Global Access Diagnostics: Transforming the Path for Equitable Access to Life Science innovations for Epidemics

Abstract

The current system of research and development (R&D) for medical countermeasures to control epidemics is inadequate and insufficient, exacerbated by a lack of focus upfront on manufacturing and access. This is the central argument presented in this thesis. The proposed solutions to this problem were trialled between October 2018 and January 2021 and are as follows. Guaranteeing access to life science innovations for epidemics is possible by establishing interconnected platforms for open research, product development, shared intellectual property, and manufacturing facilities delinked from private profit and shareholder return. Without a concerted effort to create and shape systems that streamline manufacture and guarantee access to life science innovations for epidemics, including a recalibration away from profit maximisation as a primary goal, R&D will not lead to the health impact intended, and epidemics cannot be controlled or eliminated. The current system has led to the disproportionate neglect of epidemics that is held back, in part, due to the sporadic, unpredictable nature that hampers the traditional commercial model of R&D on which there is an over-reliance. The current system is imbalanced with an academic fetishisation of the generation and documentation of knowledge without an equal emphasis on the steps necessary to convert theory to reality, or indeed the new systems that might be necessary to be constructed for their delivery. Unaddressed, the status quo leaves the global population exposed to avoidable harm and unnecessary risk.

This thesis offers not a single solution to the challenges facing epidemics and their inadequate tools for treatment, prevention, or timely detection. Instead, multiple paradigm shifts are proposed, that are achievable and necessary, as evidenced by their introduction and delivery during this doctorate. These include, but are not limited to, delinking research, development, intellectual property and manufacturing facilities from private profit and shareholder returns through the establishment of the Global Access Diagnostics. Rapid diagnostics can be enablers that enhance surveillance systems and are exemplified in the thesis to offer focus and pragmatic evidence to inform change. Furthermore, the opportunity to harmonise the validation of performance and regulatory approvals of novel medical countermeasures is at a unique crossroads with the emergence of a novel virus, SARS-CoV-2, that causes coronavirus disease 2019 (COVID-19).

Firstly by building two not for profit manufacturing facilities in the UK and Senegal — Global Access Diagnostics and diaTROPIX, respectively — secondly by establishing the Global Access Foundation, a charitable organisation dedicated to life science innovations for epidemics, and thirdly by transforming a pioneer in biotechnology, Mologic, from a private company into a social enterprise, this thesis shares insights into the seeds of a new system that is not overly reliant on financial incentives and offers an “end to end” solution that prioritises access to novel life science innovations for epidemics.

Establishing new entities with the capability to develop life science innovations for epidemics required, and benefited from, the support and unique characteristics offered by combining private, public, philanthropic and multilateral institutions. Whilst philanthropic support was necessary to achieve the milestones outlined in this thesis, the content of the thesis focuses on the problems, gaps, and opportunities seized to guarantee access to life science innovations for epidemics, with rapid diagnostics as an exemplar.