Scaling Up African Pharmaceutical Manufacturing in a Time of COVID-19

Emily Kaine, MD, is the senior vice president for global health at the U.S. Pharmacopeia. Jude Nwokike is a vice president for global public health at the U.S. Pharmacopeia.

The COVID-19 pandemic has caused massive disruptions to global supply chains. Africa is particularly vulnerable with respect to pharmaceuticals, both because between 70 and 90 percent are imported and because the continent generally lacks the political sway and bargaining power of other regions. In the short-term, the most acute issue is the need for huge quantities of quality-assured protective equipment, tests and medicines to treat the symptoms of COVID-19. Significant shortages of other essential medicines could materialize. With access to such essential medical products across the continent challenged, there has been a commensurate uptick in substandard and falsified products related to the testing or treatment of COVID-19. 

But many countries in Africa have underutilized capacity to produce quality-assured, essential pharmaceutical products locally. In Nigeria, one of the countries with the greatest potential for rapidly scaling up production, pharmaceutical manufacturing production currently utilizes around 40 percent of actual installed capacity. Manufacturing output remains lower than its potential in part due to inconsistent demand, challenges in sourcing active and raw ingredients, unfavorable market conditions, and a lack of available investment to scale up operations, modernize equipment, and resolve local infrastructure limitations. Here are some ways to make use of this potential. 

• Insufficient knowledge about the real capacity of local manufacturing sectors, sources of component parts, and expected market demand is hindering efforts to make use of local excess capacity. Pharmaceutical manufacturing associations—along with market intelligence firms, multilateral agencies, and international donors—should lead a comprehensive mapping of the existing technical capacity, resources, and sources of raw materials available on the continent. Meanwhile, governments should work to forecast demand for locally produced products and create a favorable policy environment for local manufacturers to compete with producers from abroad, allowing them to better manage the risk associated with capital investments for scale up.
• Manufacturers and regulators must work to improve quality by applying international public quality standards to gain a competitive foothold, not only locally but in the broader global supply chain.
• The African Medicines Agency (AMA), a continental effort to harmonize medicines regulation, should be fully ratified and quickly scaled up to advance regulatory reliance, mutual recognition, and risk-based regulatory practices. The AMA will help support production of active ingredients in Africa, streamline market access, and reduce barriers to market entry for manufacturers. As of April 30, eleven countries had signed it and two had ratified it. 
   

Progress can already be seen on multiple fronts. Ethiopia and South Africa have developed national strategies and manufacturing roadmaps that address common pitfalls such as sourcing active ingredients; addressing financial barriers; and improving quality in line with international standards. And these plans are starting to translate into specific gains. South Africa and Egypt are beginning to produce active ingredients locally—the first step in overcoming a major hurdle that makes it difficult for African manufacturers to compete with imported products from Asia. Ethiopia, meanwhile, is developing a pharmaceutical manufacturing industrial park to spur national and regional manufacturing activities. 

National central banks, such as the Central Bank of Nigeria, are working to stimulate the sector by extending lines of credit to local manufacturers. In addition, Afrexim Bank, the UN Economic Commission for Africa (UNECA), and the African Center for Disease Control recently announced emergency interventions to rapidly respond to supply and policy gaps, including for medical products. Afrexim Bank further announced a $3 billion funding facility that includes funding to support local production of COVID-19 related health products. As part of this effort, UNECA and Afrexim Bank have compiled a list of fifty local pharmaceutical companies which have the capacity or have shown interest in supplying priority products.  

COVID-19 is expected to drive countries to enact procurement incentives such as prioritizing and incentivizing the procurement of locally produced products, providing advanced market commitments, and establishing pooled procurement mechanisms such as those being developed by UNECA, the Federation of African Pharmaceutical Manufacturers Associations (FAPMA), and the WHO. Countries should also push global procurement agencies to consider similar incentives to further support the continent’s nascent pharmaceutical industry. Scaling up African pharmaceutical capacity will help provide sustainable access to quality medical products and increase health security during the COVID-19 pandemic and beyond.