Master Arnesh Shaw vs Union Of India & Anr.

Prathiba M. Singh, J. (ORAL)

This hearing has been done through hybrid mode.

The present batch of petitions have been filed by the Petitioners who are children suffering from rare diseases. 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. Oral submissions in these matters concluded on 31st August, 2024.

This Court has repeatedly directed M/s. Sarepta Therapeutics from time to time to place on record information relating to its pricing and other details for DMD medication.

On 1st August, 2024, M/s. Sarepta was directed to place on record an affidavit in the following terms:

On 21st August, 2024, another opportunity was provided to M/s. Sarepta Therapeutics to place the affidavit in terms of order dated 1st August, 2024 on record. The relevant directions as contained in the order dated 21st August, 2024, read as follows:

Thereafter, on 31st August, 2024, oral submissions were heard on behalf of M/s. Sarepta. The directions contained in orders dated 1st August, 2024 and 21st August, 2024 were not complied with. Considering that the present batch of matters are not adversarial in nature, M/s. Sarepta was again directed to place on record its affidavit by 9th September, 2024. Further, in view of the concerns expressed relating to supplies of medicines, directions were also issued to M/s. Sarepta to place on record details in respect of distributors and the Standard Operating Procedure (‘SOP’). The relevant portion of the said order is as follows:

Thus, another opportunity was granted to M/s. Sarepta Therapeutics on 9th September, 2024 to file its affidavit, which has been extracted above.

Today, the Court has been presented with a document titled ‘Procedure and Distribution System of eteplirsen, goloditsen and casimersen in India’ on behalf of M/s Sarepta Therapeutics, Inc., India. The said document is provided on the letterhead of ‘my tomorrows’, which is stated to be a Netherland based company called ‘Impatients N.V.’. All the contact details provided in the said document are of Netherlands. It is noticed that the said document does not provide details of any individual distributor in India or otherwise, who can be contacted for placing of orders. Further, the said document is also silent on the timelines for supplying the orders placed with M/s. Sarepta and as to who would be responsible for the same.

During the course of this litigation, it has been noticed by the Court that there is sufficient delay between the time of placement of orders and supplies being made to the patients by M/s. Sarepta.

When there are a large number of DMD patients in India, it is expected that a company like M/s. Sarepta, which also claims to hold patents in respect of the concerned medicinal/pharmaceutical products, ought to have adequate measures in place to ensure its availability for Indian patients, considering the provisions under the Patents Act, 1970 to ensure that medicinal products which are patented, that too those which are completely unaffordable, are available at reasonably affordable prices to the public. This Court has given sufficient opportunity to M/s. Sarepta to negotiate with the NRDC and also to place proper documents on record to show that it has adequate distribution facilities in India to supply, if orders are placed upon it. Insofar as pricing is concerned, Mr. Chawla on behalf of M/s Sarepta submits that the prices offered to the NRDC are the lowest in the world.

Considering that repeated opportunities have been granted, let a proper affidavit of a responsible/competent person from M/s. Sarepta based in India, and that of a distributor of M/s. Sarepta in India who is competent to supply the concerned medicinal products with proper timelines, be placed on record within three days from the date of release of the present order. This permission is being granted subject to payment of cost of Rs.1 lakh into the ‘AIIMS Rare Disease Fund’. Let the costs be deposited within one week. The details of the AIIMS Main Rare Disease Fund A/c is as follows: A/c Name: AIIMS MAIN RARE DISEASE FUND A/C Bank A/c No.: 38345842682 Bank Name: STATE BANK OF INDIA IFSC Code: SBIN0001536 MICR: 110002005

Further, ld. Sr. Counsel Mr. Darpan Wadhwa appearing for M/s. Roche has handed over a note of written submissions to the Court. The same is taken on record.

On 9th September, 2024, the ld. Amicus apprised the Court that the doses for 14 patients had not been procured, though AIIMS had communicated regarding the release of funds for the said purpose to the Ministry of Health and Family Welfare (‘MoHFW’). In respect of the same, this Court directed as follows on 9th September, 2024:

Today, Mr. Swarnendu Singha, Under Secretary, Ministry of Health and Family Welfare (hereinafter ‘MoHFW’), is present in Court. According to Mr. Singha, the budget allocated for payments in terms of the National Rare Diseases’ Policy has been exhausted.

In the opinion of this Court, since treatment of the 14 patients has already commenced, it is directed that the MoHFW shall grant approval to AIIMS to place orders on M/s. Sarepta for the supply of the necessary medicines and release the corresponding funds, based on the price last quoted by M/s. Sarepta to the National Rare Diseases’ Committee (‘NRDC’). The said approval shall be granted by 19^th September, 2024, failing which action for contempt would be liable to be taken.

Upon receiving the approval, AIIMS shall place the order on the designated distributor, whose details shall be communicated by Mr. Anish Chawla, ld. Counsel appearing for M/s. Sarepta to Mr. Tanveer Oberoi, ld. Counsel appearing for AIIMS.

The concerned distributor of M/s. Sarepta, who would be taking responsibility for supplying the medicines, shall remain present in Court on the next date of hearing.

It is submitted that further doses for four patients i.e., two patients suffering from Gaucher’s disease and two patients suffering from MPS have not been provided.

This Court is of the opinion that the medicines for these four patients ought not to be discontinued. The same is being directed after considering the following facts:

^ that, as per affidavit dated 19th July, 2024, filed by the Union of India, the budget for expenditure under the National Rare Diseases’ Policy, 2021 since FY 2022-2023, has, in fact, been reduced from previous years, and,

^ that these four patients have already been administered the medicines.

Let the MoHFW release a sum of Rs.10 crores to AIIMS by the next date of hearing, so that even the non-DMD patients may be provided the requisite treatment(s) till the final judgment of this Court in these batch matters. It is made clear that the said approval/release of funds shall be subject to the final outcome in these batch matters.

Let a comprehensive status report in respect of all the directions contained in the present order be filed by the next date of hearing, by the respective parties, in respect of whom the directions have been issued.

List on 24^th September, 2024 at 4:00 pm.

These are part-heard matters.