gms | German Medical Science

Noninvasive prenatal testing (NIPT) uses a blood sample taken from the pregnant woman to provide information to determine the likelihood of the fetus being born with certain genetic traits. Currently the testing looks specifically for the autosomal trisomies 13, 18 and 21. The ‘detection rates’ for Down syndrome (trisomy 21) appear to be particularly high. Since 2012, NIPT has been available for pregnant women as optional screening test that they have to finance privately ([6], p. 10). Last year, the Institute for Quality and Efficiency in Health Care (IQWiG), commissioned by the Federal Joint Committee (G-BA), presented its final report on evaluating NIPT as a screening test “to determine the risk” of the stated trisomies in “risk pregnancies” [5]. The findings of the study were aimed at helping to determine whether and under which conditions NIPT should fall under the regular prenatal interventions funded by statutory health insurance. This process attracted not only public ([6], p. 10), but also parliamentary attention [3]. The ongoing controversy surrounding the issue pertains to the ethical impli-cations of using NIPT, in particular, and how to integrate ethical considerations into evaluations of prenatal screening, in general. In this document, the German Society of Midwifery Science (DGHWi) will outline its position with regard to the statutory health insurance coverage of NIPT. At the same time, DGHWi will call for ethical issues not to be decoupled from social, technical and political issues.

NIPT has been available to and used by pregnant women in Germany for several years and its use is expected to grow in future. Currently access to NIPT is only controlled by the fact that it has to be privately funded, which disadvantages couples with limited financial resources. It is well known that high costs do not necessarily deter people from using (actual or supposed) health-related services ([4], p. 90). The option of purchasing NIPT directly on the Internet means that women are left to undergo the procedure as well as to deal with any possible consequences of the test results alone. This situation has to change. Yet even the solution proposed by the G-BA that costs be covered by health insurance exclusively for so-called high-risk pregnancies seems unsatisfactory because the risk criterion is highly ambiguous and unreliable. Moreover, this process does not prevent women and families who are not classified as having a high-risk pregnancy from undergoing the screening by paying for the procedure themselves. As a result, the aforementioned problems still apply to the majority of women and families. The third and, in the given circumstances, best option would be to offer NIPT as a treatment covered by statutory health insurance under certain conditions. This is the only way to regulate access to this screening and to guide and support how it is dealt with.

It can be assumed that, if the costs of NIPT are covered by statutory health insurance, there would be fewer children born with Downs syndrome. Whether and to what extent this possible development contravenes the UN Convention on the Rights of Persons with Disabilities (CRPD) – particularly Article 8: Awareness-raising in which the states that are party to the Convention undertake “to raise awareness throughout society regarding persons with disabilities and to foster respect for the rights and dignity of persons with disabilities” [2] – should be the subject of an ongoing critical appraisal of the coverage of the screening by statutory health insurance and the consequences thereof. Yet, the marketing strategies of the NIPT providers are indeed fuelling reductionist and deficit-oriented discourses on living with a disability and suggest a concept of health or normality which excludes people with trisomy 21 as well as 13 and 18 [1]. The potential benefits provided by the screening being regulated by the state, including early and comprehensive discussions about the procedure as well as the purported health and safety benefits professed by the providers, could result in improved awareness-raising regarding persons with disabilities, as specified in the CRPD, while combatting stereotypes, prejudices and harmful practices. In more concrete terms, supporting measures could be taken to care for the children concerned in the best possible way if their special care needs are already known antepartum. To achieve these objectives, it is essential that several accompanying structural measures are implemented.

First and foremost, impartial information about and counselling on NIPT must be improved and its availability increased. The extensive professional network of psychosocial information and advisory centres and the relevant patient organisations must be involved throughout this process. The screening procedure needs to be coupled with this counselling. Women and families who care for children with special needs need comprehensive government support. Here, social policy measures are needed to enable the caregivers to go out to work and participate in society. One example could be to provide easy access to integrated childcare and schools. The political, social, material, and structural conditions for people living with impairments must be further improved in order to enhance our coexistence. Ultimately, it is important to strengthen the possibilities of carrying a child to term and putting it up for adoption as alterna-tives to the termination of a pregnancy. Last, but not least, coverage of NIPT by statutory health insurance must be accompanied by extensive social science research to facilitate a better understanding of this complex technology and its ethical, political and social implications. Under the conditions described and accompanied by an ongoing public and scientific debate on the procedure and its effects, preliminary coverage of NIPT by statutory health insurance would be a feasible option.

This position statement was made available to members of the DGHWi for comments from 03.03.2019 to 01.04.2019 and was revised based on the comments received. This position statement is scheduled for revision by 31.07.2024.

The authors declare that they have no competing interests.