Published on: February 1, 2025

SMA Patients and Experts Refute Government Affidavit in Kerala Court, Demand Urgent Action on Treatment Costs

The recent affidavit filed by the Central Government in the Kerala High Court regarding the treatment of Spinal Muscular Atrophy (SMA) has drawn sharp criticism from patients, experts, and advocacy groups. The government, while acknowledging the exorbitant cost of SMA therapies (ranging from ₹50 lakh to ₹8 crore per patient annually), has suggested relying on crowdfunding and state-level interventions, effectively abdicating its constitutional responsibility to ensure accessible healthcare for all citizens.

The affidavit states that the estimated annual expenditure for treating all SMA patients in India could range between ₹6,400 crore and ₹34,000 crore, deeming it an unmanageable financial burden. This stance, however, disregards the potential for significantly reducing treatment costs. Research by Melissa Barber, an expert affiliated with Yale University, indicates that generic Risdiplam could be produced in India for as little as ₹3,000 per year.

Saifullah Khalidi, an SMA patient, emphasized the need for the government to explore avenues for reducing treatment costs. “Instead of shifting the burden on patients and their families, the Ministry of Health needs to look for ways and means to reduce the cost of Risdiplam,” he stated. He highlighted the potential for generic production as a viable and cost-effective solution.

The affidavit also erroneously claims that Risdiplam may not be efficacious in all adult patients. Chetali Rao, a legal and pharma expert working on rare diseases, countered this assertion, stating that “SMA impacts individuals differently, but it is universally marked by progressive muscle weakness and loss of function. Data from trials for Risdiplam reinforce long-term efficacy and safety profile in some of the most severely affected people with SMA type 2 and 3, including patients with advanced disease.”

SMA activist Poorva Mittal emphasized the government’s moral and constitutional obligations. “While the high prices of SMA treatment/medicines is a fact, it does not absolve the responsibility of the government from its moral and constitutional obligations. The government is empowered with effective law and policy tools and therefore should facilitate the availability of Risdiplam at an affordable price using those tools. Section 100 of the Indian Patents Act empowers the government to issue a government-use license to facilitate affordable generic production. It is also a well-known fact that Indian companies possess the ability to produce the generic version of Risdiplam,” she stated.

The Working Group on Access to Medicines and Treatments strongly urges the Ministry of Health and Family Welfare to reconsider its position stated in the affidavit and take immediate action to ensure affordable access to life-saving SMA treatments for all patients in need.

For further clarifications, kindly contact:

Dr. Grageya Telakapalli at +91 99489 71353 Working Group on Access to Medicines and Treatment