Development of Africa’s pharmaceutical manufacturing framework critical in HIV battle

The 12th International Aids Society Conference on HIV science was recently held in Brisbane, Australia, featuring studies that have come to represent important advances in HIV prevention, treatment and cure research.

The conference offered the World Health Organization (WHO) an opportunity to announce that there is almost zero risk of transmitting HIV when a person has an HIV viral load measurement of less than 1,000 copies per millilitre of blood, commonly referred to as having a suppressed viral load.

The evidence of the latest advancements in the WHO’s scientific research on HIV viral suppression confirms that people with HIV with an undetectable level of the virus through the consistent use of antiretroviral (ARV) therapy do not transmit HIV to their sexual partners and are at low risk of transmitting HIV to their children.

These findings have underscored the significance of meeting the Joint UN Programme on HIV/Aids (UNAids) “95-95-95” targets, which call for 95% of people living with HIV to be aware of their status, 95% of those aware of their status to be on ARV therapy, and 95% of those on therapy to achieve viral load suppression.

Achieving these targets across Africa will remain a critical undertaking to improve the lives of those living with HIV at the global epicentre of the virus. According to UNAids’ 2023 epidemiological estimates, over 65% of the global population living with HIV is based in eastern, southern, western and central Africa, with a collective 25.6-million infections in 2022. 

The WHO’s research and findings must incentivise public and private stakeholders to work together to spearhead the development of Africa’s pharmaceutical and biological manufacturing framework to improve ability to prevent, detect and limit transmission of the virus. In fact, we should aim to offer a world-leading response to this crisis, given the WHO’s recent announcement regarding the impact of viral suppression on direct and vertical transmission rates.

To achieve this we must decrease our reliance on foreign pharmaceutical imports and develop a sustainable, pharmaceutical manufacturing framework that will remain dedicated to securing Africa’s own supply of life-saving ARVs over the long term (reports indicate that up to 80% of HIV drugs dispensed in Africa are imported). At present, a number of external risk factors, including geopolitical, logistical and financial circumstances, could affect these regions’ access to life-saving ARVs. 

African scientists must be supported to develop their own intellectual property to develop active pharmaceutical ingredients (API) if we want to build an end-to-end manufacturing framework on the continent. The industry is based on “fill-and-finish” operations alone. This is not strategic or economically sustainable over the long term.

To date, local manufacturers have remained at a competitive disadvantage when it comes to APIs due to a number of different market forces, including poor and inefficient production value chains, the high cost of production of medicines and vaccines, and poor financing and financing models. Thankfully, a number of international organisations and banks have already heeded the call to improve these circumstances, paving the way for manufacturing operations for improved healthcare outcomes.

The localised production of medical devices and testing kits to help prevent and detect HIV already offers a commercially attractive opportunity to the private market, with few barriers to entry. However, pre-exposure prophylaxis (PrEP) — the use of medications to prevent the spread of disease in people who have not yet been exposed to a disease-causing agent, usually a virus — requires a little more work.

By investing in the development of advanced HIV technology in Africa with a locally based manufacturing framework for APIs, we could begin to manufacture PrEP locally, for people who don't have HIV and are at risk of being infected.

SA’s present capacity to manufacture PrEP tablets remains negligible at best, and should be improved. That said, our vision to ensure long-term medicine security should focus on the production of biologics instead. Injectable PrEP with cabotegravir offers an effective alternative to protect adults and adolescents at risk of contracting HIV through sex.

While Cipla has announced plans to manufacture these at two of their plants in SA, a production date is yet to be confirmed. Investing (locally) in a biologics facility with the capacity to manufacture APIs and supply PrEP injectables will remain an undertaking to help make the injectable more affordable in emerging markets across the continent today. 

mRNA vaccine technology is at the forefront of making this possible. If we can develop the technology and APIs to manufacture PrEP locally, with other mRNA-based products, SA could position itself at the forefront of this initiative. The world-renowned Afrigen Biologics mRNA hub in Cape Town already aims to contribute to this project by working on the development of new vaccines for diseases that are rampant in lower and middle-income countries. 

The Partnership for African Vaccine Manufacturing (PAVM) offers a leading example of how we might take a pan-African approach to develop convening power and technical capabilities to galvanise global and regional stakeholders around this goal. The PAVM recently formalised a sustainable ecosystem of action-orientated partners in support of achieving the AU’s vision of 60% locally produced vaccines by 2040 (at present, over 99% of vaccines in Africa are imported from manufacturers overseas).

To support the PAVM’s vision for 2040 and the bankability of this project, the African Development Bank is implementing a flagship programme in support of local vaccine manufacturing. Afreximbank also aims to support PAVM targets with innovative financing solutions across the vaccine manufacturing value chain, through the availing of financial advisory services, project finance and risk-bearing instruments.

The Team Europe Initiative on manufacturing and access to vaccines, medicines and health technologies in Africa may offer one of the most successful case studies to date. The initiative has agreed to support a large-scale investment in vaccine production by the Institut Pasteur in Dakar, Senegal. Its commitment to this undertaking has been rolled out alongside other support measures to reduce Africa’s dependence on vaccine imports and to strengthen future pandemic resilience on the continent.

Similar initiatives and funding are available from the US President’s Emergency Plan for Aids Relief and the Coalition for Epidemic Preparedness Innovations today. 

A united and co-ordinated approach to develop Africa’s pharmaceutical manufacturing framework will remain a critical undertaking to reach global 95-95-95 targets in Africa. This must be supported by the localised production of APIs, ARVs and PrEP injectables for Africa, in Africa, to simultaneously insulate the region from its reliance on HIV medicinal imports. We will have to leverage the expertise of our closest allies and make use of all grant funding opportunities to make this a reality.

One thing is certain: a united Africa is a force to be reckoned with, and anything is possible if we believe in ourselves. Perhaps SA, with its intellectual capacity and infrastructure, can lead the charge to improve medicine and vaccine supply security for the whole continent soon. 

Mynhardt is group executive & business strategist, and Dr Ndembi chief science adviser, to the office of the director-general of the Africa Centres for Disease Control and Prevention.