Regulating human reproductive and developmental biotechnologies: a UK reference model.

Abstract

Rapid scientific change is exposing the limits of the UK's regulation of human reproductive and developmental biology. Embryo-like structures, in vitro gametogenesis, organoids and heritable genome editing advance understanding of human development and physiology and support new applications in assisted reproduction and clinical care, yet the current regulatory framework is ill-equipped to govern them coherently. A case is made for coordinated, technology-neutral regulatory change. The article proposes the principles of a model UK Human Reproductive and Developmental Biotechnology Act and regulator, the Human Reproductive and Developmental Biotechnology Authority-or HRBA, pronounced 'harbor'-to provide a permissions route across research and translation. The model Act is a modular, risk-tiered scheme with consistent standards and tailored red lines. It is designed to accommodate boundary cases, to integrate and build upon the existing remit of the Human Fertilisation and Embryology Authority, and coordinate with other established regulators to retain institutional expertise and avoid unnecessary duplication. The proposal is ambitious and would help give effect to UK Government commitments to safely advance the life sciences in this area. But even if piecemeal amendments are ultimately favored, it clarifies the underlying choices and trade-offs and provides a benchmark against which changes can be tested.