中国和欧洲精准医疗发展现状研究

摘要/Abstract

摘要：

随着精准医学相关技术不断成熟，精准医学体系逐渐成熟走向应用。全球精准医学处于高速发展阶段，其科学和社会价值日益凸显，但整体也面临多方面发展瓶颈，个体化诊疗体系尚未形成。本项目组采用科学文献检索、灰色文献搜索、咨询“地平线2020”国家咨询联络点、中国-欧盟精准医疗合作支持计划（IC2PerMed）专家调查等方法，系统梳理了中国、欧盟精准医疗有关的政策措施、规划方案和行动计划等资料和信息，对各种信息进行标准化、结构化处理并进行对比分析，形成本报告。报告内容涵盖：精准医疗概念演变过程；国际精准医疗联盟介绍；中欧精准医疗领域政策措施、规划方案和行动计划相关性的详细信息；中欧精准医疗模式下医疗健康研究的重点方向；全球精准医疗发展目标。本报告深入分析中欧精准医疗战略，找出双方战略、计划和行动的共同点、差异和差距；明确了各自的PM创新重点；指明了中欧医疗健康研究资助机制各自的优势与不足；探寻了未来全球卫生领域合作的热点。该报告一方面为IC2PerMed的专家小组在精准医疗国际标准、可转移性和扩大合作研究领域提供信息支撑，另一方面，也为促进欧盟和中国之间精准医疗领域合作指引方向，为促进中欧精准医疗合作奠定了坚实的基础。

关键词: 精准医学, 个体化医疗, 中国-欧盟国际精准医疗领域合作支持计划（IC2PerMed）, 国际精准医疗联盟, 科技创新合作

Abstract:

With the continuous maturation of personalized medicine-related technologies， the precision medicine system is gradually advancing and moving towards application. Global precision medicine is in a phase of rapid development， and its scientific and social value is increasingly becoming prominent. However， it also faces various developmental bottlenecks， and a personalized diagnosis and treatment system is yet to be formed. This project team employed methods such as scientific literature retrieval， grey literature search， consultation with the "Horizon 2020" national contact point， and expert surveys from the Integrating China in the International Consortium for Personalized Medicine Project （IC2PerMed） to systematically review policies， plans， and action plans related to precision medicine in China and the EU， and to study various information by using standardization， structuralization， and comparison analysis， and generated this report. This report covers the following aspects： the evolution of the concept of precision medicine， introduction to the International Consortium for Personalized Medicine， detailed information regarding the relevance of policies， plans， and action plans in the precision medicine field in China and the EU， key directions for medical and health research under Chinese and European precision medicine models， and global precision medicine development goals； analyzes insights of Chinese and European precision medicine strategies， identifying commonalities， differences， and gaps in strategies， plans， and actions between the two parties； determines each party’s key points in precision medicine innovation； indicates the strengths and weaknesses of each party’s respective medical and health research funding mechanisms； and explores hotspots for future global healthcare collaboration. On the one hand， this report provides information support for the expert group of IC2PerMed in investigating the international standards of precision medicine， transferability， and expanding research areas. On the other hand， it lays a solid foundation for promoting and guiding the direction of partnership in the precision medicine field between the EU and China.

Key words: Precision medicine； , Personalized healthcare； , Integrating China in the International Consortium for Personalized Medicine , （IC2PerMed）； , International Consortium for Personalized Medicine； , Cooperation in scientific and technological innovation

中图分类号:

R197
R95

王闻雅, 王丽丽, 黄慧瑶, 周童心, 章颖, 杜利, 俞悦.

中国和欧洲精准医疗发展现状研究 [J]. 中国医药导刊, 2024, 26(1): 2-43.

WANG Wenya, WANG Lili, HUANG Huiyao, ZHOU Tongxin, ZHANG Ying, DU Li, YU Yue.

Analysis of the Current Standing of Precision Medicine in China and Europe [J]. CHINESE JOURNAL OF MEDICINAL GUIDE, 2024, 26(1): 2-43.

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［77］ Ministry of Social Affairs of Estonia. Research，Development and Innovation Strategy for the Estonian Health System 2015-2020［EB/OL］. ［2023-12-01］.https：//www.sm.ee/sites/default/files/content-editors/eesmargid_ja_ tegevused/Tervis/strategy_research_and_innovation_for_health.pdf.

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［79］ Ministry of Health， Italy. Plan for health system innovation based on omics sciences［EB/OL］. ［2023-12-01］ .http：//www.salute.gov.it/portale/news/p3_2_1_1_1.jsp？menu=notizie&id=3270.

［80］ DAEI. 2018-2022 年法国国家健康战略-综述［EB/OL］. （2018-04）［2023-12-01］.https：//cn.ambafrance.org/IMG/pdf/2018-2022_-_.pdf.

［81］ Ministry of Social Affairs and Health of Finland. Act on the Secondary Use of Health and Social Data［EB/OL］. （2019-04-26）［2023-12-01］.https：//stm.fi/documents/1271139/1365571/The+Act+on+the+Secondary+Use+of+Health+and+Social+Data/a2bca08c-d067-3e54-45d1-18096de0ed76/The+Act+on+the+Secondary+Use+of+Health+and+Social+Data.pdf.

［82］ HM Government.Genome UK：The future of healthcare［EB/OL］. （2020）［2023-12-01］.https：//assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/920378/Genome_UK_-_the_future_ of_healthcare.pdf.

［83］ The Scottish Government. A National Clinical Strategy fo Scotland. ［EB/OL］. （2016-02）［2023-12-01］.https：//www.gov.scot/binaries/content/documents/govscot/publications/strategy-plan/2016/02/national-clinical-strategy-sco tland/documents/national-clinical-study-scotland/national-clinical-study-sco tland/govscot%3Adocument/00494144.pdf.

［84］ Cancer Research UK. CRUK Stratified Medicine Programme［EB/OL］.［2023-12-01］.https：//www.cancerresearchuk.org/sites/default/files/smp1_ booklet_1.2_-_no_marks.pdf.

［85］ AVIESAN.Plan France Médecine Génomique 2025［EB/OL］. （2016-06-22）［2023-12-01］.https：//aviesan.fr/en/aviesan/accueil/toute-l-actualite/plan-france-medecine-genomique-2025.

［86］ Genomic Medicine Sweden. National Initiative for Precision Medicine［EB/OL］. （2023-09-13）［2023-12-01］.https：//ki.se/en/mmk/genomic-medicine- sweden-national-initiative-for-precision-medicine.

［87］ Archives of Public Health. Roadbook for the implementation of next-generation sequencing in clinical practice in oncology and hemato-oncology in Belgium［EB/OL］. （2018-09-06）［2023-12-01］.https：//archpublichealth.biomedcentral.com/articles/10.1186/s13690-018-0295-z.

［88］原国家食品药品监督管理总局，原国家卫生计生委.食品药品监管总局办公厅国家卫生计生委办公厅关于加强临床使用基因测序相关产品和技术管理的通知［EB/OL］.（ 2014-02-14）［2023-12-01］.http：//www.nhc.gov.cn/yzygj/s3593/201402/c395a20d3815430d8b1a54313ce23b2b.shtml.

［89］原国家卫生计生委.人口健康信息管理办法（试行）［EB/OL］. （2014-05-20）［2023-12-01］.http：//www.nhc.gov.cn/mohwsbwstjxxzx/s8553/201405/916e50f62c804ae68de6bd811edcaf38.shtml.

［90］国务院.国务院关于取消非行政许可审批事项的决定［EB/OL］.（ 2015-05-10）［2023-12-01］.http：//www.gov.cn/xinwen/2015-05/14/content_2861932.htm.

［91］原国家卫生计生委医政医管局.药物代谢酶和药物作用靶点基因检测技术指南（试行）［EB/OL］.（2015-07-31）［2023-12-01］. http：//www.nhc.gov.cn/yzygj/s3593/201507/fca7d0216fed429cac797cdafa2ba466.shtml.

［92］国务院.国务院关于积极推进“互联网+”行动的指导意见［EB/OL］. （2015-07-04）［2023-12-01］.http：//www.gov.cn/zhengce/content/2015-07/04/content_10002.htm.

［93］国务院.促进大数据发展行动纲要［EB/OL］. （2015-09-05）［2023-12-01 ］.https：//www.gov.cn/zhengce/content/2015-09/05/content_10137.htm.

［94］科技部.科技部关于发布国家重点研发计划精准医学研究等重点专项2016年度项目申报指南的通知［EB/OL］. （2016-03-11）［2023-12-01］.http：//www.gjzjsb.com/2016/0311/5073.html.

［95］国务院办公厅.国务院办公厅关于促进医药产业健康发展的指导意见［EB/OL］. （2016-03-11）［2023-12-01］.http：//www.gov.cn/zhengce/content/2016-03/11/content_5052267.htm.

［96］新华社.中共中央国务院印发《国家创新驱动发展战略纲要》［EB/OL］. （2016-05-19）［2023-12-01］.http：//www.gov.cn/xinwen/2016-05/19/content_5074812.htm.

［97］国务院办公厅.国务院办公厅关于促进和规范健康医疗大数据应用发展的指导意见［EB/OL］. （2016-06-21）［2023-12-01］.http：//www.gov.cn/zhengce/content/2016-06/24/content_5085091.htm.

［98］中国政府网.中华人民共和国网络安全法［EB/OL］. （2016-11-07）［2023-12-01］.https：//www.gov.cn/xinwen/2016-11/07/content_5129723.htm.

［99］国务院办公厅.国务院办公厅关于促进“互联网+医疗健康”发展的意见［EB/OL］. （2018-04-28）［2023-12-01］.http：//www.gov.cn/zhengce/content/2018-04/28/content_5286645.htm.

［100］国家卫健委.关于印发国家健康医疗大数据标准、安全和服务管理办法（试行）的通知［EB/OL］.（2018-09-14）［2023-12-01］.http：//www.nhc.gov.cn/mohwsbwstjxxzx/s8553/201809/f346909ef17e41499ab766890a34bff7.shtml.

［101］中国政府网.中华人民共和国人类遗传资源管理条例［EB/OL］.（2019-05-28）［2023-12-01］.https：//www.gov.cn/gongbao/content/2019/content_5404150.htm.

［102］中国政府网.中华人民共和国基本医疗卫生与健康促进法［EB/OL］.（2019-12-29）［2023-12-01］.https：//www.gov.cn/xinwen/2019-12/29/content_5464861.htm.

［103］中国政府网.中华人民共和国生物安全法［EB/OL］.（2020-10-17）［2023-12-01］.http：//www.npc.gov.cn/npc/c30834/202010/bb3bee5122854893a69acf4005a66059.shtml.

［104］中国政府网.中华人民共和国数据安全法［EB/OL］.（2021-06-11）［2023-12-01］.http：//www.cac.gov.cn/2019-05/28/c_1124546022.htm.

［105］中国政府网.中华人民共和国个人信息保护法［EB/OL］.（2021-08-20）［2023-12-01］.http：//www.gov.cn/xinwen/2021-08/20/content_5632486.htm.

［106］中国政府网. 中共中央关于制定国民经济和社会发展第十三个五年规划的建议［EB/OL］.（2015-11-03）［2023-12-01］.http：//www.gov.cn/xinwen/2015-11/03/content_5004093.htm.

［107］中国政府网.中华人民共和国国民经济和社会发展第十三个五年规划纲要［EB/OL］.（2016-03-17）［2023-12-01］.https：//www.gov.cn/xinwen/2016-03/17/content_5054992.htm.

［108］科技部. 科技部关于发布国家重点研发计划精准医学研究等重点专项2017年度项目申报指南的通知［EB/OL］.（2016-10-12）［2023-12-01］.http：//www.most.gov.cn/mostinfo/xinxifenlei/fgzc/gfxwj/gfxwj2016/201610/t201 61012_128170.htm.

［109］中国政府网.国务院关于印发“十三五”国家科技创新规划的通知［EB/OL］.（2016-08-08）［2023-12-01］.https：//www.gov.cn/zhengce/content/2016-08/08/content_5098072.htm.

［110］中国政府网. 中共中央国务院印发《“健康中国2030”规划纲要》［EB/OL］.（2016-10-25）［2023-12-01］.http：//www.gov.cn/xinwen/2016-10/25/content_5124174.htm.

［111］科技部.科技部关于发布国家重点研发计划精准医学研究等重点专项2017年度项目申报指南的通知［EB/OL］.（2016-10-12）［2023-12-01］.http：//www.most.gov.cn/mostinfo/xinxifenlei/fgzc/gfxwj/gfxwj2016/201610/t201 61012_128170.htm.

［112］中国政府网. 国务院印发《“十三五”国家战略性新兴产业发展规划》［EB/OL］.（2016-12-19）［2023-12-01］.https：//www.gov.cn/xinwen/2016-12/19/content_5150197.htm.

［113］中国政府网. “十三五”国家信息化规划［EB/OL］.（2016-12-15）［2023-12-01］.http：//www.gov.cn/zhengce/content/2016-12/27/content_5153411.htm.

［114］国家发展改革委. 国家发展改革委关于印发《“十三五”生物产业发展规划》的通知［EB/OL］.（2016-12-19）［2023-12-01］.https：//www.ndrc.gov.cn/xxgk/zcfb/tz/201701/t20170112_962867.html.

［115］国务院.“十三五”卫生与健康规划［EB/OL］.（2017-01-01）［2023-12-01］.https：//www.gov.cn/zhengce/content/2017-01/10/content_5158488.htm.

［116］科技部.科技部关于印发《“十三五”生物技术创新专项规划》的通知［EB/OL］.（2017-05-10）［2023-12-01］.http：//www.most.gov.cn/mostinfo/xinxifenlei/fgzc/gfxwj/gfxwj2017/201705/t201 70517_132857.htm.

［117］科技部，原国家卫生计生委，国家体育总局，等.“十三五”卫生与健康科技创新专项规划［EB/OL］.（2017-05-16）［2023-12-01］.http：//www.nhc.gov.cn/qjjys/s3577/201706/1f3657c3dfc94d138ebbb2a4f791896c.shtml.

［118］科技部. 科技部关于发布国家重点研发计划大气污染成因与控制技术研究等重点专项2018年度项目申报指南的通知［EB/OL］.（ 2017-12-06）［2023-12-01］. http：//www.most.gov.cn/mostinfo/xinxifenlei/fgzc/gfxwj/gfxwj2017/201712/t20171212_136.

［119］国家卫健委. 国家卫生健康委办公厅关于建立全国罕见病诊疗协作网的通知［EB/OL］.（2019-02-15）［2023-12-01］.http：//www.nhc.gov.cn/yzygj/s7659/201902/3a8228589bf94e6d9356008763387cc4.shtml.

［120］中国政府网. 中共中央关于制定国民经济和社会发展第十四个五年规划和二〇三五年远景目标的建议［EB/OL］.（2020-11-03）［2023-12-01］.https：//www.gov.cn/zhengce/2020-11/03/content_5556991.htm.

［121］国务院.中共中央国务院关于加强新时代老龄工作的意见［EB/OL］.（2021-11-18）［2023-12-01］.https：//www.gov.cn/gongbao/content/2021/content_5659511.htm.

［122］国家发展改革委. 国家发展改革委关于印发《“十四五”生物经济发展规划》的通知［EB/OL］.（2021-12-20）［2023-12-01］.https：//www.gov.cn/zhengce/zhengceku/2022-05/10/content_5689556.htm.

［123］中国政府网. “十四五”健康老龄化规划［EB/OL］.（2022-02-07）［2023-12-01］.https：//www.gov.cn/gongbao/content/2022/content_5692863.htm.

［124］科技部. 科技部国家卫生健康委关于印发《“十四五”卫生与健康科技创新专项规划》的通知［EB/OL］.（2022-11-01）［2023-12-01］.https：//www.most.gov.cn/xxgk/xinxifenlei/fdzdgknr/fgzc/gfxwj/gfxwj2022/202301/t20230116_ 184248.htm..

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［126］原国家卫生计生委. 国家卫生计生委医政医管局关于开展高通量基因测序技术临床应用试点单位申报工作的通知［EB/OL］.（2014-03-18）［2023-12-01］.http：//caivd-org.cn/article.asp？id=553.

［127］国家发展改革委.国家发展改革委关于实施新兴产业重大工程包的通知［EB/OL］.（2015-07-23）［2023-12-01］.https：//www.ndrc.gov.cn/xxgk/zcfb/tz/201507/t20150723_963393.html.

［128］原国家卫生计生委医政医管局.肿瘤个体化治疗检测技术指南（试行）［EB/OL］.（2015-07-31）［2023-12-01］.http：//www.nhc.gov.cn/yzygj/s3593/201507/fca7d0216fed429cac797cdafa2ba466.shtml.

［129］原国家卫生计生委.国家卫生计生委办公厅关于规范有序开展孕妇外周血胎儿游离DNA产前筛查与诊断工作的通知［EB/OL］.（2016-11-09）［2023-12-01］.http：//www.nhc.gov.cn/fys/s3581/201611/0e6fe5bac1664ebda8bc28ad0ed68389.shtml.

［130］国家发展改革委.战略性新兴产业重点产品和服务指导目录（2016版）［EB/OL］.（2017-02-04）［2023-12-01］.https：//www.ndrc.gov.cn/xxgk/zcfb/gg/201702/t20170204_961174.html.

［131］原国家卫生计生委，国家中医药局. 关于印发进一步改善医疗服务行动计划（2018-2020年）的通知［EB/OL］. （2017-12-29）［2023-12-01］. http：//www.nhc.gov.cn/yzygj/s3594q/201801/9df87fced4da47b0a9f8e1ce9fbc7520.shtml.

［132］原国家卫生计生委.肿瘤多学科诊疗试点工作方案（2018-2020年）［EB/OL］.（ 2018-08-27）［2023-12-01］.http：//www.nhc.gov.cn/yzygj/s3594q/201808/0cfe48391dd14876951cf6262e28c062.shtml.

［133］中国政府网.健康中国行动（2019-2030年）［EB/OL］.（2019-07-15）［2023-12-01］.https：//www.gov.cn/xinwen/2019-07/15/content_5409694.htm.

［134］国家卫健委.关于深入推进“互联网+医疗健康”“五个一”服务行动的通知［EB/OL］.（2020-12-10）［2023-12-01］./www.nhc.gov.cn/guihuaxxs/s7788/202012/15029c3f5e3f4dc78d6a7596567367c6.shtml.

［135］ EEAS.EU-China 2020 Strategic Agenda for Cooperation［EB/OL］.（2013-11-23）［2023-12-01］.https：//eeas.europa.eu/archives/docs/china/docs/eu-china_2020_strategic_agenda_en.pdf.

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［137］ ICPerMed.The ICPerMed vision for 2030［EB/OL］.（ 2019-09）［2023-12-01］.https：//www.icpermed.eu/media/content/Vision_Paper_2019.pdf.

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