病原微生物遗传资源共享利用制度现状、展望与应对建议

Status, prospect and proposals of sharing and utilization system of pathogenic microbial genetic resources

摘要:

国际社会关于病原微生物遗传资源讨论的起点和最终目标均是公共卫生健康风险的预防、防范和应对，及时共享病原体及其核酸序列数据和相关元数据对于实现早期识别、风险评估，以及制定和执行诊断、疫苗和治疗方法等对策至关重要。建立公平公正的病原微生物遗传资源惠益分享机制，已经成为确保病原体及其相关数据及时、快速共享的关键要素。病原微生物遗传资源或其数据信息的获取与惠益分享相关提案和讨论体现出缔约方越发重视国家权益和国内利益相关方主体权益保障。我国病原微生物遗传资源监管立法突出公共卫生健康和生物安全风险预防、防范和应对，与现行国际规则的宗旨以及国际规则的讨论进程总体契合，作为新兴生产要素的科学数据的管理制度和管理体系建设尚处于快速发展和不断探索阶段，国内微生物遗传资源共享利用的行业实践逐渐成形。本文梳理了国际社会和我国病原微生物遗传资源共享利用制度现状，并基于病原微生物遗传资源国际制度发展趋势和我国病原微生物遗传资源共享利用实践需求，提出了病原微生物遗传资源共享利用制度展望以及应对建议。

Abstract:

The starting point and ultimate goal of the international community’s discussion on pathogenic microbial genetic resources are the prevention, preparedness, and response of public health risks. Timely sharing of pathogens, their nucleotide sequence data and relevant metadata is of paramount importance in enabling early identification, risk assessment, diagnosis, vaccine development, and selection of therapies. Establishing the mechanisms for fair and equitable sharing of the benefits arising from the utilization of the concerned resources has become a critical element of ensuring expedited pathogen sharing. The proposals and discussions on the access and benefit-sharing of pathogenic microbial genetic resources or their data information reflect that the parties pay more attention to the protection of rights and interests of their nations and domestic stakeholders. The regulatory legislation of pathogenic microbial genetic resources in China highlights the prevention, preparedness, and response of public health and biosafety risks, which is in line with the purpose of the current international rules and its discussion process. The establishment of the management system and regime of scientific data as a new factor of production is in the stage of rapid development and necessitates continuous exploration. The industrial practice of domestic microbial genetic resources sharing and utilization gradually matures. This paper reviews the current situation of the sharing and utilization system of pathogenic microbial genetic resources in the international community and China. Based on the development trend of the international system of pathogenic microbial genetic resources and the practical needs of the sharing and utilization of pathogenic microbial genetic resources in China, this paper presents the prospect of the sharing and utilization system of pathogenic microbial genetic resources. Furthermore, this paper puts forward proposals to improve the sharing and utilization system of pathogenic microbial genetic resources in China. First, we should coordinate the consideration of future implementation of the convention with major issues such as overall national security, ethics, politics, and diplomacy, take into account the protection of national sovereignty rights and interests of stakeholders, and actively participate in the building of an international system for the sharing and utilization of pathogenic microbial genetic resources. Second, in view of the weak aspects of the development of the pathogenic microorganism sharing and utilization system in China, we should step up the establishment of the pathogenic microorganism genetic resources access and benefit-sharing system. Third, we should carry out pilot demonstration and take the lead in forming a pattern of sharing, utilization, and benefit-sharing based on industry self-discipline before the improvement of system. Fourth, we should strengthen the infrastructure construction and personnel training for genetic resources of pathogenic microorganisms. Furthermore, we should ensure the security of national resources, improve the prevention, preparedness, and response of public health risks, and support the development strategy of national resources protection, public health, and public safety with high-quality talents.