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The US drugmaker Johnson & Johnson is being subject to an investigation by South Africa’s Competition Commission as a result of the high prices set for tuberculosis (TB) medicine named bedaquiline, in addition to its decision for its 20-year patent until 2027 to prevent cheaper generics from entering the country.

The investigation was revealed to the public at a media briefing of Médecins Sans Frontières (MSF) last week by the country's health department and the Health Justice Initiative (HJI) legal organization.

The patent refers to that for bedaquiline compounds in South Africa, which expired in July but was extended to 2027, prompting accusations against J&J of evergreening - which means when pharmaceutical manufacturers make trivial alterations to medicines or their applications to keep their monopoly on the market.

The founder, and director of HJI, Fatima Hassan, said, "The Competition Commission believes J&J could be in contravention of Section 8 of the Competition Act, which deals with excessive pricing and exclusionary conduct, which, in this case, refers to the practice of evergreening [because it results in excluding others from the market]," adding: "We believe this is unprecedented. We do not know of other investigations by the Competition Commission into a pharmaceutical company for evergreening."

It is false to suggest—as some recently have—that our patents are being used to prevent access to SIRTURO® (bedaquiline), our medicine for MDR-TB.

In fact, we have already entered into a collaboration with the Stop TB Partnership’s Global Drug Facility ("GDF")—the largest… pic.twitter.com/3pYy8AYhYW

— Johnson & Johnson (@JNJNews) July 12, 2023

Suffer more, pay more

South Africa records one of the highest TB rates in the world, and although it is curable, it ranks as the country’s top cause of death.

Bedaquiline, alongside a combination of other drugs, intends to treat multidrug-resistant TB, which is not treatable with regular remedies. A gamechanger, bedaquiline challenges previous treatment, which consisted of two years of painful injections carrying side-effects, such as hearing loss and a high death rate.

The drug, required to be taken for a duration of six months, is already being given by the health department to the public in need since 2018.

'J&J prioritizes profit over needs of vulnerable'

Currently, the health department purchases the six-month course for each patient in need at 5,400 rand ($286), but starting October 1, when the new contract with the manufacturer begins, it will become 5,500 rand ($290). Meanwhile, nations that purchase it through the Stop TB partnership’s Global Drug Facility only pay around 2,446 rand ($129) - less than half. 

The Global Drug Facility uses pooled procurement for payment negotiation, which makes bargaining for lower prices for TB medicines possible, but those like South Africa, with open tender systems, are not legally able to purchase it through such systems.

Candice Sehoma of MSF expressed: "We are enraged to witness that J&J prioritizes profit over the needs of the most vulnerable populations in a country with a high burden of drug-resistant TB," urging "J&J to offer the same price of 2,446 rand for bedaquiline to the South African government as they have offered to countries that are part of the Global Drug Facility deal."

'Addressing health inequities'

Health activists have been calling for the past 10 years for a change in the legislation to contain evergreening.

Russell Rensburg, the director of the Rural Health Advocacy Project at Wits University in Johannesburg, explained: "Something for our legislators to consider is why we haven’t fixed our [patent] laws to ensure we don’t expose ourselves to these kinds of exploitative practices. Fixing the patent laws is essential to addressing health inequity."

In light of this, global leaders are partaking in a high-level discussion this week at the United Nations General Assembly in New York for the fight against TB, and discuss practices such as evergreening.

In its statement, the Competition Commission informed Johnson & Johnson of its investigation: "Johnson & Johnson is a longstanding and committed partner in South Africa’s fight against multidrug-resistant tuberculosis. Today, all patients in South Africa who require bedaquiline, our medicine for multidrug-resistant tuberculosis, have access to it thanks to our collaboration with the government of South Africa and other partners, which has contributed to a steady decline in TB incidence."

"We will continue to work collaboratively with our partners to ensure we can achieve our shared goal of ending TB," the company further said.