Supreme Court Questions Roche on High Pricing of SMA Drug Risdiplam in India
Key Insights
The Supreme Court of India has issued a notice to F. Hoffmann-La Roche Ltd regarding the pricing of Risdiplam, a medication for Spinal Muscular Atrophy (search) (SMA (search)), questioning why it's more expensive in India than neighboring countries.
The case involves a 24-year-old woman with SMA (search) who challenged the high cost of treatment, with her counsel arguing that government intervention in Pakistan and China has made the same medication more affordable in those countries.
The Court has requested information on Risdiplam pricing in neighboring countries and whether the drug manufacturer would consider supplying it at lower rates in India, with the next hearing scheduled for April 8.
A bench of the Supreme Court of India led by Chief Justice Sanjiv Khanna has questioned Swiss pharmaceutical giant F. Hoffmann-La Roche Ltd about the possibility of making Risdiplam, a critical medication for Spinal Muscular Atrophy (search) (SMA (search)), available at lower prices in India.
The court issued a notice to the drug manufacturer after hearing arguments in a case involving a 24-year-old woman suffering from SMA (search), a rare genetic disorder that affects motor neurons and causes muscle wasting and weakness.
Court Seeks Pricing Transparency Across Borders
The Supreme Court bench, which also includes Justices Sanjay Kumar and KV Viswanathan, has specifically requested information on Risdiplam pricing in neighboring countries. The court ordered: "This Court shall be informed, on the next date of hearing, the price fixed for the aforesaid drug in neighbouring countries. If the price is lower than in India, the Court shall also be informed as to whether the drug can be supplied at the same lower price in India also."
Senior advocate Anand Grover, representing the patient identified as Seba, informed the court that the medication is available at significantly lower prices in Pakistan and China due to government intervention in those countries. He questioned why the Indian government couldn't similarly negotiate with the global drug manufacturer to make the treatment more affordable.
The Financial Burden of Rare Disease Treatment
The case highlights the substantial financial burden faced by patients with rare diseases in India. The current dispute stems from a Kerala High Court order that directed the Central government to provide medicines worth ₹18 lakh to Seba, exceeding the ₹50 lakh cap that such patients are entitled to under existing government schemes.
The Centre challenged this ruling in the Supreme Court, which stayed the High Court's order on February 24 while encouraging both parties to explore alternative solutions. The court suggested that the patient seek financial aid from other sources while also allowing her to contact the drug manufacturer directly to request concessional pricing.
The Broader Impact on SMA Patients
SMA (search) is classified as a Group III rare disease in India. Risdiplam, marketed under the brand name Evrysdi, is one of the few approved treatments for this condition. The medication works by increasing the production of the survival motor neuron (search) (SMN) protein, which is essential for the survival of motor neurons.
The court acknowledged the wider implications of this case, noting that "several patients are suffering in India with the disorder." A more affordable pricing structure for Risdiplam could potentially benefit numerous SMA (search) patients across the country who currently struggle to access this life-changing treatment due to its prohibitive cost.
Next Steps in the Legal Process
The Supreme Court has scheduled the next hearing for April 8, with its interim order of February 24 remaining in effect until then. The court has explicitly invited F. Hoffmann-La Roche Ltd to respond to the concerns raised about differential pricing across countries.
This case represents a significant development in the ongoing global debate about pharmaceutical pricing, particularly for treatments targeting rare diseases. The court's approach suggests a potential shift toward greater scrutiny of international pricing disparities and increased pressure on pharmaceutical companies to justify their pricing strategies in developing markets like India.