Anticipatory Governance of Noninvasive Prenatal Testing for “Non-Medical” Traits: Lessons from Regulation of Medically Assisted Reproduction

This article refers to:

Non-Invasive Prenatal Testing for “Non-Medical” Traits: Ensuring Consistency in Ethical Decision-Making

Bowman-Smart et al. (2023) sketched a hypothetical scenario involving noninvasive prenatal testing (NIPT) for “non-medical” traits available for expectant parents in the near future. By critically discussing the case for and against this expanded scope of NIPT, the authors call for a consistent ethical framework before these emerging technologies become widespread. We strongly favor the anticipatory governance of NIPT for non-medical traits. This commentary attempts to take lessons from the regulation of medically assisted reproduction and focuses on explicating the approach of anticipatory governance concerning the issue of NIPT for non-medical traits.

First, based on lessons learned from the regulation of medically assisted reproduction, we illustrate the necessity of a regulatory approach to anticipatory governance and produce governance recommendations around NIPT for non-medical traits.

Since the world’s first in vitro fertilization baby was born in 1978, significant advances have been made in reproductive medicine. Approximately 10 million children are born worldwide through assisted reproductive technology (ART) (von Schondorf-Gleicher et al. 2022). However, over the past decades, the proliferation of ART has brought about ethical, legal, and social issues, as it has benefited and brought happiness to the lives of individuals and couples around the world. Here, we highlight the specific lessons that we can learn from medically assisted reproduction in NIPT for non-medical traits.

As an integral part of ART procedures, preimplantation genetic testing (PGT) enables the practitioner to select embryos predicted to be free of a specific genetic condition or chromosomal abnormalities prior to transfer. However, in theory, PGT can be used to select any genetically determined characteristics desired by expectant parents, including sex and other non-medical traits. Although the policy and legislative approaches to PGT vary widely between countries (including public ordering, private ordering, or a mixture of the two models), its regulation has followed a linear path across the world during the last decade, with incremental changes driven by scientific advances and greater social uptake. Despite its greater social acceptability, widening of the permissibility criteria for PGT remains controversial (Ginoza and Isasi 2020). Related social, ethical, and policy debates have elicited the need for forward-looking governance for PGT. Similarly, the scope of NIPT is expected to expand to include a detailed analysis of the fetal genome, including non-medical traits (Bowman-Smart et al. 2023), and we believe that there is also an urgent need for anticipatory governance in NIPT for non-medical traits.

Sex selection for non-medical purposes is one of the most contentious and heavily regulated applications of PGT. In many areas of the world, sex selection is a common phenomenon, which may be motivated by a son preference and possibly also for family balancing (Bowman-Smart et al. 2020). For example, in China and India, sex-selective termination of pregnancy (TOP), often driven by son preference, distorts the natural sex ratio and has several negative social effects. Thus, regulations place a blanket prohibition on prenatal sex determination in these countries (Ginoza and Isasi 2020). However, NIPT may facilitate an increase in sex-selective TOP, owing to its ease, safety, accuracy, and availability early in gestation. Widespread sex selection could not only lead to harm at the social level (increase the disturbance of the sex ratio in countries with cultural son preference) but also lead to ethical concerns at the individual level (sex selection for family balancing) (Bowman-Smart et al. 2020). We believe that the regulatory lessons of the disclosure of fetal sex information to pregnant women should be learned with the use of NIPT for sex-determination.

Cross-border travel to access reproductive services is a significant topic that has constantly raised significant socio-ethical and legal controversies. Because of the differences in ART regulations across nations, individuals from countries with more restrictive regulations could travel to countries with more permissive ones to seek services unavailable in their home country (Ginoza and Isasi 2020), and surrogacy could be cited as an example. Although surrogacy is banned in many countries, some allow altruistic surrogacy, whereas in others such as Ukraine, even commercial surrogacy has become a well-fledged form of fertility tourism. Many critics have denounced commercial surrogacy as a “global baby business,” which results in the exploitation of women and commodification of human life. Although to minimize the risks posed by commercial surrogacy, improvements in national laws may not be sufficient, and the main effort needs to be made to pursue an international consensus (Piersanti et al. 2021). However, due to the different social, cultural, and legal contexts across countries, there are inevitable difficulties in reaching global agreements in many areas of medically assisted reproduction. Therefore, as the attitudes toward TOP and the importance of informed and free choice regarding NIPT vary greatly among countries (Ravitsky et al. 2021), we believe that the anticipatory governance of NIPT for non-medical traits is worthy of global conversation.

Furthermore, we analyze the anticipatory governance of NIPT for non-medical traits.

Anticipatory governance motivates activities designed to build capacities in foresight, engagement, and integration, as well as through their production ensemble. In our opinion, foresight focuses on the construction and evaluation of plural sets of possible and desired futures by different stakeholder communities; engagement centers on the substantive exchange of ideas among publics and between them and technoscientific decision-makers; and integration brings the foresight and engagement activities into the domain of scientific practice to enhance reflexiveness. The integration of societal needs and values throughout innovation systems and processes is the overall aim of anticipatory governance. Because these three capacities are ensembles, we do not treat them separately in the following discussion. In short, we describe anticipatory governance as an innovative approach to building capacities in foresight and multi-stakeholder engagement to enhance preparedness and reduce the possible risk of emerging technologies in the future (Guston 2014; Muiderman et al. 2021; Nelson, Selin, and Scott 2021; Sarewitz 2011).

As more inclusive and participatory governance can improve the quality and efficacy of decision-making on contentious, complex, and socially important issues (Nelson, Selin, and Scott 2021), we contend that all stakeholders regarding NIPT for non-medical traits, including the public, social and natural scientists, policymakers, local governments, professional societies, companies, and public and private insurance providers should be engaged in the global governance of NIPT. Efforts should be made to expand the breadth and depth of future possibilities and to build broadly applicable reflective and responsive capacities (Nelson, Selin, and Scott 2021). There are many questions that need forward-looking deliberation around NIPT for non-medical traits, including what screening should be permissible; what information should be provided; what uses should be funded by the government; how to regulate the commercial direct-to-consumer sector; how to provide genetic counseling services; how to reduce the burden of choice, inequities, and negative impacts on the children, families, and society; how to guarantee reproductive liberty and autonomy; and how to apply the principle of procreative beneficence (Bowman-Smart et al. 2023).

It is worth noting that public engagement is much more limited than desirable in governance practices (Nelson, Selin, and Scott 2021; Zhang et al. 2022). We agree with Bowman-Smart et al. (2023) that the voices of those who will be using these services, i.e., prospective parents, are critical. As the use of NIPT increases, its benefits and concerns are examined through bioethical analyses, surveys, and qualitative studies (Marcon, Ravitsky, and Caulfield 2021). However, publications related to public opinion on NIPT for non-medical traits are limited. We believe that it is advisable to hold consensus conferences, citizens’ panels, and deliberative public debates or forums. Rather than only bracketing the public into questions about categorical ethical distinctions within tightly constrained imaginations of possible futures (Nelson, Selin, and Scott 2021), public engagement needs to explore what, why, and how the public thinks to expand the scope of NIPT to non-medical traits, as well as to provide them the opportunity to address their own needs and concerns in credible and actionable ways regarding the use of these emerging technologies.

In summary, in this commentary, by drawing lessons from the regulation of medically assisted reproduction, we defend the need for anticipatory governance in NIPT for non-medical traits. As the scope of NIPT is likely to expand in the near future, we wish to evoke and motivate further discussion regarding this emerging and controversial domain to enforce responsible innovation and governance of NIPT worldwide.

DISCLOSURE STATEMENT

No potential conflict of interest was reported by the author(s).

Additional information

Funding

This work was supported by the Province-Ministry Co-construction Major Project on Tackling Key Problems of Henan Provincial Medical Science and Technology Plan [Grant No. SBGJ202101003].