New Delhi/Geneva, 20 April 2021 – Next week the Indian government is expected to decide whether it is willing to override patents on two critical tuberculosis (TB) drugs following a court petition filed at the Mumbai High Court by two survivors of TB and activists. If the government is willing to issue the ‘compulsory licenses,’ it would increase access to the newer TB drugs bedaquiline and delamanid for people with multidrug-resistant (MDR) and extensively drug-resistant (XDR) TB in India. The international medical humanitarian organisation Médecins Sans Frontières/Doctors Without Borders (MSF) supports the court petition and urges the Indian government to take this critical step that would allow price-lowering competition among generic manufacturers for drug-resistant (DR) TB medicines in India.
XDR-TB survivor Meera Yadav and TB survivor Brinelle D’Souza, on behalf of the Mumbai chapter of the civil society network Jan Swasthya Abhiyan (JSA), filed the petition in March at the Mumbai High Court. If operationalised, a compulsory license would allow alternative producers to manufacture bedaquiline and delamanid in India, leading to more supply and lower prices of these drugs for the country’s public health system. The present Patents Act in India allows such licenses, but the country has only ever issued one compulsory license so far, for a cancer drug in 2012.
Bedaquiline and delamanid are part of World Health Organization (WHO) recommended all-oral treatment regimens for DR-TB that are safer, more effective, and easier to take than older, more toxic drugs, including injectable medicines that can cause intolerable side effects, such as deafness and psychosis.
“When I was diagnosed with XDR-TB in 2013, I began an extremely painful journey of being treated with medicines with terrible side effects that did not help me and ultimately I lost one of my lungs,” said Meera Yadav, XDR-TB survivor in Mumbai, India and co-petitioner. “After several years, I was able to access the newer TB drugs that saved my life and was finally given a ray of hope. I don’t want anyone else to have to go through this agonising experience – anyone with tuberculosis should have access to these lifesaving medicines immediately.”
Both bedaquiline and delamanid are patented in India until 2023, resulting in major hurdles for people’s access through the public health system. The monopolies on these drugs mean that the originator pharmaceutical corporations, Johnson & Johnson (J&J) and Otsuka, have the sole right to supply India’s national TB programme with bedaquiline and delamanid, respectively. J&J, however, did not participate in the procurement process, which has left the national TB programme scrambling to procure bedaquiline through the Global Drug Facility, an organisation run by the Stop TB Partnership that supplies TB drugs to low- and middle-income countries. India has also relied heavily on donations to access bedaquiline and delamanid but the donations have been small, intermittent and unsustainable and come nowhere close to responding to this national health emergency.
Today, according to WHO and India’s new national TB guidelines, nearly all people with DR-TB are eligible for all-oral treatment regimens. The government will have to scale up access to these newer drugs to provide them to more than 50,000 people with DR-TB who access the drugs through the national TB programme every year in India.
“There is simply not enough bedaquiline and delamanid available in India today to meet the large public health need because patents on these drugs are preventing alternative suppliers from producing lower cost generic versions,” said Brinelle D’Souza, Co-convenor of the Mumbai Chapter of JSA. “India is forced to rely on single suppliers who do not participate in the procurement process and can charge monopoly prices to access these lifesaving medicines. This has led to care providers rationing or even not prescribing the drugs out of fear of running out of supplies. For states like Maharashtra with particularly high TB burdens, including in Mumbai where I’m from, this is particularly devastating. Bedaquiline and delamanid must urgently be made available to everyone who needs them, which can only be done by issuing a compulsory license so that generic manufacturers can make the drugs.”
Voluntary measures that rely on the companies’ willingness to address public health needs have failed in the past. Several Indian generic manufacturers have the capacity and technology to manufacture bedaquiline, but J&J has refused to offer a license to manufacturers to produce the drug. Efforts to procure bedaquiline failed as of 2020 when J&J was unwilling to reduce the price for India’s national TB programme. On the other hand, Otsuka entered into a secret agreement with US pharmaceutical corporation Mylan to supply India, but it has failed to bring down the prices of delamanid.
“We cannot emphasise enough just how urgent it is for India to have greater access to these newer tuberculosis treatments,” said Dr Márcio da Fonseca, Infectious Disease Advisor at MSF's Access Campaign. “A continuous, sustainable and affordable supply of these medicines is critical to save as many lives as possible. As a doctor, I feel powerless when safe and effective drugs exist but our medicine cabinet is empty. If alternative manufacturers are able to produce in India, it would bring hope for people both within and outside the country.”
J&J and Otsuka charge India about US$350 and about $1,200 for a six-month treatment course of bedaquiline and delamanid respectively. According to MSF’s experience, some people with DR-TB may require both of the newer drugs for the entire duration of their treatment, and not only the first six months, therefore increasing the cost even further.
“As long as the patents on these newer TB drugs are in place, other suppliers are excluded from producing and making lower cost generic versions of the drugs – that's why we’re urging India to issue a compulsory license,” said D’Souza.
TB is one of the world's deadliest infectious diseases, and DR-TB is a global health emergency. The WHO has estimated that only 1 in 3 people with DR-TB is started on treatment, and those treated have faced exceedingly poor treatment success rates of 56% for MDR-TB and 39% for XDR-TB, as of 2018.
In 2019, nearly half a million people globally developed rifampicin-resistant TB (RR-TB), of which 78% had MDR-TB. India (27%), China (14%) and the Russian Federation (8%) were the countries with the largest share of the global DR-TB burden. India had an estimated 124,000 DR-TB cases in 2019. The country declared TB a national emergency in 2014.
In 2019, only 2.6% of people (1,738 people/66,255 people) notified by the India’s national TB programme to have MDR/RR-TB were put on an all-oral treatment regimen. Between January 2016 and May 2020, 11,427 people with MDR-TB and 1,481 people with XDR-TB died in India. These figures could be even higher given that some TB-related deaths may go unrecorded.
Jan Swasthya Abhiyan (JSA) is a network of organisations and individuals collectively working on health issues and is part of the People’s Health Movement. The Mumbai Chapter of JSA has been working towards realising the right to health and healthcare as basic human rights for all the people residing in the Mumbai Metropolitan Region.
Meera Yadav is an XDR TB survivor. Meera was diagnosed with TB in 2013 and had to undergo treatment with older drugs, including injectables with limited efficacy and faced not only impaired hearing but also repeated treatment failure. She even had to surgically remove one of her lungs as it had collapsed due to TB. After several years of struggle, she was cured after being prescribed a regimen containing both the new drugs – bedaquiline and delamanid. Meera now leads a healthy life in Mumbai and advocates for better access to TB care and treatment.