The case for adaptive governance in emerging biotechnology

The proposed 'Regulating for Growth Bill', announced in the recent King's Speech, signals an important shift in how the UK Government is thinking about the regulation of emerging technologies. While the legislative proposals apply across a range of sectors, including AI and advanced digital technologies, they are also highly relevant to emerging biotechnologies.

The accompanying briefing notes indicate that the Bill will include new regulatory sandboxing powers, allowing emerging technologies to be tested under controlled regulatory conditions. That development is particularly significant in areas where scientific progress is rapid, uncertainty is unavoidable, and conventional regulatory models may struggle to keep pace.

In 2024, I chaired a Nuffield Council on Bioethics review examining the ethical and governance questions raised by human stem cell-based embryo models (SCBEMs). These are laboratory-grown structures derived from stem cells that model aspects of early human embryonic development. They have significant potential both as research tools and for future translational applications, including improving understanding of infertility, miscarriage, developmental disorders and drug safety in pregnancy. Yet despite rapid scientific advances, there is currently no specific legal or regulatory framework governing this research in the UK.

The review was established at a time when international scientific developments had begun to attract significant public and policy attention. Researchers are now increasingly able to model early stages of human development in vitro using stem cells, raising important questions not only about scientific opportunity, but also about governance, oversight and public confidence (see BioNews 1335).

One of the central conclusions of our review was that governance should not be understood simply as a mechanism for restricting innovation. In fast-moving and ethically sensitive areas of science, clear, proportionate and publicly accountable governance can actively support responsible innovation by creating regulatory clarity, public reassurance and greater confidence for researchers and investors alike.

The report therefore proposed a staged and proportionate governance framework for SCBEM research. In the short term, we supported embedding the SCBEM Code of Practice that had been recently developed by PET (the Progress Educational Trust) and Cambridge Reproduction (see BioNews 1246), alongside the creation of a dedicated oversight committee and register. In the medium term, we recommended legislation enabling the development of a regulatory sandbox model for SCBEMs (see BioNews 1267).

One attraction of sandbox approaches is that they allow governance frameworks to develop alongside the technologies they oversee. Rather than imposing rigid regulatory structures prematurely, sandboxing enables regulators, researchers and policymakers to learn iteratively under close regulatory supervision. This can be particularly valuable where future scientific trajectories remain uncertain, but where waiting for complete certainty before engaging with governance would itself create risks.

The UK already has experience with regulatory sandboxing in sectors such as financial technology. Applying similar approaches in biotechnology raises additional ethical and societal considerations, but the underlying logic is comparable: enabling innovation while maintaining appropriate oversight and accountability.

Importantly, our review did not advocate deregulation. Nor did it propose that embryo models should simply be incorporated into existing embryo legislation without distinction. Instead, we argued that governance frameworks should be adaptive, proportionate and tailored to the particular features and risks of the technology in question.

The current public debate around regulation sometimes falls into an unhelpful binary between 'innovation' and 'regulation', as though the two are necessarily in tension. In practice, poorly designed regulation can certainly inhibit scientific progress. But the absence of credible governance frameworks can also create uncertainty, erode public trust and destabilise research environments.

This is particularly true in areas involving human developmental biology, reproductive science and emerging forms of stem cell research, where public confidence and institutional legitimacy matter greatly. The UK's international reputation in these fields has historically depended not only on scientific excellence, but also on its capacity to develop governance arrangements that command broad public and political confidence.

That is one reason why the Government's interest in sandboxing powers is important. These powers could provide a more flexible and responsive framework for governing emerging technologies, such as embryo models and in vitro gametogenesis, whose future uses and implications cannot yet be fully anticipated.

One challenge now will be determining which emerging technologies are appropriate candidates for sandboxing, and under what conditions. Another will be ensuring that any new framework combines flexibility with accountability, and support for innovation with public legitimacy. Achieving that balance will require sustained engagement between scientists, regulators, policymakers, ethicists and the wider public, alongside careful consideration of the legal mechanisms needed to enable sandboxing approaches, including where existing regulatory requirements may need to be modified, disapplied or extended in a safe and proportionate way.

The UK has an opportunity to demonstrate that effective governance is not the opposite of innovation, but one of the conditions that allows innovation to flourish responsibly and sustainably.