An opportunity for the Supreme Court to enable access to medicines for rare diseases
Two recent interim orders of the Supreme Court to stay High Court decisions which enabled access to treatment for rare diseases are not only morally and ethically concerning but also block the treatment of people living with rare diseases
K. M Gopakumar
Published on: 15 April 2025, 02:04 pm
TWO RECENT INTERIM ORDERS of the Supreme Court have pushed the lives of people living with rare diseases to the edge. These two orders were passed in two separate special leave petitions (‘SLP’) filed by the Union challenging the High Court orders of Delhi and Kerala which advanced access to treatment for rare diseases. These interim orders virtually blocked any possibility of affordable treatment to many people living with rare disease (‘PLRD’) who need treatments that are available at a high cost such as Spinal Muscular Atrophy (‘SMA’), Cystic fibrosis (‘CF’), Duchenne muscular dystrophy (‘DMD’) etc. Apart from staying the orders of the High Courts, these interim stay orders raise concerns about the scope of the right to life guaranteed under Article 21 of the Constitution. In a letter, nearly 220 mothers and caregivers of children living with SMA and CF have written to the Chief Justice of India (‘CJI’) seeking justice.
The letter requests CJI “to take “suo motu” cognizance of this dire situation and direct the expeditious resolution of pending legal cases concerning rare disease treatments. We further urge the judiciary to reinforce the government’s obligation to ensure access to life-saving medicines through compulsory licensing, price control, and local production to allow price-lowering generic competition, as provided under Indian law”.
Instead of taking law and policy measures to bring down the cost of medicines through local production under the existing law and policy framework, the Union is citing the exorbitant cost of treatment as a reason for not providing assistance beyond the one-time assistance of Rs 50 lakhs to each PLRD.
Further, the letter also seeks answers to the following questions.
“Why are our children dying when India has the capability to produce these life-saving medicines at a fraction of the cost?
Why do courts prioritize patent enforcement over the fundamental right to life under Article 21 of the Constitution?
Why do our legal cases remain indefinitely stalled while our children's lives are slipping away?”
These litigations and the letter challenge the lack of effective implementation of the National Policy for Rare Diseases 2021 (NPRD). The failure of the effective implementation of NPRD primarily emanates from the failure of the Union government to take measures to facilitate the availability of medicine/treatment for rare diseases. Instead of taking law and policy measures to bring down the cost of medicines through local production under the existing law and policy framework, the Union is citing the exorbitant cost of treatment as a reason for not providing assistance beyond the one-time assistance of Rs 50 lakhs to each PLRD. In the absence of availability at an affordable price, neither individuals nor state governments can procure medicine on a sustainable basis resulting in the denial of the right to life and health. Often the high prices result in the denial of access and thus violate the enjoyment of the right to health.
