Ngqabutho Mpofu (Treatment Action Campaign): 27 61 807 6443| firstname.lastname@example.org
Lotti Rutter (Health GAP): +27 82 065 5842| email@example.com
(Durban, South Africa)— Today activists stormed the corporate stall of multinational pharmaceutical company Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson) at the 9th South African AIDS Conference. The activists demanded that Janssen urgently drop the price of bedaquiline—a lifesaving treatment for drug resistant tuberculosis (DR-TB)—in South Africa and across the world.
“Globally people are suffering and dying needlessly of DR-TB because governments are unable to afford to procure bedaquiline to save their lives. Instead, people with DR-TB face severe pain and risk deafness taking horrendous treatments that have little value in treating this disease,” said Phumeza Tisile, an XDR TB survivor working with TB Proof.
Bedaquiline was recommended as a core agent for treating DR-TB by the World Health Organization (WHO) in 2018 but virtually no high burden DR-TB countries have been able to make this drug widely available. It is less toxic and far more effective at curing people than previous drugs, marking a major advance in DR-TB treatment. It replaces the painful injectable drugs (kanamycin, capreomycin, and amikacin) that cause high rates of hearing loss and many other severe side effects. However, many people across the world are still unable to access bedaquiline because of the high price tag, forced to endure inferior, less effective, and more toxic alternatives.
Janssen—which introduced the medicine and got accelerated approval for it by the United States Food and Drug Administration (US FDA) in 2012—has employed a complex set of strategies involving ad-hoc discounts, donations, abusive patenting and non-transparent pricing to obstruct affordable access to the drug in countries where it is needed the most. The research and development (R&D) of bedaquiline has benefited greatly from public and philanthropic funding and government tax credits. As a reward for developing bedaquiline, Janssen also received a US FDA “priority review voucher” which it used to secure expedited FDA review of a biologic medicine (Tremfya), expected to generate $1.56 billion in sales in 2020. At the same time, it is governments of the developing world and international NGOs that have largely provided the data for the WHO recommendation for large scale adoption of bedaquiline and practically borne the costs of the later stage clinical development of the drug.
Despite large-scale public investment in the R&D for this drug, Janssen currently charges the South African government and other Global Drug Facility (GDF) eligible countries around $67 per person per month ($400 for a six-month course) for bedaquiline. For non-GDF countries, Janssen announced a tiered pricing structure whereby countries would be charged $900, $3,000 or $30,000 for a six-month course, depending on the economic status and TB burden of the country. However, researchers from the University of Liverpool have estimated that bedaquiline could be produced and sold profitably for between $8 and $16 per month (between $48 and $96 for six months)—roughly 25% of the price charged to the South African government and others through the GDF and about 0.3% of the price charged in other wealthier parts of the world. The price of bedaquiline becomes even more unsustainable for patients who might require it for 18 to 20 months.
Janssen has attempted to deflect pressure from activists by launching a donation program with USAID for some Global Fund eligible countries; but that programme ended in March 2019, highlighting the unsustainability of such approaches. “Donations are public relations exercises—reliance on donations not only creates dependence on a single supplier but also stifles governments’ willingness to pursue more sustainable pathways such as local production by generic manufacturers,” said Umunyana Rugege from SECTION27. As such activists in India recently demanded that the Indian government stop receiving donations from the company. “Janssen’s discounts and donations may provide it with a much-needed PR boost to divert public attention and scrutiny from their and J&J’s growing list of scandals and lawsuits—from faulty hip implants in India to the irresponsible promotion of opioids in the United States—but they do little to provide people with DR TB with a sustainable, predictable supply of bedaquiline.” As it stands with the donation programme having ended, there is now no clarity on how countries can procure bedaquiline at the current $400 price.
The WHO estimates that there were 558,000 people with drug resistant TB across the world in 2017. In South Africa alone, this is estimated at 14,000 people, a number that appears to be coming down, largely as a result of widespread HIV treatment coverage that means people living with HIV are healthier and less likely to contract TB. However, with many people with TB in the country going undiagnosed even today, this number could be much higher than estimated.
“Overinflated price tags mean many people die without accessing lifesaving treatments. They also force governments to divert scarce health budgets to drug procurement at the expense of broader health spending needs,” said Anele Yawa from the Treatment Action Campaign. “The South African government, unlike many governments, are doing the right thing: Changing national guidelines to recommend bedaquiline for DR-TB treatment and making sure people with DR-TB can access it. However, whilst this is a good thing, the price should be lower so that we have more money for other things like hiring more health workers to find, diagnose and treat people with TB including those currently going undiagnosed, or on improving TB infection control in public spaces, or buying and rolling out diagnostics tests at clinics like the TB LAM test shown to prevent deaths among PLHIV with advanced HIV disease.”
“Janssen must immediately drop the price of bedaquiline to ensure that all people with DR-TB are able to access it, in South Africa and across the world,” said Lotti Rutter from Health GAP. “Further Janssen must stop impeding access through their strategies to control the price and rollout of bedaquiline. Be it through abusive patenting that is extending their patent monopoly beyond the 20 years allowed, or through setting ad hoc prices and discounts as well as rolling out a donation program that allows Janssen to selectively pick who gets what price, and who will live and who will die.”
“We cannot wait any longer whilst Janssen plays its malicious games with our lives. It is time for the government to act. Given how much our governments have invested in the development of bedaquiline, and the people with DR-TB who have made the clinical trial process possible—this is the “people’s drug”,” continued Rutter. “We demand that governments the world over revoke all secondary patents on bedaquiline as well as issue compulsory licenses now to bypass the drug’s patents and ensure access to multiple sources of more affordable generic bedaquiline.”