Kalidasan V, Theva Das Kumitaa
Infectomics Cluster, Advanced Medical and Dental Institute, Universiti Sains Malaysia, Kepala Batas, Malaysia.
Front Bioeng Biotechnol. 2021 Mar 11;9:649203. doi: 10.3389/fbioe.2021.649203. eCollection 2021.
Gene editing platforms have revolutionized the field of genetics with a direct impact on the public health system. Although there are apparent benefits, it is often accompanied by public debates over its uncertainties and risks. In the Malaysian context, modern biotechnology has raised questions about how to best govern gene editing in regulations, biosafety, and biosecurity. Even though standards and guidelines on stem cell and cell-based therapies have been developed, there are no appropriate legal frameworks available for gene editing yet. Nevertheless, biosafety regulations were established to balance promoting biotechnology and protecting against their potential environmental and human health risks. There is also a need to address the potential of genetically modified organisms (GMOs) as bioweapons. Numerous frameworks from several international organizations may provide valuable input in formulating documents on gene editing. By establishing comprehensive guidelines, legal policies, and standards to tackle the challenges and risks associated with gene editing, Malaysia can successfully apply this modern technology in this country.
基因编辑平台彻底改变了遗传学领域，对公共卫生系统产生了直接影响。尽管有明显的益处，但它往往伴随着公众对其不确定性和风险的争论。在马来西亚的背景下，现代生物技术引发了关于如何在监管、生物安全和生物安保方面对基因编辑进行最佳治理的问题。尽管已经制定了关于干细胞和基于细胞的疗法的标准和指南，但目前还没有适用于基因编辑的法律框架。然而，生物安全法规的制定是为了在促进生物技术发展和防范其潜在的环境及人类健康风险之间取得平衡。还需要应对转基因生物作为生物武器的可能性。几个国际组织的众多框架可能为制定基因编辑文件提供有价值的参考。通过建立全面的指南、法律政策和标准来应对与基因编辑相关的挑战和风险，马来西亚能够在本国成功应用这项现代技术。
