South Africa, Colombia and others are fighting drugmakers over access to TB and HIV drugs

South Africa, Colombia and other countries that lost out in the global race for coronavirus vaccines are taking a more combative approach towards drugmakers and pushing back on policies that deny cheap treatment to millions of people with tuberculosis and HIV.

Experts see it as a shift in how such countries deal with pharmaceutical behemoths and say it could trigger more efforts to make lifesaving medicines more widely available.

In the COVID-19 pandemic, rich countries bought most of the world’s vaccines early, leaving few shots for poor countries and creating a disparity the World Health Organization called “a catastrophic moral failure.”

Now, poorer countries are trying to become more self-reliant “because they’ve realized after COVID they can’t count on anyone else,” said Brook Baker, who studies treatment-access issues at Northeastern University.

One of the targets is a drug, bedaquiline, that is used for treating people with drug-resistant versions of tuberculosis. The pills are especially important for South Africa, where TB killed more than 50,000 people in 2021, making it the country’s leading cause of death.

In recent months, activists have protested efforts by Johnson & Johnson to protect its patent on the drug. In March, TB patients petitioned the Indian government, calling for cheaper generics; the government ultimately agreed J&J's patent could be broken. Belarus and Ukraine then wrote to J&J, also asking it to drop its patents, but with little response.

In July, J&J’s patent on the drug expired in South Africa, but the company had it extended until 2027, enraging activists who accused it of profiteering.

The South African government then began investigating the company’s pricing policies. It had been paying about 5,400 rand ($282) per treatment course, more than twice as much as poor countries that got the drug via a global effort called the Stop TB partnership.

In September, about a week after South Africa’s probe began, J&J announced that it would drop its patent in more than 130 countries, allowing generic-makers to copy the drug.

“This addresses any misconception that access to our medicines is limited,” the company said.

Christophe Perrin, a TB expert at Doctors Without Borders, called J&J's reversal “a big surprise” because aggressive patent protection was typically a “cornerstone” of pharmaceutical companies' strategy.

Meanwhile, in Colombia, the government declared last month that it would issue a compulsory license for the HIV drug dolutegravir without permission from the drug’s patent-holder, Viiv Healthcare. The decision came after more than 120 groups asked the Colombian government to expand access to the WHO-recommended drug.

“This is Colombia taking the reins after the extreme inequity of COVID and challenging a major pharmaceutical to ensure affordable AIDS treatment for its people,” said Peter Maybarduk of the Washington advocacy group Public Citizen. He noted that Brazilian activists are pushing their government to make a similar move.

Still, some experts said much more needs to change before poorer countries can produce their own medicines and vaccines.

When the coronavirus pandemic hit, Africa produced fewer than 1% of all vaccines made globally but used more than half of the world’s supply, according to Petro Terblanche, managing director of Afrigen Biologics. The company is part of a WHO-backed effort to produce a COVID vaccine using the same mRNA technology as those made by Pfizer and Moderna.

Terblanche estimated about 14 million people died of AIDS in Africa in the late 1990s-2000s, when countries couldn’t get the necessary medicines.

Back then, President Nelson Mandela’s government in South Africa eventually suspended patents to allow wider access to AIDS drugs. That prompted more than 30 drugmakers to take it to court in 1998, in a case dubbed “Mandela vs. Big Pharma.”

Doctors Without Borders described the episode as “a public relations disaster” for the drug companies, which dropped the lawsuit in 2001.

Terblanche said that Africa's past experience during the HIV epidemic has proven instructive.

“It’s not acceptable for a listed company to hold intellectual property that stands in the way of saving lives and so, we will see more countries fighting back,” she said.

Challenging pharmaceutical companies is just one piece to ensuring Africa has equal access to treatments and vaccines, Terblanche said. More robust health systems are critical.

“If we can’t get (vaccines and medicines) to the people who need them, they aren’t useful,” she said.

Yet some experts pointed out that South Africa's own intellectual property laws still haven't been changed sufficiently and make it too easy for pharmaceutical companies to acquire patents and extend their monopolies.

While many other developing countries allow legal challenges to a patent or a patent extension, South Africa has no clear law that allows it to do that, said Lynette Keneilwe Mabote-Eyde, a health care activist who consults for the nonprofit Treatment Action Group.

The South African Department of health didn't respond to a request for comment regarding drug procurement and patents.

Andy Gray, who advises the South African government on essential medicines, said J&J's recent decision to not enforce its patent may have more to do with the drug's limited future earnings than caving to pressure from activists.

"Because bedaquiline is not ever going to sell in huge volumes in high-income countries, it's the sort of product they would love to offload at some stage and perhaps earn a royalty from,” said Gray, a senior lecturer in pharmacology at the University of KwaZulu-Natal.

In its annual report on TB released earlier this month, the World Health Organization said there were more than 10 million people sickened by the disease last year and 1.3 million deaths. After COVID-19, tuberculosis is the world's deadliest infectious disease and it is now the top killer of people with HIV. WHO noted only about 2 in 5 people with drug-resistant TB are being treated.

Zolelwa Sifumba, a South African doctor, was diagnosed with drug-resistant TB in 2012 when she was a medical student and endured 18 months of treatment taking about 20 pills every day in addition to daily injections, which left her in “immense pain” and resulted in some hearing loss. Bedaquiline was not rolled out as a standard treatment in South Africa until 2018.

“I wanted to quit (treatment) every single day,” she said. Since her recovery, Sifumba has become an advocate for better TB treatment, saying it makes little sense to charge poor countries high prices for essential medicines.

“TB is everywhere but the burden of it is in your lower and middle-income countries,” she said. "If the lower income countries can’t get it (the drug), then what’s the point? Who are you making it for?”