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<p>The rapid advancement of human germline gene editing (HGGE) technology has brought opportunities for gene therapy in patients with rare diseases. However, due to risks related to technical safety, ethics, and societal concerns, some countries have explicitly prohibited the application of germline gene editing. In reality, the use of HGGE for correcting genetic diseases contributes to safeguarding the fundamental rights of patients with rare genetic disorders and their offspring. The off-target effects of CRISPR/Cas9 gene editing technology are controllable, and preliminary clinical successes have been achieved, with a low probability of substantial harm. Moreover, the expected number of actual applications is minimal, meaning it will not significantly alter the human gene pool in the short term. When applied reasonably, HGGE for correcting genetic diseases does not pose the aforementioned ethical or social risks. Its application is ethically justified, and by implementing matching safety safeguards and regulatory frameworks, the legalization of HGGE for genetic disease correction can be achieved, thereby balancing technological innovation with human rights protection.</p>

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From Prohibition to Prudent Opening

  • 期刊论文

  • 发表日期：

    2026年3月13日

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  • Lijie Wang,
  • Shunbin Zhang,
  • Wei Zhong,
  • Kainan Zhu,
  • Quan Yang,
  • Zichuan Ma,
  • Jianzhen Li

摘要

The rapid advancement of human germline gene editing (HGGE) technology has brought opportunities for gene therapy in patients with rare diseases. However, due to risks related to technical safety, ethics, and societal concerns, some countries have explicitly prohibited the application of germline gene editing. In reality, the use of HGGE for correcting genetic diseases contributes to safeguarding the fundamental rights of patients with rare genetic disorders and their offspring. The off-target effects of CRISPR/Cas9 gene editing technology are controllable, and preliminary clinical successes have been achieved, with a low probability of substantial harm. Moreover, the expected number of actual applications is minimal, meaning it will not significantly alter the human gene pool in the short term. When applied reasonably, HGGE for correcting genetic diseases does not pose the aforementioned ethical or social risks. Its application is ethically justified, and by implementing matching safety safeguards and regulatory frameworks, the legalization of HGGE for genetic disease correction can be achieved, thereby balancing technological innovation with human rights protection.