《人类遗传资源管理条例实施细则》对医疗机构国际合作中人类遗传资源管理带来的挑战及应对建议——以北京大学肿瘤医院为例

Challenges and suggestions for human genetic resource management in international cooperation of medical institutions caused by the Implementation Rules of the Regulations on the Management of Human Genetic Resources:A case study of Peking University Cancer Hospital

目的根据北京大学肿瘤医院国际合作项目人类遗传资源管理实践,结合人类遗传资源管理法律法规的发展方向,拟为医疗机构加强人类遗传资源管理提出参考建议。方法梳理2019年7月—2023年6月北京大学肿瘤医院在科技部政务平台中获得国际合作科学研究审批的项目,分析医院人类遗传资源管理现状,总结新的法规实施后对医疗机构人类遗传资源管理带来的挑战并提出应对建议。结果共获批1276项人类遗传资源国际合作项目,其中首次申报345项,变更申报931项。涉及453项研究,其中药物或器械上市临床研究286项,占比63.13%,Ⅰ期药物临床试验100项,占上市研究的34.97%。上市研究平均每个项目变更3.14次,非上市研究平均每个项目变更1.56次。结论《人类遗传资源管理条例实施细则》(以下简称"《细则》")限缩涉及人类遗传资源的国际合作项目的管理范围,将管理权限下放到医疗机构;调整了国际合作临床试验备案的适用范围,可能导致部分行政审批项目转为备案;调整了人类遗传资源国际合作科学研究项目审批流程。建议医疗机构加强《细则》适用范围以外样本及知识产权的管理,加强国际合作科学研究的全过程管理,关注并及时传达人类遗传资源管理动态。

Objective According to the international cooperation project of Peking University Cancer Hospital on human genetic resource management practices,combined with the development direction of human genetic resource management laws and regulations,and propose reference suggestions for medical institutions to strengthen human genetic resource management.Methods Sort out the projects that Peking University Cancer Hospital obtained international cooperation approval on the government platform of the Ministry of Science and Technology from July 2019 to June 2023,analyze the current situation of human genetic resource management in the hospital,summarize the challenges brought by the implementation of new regulations on human genetic resource management in medical institutions,and propose corresponding suggestions.Results A total of 1276 international cooperation projects on human genetic resources have been approved,including 345 initial declarations and 931 change declarations.Involving 453 studies,including 286 clinical trials of drugs or devices on the market,accounting for 63.13%,and 100 clinical trials of Phase I drugs,accounting for 34.97%of the market studies.On average,there are 3.14 changes per project for listed research,and 1.56 changes per project for non listed research.Conclusions Regulations on the Management of Human Genetic Resources(short for Rules)limit the management scope of international cooperation projects involving human genetic resources and delegate management authority to medical institutions.Adjusting the scope of application for international cooperative clinical trial filing may result in some administrative approval projects being transferred to filing.The approval process for international cooperative scientific research projects on human genetic resources has been adjusted.Suggest medical institutions to strengthen the management of samples and intellectual property outside the scope of application of Rules.Strengthen the entire process management of international cooperation in scientific research.Pay attention to and timely communicate the dynamics of human genetic resource management.