Johnson & Johnson pricing agreement for critical TB drug still unfairly restricts access in countries where the need is greatest

• Open letter from Unitaid’s Executive Director calls on the drug company to drop secondary patents for the drug-resistant TB (DR-TB) medicine bedaquiline, and to make negotiated rates available to all countries, regardless of how they purchase drugs.
• The letter follows advocates’ unanswered calls for broad access to bedaquiline, which is critical to achieving the reduction in TB agreed at the United Nations High-Level Meeting on 22 September.
• Bedaquiline is a vital component of all shorter treatment regimens for DR-TB, the most deadly and difficult to treat form of TB that affects millions of people worldwide.
• A recent agreement between Johnson & Johnson and the Global Drug Facility lowers the price of a six-month supply of bedaquiline to US$130, but the deal is an incomplete solution that will restrict access to lower cost medicines in the near future.
• Upcoming competition from multiple generic manufacturers is expected to lead to lower prices, but these products will remain unavailable in the countries with the greatest MDR-TB burden.

Geneva, 29 September 2023 – In an open letter to the Chief Executive Officer of Johnson & Johnson (J&J), Unitaid, while acknowledging the investments J&J has made to develop and market innovative medicines to treat tuberculosis (TB), expressed its concern that the recent agreement between J&J and the Global Drug Facility (GDF) to lower the price of bedaquiline is an incomplete solution that will hinder access long-term.

Drug-resistant TB (DR-TB), the most dangerous and deadly form of TB, affects nearly half a million people every year. Because so few currently access appropriate treatment, millions of people worldwide are in critical need of bedaquiline.

The J&J/GDF agreement saw a historic 55% price reduction of the drug, which is a welcome step in increasing access to this critical medicine that underpins all shorter regimens for treating DR-TB. However, the agreed price of US$130 for a six-month supply of J&J’s SIRTURO® (bedaquiline) is only available to countries when purchasing through GDF, which effectively excludes several countries where the rates of MDR-TB are highest.

Additionally, following the Indian Patent Office’s rejection of J&J’s secondary patent application for bedaquiline in the country in April, several generic manufacturers are expected to enter the Indian market, home to the highest number of people with MDR-TB in the world. This is likely to further reduce the cost of generic bedaquiline but secondary patents in place in low- and middle-income countries will restrict availability to these vital medicines in a subset of countries with the highest burden of disease.

Unitaid is calling on J&J to remove secondary patents or provide a comprehensive license to generics and allow all countries to purchase bedaquiline at the negotiated rates, including those excluded from the agreement or not procuring through GDF.

This follows numerous advocates’ unanswered calls for equitable access to bedaquiline in recent months, including action from nations not able to benefit from access prices such as South Africa, Belarus, and Ukraine, among others.

Meeting these demands is essential to fulfilling the commitment made by heads of state at the United Nations High-Level Meeting on TB on 22 September to reach 1.5 million people with DR-TB treatment by 2027.

Unitaid’s open letter to J&J is reproduced in full here.

Source: Unitaid