Blog6th July 2026
Regulate to Innovate: Drawing on Principles to Facilitate Ethical Progress in Bioscience Research
Sarah Devaney
The regulatory approach adopted to oversee a given sector has an enormous influence on its practices and outcomes. The clarity or otherwise of the boundaries of what is permitted, the role of regulators and the relationships they have with those they oversee, and mechanisms of compliance, enforcement and sanctions will all contribute to whether and how regulated activities meet their aims.
The regulation of innovation in UK bioscience research is no exception. Take the well-established framework overseeing research involving live human and admixed embryos: the Human Fertilisation and Embryology Act 1990. It is overseen by a regulator which has decades of experience in providing guidance on standards for scientists and clinicians, and a variety of compliance mechanisms to draw on. The 1990 Act sets criminal sanctions for egregious breaches of its terms.
This combination of features has contributed to the framework remaining in place for approaching four decades, despite the acute demands which revolutions in bioscience have periodically placed on its legitimacy. In the past, these have been responded to through amendments in both primary and secondary legislation.
This would not have happened as successfully without the thread of ethics which lies at its core. Respect for embryo or gamete donor autonomy, for example, has provided guardrails for decision making and, when necessary, legislative amendments.
We find ourselves now at another moment of pressure for the 1990 Act. Stem cell based embryo models, in vitro gametogenesis and the ability to culture embryos beyond the legally mandated 14 day limit, are testing its credibility and claims that the regulatory framework is ripe for modernisation are building.
The current state of pressure on the legislation is distinctive in that these advances are taking place within the context of other revolutions in research and development methods. Many of these rely on the use of health data, and may utilise AI to accelerate their outcomes. Questions of regulators’ remits arise as new biotechnological advances combining human and non-human, and live and artificial, place pressure on once easily definable regulatory boundaries.
The recent House of Lords debate on fertility treatment regulation noted that the regulatory framework must deal with the ethical issues associated with current and future developments in fertility science. This can be done by placing both ethical and regulatory principles at the framework’s core.
Settlement on precisely what these should be arrived at through collaboration between industry, regulators and other stakeholders, including the public. Examples of relevant ethical principles might include representation in research; equity of access to resulting technologies; and solidarity in the pursuit of health benefits for society. Regulatory principles such as transparency, accountability, sustainability and certainty combined with flexibility also need to be in place.
Beyond a settlement on relevant principles, other challenges arise, such as how to ensure that generative AI adheres to these principles. Oversight of the sector by a regulator or regulators who have expertise both in the subject matter and in cutting edge regulatory strategies is needed.
We now find ourselves at a point in which it is critical to establish agile, anticipatory, adaptive, proportionate, responsible regulation of innovative technologies, with ethics at its heart. This will enable the UK to maintain the reputation of its science research ecosystem, to comply with Government’s growth agenda, to engender public trust, and to facilitate the capacity of bioscience to contribute to improved health for society.