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Judgment
Prathiba M. Singh J. (Oral)
This hearing has been done through hybrid mode.
On the last date of hearing, the Court was informed that the National Rare Diseases’ Committee (NRDC) has had meetings with various pharmaceutical companies. Active deliberations in respect of pricing and supplies of medicine were stated to be underway. The Court had requested the Committee to take a specific position as to how the treatment of the patients who have already received medical doses should be proceeded with. The Court had further directed NRDC to put up a comprehensive report before the Court.
At the very outset of the hearing today, Mr. Pravin Anand, ld. Counsel submits under instructions that the Managing Director (MD) of Roche India had a meeting with the NRDC on 30th August, 2023. It is his submission that after some deliberations, it has been agreed that Roche would submit a proposal to the Committee within a week of the date of the meeting, which they intend to do shortly.
On behalf of the NRDC, a status report dated 1st September, 2023 has been handed over to the Court as per which the Committee has held deliberations with representations of various companies who manufacture and sell drugs for rare diseases including M/s Sanofi Therapeutics, M/s Sarepta, M/s Roche Pharma, and M/s Takeda Pharmaceuticals. In addition, it is submitted by Mr. Swarnendu Singha that negotiations are also underway with three other entities including M/s BioMarin Pharmaceutical, M/s Novartis and M/s Pfizer.
Further, as per the status report, the Committee is in active deliberations with all these companies who have agreed to give their proposals to the Committee by 15th September, 2023.
As per the Committee’s status report, it has decided to put in place a mechanism to provide treatment to patients suffering from rare diseases for at least five years and has, on the said basis, called for proposals from the companies. Relevant portion of the report is set out below:
“6.The third meeting of National Rare Diseases' Committee was held under the Chairmanship of Secretary DHR & DG ICMR on 17.07.2023. In the 3rd meeting of NRDC, representatives from M/s Sarepta Therapeutics, M/s. Sanofi, M/s. Roche Pharma were invited for discussions.
7.As per the mandate of the Committee, positive discussions were held with those pharma entities towards negotiation for reduction of prices of the drugs used for treatment of rare disease patients and options would be explored for central procurement. It is also informed that a physical meeting with representatives of M/s Sanofi India was again held on 01.08.2023 so as to understand the requisite data they require for preparation of a proposal for price negotiation from their side.
8.Fourth and Fifth meetings of NRDC were held on 24.08.2023 and 30.08.2023 under the Chairmanship of Secretary, DHR & DG, ICMR. In the 4th meeting, the Committee met with the representatives of M/s Sanofi India and M/s Takeda Bio- pharmaceuticals Pvt. Ltd. In the 5th meeting, the Committee met with M/s Sarepta and M/s Roche Pharma for further discussions relating to pricing and supplies of medicines. The Committee had decided to meet more companies like Pfizer, Novartis etc.
9.As regards continuance of the treatment of the 14 DMD patients who have already exhausted max. limit of Rs. 50 lakhs, it is stated that the Chairman of the Committee made an appeal to the companies to support treatment of the patients ensuring continuity till the time a final decision is arrived at.
10.The Committee has decided to approach Secretary, Department of Public Enterprises for requesting them to sensitize the PSUs to support the treatment of rare diseases patients from Corporate Social Responsibility (CSR).
11.All the Pharma companies to whom the Committee has met, have agreed to submit their proposal in respect of the offered price of drugs in a sealed envelope by 15.09.2023 to the Committee. The Committee has decided to put in place a mechanism to provide treatment to the rare diseases patients for atleast 5 years or so.”
Ld. counsel for the Petitioner has also placed on record an email which he has received from M/s Sarepta. However, after having heard the submissions from ld. Counsels for the parties, this Court is of the opinion that the Committee ought to continue its deliberations with the companies and put up its final proposal by the next date of hearing.
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.
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.
In W.P. (C) 4536/2023, the appearance of Mr. Sushil Raja, ld. counsel for the Union of India shall be recorded.
List on 13th October, 2023.
W.P.(C) 6089/2023 & CM APPL. 23902/2023
W.P.(C) 10606/2023 & CM APPL. 41165/2023
W.P.(C) 10867/2023 & CM APPL. 42110/2023
W.P.(C) 10870/2023 & CM APPL. 42114/2023
These are four 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 put up its report before the next date of hearing.
List on 13th October, 2023.