线粒体置换技术的挑战及其规制

Challenges and regulation of mitochondrial replacement techniques

线粒体置换技术(Mitochondrial Replacement Techniques,MRT)旨在帮助因携带缺陷线粒体DNA(mitochondria DNA,mtDNA)而患严重线粒体疾病的女性生育具有自身遗传物质和血缘关系的健康子代。然而,该技术尚处于基础研究向临床转化的初期,不仅存在科学、安全争议,而且伴随一系列伦理及社会担忧。各国正积极推进该领域的立法、修法及政策制定工作。基于科技发展、伦理文化、政治立场等要素,各国政策对MRT相关问题有着不同的态度与规制举措,这同样给MRT健康发展带来重大挑战。MRT规制制度的构建,需基于科技进展并依据我国国情、患者需求、风险考量和既有辅助生殖技术规制框架综合设计,以推进MRT负责任的应用,进而增进人民福祉。

Mitochondrial replacement technique(MRT)research and clinical trial aim to help women carrying severe defective mitochondrial genes give birth to healthy infants which are genetically and consanguineously related to these women.However,MRT is still in its early stage of applying the basic research to clinical trial,and there are not only scientific and security controversy,but also a series of ethical and social concerns.Several jurisdictions are actively promoting legislation,revision,and policy formulation regarding the MRT.Nevertheless,different jurisdictions may have diverse attitudes and regulatory initiatives towards MRT related issues based on multidimensional factors,such as the development of science and technology,ethical culture,and political stance,which also poses a significant challenge to the development of MRT and responsible governance of this research field.The construction of a regulatory system for MRT requires a comprehensive design based on our national condition,patient needs,technological advances,and risk considerations,as well as the existing regulatory framework for assisted reproductive technologies.In doing so,we can advance the responsible application of MRT and thereby promote human well-being.