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The Johnson & Johnson campus in Irvine, Calif., in 2019.MARK RALSTON/AFP/Getty Images

For years, researchers conducted trials of the world’s newest tuberculosis drug on hundreds of people in South Africa’s impoverished townships, where TB is the biggest killer.

The trials yielded valuable data for Johnson & Johnson, the manufacturer of bedaquiline. But when it came time to discuss prices, South Africa couldn’t get much of a break. It is now paying twice as much for the drug as many other countries.

The high price of the drug – crucial for combating a version of the disease known as multidrug-resistant TB – has triggered a political and legal fight in South Africa, the latest in an expanding global battle over prices and access.

Health activists, complaining of profiteering by manufacturers, are pushing for rollbacks in the price of vital treatments and tests for infectious diseases that kill millions in developing countries. The death toll from tuberculosis alone is more than a million people annually, putting it at the centre of the fight.

The pricing issue rose to prominence when COVID-19 vaccines first emerged. Many poorer countries struggled for affordable access to the vaccines during the pandemic. This month, after activists won a court battle for full disclosure of South Africa’s vaccine contracts, they discovered that the multinational producers were charging higher prices to the South African government than they were to wealthier countries.

Now the campaigners are applying those lessons to tuberculosis. They achieved a key victory last week when two companies, Cepheid and Danaher Corp., announced a 20 per cent cut in the price of their Xpert test for tuberculosis, after years of pressure from health groups.

“This reduction is a significant step, considering the corporations have refused to reduce the price of this test for over 10 years,” said a statement by Médecins Sans Frontières (Doctors Without Borders).

More than one-third of people with TB are undiagnosed, so a reduction in testing costs can save lives, MSF said. But it noted that some tests – for a type of tuberculosis called extensively drug-resistant TB – are still three times more expensive than their production cost. It is pushing for similar price reductions for these tests.

The dispute over bedaquiline is one of the latest fronts in this global campaign. This month, South Africa’s Competition Commission disclosed that it is investigating Johnson & Johnson for two issues: the high price of its TB drug, and its decision to prolong its patent in South Africa for several more years to block cheaper generics from being sold in the country.

The Competition Commission has given few details of its investigation, but it is reportedly looking into whether J&J is violating South Africa’s competition laws that prohibit excessive pricing and “exclusionary” conduct – keeping other companies out of the South African market.

In response to questions from The Globe and Mail, J&J said it plans to co-operate with the Competition Commission but would not comment further while the inquiry is underway.

Asked about the allegations of excessive prices and unfair patent practices, J&J did not respond directly. Instead it emphasized that all South African patients who need bedaquiline have access to it today, and that the drug has contributed to a decline in TB in the country.

Worldwide, about half a million people develop drug-resistant tuberculosis every year. Bedaquiline, approved by U.S. regulators in 2012 and widely distributed in South Africa since 2018, has produced dramatic results in many patients. Previous treatments were much less effective and often produced side effects such as hearing loss.

Under a form of pooled purchasing, using high volumes to negotiate a lower price, most low-income and middle-income countries are now able to obtain bedaquiline for the equivalent of about $175 for a six-month treatment course. But South Africa will be obliged to pay about $395 for the same drugs. This is partly because its open-tender procurement rules do not allow access to pooled purchasing agreements, but also because J&J would not share the lower price with it.

According to MSF, researchers have found that J&J could sell a six-month treatment of bedaquiline for the equivalent of $138 and still make a profit.

“We are enraged to witness that J&J prioritises profit over the needs of the most vulnerable populations in a country with a high burden of drug-resistant TB,” said Candice Sehoma, an access campaigner at MSF’s South African office.

Data by health activists shows that 1,235 South Africans have participated in clinical trials of bedaquiline since 2010. South Africa’s contribution to these clinical trials makes the higher prices today “particularly unjust,” Ms. Sehoma said in a statement.

The investigation by the Competition Commission is “a huge promising step in the fight against a systemic denial of access to a lifesaving medicine,” she said.

At a United Nations high-level meeting on tuberculosis on Friday, officials reported that progress on key targets was too slow. The UN had aimed to treat 1.5 million people annually for multidrug-resistant TB by now, but it only reached 55 per cent of this goal.

Total funding for TB services in low-income and middle-income countries has fallen from US$6.4-billion to US$5.8-billion over the past five years, leaving it just halfway to its annual target, the World Health Organization reported.

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