Delhi High Court: In a case wherein a petition was filed for making available medication and treatment for children with rare diseases Spinal Muscular Atrophy (‘SMA’) at an affordable price, a Single Judge Bench of Prathiba M. Singh, J., directed that the National Rare Disease Committee (‘Committee’) shall invite companies manufacturing and marketing medicines for SMA to explore the possibility of procuring the medication at a reasonable cost. The Court further directed the Committee to file a status report by the next date of hearing on the progress made by it in negotiation with companies manufacturing and marketing medicines for rare diseases.
Background
The petitioner, FSMA India Charitable Trust, which was stated to be a body formed by family members of patients suffering from SMA and was registered under the Societies Registration Act, 1860. The petitioner submitted that SMA was a rare, neuromuscular, progressive genetic disease, which affected the nervous system and required medication intervention regularly. Further, the treatment for the patients suffering from SMA was expensive and SMA affected individuals were also substantial in number and various drugs, which were available as on today in India, were not readily available at affordable prices.
Counsel for the respondents submitted that three medications which were available for SMA were manufactured by Biogen, Novartis, and Roche and as far as the medication called Evrysdi-Ridisplam manufactured and marketed by Roche was concerned, the same costs Rs. 6,23,000 per bottle in India of which a patient weighing more than 20 kgs needed 36 bottles in a year. However, the same was available at a much more reasonable price in other countries, like, China and Pakistan, where the same were made available at less than 1/10th of the prices in India, that is, Rs. 44,692, and Rs. 41,002 per bottle, respectively.
Thus, the prayer in this petition was for making available medication and treatment for children with rare diseases SMA at an affordable price.
Analysis, Law, and Decision
The Court stated that it had been dealing with a batch of writ petitions filed by the family members of patients suffering from rare diseases such as DMD, Gaucher, Hunter’s syndrome and as part of the said batch of the petitions, this Court had appointed a Committee vide order dated 15-3-2023 and the mandate of the Committee was broadly to take all steps needed for implementation of the National Rare Disease Policy, 2021 (‘Policy’). The mandate included the following:
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Procurement of therapies and drugs and creation of associated logistical framework for administration of treatment for patients with rare diseases;
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Recommending necessary steps for the indigenization of therapies, medicines for rare diseases and identify the manner in which the same could be made accessible to the lakhs of patients who, as per the Policy, were suffering from rare diseases;
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The Committee, while working broadly under the umbrella of the Policy, would undertake a periodic review of the Policy and recommend to the Ministry of Health and Family Welfare the changes needed in the Policy if the same was deemed necessary.
The Court noted that the Committee was currently holding deliberations with various companies including Sarepta, Sanofi etc., to explore the possibility of obtaining medications at a more reasonable price for children affected with rare diseases. The Court opined that “it seemed that there was a possibility of the Committee speaking to these companies to source medication for SMA patients”.
Thus, the Court directed that the Committee shall look into the note, which had been submitted by Counsel for the respondents and then invite companies manufacturing and marketing medicines for SMA to explore the possibility of procuring the medication at a reasonable cost. The Court opined that effective deliberations between the companies and the National Rare Diseases Committee and a positive response from the Companies would have substantial impact on the lives of children who were suffering from rare diseases.
The Court further directed the Committee to file a status report by the next date of hearing on the progress made by it in negotiation with companies manufacturing and marketing medicines for rare diseases.
The matter would next be listed on 3-8-2023.
[FSMA India Charitable Trust v. Union of India, W.P. (C) 11610 of 2017, Order dated 21-7-2023]
Advocates who appeared in this case :
For the Petitioner: Ashok Agarwal, Kumar Utkarsh, Manoj Kumar, Shyel Trehan, Advocates; Shivalika Rudrabatla, Amicus Curiae;
For the Respondents: Kirtiman Singh, CGSC; Anand Grover, Senior Advocate; Vidhi Jain, Vijay Joshi, Saurabh Chauhan, Varun Jain, Rohin Bhatt, Pravin Anand, Shrawan Chopra, Prachi Agarwal, Achyut Tewari, Advocates.
