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Understanding the challenges for the responsible introduction of new reproductive technologies

A new study has contributed to an increased understanding of the prerequisites and challenges for the responsible introduction of new reproductive technologies, including expanded carrier screening, non-invasive prenatal diagnosis and germline genome editing.

Published in PLOS One, the study examined emerging technologies that are expected to have a large impact on the field of reproductive medicine and genetics in the near future.

Researchers from the Department of Human Genetics and Amsterdam Reproduction and Development Research Institute provided a case study of the Netherlands, to investigate how culture, structure and practice in healthcare is being shaped by innovations and changing dynamics in genetic and reproductive medicine.

“Implementing new technologies in an existing field involves changes and transitions for a broad range of stakeholders in structure, culture and practice,” the authors write.

Responsibly introducing reproductive technologies

Reproductive and genetic medicine are evolving rapidly, and new technologies are already impacting current practices. This includes technologies that can identify a couples’ risk of having a child with a genetic disorder. Responsible implementation of new technologies requires evaluation of safety and ethics. Premature implementation of new technologies can be a risk for future recipients in reproductive medicine.

Great commotion was caused across the globe when the first case (and last up to now) of genome edited babies in China was reported. However, a global moratorium is in place that prohibits GGE in a clinical setting.

Recently, the World Health Organization published recommendations for governance and oversight of human genome editing and one of their recommendations was to facilitate an inclusive global dialogue. 

Professional perspectives

Professionals from different disciplines in the field of reproductive and genetic healthcare in the Netherlands participated in the study. Participants included clinical geneticists, clinical embryologists, researchers, governmental and health insurance representatives, ethicists, legal experts and representatives from patient organisations.

Healthcare professionals provide valuable insights for shaping governance processes. Their willingness to adopt these technologies and guide the necessary systemic changes is required for the successful implementation of these technologies.

Three emerging technologies were explored: expanded carrier screening (ECS), non-invasive prenatal diagnosis (NIPD) and germline genome editing (GGE).

Definitions of reproductive technologies, van Dyke et al, PLOS One

ECS, NIPD and GGE

For ECS, the study found that several structural changes may be necessary in order to become established in preconception care. Healthcare providers warned that current capacities of prenatal diagnosis and preimplantation genetic testing (PGT) would likely be insufficient if ECS becomes mainstream. More professionals will have to be trained to provide counselling, and reimbursement of the test will be needed to safeguard equal access, among others.

Concerning NIPD, the study noted that this technology is not yet embedded in care formally in the Netherlands or many other countries. However, it is expected that NIPD will be embedded as a matter of due course. In the prenatal context, few structural hurdles were identified for NIPD implementation. The availability for couples with a known increased risk seemed feasible on the short term. However, the authors noted with doubt that NIPD would become a more popular technology than PGT among couples, since PGT is preferred over pregnancy termination. 

GGE was believed to be far from clinical implementation. Because GGE affects subsequent generations, GGE would benefit from a strong governance model with international oversight and cooperation. The authors write that good governance should be in place to prevent abuse, to safeguard research and possibly guide human application.

A Dutch case study

The research presented the Netherlands as a case study. Previous implementation examples in the Netherlands suggests the introduction of new technology involves an organised collective learning process, with pilot studies and stepwise implementation.

The Netherlands acts carefully, but as a consequence is not a pioneer in reproductive technology worldwide. Nevertheless, this Dutch approach has advantages such as building public support and opportunities to learn from small-scale implementation. The insights gained from this method can also inspire and educate other countries.

“Given the difference between healthcare systems in countries it is not possible to simply implement elements a reproductive genetic healthcare system from one country in another country. It is important to understand the contexts of innovation, by unravelling the culture, structure and practice,” the authors noted.

Written by Poppy Jayne Morgan, Front Line Genomics

Image Credit: Canva