Richard Gordon
The Covid-19 pandemic has highlighted the challenges around the supply of medicines to the developing world. Whether it be vaccines or drugs, the events of the past 12 months have exposed the inequities of the current supply model.
Nowhere has this been more obvious than in Africa. Africa is not helpless, however, and there is a firm desire by many countries to use the recent experience to ensure that this never happens again. A number of recent activities point to this shift in emphasis. Now is the time to build on this momentum, as well as focus on some of the key issues that need to be addressed.
The first argument against investing in manufacturing capacity in Africa relates to cost-competitiveness, as it is thought to be too expensive to make drugs in Africa. While this is true in some cases, it does not apply universally.
A recent pre-feasibility study for the establishment of manufacturing plants for essential medicines and health commodities in the Southern African Development Community (SADC) showed that several essential medicines can be made more cost effectively in Africa. There is a caveat, as this model relies on the need for longer-term commitments for procurement, the implementation of a pooled procurement strategy for the region, and, most importantly, government incentive schemes such as tax breaks and duty-free capital goods.
No country in Africa can sustain a market by itself. In the case of a single country manufacturing drugs for itself, where the market is large and therefore capable of sustaining a product – as in India, China and the United States – the situation is different. In Africa, which is made up many countries with different disease priorities and regulatory systems, a different commercial model is required.
If the establishment of manufacturing in Africa is the goal, then some of the answers must lie in market shaping between governments, combined procurement, and leveraged pricing.
Distinguishing different strategies for biologics, complementary products and drug molecules is key. Many stakeholders refer to drugs as though they were all the same, thereby confusing the agenda.
There is a world of difference between a pharmaceutical drug, a complex natural product and a complementary medicine in terms of manufacturing levels and regulatory approvals. The same applies for vaccines, biologics and biosimilars. Therefore, the manufacturing strategies for each class need to be managed differently by specialist teams.
If the continent wants to make its own quality-approved or World Health Organization-prequalified medicines, sustainability in portfolio balance has to operate on a regional or pan-African level. The economics do not work for a “one country, one drug” approach. Manufacturers will need a portfolio of medicines in different disease areas to balance the risk and make the business model work. It cannot, for instance, only be anti-retroviral (ARVs).
Many governments and role players have invested significant resources in establishing systems, infrastructure and processes. Understanding these investments is also crucial, and will save new entrants time and money by enabling them to work with established entities instead of duplicating existing structures.
There is a lot of momentum building in the manufacture of drugs and their access into Africa. There has never been this much activity, and it a clear sign that progress is being made. Recent activities include the establishment of the African Continental Free Trade Area (AfCFTA), with operations commencing as of January 1, 2021.
Moreover, a concerted effort to build capacity in the area of skills and infrastructure can never be overlooked. For example, South Africa’s Department of Science and Innovation (DSI) has invested in infrastructure for flow chemistry at the University of Pretoria and Nelson Mandela University. The goal is to train scientists, develop intellectual property and build a track record of Innovation.
The DSI, through the Technology Innovation Agency (TIA) and North-West University, has created an active pharmaceutical ingredients (API) cluster with the goal of driving innovation and funding in the API manufacturing sector. In addition, a Biologics API cluster platform was recently established at the Council for Scientific and Industrial Research (CSIR).
There has been significant investment in setting up new small-scale manufacturing entities for APIs. Chemical Process Technologies (CPT) Pharma is an example of a company that recently received funding from TIA and the Industrial Development Corporation.
Located in Waltloo, Pretoria, the CPT Pharma plant will be used for the scale-up of API production processes and the manufacture of batches for stability testing. CPT Pharma was audited by the South African Health Products Regulatory Authority in November 2019 and received its licence in August 2020.
Several product development partners are working across Africa, investigating approaches to manufacturing drugs in Africa for diseases in Africa. Several manufacturing deals have been struck, including turnkey projects, tech transfers and investments by international companies.
These companies hold majority shares in African pharmaceutical companies that are already operational in Africa. Most of this activity is focused in Kenya, Uganda, Cote d'Ivoire and Nigeria.
The acquisition of the manufacturing facility of Sandoz, a global leader in generic pharmaceuticals and biosimilars, by Kiara Healthcare, a local pharmaceutical manufacturing and health-care services company based in Johannesburg, and subsequent investment by Imperial Logistics, is a recent example of how the landscape is changing.
It is not only African governments that see this as important. A recently established project, Support towards Industrialisation and the Productive Sectors in the SADC region (SIPS), is being funded by the European Union and the German government, and is being jointly implemented by the SADC and German development agency the Deutsche Gesellschaft für Internationale Zusammenarbeit (GIZ).
The SIPS project aims to enhance private sector participation in the regional ARV and Covid-19-relevant medical and pharmaceutical products value chain. This will focus on incorporating international development programmes into a regional strategy, such as the Cooperation for the Enhancement of SADC Regional Economic Integration (CESARE).
Africa is fast realising that local manufacture of medicines is a necessity and not an option. Those seeking to build on this momentum should partner with entities in Africa to build critical mass, with the ultimate goal of developing an industry for African-based manufacturers. This will set the path towards self-sustainability, which will best be achieved if regionalisation of access is carried out in parallel to infrastructure development.
* Professor Gordon is a director at the South African Medical Research Council. He leads the DSI-TIA API manufacturing cluster, and is working with the Medicines for Malaria Venture and others to build manufacturing capacity on the continent.
** The views expressed here are not necessarily those of IOL.