Johnson & Johnson and Cepheid must expand access to TB drug and tests

NEW YORK, SEPTEMBER 12, 2023 — As world leaders prepare to meet next week for the United Nations High-Level Meeting (HLM) on tuberculosis (TB), the international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF) is calling on US-based corporations Johnson & Johnson (J&J) and Cepheid to publicly announce in time for the HLM on September 22 that they will take action to increase access to the lifesaving TB drug bedaquiline and GeneXpert tests, respectively, for people who need them.

The UN declaration that has been prepared for this meeting includes ambitious commitments from governments to ramp up TB testing, treatment, and prevention efforts in light of innovative medical tools that have become available over the last decade. Despite this progress, some of the most important products—the J&J drug bedaquiline and Cepheid GeneXpert diagnostic tests—do not reach hundreds of thousands of people who need them because of these corporations’ monopolies.

To increase global access, MSF is calling on J&J not to enforce any “secondary” patents for bedaquiline in any country with a high burden of TB, and to withdraw and abandon all pending secondary patent applications for this critical drug everywhere. Related to Cepheid, MSF is calling on the company and its parent corporation Danaher to drop the price of the GeneXpert tests from $15 and $10 to $5.

“After a gap of half a century, we finally have groundbreaking oral TB drugs like bedaquiline and crucial diagnostic tests like GeneXpert, and yet people in high-TB-burden countries continue to die or endure needless suffering because corporate monopolies prevent them from accessing these lifesaving tools,” said Dr. Christos Christou, MSF's international president. “We are calling on J&J, as well as Cepheid and its parent company Danaher, in the strongest possible terms to do the right thing now and pledge to make bedaquiline and the GeneXpert tests universally available and affordable to help countries tackle this age-old killer disease and save many more lives worldwide.”

The TB drug bedaquiline, developed by J&J, is the World Health Organization-recommended backbone of drug-resistant-TB (DR-TB) treatment regimens since it’s a shorter, better-tolerated, and more effective treatment option for people with DR-TB. However, access to more affordable generic versions of this drug will continue to be widely 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. Given that taxpayer investment in the development of bedaquiline was up to five times that of J&J’s own investment, this aggressive patent evergreening strategy employed by the company to extend its monopoly on this drug beyond the 20-year primary patent is unacceptable.

Earlier this year, the Indian Patent Office rejected J&J’s attempt to extend its monopoly in India on bedaquiline past its July 2023 expiration. MSF has since 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.

The suit, which ultimately ended J&J’s patent monopoly in India, was brought by Nandita Venkatesan and Phumeza Tisile, DR-TB survivors who could not access bedaquiline and had to take older drugs with severe side effects like permanent hearing loss. J&J recently announced a deal with the Stop TB Partnership/GDF allowing access to generics in many countries and quoted a price drop of $130 per six-month treatment course. However, this deal 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 former MSF patient and 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 Cepheid has revolutionized TB testing since entering the market in 2010. However, 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. MSF analysis has estimated that it costs Cepheid less than $5 to manufacture one GeneXpert TB test, while Cepheid has been charging MSF and high-burden low- and middle-income countries double and triple that price per TB test. Based on this evidence, MSF has renewed its “Time for $5” campaign, calling on Cepheid to lower the price of the GeneXpert cartridges to $5 each for TB and other diseases for which it produces cartridges, including COVID-19, HIV, and hepatitis.

While advances in tackling TB have been made, TB remains the top infectious killer with approximately 10.6 million new cases and 1.6 million deaths in 2021. Only approximately 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 DR-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, MSF TB working group lead. “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 prioritizing 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.”

MSF 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 like conflict zones, prisons, refugee camps, and rural areas with limited health care options. In 2022, MSF treated more than 17,000 people with TB, including 2,300 people with DR-TB, in more than 60 TB projects in 41 countries.

Source: Médecins Sans Frontières