Bioconstitutional visions in the debate on non-invasive prenatal testing in Germany

ABSTRACT Since the summer of 2022, statutory health insurance in Germany reimburses the costs of using non-invasive prenatal testing (NIPT), a new technology used in prenatal testing, in ‘justified individual cases’. Analysing moments in the long debate on NIPT in Germany through the framework of bioconstitutionalism and with pragmatic lenses helps us to understand how and why this comparatively unique reimbursement decision became a reasonable and moral one. Conflicts and conversations in these moments reveal two competing definitions and visions of human life relating to measures deemed desirable and legitimate to protect that life. Actors articulating a liberal bioconstitutional vision framed NIPT as a biomedical technology that could protect the lives of foetuses and enable women to exercise their right to know without putting their pregnancy at risk. Actors foregrounding a societal bioconstitutional vision framed NIPT as a selective technology and spoke in the name of all those lives that would be affected by the direct and indirect consequences of NIPT. When public health care authorities endorsed NIPT as a biomedical technology to be reimbursed in individual cases, they sought to reconcile elements of both visions. The case of Germany shows that enduring controversies on reproductive technologies can put constraints on what state authorities are allowed to do. It also suggests that moral controversies on reproductive technologies and the salience of private markets of reproductive care might be the two sides of the same coin.


Introduction
Since the summer of 2022, Germany's public health care system reimburses the costs for some uses of non-invasive prenatal testing (NIPT).In September 2019, the Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) concluded that it was no longer 'justifiable' to 'withhold' (G-BA, 2019c, p.1) this technology from pregnant women.It decided to add the use of NIPT in 'justified individual cases' (G-BA, 2019b, p. 1) to the list of services that all statutory health insurances must provide free of cost to pregnant women, under the condition that biomedical professionals would use a standardized information brochure when counseling pregnant women.
The information brochure was published in 2021 (G-BA, 2021).It explained that NIPT did 'not belong to the generally recommended examinations during a pregnancy' and would be paid by Germany's statutory health insurances only 'if you and your doctor have decided together that the test makes sense for you' (G-BA, 2021, p. 1).But why have authorities in Germany endorsed NIPT as a test to be covered in 'justified individual cases'?And why did the information brochure underscore that NIPT was not a 'generally recommended' test?In this article, I seek to understand why and how the provision of NIPT in 'justified individual cases' became a moral and reasonable choice in Germany.I will also raise the question of how the special case of Germany might help us understand the salience of commercial companies in the global emergence of NIPT.
NIPT is a new technology used in prenatal testing.It capitalizes on the short fragments of foetal DNA (named: cell-free foetal DNA) present in the blood of pregnant women, where they are shed from the placenta and circulate as a minor percentage of women's cell-free DNA.The DNA fragments can be retrieved with a blood draw.Methods such as next-generation sequencing technologies are combined with bioinformatic algorithms to produce information about the likely presence or absence of calculable variations in the foetal genome.NIPT has been used in particular for the early detection of trisomy 13, trisomy 18, and trisomy 21, the three common autosomal trisomies, which are associated with Patau syndrome, Edwards syndrome, and Down syndrome.
Since its launch in 2011, NIPT has been added to an already 'tangled' (Löwy, 2018) assemblage of technologies used to produce information about the health of foetuses and women during pregnancies.Since the 1960s, biomedical professionals have used invasive methods, such as amniocentesis, to diagnose foetal conditions during pregnancies.These involve inserting a needle into a pregnant woman's uterus to extract foetal cells, which are analysed to generate insights on the chromosomes or genes of a foetus (Rapp, 2000;Löwy, 2017Löwy, , 2018)).They require biomedical professionals skilled enough to perform biopsies and are associated with iatrogenic risks for foetuses and pregnant women.Since the 1980s, biomedical professionals have tinkered with non-invasive methods, which do not involve iatrogenic side-effects.Since the turn of the centuries, they have used algorithms combining hormone levels, ultrasound markers, and women's age to calculate women's individual risk numbers of carrying a foetus with one of the three common autosomal trisomies in 'first trimester screening', using these numbers to inform decisions about when to perform invasive procedures (Löwy, 2017(Löwy, , 2018)).
Over the past decade, NIPT has transformed the prenatal testing assemblage.Scholars have pointed to the salience of commercial providers and their competition for market shares to explain the remarkable quick diffusion of this technology (Löwy, 2022).Initially, NIPT was adopted predominantly in private markets of reproductive care, in which women and couples pay for these tests out of pocket or via private insurances (Metzler, 2020;Löwy, 2022).However, while NIPT continues to be used in privately funded markets, public health care authorities in several countries have also integrated some uses of NIPT into public health care systems, often following the paths of previous approaches towards prenatal testing technologies (Gadsbøll et al., 2020;Löwy, 2022).
Several European countries that had previously provided first-trimester screening within public health care settings embraced NIPT as second-tier screening tests.Authorities in Switzerland, Denmark, France, and the UK have given women access to publicly funded NIPT for common autosomal trisomies in cases in which first-trimester screening indicated elevated risk numbers (Lou et al., 2018;Ravitsky et al., 2021;Perrot and Horn, 2022).Some countries have also embraced NIPT as first-tier-screening tests, offering it to all pregnant women.In Belgium, NIPT has been offered to all pregnant women.In the Netherlands, the provision of NIPT to all pregnant women has been the subject of a study since 2017 (Ravitsky et al., 2021).
When placed on this map, the reimbursement decision of the G-BA becomes even more remarkable.Public health care authorities in Germany have never embraced first-trimester screening.This helps to explain why authorities in Germany have not endorsed NIPT as a screening test.However, it does not explain why they did end up adopting NIPT as a test to be reimbursed in individual cases rather than leaving it in privately funded markets of reproductive health.
In this article, I seek to understand how and why this choice became a reasonable and moral one in Germany.I build on the literature that has engaged with the NIPT debate in Germany (Braun and Könninger, 2018;Foth, 2021;Braun and Könninger, 2022;Perrot and Horn, 2022;Raz et al., 2022;Bowman-Smart et al., 2023).This has emphasized Germany's 'unique ethical and policy landscape' (Bowman-Smart et al., 2023: p. 562), the importance of Germany's history and the 'imperative' of '[p]reventing anything that resembles the crimes of the Nazi era' (Foth, 2021, p. 519).This 'imperative' has rendered concerns on the consequences of NIPT on foetuses and persons with Down syndrome particularly salient in Germany (Perrot and Horn, 2022;Raz et al., 2022;Bowman-Smart et al., 2023).The body of literature explains why German authorities have not embraced NIPT as a tool for population-wide screening for common autosomal trisomies.However, it still leaves us with the puzzle of why they have decided to provide NIPT to pregnant women on an individual basis.Was this decision an instance of 'a tension between a moral unease towards selective practices on the one hand, and a reluctance to impose effective restrictions on the other' (Braun and Könninger, 2022, p. 151) as critical scholars suggested?
In this article, I argue that the choice of German authorities gained its meaning not despite but in light of the moral unease towards reproductive technologies.I will build on the understanding that the imperative to avoid a repetition of the past and the state's mandate to protect human life and its dignity are essential to understand the German case (Jasanoff and Metzler, 2020;Foth, 2021).However, I will also argue that it is necessary to unpack competing interpretations of what this mandate means in practice to understand the German controversy and its settlement.I will revisit three moments in the long NIPT debate in Germany combining the framework of 'bioconstitutionalism' (Jasanoff, 2011;Hurlbut, et al., 2020a) with pragmatic lenses (Boltanski and Thévenot, 2006;Callon et al., 2011;Barthe et al., 2016;Laurent, 2017;Sharon, 2018).
I will take the problems that actors assembled as a lens to distill elements of competing bioconstitutional visions, i.e. definitions and visions of human life which sustained and were sustained by competing framings of (un)desirable uses of technologies.I will argue that dynamics and overlaps between two visions, a liberal and a societal one, and authorities' efforts to do justice to both of them can help us understand how the choice to provide NIPT on an individual basis became a moral one.In the conclusion, I will also raise the question whether the case of Germany might help us interpret the salience of commercial actors in the global emergence of NIPT as an effect of the contestation of the legitimacy of public authorities' power.
I ask: What kind of actors assembled around NIPT? How did they frame NIPT?What kind of values and visions of human life needing care did they articulate?How did these competing visions enter into conflict and conversation?And what can we take away from this particular case to understand the remarkable salience of commercial companies in the global emergence of NIPT?

Analytical perspective
Protecting human life and enhancing human well-being belong to the highest goods of organized collectives.However, the measures and instruments that collectives deem legitimate to protect human life and the distribution of responsibilities for their oversight vary.Such variations are also tied to different definitions and visions of the nature of human life that collectives seek to protect.
Sheila Jasanoff and colleagues have introduced the framework of 'bioconstitutionalism' (Jasanoff, 2011;Hurlbut et al., 2020a) to direct attention to the mutual relationship between understandings of human life and measures taken to protect it.They argued that understandings of what human life is and what it ought to be are shaped by a: … constant, mutually constitutive interplay of biological and legal conceptions of life, the former focusing on life's definition and the latter on its entitlements.(Jasanoff, 2011, p. 3) They gauged attention to interactions between biology and law which are sustained by and sustain the distribution of power and authority in organized collectives.They argued that situated interactions between biology and law shape nation-specific assemblages of values, instruments, and practicesor fullblown 'bioconstitutional imaginaries' (Hurlbut et al., 2020b).These describe the nature of human life to be cared for and prescribe the 'states' responsibilities toward the lives in their care' (Hurlbut et al., 2020a, p. 981).
Such imaginaries are constitutional, as they define and confine the matters authorities are expected and allowed to take care of and prescribe the norms authorities ought to attend when performing their responsibilities.They are bioconstitutional, as they rest upon and enact 'notions of the human that are at once and the same time biological and legal' (Hurlbut et al., 2020a, p. 983).They are constitutive of those situated conceptions of human life that legitimize and limit measures that collectives deem appropriate to take care of it.
Bioconstitutional imaginaries can be distilled with different methodologies.Several scholars have used cross-country comparisons to induce nationspecific bioconstitutional imaginaries from regulations of biomedical technologies (e.g., Aarden, 2016;Jasanoff and Metzler, 2020;Hurlbut et al., 2020b).They have demonstrated that cross-country comparisons help to reveal the situatedness of configurations of biomedical technologies and unpack their entanglements with modes of governance.Comparisons help to make visible and explain stable differences between collectives organized as nation states.They are also a helpful remedy against rash universalisations of moralities sustaining uses of biomedical technologies.However, cross-country comparisons also come with the risk of neglecting similarities cutting across countries and making invisible differences within countries.
Another methodology capitalizes on differences within countries, which become visible when emerging technologies are entangled in disputes or fullblown controversies.This methodology uses pragmatic lenses to analyse the actors' articulations and actions in symmetrical ways (Callon et al., 2011;Barthe et al., 2016;Laurent, 2017).When new technologies emerge, their pioneers simultaneously define problems that their innovations help to solve and envision worlds their innovations help to enable (Laurent, 2017).They name the lives their innovations protect and mobilize values to substantiate their desirability and justify their legitimacy (Boltanski and Thévenot, 2006;Sharon, 2018).However, in disputes on emerging technologies, the pioneers' visions are never alone (Venturini, 2010).
Sceptics and critics articulate 'matters of concern' (Callon et al., 2011) that they deem insufficiently addressed or altogether silenced in the pioneers' problem definitions and visions.They lend their voice to lives affected by these technologies and mobilize alternative values to criticize the innovations (Boltanski and Thévenot, 2006).Following biomedical technologies to moments in which actors disagree on their value allows us to distill competing definitions and visions of human life from a symmetrical analysis of: the actors' competing framings of technologies; the lives and values they mobilize to justify or criticize uses of these technologies; and the actions they require authorities to take.
Methodologies studying a single controversy with pragmatic lenses also have disadvantages.They help us to elucidate competing conceptions of human life at work in one case, but they do not allow us to make judgements on their stability or scales.This makes it necessary to adjust the conceptual terminology.Engagements with a single controversy do not allow us to infer to nationspecific bioconstitutional imaginaries; but they allow us to distill elements of competing bioconstitutional visionsi.e.definitions and visions of human life, which sustain and are sustained by competing framings of (un)desirable uses of technologies.

Methods
In this article, I combined the analytical framework of bioconstitutionalism with pragmatic methodologies.The framework of bioconstitutionalism informed my research questions, which I sought to answer adapting pragmatic lenses.Specifically, I followed the emergence of NIPT in Germany to moments of public disputes, taking the problems (Herrmann, 2009;Laurent, 2017) that actors assembled as a lens to distill elements of competing bioconstitutional visions.
I used materials that I collected while following NIPT to moments in which it was envisioned, endorsed, or problematized in public.I attended 17 conferences of professional societies and public discussion events held both within and outside of Germany from the spring of 2016 to the autumn of 2019.I collected publicly accessible documents (including policy papers, press releases and media reports), and I conducted three qualitative interviews with key actors in the spring of 2020.Fieldnotes from the conferences and workshops informed the selection of the three moments, which I analysed in more detail.
When analysing data, I asked: How did actors frame NIPT?What kind of lives and values did they mobilize?What kind of actions did they deem legitimate or necessary?I clustered the framings of NIPT, the lives and values that actors mobilized, and the actions they called for into two competing bioconstitutional visionsa liberal one and a societal one.These two do not exhaust all definitions and visions of human life articulated in the NIPT debate in Germany.However, differences and similarities and dynamics between these two visions can help us understand how and why the decision to provide NIPT in individual justified cases became a moral one.

The launch of NIPT
The NIPT debate in Germany commenced in 2012, when the commercial company LifeCodexx developed and launched the 'PraenaTest', which it presented as 'noninvasive molecular genetic blood test' (Decker, 2012b) for the early detection of trisomy 21.
Saving foetal lives and relieving women from worry LifeCodexx issued several press releases in which it described its innovation, defined the problem it helped to address, and mobilized lives and valueslegitimizing the desirability of its innovation by naming the human lives it helped to protect.
LifeCodexx's starting point was a bottleneck in prenatal testing whereby 'chromosome disorders during pregnancy can only be reliably diagnosed with invasive prenatal methods' (Lutz, 2011).The company did not explain why the reliable diagnosis of chromosome disorders during pregnancy was desirable.It focused on the troublesome nature of invasive methods needed for diagnostics, explaining that '[i]n about one in a hundred of these highrisk interventions, this leads to miscarriage' (Lutz, 2011).
In numerous press releases, LifeCodexx described the elements it sought to combine to develop a test that could mitigate the side-effect of invasive procedures, while also complying with the provisions of the Gene Diagnostic Act (Gendiagnostikgesetz), the law that governs genetic testing in Germany since 2010.The envisioned test involved 'cell-free foetal DNA from maternal blood' (Lutz, 2011); physicians sufficiently qualified to 'inform' and 'council' pregnant women before a blood draw to comply with the provisions of Germany's Gene Diagnostic Act (Decker, 2012a); test tubes that transported blood samples from the offices of physicians to the company's lab; and its 'proprietary bioinformatical evaluation method' (Setzer, 2012a), which could 'reliably exclude or confirm a trisomy 21' (Decker, 2012c).
The company substantiated the value of its innovation, mobilizing human lives that it would protect and values enshrined into German law.It envisioned women at an 'increased risk for chromosomal variations in the unborn child' (Setzer, 2012a) as users, for whom the test could serve as 'decision support for or against invasive diagnostics' (Decker, 2012a).NIPT could help 'reduce the number of unnecessary invasive examinations' (Setzer, 2012b) and 'reduce the number of miscarriages caused by complications from invasive diagnostic methods' (Setzer, 2012a).Quantifying this argument, the company claimed that its innovation could: … save the lives of up to 700 children in Germany alone who die each year from complications in invasive examinations.(Decker, 2012b) In addition to saving foetal lives from iatrogenic side effects, NIPT would also help 'desperate women' fulfill their desire to obtain 'certainty about the health of their child' (Nieder, 2012) and 'relief from worry' (entlasten) (Decker, 2012c) the overwhelming part of them.Therewith, the company would empower women to exercise their 'right to know' (Decker, 2012a) without forcing them to choose between putting a desired pregnancy at risk and learning about the health of 'their child'.

Selecting lives
While LifeCodexx was still working on the market-release of its test, groups and actors began to mobilize against it.Ranging from the Disability Officer of the Federal Government (Behindertenbeauftragter der Bundesregierung) and Down syndrome associations to the Gen-Ethics Network (Gen-Ethisches Netzwerk), the groups were very heterogeneous (cf.Braun and Könninger, 2018;Foth, 2021).However, they converged in regard to framing NIPT as an instrument of selection and drawing attention to the consequences of NIPT on forms of life, which the company had silenced.
While LifeCodexx focused on the knowledge that NIPT promised to produce, its critics pointed to consequences they deemed to be inextricably linked to that knowledge.They argued that 90% of women who learned that they were carrying a foetus with trisomy 21 chose to interrupt the pregnancy (Behindertenbeauftragter, 2012), linking NIPT to the interruptions of pregnancies and 'selective abortions' (Foth, 2021).
While criticizing the narrow framing of NIPT, they lent their voices to the lives that would be affected by the direct and indirect consequences of NIPT.The Disability Officer of the Federal Government drew attention to (unborn) 'children' whose 'right to life' would be endangered and denied (Behindertenbeauftragter, 2012).On the basis of a legal opinion, he also argued that NIPT was at odds with the provisions of the Gene Diagnostic Act, which limited genetic tests during pregnancies to those conducted for medical and therapeutic purposes.The Disability Officer argued that NIPT did not have a therapeutic purpose, as it focused on a condition that was 'neither treatable nor curable' (Behindertenbeauftragter, 2012).Instead, the test was 'about the selection of people with Down syndrome' (Behindertenbeauftragter, 2012).It threatened to 'intensify the dragnet search (Rasterfahndung) for people with Down syndrome' (Behindertenbeauftragter, 2012).
His concerns on the negative side effects of NIPT on children and persons with Down syndrome were shared by other organizations (AFP and dpa, 2012).While they did not mobilize the 'right to life' of unborn foetuses to draw the desirability of NIPT into question, they shared the concern that the non-invasive nature of NIPT might seduce women to rashly use such tests without thinking about their possible consequences and eventually also increase the societal pressure on women to perform prenatal tests (Kawa, 2012).Critics argued that German society would be affected by the negative consequences of yet another prenatal test that infringed on the fundamental values and legal norms of the German polity, including the state's declared commitment to 'protect disabled people from discrimination' (Wagenmann, 2012).
A debate on the desirability of prenatal testing When NIPT was launched in Germany, it was quickly entangled in a controversy about its desirability and legitimacy.Actors articulated competing framings of the technology, spoke on behalf of different forms of human life affected by the technology's consequences and mobilized different values and rights, thus transforming the NIPT debate into a bioconstitutional debate on the lives to be attended to.
A commercial company framed NIPT as a 'better amniocentesis' (Interview 3) that could produce reliable knowledge on the absence of foetal trisomies without the need for invasive procedures, thus sparing foetuses and pregnant women of the iatrogenic side effects of invasive procedures.Concerned groups criticized this biomedical framing as too narrow.They addressed blind spots in the reasoning of the commercial company and argued that the technology would increase the number of selective abortions.While the company spoke in the name of the lives of foetuses and the right to know of women, concerned groups lent their voice to foetuses, children, and people with Down syndrome who the test discriminated against.They problematized the low-threshold nature of the test, which threatened to turn prenatal testing into a routine for pregnant women.For them, the test was not a solution to a biomedical problem, but a societal problem in itself.
By mobilizing terms such as 'selection,' 'dragnet search,' and 'eugenics' (Bahnsen, 2011;Proppnig and Schott, 2014), concerned groups mobilized terms that resonate with darkest period in German history.They took the launch of NIPT as an occasion to reopen past settlements on prenatal testing and on the permissibility of abortions performed after a diagnosis of a foetal condition (cf.Braun and Könninger, 2018, p. 252;Foth, 2021, p. 519).However, other actors were reluctant to engage in this debate.They mobilized cardinal values from past settlements, such as pregnant women's right to know, to justify the desirability and permissibility of NIPT.When LifeCodexx announced the upcoming market release of its test, it entitled its press release as follows: 'PraenaTest® meets all legal requirements and complies with the constitution' (Decker, 2012a).

NIPT and the Federal Joint Committee
Once NIPT was launched, it was adopted quickly in Germany.In particular those biomedical professionals, who had established first-trimester screening tests in Germany in the past, offered it in private centers of prenatal care.An unknown number of women consumed NIPT as 'individual health services' (individuelle Gesundheitsleistungen), paying them out of pocket or via private insurances.From 2013, other companies began to compete with LifeCodexx for shares in the private testing market in Germany.The competition led to a remarkable 'downward price spiral' (fieldnotes July 2017).Prices for NIPT decreased from more than 1200 Euros in 2012 to between 485 and 825 Euros in 2015 (DBT, 2015, p. 2) and then to approximately 250 Euros per test in 2020 (Interview 2).
As in other countries, commercial providers of NIPT also expanded the scope of information from trisomy 21 to all common autosomal trisomies, including trisomy 13 and trisomy 18, offered reports on the likely absence or presence of sex chromosome anomalies or microdeletion syndromes, i.e. conditions associated with the loss of large chunks of chromosomes.Professional societies began to join forces to deliberate on how NIPT ought to be combined with other prenatal tests and on the value of expanding the scope of NIPT (Schmid et al., 2015).
Public debates on NIPT remained remarkably unaffected by the ways in which NIPT was adopted in Germany's private markets of reproductive care.Disputes continued to focus on the desirability or undesirability of using NIPT in the early diagnosis of trisomy 21.However, while in a first moment, actors had disagreed on the very legitimacy of NIPT, in a second moment disputes involved the question of whether the tests' costs should be reimbursed by the statutory health insurances.

Social justice
Public debates on NIPT gained new salience when it became publicly known that the G-BA deliberated on whether to include NIPT in the 'benefit catalogue of the statutory health insurance funds', which defines the services that all statutory health insurances in Germany must cover.The G-BA is the highest authority of the 'shared self-governance' of the German public health care system.Its legal mandate is to ensure that all insured people have access to 'sufficient, appropriate and economic health care' (G-BA, n.d.).
As was the case for the first moment, this second moment in the NIPT debate was triggered by LifeCodexx.In 2013 the company made an application for a 'trial' (Erprobung) of NIPT.It used a new opportunity that the German legislator had created for new 'examination methods' with yet to be proven 'potential' in terms of providing an alternative to established methods (G-BA, 2014, p. 2).The short time between the market release in 2012 and the application in 2013 suggests that the reimbursement by statutory health insurances had been part of the company's business plan from the beginning.
In April 2014, a committee of the G-BA began to work on possible guidelines for a trial that would produce the evidence required to make decisions about its coverage.Trials and studies on NIPT had also taken place in other countries, which have integrated NIPT into their public health care services (Ravitsky et al., 2021).Remarkably, however, the German health care authority did not choose to follow the path of other authorities in Europe.Instead, it chose to narrow down the problem at hand and use its routine practices to address it.
In the summer of 2016, the G-BA decided to assess NIPT through its routine 'methods assessment procedure', basing its assessment on the findings of studies on the performance of NIPT that had been published in the meantime (G-BA, 2016b).The G-BA mobilized the 'motherhood guidelines', which are the provisions that determine the range of services that statutory health insurances must cover during pregnancies, as a baseline for its reasoning.The guidelines entitled women at risk of foetal trisomies to access invasive procedures for diagnostic purposes.The G-BA used the latter as the moral baseline to assess NIPT, or NIPD, which is the acronym for 'noninvasive prenatal diagnostics' that the committee used in many of its documents.The committee assessed whether 'the reliability of the results of NIPD alone (or if necessary, in combination with other noninvasive tests)' (G-BA, 2016a, p. 9) was good enough to reduce the 'number of invasive procedures and the complications associated with them' (G-BA, 2016a, p. 9).
In line with its routine practices and procedures, the G-BA sought to solve this puzzle with evidence.In January 2017, the committee asked the Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, IQWiG), the body responsible for assessing the evidence on new biomedical technologies, to evaluate the 'current medical state of the art' (G-BA, 2017, p.1), and to provide evidence on whether the results of NIPT could be reliable enough to reduce the number of invasive procedures.Thus, the G-BA subscribed to the framing of NIPT as a 'better amniocentesis', i.e. a biomedical technology that could reduce the number of invasive procedures, which LifeCodexx had introduced when launching its test (cf.Bowman-Smart et al., 2023, p. 564).
The G-BA also foregrounded values to justify the desirability of prenatal diagnostics, the public health care system's responsibility in providing it, and the legitimacy of the authority's assessment of NIPT.The committee noted that NIPT could help 'reduce the uncertainty' in risk pregnancies, thereby contributing to the 'faster emotional relief' of women without itself constituting 'a health hazard for the expectant mother and the foetus' (G-BA, 2016a, p. 11).In addition, the G-BA mobilized social justice concerns.It noted that knowledge about NIPT was by now widespread among 'women with at-risk pregnancies', who could choose to perform NIPT (paying its costs out of pocket) instead of opting for invasive procedures (which were reimbursed by the statutory health insurances).However, the use of NIPT constituted 'a considerable financial burden for women and couples' (G-BA, 2016a, p. 3).
Thus, the G-BA pointed to inequities in the access to NIPT to legitimize its potential publicly funded provision and the authority's assessment of the technology.Compensating social inequities is a cardinal value of the public health care system in Germany, which is also enshrined into the legal mandate of the G-BA.Mobilizing social justice helped to legitimize the authority's assessment of NIPT.
A 'public seal of approval'?
The long methods assessment process of the G-BA was accompanied by disputes, in which several groups mobilized concerns, lives, and values that were excluded from the G-BA's narrow framing of the problem as a biomedical one, now tied to matters of social justice.These groups, lives and values overlapped with those present when NIPT was launched.However, in this second moment several members of the Bundestag, one of the chambers of German parliament, weighed in on the debate, thereby rendering it yet more visible (DBT, 2015).
Concerned groups continued to worry that NIPT would lead to a widespread use of prenatal testing, transforming it into a routine, which would undermine women's 'right not to know'the second side of the statutory right to 'informational self-determination' (cf.Bowman-Smart et al., 2023, p. 564).They also worried about the consequences of a potential endorsement of NIPT by the 'solidarity community', noting that women and couples would interpret coverage for NIPT as a 'public seal of approval' (Interview 3).
Critics and sceptics also resumed the argument that NIPT did not have a medical value, as it was not associated with a therapeutic benefit for foetuses with Down syndrome, to undermine the legal mandate of the G-BA to handle this technology (cf.Braun and Könninger, 2018, p. 262;Braun and Könninger, 2022).In addition, they questioned whether the authority and its 'administrative channels' (Gen-ethisches Netzwerk, 2014) served as appropriate spaces in which to manage a technology that affects values fundamental to German society.In a public letter, four members of the Bundestag noted that the committee's legal mandate to assess the 'diagnostic and therapeutic value of new methods and their medical necessity and economic efficiency' excluded 'ethical and societal consequences' (Hüppe et al., 2016, p. 1-2).They called for public debates in which the publics affected by the consequences of NIPT should be involved.
Notably, in this second moment a few biomedical professionals also challenged the framing of NIPT as a better amniocentesis or quasi-diagnostic technology that could serve as a substitute for invasive procedures and save foetal lives (BVNP, 2016).They argued that this framing overestimated the risks associated with invasive procedures and insisted that NIPT could not substitute invasive procedures, which cover a broader spectrum of foetal conditions.The professionals underlined that NIPT should always be combined with a qualified ultrasound to ensure that foetal anomalies, which NIPT could not detect, would not be missed (G-BA, 2019a).

Responding to concerns
The G-BA was visibly impressed by the concerns that its method assessment generated.Over the long period in which the G-BA evaluated NIPT, it issued several press releases in which it foregrounded the values that justified the legitimacy of its work.The committee dismissed the concerns raised by biomedical professionals, noting that an eventual inclusion of NIPT into the motherhood guidelines was meant to 'avoid invasive procedures' and 'not to detect any detectable anomalies' (G-BA, 2019a, p. 652), therewith underlining that screening for foetal anomalies was not a legitimate goal in Germany.
In responding to critics that questioned its mandate to assess NIPT, the committee explained that it was not only allowed but also expected to scrutinize scientific evidence to ensure that all German citizens could benefit from biomedical progress (G-BA, 2015, p.1).However, the G-BA conceded that NIPT might affect a number of ethical and societal consequences that were outside of its mandate.It invited other authorities, including the German Ethics Council and the Bundestag, to spearhead debates on these consequences (Deutsches Ärzteblatt, 2018).

NIPT in the Bundestag
On April 11, 2019, members of the Bundestag, one of the two chambers of German parliament, gathered in an orientation debate, which members of several parties had initiated.In this debate, the elected representatives of the German people assembled in a single space many of the same framings of NIPT, lives, matters of concerns, and values that had been percolating in press releases, media reports, and position papers across the German territory for more than half a decade.Members of parliament converged in dismissing the use of NIPT to screen for common autosomal trisomies on a populationwide scale.However, they assessed the moral permissibility of testing for trisomies differently when testing was pursued on an individual scale in response to personal needs.

Women's right to know
A first group, which also constituted the majority, side-lined with arguments previously made by LifeCodexx and the G-BA to substantiate why they deemed NIPT a significant biomedical innovation, which should also be funded by the statutory health insurances.The group endorsed NIPT as a technological accomplishment made within the field of prenatal testing, underlining that the latter was recognized as 'generally accepted medical monitoring of pregnant women' (DBT, 2019, p. 11331).They argued that NIPT 'could rule out the risk of miscarriages' (DBT, 2019, p. 11331), thereby sparing foetuses, women, and couples of the side effects of amniocentesis, which one member described as 'one dead child who could have grown up healthy' (DBT, 2019, p. 11315) per 200 cases of amniocentesis.
While more conservative politicians underlined that NIPT helped save foetal lives, liberals and social democrats mobilized the value of women's self-determination to justify the desirability of NIPT and its coverage.They spoke on behalf of women and couples who could not cover the costs of NIPT.One member of the Bundestag argued that it would be 'unethical' to: … put pregnant women who do not have the necessary financial means in front of the choice of either living with insecurity or, alternatively, taking the risk of miscarriage for their child, [applause from members of almost all parties] although the information [on the presence or absence of trisomies] is so easy and risk-free to obtain.(DBT, 2019, p. 11329) Similar to others, she argued that 'prenatal blood tests on trisomies in at-risk pregnancies' should be made accessible to all women in Germany, adding that: hether a pregnant woman wants to take such blood tests is up to her free, selfdetermined decision.(DBT, 2019, p. 11329) Women's right not to know A second smaller group of politicians argued explicitly against the 'social policy problem' (soziales Problem) framing of their colleagues, contending that the problem at hand was a far broader 'socio-political' (gesellschaftliches) one.Similar to the concerned groups outside of the Bundestag, they assembled the consequences of NIPT by equating prenatal knowledge with selective abortions.A member of the Green Party invited her colleagues to reflect on the purpose of NIPT and answered the question on her own as follows: It serves selection.The vast majority of foetuses are aborted if it is suspected that the future child would be born with trisomy 21. (DBT, 2019, p.11319)Many members of Parliament spoke on behalf of parents with children with Down syndrome or persons with Down syndrome.These children and their parents, as well as other persons with disabilities, were the lives who would be affected by the negative consequences of NIPT.They were the lives in need of protection.
In their view, the problem to be addressed was not how to ensure equal access to an undesirable technology but why so many women felt the need for prenatal testing and 'why so many women think that they cannot carry their Down syndrome child to term' (DBT, 2019, p. 11 333).Most members within this group did not question the value of the self-determination of women, yet they did question whether pregnant women were in a position to make self-determined decisions.They pointed to societal elements that shaped the desires of women and infringed upon their 'right not to know.'They were concerned that providing NIPT would reinforce these societal conditions, thereby infringing on women's self-determination, devaluing the lives of people with Down syndrome and other conditions, and jeopardizing the state's commitment to protect human life and dignity by rendering Germany more inclusive.

The G-BA's decision
In September 2019, while the members of the Bundestag, who had initiated the orientation debate, were still puzzling on how to move on, the G-BA announced that it had decided to amend the 'motherhood guidelines' in such a way as to include the use of NIPT in 'justified individual cases.'The G-BA explained that its evaluation had shown that the results from NIPT on common autosomal trisomies were reliable enough to avoid invasive procedures in the case of negative test results.Invasive procedures would only be necessary to confirm a positive result of an NIPT.Therewith, the number of invasive procedures could be reduced (G-BA, 2019b, p.1)In a letter to 10 members of the German Bundestag, who had asked the G-BA to postpone its decision, the chairman of the G-BA wrote that it 'does not seem justifiable' to continue to 'withhold this lower-risk test procedure from affected pregnant women', especially since the tests were also 'approved and available' (G-BA, 2019c, p.1) in Germany.
However, the G-BA was also at pains in underlining that its decision was not meant to open the doors to screening or the routine use of NIPT in all pregnancies.It underlined that access to publicly funded NIPT would not depend on statistically calculated risk factors.Instead, the medical and personal need for an NIPT would have to be decided on an individual basis.To enable such decisions, women had to be counseled with the mandatory use of an informed person brochure, which should help women 'make an independent (eigenständig) informed decision as to whether they consider this prenatal genetic examination to be necessary' (G-BA, 2019b, p. 2).

Discussion
In this article, I sought to understand how and why the choice of German authorities to provide NIPT in individual cases became a moral one.I combined the bioconstitutionalism framework with pragmatic methodologies, arguing that the dynamics between two competing bioconstitutional visions could help us understand how the decision of German authorities gained their meaning not in spite but in light of the moral unease towards reproductive genetic technologies in Germany.I analysed three moments in the long NIPT debate in more details, using the problems that actors assembled, i.e. the framings of NIPT they construed, the values and lives they implicated, and the actions they required, as a lens to distill elements of competing bioconstitutional visions at stake in the debate.
What kind of problems have actors assembled?Some actors framed the problem at hand as a biomedical problem tied to matters of social justice.A commercial company problematized the iatrogenic side effects of invasive methods and envisioned NIPT as a tool that could mitigate them.This framing was later endorsed by the G-BA and members of the Bundestag.Mobilizing past decisions on the provision of invasive methods and regulations on genetic testing as a moral baseline, they endorsed NIPT as a better amniocentesis.NIPT could reduce the burden of the emotionally troublesome and potentially harmful uncertainty in risk pregnancies without putting pregnancies at risk.Given that invasive procedures would be needed only to confirm NIPT results that indicated the presence of a foetal autosomal trisomy, NIPT would reduce the number of invasive procedures.This could help to save foetal lives, while also enabling women to exercise their right to know.
In all these moments, concerned groups contested this construction of the problem as too narrow and mobilized matters of concern that actors envisioning and endorsing NIPT silenced.They did not deem the use and provision of NIPT as a solution to a biomedical problem, but a socio-political problem in itself.While proponents of NIPT foregrounded the knowledge it promised to produce, sceptics and opponents pointed to its consequences.They linked NIPT with abortions and framed NIPT as an instrument of selection, thus mobilizing Germany's historical responsibility into the debate (Foth, 2021).They underlined that NIPT did neither have a medical nor a therapeutic value, first questioning the permissibility of its uses and later the G-BA's authority to assess it.And they emphasized that the use and endorsement of a selective technology was at odds with German authorities' declared commitment to work against discriminations of persons with disabilities.They spoke on behalf of those groups and lives that would be negatively affected by the consequences of NIPT: the foetuses with trisomies who would be aborted; the children born with Down syndrome and their families whose lives would be devalued; the pregnant women who would be pressured to perform prenatal testing; and German society whose fundamental values would be harmed.
These two competing constructions of the problem were sustained by and sustained two competing bioconstitutional visions: a liberal one and a societal one.The competing visions were not so much tied to differences in the 'interplay of biological and legal conceptions of life' (Jasanoff, 2011, p. 3).Differences were not associated with competing conceptions of human biology, nor disputes on when human life begins.The moral status of unborn life was not a matter of contention.The differences in the conception of human life were associated with competing sociological and political theories.Both visions approached human life in biosocial termsas emerging forms of biology entangled in social relationships.However, they conceptualized the social on different scales.
The biomedical and social policy problem that proponents of NIPT assembled was sustained by a liberal bioconstitutional vision.This defined and envisioned human life on the level of individual citizens and their entanglements in family relationships.It supported uses of technologies that could protect individual lives and enhance family relationships.Given that this liberal vision also included unborn human lives as worthy of protection, it sustained the endorsement of NIPT as a technology that could protect unborn human life from iatrogenic side effects.However, as the liberal vision entangled unborn human life in a relationship with their expecting parents, it also supported uses of NIPT to allow women and couples to learn about the health of their unborn child, enabling them to decide on how to act on this information.In this liberal vision, authorities had the responsibility to ensure that women were adequately informed and counseled to enable them to make self-determined decisions on prenatal testing.Authorities were expected to regulate the conditions in which women and couples made their decisions; but they were not allowed to take decisions on behalf of them.The latter understanding had already been enshrined into the provisions of the Gene Diagnostic Act, which actors mobilized in the NIPT debate.In the NIPT debate, authorities' duty to regulate conditions in which women and couples could make self-determined decisions was extended to providing access to prenatal testing technologies to ensure that social inequities would not undermine the self-determination of poorer couples and women.
The problematization of NIPT as a socio-political problem was tied to a societal bioconstitutional vision.While proponents of NIPT approached life on the level of individuals and families, sceptics of NIPT conceptualized human life on a societal scale.They situated the personal decisions of individuals in a socio-political context that arises from the sum of individual decisions.
In their problematizations, it was human life on a societal scale that NIPT put at stake.
How do dynamics between the two competing visions then help us understand the NIPT debate and its settlement?First, the two visions show that the NIPT debate did not only concern uses of an emerging technology; it was also a debate on how the state's mandate to protect human life ought to be interpreted in practiceand (perhaps): an occasion to revisit past settlements.This might help explain the slightly redundant nature of the NIPT debate in Germany and its overlaps with previous debates on technologies intersecting with unborn human life (Foth, 2021;Braun and Könninger, 2022).
Second, similarities between the two visions also illustrate why the use of NIPT to screen for common autosomal trisomies on a population-wide scale was undesirable in Germany (Foth, 2021).The liberal vision does not have the resources to deliberate uses of technologies beyond individuals and families.The societal vision conceptualizes human life on a societal scale, but it simultaneously draws into questions the legitimacy of interventions on this scale.The common intersection of the two visions is that interventions at the population level are unthinkable.
Third, dynamics and overlaps between the two competing bioconstitutional visions also help to understand how and why providing NIPT in individual cases became a moral choicenot despite the ambivalence towards prenatal testing but in light of it.Indeed, women and their decisions were the common intersection of the otherwise different visions.Those envisioning and endorsing NIPT as a solution to iatrogenic side effects of invasive procedures envisioned pregnant women with at-risk pregnancies as the users of NIPT, whose health and right to know would be enhanced by NIPT.For concerned groups, pregnant women and their wishes were part of the problem that NIPT threatened to aggravate by inducing yet more women to venture into prenatal testing without reflecting on its possible consequences.
Actors diverged in how they framed pregnant women and the social ties they were entangled in; however, they converged in implicating women as the subjects that authorities were allowed and expected to govern when overseeing NIPTeither by ensuring that all women were appropriately counseled and by providing access to NIPT to those with less financial means; or by conducting public debates on prenatal testing to help women understand that when they use prenatal tests they might act against their very own wishes.Actors held different understandings of how women's selves were situated in society and how their selfdetermination ought to be enabled.The liberal vision focussed on women's right to know; the societal vision foregrounded their right not to know.However, they converged in framing women's self-determination as a good that public authorities and technologies were allowed and expected to protect.
Forth, the two vision's common focus on women as subjects to be governed and the related mandate of authorities to enable and oversee women's choices is also reflected in the G-BA's decision.When the authority made NIPT eligible for funding in 'justified individual cases' without defining such cases, it did not prescribe uses of NIPT; it standardized the information that biomedical professionals had to provide to women when counseling them.In this way, the G-BA reconciled elements from both bioconstitutional visions.It endorsed elements of the liberal vision as a framework that justified its decision's legitimacy; and it used elements of the societal vision to substantiate what it was prohibited from doing.
Consistent with the liberal vision, it empowered individual women to benefit from biomedical technologies.It entrusted biomedical professionals with ensuring that NIPT would not be used without thorough reflections on whether its use was justified in light of women's personal situations.In addition, it also sought to do justice to the societal vision, by emphasizing that the reimbursement of NIPT was not a general recommendation of the test.Not recommending the test, yet, making conditions in which individual women could make personal decisions to perform such a test allowed the authority to reconcile elements from the two competing visions.

Conclusion
In this article, I asked why and how the endorsement of NIPT on an individual basis became a reasonable and moral choice in Germany.I combined the bioconstitutionalism framework with pragmatic methodologies to answer this question.I revisited three moments in the long NIPT debate, using the problems that actors assembled as a lens to distill elements of two competing bioconstitutional visions: a liberal and a societal one.Both visions approached human life in biosocial terms, yet they conceptualized the social on different scales.The liberal vision conceptualized human life on the scale of individual citizens, who were embedded in family relationships; the societal vision conceptualized human life on a societal scale.
Differences between these visions rendered the NIPT debate controversial.Their similarities help us understand the settlement of the NIPT debate.Both visions converged in pointing to pregnant women as the subjects whose choices authorities were allowed and expected to govern by providing conditions in which they could make self-determined decisions, conceptualizing these conditions and their relations to women's selves differently.When the G-BA decided to provide NIPT in individual cases, it reconciled elements from both visions: the liberal vision's understanding that authorities were expected to provide conditions in which women could gain knowledge on the health of their unborn children; and the societal vision's prohibition to recommend such tests to women or to embrace them on a collective scale.
The moment in which the G-BA reconciled elements from the two competing visions could be interpreted as the crystallization of a German bioconstitutional imaginary.However, such an interpretation would need to be solidified with further research.This could explore what happened after the G-BA's decision and ask whether the decision of the G-BA materialized in practices and institutions.Alternatively, comparisons could help us move from descriptions of bioconstitutional visions to bioconstitutional imaginaries, e.g. a comparison of the NIPT debate in Germany with the NIPT debates in other countries or with debates on other reproductive technologies in Germany.These methodologies could help us make judgements on the stability and scale of the conceptions of human life, which I referred to as bioconstitutional visions in this paper, as the methodologies I used would make such judgements rash.
Alternatively, future research could also build on findings of the German NIPT case to better understand transformations in the distribution of power and responsibilities observed in its global emergence (Löwy, 2022).Such research could follow up on the NIPT case in Germany, approaching it not as a unique case but a focussing glass that makes visible phenomena not limited to Germany.This would not deny that Germany is a special case.However, cases such as the recent US Supreme Court's revocation of the US-American abortion settlement demonstrate that while the reasons for the controversial nature of reproductive technologies might well be specific to Germany, controversies on reproductive technologies are not unique to Germany.
Specifically, future research could explore associations between enduring bioconstitutional debates on what human life is and on what it ought to be and the flourishing of private markets of reproductive care and help shed new light on the power of commercial companies.Indeed, the NIPT debate in Germany begs the question of whether the observed salience of commercial actors in the global emergence of NIPT could also be interpreted as an effect of controversies that simultaneously question and undermine the legitimacy of state actors.
Two features of the case of NIPT in Germany substantiate this question.First, a remarkable feature of the German NIPT debate was the stability of the framing of NIPT as a life-saving biomedical technology, which was key for the endorsement of NIPT (Bowman-Smart et al., 2023, p. 564).This framing was introduced by a commercial company when it launched its innovation in 2012.It was not unique to Germany.Several commercial companies framed NIPT as a substitute for invasive methods when they launched first tests from 2011 on (Löwy, 2018;Metzler, 2020); however, in Germany, this framing remained remarkably stable over time.
The remarkable stability of the framing might have been the effect of the company's clever strategy, which had managed to frame its innovation as a solution to a problem that resonated with the German imperative to protect unborn human life; however, the stability might also be due to the fact that very few actors have ventured into envisioning other uses of NIPT in Germany.Concerned groups in civil society and parliament dismissed the technology altogether.Proponents in the G-BA and in parliament limited themselves to evaluating the company's vision.In theory, they could re-envision uses of NIPT.The criticism they faced when evaluating NIPT helps to understand why they did not do this in practice.This begs the question of whether enduring disputes on what public authorities are allowed to do give commercial companies the powerand, perhaps, indeed: a monopolyto envision desirable uses of technologies.Commercial actors might gain salience and voice when the legitimacy of public authorities' actions is contested.
Second, the list of issues not discussed in the NIPT debate is instructive, too.These included the use of NIPT for conditions other than the three most common autosomal trisomies and the relationship of NIPT to other widespread prenatal testing technologies, such as first-trimester screening.While public health care authorities endeavored to find a workable settlement for uses of NIPT to identify common autosomal trisomies in risk pregnancies, they tacitly delegated to private markets these issues.
Scholars have interpreted the co-existence of public debates, in which the ambivalence of prenatal testing is discussed, and the existence of private markets of reproductive care as a failure of state authorities to realize their responsibility (Braun andKönninger, 2018, 2022).However, this interpretation seems to subscribe to the societal bioconstitutional vision and to use it as a critical framework to evaluate authorities' actions.Alternatively, the authorities' permissive attitude towards private markets could also be interpreted as a way in which they seek to perform their multiple responsibilities in light of the ambivalence of these technologies.Enabling and regulating markets of reproductive care seems to allow authorities to enable individuals to exercise their reproductive rights without forcing authorities to venture into directing technologies towards desirable uses.This seems to be more than a negligent attitude of laissez-faire.Enabling personal choices in private markets of reproductive care seems to serve the moral purpose of doing justice to competing expectations on what public health care authorities are allowed and expected to do.
While it would be rash to jump to conclusions from a single case, the case of Germany suggests that the salience of commercial companies in markets of reproductive care and deep-seated moral controversies might be the two sides of the same coin.Further research could compare the case of Germany with other cases, in which reproductive technologies are controversial, and explore relationships between enduring public controversies and the flourishing of private markets in systematic ways.Such research could use the bioconstitutionalism framework to shed new light on contemporary redistributions of power and responsibilities across individual countries.It could also help to understand the power of commercial companies in more relational terms, i.e. not merely as the cause of contemporary transformations but also as their effects.
Such research could follow around emerging reproductive technologies to sites in which a variety of actors define and envision forms of human life that uses of technologies help to protect to substantiate the (un)desirability of such innovations.It could then explore how commercial actors, public authorities, and concerned groups enter into conflict and conversation and share and distribute responsibilities in such disputes.Such research might show that the power of commercial companies is not merely a reason for contemporary controversies on emerging technologies; it might also be their effect.
editing of the manuscript's first version was funded by the University of Vienna's Faculty of Social Sciences.I would also like to acknowledge support by the Open Access Publishing Fund of Karl Landsteiner University of Health Sciences, Krems, Austria.