The South African Health Technologies Advocacy Coalition (SAHTAC) in partnership with PATH, South African Medical Research Council (SAMRC), Kgoroko Social Investment convened a side event at the 11th South African AIDs Conference on 21 June 2023 at the Durban International Convention Centre. The side event titled Expanding Local Pharmaceutical Manufacturing to End the HIV Epidemic brought together multi sectoral leaders from governments, donors’ agencies, regulatory authorities and implementing partners to discuss and explore the expansion of the Africa’s HIV medicines and medical products landscape. The discussions focussed on understanding whether the current HIV products are addressing Africa’s needs including products in the pipeline for the prevention, treatment, and management of HIV. Further discussions explored whether African policies are favourable to allow introduction of new and advanced HIV technologies and the changes required to make the policy environment favourable for the introduction of these products. Lastly establishing mechanisms must be put in place to expand the R&D and manufacturing of HIV medical countermeasures in Africa?
In December 2022, PEPFAR announced its commitment to procure 15 million HIV tests produced by African manufacturers in 2025 and to work with partners to have 2 million PLHIV using African manufactured first line ART by 2030. As one of the biggest donors and procurers of HIV medical countermeasures towards ending the epidemic on the continent, PEPFAR currently procures less than 1% of all medicines and medical products from African manufacturers with the main cited reason being limited number of high-volume manufacturers that can meet the demand. At the same time a recent report by PATH shows that there are over 140 diagnostics manufacturers on the continent, some with the capacity to manufacture test kits. The report also suggests that in order to strengthen the diagnostics ecosystem on the continent, we would need greater regional coordination to standardize regulations and standards. This announcement by PEPFAR challenges the African content to consider this opportunity and examine its manufacturing ecosystem.
There are several challenges that arise as the African manufacturing ecosystem expands, one of which is ensuring compliance to Good Manufacturing Practice (GMP) to ensure the safety, effectiveness, and efficacy of the medical products. This means greater capacity demands from national and regional regulatory authorities as well as manufacturing standards that meet international manufacturing standards. To achieve these outcomes, massive investments must be made on the continent’s manufacturing and R&D agenda by both domestic and foreign funding sources. Additionally, the continent must open the market for the products and guarantee competitive prices for the products by ensuring that national, regional and continental policies favor procurement from local manufacturers. The conversation aimed at exploring the expansion of the Africa’s local manufacturing of HIV medicines and medical products to end the HIV epidemic. The meeting had the following objectives:
− Present the opportunity that this has for African manufacturers.
− Deep dive into the demand side barriers and practical solutions for expansion
− Explore the regulatory ecosystem changes to be made that would support the expansion of production in Africa.
3.Keynote Speaker Steve Letsike – CSF National Chairperson and SANAC Co-Chairperson
Steve noted the commendable strides in the fight against HIV/AIDS that South Africa has achieved over the past couple of years. She highlighted that there is notable impact on interventions put in place in the prevention, treatment, and management of HIV. She explained that this has resulted in more people knowing their HIV status, getting into treatment, and having a better quality of life. She reflected on the progress that South Africa has achieved in the fight against HIV with the biggest treatment programme in the world with over 5 million people on treatment. She emphasised that the need to engage in the conversation of local manufacturing of health products and technologies to diagnose, prevent, treat, and manage HIV is long overdue. She challenged the audience to reflect on the number of products needed for managing HIV and where these products were produced or manufactured. She further paused the question of why we are not manufacturing these products ourselves seeing as we are the ones that need them the most. She highlighted the recent public health threat of COVID 19 where African nations were the last recipients of covid the vaccine and the Global North received vaccine first. The Clarion call is the urgent need for South Africans to come together and invest in the manufacturing agenda and Health R&D from both domestic and foreign funding sources.
Additionally, she stressed that the continent must open up the market for the products and guarantee competitive prices for the products by ensuring that national, regional and continental policies favour procurement from local manufacturers. We highlighted that we are in a period when regional agencies such as the Africa CDC are calling for Africa as a region to manufacture 60% of vaccines on the continent by 2040, there is increased focus on local manufacturing needs, not only for vaccines but pharmaceuticals, diagnostics and other medical products. She explained that HIV being a major contributor to the disease burden on the continent, a clarion call to invest in R&D and manufacturing of health products to address the disease would be a key contributor to the economic and health growth of the continent.
4. Sphindile Magwaza- PEPFAR
Sphindile presented PEPFAR’s first strategy to support regional manufacturing in Africa. The strategy was released in December 2022 outlines about 5 pillars and three enablers, one of these pillars is strengthening public health systems and security globally. One of the pillars focuses on building resilient supply chain. Local manufacturing is mentioned as one of the key activities that will be supported by these pillars. The main reason for this initiative is because sub-Saharan Africa, has 65% of HIV burden globally and yet Africa imports 90% of health commodities. She highlighted that there is a huge public health demand for health commodities, and we are unable to meet this demand. Hence the need to support Africa to strengthen self-reliance and to ensure there is sourcing of diverse pharmaceutical and diagnostic products.
Sphindile stated that PEPFAR has placed a target to purchase 15 million rapid HIV test kits by 2025. Since PEPFAR has a large buying power, the aim is to use the HIV rapid test kits as an entry point then escalate to other health products. She further explained that PEPFAR wants to support the regulatory framework and independence across countries. This includes support for the African Medicine Agency by promoting harmonisation across the region. She stated that PEPFAR would like to closely support the strategic partnership working with other donors, working with local partners to develop and strengthen policies in integrating investment to support local manufacturing. She emphasised that PEPFAR aims to support and monitor investments that are channelled towards building capacity in manufacturing. The support will cover the whole value chain, starting with the research and development, regulatory approval, sourcing and as well as the actual component of manufacturing including packaging and up to the end user.
She explained that currently PEPFAR is working with WHO focusing on issues around pre-qualification for local manufacturers in Africa, making sure that there are processes that could be expedited to support the regulatory process. The pre-qualification and approvals also involve the African Medicines Agency in ensuring that there is a development of regulatory harmonisation across the region. She stated that there are still challenges in the region regarding local manufacturing, one of which is the cost related to WHO pre-qualification. At global level there are negotiations going on to manage the cost related to manufacturing and regulatory approval. Lastly, she emphasised that PEPFAR wants to galvanise multi stakeholder coordination so that in each country, all local partners, private sector, communities come together to define their own way of working and define the costing. This will be done according to the economic development and based on the public health needs of the country. PEPFAR also wants to support good manufacturing practises and capabilities and in ensuring that whatever is being develop within African countries, is approved by regulatory bodies in country, at regional level and with WHO.
5.Madoda Sambatha MEC for Health- North-West Province
The role of African government departments in promotion of local manufacturing processes.
Mr Sambata asserted that there is a lot of ideology attached to manufacturing. He made an analogy of the mining sector explaining that South Africa has the highest global platinum reserves but the platinum that has not been touched yet. He stated that unfortunately we are not doing good on beneficiation. He urged the audience to advocate for the development of capacity for manufacturing and as a country we should move towards beneficiation. He explained that the lessons we learn from COVID manufacturing is that if we do not manufacture our own medical products we will always have to rely on the Global North. When there is a global health crisis, we will be last in line to receive help. He highlighted the issue of regulatory bodies and government departments and stated that the National Department of Health and the Department of Science and Technology are not well coordinated to deliver the mandate of manufacturing of pharmaceuticals. There is an overlap that needs to be corrected and coordinated. He expressed that there is poor political will for local manufacturing and this needs to change if we want to achieve full pharmaceutical manufacturing capacity.
6.Dr Morena Makhoana BIOVAC CEO-
Dr Makhoana explained that the World Economic Forum is talking about regional manufacture and the World Health Organisation that is promoting local and regional manufacture. He stated that global bodies like GAVI in the vaccine space are talking about an advanced market commitment that would be tailor made towards African manufacturers. This is particular in vaccines, and we have the Africa CDC talking about 60% of vaccines should be manufactured on the continent by 2040. He expressed that what is missing is what is being said by governments on the continent. What are they committing in turn around local manufacturing. He explained that while we are looking to global bodies to help but the question is how do we help ourselves in terms of local manufacturing. He explained that we need to have policy coordination, but then policy must turn into action. He quoted what President Macron said that ‘50% of medications that France consumes must be produced in France’. The French president said that France should secure its supply chain, either by completely reassuring or diversifying and continuing to innovate in France. Dr Makhoana noted that if global North countries that are highly developed are talking about local manufacturing, then we should be talking more about local pharmaceutical manufacturing. He explained that on the continent we produce about 3% of global manufacturing pharmaceuticals and when it comes to vaccines, we manufacture less than 1%. He further shared that we produce 3% of normal pharmaceutical products and about 1% of vaccines, yet we Africa is 16% of the global population on the continent. He further stated that we have 24% of the global disease burden, these statistics warrants us to think more seriously about producing our own health products.
7.Deon Poovan – Senior Manager: Inspectorate and Regulatory Compliance at South African Health Products Regulatory Authority
Deon explained that a robust regulatory system is necessary to ensure that manufacturers adhere to certain standards and attain licences for manufacturing. The standards must be aligned to WHO standards, and this will allow the manufacturer not only to manufacture locally, but also opens and enables that manufacturer to participate in the global market. He explained that the regulatory system strengthening also assists in the control of the supply chain and this assist in ensuring that the registered products are found in the supply chain from the manufacturer to the end user. This is necessary in terms of public health requirements because that will prevent any sort of substandard and falsified medicines entering the country and it becomes a great incentive for investment.
He stressed that it is a great incentive when people understanding that when they manufacture products, those products will be of safe quality and efficacious. These products must be manufactured in GMP environments under a supply chain or licence system that is controlled. He highlighted that African policies and the African context need to ensure that the needs of the people are met in terms of medicine. He alluded to the need for a policy shift with considerations of how the procurement needs to be done against specifications that will benefit the local industry. He explained that a better regional cooperation will benefit the whole continent and then leverage off stronger regulatory authorities with better systems. While countries can work on their own regulatory authorities, but regional cooperation would help the continent gain strides towards achieving an effective regulatory body.
8.SAHTAC’S Call to action- Taonga Chilalika
Health Research & Development: The Key to a Healthy and Prosperous Africa
Health citizenry is essential to building the wealth of a nation. Over the last few decades, investments in new innovations and collaborative action has helped many African countries tackle critical health problems. Across the continent, people are becoming healthier and living longer and, in turn, are becoming more productive members of their societies.
The global community has agreed to a set of ambitious goals, including ones focused on eradicating disease and improving the health and well-being of all. But we can’t reach these goals using only the health tools we have today. We must embrace innovation, actively look for new, homegrown solutions, and focus our resources where it matters most.
We need to be willing to invest in a healthier future. This is where research and development come in. R&D enables us to find creative ways to tackle our emerging health problems. It helps us develop or adapt health technologies that are affordable and have the potential to transform health and societies. But with limited resources and competing priorities, is it worth investing in research and development?
Here are the facts: Investing in health R&D saves lives. The global roll-out of HIV treatment has saved millions of lives: an estimated 16.6 million [11.7 million–24.2 million] AIDS-related deaths have been averted over the last two decades, including a 47% decline in AIDS-related mortality since 2010 (Source: UNAIDS special analysis, 2021).
Investing in health R&D saves money. For example, a recent report from Mozambique highlights that the implementation of a rotavirus vaccine in 2015, has resulted in approximately 4600 deaths averted over 4 years and saved approximately US$3.1 M in health costs (Source: Clin Infect Dis. 2023 Apr 1; 76(Suppl 1): S1–S4).
Early trials of novel vaccines against TB in adults have suggested substantial protection against TB, a recent study shows that, when considering the monetized value of health gains, it is estimated that the introduction of an adolescent/adult vaccine could produce $283 to 474 billion in economic benefits by 2050 (Source: PLOS, Portnoy et al, 2023).
Our colleagues from the SAMRC will tell us that one of the best industry creations is biotech. If you create one science job, you create ten other jobs to service it. We also know that in order for devices and tools to improve the lives of those who need them the most, they must be affordable, accessible, and appropriate for the communities and settings in which they’ll be used. (Source: Dr Richard Gordon, SAMRC)
We have heard from the Department of Science & Innovation that it is critical for all countries, especially where the burden is highest, to invest in health R&D, to reduce the amount of imports, and increase our ability to manufacture. (Source: Glaudina Loots, DSI.)
Currently the total government plus science council spend on health research represents just 0.033% of the GDP, thus remaining well below the aspirational target of 0.15% of the GDP set by the NHRC in 2014. (Source: S Afr Med J 2020;110(4):274-283. https://doi.org/10.7196/SAMJ.2020.v110i4.14349)
We must harness OUR expertise and ingenuity and bring together governments, the private sector, and civil society to identify and advance health technologies that will not only save lives but will also grow our economies.
The evidence is clear. The question is: Can we afford not to prioritize health research and development?