Non-Invasive Prenatal Screening: Navigating the Relevant Legal Norms

The implementation of non-invasive prenatal screening (NIPS) in Canada will be affected by legal norms. The law can shape physician behaviour, help to crystallize standards of care, influence utilization patterns, and reflect and reinforce patient expectations. In Canada, failure to inform a patient about NIPS, or misinterpretation of NIPS results, could result in a successful "wrongful birth" claim if the patient subsequently gives birth to a child with a condition that had been detectable. Given that research shows that physicians' decisions are influenced by concerns about liability, malpractice law seems likely to encourage increased recommendation and use of NIPS. Physicians' fiduciary and negligence-based disclosure standards require they consider both objective factors as well as a specific patient's subjective and reasonable beliefs, fears, desires, and expectations. Thus, physicians likely must address dominant public discourses and controversies relevant to NIPS. Given the existence of spin, hype, and misinformation about NIPS, there is an increasing need for a robust consent process and, when appropriate, genetic counselling. In sum, the law will define and bound the acceptable behaviour of physicians recommending or administering NIPS, and nudge the technology's implementation forward. Physicians and policymakers should be aware of the potential impact of these legal norms on both utilization and public expectations.