Delhi HC forms panel to monitor crowdfunding for rare disease treatment

The bench stated, “Given the exorbitant cost involved in affording adequate treatment to those afflicted with rare disease and the resource constrains in allocating budgetary outlays for the same, it is imperative that all efforts be made to ensure that the innovative measure undertaken by the Government of India by setting up of voluntary Crowd Funding Platform, receives the success and results that it deserves.”

The petitioner had approached the court seeking financial assistance for importing an expensive injection required for her child’s treatment. Considering the high cost involved and the growing need for structured funding mechanisms for rare disease therapies, the court directed the formation of the committee to oversee and encourage transparent and effective crowdfunding efforts.

According to the petitioner, an infant diagnosed with Spinal Muscular Atrophy (SMA) Type 1 on 25.07.2024, a rare and life-threatening genetically inherited degenerative neuro-muscular disease, which progressively weakens the muscles used for movement, swallowing and breathing. The potential life-saving treatment for the said disease is one-time intravenous infusion (injection) of Zolgensma, a gene therapy developed by a Swiss pharmaceutical company known as Novartis, specifically for children below the age of two with SMA. The said therapy is neither presently approved nor manufactured in India, but can be imported from the USA with a doctor’s recommendation and government’s approval.

Unfortunately, despite the petitioner having a recommendation letter dated 30.07.2024 from the Chairperson and Senior Consultant of Sir Ganga Ram Hospital, New Delhi and a letter dated 17.08.2024 from AIIMS, recommending for import and administration of Zolgensma, owning to the exorbitant cost of procurement (amongst the most expensive ones in the world, with a single dose costing approximately Rs.17.50 crores), parents of the petitioner are unable to import the said drug for treatment.

In July 2017, the Ministry of Health and Family Welfare formulated a National Policy for Treatment of Rare Diseases (NPTRD, 2017). However, the implementation of this policy faced certain challenges and was consequently kept in abeyance. Subsequently, an expert committee was constituted in November 2018 to review the NPTRD 2017. Based on the report of the Expert Committee and with the approval of the competent authority, a draft National Policy for Rare Diseases was finalised and placed in the public domain on 13.01.2020 to invite comments/views from the stakeholders, general public, organisations and States/Union Territories.

Eventually, the National Policy for Rare Diseases, 2021 (hereinafter “NPRD 2021”) came to be formulated, providing government coverage of ₹50 lakh. Observing that the crowdfunding platform under this policy has, until now, gathered only a small sum, the court expressed its intention to strengthen measures for facilitating the treatment of rare diseases. The petitioner has put forth certain suggestions for the purpose of setting up of a committee to exercise an oversight of the Crowd Funding Platform already set up by the Ministry of Health and Family Welfare, Government of India and to ensure that maximum efforts are made to ensure that requisite amount of funds are funnelled into the Crowd Funding platform, including by way of CSR contributions.

“While this Court is not inclined to accept the suggestions made by the learned counsel for the petitioner in toto, this Court is in an agreement that it would be salutary if a committee is set up comprising of senior officials from the Ministry of Health and Family Welfare and the Ministry of Corporate Affairs, Government of India along with expert/s in the field of rare diseases for the effective implementation,” the bench stated.

The Committee shall comprise of the following members: a) Dr. Rajiv Bahl, Secretary, Department of Health Research, Ministry of Health and Family Welfare, Government of India and Director General, Indian Council of Medical Research as Chairperson of the Committee; b) Dr. V.K. Paul, Member (Health), Niti Aayog, Government of India; c) An officer at the level of Joint Secretary, MoCA, Government of India [who is in charge of overseeing implementation of the Companies (Corporate Social Responsibility Policy) Rules, 2014], to be nominated by the Secretary, MoCA; and d) An officer at the level of Joint Secretary in the Department of Public Enterprises, Ministry of Finance, Government of India, to be nominated by the Secretary of the Department.

The tasks of the committee should be as follows:

1. The Committee shall take adequate steps to spread awareness as regards the existence and objective of aforesaid platform, with the aim to encourage potential donors to make contribution. 

2. The committee shall make an endeavour to reach out to Public Sector Undertakings (PSUs) to sensitise them and encourage them to make a voluntary contribution to ensure that CSR funds are funnelled to the Crowd Funding Platform.

3. It shall also take steps to ensure that necessary action is taken in furtherance of and for effectuating the NPRD 2021, and to ensure that the outcomes contemplated thereunder are achieved to the maximum extent.

4. The Committee shall meet at least once a month in the office of the Chairperson or as may be decided by the Committee.

To view the official order, click on the link below: