The licensing agreement reached between Johnson & Johnson (J&J) and the Stop TB Partnership on Thursday to allow the generic production of the tuberculosis drug, bedaquiline, is simply a “stop-gap” measure that applies to a limited number of countries, according to Médecins Sans Frontières (MSF).

At least nine countries in the Eastern Europe and Central Asia region with some of the world’s highest burden of drug-resistant TB are likely to be excluded from this deal, according to MSF.

While the countries included in the deal have not yet been made public, J&J has an exclusive commercial agreement with Russia’s Pharmstandard to supply bedaquiline to a number of countries in Eastern Europe and Central Asia and these are thus unlikely to benefit from the Stop TB deal.

Over the past week, J&J has faced public outrage for seeking to extend its patent on bedaquiline, the primary medication to treat drug-resistant TB. The global patent is due to expire next Tuesday but medicine access activists have accused the company of seeking secondary patents in 66 countries. 

US author John Green’s social media posts about the extension of the bedaquiline patent received significant traction, causing #PatientsnotPatents to trend on Twitter on Thursday.

Johnson & Johnson (@JNJGlobalHealth) is unjustly extending a patent on a life-saving tuberculosis drug. Today's the day for them to realize denying MDR-TB patients treatment is not worth the harm they're causing to core brands like Tylenol and Neutrogena. https://t.co/JArPHWpmv5

— John Green (@sportswithjohn) July 11, 2023

In the midst of the media row, the Stop TB Partnership announced on Thursday that, “following lengthy negotiations”, J&J had granted licenses to its Global Drug Facility (GDF) to “tender, procure, and supply generic versions of bedaquiline for the majority of low-and middle-income countries, including countries where patents remain in effect”.

The GDF plans to launch a global, competitive tender for bedaquiline by the end of July and has reached out to potential suppliers about the process, according to the Stop TB announcement.

But MSF’s Christophe Perrin described the deal as “just a stop-gap because bedaquiline will only be available to a limited number of countries that will be included in this agreement, procuring through the Global Drug Facility”. 

“We remain concerned that J&J retains the global authority to determine access to lifesaving generic versions of bedaquiline in countries with a high burden of TB, even after the expiration of the main patent next week,” said Perrin.

“By continuing to pursue an extension of their monopoly on the drug in many countries, including 34 high-TB-burden countries where J&J still has a secondary patent on bedaquiline, J&J is maintaining control over countries’ ability to offer more people the treatments they need to stay alive and healthy.  

“We reiterate our call on J&J to publicly announce it will not enforce any secondary patents on bedaquiline in any country with a high burden of TB, and withdraw and abandon all pending secondary patent applications for this lifesaving drug,” added Perrin.

However, J&J has denied claims that its patents have prevented TB patients from access to bedaquiline.

“Unfortunately, the most significant barrier to treatment access for patients today is the fact that millions of patients with TB go undiagnosed every year. This is a challenge that we have invested significant resources to overcome and must all get behind if we are to achieve the global goal of ending TB,” said the company.

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

Key medicine for drug-resistant TB

Bedaquiline is the cornerstone of the best available regimens to cure drug-resistant TB (DR-TB), which is a tough-to-treat form of TB that nearly half a million people get each year, according to the Treatment Action Group (TAG).

“Many countries with high burdens of TB are unable to fully scale up access to DR-TB treatment due to the high cost, up to 70% of which is driven by the price of bedaquiline,” according to TAG.

“Recent estimates suggest that generic versions could shave up to 80% off the price of the drug, resulting in major savings for already cash-strapped TB programs in low- and middle-income countries. Around three-quarters of people in need of treatment for DR-TB live in countries affected by the secondary patents, including countries experiencing active conflicts or humanitarian crises such as Ukraine, Cameroon, Sierra Leone, and Malawi,” added TAG.

The current price that Pharmstandard currently charges the Russian Federation for bedaquiline is around 17 times higher than that agreed on between J&J and Stop TB.

Image Credits: The Global Fund / Evgeny Maloletka, Médecins Sans Frontières.