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Judgment
Prathiba M. Singh J. (Oral)
This hearing has been done through hybrid mode.
The present batch of petitions has been filed by the Petitioners who are children suffering from rare diseases. The Petitioners, who are in their tender years are facing hardships that are both physically daunting and emotionally taxing. The condition of the Petitioners is deepened by the rarity and complexity of their conditions. 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. In the present batch of cases, the Court is not only focused on providing immediate relief to the Petitioners in the form of access to necessary treatments and medications but is also attempting a holistic and comprehensive solution to ensure equitable access to drugs needed for persons with rare diseases.
Communication from M/s. Sarepta Therapeutics
Vide order dated 2nd November, 2023, this Court recorded the stand of the Union of India, wherein the Court was informed of a positive development regarding the treatment of children with Duchenne muscular dystrophy (hereinafter, ‘DMD’). It was stated that M/s Sarepta Therapeutics had agreed to provide free therapy for 14 children who had already begun treatment, covering a three-month period. It was also understood that M/s Sarepta Therapeutics had committed to continue treating these patients for the next three months, and supply the medication free of cost. Accordingly, Dr. Madhulika Kabra, AIIMS was asked to expedite the procurement of medicines for these 14 patients to resume their treatment and place the order for therapies within one week. Additionally, the National Rare Diseases’ Committee (hereinafter, ‘NRDC’) was instructed to present its final proposal before the next hearing based on their ongoing discussions with companies.
Further, as per status report dated 6th December, 2023 filed by AIIMS, vide email dated 5th December 2023, M/s Sarepta Therapeutics communicated to Dr. Madhulika Kabra, AIIMS that M/s Sarepta Therapeutics would be willing to provide 3 months’ free treatment to the 14 DMD patients, if a path forward could be agreed upon for all the patients that were identified.
Thereafter, on 7th December 2023, Mr. Charles Gerrits from M/s Sarepta Therapeutics appeared online via the video-conferencing link. On the said date, it was clarified that if M/s Sarepta Therapeutics wished to be heard, they would need to engage a counsel for representation before this Court.
As recorded in the previous order, the NRDC submitted a note to the Court, containing quotations from various manufacturers for treatments of specific medical conditions. The said note, provided in a sealed cover, details the best prices offered to the Union of India for diseases like Gaucher’s Disease, Pompe’s Disease, Fabry’s Disease, and Spinal Muscular Atrophy (both drug and gene therapy). This Court further noted that M/s Sarepta Therapeutics had given a quotation to the NRDC for Duchenne Muscular Dystrophy (‘DMD’) treatment under the condition of confidentiality. Consequently, no financial figures for DMD treatment were available on the last hearing for the Court's consideration.
The said note prepared by the NRDC also stated that the final report has been prepared and is pending approval from competent authorities, and further time was sought to place the same on record. Thus, on the last date, this Court directed that the NRDC’s final report be submitted. The MoHFW and other competent authorities were also directed to expedite the processing and approval of the NRDC’s report.
Today, M/s Sarepta Therapeutics is represented before this Court. Mr. Saurabh Kripal, ld. Sr. Counsel, has handed over to the Court a communication/submission on behalf of M/s. Sarepta Therapeutics, as sent by Mr. Charles Gerrits, through its counsel- Mr. Anish Chawla.
The court has perused the terms contained in the said email. In terms thereof, the following directions are issued:
Let the said communication/submission, including two emails dated 4th January, 2024 be placed before the NRDC on 8th January, 2024, when the next meeting is scheduled.
Representatives of M/s. Sarepta Therapeutics, along with ld. Counsel Mr. Anish Chawla, may attend the meeting either online or physically or through hybrid mode.
The final report of the NRDC has been handed over to the Court by Mr. Kirtiman Singh, ld. Counsel in a sealed cover. The Court has also perused through the final report. In respect of the above development, and communication from M/s. Sarepta Therapeutics, the NRDC is free to conduct its negotiations with M/s. Sarepta Therapeutics, and thereafter, place its report in respect of DMD as well.
In view of the order passed above, the Court defers orders on the final report. Orders shall be passed after perusing the same and after the NRDC holds negotiations with M/s. Sarepta Therapeutics.
In the meantime, it is directed that the NRDC shall place before the Court on record, the final negotiated price for each of the rare diseases negotiated by them, with the respective companies, in a sealed cover at least two days before the next date of hearing.
In a positive development, M/s. Sarepta Therapeutics has also agreed to provide free treatment for 14 patients for three months. The following are the 14 patients suffering from DMD for whom free treatment shall be provided:
| S. No. | Case No. | Petitioner Name |
|---|---|---|
| 1 | W.P.(C) 5315/2020 | Master Arnesh Shaw |
| 2 | W.P.(C) 322/2021 | Keshav Sharma |
| 3 | W.P.(C) 1611/2021 | Lakshya Kumar Goyal |
| 4 | W.P.(C) 3682/2021 | Harshit Soni |
| 5 | W.P.(C) 3689/2021 | Dhananjay Bhardwaj |
| 6 | W.P.(C) 3729/2021 | Manish |
| 7 | W.P.(C) 3729/2021 | Chirag |
| 8 | W.P.(C) 3859/2021 | Siddharath Swarankar |
| 9 | W.P.(C) 4067/2021 | Anshu |
| 10 | W.P.(C) 4259/2021 | Ishaan |
| 11 | W.P.(C) 4812/2021 | Nikhil Yogender Singh |
| 12 | W.P.(C) 5394/2021 | Udayveer Singh Guleria |
| 13 | W.P.(C) 5395/2021 | Master Ayushman Chaturvedi |
| 14 | W.P.(C) 14317/2021 | Shreyansh Aarav |
Accordingly, let Dr. Kabra proceed, place the required order on M/s. Sarepta Therapeutics. Mr. Anish Chawla is directed to provide all necessary assistance to Dr. Kabra and the Petitioners, so as to enable them to receive the required treatment.
In terms of the orders dated 7th December, 2023 and 2nd November, 2023, the supplies of the drugs shall, therefore, be made within a period of two weeks by M/s. Sarepta Therapeutics.
Let the electronic record of W.P.(C) 5315/2020 titled “Master Arnesh Shaw v. Union of India” be obtained by the counsels appearing for M/s. Sarepta Therapeutics. If they wish to make any submissions on the next date they may do so.
The email dated 4th January, 2024 which has been handed over to the Court by M/s. Sarepta Therapeutics’ counsel shall be kept in safe custody of the Court Master. The email dated 4th January, 2024 shall be communicated to the Committee by tomorrow i.e., 6th January, 2024.
Continuation of treatment
On 2nd November 2023, this Court directed, inter alia, that AIIMS shall commence the procurement of medicines for all those patients/Petitioners whose evaluations had been completed and were amenable to treatment. The said directions were to be carried out as per the fund allocation of Rs.50 lakhs per patient, in accordance with the Rare Diseases Policy, 2021.
Vide order dated 7th December, 2023, this Court directed that AIIMS shall continue the treatment of patients suffering from rare diseases, except DMD, for whom treatment had already commenced. Further, the MoHFW was directed to release the necessary funds to AIIMS, to ensure that there was no interruption in the ongoing treatment.
Today, an affidavit dated 4th January, 2024 has been placed before the Court. As per the said affidavit, subsequent to the last hearing, AIIMS, New Delhi, received Rs. 25 Crores for the financial year 2023-24, specifically for treating patients with rare diseases. The said fund is in addition to Rs. 10 Crores already released for the same financial year. The said affidavit reads as follows:
“3.The Answering Respondent further respectfully submits that subsequent to the last date of hearing an amount of Rs. 25 Crores has been remitted to AIIMS, New Delhi for the Financial Year 2023-24 subject to the condition that the funds are to be utilized for the treatment of rare diseases patients by AIIMS in a manner as deemed appropriate by the Medical Experts at AIIMS, New Delhi. Copy of letter dated 11.12.2023 and sanction order dated 22.12.2023 are annexed herewith and marked as Annexure - 2 (COLLY). It is relevant to mention that this amount is in addition to the amount of Rs. 10 Crores that had already been released for the Financial Year 2023-24 and in respect of which an affidavit dated 10.05.2023 was filed placing the same on record.
4.It is respectfully submitted that in terms of the order dated 07.12.2023 passed by this Hon'ble Court, it was directed that the issue of unspent amount from the budget for Rare Diseases be dealt with in the final report of the NRDC. The relevant portion of the order dated 07.12.2023 is reproduced hereunder: -
“23.In so far as the Rare Diseases Fund (hereinafter, 'RDF') is concerned, this Court has repeatedly observed that more than Rs. 200 crores of unspent amount from the budget for rare diseases continues to remain with the MoHFW and the same has not been released. The said issues shall be dealt with in the final report of the NRDC."
5.In terms of the directions of this Hon'ble Court, it is respectfully submitted that in regard to transferring the entire unspent funds from the previous years' budgetary allocation to provide treatment for eligible patients diagnosed with treatable conditions, it is stated that unspent balance of the previous year's budget in respect of each and every Ministry/Department, attached and subordinate bodies of Government of India is governed by the provisions of the General Financial Rules (GFR), 2017, which prohibit accumulation of the funds across financial years. It is further stated that the funds provided during the financial year and not utilized before the close of that financial year, shall stand lapsed at the close of the financial year in terms of Rule No. 62(1) of GFR.
6.In view of the afore mentioned facts and circumstances, it is most respectfully prayed that this Hon'ble Court may be pleased to pass such other and further orders as it may deem fit and proper.”
Clinical Trials
Vide order dated 6th March, 2023, this Court noted that the DART trial had already been approved by the Drugs Controller General of India (hereinafter, ‘DCGI’), and therefore, directed the NRDC to hold a meeting on clinical trials for developing indigenous therapies for rare diseases including DMD and Gaucher with DART/ Hanugen Therapeutics Pvt. Ltd. Keeping this development in mind, on the last date, this Court directed as follows:
“16.Today, given M/s Sarepta Therapeutics’ stance, insofar as status of Clinical trials for DMD, ld. Amicus is advised to contact Hanugen Therapeutics Pvt. Ltd. and DART to inquire about the progress of trials of the indigenous therapies for DMD.
17.Hanugen Therapeutics Pvt. Ltd and/or DART are free to appear before the Court on the next date for the provide the status of the said trials.
18.Insofar as the DGCI is concerned, there is no representation despite specific orders of the Court on 2nd November, 2023. Repeatedly, the DCGI has been asked to place on record the details of all the trials taking place in India for DMD, in respect of approvals for trials sought by different manufacturers. However, till date, no such affidavit is forthcoming by the DCGI.
19.Upon specific directions issued by the Court, during the hearing, Dr. Rajeev Raghuvanshi, DCGI joined online and submitted that the data in respect of all the pending trials for the rare diseases is available with the DCGI, and that the same would be placed on record within a week.
20.The Court notes the communication from M/s Sarepta Therapeutics dated 10th May, 2023, addressed to one of the Petitioners, stating that at least two clinical trials for the treatment of DMD are being conducted in India without a placebo control group.
21.Let the DCGI include details of all the Clinical trials for the treatment of DMD by Sarepta Therapeutics or any other entity in its report. Further, specific information shall be given in the said report, specifying if the said trials are ‘open to recruitment’ and, if so, the number of participants from India that can be enrolled in the said Clinical trial. The DCGI shall submit as to the manner in which the recruitment for the trials can be maximised.
22.Let the DCGI place on record a status report concerning all Clinical Trials concerning DMD as a last opportunity within two weeks.”
Today, the DCGI has filed its affidavit dated 21st December, 2023, stating that four trials are currently ongoing in respect of DMD. The said affidavit reads as under:
Details of all the Clinical trials taking place in India for treatment of Duchenne Muscular Dystrophy (DMD) is as below:._
The ld. Amicus Curiae Ms. Trehan submits that there is no access to information for the patients suffering from rare diseases in respect of the companies conducting clinical trials. Patients often lack crucial information about these complex trials, hindering their decision-making process. To address this, the ld. Amicus suggests that the DGCI ought to take further steps to establishing a mechanism for expanded trials, which would allow more Petitioners to participate.
Status Report on behalf of AIIMS:
Vide order dated 7th December, 2023, this Court directed the AIIMS, New Delhi to, inter alia, place on record a report as to the feasibility of providing treatment to the Petitioners in W.P.(C) 15263/2023, W.P.(C) 15301/2023, W.P.(C) 15302/2023, W.P.(C) 15315/2023, W.P.(C) 15334/2023, W.P.(C) 15336/2023, W.P.(C) 15618/2023, W.P.(C) 15639/2023.
The relevant extract of the status report dated 4th January, 2024 is as follows:
List for hearing on 19th January, 2024.
W.P.(C) 16267/2023 & CM APPL. 65509/2023
W.P.(C) 16361/2023 & CM APPL. 65805/2023
These are fresh petitions filed by children who are suffering from rare diseases seeking directions to the Respondents to provide continuous and uninterrupted treatment to them.
Issue notice. Let AIIMS examine the case of these patients and place its report by the next date of hearing.
List for hearing on 19th January, 2024.