South Africa’s Competition Commission (Commission) has decided to drop investigations and not prosecute a complaint against Johnson & Johnson and its subsidiary, Janssen Pharmaceuticals, over alleged anti-competitive conduct.
Earlier, the companies applied for a secondary patent for their drug bedaquiline, marketed as Sirturo. This move aimed to block generic manufacturing of the product until 2027, thereby limiting access to the lifesaving tuberculosis medicine due to its high price in South Africa.
This triggered a huge uproar from the country and advocacy groups.
In a press release, the Commission justified the decision to not move forward with prosecution after “extensive engagements” resulted in the two companies agreeing not to impose the Bedaquiline patent in 134 low- and middle-income countries, including South Africa.
Additionally, the companies agreed to implement a 40% drop in the procurement price of the drug for the South African government from the initial R5577.12 ($308.67) to R3148 ($174.23).
According to the Commission, the new price is similar to that J&J offers to the Stop TB partnership’s Global Drug Facility (GDF). Last year, the organization announced price reductions of an estimated 55% for bedaquiline, but the agreement crucially didn’t include countries like South Africa, which bear a heavy burden of drug-resistant TB.
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Bedaquiline is the first anti-TB drug to exhibit a new mechanism of action in more than four decades.
The drug is a key component of nearly every regimen recommended by the World Health Organization (WHO) for the treatment of drug-resistant TB..
Bedaquiline, in combination with pretomanid, linezolid, and moxifloxacin, comprises BPaLM, which is the preferred regimen recommended by the WHO for the treatment of DR-TB.
For patients with resistance to moxifloxacin, WHO recommends the use of BPaL (bedaquiline, pretomanid, and linezolid) for DR-TB treatment.
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