A Normative Review on Non-Invasive Prenatal Diagnosis (NIPD): Focusing on the German Discussion on PrenaTest®.

Development & reproduction Pub Date : 2021-06-01 Epub Date: 2021-06-30 DOI:10.12717/DR.2021.25.2.113
Na-Kyoung Kim
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引用次数: 1

Abstract

This article aims to introduce German discussion on the approval of the non-invasive prenatal diagnosis (NIPD), which started with the development of PrenaTest® by LifeCodexx AG. The discussion started with the concern that the non-invasive nature of NIPD, such as PrenaTest®, may rapidly expand the use and scope of similar tests, thus leading to a new era of eugenics. Based on this concern, the need for clear clinical guidelines on specific indications for NIPD has been suggested. Along the same line, it was discussed whether PrenaTest® is against the Basic Law prohibiting discrimination on grounds of disability and whether the test is outside the scope of the purpose of gene testing limited by Genetic Diagnosis Act. Through such discussion, the Federal Ministry of Health of Germany established the preconditions for inclusion of NIPD in the German public health insurance system. For this, the German motherhood guideline was amended and the information for the insured persons provided to pregnant women was included in the amended guideline. Such discussion made in Germany provides insight on which points should be considered when various gene testings are accepted in Korea , in which genetic communication has not been systematized yet. In particular, German counseling system for pregnant women will provide valuable insights for Korea where the direction for regulations on abortion has not been established even after the ruling by the Constitutional Court that charges for abortion are against the constitution.

无创产前诊断(NIPD)的规范性回顾:以德国对PrenaTest®的讨论为重点。
本文旨在介绍德国对无创产前诊断(NIPD)批准的讨论,该讨论始于LifeCodexx AG公司开发的PrenaTest®。讨论开始于对NIPD的非侵入性的担忧,如PrenaTest®,可能会迅速扩大类似测试的使用和范围,从而导致优生学的新时代。基于这一考虑,有必要就NIPD的具体适应症制定明确的临床指南。同时,还讨论了PrenaTest是否违反了禁止残疾歧视的《基本法》,是否超出了《基因诊断法》所限定的基因检测目的范围。通过这种讨论,德国联邦卫生部确定了将NIPD纳入德国公共健康保险体系的先决条件。为此,修订了德国的孕产准则,并将向孕妇提供的被保险人的资料列入修订的准则。在德国进行的讨论,让人深刻认识到,在基因交流尚未形成体系的韩国,接受各种基因检测时应该考虑哪些问题。特别是,德国的孕妇咨询制度,对宪法裁判所做出“堕胎是违宪行为”的判决后仍未确定堕胎规制方向的韩国来说,是非常有价值的借鉴。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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