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Paper short abstract:

Multi-sector partnerships purportedly streamline costs of innovation by scripting pharmaceutical regulation as risk management. Consumer choice is manipulated in models of risk-harm-benefit. Using ethnographic evidence, a cosmopolitical proposal is advanced for a responsible regulatory landscape.

Paper long abstract:

Global multi-sector partnerships between pharmaceutical companies, academic researchers, disease advocates, and the general public are promoted by funding agencies as a way of streamlining and sharing risks and costs of innovation development. We have perhaps naively expected governments to protect us from preventable dangers through regulations that provide assurance of the safety, efficacy and quality of novel products. A rescripting of regulatory responsibility worldwide, however, has been emphasising the management of risks in light of ubiquitous uncertainty. Not being able to predict and control the unexpected relieves governments pandering to industry of their responsibilities. Consumer choice and rights are being manipulated in algorithms employing measures and models of risk-harm-benefit and cost. Attending to a political ecology, Isabelle Stengers' cosmopolitical proposal asks us to imagine a "worldwide civil society" where everyone, all shareholders, have a voice. But how do we ensure equity for the less powerful against profit interests? This paper explores regulatory incidents of these phenomena, gained through longitudinal ethnographic research with scientists, clinicians, and regulators involved in the safety and efficacy of emerging biologic and vaccine technologies. Case studies are used to explore a cosmopolitical proposal that makes space for an open ethical regulatory landscape, one that commands and controls reliable and verifiable evidence by recognizing and remaining responsible for unpredictabilities and power inequities.