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2023 DIGILAW 4586 (DEL)

Master Arnesh Shaw. v. Union of India & Anr

2023-08-03

PRATHIBA M.SINGH

body2023
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. 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 last meeting of NRDC was held on 17th July, 2023 and discussions relating to pricing and supplies of medicines with various pharma companies is underway. Dr. Madhulika Kabra from AIIMS, who has also joined the proceedings virtually, submits that deliberations of the Committee are being actively conducted and there would be some resolution in the near future. 8. Dr. Dr. Madhulika Kabra from AIIMS, who has also joined the proceedings virtually, submits that deliberations of the Committee are being actively conducted and there would be some resolution in the near future. 8. Dr. Kabra assures the Court that if any ongoing clinical trials or which are to be conducted at AIIMS, New Delhi for any of the rare diseases in respect of treatments which are globally are now well accepted, an attempt would be made to enroll the Petitioners into the trials so as to make the treatment available to them. 9. Insofar as the Customs and GST issues is concerned, Mr. Singha submits that the same has been flagged to the Ministry of Finance and the Government is hopeful of informing the Court about the outcome of the said issue on the next date. 10. Mr. Anand Grover, ld. Sr. counsel representing Cure SMA Foundation of India submits that the Foundation is willing to nominate two representatives if the Committee is willing to meet with the said representatives. Since Cure SMA Foundation is stated to be having parents of SMA patients as its members, who are more than thousand in number, the Committee may consider calling two representatives for an interaction to understand practical issues faced by SMA patients. Let the names of the representatives be provided to the NRDC within one week. 11. Mr. Grover, ld. Senior Counsel shall further place on record a complete list of all the members of its organisation including their age groups, as also their current weight, so that the said data can also be communicated to the Centres of Excellence. Duchenne Muscular Dystrophy (DMD) 12. One of the major issues that have been repeatedly highlighted to this Court is the non-continuation of medication to DMD patients who are 14 in number due to exhaustion of funds provided under the National Rare Diseases Policy, 2021. These patients have already received treatment till about March-April this year under the Policy. The concern of these patients and their parents is that if further doses are not administered, it would have an adverse impact on their health. 13. In the next meeting of the NRDC, a specific position shall be taken on how to proceed with these 14 DMD patients who have already received medical doses. 14. A comprehensive report of all deliberations of the next meeting of the NRDC shall be placed on record. 13. In the next meeting of the NRDC, a specific position shall be taken on how to proceed with these 14 DMD patients who have already received medical doses. 14. A comprehensive report of all deliberations of the next meeting of the NRDC shall be placed on record. 15. Insofar as Ms. Alishba Khan is concerned, who is a patient suffering from Gaucher, Dr. Kabra has informed the Court that Sanofi has agree to provide three months of medication further on humanitarian considerations, at this stage. 16. List these matters on 1st September, 2023. 17. These are part-heard matters. W.P.(C) 10031/2023 and CM APPL. 38666/2023 W.P.(C) 10063/2023 and CM APPL. 38727/2023 W.P.(C) 10064/2023 and CM APPL. 38728/2023 18. These are three petitions filed by children who are suffering from DMD seeking directions to the Respondents to provide continuous and uninterrupted treatment to the them. 19. Issue notice. 20. Let the said Petitioners be examined under the supervision of Dr. Kabra and a report be placed on record as to the feasibility of providing them treatment. 21. List on 1st September, 2023. W.P.(C) 8978/2023 & CM APPL. 34032/2023 22. Mr. Aggarwal, ld. Counsel appearing for the Petitioner wishes to withdraw the present petition. Accordingly, the same is dismissed as withdrawn.