with respect to the principles of comprehensiveness and equity. The aim of this article is to discuss resilience from the perspective of national regulatory agencies - especially when they are faced with public health emergencies (PHEs) - and their contribution to health system resilience, taking as a model the work of the Brazilian Health Regulatory Agency (ANVISA). In the context of PHEs, health regulators have been improving their practices and working on several fronts. Regulatory agencies have used specific regulatory instruments to speed up access to effective and safe products for responding to pandemics, to ensure the quality of care, and to communicate with the public. ANVISA specifically has brought new areas of action under its purview, such as overseeing the development of mechanical ventilators. It is crucial to recognize the interdependence between improving response capacity and improving performance in dealing with PHEs. Examples include the fast-track approval of COVID-19 vaccines, which allowed more rapid vaccination; cooperation among regulatory agencies; and, in the case of Brazil, work by ANVISA to strengthen the role of the country's Unified Health System (SUS) and the right to health in the face of disinformation and denialism.

摘要

卫生系统的绩效与保障健康权相关,健康权是人权的一个重要组成部分,其中包括健康保护权。国家的监管行动旨在降低健康风险,从而有助于提高卫生系统的绩效,特别是在全面性和公平性原则方面。本文的目的是从国家监管机构的角度探讨复原力——尤其是当它们面对突发公共卫生事件(PHE)时——以及它们对卫生系统复原力的贡献,以巴西卫生监管局(ANVISA)的工作为范例。在突发公共卫生事件的背景下,卫生监管机构一直在改进其做法并在多个方面开展工作。监管机构使用了特定的监管手段,以加快获取应对大流行病的有效和安全产品,确保医疗质量,并与公众进行沟通。ANVISA尤其将新的行动领域纳入其职权范围,例如监督机械通气设备的开发。认识到提高应对能力与提高应对突发公共卫生事件的绩效之间的相互依存关系至关重要。例子包括快速批准新冠疫苗,从而实现更快接种;监管机构之间的合作;以及就巴西而言,ANVISA在面对虚假信息和否定态度时为加强该国统一卫生系统(SUS)的作用和健康权所做的工作。

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本文引用的文献

1
Health policy and regulatory authorities: challenges of technology regulation in Public Health Emergencies.卫生政策和监管机构:突发公共卫生事件中技术监管的挑战。
Cien Saude Colet. 2024 Jul;29(7):e03442024. doi: 10.1590/1413-81232024297.03442024. Epub 2024 Feb 29.
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Strengthening regulatory systems globally: a crucial step towards pandemic preparedness and response.全球加强监管体系:迈向大流行防范与应对的关键一步。
BMJ Glob Health. 2023 Aug;8(8). doi: 10.1136/bmjgh-2023-012883.
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Essential medicines concept and health technology assessment approaches to prioritising medicines: selection versus incorporation.基本药物概念与药物优先排序的卫生技术评估方法:选择与纳入
J Pharm Policy Pract. 2023 Jul 13;16(1):88. doi: 10.1186/s40545-023-00595-4.
4
The resilience of Brazilian Unified National Health System in the context of the COVID-19 pandemic: how to strengthen?新冠疫情背景下巴西统一国家卫生系统的韧性:如何加强?
Cad Saude Publica. 2022 Oct 14;38(10):e00097522. doi: 10.1590/0102-311XPT097522. eCollection 2022.
5
Regulatory reliance pathways during health emergencies: enabling timely authorizations for COVID-19 vaccines in Latin America.卫生紧急情况期间的监管依赖途径:助力拉丁美洲新冠疫苗的及时授权
Rev Panam Salud Publica. 2022 Aug 30;46:e115. doi: 10.26633/RPSP.2022.115. eCollection 2022.
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Brazil's health system functionality amidst of the COVID-19 pandemic: An analysis of resilience.新冠疫情期间巴西卫生系统的功能:恢复力分析
Lancet Reg Health Am. 2022 Jun;10:100222. doi: 10.1016/j.lana.2022.100222. Epub 2022 Mar 5.
7
WHO collaborative registration procedure using stringent regulatory authorities' medicine evaluation: reliance in action?使用严格监管机构药品评估的世界卫生组织合作注册程序:付诸实践的信赖?
Expert Rev Clin Pharmacol. 2022 Jan;15(1):11-17. doi: 10.1080/17512433.2022.2037419. Epub 2022 Feb 12.
8
COVID-19 and the medicines regulation challenges in times of pandemic.COVID-19 与大流行时期的药品监管挑战。
Cien Saude Colet. 2021 Oct;26(10):4693-4702. doi: 10.1590/1413-812320212610.11472021. Epub 2021 May 28.
9
Multi-country collaboration in responding to global infectious disease threats: lessons for Europe from the COVID-19 pandemic.应对全球传染病威胁的多国合作:欧洲从新冠疫情中吸取的教训
Lancet Reg Health Eur. 2021 Oct;9:100221. doi: 10.1016/j.lanepe.2021.100221. Epub 2021 Oct 7.
10
Worldwide Assessment of Low- and Middle-Income Countries' Regulatory Preparedness to Approve Medical Products During Public Health Emergencies.中低收入国家在突发公共卫生事件期间批准医疗产品的监管准备情况的全球评估。
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