People with drug-resistant TB could soon have access to critical medication at a far lower cost after Johnson & Johnson’s application to extend a patent was rejected by Indian authorities, and after activists from South Africa and India teamed up to help slash the medicine prices.
The decision will affect other parts of the world as well, as many low-income countries get their drugs from companies in India.
J&J had wanted to extend its patent on bedaquiline, which expires in July, until 2027, which would have prevented cheaper generic versions reaching the market.
Now, bedaquliine will be available at a cost of less than a fifth of its current price.
For the two women who have been fighting to make a drug for the disease affordable to all, it’s a massive victory, writes Amrit Dhillon for Bhekisisa.
Phumeza Tisile from South Africa and Nandita Venkatesan from India filed a petition in 2019 with the Indian Patent Office to stop J&J’s application, a petition supported by medical NGO Médecins Sans Frontières (MSF).
The decision by the patent office opens the door for other companies to produce accessible versions, with some health experts estimating that the costs of treatment could be cut by 80%, from $46 (R832) a month per patient to $8 (R145).
Given that India sends generic drugs to many low-income countries, this breakthrough will help patients in states that obtain their TB drugs through the World Health Organisation (WHO).
Bedaquiline is seen as the last resort for people with advanced TB. Like most treatments for drug-resistant TB, it has unpleasant side effects, but when the FDA approved it in 2012 it was the first new drug for the disease in 40 years.
Pharmaceutical companies in India have started work on generic versions of the drug, with some having already submitted data to the WHO and been pre-qualified to become suppliers. A version is expected to be available as soon as August.
Venkatesan, who lost her hearing in 2013 after treatment for intestinal TB and has had to endure years of painful operations and injections, said she became emotional when the patent office announced its decision last week.
“The verdict is too late for me, my hearing has gone for good. But the fight had to be fought because if something better and easier is available, then why shouldn’t patients have access to it?” said the 33-year-old journalist from Mumbai.
Tisile is a research assistant, a project lead and an advocacy officer at TB Proof, an organisation based in Cape Town, and adviser to the LIGHT global health research programme. She has a degree in social sciences and is also, in her own words a “TB person” – more specifically, an Extremely Drug Resistant (XDR) TB survivor, who has long been advocating for improved diagnosis and treatment of TB.
South Africa has the eighth highest TB incidence globally at a rate of 537 per 100 000 population per year – one of the 16 countries that account for 93% of the global TB burden.
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Leena Menghaney, a global intellectual property adviser at MSF in New Delhi, said: “Bedaquiline was a breakthrough drug for TB and now it’s going to be more easily available.”
J&J’s “evergreening” – continuously extending patent rights – was “unacceptable”, she said. “All the company did was change the compound into a salt to justify an extension.”
India has the highest burden of TB and drug-resistant TB in the world. More than 1 000 of its citizens die of the disease every day.
India’s target is to end TB by 2025, five years earlier than the global deadline of 2030.
Bedaquiline is procured by the Indian Government for its TB programme and is available in most TB clinics in large cities, but not in smaller towns and in rural areas.
“Now, when the price of the generic version comes down, it will be much cheaper for the government to buy, and this will make it more accessible,” said Venkatesan.
She understood the argument made by J&J that the massive cost of developing a new drug has to be recouped through patents. “But their patent lasted 20 years. That’s a good chunk. Why try to extend it? Why not be cognisant of the fact that lives are at stake?”
See more from MedicalBrief archives:
Treatment gaps and poor governance hold back progress in reducing TB
MSF trial finds better, shorter, more effective treatment for MDR-TB
Drug combo for six months successful in treating drug-resistant TB