JUSTICE FOR THE RARE: UNRAVELING DELAYS, ACCESS, AND THE FIGHT FOR LIFE-SAVING DRUGS IN INDIA

In a landmark move, the Delhi High Court recently addressed the plight of patients suffering from Duchenne Muscular Dystrophy (DMD), a debilitating rare disease. The case, Master Arnesh Shaw v. Union of India¹, shed light on the severe challenges that DMD patients face in accessing life-saving medication, mainly due to delays caused by pharmaceutical companies and the government’s inadequate funding. This particular case serves as a wake-up call for the need to ensure timely treatment and equitable access to patented drugs for rare diseases in India.

Rare diseases, by their very nature, often fall through the cracks of our healthcare system. The high cost of treatment, limited availability of drugs, and insufficient funding often make life-saving medication a distant dream for those affected. This blog delves into the recent Delhi High Court order that addressed these issues head-on, holding Sarepta Therapeutics accountable for delays and directing the Ministry of Health and Family Welfare (MoHFW) to expedite fund allocation.

On September 13, 2024, the Delhi High Court made a pivotal decision in the case of Master Arnesh Shaw v. Union of India & Anr. The case centered around the unavailability of essential drugs for patients with DMD, a progressive and life-threatening condition that primarily affects children. This case was one among several petitions filed to address the larger issue of access to treatment for rare diseases in India.

The primary concern in this case was the significant delay caused by Sarepta Therapeutics in providing crucial pricing and supply details for DMD drugs, which severely hindered the procurement of these medications. Despite the urgency and multiple directives from the court, Sarepta failed to act promptly, leaving patients without access to life-saving treatment. Justice Prathiba M. Singh, who presided over the case, recognized the gravity of the situation and took a strong stance against Sarepta’s inaction, imposing penalties on the company. This decision was not just a rebuke but a clear message that corporate negligence in matters of public health would not be tolerated.

The court’s intervention became even more critical when the MoHFW revealed that the funds allocated for the National Rare Diseases Policy (NRDP) 2024 had already been exhausted, specifically impacting 14 patients with DMD and other rare diseases. This shortfall highlighted the systemic gaps in India’s approach to managing rare diseases, emphasizing the need for a more sustainable and well-funded strategy.

Key Highlights from the Delhi High Court Order

The Delhi High Court’s order marked a significant moment in the fight for equitable access to rare disease treatment in India. Here are the key highlights of the order:

1. Imposition of Penalties on Sarepta Therapeutics: The court took a strong stance against Sarepta’s three-month delay in disclosing pricing and supply details for DMD drugs. Justice Prathiba M. Singh emphasized the dire consequences of such delays, especially for children suffering from a progressive disease like DMD. The imposition of penalties serves as a warning to pharmaceutical companies that delays in providing essential information for life-saving treatments will not be tolerated.
2. Funding Shortfalls and Government Accountability: During the hearing, the MoHFW informed the court that the allocated funds under the NRDP for 2024 had been exhausted, affecting the timely treatment of patients with rare diseases. In response, the court ordered the ministry to release Rs. 10 crores to AIIMS by the next hearing date to ensure the continued treatment of non-DMD rare disease patients. This directive not only ensured immediate relief for patients but also underscored the government’s responsibility to provide adequate funding for rare diseases.
3. Directives for Immediate Procurement of DMD Drugs: The court directed the MoHFW to authorize AIIMS to place orders with Sarepta for the supply of DMD drugs based on the last price quoted to the National Rare Diseases Committee (NRDC). This step aimed to expedite the procurement process and ensure that patients receive the treatment they desperately need.
4. Emphasis on Transparency and Accountability: In light of Sarepta’s failure to provide timely information, the court directed the company to comply fully with its orders and submit all relevant details regarding the pricing and supply of DMD drugs. This move is expected to set a precedent for holding pharmaceutical companies accountable for delays and ensuring transparency in the procurement process.

The Ministry of Health and Family Welfare’s Role and Responsibilities

The Ministry of Health and Family Welfare (MoHFW) plays a pivotal role in ensuring access to treatment for rare disease patients in India. However, the recent case exposed significant gaps in its approach to addressing rare diseases, especially concerning funding and policy implementation.

The depletion of funds under the NRDP 2024, despite the allocation of Rs. 74 crores for rare disease treatment in the past year, highlights a crucial issue: the financial resources are insufficient to meet the growing needs of rare disease patients. The Delhi High Court’s order directed the MoHFW to release additional funds promptly, demonstrating the ministry’s obligation to respond swiftly to the healthcare needs of vulnerable populations.

The court also criticized the lack of foresight in budgeting for rare disease treatments, particularly given the rising costs of patented drugs. It urged the MoHFW to take a more proactive approach in securing sustainable funding and exploring alternative solutions, such as public-private partnerships and increased industry involvement, to bridge the funding gap.

Implications of the Delhi High Court’s Decision

The Delhi High Court’s decision in the Master Arnesh Shaw case has far-reaching implications, especially for patients battling rare diseases and the broader healthcare landscape in India. By holding Sarepta Therapeutics accountable for its delays, the court sent a strong message to pharmaceutical companies about their responsibility toward ensuring timely access to life-saving drugs. This decision reinforces the idea that corporate interests cannot override public health, especially when it comes to life-threatening conditions.

Moreover, the court’s intervention highlights the judiciary’s role as a guardian of public health, capable of stepping in when government policies or corporate actions fail to meet the needs of vulnerable populations. The order serves as a precedent for future cases, signaling that companies involved in supplying essential medications must act with urgency and transparency.

The decision also brought attention to the inadequacies of India’s rare disease policy, particularly the challenges posed by the high costs of patented drugs and the lack of sustainable funding. This case underscores the necessity for the government to re-evaluate its approach to rare disease treatment, ensuring that patients do not suffer due to administrative or financial constraints.

The Broader Issue: Access to Medicines for Rare Diseases in India

The case of Master Arnesh Shaw v. Union of India is a microcosm of a larger issue: access to affordable medicines for rare diseases in India. Although the National Rare Diseases Policy (NRDP) 2024 attempted to address these challenges, its limitations have become increasingly evident. One of the primary issues is the lack of consistent funding, which often results in patients being unable to access the treatment they desperately need.

The high cost of patented drugs remains a significant barrier, making it impossible for many families to afford treatment without government support. While the NRDP provides financial assistance of up to Rs. 50 lakhs per patient, this amount is often insufficient given the exorbitant prices set by pharmaceutical companies for certain rare disease treatments. This reality raises critical questions about the role of patents in healthcare and whether access to life-saving medication should be restricted by profit-driven motives.

Additionally, the complexities of diagnosing and treating rare diseases pose another challenge. With only a limited number of healthcare facilities equipped to handle such cases, patients often experience delays in receiving a diagnosis and appropriate treatment. These factors highlight the urgent need for a more comprehensive and inclusive approach to addressing rare diseases in India, one that prioritizes patient welfare over commercial interests.

Conclusion

The Master Arnesh Shaw v. Union of India case has been a critical reminder of the gaps that exist in India’s healthcare system, particularly concerning the treatment of rare diseases. The Delhi High Court’s intervention serves as a beacon of hope for rare disease patients, demonstrating that the judiciary can play a pivotal role in safeguarding public health.

Pharmaceutical companies must also recognize their role in this ecosystem and act as partners rather than obstacles to patient care. Greater transparency, willingness to engage in fair pricing, and collaboration with healthcare providers are essential steps toward ensuring that patients with rare diseases receive timely and affordable treatment.

Ultimately, the fight for access to life-saving medication for rare disease patients is a fight for the right to health: a right that should not be determined by one’s financial status or the profitability of a pharmaceutical product. It is a call to action for all stakeholders to come together and ensure that no patient is left behind in their pursuit of health and life.

1.  Master Arnesh Shaw v. Union Of India, 2024 SCC OnLine Del 6480. ↩︎