Supreme Court order risks interrupting treatment for young woman with Spinal Muscular Atrophy

On Rare Diseases Day, experts and patients have expressed deep concerns over the recent developments in the Supreme Court regarding the treatment of Spinal Muscular Atrophy (SMA). The ongoing legal cases have significant implications for SMA patients’ access to treatment, with the most recent order leading to the interruption of treatment for Seba, a young woman from Ernakulam, Kerala, who is battling SMA.

Patients and their families are urgently calling for action to ensure that the benefits of scientific progress, including life-saving medications for rare diseases, become accessible to all who need them. The need for affordable life-saving drugs for rare diseases has never been more critical.

Since early 2021, the High Courts have been addressing petitions related to SMA, calling for local production and generic competition to address challenges like the high cost of medications caused by patent monopolies. Effective therapies, such as risdiplam, have proven to be lifesaving, but remain out of reach for many due to their prohibitive cost. Despite the availability of funding under the National Policy for Rare Diseases, the high price of risdiplam – priced at Rs 6.2 lakh per bottle by Roche – continues to limit access. For patients weighing under 20 kg, one bottle is required each month, and those above 20 kg may need up to three bottles per month, making the treatment unaffordable.

Following a special leave petition filed by the Union of India, the Supreme Court on February 24, 2025, stayed the Kerala High Court Division Bench’s order that had previously directed the government to provide the medication as an interim measure due to Seba’s critical condition and also directed the Single Judge to address the issues raised in Seba’s writ petition. In her writ petition, Seba has called for the continuation of her treatment with risdiplam beyond the Rs 50 lakh cap under the National Rare Disease Policy, emphasising that the drug’s exorbitant cost demands a sustainable solution, including compulsory licensing for low-cost generic supply.

This decision has effectively halted the provision of the drug to Seba till the SLP is heard by the Supreme Court.

Seba, an author and SMA patient voiced her disappointment, emphasising that many deaths from SMA could be prevented if the government fulfilled its constitutional duty to ensure access to life-saving treatment. “I will not give up and will continue to challenge the stay that has blocked my access, along with hundreds of other SMA patients, from receiving treatment that prevents hospitalisation and extends our lives. We cannot allow this moratorium on compulsory licenses at the expense of our lives to continue in India,” she said.

The Supreme Court’s order has raised alarms among patient advocacy groups and healthcare experts, who warn that Seba faces discontinuation of her treatment and continued delays by the Indian government in securing generic production and supply of rare disease medications at a fraction of the cost of patented medicines are in direct conflict with health safeguards enshrined in national laws and international trade rules. These delays are putting the lives of those suffering from SMA in further danger.

‘I also live with SMA,’ said Saifullah Khalidi, an SMA patient. ‘My journey with this condition has been a daily struggle—one where I watch my body weaken little by little. Each day, I have to rely on others for the simplest tasks, from getting dressed to moving from one place to another. My condition is progressive, and without intervention, it will only continue to worsen. For patients like me, a treatment finally exists. At nearly Rs6 lakhs per bottle, or around ₹70 lakh annually, Risdiplam remains entirely out of reach for most people with SMA. My friend Seba deserves a chance, just like I do, just like so many of us do. Life-saving medicine shouldn’t be out of reach—it’s not a privilege; it’s a basic right. I’m calling on the government to step up, do what’s right, and make these medicines affordable. No one should have to fight this hard just to stay alive or live a life of dignity.’

SMA patients, their families, and advocates are urging the government to take immediate action to address the growing crisis and ensure that all those in need have access to the treatments that could save their lives.