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

Scientists work at an Afrigen Biologics and Vaccines facility in Cape Town, South Africa, on Oct 19, 2021. [AP Photo]

South Africa, Colombia and other countries that lost out in the global race for coronavirus vaccines are taking a more combative approach toward 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 Johnson & Johnson's patent could be broken. Belarus and Ukraine then wrote to the company, also asking it to drop its patents, but with little response.

In July, Johnson & Johnson'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, Johnson & Johnson 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 tuberculosis expert at Doctors Without Borders, called Johnson & Johnson'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 Health care. The decision came after more than 120 groups asked the Colombian government to expand access to the World Health Organization-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 from the late 1990s into the 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 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.

In its annual report on tuberculosis 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.