The government has an obligation to invest in research for indigenous therapies, and the court can direct the commencement of treatment and release of funds for rare diseases treatment under the Rare Diseases Policy.

JUDGMENT

Prathiba M. Singh, J. (Oral)--This hearing has been done through hybrid mode.

2. The present batch of petitions has been filed by the Petitioners who are mostly children suffering from Rare Diseases. The case of the Petitioners is that medicines and therapies for the said diseases are exorbitantly expensive. 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.

Indigenous Development of Treatment, Therapies & Medicines for Rare Diseases

3. On the last date of hearing, the Court had directed Ms. Alka Sharma, Managing Director, BIRAC and Mr. Rajesh Gokhale, or any senior official from the Department of Biotechnology (DBT) nominated by Mr. Gokhale, to hold a meeting with the representatives of Hanugen to explore the framework under which funding for clinical study for therapeutic evaluation of indigenous treatment in respect of DMD patients can be done. The relevant portion of the said order reads as under:

"13. Let the present order along with order dated 22nd December, 2022 be placed before Ms. Alka Sharma, Managing Director, BIRAC and Mr. Rajesh Gokhale, Secretary, Department of Biotechnology (DBT). Ms. Alka Sharma and Mr. Rajesh Gokhale, or any senior official from DBT nominated by Mr. Gokhale, are requested to hold a meeting with the representatives of Hanugen in order to explore the framework in which funding for clinical trial for DMD can be done, in the larger interest. Previous orders passed by this Court would show that the budgets which were kept aside for rare diseases have not even been completely utilised. Relevant portion of the order dated 23rd March, 2021 reads as under:

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14. The Government thus has an obligation to invest in this research to enable development of indigenous therapies.

15. The officials ought to bear in mind that there are 28 writ petitions which have been filed before the Court seeking funding for medicines and therapies. As per the Rare Diseases policy of the Government itself, a sum of Rs.50 lacs per patient has to be set aside for providing medicines per patient. This would involve a substantial amount of money being spent.

16. In this background, let the meeting for negotiating an agreement for the development of indigenous therapies for DMD and vesting the intellectual property and other rights with the Government be held on 2nd February, 2023 at 5:00 pm.

17. The representatives of DART/Hanugen, who are present in Court, shall also attend the said meeting.

18. In order to enable effective discussions, Ms. Shyel Trehan, ld. Counsel and Mr. Kirtiman Singh, ld. CGSC shall also join the said meeting.

19. Mr. Amit Kumar from BIRAC, who is present in Court today shall brief the concerned officials about the events that have transpired in these proceedings in order to ensure that effective deliberations can take place."

4. Today, minutes of the meeting held on 2nd February, 2023 have been handed over to the Court. Unfortunately, the minutes of the meeting show that there has been no progress whatsoever in respect of the directions issued by the Court. A perusal of the minutes shows that BIRAC is bound by the Biotechnology Industry Partnership Programme (BIPP) under which the Grant-in-aid Letter Agreement was entered into with Hanugen Therapeutics Pvt. Ltd. The stand taken by BIRAC is that it is mandatory for Hanugen to contribute 50% of the total project cost.

5. In view of this position, the Court is of the opinion that the matter would have to be now referred to the Secretary, Ministry of Health and Family Welfare (MH&FW) to take a decision in respect of clinical trials that are to be conducted for testing the therapies for rare diseases including DMD.

6. Let the orders passed by this Court dated 18th October, 2022, 29th November, 2022, and 9th December, 2022 be communicated by Mr. Kirtiman Singh, ld. CGSC to the Secretary, MH&FW who shall file the stand of the Ministry