WHO Director-General Dr. Tedros Adhanom Ghebreyesus greets African Professor Petro Terblanche at mRNA facility in South Africa
The establishment of an “mRNA hub” in South Africa to build vaccine development capacity in low- and middle-income countries (LMICs) during the COVID-19 pandemic has been widely hailed as a solution to Africa’s lack of manufacturing capacity. I was welcomed.
But three years after its launch in June 2021, the hub faces uncertainties, risks and shortages. This includes the possibility that it will simply become a ‘technological solution’ in the current mold of the biopharmaceutical industry, rather than a true transfer of knowledge and capabilities to small and medium-sized enterprises. According to recent reports
The authors, Professor Matthew Helder (Professor of Applied Public Health at Dalhousie University in Canada) and Professor Ximena Benavidez of Yale University in the US, base their observations on interviews with 35 key people and numerous documents, including: The information was obtained through an access to information request. Government of Canada.
The hub is an initiative of the World Health Organization (WHO) and the Pharmaceutical Patent Pool (MPP). Following the failure of high-income countries to share coronavirus vaccines at a time of great need, the WHO and MPP, made up of biopharmaceutical company Afrigen Biologics, vaccine manufacturer Biovac, and the SA Pharmaceuticals Research Council, A South African consortium was selected. The partners aim to set up facilities capable of developing and producing mRNA vaccines in LMICs.
Once this was completed, we would teach the same method to other facilities in LMICs around the world.
The mRNA program currently includes a South African consortium and 14 other LMIC-based partners.
Current mRNA program partners
Support voluntary IP transfer
However, the authors argue that the way hubs are managed and operated does not adequately transfer power and capacity to LMICs.
“The designers of this program are working within the existing biopharmaceutical production system, while at the same time focusing on program design and priorities aimed at filling gaps in equitable access to mRNA-based interventions. “We maintain control,” they claim.
“In particular, the MPP has proven to be the best option for increasing local production capacity in LMICs, despite failing to attract cooperation from more established mRNA manufacturers and slowing adoption of the mechanism in the context of COVID-19. We continue to champion voluntary (intellectual property) licensing as a means to a more innovative end-to-end approach to research, development and manufacturing.”
They also argue that the program’s “technical outcomes” are uncertain absent “significant reforms and concerted efforts to redistribute not only intellectual property but also agency to LMIC actors.” I am doing it.
Without these, “the program that WHO and MPP bill as a joint effort to improve LMIC manufacturing capacity for LMICs would fail to solve the problem of equitable access to biopharmaceutical innovation.” There’s a risk.”
“According to the current situation”
The authors observe that while the mRNA program has the potential to improve knowledge sharing, it was developed “in line with the current state of affairs” in global biopharmaceutical production.
They argue that this includes “weak conditions on the affordability of products, the freedom of participants to contract with third parties, and the acceptance of market-based competition.”
The WHO and MPP also have “strict control over the program,” which is “a dynamic that often operates in global health that undermines the ability of LMIC-based manufacturers to produce mRNA products in response to local health needs.” ,” they said. claim.
For example, MPP created its own technology transfer unit to manage technology transfer within the mRNA program. But technology is usually transferred from one party with direct experience of use to another by sharing practical know-how.
“I’ve worked in this industry for over 30 years and we don’t have remote groups that do technology transfer. If a group does technology transfer, they have to be in the facility where they’re sending that technology,” said one participant. told the authors.
The hub’s donors – France, the European Commission, Germany, Norway, Belgium, Canada, South Africa and the African Union – are contributing $117 million to the program ($89 million has been received to date) .
However, some high-income countries (HICs) that are investing in mRNA programs are also making demands that shape the programs. Canada, for example, stipulated that its funds would be allocated only to the Cape Town hub and four other countries: Senegal, Nigeria, Kenya and Bangladesh.
“According to one interviewee, HIC supports technology transfer to LMICs, but hopes that such transfers do not extend to upstream inputs for mRNA vaccine production, including novel LNPs and antigens. “There are,” the authors point out.
Charles Gore (MP), Petro Terreblanche (Afrigen), WHO Director Dr. Tedros Ghebresas, South African Health Minister Dr. Joe Parra, and Norwegian International Development Minister Anne Tvinerheim on April 20, 2023, in Afrigen. I attended the ribbon cutting to officially open the port.
Conflicting legal agreements – and silent pricing
The report created a series of legal agreements, including a technology transfer template, that MPP grants LMICs a “non-exclusive, royalty-free, non-sublicensable, non-transferable, irrevocable, fully paid, royalty” points out. “Free license” for technology.
They will also gain access to the rights held by Afrigen and Biovac to “manufacture, manufacture, use, offer for sale, sell, sell, export or import” products in their respective territories and other LMICs .
In return, LMICs must grant MPPs worldwide, non-exclusive, royalty-free licenses to their data and inventions to “facilitate the development and equitable access of medical technologies.”
Brazil’s Bio Manguinhos warns that technology developed with funding from the Brazilian government “will flow from participating LMICs (which in some cases are commercial for-profit organizations) to manufacturers without anything in return. The official, Patricia, said that the government was reluctant to accept the idea that the government would “become a major player.” Neves described this as an “injustice”.
South Africa also disputes the absence of royalties, with the agreement with MPP stipulating that any license may include a “royalty sacrifice”.
Meanwhile, Indonesia’s BioFarma negotiated the right to sell its products to HIC.
“The MPP also stops short of requiring that the resulting mRNA products be made affordable to those in need outside of a public health emergency of international concern (PHEIC). “There was no such thing,” the authors point out.
If an mRNA product developed by a LMIC partner targets a PHEIC, it cannot charge more than the cost of production plus a 20% markup.
“Traditionally, MPP has not intervened in pricing. Our model is based on competition, and it is clear that we have the potential to offer this to 15 companies around the world,” said MPP Executive Director Charles Gore told the author.
In contrast, the authors argue that MPPs “seem comfortable relying on free market competition among LMIC-based manufacturers instead of imposing affordability provisions for products produced through participation in mRNA programs.” ”.
Beyond the new coronavirus
A researcher at the WHO mRNA Hub in Afrigen, South Africa.
It took Professor Petro Terblanche’s Afrigen just two months to develop an mRNA vaccine for COVID-19, based largely on Moderna’s “recipe” published online. This knowledge was then transferred to facilities in countries such as Bangladesh, Serbia, and Brazil.
Afrigen’s vaccine is currently in clinical trials, but the urgency associated with COVID-19 has passed. Given the limited demand for COVID-19 vaccines, expanding the program’s focus upstream is considered critical to the overall sustainability of the program.
According to the authors, at a meeting in Bangkok in late 2023, WHO and MPP officials will “engage partners within and outside the program to focus on pathogen-focused research and development of common interest in the region.” “Potential sub-consortiums” were outlined.
Afrigen is increasingly focused on developing second-generation technologies critical to mRNA production, such as novel lipid nanoparticles (LNPs), and new disease targets such as tuberculosis, malaria, and HIV.
“A key question is whether the funding set aside for the program and supporting the development of these second-generation mRNA technologies is being leveraged into a common set of efforts aimed at improving equitable access. “, the authors point out.
Afrigen is targeting 11 potential diseases for mRNA product development, but proposals focused on Lassa fever, RSV, and other disease targets have been rejected by various funders.
Terblanche acknowledged that market rewards “will have to be prioritized,” especially since MPs expect the program to be “self-sustaining” by 2026.
However, a growing number of ‘use patent’ applications in South Africa and other LMICs, claiming intellectual property for the use of mRNA technology, threaten to thwart the research and development plans of Afrigen and its partners.
Recalling that some of the companies participating in the influenza vaccine hub later halted production, WHO’s Martin Friede said that if a small number of LMIC manufacturers were successful in producing mRNA vaccines, the program would be a success overall. I estimate that it will.
Meanwhile, Congressman Gore said, “We are giving money to develop and transfer (technology) to (Africa),” but “they don’t have a business model (yet).” pointed out.
MPP’s Marie-Paul Kieny speculates that Afrigen will probably eventually succumb to market forces. After that, we are fully aware that Afrigen is a private company and at some point we will try to find someone who will try to buy them and make a profit,” she told the author. .
“lack of imagination”
But the authors argue that “Afrigenn’s exit was all but inevitable in the eyes of those who designed the program,” which reflects a “fundamental lack of imagination about how mRNA programs are managed.” It states that there is.
A more “inclusive and decentralized” governance structure could “protect initiatives such as mRNA programs from risks and constraints posed by dominant market actors.”
This decentralized structure, they argue, could involve “representatives from participating LMICs who can lead the research and development of programs for local populations” in overall governance and day-to-day decision-making. There is.
“Second, multiple actors will need to act as regional mRNA hubs, as originally planned, to reduce the risk that the failure of one organization (or its acquisition by an external actor) will undermine the entire program.” they claim.
“Instead, WHO and MPP will organize program decision-making within two carefully selected committees (the Scientific and Technical Review Committee and the mRNA Scientific Advisory Committee), which will be important to private actors such as Afrigen. He delegated many important roles and maintained discretion over any project. “Over the first two years of the program’s operation, there was limited input from LMIC governments and civil society,” they note.
“Whether MPP, which has risen to prominence in the global health field during the pandemic as a result of its role as a central intermediary of the entire mRNA program, will relinquish some of its control over time and take the following steps: remains to be seen to truly empower LMIC manufacturers,” they observe.
Image credit: WHO, WHO, Kelly Cullinan.
Combating the infodemic in health information and supporting health policy reporting from the Global South. Our growing network of journalists in Africa, Asia, Geneva and New York connects the dots between local realities and global debates with evidence-based, open-access news and analysis. To donate as an individual or organization, click here with PayPal.
