The EspeRare Foundation is pleased to announce the publication of its article “Prenatal therapies: a Points to Consider framework for responsible innovation” in BMC Medical Genomics. This work, co-authored by McGill scholars Eric M. Meslin & Bartha Maria Knoppers, and by EspeRare’s Caroline Kant & Sebastien Mazzuri, introduces the first international framework dedicated to the ethical, legal, and governance dimensions of developing and applying innovative prenatal therapies.
Prenatal therapies represent a transformative frontier in medicine, enabling medical interventions before birth to prevent or mitigate severe congenital conditions. As these interventions rapidly progress from experimental research toward clinical implementation, they raise novel and complex questions, including around maternal–fetal risk, consent, regulatory oversight, and equitable access.
To address these challenges, the authors developed a comprehensive “Points to Consider” (P2C) framework. The P2C identifies nine key ethical and governance domains, ranging from maternal & fetal well-being, future-proof risk–benefit assessment, and responsible science & clinical care, to patient & public engagement, funding sustainability, public health integration, and international collaboration. Together, these points provide a structured reference to guide responsible innovation across the entire research-to-clinic continuum.
“Prenatal therapies are redefining the boundaries of prevention and care,” said Dr. Sebastien Mazzuri, Director of Innovation, Research, and Bioethics at EspeRare. “This framework is an invitation for researchers, clinicians, regulators, and policymakers to work together in ensuring these scientific advances are pursued ethically, inclusively, and for the benefit of future generations.”
The P2C was developed through an international, multidisciplinary collaboration engaging leading experts in bioethics, human rights, and regulatory science. It aims to serve as a practical tool to promote shared understanding, stakeholder dialogue, and ethical accountability as prenatal therapies move toward broader clinical application.
EspeRare will now look to activate the framework through further consultation and stakeholder engagement, working with patient communities, professional societies, and regulatory partners to translate its principles into actionable recommendations and best practices for real-world adoption.
Read the publication here
Read more about EspeRare’s efforts in Prenatal Therapies
