The court emphasized the importance of access to medicines for children suffering from rare diseases and directed the NRDC to explore the possibility of procuring medication at a reasonable cost.

JUDGMENT

Prathiba M. Singh J. (Oral)

1. This hearing has been done through hybrid mode.

2. The present batch of petitions has been filed by the Petitioners who are children suffering from rare diseases. The case of the Petitioners is that medicines and therapies for the said diseases are exorbitantly expensive and if the same are not made available, the health and physical well-being of these children would be severely jeopardised. These matters have been heard by the Court from time to time and various directions have been issued for enabling treatment and making medicines available to the Petitioners.

Spinal Muscular Atrophy (SMA)

3. In W.P.(C) 11610/2017 titled FSMA India Charitable Trust v. Union of India, vide order dated 17th July, 2023, Court notice was issued to Mr. Pravin Anand, ld. Counsel, who regularly appears for some of the pharmaceutical companies making therapies for SMA, to assist the Court. On the last date of hearing, i.e., 21st July, 2023, after hearing the parties, and Mr. Pravin Anand, ld. Counsel, the Court had passed the following order:

"10. Accordingly, it is directed that the National Rare Diseases Committee shall look into the note, which has been today submitted by Mr. Anand Grover, ld. Senior Counsel and invite companies manufacturing and marketing medicines for SMA in order to explore the possibility of procuring the medication at a reasonable cost.

11. It is emphasized that effective deliberations between the companies as also the National Rare Diseases Committee as also a positive response from the Companies would have substantial impact on the lives of children who are suffering from rare diseases.

12. Mr. Anand, ld. Counsel would also seek instructions as to whether the said companies would be willing to make available medications at reasonable prices, for these children, who are suffering from rare diseases, as part of their overall Corporate Social Responsibility (CSR).

13. The note, which has been handed over by Mr. Anand Grover shall be placed before the Committee by Mr. Kirtiman Singh's office. Let a status report be filed by the Committee by the next date of hearing on the progress made by it in negotiation with companies manufacturing and marketing medicines for rare diseases."

4. Today, it is submitted by Mr. Pravin Anand, ld. Counsel for Roche that they manufacture `Evrysdi-Ridisplam' which is the only approved treatment for SMA in India. He submits that the Company has put in substantial efforts to make the drug available for patients suffering from Spinal Muscular Atrophy (SMA) both on compassionate considerations as also commercially. It is his submission that in total 168 patients are being provided Roche's medicine for SMA. Out of the 168 patients, 56 patients are receiving the treatment for free from Roche under the company's Compassionate User Program (CUP). There are further 53 patients who are receiving the treatment, the cost of which is being borne under various government policies. The remaining 59 patients are, in fact, purchasing the drug under a `Patient Access Program' of Roche under which for every two bottles which are purchased, three bottles of medicines are given free of cost.

5. In addition, it is submitted by Mr. Pravin Anand, ld. Counsel, that if the patients import rare diseases medicines, there are no taxes and customs charges. However, in case companies import such medicines, 11% of the cost of the medicine is charged as custom duty, and 12% of the cost is charged as GST. If an exemption is granted of these taxes, price of the medicines will considerably reduce.

6. He, further, informs the Court that three pharmaceutical companies involved in research, manufacture and sale of therapies of rare diseases, i.e., Sanofi, Sarepta and Roche have had meetings with the National Rare Diseases' Committee (NRDC) on 17th July, 2023 and are in active negotiations in respect of the pricing.

7. Ms. Jain, ld. Counsel along with Mr. Singha informs the Court that the las