[This post is authored by Sunidhi Das. Sunidhi is a second year student at NLSIU, Bangalore and is very enthusiastic about IP law and policy. Also a big thanks to Bharathwaj Ramakrishnan, Md. Sabeeh Ahmad, Praharsh, and Swaraj Paul Barooah for their input. Long post ahead.]
On October 4, 2024, the Delhi High Court issued a judgment in Master Arnesh Shaw v. Union of India, directing the Union Government to allocate ₹974 crore to the National Fund for Rare Diseases (NFRD) for 2024-25 and 2025-26. This fund, pivotal for patients grappling with rare conditions like Duchenne Muscular Dystrophy (DMD) and Spinal Muscular Atrophy (SMA), is aimed at mitigating the crippling costs of treatment for these often-overlooked diseases. Interested readers can take a look at the previous posts on the case here and here. [Note: Presently, the decision is partially stayed by the Supreme Court and has clubbed it with another ongoing case with similar issues.]
The High Court’s decision is undeniably a step toward equity in healthcare, underlining the state’s responsibility under Article 21 of the Constitution to provide life-saving treatments. However, the case also spotlights a recurring issue in Indian jurisprudence: the fine line between judicial activism and judicial overreach. While the Court’s move to ensure funding is laudable, the additional directives—especially those micromanaging the Rare Diseases Policy—warrant scrutiny.
This piece examines the judicial overreach embedded in the Court’s directive establishing the National Fund for Rare Diseases, arguing that, while driven by an acute public health need, the judgment disrupts the separation of powers by encroaching upon legislative and executive functions. Through an analysis of the Court’s intervention in budgetary allocations, administrative responsibilities, and healthcare policy-making, this post contends that the judgment, though well-intentioned, raises questions regarding judicial bounds.
What the Court Ordered
At its core, the judgment does three things (Other directives outlined from pg 174 onward):
- It compels the government to transfer funds to the NFRD as envisioned in the Rare Diseases Policy, addressing long-standing delays.
- It directs the National Rare Diseases Committee (NRDC) to take on specific functions, such as reviewing recommendations from Centers of Excellence (CoEs), conducting periodic policy reviews, and streamlining administrative processes.
- It requires the Ministry of Health and Family Welfare (MoHFW) to ensure sustained monitoring through monthly progress reviews, including patient data tracking and fund utilization via a centralized portal.
The Thin Line Between Activism and Overreach
The Court’s directive to ensure the transfer of ₹974 crore to the NFRD falls within acceptable bounds of judicial intervention. The Rare Diseases Policy specifies a corpus fund, and the Court is merely holding the government accountable for its implementation. Where the judgment veers into possible overreach territory is in its granular mandates, such as directing how the NRDC should function, the manner of its meetings, and even its scope of review.
For instance, mandating that reviews be held which will include regular monitoring of fund disbursement, identification of delays, and adjustments as needed. The court further mandated that the first review meeting be held within 30 days of the order to initiate the fund’s operational management. Here, the Court seems to be assuming a policymaking role insofar as when and what the reviews are concerned. Similarly, instructions on fund disbursement mechanisms and patient monitoring tread into the operational domain of the MoHFW, undermining the principle of separation of powers. More importantly, the NRDC was a Court constituted committee. This raises another question of whether the courts are empowered to constitute such committees that the executive conventionally formulates.
While the judgment seemingly raises concerns about potential overreach, it is worth noting that these steps were taken after the systemic failure on the part of the executive. In that case what else could the Court have done? Furthermore, it is also important to note that several directives in the decision reflect appropriate judicial intervention, staying within the judiciary’s constitutional mandate. These directives focus on enforcing the government’s existing obligations, aligning with the judiciary’s role in upholding rights and ensuring executive accountability.
A Precedent Worth Pondering
Courts stepping in to uphold healthcare rights is not new. The Paschim Banga Khet Mazdoor Samity v. State of West Bengal (1996) laid the foundation for treating healthcare as integral to Article 21. More recently, the Association of Medical Super Speciality Aspirants and Residents v. Union of India (2019) case reiterated the government’s obligation to ensure equitable healthcare. However, this judgment goes further by dictating administrative processes—a step that risks diluting the roles of other branches of government. The intent to fill the governance void is understandable, especially given the glaring underutilization of allocated funds by CoEs in previous years. Yet, such interventions can set troubling precedents for how courts handle governance failures in other sectors
Blurring Boundaries: Judicial Directives on Policy Matters
A notable aspect of the judgment involved a directive to transfer unspent budget allocations for rare diseases to a new “Rare Diseases Fund” under the management of the All India Institute of Medical Sciences (AIIMS). The Court further instructed the government to reallocate Rs. 53 crores from a Kerala High Court fund for the treatment of rare diseases, prepared in an unrelated case, to this rare diseases fund. These directives represent a complex intersection of judicial activism and financial policy-making. Courts are traditionally expected to interpret the law rather than dictate specific fiscal allocations or the ways in which the funds should be utilized, functions lying squarely within the executive domain.
For instance, the Court’s directive to reallocate ₹53 crores from an unrelated Kerala High Court fund highlights a potential issue of judicial overreach into fiscal policy making, as it steps into areas typically reserved for the legislature and executive. The Court is seemingly unequipped to pass a direction especially since the allocated fund could be put to use by the executive in different ways, indicatively in the Kerala Rare Disease Policy or for treatment of rare disease patients in the state itself, especially when there is a pending petition at the Kerala High Court by a SMA patient. These instances are merely indicative to argue that the executive is best suited to make the decisions of fund allocation/reallocation, and the courts duty is limited to ensuring that these funds are utilised for the reasons they have been accumulated for. While the judicial focus on ensuring proper fund utilization aligns with its accountability role, the intervention in financial reallocation risks encroaching on the executive’s responsibility for budgetary decisions.
A catena of judgments has emphasized the judiciary’s limited role in policy making , ordering the exercise of restraint in areas requiring specialized expertise. In Rajeev Suri v. Delhi Development Authority (2021), the Supreme Court emphasized that the judiciary acts as a check on the government rather than imposing its version of governance. The Court clarified that its role is to oversee decisions from the executive to the citizens, but not to impose its interpretation of good governance.
In Premium Granites & Anr. v. State of T.N. & Ors. (1994) this Court restated that it is not the domain of the Courts to embark upon the uncharted ocean of public policy in an exercise to consider as to whether a particular public policy is wise or a better public policy can be evolved. Such exercise must be left to the discretion of the executive and legislative authorities, as the case may be.
The Supreme Court has previously addressed such issues in Divisional Manager, Aravali Golf Club v. Chander Hass (2007), cautioning against judicial involvement in policy matters. This case emphasized that the judiciary should avoid assuming roles meant for the executive, particularly in areas demanding specialized knowledge. Judicial directives like these could risk expanding the judiciary’s role beyond constitutional boundaries, especially in complex areas such as public health and economic policy.
For more discussion on the need for the courts to have a restrained approach to policy-making, interested readers can also look at this post by Pragya Singh and Lakshita Handa.
Enforcing Patient Rights to Access Healthcare and Ensuring Transparency and Accountability
One of the judgment’s commendable aspects is its reinforcement of patients’ rights to timely and adequate healthcare, especially for individuals affected by rare diseases who often face systemic neglect. By emphasizing the fundamental right to health under Article 21 of the Constitution, the Court effectively reminded the executive of its duty to prioritize vulnerable populations, particularly children with life-threatening conditions. This aligns with the judiciary’s established role in protecting fundamental rights without crossing into policy-making, similar to the Court’s approach in Paschim Banga Khet Mazdoor Samity v. State of West Bengal (1996), where the judiciary emphasized the state’s duty to provide medical facilities.
Also, the Court mandated that AIIMS, as the nodal agency for the Rare Diseases Fund, to provide periodic reports to the MoHFW on contributions received and the utilization of the fund. These measures support the broader principle of transparency in governance, ensuring that executive actions are scrutinized while maintaining a clear distinction between judicial review and administrative functions. Specifically on this issue, the Court emphasized its role in monitoring rather than intervening in policy creation. It stated that it would oversee the disbursement of funds to ensure that the allocated budget for rare diseases is effectively utilized. The Union of India was directed to conduct monthly reviews to assess fund usage and hold meetings with the Ministry of Health and Family Welfare (MoHFW), the National Rare Diseases Committee (NRDC), and the Centres of Excellence (CoEs) to track fund allocation and implementation progress.
International Legal Frameworks and the Right to Health
Another interesting aspect of the judgement is the reliance on international human rights instruments like Article 12 of the ICESCR and Article 24 of the CRC, which affirm the right to the “highest attainable standard of health.” The Court also referenced Brazil’s proactive judicial approach to healthcare, citing Petição 1246 (1997), where Brazil’s Supreme Federal Court ordered state funding for experimental Duchenne Muscular Dystrophy (DMD) treatment, prioritizing the right to life over fiscal constraints. The Brazilian courts, leveraging Article 196 of their Constitution, have consistently mandated universal healthcare access, including high-cost treatments for rare diseases. This approach sometimes leads to prioritizing costly treatments for individuals, potentially diverting funds from broader health initiatives and creating inequities in resource allocation. India, while recognizing the right to health under Article 21, has traditionally exercised caution in directing budgetary allocations. By highlighting Brazil’s interventionist stance, the judgment signals that stronger judicial action may be essential to address policy gaps for vulnerable groups like rare disease patients.
Some (Realistically) Ambitious Directions
The Court offers ambitious directives to pharmaceutical companies, aiming to enhance the availability and affordability of therapies. Efforts to streamline drug distribution, such as simplifying procurement processes, show promise but still face hurdles due to complex documentation requirements that delay timely access to medications. Negotiations for price reductions, like Sarepta’s voluntarily offering a discount are steps forward (para 331), but reliance on corporate goodwill is not the solution considering the unpredictable nature of philanthropic commitments by pharmaceutical companies. These measures in no way replace the need for stronger regulatory mechanisms, such as mandatory price controls under the Drug Price Control Order (DPCO).
Similarly, the push for indigenizing drug manufacturing is vital for reducing dependency on imports, yet it demands substantial investment in R&D, infrastructure, and leveraging provisions under the Patents Act to encourage local production. Strict adherence to timelines is feasible but requires capacity building and improved workflows within CoEs. Global collaborations for research and open-access models present opportunities to fast-track treatment availability but must align strategically with domestic production goals. Patent restrictions and reliance on high-cost imported therapies like gene and exon-skipping treatments remain major hurdles, underscoring the importance of utilizing legal tools to enforce affordable access while balancing international trade obligations. Therefore, while the judgement aims to resolve a major problem of inaccessibility of essential drugs for treating rare diseases these realistic challenges pose major hurdles in the effective implementation of the decision.