MSF demands J&J give up its patent monopoly on TB drug to put lives over profits
Access to TB drug bedaquiline, a backbone medicine for drug-resistant TB treatment regimens, remains out of reach for too many
Access to affordable generic versions of bedaquiline is presently being blocked by Johnson & Johnson (J&J)’s secondary patents in at least 25 of the 43 countries with a high burden of Tuberculosis (TB) or drug-resistant TB (DR-TB). With more effective and patient-friendly treatment regimens available for people with DR-TB, there is a need, now more than ever, to accelerate access to affordable treatment and save more lives.Ahead of J&J’s annual shareholders meeting, the international medical humanitarian organisation Doctors Without Borders (MSF) demands that the US corporation publicly commit now to not enforce its secondary patents on the TB drug bedaquiline in all countries with a high burden of TB, and allow generic manufacturers to supply more affordable, quality-assured generic versions of this lifesaving drug to everyone, everywhere who needs it.
“Back when HIV treatment was first rolled out, competition among generic producers helped lower drug prices and accelerated treatment rollout in many countries. We are deeply concerned that the persistent high price of bedaquiline will continue to block countries from rolling out the newer, shorter, game-changing, all-oral regimens for treating deadly, drug-resistant forms of TB. It is high time that J&J act responsibly by pledging not to enforce secondary patents for bedaquiline, withdrawing all related patent applications, and not pursuing any action against generic manufacturers who could export affordable versions of the drug to high-TB-burden countries where secondary patents remain,” says Christophe Perrin, TB Pharmacist with MSF’s Access Campaign.
Bedaquiline is the backbone of almost all treatment combinations newly recommended by the World Health Organisation (WHO) for DR-TB, but currently accounts for 35-40% of the price of shorter, and 35-70% of longer, regimens.
It is the main cost driver in the WHO-recommended, 6-month, all-oral BPaLM regimen (comprised of bedaquiline, pretomanid, linezolid and moxifloxacin), with bedaquiline accounting for US$272 (R5 004,56) out of the total $570 (R 10 487,49) price for the treatment combination. J&J currently prices the drug at $1.50 (R27,59) day for an adult treatment, $272 (R5 003,68) /six months. But with scale-up and generic competition, the price of bedaquiline would be expected to drop, bringing it closer to its target price of $0.50 (R9,19) per day as estimated by researchers.
“The introduction of the new 6-month BPaLM regimen in Sierra Leone has been a ground-breaking milestone,” says Dr Manisha Kumar, MSF Medical Coordinator in Sierra Leone. “Being the first country to routinely offer this shorter and more effective drug-resistant TB treatment outside the setting of a clinical trial is revolutionary, especially considering that many people here struggle to access care due to distance, bad roads and high transportation costs. Adherence to longer treatment regimens and stigma also continue to pose significant challenges. With the lower pill burden and shorter duration of BPaLM, more people with drug-resistant TB can be cured faster and with less suffering.”
TB was the leading infectious disease killer until the COVID pandemic. The number of people newly diagnosed with TB including DR-TB, in 2020 fell by 18% from the previous year due to disruptions to health systems and services caused by the pandemic, with only a partial recovery in 2021. In 2021, only one in three people with DR-TB received treatment for the disease.
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About Doctors Without Borders (MSF)
Doctors Without Borders (MSF) is a global network of principled medical and other professionals who specialise in medical humanitarian work, driven by our common humanity and guided by medical ethics. We strive to bring emergency medical care to people caught in conflicts, crises, and disasters in more than 70 countries worldwide.
In South Africa, the organisation is recognised as one of the pioneers of providing Antiretroviral Treatment (ART) in the public sector and started the first HIV programmes in South Africa in 1999. Until today, the focus of MSF’s interventions in the country has primarily been on developing new testing and treatment strategies for HIV/AIDS and TB in Eshowe (Kwa-Zulu Natal) and Khayelitsha (Western Cape).
In Tshwane, we run a migration project, and we offer medical and psychosocial care to migrants, refugees, and asylum seekers, who struggle to access public health services under South Africa’s increasingly restrictive.
Previously we offered free, high-quality, confidential medical care to survivors of SGBV in Rustenburg.
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Matluba Ahmedoba, 34, at the Kara-Suu hospital, Kyrgyzstan. Her tuberculosis (TB) had developed to an extensively drug-resistant tuberculosis form. She is waiting for approval to start a newly released Bedaquiline treatment. Photographer: MSF. Date: 28/02/2018. Location: Kyrgyzstan