I use the examples of medical devices, clinical trials and health data, to look at the framing of harm through the language of technological risk and failure. Across the examples, there is little or no suggestion of failure by those formally responsible. Failure is seen as arising when harm becomes refracted through calculative techniques and judgments, and reaches a point where the expectations of safety built into technological framings of regulation are thwarted. Technological framings may marginalise the contribution patients, research participants and others can make to regulation, which may in turn underlie harm and lead to the construction of failure. This marginalisation may amount to epistemic injustice. Epistemic injustice and its link to failure, which has normative weight over and above harm, can present a risk to organisational standing and reputation. This risk can be used to improve the knowledge base to include stakeholder knowledges of harm, and to widen responsibilities and accountabilities. This promises to allow regulation to better anticipate and prevent harm and failure, and improve the efficacy and legitimacy of the health research enterprise.

Critiques of global public health security (GPHS) and proposed solutions tend to overlook the potential of the individuals and groups that are subject to and governed by GPHS – “the governed” – to contribute their “on the ground” knowledge and experience to decision-making in order to improve regulatory responses. This article argues for the development of a more reflexive approach as a way of ensuring the epistemic integration of these knowledges with the scientific-technical knowledges that currently dominate decision-making processes. I identify human rights as the conceptual lens that is most likely to enable reflexivity by the governed and regulators, and understanding and communication between them. The governed can use perceived or actual breaches of human rights to articulate “on the ground” knowledges as institutional risks to reputation and standing and, in turn, threaten the production and legitimation of organisational identity, socio-political orders and projects of rule. The particular sensitivity of regulators to these risks could compel epistemic integration. This more reflexive approach to GPHS promises to improve the knowledge base, efficacy, accountability and legitimacy of decision-making at multiple levels: WHO, EU, national and “on the ground”.

This chapter explores how the EU is a largely overlooked exporter of normative power through its facilitation and use of clinical trials data produced abroad for the marketing of safe pharmaceuticals at home; a move that helps to foster the growing resort to pharmaceuticals as a fix for public health problems. This is made possible by the EU’s (de)selection of international ethical frameworks in preference to the international technical standards it co-authors with other global regulators. Clinical trials abroad underscore how ethics are contingent and revisable in light of market needs, producing weak protections for the vulnerable subjects of EU law. I argue that these components and effects of the regime are ultimately about that which undergirds, shapes and directs regulatory design. That is, I point to the use, infiltration, perpetuation and extension of market-oriented ideas, values and rationalities into formally non-market domains like biomedical knowledge production and public health. I explain how these are central to efforts at producing and legitimating the EU, its related imagined socio-political order based on a more innovative, profitable and competitive pharmaceutical sector in order to foster economic growth, jobs and prosperity, and with them the project of European integration. ‘Bioethics as risk’ is highlighted as a way to reshape and redirect the regulatory regime in ways that are more consistent with the spirit and letter of the ethical standards (and through them the human rights) the EU claims to uphold.