'Our project, your problem?' A case study of the WHO's mRNA technology transfer programme in South Africa

Abstract

In June 2021 the World Health Organization (WHO) and the Medicines Patent Pool (MPP) launched an mRNA technology transfer programme. With a South African consortium serving as the hub, the programme aimed to increase vaccine manufacturing capacity in low- and middle-income countries (LMICs) in view of the "vaccine apartheid" that was observed during COVID-19. Following Clarke's "situational analysis," the present study assessed whether the mRNA programme differs from the approach and practices that comprise current biopharmaceutical production. Numerous documentary sources, including legal agreements underpinning the programme, funding agreements, and patent filings, were reviewed. Semi-structured interviews with 35 individuals, ranging from the programme's architects and university scientists to representatives from LMIC vaccine manufacturers taking part in the programme were also conducted. While the mRNA programme may improve the sharing of knowledge, other design features, in particular, weak conditionalities around product affordability, participants' freedom to contract with third parties, and acceptance of market-based competition, are in line with the status quo. Further, WHO and MPP's tight control over the programme evokes the dynamics that are often in play in global health, to the detriment of empowering LMIC-based manufacturers to generate mRNA products in response to local health needs.

Fig 1. Ownership and experience of mRNA hub and spokes participating in the mRNA programme.

Notes: (1) Two participating manufacturers, Biovac (South Africa) and Biovaccines Nigeria, are shown on the boundary between public and private ownership because each entity is a public-private partnership. All other entities depicted in the figure are state-controlled enterprises (i.e., publicly owned) or private companies. (2) For the purposes of this figure, the term ‘experienced’ refers to entities that have produced at least one vaccine that has been licensed for clinical use. Several manufacturers that fall into the ‘experienced’ half of the figure have produced more than one vaccine. The entities in the ‘inexperienced’ sphere have not yet fully developed a vaccine; however, some have generated sales through other products.

Fig 2. A schematic representation of the mRNA programme in principle versus in practice.

Notes: (1) This figure provides a schematic representation of the organizations and actors involved in the mRNA programme, and the inter-relationships between them. We contrast how the mRNA programme has been described in principle (Panel A) where Afrigen is described as the “hub” and manufacturers in LMICs are partners (or spokes), versus how the mRNA programme appears to work in practice based upon our findings (Panel B). (2) There are several important differences between Panel A and Panel B, including the fact that all of the technology transfer agreements are between partnering manufacturers and MPP (represented by double-arrowed lines). The only direct collaboration between Afrigen and a partner is with Bio-Manguinhos; the two organizations are in negotiations regarding a partnership focused on RSV (represented by the dashed line). Panel B also shows that all of the funding that has been secured for the programme flows through MPP (and WHO to a lesser extent). Members of the South African consortium as well as programme partners must negotiate access to funding from MPP, which, together with WHO, has delegated decision-making to the mSAC and STeRCo committees. Finally, Panel B also highlights other actors involved in the programme, including researchers at the University of Witwatersrand, the University of Cape Town, and North-West University (represented as Wits, UCT, and North-West, respectively), and the Belgium-based company, Quantoom, which has formed bilateral relationships with Afrigen and the majority of LMIC-based manufacturing partners. (3) While the figure’s details derive from our research findings, they are not intended to provide a comprehensive picture of the mRNA programme. For example, recently the programme’s architects have put into place a “Funders Forum” for countries and organizations that have provided financial support for the mRNA programme, and four new R&D consortia involving programme partners and outside actors were announced in March 2024 [89]. In order to limit the complexity of the figure, these new structures are not represented here.