“This deal is big step backwards for global public health – it allows J & J to keep selling higher-priced BDQ where the most profits can be made, instead of making it available where the most urgent need exists.”, says Othoman Mellouk, Campaign Lead at MMA.
Drug-resistant tuberculosis (DR-TB) is a major threat to global public health. The COVID-19 pandemic has reversed years of progress towards ending TB as a public health challenge by 2030. In 2021, the world’s burden of DR-TB increased for the first time in years, and only a third of the 455,000 people diagnosed with DR-TB were treated.[1]
Bedaquiline (BDQ) has become the backbone of treatment regimens for DR-TB. But high pricing and an insufficient – and exhausted – donation program have diminished the public health impact of this important medicine in many low- and middle-income countries (LMIC), which have been forced to use longer, less effective and more toxic regimens for DR-TB.
Bedaquiline Pricing
2012: BDQ’s patent holder, Janssen, which is a subsidiary of Johnson and Johnson (J & J), used a tiered pricing system for BDQ: a six-month treatment course was $900 in low-income countries, $3,000 in middle-income countries, and $30,000 in high-income countries.[2]
2014: Janssen and the U.S. Agency for International Development (USAID) established a donation program for most Global Fund eligible countries; the Global Drug Facility GDF) eventually distributed 60,000 treatment courses.1
2018: South Africa struck a deal with J & J for $400 per treatment course, which also became the price for GDF-eligible countries.[3]
2020: The GDF announces a further price reduction for BDQ, bringing the price down to $272 per treatment course.[4]
The primary patent on BDQ expired in July of 2023, bringing hope that affordable generic versions would become available in LMIC, since experts have estimated that generic BDQ could be profitably mass-produced for only $48 – 102 per treatment course.[5]
But J & J has been filing secondary patents on BDQ, a practice known as evergreening, which allows pharmaceutical companies to extend the life span of their patent monopolies and retain revenues by patenting new forms (salts, polymorphs, etc.) of known substances and claiming that known treatment methods are inventive (oral administration, administering BDQ with a meal, combining a known medicine with other medicines). Activists have demanded that J & J withdraw all patent applications for BDQ and agree not to enforce secondary patents or pursue any action against generics manufacturers.
But instead of enabling access to BDQ where it is urgently needed, J & J chose to make a market-driven deal with the GDF. The deal allows some LMIC to access affordable generic versions of BDQ – but it excludes some of the countries with the most urgent need for this drug. Overall, nine of the eleven countries excluded from the new GDF/J & J deal are among the world’s 30 nations with the highest burdens of DR-TB. Based on the most recent World Health Organization (WHO) data, from 2021, these excluded countries were home to at least 112,100 people living with DR-TB, but barely 50% (57,408) were able to access treatment.
Table 1. Countries That Are Not Eligible to Purchase Generic Bedaquiline Under the J & J/ GDF Deal
Sources: STOP TB Partnership/Global Drug Facility: Frequently Asked Questions https://www.stoptb.org/sites/default/files/2023.07.19_faqs_jj-gdf_license_sirturo_final_1.pdf and https://www.who.int/teams/global-tuberculosis-programme/tb-reports/global-tuberculosis-report-2022/tb-disease-burden/2-3-drug-resistant-tb
“It is outrageous that this deal excludes some of the countries with the world’s highest burden of drug-resistant tuberculosis. This deal was engineered so that J & J could keep control of profitable markets, instead of addressing a major threat to global public health with a drug that was developed mainly with public funding. J & J must agree not to enforce or apply for evergreening patents on BDQ,” says Mellouk.
According to Maria Shibaeva, from ITPC – EECA, “Activists need to keep the pressure on J & J, to prevent them from filing more evergreening patents, and to oppose the ones that have already been filed or granted. Countries need to consider granting a compulsory license (CL) for BDQ, instead of letting their health budgets be drained to fill pharma’s pockets.”
Excluded LMIC can oppose the secondary patents on BDQ, or grant a compulsory license (CL), which would allow them to produce or import generic BDQ. Community-led organizations in the Make Medicines Affordable (MMA) campaign have been working to improve access to BDQ by filing 15 oppositions against J & J’s evergreening patents on BDQ, in Belarus, Brazil, India, Kazakhstan, Kyrgyzstan, Moldova, Thailand, Ukraine, and Vietnam. In October of 2020, the Brazilian patent office rejected the evergreening patent application on BDQ, and in June of 2023, Thailand’s patent office rejected two of four pending evergreening patent applications.
Sergey Kondratyuk, Project Manager at MMA stresses that “these licenses make it harder for countries to access affordable generic versions of BDQ – even if they grant a compulsory license or successfully oppose secondary patents on the drug,”.
In some cases, voluntary licensing deals have worsened access. Signing the GDF/J & J voluntary license (VL) could lock down generic manufacturers, by preventing them from supplying affordable versions of BDQ to excluded countries even in the absence of patents. In these excluded countries, accessing affordable generic BDQ may be difficult – even if they issue a compulsory license or oppose evergreening patents.
“J & J and GDF need to improve this license by making it fully transparent and including all low- and middle-income countries (LMIC), to make affordable generic versions of BDQ available around the globe – not just where J & J decides to provide it,” says Evgenii Goloshchapov – consultant on human rights and legislation, from “Positive Initiative”, MMA’s partner in Moldova.
