Pharma industry pushes for Africa to get licence to make generic HIV injection

An industry association representing SA pharmaceutical manufacturers has criticised the Medicines Patent Pool (MPP) for failing to grant licences to African generic drug makers to make cheap copies of ViiV Healthcare’s long-acting cabotegravir injection, which prevents HIV infections.

Africa bears a disproportionate share of the world’s HIV/Aids burden, and the AU is pushing hard for 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 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 industry. The MPP signed sublicences 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.”

Only four African companies are among the dozens of drug makers awarded sub-licences flowing from the agreements signed by the MPP with 18 patent holders on products for HIV, tuberculosis, malaria, cancer and Covid-19.

Three of these companies are South African: Adcock Ingram, which has licences for nine HIV products; Biotech, with a licence for a Covid-19 antibody test; and CPT Pharma, with one for a Covid-19 treatment. The fourth, Kenya’s Universal Corporation, has a licence to make generic HIV treatments. Africa’s biggest generic drug manufacturer, SAbased Aspen Pharmacare, has 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 daily pills to prevent HIV, whether it will be affordable and readily available in countries hard hit by the virus remains an open question.

Thievenaz said the price of generic cabotegravir had yet to be determined, but the MPP expects competition among producers to help drive down prices to levels middle-and lowincome countries can afford.