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Alice Street, 23.10.14
University of Edinburgh Our Changing World Lecture Series
Alice Street, Ann H Kelly, Imogen Bevan, 5.01.18
Presented at: The Regulation of Diagnostic Technologies, University of Cambridge
On July 7th 2015 the WHO launched the Emergency Use Assessment and Listing procedure (EUAL), a fast-track “diluted” version of the WHO pre-qualification process to guide diagnostic procurement in situations where, as a WHO representative put it, “the manufacturer will not have adequate data to make a claim”. The EUAL was developed in direct response to the declaration of a Public Health Emergency of International Concern (PHEIC) in West Africa, where an Ebola Virus Disease (EVD) outbreak had rapidly and tragically developed into a regional epidemic. A lack of available diagnostic tools to accurately identify cases and map transmission dynamics was a key factor driving that amplification a formidable obstacle to bringing it under control. Despite an unprecedented surge in development, few new diagnostic tests for EVD had reached a mature stage of development, and no existing tests had undergone premarket regulatory assessment. Ebola’s high mortality rate and transmission intensity compelled a departure from conventional systems of medical regulation and governance. Speed was of the essence, necessitating the relaxation of regulatory scrutiny and quality controls in a bid to accelerate diagnostic development and approval within the outbreak timeframe.
This paper analyses how the tensions between the humanitarian imperatives of disease control and regulatory assessments of risk played out in the accelerated development, testing and licensure of Ebola diagnostics. The lack of regulation for diagnostic devices in low and middle income countries has long concerned the global health community. In addition to its implications for patient safety, regulatory gaps and rules can discourage manufacturers from investing in high-quality devices. To help incentivize the industry to develop affordable, easy-to-use diagnostic devices for resource-limited settings, the WHO developed its routine pre-qualification process, which aims to provide a transparent, scientifically robust assessment, including dossier review, laboratory evaluation, and site visits to manufacturers. But, notoriously slow and complicated, the review process is regarded by many in the industry as an impediment rather than catalyst to innovation. In recent years, the WHO has developed guidance documents, convened conferences and offered bespoke advice to manufacturers in the hope of stimulating industry interest. But in 2015, with the WHO facing a rapidly spreading EVD outbreak and a growing public outcry over their sluggish response, it was agreed that more drastic measures would be required. The exceptional nature of the PHEIC justified compromises in the quality of scientific evidence that manufacturers provided in the hope that this would encourage manufacturers with ebola-ready technology to come forward.
This paper examines how these emergency measures played out over the course of the epidemic and its aftermath. It draws on document-based analysis of grey literature generated by the WHO, ministries of health, and other global health organisations, alongside interviews with manufacturers, researchers and WHO officials. Analysis focused on the criteria used in EUAL assessments, the different stakes actors held in the EUAL process, and the ethical, scientific and operational dilemmas individuals and institutions faced as they navigated a novel space of regulatory flexibility.
Our analysis of the findings focuses on three thematic areas. We begin by describing the operational logistics, social and institutional negotiations, and bureaucratic practices involved in the production of EUAL evidence. Here we develop the notion of the ‘evidentiary threshold’ to elaborate the varying power of diagnostic devices to marshal public health authority and short-circuit scientific contestation. We then examine the precise nature of EUAL exceptionalism, focusing on the risks that were assessed and the places where compromises were deemed necessary. While the evidentiary threshold for analytical and clinical accuracy was often flexible, we point to manufacturing capacity and future supply as key concerns for the WHO, and consider latent tensions between market-based and humanitarian value frameworks and temporal logics in the design of the EUAL procedure. Finally, we focus on the aftermath of the epidemic, charting institutional reflections on the successes and limitations of the EUAL, and tracing the normative and technical contours of the emerging paradigm of emergency research and development.
Alice Street, 6.04.18
Presented at: Speculative Futures: A symposium and workshop exploring creative practices in health, technology and medicine in the global South, Slought Institute, Philadelphia
Speculative investments in a new generation of point-of-care diagnostic devices designed for resource-limited settings by philanthropists, development agencies and angel investors have focused on their capacity to revolutionise health service delivery in lower and middle income countries. Yet while the number of academic groups, organisations and companies devoted to researching and developing such devices in North America and Europe have multiplied over the past decade, the number of success stories are few and far between. This paper takes the failure of diagnostic speculation as a prompt to reimagine what a diagnostic revolution in global health might look like. It explores the alternative versions of diagnostic innovation that are emerging in the margins of global health, in spaces of citizen science, informal innovation, or academic deviance, and in both the North and South, to examine the alternative versions of medicine, science and development that such initiatives might offer for a post-Establishment future
Ann Kelly, Alice Street, Imogen Bevan, 1.02.18
Presented at: Liminal Spaces Workshop: Regulating for Uncertainty, Wellcome Collection, London
This paper explored how the tensions between the humanitarian imperatives of disease control and regulatory apprehensions of risk played out in the accelerated development, testing and licensure of Ebola diagnostics. Through the notion of the ‘evidentiary threshold’, she traced the normative and technical contours of the emerging paradigm of emergency research and development. Important questions were raised around the commitment to data sharing, lack of cross-validation and downstream challenges of gaining access to, and testing of, samples. These issues are compounded by regulatory ambiguity, lack of harmonisation, differences between minimum thresholds for approval versus deployment, and call for convergence between national regulatory structures. There can often be a disjunct between approval mechanisms that support and promote product development in the emergency context and the cross-over into the non-emergency context whereby access or further use is denied, blocked or subjected to entirely different, stand alone, regulatory paradigms.
Ann Kelly, 25.01.18
Presented at: Kings engaged in Africa 2018: security and development, Kings College London
Nanda Kishore Kannuri, 17.01.18
Presented at: Investigating diagnostics in global health: DiaDev Launch Event, University of Edinburgh
This presentation explored the questions around trust that emerge when malaria diagnostic tests transgress public/private and informal/formal boundaries in public health. What is the difference between trusting an individual, a system, or a device? Do diagnostic devices reduce uncertainty? And how does the diagnosis of malaria feed into the normalization of a disease?
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