A WHO remit to improve global standards for medical products of human origin.

IF 8.4 2区 医学 Q1 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Bulletin of the World Health Organization Pub Date : 2024-10-01 Epub Date: 2024-09-02 DOI:10.2471/BLT.24.291569
Eoin McGrath, Marisa R Herson, Matthew J Kuehnert, Karen Moniz, Zbigniew M Szczepiorkowski, Timothy L Pruett
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Abstract

In recent decades, considerable advances have been made in assuring the safety of blood transfusion and organ transplantation. However, with the increasing movement of medical products of human origin across international boundaries, there is a need to enhance global norms and governance. These products, which include blood, organs, tissues, cells, human milk and faecal microbiota, are today crucial for health care but they also pose unique risks due to their human origin, such as disease transmission and graft failure. Moreover, the demand for medical products of human origin often exceeds supply, leading to dependence on international supply chains, and emerging technologies like cell and gene therapy present further challenges because of their unproven efficacy and long-term risks. Current regulatory mechanisms, especially in low- and middle-income countries, are insufficient. The World Health Organization (WHO) has both the mandate and experience to lead the development of international quality and safety standards, consistent product nomenclature, and robust traceability and biovigilance systems. An international, multistakeholder approach is critical for addressing the complexities of how medical products of human origin are used globally and for ensuring their safety. This approach will require promoting uniform product descriptions, enhancing digital communication systems and leveraging existing resources to support countries in establishing regulations for these products. As illustrated by World Health Assembly resolution WHA77.4 on transplantation in 2024, WHO's ongoing efforts to ensure the safe, efficient and ethical use of medical products of human origin worldwide provide the opportunity to galvanize international cooperation on establishing norms.

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世卫组织的一项任务是改进全球人源医疗产品标准。
近几十年来,在确保输血和器官移植安全方面取得了长足的进步。然而,随着源于人类的医疗产品越来越多地跨国流动,有必要加强全球规范和管理。这些产品包括血液、器官、组织、细胞、人乳和粪便微生物群,是当今医疗保健的关键,但也因其来源于人类而带来独特的风险,如疾病传播和移植失败。此外,人类来源的医疗产品往往供不应求,导致对国际供应链的依赖,而细胞和基因治疗等新兴技术因其未经证实的疗效和长期风险而带来更多挑战。目前的监管机制,尤其是中低收入国家的监管机制还不够完善。世界卫生组织(WHO)拥有领导制定国际质量和安全标准、统一产品命名以及健全的可追溯性和生物警戒系统的授权和经验。一个国际性的、多方利益相关者参与的方法对于解决全球范围内如何使用源自人类的医疗产品的复杂性以及确保其安全性至关重要。这种方法需要推广统一的产品说明,加强数字通信系统,并利用现有资源支持各国制定这些产品的法规。正如世界卫生大会关于 2024 年移植问题的第 WHA77.4 号决议所示,世卫组织正在努力确保在全球范围内安全、高效和合乎道德地使用源自人类的医疗产品,这为激发国际合作制定规范提供了机会。
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来源期刊
Bulletin of the World Health Organization
Bulletin of the World Health Organization 医学-公共卫生、环境卫生与职业卫生
CiteScore
11.50
自引率
0.90%
发文量
317
审稿时长
3 months
期刊介绍: The Bulletin of the World Health Organization Journal Overview: Leading public health journal Peer-reviewed monthly journal Special focus on developing countries Global scope and authority Top public and environmental health journal Impact factor of 6.818 (2018), according to Web of Science ranking Audience: Essential reading for public health decision-makers and researchers Provides blend of research, well-informed opinion, and news
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