Johnson & Johnson lifts patent on MDR-TB drug but it may be years before South Africa benefits

Bedaquiline is a key component in the cocktail of drugs used to treat multidrug-resistant tuberculosis (MDR-TB) which develops when the TB bacteria build resistance to two of the strongest anti-TB drugs. J&J is currently the sole manufacturer of bedaquiline.

The announcement paves the way for the manufacturing of cheaper, generic versions of the drug to be sold in 134 low-and middle income countries.

This is an important move towards equitable access to TB treatment. But it is unclear how soon the changes will filter down to national programmes in high burden countries like South Africa.

Dr Norbet Ndjeka, chief director of TB control and management at the National Department of Health, tells Health-e News that it might still take years before the country could benefit from the lifting of patents on bedaquiline.

“It is a long process to have any drug, including a generic version, registered in the country. It can even take years. We are just optimistic that it will not take too long as there is an Indian-based pharmaceutical company that has already started manufacturing a generic version of bedaquiline. For now we just have to wait and see how everything unfolds,” he says.

The high cost of care

TB is a leading cause of death in South Africa with around 300,000 cases reported each year. According to Ndjeka, the department spends around R300 per patient for a six-month TB treatment regimen.

The cost of treating MDR-TB is exponentially higher.

“Bedaquiline alone for a period of six-months costs us R 5400. When we put together the cost of all the other drugs used together with bedaquiline, we are spending in the region of R20 000 per person for an entire six-month treatment period,” says Ndjeka.

Ndjeka says South Africa treats between 7000 to 8000 MDR-TB patients each year. The country spends an estimated R160 million annually to procure drugs to treat MDR-TB.

Ndjeka says that even if a generic version of bedaquiline was to be made available in the next few months, the country would not rush into procurement.

“We have an excess stock of bedaquiline on our shelves to last us for the next two years,” he explains.

For now, South Africa’s contract with J&J is set to be extended by a further two-years from October 2023. Under the new arrangement the country will now be set to buy  the drug for an increased price of R5,500.

Bone of contention

Patents and the cost of bedaquiline have been a point of concern for at least the last decade.

“We have been calling for them to reduce their prices for bedaquiline for many years. Says Candice Sehoma from Doctors Without Borders (MSF).

Calls have been mounting on the pharmaceutical company to reduce the cost.

Recently the Competition Commission in South Africa launched an investigation into J&J over the price of the drug. Sehoma says the Competition Commission should still conduct its investigation, regardless of J&J’s recent turnaround.

“It is very important that they continue with the investigation. It will set a precedent to other pharmaceutical companies,” says Sehoma.

Speaking to Health-e News, Siyabulela Makunga, Competition Commission spokesperson, says that despite the bedaquiline patent announcement by J&J, the commission is still continuing with its investigations.

“The investigations into over-pricing of a tuberculosis drug by Johnson & Johnson is still continuing and at this stage we are not at the right place to share anything further than that with the public,” says Makunga.

Ndjeka says that the National Department of Health will be meeting with both Competition Commission of South Africa and J&J in the coming weeks to map a way forward on the investigations and future procurement contracts.

Source: Health-e News