Year: 2023
Type: book-chapter
Abstract: I. NIPT in the Private SectorThe first non-invasive prenatal test (NIPT) available in Germany was marketed in 2012 under the trade name PraenaTest by the company LifeCodexx.Under § 3(1)(b) of the former Medical Devices Act (Medizinproduktegesetz, MPG) 1420 the test qualified as a medical device for the detection of disability and therefore only required a CE mark to be placed on the market in Germany. 1421 Its placing on the market immediately sparked considerable controversy and public debate.After a series of articles denouncing the market entry of the test in national newspapers 1422 a legal expert opinion commissioned by the Federal Government Commissioner for Matters relating to Persons with Disabilities was released. 1423 The opinion, drafted by Klaus Ferdinand Gärditz, argued that the test could not lawfully be placed on the market. 1424 According to § 4(1) of the old MPG it was prohibited to place a medical device on the market when there were reasonable grounds for suspecting that they directly or indirectly endangered the safety and health of patients or third parties.In the legal expert's view the medical device legislation would lead to a ban on the marketing of NIPT and an obligation on the competent authorities to prevent it from being placed on the market 1425 because the foetus was 1420 The Medical Devices Act was replaced in May 2021 by the Medical Devices Implementation Act (Medizinprodukterecht-Durchführungsgesetz, MPDG).1421 According to the then current § 6(1) MPG, as pointed out by Huster, 'Der Gemeinsame Bundesausschuss als Ethikbehörde?' (2017) 35(4) MedR p. 282, 283.1422 As reported by Braun and Könninger, 'Realizing Responsibility.:
Author: Irene Domenici
Language: English
Subfield: Law
Field: Social Sciences
Domain: Social Sciences
Open Access status: hybrid
Funder: Amicus Therapeutics
OpenAlex ID: W4387942646