Who decides in complex cases involving children?

Wille and Sombroek-van Doorm wrote an article in the Dutch Journal of Youth Law (Tijdschrift voor Jeugdrecht), addressing one of the most delicate legal-ethical questions in regenerative medicine:

Who decides in complex cases involving children?

Their article offers a thoughtful analysis of informed consent in pediatric stem cell-based gene therapy, combining insights from children's rights and healthcare law. It emphasizes the importance of age-appropriate information, actual decision-making capabilities of the child, meaningful participation, and transparent decision-making, especially when treatments are still experimental and outcomes uncertain. The authors call for a consent process that is both legally sound and ethically robust ensuring that children are not merely protected, but genuinely heard.

What’s next for WP7?

Looking ahead, Wille, in collaboration with Van Lessen Kloeke, is working on a new publication on the legal and ethical challenges surrounding unlicensed use of Advanced Therapy Medicinal Products (ATMPs) under the so-called 'hospital exemption'. ATMPs are based on genes, tissues, or cells, which are mainly used to treat rare diseases. The hospital exemption is an exemption for ATMPs created under the EU pharmaceutical rules, that allows under strict conditions the preparation and use of certain custom-made ATMPs without a marketing authorisation.

Why does this matter for Cure4Life?

As technology advances across the consortium, Work Package 7 reminds us that legal and ethical considerations are not peripheral - they are foundational. Their work bridges science and society, ensuring that innovation proceeds responsibly, with attention to the needs and rights of patients, especially the most vulnerable.

Through Work Package 7, Cure4Life shows that genuine progress in stem cell-based gene therapy requires more than scientific excellence - it demands legal foresight and ethical integrity.