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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 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.
Communication from M/s Sarepta Therapeutics:
At the outset, the Union of India has placed on record a positive development from the National Rare Diseases’ Committee (NRDC). The company-M/s Sarepta Therapeutics, has agreed to provide their therapy free of charge for 14 children, who have already been administered treatment, covering three months of therapy.
Accordingly, as these patients have already commenced treatment, M/s Sarepta Therapeutics has committed, as per the communication received by the NDRC, to continue treating these patients with Duchenne muscular dystrophy (DMD) for the next three months, and to supply the medication free of cost during this period.
In view of this development, Dr. Madhulika Kabra from AIIMS, who is present virtually, is requested to place the order with M/s Sarepta Therapeutics and expedite the procurement of the medicines for these 14 patients, ensuring that their treatment may be resumed. Insofar as a permanent solution for these children is concerned, the NRDC is still in working on arriving at a permanent solution.
It is directed that Dr. Kabra shall place the order for the products/therapies with M/s. Sarepta Therapeutics within one week for these 14 children with M/s Sarepta Therapeutics.
Vide order dated 1st September 2023, this Court directed that the NRDC ought to continue its deliberations with the companies and put up its final proposal. Insofar as the final report of the NRDC is concerned, Mr. Singha assures that the report would be placed on record before the next date of hearing.
Continuation of treatment of Medhansh Jhawar and Kenith Jhawar:
Vide 1st September 2023, this Court categorically directed as follows:
“8.Insofar as Medhansh Jhawar and Kenith Jhawar in W.P.(C) 1491/2021 & W.P.(C) 1511/2021 are concerned, these two children have received treatment both from Rs.50 lakhs, as provided by the National Rare Diseases Policy, 2022 which is provided by the Government, as also through crowd funding through other sources.
9.If the funds are exhausted for these two candidates, who are already undergoing treatment, it is directed that AIIMS shall continue to give the treatment to these two children till the matter is heard on the next date. Insofar as Ms. Alishba Khan is concerned, the treatment has already recommenced.”
Further, on 13th October 2023, this Court noted that despite specific orders, the treatment in respect of Medhansh Jhawar and Kenith Jhawar in W.P.(C) 1491/2021 & W.P.(C) 1511/2021 respectively, was stopped by AIIMS. Therefore, on 13th October 2023 it was directed as follows:
“9.It has been pointed out by Mr. Rahul Malhotra, ld. Counsel, that insofar as the Petitioner in W.P.(C) 1491/2021 i.e., Medhansh Jhawar and W.P.(C) 1511/2021 i.e., Kenith Jhawar is concerned, despite specific orders of the Court on 1st September, 2023 that their treatment shall be continued till the next date, their treatment has been stopped by AIIMS. It is submitted that the next dose which was to be received on 12th October, 2023 has not been administered. Mr. Rahul Malhotra, ld. Counsel submits that their father approached Dr. Madhulika Kabra personally who completely refused to continue the treatment. …
11.It is clear that the medicines that these children have received would be completely rendered useless if the treatment is not continued. The order is crystal clear that the treatment of these children has to be continued. Accordingly, Dr. Madhulika Kabra shall immediately recommence their treatment until further orders of this Court.”
Today, insofar as Medhansh Jhawar and Kenith Jhawar in W.P.(C) 1491/2021 & W.P.(C) 1511/2021 respectively are concerned, despite repeated orders of this Court the treatment of these two children has not been continued by AIIMS.
The nature of the present batch of petitions is intrinsically non-adversarial, and it is not the intention of this Court to seek deficiencies in actions taken by AIIMS. Compliance with the orders of this Court is expected as a part of a collective effort to address the challenges faced by children with rare diseases. Ld. Counsel for AIIMS Mr. Oberoi also agrees that AIIMS also does not intend to frustrate the objectives of the Court’s directions in the previous orders.
At this stage, Dr. Kabra and Mr. Oberoi, ld. Counsel have submitted that there is a communication from the Government of India stating that a budget of Rs.10 crores has been allocated for children with rare diseases. It is made clear that a sum of Rs.10 crores was released pursuant to the orders passed by this Court on various instances, i.e. 15th February 2023, 6th March 2023 and 10th July 2023.
Irrespective of any communication that may have been issued, since these are two children i.e. Medhansh Jhawar and Kenith Jhawar in W.P.(C) 1491/2021 & W.P.(C) 1511/2021 who need the MPS II (‘Hunter Syndrome, Attenuated Type’) treatment, AIIMS is directed to continue their treatment till further orders of this Court, from the funds received from the Government of India. The health of these children cannot be compromised in this manner.
Directions for treatment of all 91 petitioners:
On 13th October 2023, fresh petitions were filed on behalf of children suffering from rare diseases, seeking directions to the Respondents to provide continuous and uninterrupted treatment to the them. The Court issued notice, directed AIIMS to examine the case of each of these patients, and to place a report.
Insofar as the following 32 patients are concerned, AIIMS has evaluated them and the position qua each of the patients is set out below:
The above table placed on record by AIIMS provides the names of individuals, their specific DMD diagnosis, detailing which exon (part of the gene) is affected, and the Ambulation status, describing whether an individual is ambulatory (able to walk) or not. Further, it is also provided whether the said petitioners can be treated with specific therapies, such as exon skipping, which is a type of therapy for DMD.
Referring to the above table, the following is clear:
14 patients are amenable to treatment,
17 patients are not amenable to treatment,
1 patient is under evaluation.
A perusal of the above information shows that several patients are not amenable to any treatment, while some of them are indeed amenable to treatment. This position also applies to various other petitioners whose writs are pending before this Court.
Accordingly, for all the 91 writ petitioners, the following directions are issued:
For all those patients/Petitioners for whom evaluations have been completed by AIIMS, and are amenable to treatment, AIIMS shall commence the procurement of medicines for the said patients/Petitioners as per the fund allocated of Rs. 50 lakhs per patient, in terms of the Rare Diseases Policy. Upon receipt of these medicines, the administration of the medicines to the patients/Petitioners shall commence in an expedited manner.
In respect of those patients/Petitioners who are not amenable to treatment, as submitted by Dr. Kabra, the standard protocol of steroid administration and provision of care shall be commenced.
In addition, both Dr. Kabra and Dr. Sheffali Gulati (who are present virtually) shall ensure that any patient/Petitioner who can be enrolled in approved clinical trials is given an opportunity to get enrolled. They shall make an effort to enroll them, so that continuous treatment can be provided to the patients/Petitioners, if they satisfy the criteria.
In respect of the above, AIIMS shall initiate and provide the necessary treatment for the patients/Petitioners within a specific timeline. Let a timeline in respect of the above directions be placed on record.
List for receiving the final report of the National Rare Diseases’ Committee on 7th December, 2023.
W.P.(C) 14141/2023 & CM APPL. 55947/2023
W.P.(C) 14150/2023 & CM APPL. 55962/2023
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 the them.
Issue notice. Let AIIMS examine the case of these patients and place its report by the next date of hearing.
List on 7th December, 2023.