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欧盟癌症健康网络:欧盟专业知识网络联合行动(JANE)发布的“绿皮书”

Health networking on cancer in the European Union: a 'green paper' by the EU Joint Action on Networks of Expertise (JANE).

作者信息

Casali P G, Antoine-Poirel H, Berrocoso S, Blay J-Y, Dubois T, Ferrari A, Fullaondo A, Hovig E, Jagodzińska-Mucha P, Ługowska I, Kaasa S, Nicoară D, Pletsa V, Provenzano S, Santoro M, Šekerija M, Van Hoof W, Vyas M, Trama A

机构信息

Medical Oncology Unit 2, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy; Department of Oncology and Haemato-Oncology, University of Milan, Milan, Italy.

Epidemiology and Public Health Unit, Cancer Centre, Sciensano, Brussels, Belgium.

出版信息

ESMO Open. 2025 Feb;10(2):104126. doi: 10.1016/j.esmoop.2024.104126. Epub 2025 Jan 27.

Abstract

Health networking is in principle a formidable instrument to address many challenges posed by cancer, one of the two most common and most lethal non-communicable chronic diseases. The European Union (EU)'s Beating Cancer Plan foresaw the addition of new health networks to the four already existing European Reference Networks on rare cancers: the Network of Comprehensive Cancer Centres and several networks of expertise (NoEs), which will be shortly deployed on items as complex and poor-prognosis cancers, palliative care, survivorship, personalised primary and secondary prevention, omic technologies, hi-tech medical resources, and cancers in adolescents and young adults. The community of experts of the EU Joint Action, due to build such NoEs, has drafted this 'green paper', incorporating 13 open questions, in an effort to foster discussion on some open questions about health networking on cancer in the EU. These affect highly diverse issues such as the following: how gaps in research into the instrument of health networking may be filled; which items lend themselves more to health networking in the EU; what degree of cooperation and harmonisation should be required of EU member states to best exploit health networking and give rise to European networks of national/regional networks; how the idea of subsidiarity may be best interpreted to support health networking in the context of EU treaties, which basically do not include health; how health networks should be funded and with what degree of cooperation between the EU and national levels; whether EU health networks should be shaped as legal entities or could give rise to secondary legal entities, also with a view to fundraising; how health networks should be best shaped to advance cancer research and how the EU regulatory system should be updated to exploit such impulse to health networks, in view of the EU General Data Protection Regulation and the new EU Health Data Space; how artificial intelligence can be exploited today within health networks and to what extent it will be able to overcome challenges such as the current lack of interoperability of electronic health records and the language barrier across the EU; and how health networks should involve patients and their groups, with regard to their formal role within EU health networks as well as their ability to have a say in items such as production of clinical practice guidelines, the design of investigator-driven clinical trials, EU regulatory decisions on medicines and devices, health service data governance, and identification of unmet needs.

摘要

健康网络原则上是应对癌症所带来的诸多挑战的有力工具,癌症是两种最常见且最致命的非传染性慢性病之一。欧盟的《战胜癌症计划》预计在现有的四个罕见癌症欧洲参考网络基础上新增健康网络:综合癌症中心网络和若干专业知识网络(NoEs),这些网络将很快应用于复杂且预后不良的癌症、姑息治疗、癌症幸存者护理、个性化一级和二级预防、组学技术、高科技医疗资源以及青少年和青年癌症等领域。欧盟联合行动的专家团队,由于要建立此类专业知识网络,已起草了这份“绿皮书”,其中包含13个开放性问题,旨在促进对欧盟癌症健康网络的一些开放性问题的讨论。这些问题涉及高度多样化的议题,如下所示:如何填补健康网络这一工具研究方面的空白;哪些议题更适合在欧盟开展健康网络建设;为了充分利用健康网络并形成国家/区域网络的欧洲网络,欧盟成员国应要求何种程度的合作与协调;在基本不涉及健康领域的欧盟条约背景下,如何最好地诠释辅助性原则以支持健康网络建设;健康网络应如何获得资金以及欧盟与国家层面之间应进行何种程度的合作;欧盟健康网络是否应塑造为法律实体,或者是否可能产生二级法律实体,同时也考虑到筹资问题;为推动癌症研究,健康网络应如何进行最佳构建,以及鉴于欧盟通用数据保护条例和新的欧盟健康数据空间,欧盟监管体系应如何更新以利用对健康网络的这种推动作用;如今如何在健康网络中利用人工智能,以及它在多大程度上能够克服诸如当前电子健康记录缺乏互操作性以及欧盟范围内的语言障碍等挑战;以及健康网络应如何让患者及其群体参与其中,涉及他们在欧盟健康网络中的正式角色以及他们在诸如临床实践指南制定、研究者主导的临床试验设计、欧盟药品和器械监管决策、健康服务数据治理以及未满足需求识别等事项上发表意见的能力。

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