Landmark Judicial Decision on Rare Disease Treatment and Healthcare Rights

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Written by Maria Therese Syriac, and verified by Sunil Jose, Managing Attorney, Suns Legal.

After a series of hearings throughout 2024, the Delhi High Court has taken decisive action to address India’s long-standing challenges in treating rare diseases, particularly focusing on children suffering from Duchenne Muscular Dystrophy (DMD) and other rare conditions. Every day, children with DMD face the progressive weakening of their muscles, gradually losing their ability to walk, breathe, and live independently. For those with Hunter Syndrome, the body’s inability to break down certain complex molecules leads to devastating physical and mental complications. While breakthrough treatments exist for these rare diseases, their astronomical costs – up to ₹6 crores annually per patient – have kept them out of reach for most Indian families. 

The Delhi High Court’s landmark judgment in Master Arnesh Shaw v. Union of India (2024) confronts this stark reality, where the promise of modern medicine collides with the limitations of public healthcare funding. The Court’s intervention culminated in an October 2024 judgment directing the Union Government to allocate ₹974 crore to the National Fund for Rare Diseases (NFRD) for 2024-25 and 2025-26.

The Case

India, as a whole, faces a significant rare disease burden, with an estimated 70 million patients affected. These diseases, occurring in roughly 1 in 2,500 people, often result in progressive damage and degeneration.

The journey began with Justice Prathiba M. Singh’s intervention in cases involving multiple petitions filed by children suffering from rare diseases including 12 children with Duchenne Muscular Dystrophy (DMD), two with Hunter Syndrome, and one adult with Von Hippel-Lindau Syndrome. Their families faced an impossible situation where treatments existed but at prohibitive costs including approximately ₹6 crores per year for DMD treatment and ₹72 lakhs annually for Hunter Syndrome. The petitioners challenged the state’s failure to cover these essential treatments, indicating a significant gap in India’s healthcare system. 

Legal Issues

The case presented several questions for the Court to consider during its hearing. First, whether the right to life under Article 21 of the Indian Constitution creates an obligation for the state to provide extremely expensive treatments for rare diseases. Second, whether the court can establish and direct the functioning of committees such as specific fund allocation for healthcare, traditionally an executive domain. Third, the extent of judicial intervention permissible in healthcare policy matters.

Petitioners’ Contentions

The petitioners argued that the right to health, being fundamental under Article 21, requires the state to ensure access to life-saving treatments regardless of cost. They highlighted the government’s previous underutilization of allocated funds, having spent only ₹7.2 crores out of an estimated budget exceeding 200 crores. The petitioners also emphasized international obligations under ICESCR Article 12 and CRC Article 24, which mandate state action for healthcare access.

Government’s Position

The Ministry of Health reported the exhaustion of funds allocated under the National Rare Diseases Policy for 2024. They raised concerns about fiscal constraints and the challenge of balancing various healthcare priorities. The government also questioned whether judicial intervention in fund allocation would violate separation of powers principles, a salient feature of our Constitution.

The Court’s Analysis

The Delhi High Court’s analysis centered on balancing fundamental rights against administrative constraints. The Court examined the systemic failure in implementing rare disease policies by drawing parallels from Brazilian courts’ approach to healthcare access. It found that the government’s inability to effectively utilize allocated funds and establish proper management systems warranted judicial intervention.

The Court referenced the landmark Paschim Banga Khet Mazdoor Samity case (1996), where the Apex Court emphasized the state’s duty to provide medical facilities, to establish the state’s obligation to provide adequate medical facilities. However, the Court acknowledged the concerns raised in the Rajeev Suri case (2021) regarding the boundaries of judicial intervention in policy matters stating that while the judiciary oversees executive decisions to protect citizens’ rights, it does not impose its own interpretation of governance.

The Verdict and Impact

The Court issued far-reaching directives, including the allocation of ₹974 crore to the National Fund for Rare Diseases for 2024-26 and establishing the National Rare Diseases Committee. It mandated monthly monitoring mechanisms and streamlined drug procurement processes.

The judgment’s core directives include mandatory transfer of funds to the NFRD as envisioned in the Rare Diseases Policy, specific functions for the National Rare Diseases Committee (NRDC), including reviewing recommendations from Centers of Excellence (CoEs) and monthly progress reviews by the Ministry of Health and Family Welfare (MoHFW), encompassing patient data tracking and fund utilization monitoring.

The judgment’s immediate impact includes enhanced funding availability and improved monitoring mechanisms. The long-term implications involve establishing a framework for rare disease management and setting a precedent for judicial intervention in healthcare policy.

The Court’s intervention addressed multiple aspects of the rare disease crisis. The Court ordered the creation of a “Rare Disease Fund” managed by AIIMS, ensuring that unspent budgets from previous allocations would be properly utilized. This addressed the shocking revelation that out of an estimated budget of over 200 crores for three years, only 7.2 crores had been actually spent. In September 2024, the Court imposed penalties on Sarepta Therapeutics for delays in disclosing crucial pricing and supply details for DMD drugs, demonstrating its commitment to holding pharmaceutical companies accountable.

The Court mandated the establishment of a National Consortium for Research and Development on therapeutics for Rare Diseases, bringing together key institutions like DBT, ICMR, DST, and CSIR to supervise and monitor treatment indigenization efforts.

Conclusion

The Master Arnesh Shaw judgment represents a watershed moment in Indian healthcare jurisprudence. While critics may view it as judicial overreach, supporters see it as necessary intervention where executive action failed. The case exemplifies the judiciary’s evolving role in ensuring fundamental rights, particularly in healthcare access.

The judgment’s true test lies in its implementation and its ability to balance judicial oversight with executive autonomy. As India grapples with healthcare challenges, this decision sets a crucial precedent for how courts can intervene to protect the right to health while respecting constitutional boundaries.

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