自1990年世界首例基因治疗在美国成功以来,基因治疗作为一种全新的治疗方式开始受到人们的广泛关注。但是,尽管体细胞基因治疗已被大多数国家接受,种系基因治疗却依然受到排斥。这其中除了人们对目前尚无法评估的技术风险让人不能接受外,主要是伦理风险限制了人们的思维。然而,种系基因治疗虽然对伦理形成了一定的冲击,但它所具有的优点仍让广大不治之症患者看到了曙光。因此,通过法律规范来保证种系基因治疗科技的发展及维护伦理道德已成为各国立法的目标。 Since 1990, the world’s first gene therapy success in the United States, gene therapy as a new treatment began to receive widespread attention. However, although somatic gene therapy has been accepted by most countries, germ-line gene therapy remains excluded. Apart from the fact that people are unacceptable to the technical risk which is not yet assessed, the main reason is that ethical risk limits people’s thinking. However, although the germline gene therapy has had a certain impact on ethics, the advantages it has still make the majority of patients with incurable diseases see the dawn. Therefore, it has become the goal of all countries to legislate to ensure the development of the science and technology of germ-line gene therapy and to safeguard ethics.