SWITZERLAND —A recent licensing agreement between pharmaceutical giant Johnson & Johnson (J&J) and the Stop TB Partnership has sparked debate over its effectiveness in expanding access to life-saving tuberculosis (TB) drug, bedaquiline.

Médecins Sans Frontières (MSF) argues that the agreement is merely a temporary solution that will benefit only a limited number of countries, potentially excluding nine high-burden nations in Eastern Europe and Central Asia.

While the specific countries covered by the deal have not been disclosed, J&J’s exclusive commercial agreement with Russia’s Pharmstandard to supply bedaquiline in Eastern Europe and Central Asia suggests that these countries may not be included in the Stop TB agreement.

In recent days, J&J has faced public backlash for attempting to extend its patent on bedaquiline, the primary medication for treating drug-resistant TB.

Activists advocating for improved medicine access have accused the company of seeking additional patents in 66 countries.

The outcry gained momentum after popular US author John Green voiced his concerns on social media, leading to the trending hashtag #PatientsnotPatents on Twitter.

Amidst the mounting pressure, the Stop TB Partnership made an announcement, stating that after lengthy negotiations, J&J had granted licenses to its Global Drug Facility (GDF) to facilitate the procurement and supply of generic versions of bedaquiline in most low- and middle-income countries, including those where patents are still in effect.

According to the Stop TB announcement, the GDF intends to initiate a global competitive tender for bedaquiline by the end of July and has already reached out to potential suppliers to begin the process.

However, MSF’s Christophe Perrin has criticized the agreement, labeling it as a mere stop-gap measure that limits access to bedaquiline to a select number of countries included in the agreement and procuring through the Global Drug Facility.

Perrin expressed concerns over J&J’s continued authority to determine access to generic versions of bedaquiline in high-burden TB countries, even after the expiration of the primary patent next week.

Perrin emphasized the need for J&J to publicly declare that they will not enforce any secondary patents on bedaquiline in high-burden TB countries and to withdraw all pending secondary patent applications for the drug.

J&J, on the other hand, denies allegations that its patents have hindered access to bedaquiline for TB patients.

The company argues that the primary challenge lies in the lack of diagnosis for millions of TB patients each year and asserts its commitment to overcoming this obstacle with substantial investments.

 

Affordability challenges surrounding Bedaquiline

Bedaquiline, a crucial medication in combating drug-resistant tuberculosis (DR-TB), plays a pivotal role in the most effective treatment regimens available.

According to the Treatment Action Group (TAG), DR-TB afflicts nearly half a million individuals each year, presenting a formidable challenge in healthcare.

Unfortunately, many countries grappling with high TB burdens face significant obstacles in providing widespread access to DR-TB treatment, primarily due to the exorbitant cost associated with bedaquiline. TAG highlights that bedaquiline accounts for up to 70% of the overall treatment expenses.

In light of recent estimates, the introduction of generic versions of bedaquiline could potentially reduce the drug’s price by as much as 80%.

This would result in substantial savings for cash-strapped TB programs in low- and middle-income countries.

Alarmingly, approximately three-quarters of individuals in need of DR-TB treatment reside in countries affected by secondary patents, including those currently embroiled in conflicts or humanitarian crises such as Ukraine, Cameroon, Sierra Leone, and Malawi, as noted by TAG.

A striking discrepancy exists between the current price charged by Pharmstandard to the Russian Federation for bedaquiline and the cost agreed upon in the licensing agreement between J&J and the Stop TB Partnership.

The price charged by Pharmstandard to the Russian Federation is roughly 17 times higher, highlighting the pressing need for more affordable access to bedaquiline worldwide.

The issue of affordability surrounding bedaquiline raises critical concerns regarding equitable access to treatment for DR-TB.

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