Daybreak - India’s TB patients can finally celebrate the end of Johnson & Johnson’s monopoly disguised as charity

Episode Date: April 5, 2023

India’s patent office decided to reject pharma giant Johnson &Johnson’s appeal to extend the patent for a life-saving TB medicine called bedaquiline which is used to treat those with drug resistant infections. But for a long time before this, Johnson & Johnson was enjoying a monopoly in India. Generic manufacturers could not make this life-saving medicine. The Indian government too, at the time, had decided to protect the pharma giant.Not just that, Johnson & Johnson was also conveniently projecting itself as a charitable organisation through its health programmes.What does the Indian govt’s decision mean for TB patients in India now?

Hi, this is Rohan Dharma Kumar. If you've heard any of the Ken's podcasts, you've probably heard me, my interruptions, my analogies, and my contrarian takes on most topics. And you might rightly be wondering why am I interrupting this episode too? It's for a special announcement. For the last few months, I and Sita Ramon, Ganesh, my colleague and the Ken's deputy editor, have been working on an ambitious new podcast. It's called Intermission.

We want to tell the secret sauce stories of India's greatest companies. Stories of how they were born, how they fought to survive, how they build their organizations and culture, how they manage to innovate and thrive over decades, and most importantly, how they're poised today. To do that, Sita and I have been reading books, poring over reports, going through financial statements, digging up archives, and talking to dozens of people. And if that wasn't enough, we also decided to throw in video into the mix. Yes, you heard that right. Intermission has also had to find its footing in the world of multi-camera shoots in professional studios, laborious editing, and extensive post-production.

Sita and I are still reeling from the intensity of our first studio recording. Intermission launches on March 23rd. To get an alert as soon as we release our first episode, please follow Intermission on Spotify and Apple Podcasts or subscribe to the Ken's YouTube channel. You can find all of the links at the ken.com slash I am. With that, back to your episode. Around the world, Big Pharma is known for maintaining its monopoly on the rights to produce a range of life-saving drugs.

Their prices are so high that most of these drugs are out of reach for millions of patients. Governments do play a role in protecting their monopolies. All of this has been a topic of debate for a long, long time now. Those who have rallied against Big Pharma's monopoly have a simple but a strong argument. They say that if there is a fatal disease spreading across the world and treatment is available, financial, political and geopolitical interests should not come in the way of patients accessing these life-saving drugs.

Look at HIV, for example. Thanks to increase access to HIV medicines, we've seen a significant reduction in fatalities from the disease over the last few decades. We've come a long way from what the disease was back in the 1980s. It was a killer. Unfortunately, though, as strong as the argument is to make life-saving drugs more accessible, the number of times this argument has managed to sway governments and regulatory authorities is so small that it is disheartening.

Which is why what happened last week in India is sort of a milestone. India's patent office decided to reject pharma giant Johnson and Johnson's appeal to extend the patent of a life-saving TB medicine called bediquillin, which is used to treat those with drug-resistant infections. Now, this is huge. Drug-resistant TB affects more than 1,000 people in India every year. Mumbai, in fact, is considered the world capital of drug-resistant TB. Some of these patients need Johnson & Johnson's patented drug

because there's literally no other treatment option left for them. So Johnson & Johnson was clearly enjoying a monopoly. Not like it went unchallenged though. Six years ago, a teenager moved to Delhi High Court. She had been suffering from an extremely drug-resistant TB for over five years and her weight had shrunk to just 25 kilos, but she was being denied access to the only drug that could save her life. And how did the Indian government respond at the time?

It chose to protect Johnson & Johnson's patent rights and business interests. Not just that, it even helped the company figure out a way to appease patients through charity. Welcome to Daybreak, a business podcast from the Ken. I'm your host, Nick Das Sharma and I Don't Chase the News Cycle. Instead, thrice a week on Monday. Wednesdays and Fridays, I will come to you with one business story that is worth understanding and worth your time. Today is Wednesday, the 5th of April. It was 2016 and the Indian government's TB control program made the Johnson & Johnson drug available, but only in a limited manner. It was

available in just five hospitals across the country. And only patients from the cities where the hospitals were based could get access to these medicines. So this teenager that I told you about, earlier was from Patna. She could not travel to Delhi for treatment, but the domicile rule meant that she could not get the drug anyway. It was an inhumane rule and a rightful demand from a dying patient. But there was something complex holding up this very obviously flawed system. Ruhi Kandahari, a writer at the Ken, has written about this multiple times. In her 2017 article, she blamed a donation-based system for procuring these drugs as the core of the problem. Here's what she wrote, and I'm quoting,

the Belgian drug maker Janssen, a sister company of Johnson and Johnson, has developed the drug which became available in the global market in 2012. In 2014, Jansen made a donation for 600 patients in India, which the Directorate General of Health Services in New Delhi approved for conditional access. It is a drop in the ocean, whereas at least 79,000 patients are estimated to be infected every year and do not have access to bediquillin. A pilot has been going on in five cities, but only patients in these cities could access the drug. Now, a patient may need anywhere between three to four courses of the drug over a span of two years. With the drug not available in private settings, patients end up running from pillar to post.

Despite this, the Indian government at the time decided to stick to the status quo and leave it to Johnson & Johnson to make donations of these life-saving drugs to its health programs. This was of course very convenient for Johnson & Johnson. Basically, it could keep its monopoly by preventing Indian manufacturers from making more affordable generic versions of the medicine. And at the same time, it could also project itself as a charitable organization. And how can anyone criticize a pharma giant that is giving away expensive life-saving drugs for free, right? You know what J.D. Rockefeller, the American industrialist, once said about charity?

He said that charity is injurious unless it helps the recipient to become independent of it. Mark Duboy, the executive director of medical NGO medicine science frontiers in the UK, argued that the Western charity model tends to separate human. humanity from the people affected by the crisis. It reduces the people in the crisis to stereotypes of victimhood devoid of one intensely human trait, which is agency. In other words, although charity in any form is considered well-intentioned in popular culture, those working in the field know there are ways of charity as a system that can reduce the independence and agency of the recipients. So in 2019, Nandita

Venkitation from India and for Mesa Tisley from South Africa filed a petition with the Indian Patent Office to stop Johnson & Johnson's application. Their appeal was backed by the medical NGO medicine sans frontiers. Over the years, as the lack of access to anti-tB drugs has become more critical, it seems that Indian authorities are finally beginning to rethink the charity system. because procuring medicines under the system so far has been excruciatingly slow. Maitri Peracha, who was a reporter at the Ken, had written about it two years ago. She said, and I'm quoting, a slew of RTI replies accessed by the Ken, reveal that procuring these drugs has been a Sisyphian exercise for the Indian government.

Between the order and the delivery of bediquillin, there is a whole year's worth of failed negotiations. consequently, India has been rationing these drugs, carefully tailoring treatment guidelines according to availability with patients forced to suffer the consequences. End quote. So what does the Indian government's recent decision mean for TB patients in India? Stay tuned to find out. The move to refuse Johnson & Johnson an extension of its patent

for this life-saving anti-t TB drug is a welcome respite, especially for the thousands and thousands of patients who may get access to this drug very soon. The decision by the Patent Office opens the doors for other companies to produce accessible versions with some health experts estimating that the cost of the treatment could be cut down by 80% now. And for the two women who've been fighting to bring down Johnson and Johnson's patent protection, it is a bitter sweet story. Nandita Venkitation and Fumesa Tesley, who filed the patent challenges against Johnson and Johnson in 2019, could not get the treatments before the disease did lasting damage to them.

In a press release by the MSF, Venkotation said, and I'm quoting, my fellow TB survivor Fumesa Tesley from South Africa and I filed a patent challenge against Johnson and Johnson in 2019 because we wanted to ensure that the safe, oral and more efficacious drug bedouillin, was available to all the people who needed it and to make sure that no one ever has to endure side effects like we did, such as permanent hearing laws due to toxic injected drugs. End quote. As for Johnson and Johnson, their reign of charity is over in India.

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