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中美卫生健康科技政策对比研究

Comparison of health science and technology policies between China and the United States

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目的 对比分析中美卫生健康科技政策部署情况及规制重点,为完善我国卫生健康科技政策体系提出建议.方法 系统梳理中美卫生健康科技政策,从时间分布、发文主体、政策类型和规制领域等方面进行量化分析、对比分析.结果 (1)在卫生健康科技政策部署数量方面,2002-2023年间中国共部署相关政策76条,年发布数量从2002年的1项增至2016年的11项以及2022年的10项;2002-2023年间美国部署相关政策110条,年发布数量从2002年2项升高至2023年的13项.(2)在政策发文主体方面,中国国家卫生健康委发文数量占比为57%,美国NIH和HHS发文数量占比分别为62%和20%.(3)在政策类型方面,中国卫生健康科技政策中战略规划、落地实施政策分别占比为41%和51%,相对而言美国两类政策占比为13%和81%.(4)在规制领域方面,中国卫生健康科技政策主要在宏观规划、生物安全、新技术监管、临床研究和产业创新领域占比较多,分别为36%、18%、11%、10%和8%,美国健康科技政策规制领域主要分布在临床研究、生物安全及动物伦理、科学数据和科研诚信等方面,占比分别为15%、12%、11%、11%和11%.结论 (1)中美在卫生健康科技政策领域均呈加速部署态势,我国卫生健康科技政策数量总体偏少,应进一步强化部署.(2)卫生健康行业部门是部署健康科技政策的重要主体,在下一步领域科技政策建设中仍处于主体地位.(3)与美国健康科技政策金字塔状分布相比,我国落地实施政策相对比例偏低,不利于落实落地,需进一步增加实施政策的部署.(4)规制领域方面,我国宏观规划类政策偏多,在临床研究、科学数据及动物伦理等方面部署不足,未来应加强临床研究和科学数据等领域政策部署.
Objective This study aims to compare the development situation and regulatory focus of the health science and technology policy between China and the United States,and put forward suggestions for improving the health science and technology policy system in China.Methods The health science and technology policies of China and the United States were systematically sorted out,and quantitative analysis and comparative analysis were conducted from the aspects of time distribu-tion,policy issuing authority,policy type,and regulation field.Results(1)In terms of the quantity of health science and technology policies,China deployed 76 related policies from 2002 to 2023,and the annual number of policies increased from 1 in 2002 to 11 in 2016 and 10 in 2022.The United States deployed 110 related policies from 2002 to 2023,and the annual number of policies increased from 2 in 2002 to 13 in 2023.(2)In terms of the policy issuing authorities,China's National Health Com-mission accounted for 57%of policy issuance,while the NIH and HHS accounted for 62%and 20%respectively.(3)In terms of policy types,strategic planning and implementation policies account for 41%and 51%of China's health science and technol-ogy policies,respectively,compared with 13%and 81%in the United States.(3)In terms of regulatory domains,China's health science and technology policies mainly focus on macro-planning,biosafety,new technology supervision,clinical re-search,and industrial innovation,accounting for 36%,18%,11%,10%,and 8%of the total,respectively.The health sci-ence and technology policies in the United States were mainly distributed in clinical research,biosafety,animal ethics,scientific data,and research integrity,accounting for 15%,12%,11%,11%,and 11%of the total,respectively.Conclusions(1)The deployment of health science and technology policies in China and the United States is accelerating.However,China has fewer overall health science and technology policies and should strengthen its policy deployment.(2)Health administration depart-ments are important entities in deploying health science and technology policies.They will remain the mainstream in the next phase of health science and technology policy deployment in the health sector.(3)Compared with the pyramid distribution of health science and technology policies in the United States,the proportion of implementation policies in China is relatively low,which is not conducive to implementation and should further increase the deployment of implementation policies(4)Regarding regulatory domains,China has an overemphasis on macro-planning policies while lacking sufficient policy deployment in areas such as clinical research,scientific data,and animal ethics.In the future,policy deployment should be strengthened in areas such as clinical research and scienific data.

HealthScience and technology policyComparative research

成晴、贾晓峰、胡志民

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中国医学科学院/北京协和医学院卫生健康管理政策学院,北京 100730

国家卫生健康委卫生发展研究中心,北京 100044

卫生健康 科技政策 对比研究

2024

中华医学科研管理杂志
中华医学会

中华医学科研管理杂志

CSTPCD
影响因子:0.515
ISSN:1006-1924
年,卷(期):2024.37(6)