US corporations J&J and Cepheid must pledge access to lifesaving TB medicines and tests for everyone in need

The TB drug bedaquiline, developed by J&J, is the World Health Organization-recommended backbone of drug resistant-TB (DR-TB) treatment regimens, and has enabled an improved, shorter, better-tolerated and more-effective treatment for people with DR-TB. However, access to more affordable generic versions of this drug will continue to be blocked by the additional ‘secondary patents’ that J&J has obtained in multiple countries with a high burden of TB, TB-HIV or DR-TB. This aggressive patent evergreening strategy employed by J&J to extend its monopoly on this drug beyond the 20-year primary patent is particularly outrageous given that public investment in the development of bedaquiline was up to five times that of the corporation's own investment. 

Following a successful effort by two women to block J&J’s attempt to obtain an additional, longer patent on bedaquiline in India, Doctors Without Borders called on J&J to withdraw all secondary patents it may have anywhere, so that all countries can import more affordable generic versions made in India. Nandita Venkatesan and Phumeza Tisile both survived DR-TB but could not access bedaquiline and had to take older drugs which made them go deaf. J&J recently announced a deal with the Stop TB Partnership/Global Drug Facility (GDF) allowing access to generics in many countries and quoted a price drop of $130 per 6-month treatment course. However, the deal still excludes key high-TB burden countries.

“Nobody should have to endure what we went through with the older drugs, when more effective options are now available that can save more lives and make treatment much more tolerable for people,” said Phumeza Tisile, a TB activist from Khayelitsha, South Africa. “What good is it to have medical advances if they’re not reaching the people who need them most? We need to see J&J and Cepheid do the right thing now.”

The GeneXpert diagnostic testing technology produced by the US corporation Cepheid (owned by parent corporation Danaher) has revolutionised TB testing since entering the market in 2010. But because of the high price that Cepheid continues to charge for the GeneXpert tests, scaling up TB testing to all people who need it remains a challenge and still forces many TB care providers to rely on cheaper but less sensitive testing using microscopes, a method developed in the 1800s. Doctors Without Borders analysis has estimated that it costs Cepheid less than $5 to manufacture one GeneXpert TB test, while Cepheid has been charging Doctors Without Borders and high-burden low- and middle-income countries double and triple that price per TB tests, and even up to four times that for other disease tests*. Based on this evidence Doctors Without Borders calls on Cepheid to lower the price of the GeneXpert cartridges to $5 each for all diseases.

While advances in tackling TB have been made, the harsh reality is that TB remains the top infectious killer, with about 10.6 million new cases and 1.6 million deaths in 2021. Only about one-third of people with DR-TB were able to access treatment, with the majority of people remaining undiagnosed and therefore untreated.  

“In our persistent efforts to provide treatment for the most difficult forms of drug-resistant TB, we remain disheartened by the significant loss of lives especially among the most vulnerable people, including people living with HIV, those affected by conflicts, and children in high-TB-burden countries,” said Dr. Cathy Hewison, TB Working Group Lead for Doctors Without Borders.

“While urgent scale-up of improved treatments and testing is the need of the hour, high prices still charged by some companies not only limit access for people who urgently need them, but also mean less money is available in health budgets to cover other crucial TB care. Cepheid and Danaher must stop prioritising their profits over people, and J&J must surrender on its persistent aggressive patenting strategy, so that more lives can be saved by this revolution in TB medical tools.” 

Doctors Without Borders is the largest non-governmental provider of TB treatment worldwide and has been involved in TB care for 30 years, often working alongside national health authorities to treat people in a wide variety of settings, including conflict zones, urban slums, prisons, refugee camps and rural areas. In 2022, Doctors Without Borders treated more than 17,000 people with TB, including 2,300 people with DR-TB, in over 60 TB projects in 41 countries.

*Cepheid charges about $10 for TB and $15 for XDR-TB (extensively drug-resistant TB) tests; $15 for HIV, hepatitis, and COVID tests; $16-19 for sexually transmitted disease tests; and about $20 for Ebola tests.