An industry association representing SA pharmaceutical manufacturers has criticised the Medicines Patent Pool (MPP) for failing to grant African generic drug makers licences to make cheap copies of ViiV Healthcare's long-acting cabotegravir injection, which prevents HIV.
Africa bears a disproportionate share of the world’s HIV/Aids burden, and the AU is pushing hard the continent's pharmaceutical manufacturers to play a bigger role in making products for combating HIV. Its drive to improve Africa’s security of supply gained fresh momentum during the coronavirus pandemic, as countries with domestic Covid-19 vaccine manufacturing capacity prioritised their own citizens when shots were in short supply, leaving African nations at the back of the queue.
Pharmaceuticals Made in SA (Pharmisa) chair Stavros Nicolaou said the dearth of African pharmaceutical manufacturers in the deal announced last week by the MPP was at odds with recent policies flighted by the US President’s Emergency Plan for Aids Relief (Pepfar) and the vaccine alliance Gavi emphasising the strategic importance of strengthening Africa’s pharmaceutical manufacturing industry. The MPP signed sub-licences with Indian generic manufacturers Cipla, Aurobindo and Viatris subsidiary Mylan.
“The fact that there is not one African manufacturer among them is puzzling, to say the least,” said Nicolaou. “The MPP has done fantastic work to improve access to HIV, TB and malaria treatments. But it is really difficult for African manufacturers to get licences from them.”
There are only four African companies among the dozens of pharmaceutical manufacturers that have been awarded sub-licences flowing from the agreements signed by the MPP with 18 patent holders on products for HIV, TB, malaria, cancer and Covid-19.
Three of these companies are South African: Adcock Ingram, which has licences for nine HIV products; Biotech, which has a licence for a Covid-19 antibody test; and CPT Pharma, which has a licence for a Covid-19 treatment. The fourth company is Kenya’s Universal Corporation Limited, which has a licence to make generic HIV treatments. Africa’s biggest generic drug manufacturer, SA-based Aspen Pharmacare has previously secured voluntary licences directly from patent holders.
MPP spokesperson Sophie Thievenaz said one African company, had bid for a licence to make generic cabotegravir, but did not meet the selection criteria. “Aurobindo and Viatris will manufacture in India. Cipla will manufacture in India and has plans to manufacture in SA as well,” she said.
Cabotegravir, administered every two months, was registered by the SA Health Products Regulatory Authority in 2022. While studies have shown it is more effective than taking daily pills to prevent HIV, whether it will be affordable and readily available in countries hard hit by the disease remains an open question.
Thievenaz said the price of generic cabotegravir had yet to be determined, but the MPP expected that competition between producers would help drive down prices to levels affordable to low- and middle-income countries
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