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

摘要

This article aims to introduce German discussion on the approval of thenon-invasive prenatal diagnosis (NIPD), which started with the development ofPrenaTest® by LifeCodexx AG. The discussion started withthe concern that the non-invasive nature of NIPD, such asPrenaTest®, may rapidly expand the use and scope ofsimilar tests, thus leading to a new era of eugenics. Based on this concern, theneed for clear clinical guidelines on specific indications for NIPD has beensuggested. Along the same line, it was discussed whetherPrenaTest® is against the Basic Law prohibitingdiscrimination on grounds of disability and whether the test is outside thescope of the purpose of gene testing limited by Genetic Diagnosis Act. Throughsuch discussion, the Federal Ministry of Health of Germany established thepreconditions for inclusion of NIPD in the German public health insurancesystem. For this, the German motherhood guideline was amended and theinformation for the insured persons provided to pregnant women was included inthe amended guideline. Such discussion made in Germany provides insight on whichpoints 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 forKorea where the direction for regulations on abortion has not been establishedeven after the ruling by the Constitutional Court that charges for abortion areagainst the constitution.