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Indian Express
a day ago
- Health
- Indian Express
High costs of life-saving drugs leave patients of rare diseases in the lurch: Will their crusade for Indian variants win?
For Seba P A, 26, from Kerala, the cost of breathing easy, moving around and enduring fewer bouts of infection comes at a steep price — nearly Rs 18 lakh per month. For long, she had managed with the Rs 50 lakh government grant under the national policy of rare diseases, one of which — Spinal Muscular Atrophy — she is battling. Now she is on a crusade to make life-saving drugs, currently under patents, affordable for persons suffering from rare diseases. Suffering from Spinal Muscular Atrophy (SMA), a rare disease that progressively affects muscle functions, her condition can be managed with Risdiplam. Developed by Swiss pharma giant Roche, one bottle of Risdiplam costs around Rs 6 lakh in India — something her taxi driver father cannot afford. In a bid to make the life-altering medicine affordable for SMA patients like herself, Seba had in December 2023 filed a petition in the Kerala High Court urging the government to invoke the compulsory licensing clause under Section 84 of the Indian Patents Act, 1970. This allows the Indian government to grant someone other than the patent holder the right to make the medicine if a product or process is nationally unavailable or overpriced. Roche holds the patent for Risdiplam till May 2035. Her case is now being heard in the Supreme Court. 'If other companies start manufacturing the drug, the prices are likely to plummet,' says Seba. Like her, patients suffering from rare diseases, who need life-long therapy, have been urging the government to invoke the compulsory licensing clause. WHY PATIENTS OF RARE DISEASES RAN OUT OF OPTIONS Two years ago, Seba's family had applied for financial aid under the Centre's National Policy for Rare Diseases, 2021, which had identified 1,000 patients, including Seba, for a one-time financial assistance of Rs 50 lakh each. 'When I was taking Risdiplam, my health was stable. I was able to speak and sing. However, the funds got exhausted in mid-February. Since then, I have already had two bouts of infections and have been confined to bed,' Seba, who loves singing and painting, tells The Indian Express. Though she is back on Risdiplam, being provided by Roche free of cost for a year while the case is on, it continues to be out of reach to other SMA patients. The mother of a 14-year-old boy from Bengaluru has been struggling to obtain medicine to treat his cystic fibrosis (CF), a genetic condition that affects cells that produce mucus, sweat and digestive juices, making them thick and sticky, clogging up lungs and the digestive system. In 2019, Trikafta, a three-drug combination sold by US-based Vertex, was approved by the US Food and Drug Administration (FDA) for CF treatment. 'Importing a three-month supply costs Rs 70 lakh. An Argentina company manufactures a slightly cheaper version that costs around Rs 21 lakh for a three-month supply,' she says. She is one of the petitioners urging the government to grant a compulsory license for the medicine. In an attempt to get the medicine from Argentina, the mother scours Facebook for Indians living there and requests them to get the medicine when they come home. 'I split the tablets to make them last at least six months. If Indian companies are given compulsory licences, I might be able to afford medicines for my son,' she says. WHAT'S THE STATUS OF COMPULSORY LICENSING CLAUSE? Despite the exorbitant cost of drugs used to manage rare diseases, India's compulsory licensing clause has been used just once in 20 years. 'Only one private company got a compulsory license once,' says Anand Grover, a senior lawyer who works on such patent cases, referring to the New Delhi-based Natco Pharma, which secured the permit to manufacture Nexavar, a cancer drug made by German multinational Bayer, in 2012. Since then, three Indian companies have unsuccessfully applied for compulsory licences — BDR Pharmaceuticals for Dasatinib (for leukemia), Lee Pharma for Sitagliptin (for diabetes), and Emcure Pharmaceuticals for Trastuzumab (for breast cancer), says Sneha Sharma, a partner at Sujata Chaudhri IP Attorneys. ROCHE VS NATCO In 2024, Roche Pharmaceuticals had filed a petition to get an injunction, claiming that Natco Pharmaceutical was in the process of launching a generic version of Risdiplam. Though its injunction was denied by the Delhi High Court in March 2025, the Swiss drug-maker has filed an appeal. The Division Bench has heard the arguments in the case and is now awaiting written statements from both parties. Meanwhile, Natco announced that if it is allowed to manufacture and market the generic version of Risdiplam, it will sell it for just Rs 15,900 per bottle (against Roche's Rs 6 lakh per bottle). Though Roche's assistance programme provides five bottles at the cost of two, patients still end up spending nearly Rs 30 lakh annually. A generic version of Risdiplam would mean that the government's Rs 50-lakh aid will last almost nine years instead of just a few months for SMA patients. Risdiplam is sold for around $500 (around Rs 42,000) per bottle in China and Pakistan. 'Risdiplam costs less in China and Pakistan where prices were negotiated with the company. Since that did not happen in India, a simple solution would be to issue a compulsory license to Natco,' says Grover. He also challenged the narrative put forth by the Swiss drug-maker, which said that a drug's exorbitant prices were meant to cover the 'high costs' of research and development (R & D). In its suit against Natco, Roche had said that it takes a company nearly 10-15 years and an estimated $2.6 billion (nearly Rs 260 crore) to bring a successful drug to the market. The company had claimed that only one in nearly 5,000 or 10,000 drugs in the research pipeline and around 12% of those in clinical trials get approved. 'Many drugs are, in fact, developed by smaller companies that are acquired by bigger ones and taken to clinical trials. Big companies often hold these patents despite not bearing initial costs of developing several candidate drugs. The figures these companies have been giving out for years are an exaggeration. Which is why we ask for actual costs the companies incur on drug R & D,' says Grover. He says studies have shown that the cost of developing Risdiplam would, at most, be $150 million, a figure that has not yet been contested by the company. HOW PHARMA MAJORS PROLONG PATENT CONTROL Pharma giants find loopholes to prolong their control over a drug. When it comes to Trikafta, the CF drug, Vertex Pharmaceuticals already holds the patent for two of these medicines in India while an application for the third is in process. 'In a blatant abuse of its monopoly, Vertex has filed and obtained multiple patents in India, thus having monopoly rights on various CFTR modulators (a class of medications designed for individuals with CF). But it has not bothered to register the medicine in India,' states a 2024 petition by CF patients in the Karnataka High Court. Sharma says a compulsory licence may also be issued if a patent holder has not worked the patent in over three years. PATENTING PHARMACEUTICALS IN INDIA When the country's new patent law was brought out in the 1970s, the government created a very important provision — it allowed for only process patenting when it came to pharmaceuticals. 'After the British left, drugs in India were very costly. A committee set up by (then PM) Mrs (Indira) Gandhi recommended dropping product patenting for pharmaceuticals. If a product is patented, you cannot do anything. But if a process is patented, you can legally make a similar drug using another process. That is what was done under the new Patent Act that came into force in 1972,' says Grover. This decision was key to the generic manufacturing of pharmaceuticals in India, earning the country the moniker of the 'pharmacy of the world.' Meanwhile, the US, which wanted to create a monopoly for itself, forced the world to accept the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement, which came into effect on January 1, 1995. While countries like Brazil, Mexico and India initially formed a block against TRIPS, threats of sanctions forced them to toe the line. India was given time till 2005 to implement provisions similar to the ones in the US — ensuring product patents and extending patent period from seven to 20 years, explains Grover. In fact, India's Patent Act, which allowed only the process to be patented, became the reason why Indian drug-maker Cipla could establish itself as the 'Robin Hood' of pharmaceuticals. In 2001, the company started selling a cocktail of antiretrovirals (medicines used to manage HIV) for less than $1 a day, driving down the prices of the medication across the world. Grover says, '(Despite TRIPS), we still tried to maintain some provisions that would help our people. Our law does not allow extending patents simply by changing the medicine's form or replacing some salts (a process called ever-greening of patents) unless there is a significant change in its efficacy. Our law also allows for both pre and post-grant opposition.' Anonna Dutt is a Principal Correspondent who writes primarily on health at the Indian Express. She reports on myriad topics ranging from the growing burden of non-communicable diseases such as diabetes and hypertension to the problems with pervasive infectious conditions. She reported on the government's management of the Covid-19 pandemic and closely followed the vaccination programme. Her stories have resulted in the city government investing in high-end tests for the poor and acknowledging errors in their official reports. Dutt also takes a keen interest in the country's space programme and has written on key missions like Chandrayaan 2 and 3, Aditya L1, and Gaganyaan. She was among the first batch of eleven media fellows with RBM Partnership to End Malaria. She was also selected to participate in the short-term programme on early childhood reporting at Columbia University's Dart Centre. Dutt has a Bachelor's Degree from the Symbiosis Institute of Media and Communication, Pune and a PG Diploma from the Asian College of Journalism, Chennai. She started her reporting career with the Hindustan Times. When not at work, she tries to appease the Duolingo owl with her French skills and sometimes takes to the dance floor. ... Read More
ABC News
02-05-2025
- Politics
- ABC News
Voting with a disability can be a challenge, even in a country like Australia
When I go to vote, my priority is to find a location with wheelchair access. Voting is a democratic right for all Australians, but for some people with disabilities, it can be an uncomfortable and sometimes distressing experience. I have a physical disability called Spinal Muscular Atrophy and I use a power wheelchair to get around. Eleanor says casting a vote with a disability can be an anxiety-inducing experience for some. ( ABC News: Rosemary Murphy ) Unfortunately, the only early polling location is 50 kilometres away from where I live in regional WA, and it's not listed as wheelchair accessible. Although there were accessible booths inside, the street parking did not have access for wheelchairs to safely cross the road and there weren't ramps. Navigating through the crowd outside is always a challenge but moving through the crowds on the inside is even harder. Eleanor being handed how-to-vote cards while approaching the polling place in Albany. ( ABC Great Southern: Rosemary Murphy ) My power wheelchair is below people's eye level and pushing through is always stressful. As I can't write for myself, I bring a carer and tell them what to put on the ballot paper for me. Eleanor requires a carer to fill out her ballot paper. ( ABC News: Rosemary Murphy ) It is always noisy inside and it can be difficult for my carer to hear what I'm saying when I'm asking them to write down my voting preferences, because I have to whisper so other people don't hear my choices. Election essentials: Find out where your For me, it's obvious I need that extra help. In some ways, it can be easier to have a disability as visible as mine when it comes to voting because there are no questions about the accommodations I need. That process isn't so easy for voters with invisible disabilities, and it's made even more difficult if they are not confident to advocate for themselves. Eleanor Beidatsch detailed her experience voting in Albany this week. ( ABC News: Rosemary Murphy ) For 20-year-old Gabe, who has anxiety and situational mutism, voting for the first time was an overwhelming experience. "Being there was anxiety-inducing for me, I hyper-focused on getting it over with so I could leave," he said. "The most difficult aspect of voting was the social interaction and navigation. "Having severe anxiety to a point I can't talk meant even basic interactions, like telling my name, was difficult and I needed to have someone with me to speak for me. "Then having no direct path of where to go once you've finished at the booth made it a little confusing." Many people affected More than 21 per cent of Australians have some type of disability, or around 5.5 million people, according to the 2022 ABS survey. Read more about the federal election: Want even more? Here's where you can find all our 2025 Catch the latest interviews and in-depth coverage on Not every eligible voter with a disability needs assistance to cast their ballot, but there are still plenty of people who can benefit from accessible polling places. Accessible polling places can make voting easier for those with a disability. ( ABC News: Rosemary Murphy ) A spokesperson from the AEC said it had increased the number of accessible polling places for the 2025 federal election by 20 per cent. "We're constantly listening to feedback from voters and working to improve our offering at subsequent elections," they said. "For 2025, the increase of 20 per cent for fully accessible polling places is something we're very proud to be able to offer. "But we know that every voter is unique, and the widespread nature of Australian federal elections unfortunately means that our most convenient offering suit the requirements of [only] some voters." 'Archaic' laws need to change Meanwhile, 75 organisations and disability advocates have signed an open letter to Prime Minister Anthony Albanese and Opposition Leader Peter Dutton, calling for changes to laws they say disproportionately prevent people with disability from voting. A cross section of the organisations that signed the open letter. ( ABC News: Gian De Poloni ) Two sections of the Commonwealth Electoral Act say anyone "by reason of cognitive impairment, is incapable of understanding the nature and significance of enrolment and voting" should be stripped from the electoral roll. Those removed need to provide medical evidence they are "capable of understanding" to be reinstated. The groups say these provisions are "archaic and offensive" and inconsistent with the UN Convention on the Rights of Persons with Disabilities. This polling place in Albany has seen a steady stream of early voters. ( ABC News: Rosemary Murphy ) More than 28,000 people were removed from the roll between 2008 and 2012 due to these provisions, according to a Australian Law Reform Commission report, which also recommended they be repealed. "It is extremely disappointing that despite significant advocacy … discriminatory laws are still in place," Down Syndrome Australia CEO Darryl Steff said. The postal vote option Postal voting has always been an option for anyone who can't vote in person or doesn't want to. I don't usually bother with postal voting because I believe that people with disabilities should be seen in public. I live in a regional area, and I can't go to the post office on my own to post my vote. Postal voting is also difficult for Eleanor because she can't write on paper herself. ( Supplied: Australian Electoral Commission via Twitter ) I also can't write on paper for myself anyway, so it makes no difference if I am in a polling booth telling my carer what to write or doing it at home. Whether you choose to vote in person or by post, voting is a human right and people with disabilities should have the same opportunity to choose our preferences based on what we want, not what is more convenient. Additional reporting by National Digital and Disability Affairs Producer Evan Young. Loading
