Clarifying the legal framework
Our project partners from the University of Mannheim focus on the legal framework of a genomic newborn screening (gNBS) program in Germany. Several laws are relevant here. Of central importance is the Genetic Diagnostics Act (GenDG), which regulates genetic testing. It is substantiated by guidelines of the Genetic Diagnostics Commission (GEKO) and special regulations contained in the Federal Joint Committee's Guildelines on Children. In addition, the provisions of custody law need to be considered, since newborns themselves are incapable of giving consent to genetic examinations and therefore are represented by their legal guardians. Since, genome analysis generates a very large amount of highly sensitive personal data, we also will consider the implications of data protection law for a gNBS program.
Practical shortcomings of the GenDG in current newborn screening.
The GenDG imposes a number of requirements on genetic testing. Even in the case of regular, non-genetic newborn screening, we are already faced with a myriad of practical problems that jeopardize sufficient compliance with legal norms.
According to the GenDG, a suitably qualified physician must provide sufficient information prior to the examination (Section 9 (1) GenDG). In addition, according to the GenDG, genetic predictive testing requires prior genetic counseling (Section 10 (2) GenDG). The GenDG places strict requirements on the person providing the counselling. In practice, however, newborn screening is often supervised by a midwife or maternity nurse, so that the requirement of a physician is not met. Similarly, the communication of test results (Section 11 GenDG) must be done by the attending physician. If a finding requires immediate intervention, this is very problematic. Such problems would be exacerbated in the context of a gNBS program.
Legal barriers for target diseases
Genomic newborn screening is a genetic serial examination in the sense of of §§ 3 no. 9, 16 GenDG. In addition, it is also a genetic examination of a person incapable of giving consent in the sense of Section 14 GenDG. It follows from the interaction of Section 14(1) and (2) GenDG and Section 16(1) GenDG that genomic newborn screening currently is permissible only for very few target diseases. Screening may only be carried out for diseases that will already manifest in childhood or adolescence and for which intervention is possible and necessary in order to avoid severe health consequences. Screening for other genetic traits, such as heterozygote status, is therefore not permitted under current legal regulations. Nevertheless, such information could be highly relevant for parents, for example in the context of family planning or a future child's welfare. For a comprehensive or at least far-reaching gNBS, the GenDG would therefore have to be amended in a number of respects.
Informational self-determination, parental rights, professional freedom
Our constitution, and in particular the provisions on fundamental rights, sets limits to any amendment of ordinary law. On the one hand, fundamental rights represent defensive rights of the citizens against the state; on the other hand, they also give rise to duties of protection on the part of the state. The state is therefore also obligated to protect individuals from encroachments on their fundamental rights that do not originate from the state itself. This is done, for example, through the legal regulations that permit genetic testing only under strict conditions.
In extending the newborn screening program to include genetic testing, fundamental rights of newborns as well as parents and, to a lesser extent, physicians would need to be considered. With regard to genetic information, the right to informational self-determination and the newborn's right not to know are of particular importance here. Both are derived from Art. 2 (1) in conjunction with Art. 1 paragraph 1 of the Basic Law. In principle, it is every person's right to self-determine (a) what information others are allowed to obtain about him and (b) what information he wishes to obtain about himself. On the parents' side, the constitutionally protected right to family planning and parental rights (Art. 6 (1) GG) are also relevant. On the part of the doctors, a restriction on genetic testing may encroach on their freedom to practice their profession (Article 12 (1) of the Basic Law) or on their freedom of research (Article 5 (3) of the Basic Law).
Prof. Dr. Ralf Müller-Terpitz
Prof. Dr. Ralf Müller-Terpitz studied law at the Universities of Bonn and Geneva. After his legal clerkship in Cologne and New York, he initially worked as a consultant in the legal/regulatory department of the Düsseldorf-based telecommunications company o.tel.o.. This was followed by a doctorate and post-doctorate at the Institute for Public Law at the University of Bonn. In 2007, he was appointed to the Chair of Constitutional and Administrative Law as well as Business Administration, Media and Information Law at the University of Passau. Since September 2013, he has held the Chair of Public Law, Law of Economic Regulation and Media at the University of Mannheim. In 2014, he was elected Director of the Institute for German, European and International Medical Law, Health Law and Bioethics (IMGB). Since 2015, he has also been a member of the Ethics Committees of the Medical Faculty in Heidelberg and the University of Mannheim. He is also a member of the interdisciplinary research group "Genetic Engineering Report" at the Berlin Institute of Health (BIH).
Hannah Lilly Straub studied law at the Universities of Erlangen-Nuremberg and Rennes. She completed her studies with the First State Examination and the Maître en droit in July 2022. Since September 2022 she is a PhD student at the University of Mannheim with Prof. Dr. Müller-Terpitz and works as a research assistant in the project NEW_LIVES.