The court mandated that the government ensure timely treatment and funding for patients suffering from rare diseases, establishing a comprehensive framework to facilitate compliance with health policies.

JUDGMENT

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 available medicines for the Petitioners.

4. Vide previous order dated 29th November, 2022, the Department of Biotechnology (hereinafter, "DBT") and Dystrophy Annihilation Research Trust (hereinafter, "DART"), were impleaded as Respondent Nos. 3 and 4 respectively in W.P.(C) 5315/2020. Affidavit dated 28th November, 2022 on behalf of the Ministry of Health and Family Welfare, Union of India was also directed to be placed on record, along with the agreement between the DBT and DART in respect of the funding of clinical studies.

5. Today, submissions have been made in part in these matters, in respect of the following directions issued by this Court, vide order dated 23rd March, 2021:

"21. In view of the above, the following directions are issued by this Court:

i) The `National Policy for Rare Diseases' shall be finalized and notified by the Government of India, on or before 31st March, 2021.

ii) As a part of the said policy, the `National Consortium for Research and Development on therapeutics for Rare Diseases' shall also be set up.

iii) A Rare Diseases Committee shall be set up at AIIMS consisting of Prof. (Dr.) Madhulika Kabra and Prof. (Dr.) P. Ramesh Menon, who shall examine the applications for treatment and funding, received from any patient suffering from Rare Diseases. The said Committee can, depending upon the condition of the patient, also co-opt any one member from any specialized field into the said Committee. The Committee would, upon examination, recommend the kind of treatment which would be made available to the patients. Upon the approval of the Committee, the expenses for the treatment involved shall be drawn from the Rare Diseases Fund after approval by the Director, AIIMS.

iv) The entire unspent budget allocated for Rare Diseases, for the years 2018-19, 2019-20 and 2020-21, as per the amounts extracted above, shall be immediately moved into a fund called the `Rare Diseases Fund', which shall be managed and utilized by AIIMS, which shall serve as a nodal agency for this fund. A separate bank account for the Rare Diseases Fund shall be opened by the Director, AIIMS for this purpose.

v) The digital platform that is created in the Policy, for the purposes of receiving crowdfunding and other kinds of funding, shall be linked to the Rare Diseases Fund. All individuals, organizations, companies etc., who wish to contribute to the said fund, shall make direct contributions. The Rare Diseases Fund shall be under the direct control and supervision of the Director, AIIMS. Periodic reports may be called for, by the Ministry of Health and Family Welfare, UOI, from AIIMS, in respect of the contributions that are received, as well as qua the utilization of the said fund.

vi) The other Institutes which shall be notified under the policy, as centres for excellence, for Rare Diseases shall also be entitled to receive applications from patients who need tr