b eqbal

Prioritizing Public Health Over Patent Rights: Spinal Muscular Atrophy Treatment Crisis

Dr. B.Ekbal

The ongoing debate in India over access to treatment for Spinal Muscular Atrophy (SMA) highlights a fundamental conflict between public health imperatives and intellectual property rights. SMA is a rare autosomal recessive genetic neuromuscular disorder caused by mutations in the SMN1and SMN2 (Survival Motor Neuron 1, 2) gene, leading to insufficient production of SMN (Survival Motor Neuron) protein, essential for the maintenance of motor neurons. Degeneration of motor neurons results in progressive muscle weakness, respiratory failure, and, in severe cases, early death. In India, SMA is among the leading genetic causes of infant mortality, underscoring the urgency of ensuring equitable access to treatment.

The Cost Barrier: A Matter of Life and Death

Recent breakthroughs have made disease-modifying treatments for SMA available. However, their exorbitant costs render them inaccessible to most patients. Zolgensma, developed by Novartis Gene Therapies, is a one-time gene therapy costing approximately ₹18 crore. Risdiplam, marketed by Roche as Evrysdi, is an oral therapy requiring lifelong administration, priced at ₹6.2 lakh per bottle, amounting to about ₹1.8 crore annually for a 20 kg patient. 

These prohibitive costs deny patients their constitutional right to life and health under Article 21 of the Indian Constitution and drive families into financial ruin. The National Policy for Treatment of Rare Diseases (NPTRD) 2021 provides financial support up to ₹50 lakh, covering only a fraction of SMA treatment costs. Kerala Health Department’s  United against Rare Diseases (KARE) program, and crowdfunding campaigns are attempting  to bridge the gap. However, such efforts are not sufficient to address a systemic problem rooted in patent-protected monopolistic pricing.

Legal Interventions: The Case for Compulsory Licensing

India’s Patents Act contains robust provisions to protect public health, notably Section 84, which empowers the Patent Controller to grant compulsory licenses in cases of unreasonable pricing or non-availability of essential medicines. India has successfully utilized this mechanism before. In 2013, a compulsory license was granted to Natco Pharma to produce Sorafenib Tosylate (marketed by Bayer as Nexavar), a cancer drug priced at ₹2.8 lakh per month. Natco’s generic version brought the cost down to ₹6,000 per month, setting a global precedent for using public health safeguards in TRIPS-compliant patent law.

The Roche vs. Natco Pharma Battle: A Turning Point?

Building on this legacy, Natco Pharma sought to manufacture a generic version of Risdiplam, offering to sell it at ₹15,900 per bottle, a 90% reduction from Roche’s price. In response, Roche filed a patent infringement suit in the Delhi High Court, claiming exclusive rights under its patent. Natco countered that Roche’s pricing was excessive and exploitative, violating public interest, and that denying affordable treatment to SMA patients amounted to infringement of the fundamental right to life. On March 24, 2024, the Delhi High Court (single bench) dismissed Roche’s petition, emphasizing that public health considerations override patent monopolies when essential medicines are priced out of reach. The court observed that monetary compensation to the patent holder cannot substitute for the loss of human life due to lack of treatment. However, Roche has since appealed to a division bench, stalling Natco’s ability to supply the generic drug. This episode underscores how prolonged litigation can be weaponized by multinational corporations to maintain market exclusivity at the expense of human lives.

The Ethical and Policy Imperative

The SMA crisis illustrates a broader ethical dilemma in pharmaceutical patenting: Should profit-driven intellectual property regimes take precedence over human survival? The SMA context presents a, moral obligation. The central government must proactively invoke compulsory licensing for Risdiplam and similar high-cost therapies. State governments, patient advocacy groups, and public health professionals should collectively push for legislative and executive action to ensure affordable, uninterrupted access to life-saving SMA therapies, prioritization of public health over patent monopolies, and a sustainable framework for rare disease management in India.

The SMA treatment crisis is not merely a question of drug pricing; it is a test of India’s commitment to health equity and justice. The Constitution enshrines the right to life and health, and the state bears the responsibility to uphold these rights over corporate profit motives. The compulsory license is not just a legal tool; it is a moral imperative. By deploying it decisively, India can reaffirm its position as a global leader in affordable medicines and ensure that no child dies for want of treatment that exists but is priced beyond reach. Large multinational companies, with their immense financial power, can use the complexities of court proceedings to obstruct attempts to produce essential medicines at lower prices. In this situation, the central government must be prepared to use compulsory licensing under the Patents Act as needed. 

A resolution should be unanimously passed by the Kerala  state assembly urging the central government to use compulsory licensing for expensive, life-saving drugs like Risdiplam and grant other companies the right to produce their affordable generic versions.