Article Text
Abstract
To maximize the impact of the findings of clinical research, long-term plans for equitable access to new, innovative health products should be included right from the outset of R&D planning. This is a complex undertaking, that requires multilayered, coordinated interventions across various disciplines and sectors, including but not limited to pharmaceutical regulation, ethical oversight, technology transfer, intellectual property ecosystem, market dynamics, production capacity, supply systems, communities engagement etc.
Partnerships grounded in the principles of fairness, respect, care and honesty as per TRUST Code (A Global Code of Conduct for Equitable Research Partnerships), and established with a thorough comprehension of the process of decolonization of global health research, are essential pre-requisites for enabling African clinical researchers, their research centres and partners to achieve these ambitious objectives. In particular, fair and collaborative partnerships will (i) enable defining a regional and continental clinical research agenda that prioritizes the population unmet health needs, and (ii) facilitate the generation of evidence and translation of research findings into concrete access to new products to all those in need, including through rapidly-available multisource and/or biosimilar quality-assured formulations.
Once fair governance mechanisms are established, collaborations -including in the clinical research field- should be empowered to adopt a systematic approach that addresses the interconnectedness of R&D with the legal, regulatory and policy determinants of access. Such an approach should include comprehensive planning from the start, addressing provisions for, among other things, quality-assurance, surveillance, sustained supply, technology transfer and market shaping. To achieve this broad scope, from R&D to ensuring product quality, availability and affordability to all, these collaborative partnerships must not be limited to researchers alone. They should actively involve regulators and policymakers within the local pharmaceutical systems. By engaging all relevant stakeholders, we could create a more comprehensive and effective framework to achieve equitable access to healthcare products.