Mr. Asit Ahmed Advocate v. Union of India & Anr

VERSUS

UNION OF INDIA & ANR...... Respondents Through: Mr. Tanveer Oberoi, Advocate for respondent (AIIMS) (30) WITH + W.P. (C) 3707/2021 & CM APPL. 11230/2021 AARAV GARG, 5 YEARS OLD, THROUGH HIS NEXT FRIEND AND NATURAL W.P.(C) 5315/2020 & connected matters FATHER SH. VIVEK..... Petitioner Through: Mr. Ashok Agarwal, Mr. Kumar Utkarsh & Mr. Manoj Kumar

VERSUS

UNION OF INDIA & ANR...... Respondents Through: Mr. Tanveer Oberoi, Advocate for respondent (AIIMS) Mr. Siddharth Khatana R1/UOI (M- 9811132326) (31) WITH + W.P.(C) 3729/2021 & CM APPL. 11269/2021 MANISH, 8 YEARS OLD, THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

PHOOL CHAND JAT & ANR...... Petitioners Through: Mr. Ashok Agarwal, Mr. Kumar Utkarsh & Mr. Manoj Kumar Ms. Shyel Trehan, Amicus Curiae with Mr. Rohan Poddar, Adv.

VERSUS

UNION OF INDIA & ANR...... Respondents Through: Mr. Tanveer Oberoi, Advocate for respondent (AIIMS) (32) WITH + W.P.(C) 3737/2021 & CM APPL. 11277/2021 SHOURYA MARU, 7 YEARS OLD, FATHER SH.

KAMAL KUMAR MARU..... Petitioner Through: Mr. Ashok Agarwal, Mr. Kumar Utkarsh & Mr. Manoj Kumar Ms. Shyel Trehan, Amicus Curiae with Mr. Rohan Poddar, Adv.

VERSUS

UNION OF INDIA & ANR...... Respondents Through: Mr. Ranvir Singh (CGSC) for R-1. Mr. Tanveer Oberoi, Advocate for 2022/DHC/005846 W.P.(C) 5315/2020 & connected matters respondent (AIIMS). (33) WITH + W.P.(C) 3859/2021 & CM APPL. 11647/2021 SIDDHARTH SWARNKAR, 9 YEARS OLD, FATHER SH.

VERSUS

UNION OF INDIA & ANR...... Respondents Through: Mr. Anuj Aggarwal, ASC, GNCTD with Ms. Ayushi Bansal, Mr. Sanyam Suri and Ms. Arshya Singh Advocates for R-1 to 5 (M:9891363718). (34) WITH + W.P.(C) 4045/2021 & CM APPL. 12213/2021 UTKARSH INDRAJIT PAWAR, 10 YEARS OLD, THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

INDRAJIT DAMAR PAWAR..... Petitioner Through: Ms. Shyel Trehan, Amicus Curiae with Mr. Rohan Poddar, Adv. Mr. Ashok Agarwal, Mr. Kumar Utkarsh & Mr. Manoj Kumar versus UNION OF INDIA & ANR...... Respondents Through: Mr. Sanjeev Sabharwal, Sr. Panel Counsel with Ms. Shweta, Advocate for UOI. Mr. Harish Kumar Garg, Advocate for UOI (M:9810150029). (35) WITH + W.P.(C) 4067/2021 & CM APPL. 12306/2021 ANSHU, 10 YEARS OLD, THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

VERSUS

UNION OF INDIA & ANR...... Respondents Through: Mr. Tanveer Oberoi, Advocate for respondent (AIIMS). Mr. Sanjeev Sabharwal, SPC, (UOI) Advocate (M-9810031680) (36) WITH + W.P.(C) 4259/2021 & CM APPL. 12948/2021 ISHAAN, 10 YEARS OLD, THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

RAJVIR SINGH..... Petitioner Through: Mr. Ashok Agarwal, Mr. Kumar Utkarsh and Mr. Manoj Kumar, Advocates (M:9662778086).

VERSUS

UNION OF INDIA & ANR...... Respondent Through: Mr. Tanveer Oberoi, Advocate for respondent (AIIMS). (37) WITH + W.P.(C) 4304/2021 & CM APPL. 13108/2021 TANAV HANDOO, 6 YEARS OLD, THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH. AMIT HANDOO..... Petitioner Through: Mr. Ashok Agarwal, Mr. Kumar Utkarsh and Mr. Manoj Kumar, Ms. Shyel Trehan, Amicus Curiae with Mr. Rohan Poddar. W.P.(C) 5315/2020 & connected matters versus UNION OF INDIA & ANR...... Respondents Through: Mr. Satya Ranjan (Sr. Panal Counsel) with Mr. Kautilya Birat, Advocates for UOI. (38) WITH + W.P.(C) 4551/2021 & CM APPL. 13949/2021 SHAURYA DAHIYA, 7 YEARS OLD, THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

VERSUS

UNION OF INDIA & ANR...... Respondents Through: Mr. Avnish Singh, (SCGC) and Mr. Aditya Vikram Dembela, Advocates Mr. Tanveer Oberoi, Advocate for respondent (AIIMS). (39) WITH + W.P.(C) 4812/2021 & CM APPL. 14844/2021 NIKHIL YOGENDERSINGH CHOUDARY, 17 YEARS OLD, THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

VERSUS

UNION OF INDIA & ANR...... Respondents Through: Mr. Ranvir Singh (CGSC) for R-1. W.P.(C) 5315/2020 & connected matters (40) WITH + W.P.(C) 5394/2021 & CM APPL. 16683/2021 UDAYVEER SINGH GULERIA, 7 YEARS OLD, THROUGH HIS NEXT FRIEND AND NATURAL FATHER SH.

VERSUS

UNION OF INDIA & ANR...... Respondents Through: Mr. Tanveer Oberoi, Advocate for respondent (AIIMS). (41) WITH + W.P.(C) 5395/2021 & CM APPL. 16686/2021 MASTER AYUSHMAN CHATURVEDI..... Petitioner Through: Mr. Anurag Ojha, Mr. Gautam Barnwal & Mr. Kumar Abhishek, Advocates (M-8969011590) Mr. Ashok Agarwal, Mr. Kumar Utkarsh and Mr. Manoj Kumar, Advocates (M:9662778086).

VERSUS

UNION OF INDIA & ORS...... Respondents Through: Mr. Niraj Kumar, Sr. Central Govt. Counsel for UOI. Mr. Jawahar Raja, ASC (C), GNCTD for respondent no.2. Mr. G.D. Sharma, Advocate for Respondent no.4. (42) WITH + W.P.(C) 9684/2021 AADHYAN JAISWAL 11 YEARS OLD THROUGH HIS NEXT W.P.(C) 5315/2020 & connected matters FRIEND AND NATURAL FATHER SH ANIL KUMAR JAISWAL..... Petitioner Through: Mr. Ashok Agarwal, Mr. Kumar

VERSUS

UNION OF INDIA & ORS...... Respondents Through: Mr. Divyam Nandrajog, Panel Counsel, GNCTD, Mr. Mohd. Shahid Khan, Mr. Bhrigu Pamidi Ghantam, Advocate. (43) WITH + W.P.(C) 14317/2021 & CM APPL. 45148/2021 SHREYANSH AARAV, 11 YEARS OLD, THROUGH HIS NEXT FRIEND AND NATURAL MOTHER SMT.

VERSUS

UNION OF INDIA & ANR...... Respondents Through: Mr. Ripu Daman Bhardwaj (CGSC) for UOI. Mr. Lakshay Kumar Goyal v/s VOI & ORS Ms. Bharathi Raju SPO with Mr. Yogesh Panwar Advocates (M- 9868895906) (44) WITH + W.P.(C) 1182/2022 & CM APPL. 3442/2022 INSHA MINOR THROUGH HER NEXT FRIEND AND W.P.(C) 5315/2020 & connected matters NATURAL FATHER SH IRSHAD AHMAD SOFI..... Petitioner Through: Mr. Ashok Agarwal, Mr. Kumar Utkarsh and Mr. Manoj Kumar,

VERSUS

UNION OF INDIA & ORS...... Respondent Through: Mr. Sanjeev Uniyal, Mr. Dhawal Uniyal and Mr. Sachin Chandela, Advocates for R-1. Mr. Kirtiman Singh, CGSC, Mr. Waize Ali Noor, Ms. Vidhi Jain, Ms. Kunjala Bhardwaj, Mr. Madhav Bajaj Ms. Durge Shandini CORAM: JUSTICE PRATHIBA M. SINGH Prathiba M. Singh, J. (Oral)

1. This hearing has been done through hybrid mode.

2. The present batch of petitions have been filed by the Petitioners who are mostly children suffering from Rare Diseases. The case of the Petitioners is that the medicines and therapies for the said Rare Diseases are exorbitantly expensive, and directions ought to be issued to the Respondents i.e., the Union of India and its Ministry of Health and Family Welfare, All India Institute of Medical Science (hereinafter, “AIIMS”), as well as, the GNCTD, to provide continuous and uninterrupted treatment to the Petitioners, free of cost.

3. These matters have been heard by the Court from time to time and various directions have been issued for enabling treatment and for making W.P.(C) 5315/2020 & connected matters available medicines for the Petitioners.

4. Vide previous order dated 9th December, 2022, this Court had recorded the developments that have taken place to date in the matter. Ld. CGSC was also directed to obtain further instructions on the various aspects captured in the order dated 9th December, 2022.

5. Today, Mr. Kirtiman Singh, ld. CGSC has obtained instructions on the said aspects. A short note dated 22nd December, 2022 has also been handed over by the ld. CGSC covering the various aspects of the matter which are being continuously monitored by the Court. This Court has heard the ld. Counsels and perused the said short note. Let the same be brought on record. Digital Crowdfunding Platform

6. Vide previous order dated 9th December, 2022, it was submitted that the crowdfunding platform is now operational. However, a need was felt for the said platform to be publicized in order to attract funding from the general public and corporate entities, including Public Sector Undertakings (“PSUs”). Accordingly, the following direction was issued by this Court, vide order dated 9th December, 2022:

7. As per the short note dated 22nd December, 2022, it is submitted that the crowdfunding platforms are being publicized using proper and effective channels, in the following manner: ● A virtual meeting was held on 17th June, 2021 by the Ministry of Health and Family Welfare (hereinafter, “MoH&FW”), with the representatives of various Ministries, industrial associations, PSUs, etc., to sensitize them about the rare diseases and the need for voluntary donations for the treatment of patients with rare diseases; ● This Court is informed that, at the request of representatives of the various PSUs and industries, a clarification has been sought by the MoH&FW vide DO Letter dated 3rd August, 2021 and 13th June, 2022 in respect of the inclusion of the subject “Donation for Rare Diseases” in Schedule VII of the Companies Act, 2013, in order to facilitate industries/corporates to contribute easily under the Corporate Social Responsibility (CSR) provision contained in Section 135 of the Companies Act, 2013. The Ministry of Corporate Affairs is yet to revert on this aspect.

8. This Court is of the opinion that, in order to ensure that there is a specific recognition of voluntary donations for rare diseases, the subject “Donation for Rare Diseases” ought to be included in Schedule VII of the Companies Act, 2013, as requested by the MoH&FW.

9. Insofar as sensitization of PSUs, industry associations, etc. is concerned, it is submitted that, vide DO letter dated 30th September, 2022 addressed by the MoH&FW, the Department of Public Enterprises (hereinafter, “DPE”) has been requested to create such a programme to sensitize PSUs and regarding resource mobilization for rare diseases under W.P.(C) 5315/2020 & connected matters CSR fund of the companies. It is submitted that, in response to the said DO letter dated 30th September, 2021, the DPE vide its DO letter dated 10th October, 2022, has further requested the Ministry of Corporate Affairs to process the said proposal.

10. Accordingly, let the Ministry of Corporate Affairs file an affidavit as to the status of the request dated 3rd August, 2021 and 13th June, 2022 made by the MoH&FW, as also, the request dated 10th October, 2022 made by the DPE, by the next date of hearing.

11. Let the Department of Public Enterprises also file an affidavit as to the request dated 30th September, 2022 made by the MoH&FW, by the next date of hearing.

12. Ld. CGSC to communicate the present order to the Ministry of Corporate Affairs and the Department of Public Enterprises, to facilitate compliance.

13. In view of the submissions made today, it is clear to this Court that the efforts in respect of the digital crowdfunding platform have not yielded much result so far, as the issue of rare diseases does not appear to have gained enough importance in the society in general. Thus, MoH&FW shall consider publicizing the crowdfunding platform by alternative means, including through television and radio platforms, as also, social media platforms, in order to attract voluntary donations for the purpose of rare diseases. Any other steps which the Ministry deems fit, may also be taken. Financial Assistance to Patients with Rare Diseases

14. It is submitted that the guidelines and procedure for providing financial assistance to patients suffering from rare diseases have also issued on 11th August, 2022 and communicated to all the Centres of Excellence W.P.(C) 5315/2020 & connected matters (hereinafter, “CoEs”). As per the said guidelines, the COEs have the option to explore the possibility of getting financial assistance from other agencies/drug manufacturers/corporate sector under CSR by signing an MoU. The content of the said MoU may be finalized by the Committee of the COE and approved by the Director of the COE. Indigenous Development of Treatment, Therapies & Medicines for Rare Diseases

15. Vide previous order dated 9th December, 2022, this Court had recorded as under:

16. Pursuant to the previous order dated 9th December, 2022, an affidavit dated 17th December, 2022, deposed by Dr. Arun Shastry, has been filed on behalf of Hanugen. A perusal of the said affidavit shows that the total budget for the clinical trials involving 54 patients would be Rs.13.15 crores. The breakdown of costs as specified in the said affidavit has been extracted below: W.P.(C) 5315/2020 & connected matters Breakup for Clinical Trial Budget Cost per Patient S.No. Head Amount (INR)

1. Drug 20,00,000

2. CRO 2,00,000

3. Hospital 2,00,000

1. Drug 10,80,00,000

2. CRO 1,08,00,000

3. Hospital 1,08,00,000

4. Overheads 54,00,000 Total 13,50,00,000/- Subtracting the sum already released by BIRAC and also put in by Hanugen (Rs.1,41,37, 500/- each) 10,67,25,000/-

17. At this point in time, the clear position of Hanugen and DART is that they are unable to fund their portion of the amount as per the Memorandum of Understanding dated 8th January, 2021 signed between the Biotechnology Industry Research Assistance Council (BIRAC) and M/s. Hanugen Therapeutics Private Limited (hereinafter, “Hanugen”). It is submitted that if the clinical trial is conducted by administering the medicines in respect of half of the total of 54 patients, the total budgetary requirement for commencing the said trial, would be a sum of approximately Rs.5.35 crores that would be required by Hanugen. It was in this background that the Court had issued the directions relating to release of Rs.[5] crores, as extracted hereinabove.

18. Upon a query put by the Court, insofar as the direction for disbursement of Rs.[5] crores to Hanugen is concerned, it is submitted that a sum of Rs.1.41 crores has already been released by BIRAC, in favour of Hanugen. The remaining amount which is to be released by BIRAC, in terms of the said MoU, would be approximately Rs.3.[2] crores.

19. Keeping all the above factors in mind, it is directed that the clinical trials, in the manner as specified in its affidavit dated 17th December, 2022, ought to be commenced and conducted by Hanugen. Under such circumstances, considering the part funding which has already been disbursed, as also, the lack of funds with Hanugen at this point in time, it is deemed appropriate to direct that an amount to the tune of Rs.5.35 crores shall be released by BIRAC in favour of Hanugen, subject to the intellectual property rights in the data, therapies, products/processes, vesting with the Government/BIRAC.

20. On the issue of intellectual property rights in the therapy/drug W.P.(C) 5315/2020 & connected matters proposed to be developed, it is noticed that in the MoU dated 8th January, 2021, the „Intellectual Property Governing Framework‟ for the said project is defined as under: “ INTELLECTUAL PROPERTY GOVERNING FRAMEWORK

1. SCOPE OF IP GENERATED DURING THE CONDUCT OF THE PROJECT a) The New Intellectual Property (IP) rights belong to company Provided this Project is not determined as a “Nationally Important Project” to be governed through specific „Order of BIRAC‟. Such cases of “Nationally Important Project” shall have specific terms of licensing, pricing or March-in-rights for the purpose of public interest demand of Government of India. b) It is the responsibility of the Fund Recipients to protect the New Intellectual Property (IP). They shall bear the expenditure involved in protecting the New IP”

21. This Court is of the opinion that the said MoU dated 8th January, 2021 was executed at a point in time when the magnitude of the issue concerning rare diseases was yet to be fully taken cognisance of by this Court. The Court has been monitoring and supervising the treatment of children suffering from rare diseases, with involvement of the Department of Biotechnology, MoH&FW, AIIMS etc. The enormity of the issues faced by the children with rare diseases leaves no doubt in the mind of the Court that the development of treatment for children with rare diseases ought to be considered as a “Nationally Important Project”. Ordered accordingly.

22. Upon a query from the Court, Dr. Shastry who is duly authorized on behalf of M/s. Hanugen Therapeutics Private Limited/DART, submits that W.P.(C) 5315/2020 & connected matters M/s. Hanugen Therapeutics Private Limited would have no objection, if the entire intellectual property, both in the data as also in any therapeutics/treatment that may be developed in the course of this project, would vest with the Government of India, subject to the terms being negotiated with BIRAC.

23. In view of the above statement of Dr. Shastry, as also, the fact that the project is now being declared as a “Nationally Important Project”, a fresh agreement shall now be entered into between BIRAC and M/s Hanugen Therapeutics Private Limited, laying down the framework of intellectual property rights which shall vest in the parties to the said agreement, in line with the above observations.

24. For the said purpose, the first meeting between the BIRAC and M/s Hanugen Therapeutics Private Limited for finalizing the said agreement shall be held on 12th January, 2023. Ms. Trehan, ld. Amicus Curiae may also assist the parties in finalizing the said agreement, if required. Mr. Amit Kumar, Legal Officer of BIRAC, who is present in Court today, shall also remain present in the said meeting. Let the draft agreement in this regard be placed before this Court, on the next date of hearing. Commencement of Treatment

25. On the last date of hearing, this Court was apprised that, despite repeated orders, the patients of Duchenne Muscular Dystrophy (“DMD”) have yet not started receiving treatment. In this regard, the order dated 9th December, 2022 records as under:

26. Mr. Oberoi, ld. Counsel for AIIMS submits that the affidavit pursuant to the order dated 9th December, 2022 has been filed by AIIMS, however, the same is not on record. Let the same be brought on record.

27. Mr. Oberoi, ld. Counsel further submits that the medicines for DMD which are being imported, are likely to be received in India by 10th February, 2022 from the United States and AIIMS is taking all the required steps for expediting the receipt of the medicines, so that treatment of the patients can be commenced.

28. In W.P.(C) 1491/2021 and W.P.(C) 1511/2021, ld. Counsel for the Petitioners submits that AIIMS has not complied with the statement made on its behalf, vide order dated 23rd February, 2022, to the effect that the requisition for the medicines for MPS II (Hunter‟s Syndrome) shall be received by 25th February, 2022, and the treatment of the Petitioners would start thereafter. However, he submits that the said medicines have not been received to date.

29. Let ld. Counsel for AIIMS do the needful to ensure that the said timelines placed before this Court, are strictly adhered to. W.P.(C) 5315/2020 & connected matters Rare Diseases Fund

30. Vide previous order dated 9th December, 2022, this Court was informed that the „Rare Diseases Fund‟ is currently being managed by the MoH&FW. Accordingly, it was directed as follows:

31. Today, ld. CGSC submits that the said status report is yet to be filed, and seeks further time to do so. Let the status report be now filed positively by the next date of hearing.

32. List these matters on 30th January, 2023.

33. These are part-heard matters.

PRATHIBA M. SINGH JUDGE DECEMBER 22, 2022 Rahul/AD