[This post has been authored by SpicyIP intern Mehnaz Khatoon. Mehnaz is a recent law graduate from Aligarh Muslim University Centre Malappuram. She is passionate about Intellectual Property Laws and is interested in pursuing a career in the corporate sector. Her previous posts can be accessed here.]
In a crucial order in the Master Arnesh Shaw vs. Union of India & Anr on 13th September 2024, the Delhi High Court took a firm stand in the ongoing legal battle concerning the availability of life-saving drugs for Duchenne Muscular Dystrophy (DMD) patients. This case, which is part of a larger batch of petitions addressing the challenges faced by rare disease patients in India, saw the Court imposing penalties on Sarepta Therapeutics for a three-month delay in disclosing critical pricing and supply details for DMD drugs. This delay hindered the timely procurement of life-saving medication, leaving many patients without access to treatment. Despite repeated court directives, Sarepta failed to provide the necessary information, resulting in the imposition of penalties for its inaction and negligence in a matter of urgent public health.
The Court’s rebuke came after Sarepta failed to promptly provide the necessary information despite repeated requests. Justice Prathiba M. Singh, who presided over the case, emphasized the grave impact such delays have on patients suffering from DMD, a progressive and debilitating condition that predominantly affects children. The Court imposed costs on Sarepta, sending a clear message about the consequences of corporate inaction in life-and-death situations.
Compounding the issue, the Ministry of Health and Family Welfare (MoHFW) informed the Court during the hearing on 13th September 2024 that the funds allocated under the National Rare Diseases Policy (NRDP) for 2024 had already been exhausted, specifically in relation to 14 patients. These patients, some of whom are suffering from Duchenne Muscular Dystrophy (DMD), as well as other rare diseases, were left without access to necessary treatment due to the depletion of allocated funds. The Court had previously directed the government to ensure that these patients received timely support, but the lack of funds has delayed their treatment further.With the government having spent over Rs. 74 crore on rare disease treatment in the past year, there are now concerns that patients suffering from non-DMD rare diseases may not receive the necessary treatment unless additional funding is secured.
In response, the Court directed the MoHFW to immediately approve 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). (Unfortunately, I was not able to find the exact price quoted by Sarepta to NRDC. In case any reader has an idea about the same, please feel free to share it in the comments below.) To address the shortfall in funds, the Court also ordered the ministry to release Rs. 10 crores to AIIMS by the next hearing date, ensuring the continued treatment of non-DMD rare disease patients until a final judgment is reached.
Incidentally, the underlying issue came up in a relevant but separate context recently as well. Highlighting the intersection of law, ethics, and medical innovation, Chief Justice of India D.Y. Chandrachud addressed a conference on ‘Gene Therapy and Precision Medicine’ in Bengaluru on 21st September 2024. He emphasized that industry participation in rare disease treatment is critical, adding, “The industry should support through CSR initiatives or investments in start-ups to further innovation in gene therapy and rare diseases.” CJI Chandrachud also highlighted the need for tax incentives to encourage investments in rare disease research, stressing that equitable access to advanced therapies like gene therapy is essential for marginalized communities. He reflected on his personal journey as a parent of children with a genetic condition, linking his legal perspective with the human side of rare disease challenges.
The exhaustion of funds under the NRDP, despite efforts such as the launch of crowdfunding portals, underscores a broader issue in India’s rare disease policy: the mismatch between the financial resources available and the growing number of rare disease patients. In 2021, the MoHFW had identified 57 rare diseases under the policy and had committed up to Rs. 50 lakhs per patient for treatment at designated Centres of Excellence (CoEs). However, the increasing costs of patented drugs and the rising number of rare disease cases have strained the government’s capacity to keep up.
This order from the Delhi High Court is particularly significant, as it signals the judiciary’s readiness to hold pharmaceutical companies accountable for their actions. Sarepta’s delay in disclosing its pricing details not only delayed treatment for vulnerable patients but also cast doubt on its willingness to collaborate transparently. The company has now been directed to comply fully with Court orders, and its future in India’s rare disease treatment framework may be under scrutiny.
Moreover, the case has thrown a spotlight on the National Rare Diseases Policy, which has faced criticism for its inability to provide sustained funding for all categories of rare diseases. While the Court’s intervention ensures immediate relief for patients, it also raises larger questions about the long-term sustainability of India’s rare disease treatment strategy, especially in the context of access to patented drugs.
As CJI Chandrachud noted, there are structural barriers in India’s healthcare system, particularly for marginalized communities. He stated, “Ensuring equitable access to advanced medical therapies for all, including marginalized communities, is essential… We must prioritize the development of indigenous technologies to innovate affordable therapies.” These comments reflect the ongoing tension between ensuring patient access and incentivizing pharmaceutical companies to innovate.
As per September 24 order, Sarepta has finally filed its affidavit and the matter has now been listed for October 3. [Please note that a hearing was conducted on September 27, but the order has not been uploaded on the DHC website.]
For an in-depth analysis of the legal and policy challenges surrounding rare diseases in India, readers can refer to this earlier coverage of this case and related matters on the blog here. Additional context on rare disease policies and Sarepta Therapeutics’ involvement can be found [here].