Prenatal therapies: The next medical frontier
We stand at a pivotal moment in the history of medicine. The development of prenatal therapies (medical interventions performed in utero before birth) offers an unprecedented opportunity. Thanks to these ground-breaking approaches, it is now possible to target severe congenital conditions during fetal development, preventing perinatal mortality or irreversible harm before a child is born.
These therapies generate immense hope, but they also raise unprecedented ethical, legal, and societal questions, such as:
- How can risks and benefits be balanced when two patients—the mother and the fetus—are involved?
- What mechanisms can ensure that consent is fully informed?
- What ethical and regulatory frameworks are needed to guarantee responsible development?
Anticipating these debates is crucial to guide researchers and clinicians, prepare health authorities for oversight, and inform the public about the benefits and the limitations of these innovative therapies. The current context, marked by unprecedented advances, provides a unique opportunity to lay the foundations for ethical and responsible governance.
Aware of these challenges, the EspeRare Foundation, a non-profit organization and pioneer in the development of maternal and fetal therapies, has launched an initiative to make these complex issues more accessible and to encourage collective, multidisciplinary, and proactive reflection. Through this approach, the Foundation seeks to act as a catalyst for shared responsibility, involving civil society as well as communities of practice, to develop collective and sustainable responses.
The P2C Framework: A World First
EspeRare has coordinated the development of an international reference framework of ethical and deontological considerations or Points to Consider (P2C).
Developed through multidisciplinary collaboration among experts in fetal medicine, bioethics, law, and regulation, the P2C highlights nine key areas:
- Maternal and fetal well-being
- Long-term risk-benefit assessment
- Responsible science and clinical care
- Use of emerging science and technology
- Patient and public engagement
- Diversified and sustainable funding
- Expansion of prenatal public health programs
- Lifecycle approach to governance
- International engagement
With the aim of sharing this work with a wider audience and securing validation by the scientific community through peer review, the EspeRare Foundation, in collaboration with our leading experts in bioethics and international law - Professor Bartha Maria Knoppers (McGill University), a global authority on data governance and health policy, and Professor Eric Meslin (University of Toronto), a recognized expert on the ethical dimensions of biomedical research and public health - has published an article in the BMC Medical Genomics, outlining the methodology and context of this P2C initiative. Their contribution has been pivotal in co-developing this framework and providing it with strong academic and international grounding.
Our aim is to ground these innovations in universal values (human rights, health equity, transparency) while providing concrete guidance for researchers, clinicians, policymakers, and other stakeholders, including families who may consider prenatal treatments.
Next Steps
To consolidate and further advance this ethical framework, we aim for it to be widely disseminated and enriched through open dialogue with the scientific and medical community, policymakers, and civil society, ensuring that it can be debated, challenged, and continuously refined.
1. Interdisciplinary Workshop
Bringing together key stakeholders and international experts, this workshop will promote dialogue around the nine P2C areas, identify key messages, highlight areas of divergence, and propose actionable recommendations for decision-makers.
2. Public Communication
Finally, outreach activities will share the conclusions with the wider public, including through a participatory public debate. These efforts will maximize the societal impact of the initiative by fostering a genuine exchange between science and society.
Eric M. Meslin is currently Adjunct Professor at the University of Toronto Dalla Lana School of Public Health, Senior Fellow at the PHG Foundation University of Cambridge, and Visiting Scholar at the Centre of Genomics and Policy at McGill University. He has had a diverse 40-year career bridging clinical, academic, government, and non-profit sectors. Trained in philosophy and bioethics from York University, Toronto and Georgetown University, Washington DC, and in corporate governance from the University of Toronto, the common focus of his work has been on ethical, and policy issues in health and science with an emphasis on genomics, global health, science policy, and human research. Dr. Meslin has held numerous academic appointments at universities in the USA, UK, Canada, Australia and France as well as executive leadership positions in Canada and USA. He has also been an advisor to and board member of many organizations including OECD, WHO, CDC, Genome Canada, ELXIR-Europe, and UK Biobank. Among his many honors, Dr. Meslin is an Elected Fellow of the Royal Society of Canada, the Canadian Academy of Health Sciences, and The Hastings Center. In 2007 he was appointed a Chevalier de l’Ordre National du Mérite (Knight of the National Order of Merit) by the Government of France.
Bartha Maria Knoppers is a Distinguished James McGill Professor Emerita and former Canada Research Chair in Law and Medicine. She is the Founding Director of the Centre of Genomics and Policy of the Faculty of Medicine and Health Sciences, McGill University. In 2007, she co-founded CARTaGENE with Dr. Claude Laberge, professor Emeritus of Medicine and Pediatrics at the Faculty of Medicine, Université Laval. She was the Chair of the Ethics and Governance Committee of the ICGC (2009-2017); Co-Chair, Ethics Working Group of the Human Cell Atlas (2018-24) and is currently, both a co-founder (2013) and a Board member of the Global Alliance for Genomics and Health. She is an Officer of both the Order of Canada and of Quebec. She holds five Doctorates Honoris Causa and was awarded the Henry G. Friesen International Prize in Health Research (2019), the Till and McCulloch Award for international policy (2020), and the Canadian Bioethics Society Lifetime Achievement award (2021) in recognition of her significant contributions to biomedical research and healthcare. In 2025, she was awarded the McGill Medal for Exceptional Academic Achievement.