An affordable version of a groundbreaking HIV-prevention drug will be made in South Africa for the first time, potentially giving millions of people at risk of HIV infection in Africa access to a two-monthly jab that can almost eliminate their chances of contracting the virus.
The Indian drug company Cipla confirmed that a generic version of the prophylaxis, long-acting cabotegravir (CAB-LA), would be manufactured at its plants in Benoni, near Johannesburg, or Durban.
Cabotegravir blocks HIV from entering a person’s cells. Studies have shown that it reduces to almost zero an individual’s chances of getting infected with the virus through sex. As it is easier to take regularly, CAB-LA has also been found to work better than a daily HIV-prevention pill, which is available for free in South Africa and several other African countries.
The confirmation follows an announcement in March that the developers of CAB-LA, ViiV Healthcare, and the UN-backed Medicines Patent Pool (MPP), had granted licences to three companies, including Cipla.
The other two companies, Aurobindo and Viatris, are also Indian corporations that are already producing antiretroviral drugs for HIV treatment.
The branded version of CAB-LA sells for about $3,500 (£2,800) for one injection in the US – a price that puts it out of reach for lower-income countries. Even at a lower, “not-for-profit” price at which the manufacturer said it would sell the medicine to 90 poorer countries, including South Africa, the brand-name version is probably too expensive for the South African government to buy.
Last year, celebrities and leading figures in healthcare, including Winnie Byanyima, executive director of UNAids, called for ViiV to lower the price of the drug. But being granted a licence to produce a generic version of a branded medicine is only the first step.
“CAB-LA is a sterile, injectable product with a very complex manufacturing process,” Kimberly Smith, ViiV’s head of research, told Bhekisisa, a health news site, last year. For a pharmaceutical company to make a generic version of the medicine, the technology behind the manufacturing must be shared, so it could take up to five years before the product is on the market.
ViiV holds the patent for CAB-LA until 2031 in South Africa, which means that unless licences were granted for other generics, the company would have no competition for at least eight years.
Even one new contender can dramatically affect medicine prices, according to an analysis by the Food and Drug Administration, the US medicines regulator. It estimated that one generic manufacturer entering the market cut the price wholesalers paid manufacturers for a drug by 39%. Products with six or more generic producers were on average 95% cheaper than when only a single branded option was available, the report found.
Less than 40% of the medicines Africa needs can be made on the continent, and only 38 countries are estimated to have any drug manufacturers. Where they do exist, the companies rarely make medicines from scratch.
When ready-made and packaged medicines are imported, they can be expensive and it is significantly cheaper to import the raw materials to make the medicine locally, according to an analysis by the consultancy McKinsey.
Intellectual property deals such as the one brokered by the MPP can also lessen the impact of medicine shortages because alternative suppliers are available. Poorer countries suffer without such an agreement, as they did during the Covid pandemic, when the west bought up most of the stock of vaccines.
By the time Africa had enough doses to vaccinate about 9% of the continent’s population in early 2021, Canada had paid for enough jabs to vaccinate its population five times over.
In 2020 India and South Africa led a campaign at the World Trade Organization for intellectual property rights to be waived on Covid vaccines, medicines and tests, proposing that pharmaceutical companies should explain how to make the drugs, as well as what was in it.
In June 2022, a watered-down version of the proposal was accepted, but it only covered vaccines until 2027 and not medicines, treatments or tests. And it only applied to patents, not technology transfers, so generics firms would only know the ingredients and not the manufacturing process.
Licensing generics did not remove the risk of drug shortages, said Esteban Burrone, MPP’s head of policy, explaining that the lower profit margins could deter manufacturers from producing generics.
For this reason, pharmaceutical companies seeking a sub-licence must agree to create “broad access” once awarded manufacturing rights. For CAB-LA, Burrone said they “zoomed in on the three manufacturers who are most ready” to address demand rapidly.
This is an edited version of an article written for the Bhekisisa Centre for Health Journalism.