Pharmaceutical Market

The South African government established the South African Health Products Regulatory Authority (SAHPRA) as an entity of the National Department of Health to make sure that both human and animal health are guaranteed. The SAHPRA is responsible for the regulation of health products intended for human and animal use; the licensing of manufacturers, wholesalers, and distributors of medicines and medical devices, radiation emitting devices, and radioactive nuclides; and the conduct of clinical trials in a manner that is compatible with the national medicines policy (SAHPRA, no date b). The SAHPRA had registered eight manufacturers who manufacture active pharmaceutical ingredients (API). Furthermore, it had registered around 152 manufacturers and packers for human and animal health products and medicines (SAHPRA, no date a). In 2011, the pharmaceutical market was worth ZAR30 billion, which is around 1.6 billion USD. Pharmaceutical products were imported for a total of ZAR 17.5 billion in 2013, compared to ZAR 8.25 billion in 2007. Furthermore, South Africa exported pharmaceuticals worth ZAR1274 million that same year (Mendoza-Ruiz, A., Acosta, A., Escamilla, E. P. V., Torres, 2017). 

Vaccination Manufacturing Capacity

South Africa has several vaccine manufacturing facilities: Aspen Pharmacare, Biovac, and Afrigen. Biovac is a biopharmaceutical company based in Cape Town and is the result of a partnership formed with the South African government in 2003 to establish local vaccine manufacturing (Biovac, no date). It is the largest vaccine manufacturing facility in South Africa. Biovac imports and distributes vaccines for BCG, hepatitis B, OPV, and measles. Further, it finishes and fills COVID-19, hexavalent, and pneumococcus vaccines. At the moment, they also research and develop vaccines for GBS and OCV (BCG and Biovac, 2023). Afrigen Biologics researches and develops several vaccines, including hepatitis B, Rift Valley Fever, TB, and COVID-19. They also produce and finish filling the COVID-19 vaccine (BCG and Biovac, 2023). Due to an agreement with Johnson & Johnson to fill, finish, package, and distribute its COVID-19 vaccines in Africa, Aspen started producing COVID-19 vaccines in March 2022. However, in August 2022, the company hadn’t received any orders and had to shut down. Since January 2023, Aspen has not been manufacturing vaccines, even though it has an operational vaccine manufacturing facility (BCG and Biovac, 2023). This shows us that it is not only important to have vaccine manufacturing plants, but for these to be self-sustainable, African countries have to buy from each other. Nevertheless, the mRNA technology transfer hub of the WHO will be located at Afrigen. From here, it will collaborate with a network of technology recipients in low- and middle-income countries (World Health Organization, no date c).